Part I
Definitions and General Information

12VAC5-230-10. Definitions.

The following words and terms when used in Chapters 230 (12VAC5-230) through 360 (12VAC5-360) this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acceptability" means to the level of satisfaction expressed by consumers with the availability, accessibility, cost, quality, continuity and degree of courtesy and consideration afforded them by the health care system.

"Accessibility" means the ability of a population or segment of the population to obtain appropriate, available services. This ability is determined by economic, temporal, locational, architectural, cultural, psychological, organizational and informational factors which may be barriers or facilitators to obtaining services.

"Acute psychiatric services" means hospital-based inpatient psychiatric services provided in distinct inpatient units in general hospitals or freestanding psychiatric hospitals.

"Acute substance abuse disorder treatment services" means short-term hospital-based inpatient treatment services with access to the resources of (i) a general hospital, (ii) a psychiatric unit in a general hospital, (iii) an acute care addiction treatment unit in a general hospital licensed by the Department of Health, or (iv) a chemical dependency specialty hospital with acute care medical and nursing staff and life support equipment licensed by the Department of Mental Health, Mental Retardation and Substance Abuse Services.

"Applicant" means any individual, corporation, partnership, association, trust, or other legal entity, whether governmental or private, submitting an application for a Certificate of Public Need.

"Availability" means the quantity and types of health services that can be produced in a certain area, given the supply of resources to produce those services.

"Bassinet" means an infant care station, including warming stations and isolettes [ , whether located in a hospital nursery or labor and delivery unit ].

"Bed" means that unit, within the complement of a medical are facility, subject to COPN review as required by § 32.1-102.1 of the Code of Virginia and designated for use by patients of the facility or service. For the purposes of this chapter, bed [ includes does include ] cribs and bassinets used for pediatric patients [ outside the, but does not include cribs and bassinets in the newborn ] nursery or [ labor and delivery neonatal special care ] setting.

"Cardiac catheterization" means a procedure where a flexible tube is inserted into the patient through an extremity blood vessel and advanced under fluoroscopic guidance into the heart chambers to perform (i) a hemodynamic, electrophysiologic or angiographic examination of the left or right heart chamber or the coronary arteries; (ii) aortic root injections to examine the degree of aortic root regurgitation or deformity of the aortic valve; or (iii) angiographic procedures to evaluate the coronary arteries. Therapeutic intervention in a coronary artery may also be performed using cardiac catheterization. Cardiac catheterization may include therapeutic intervention, but does not include a simple right heart catheterization for monitoring purposes as might be performed in an electrophysiology laboratory, pulmonary angiography as an isolated procedure, or cardiac pacing through a right electrode catheter.

"Certificate of Public Need" or "COPN" means the orderly administrative process used to make medical care facilities and services needs decisions.

"Charges" means all expenses incurred by the provider in the production and delivery of health services.

"Commissioner" means the State Health Commissioner.

"Competing applications" means applications for the same or similar services and facilities that are proposed for the same [ health ] planning district, or same [ health ] planning region for projects reviewed on a regional basis, and are in the same batch review cycle.

"Computed tomography" or "CT" means a noninvasive diagnostic technology that uses computer analysis of a series of cross-sectional scans made along a single axis of a bodily structure or tissue to construct a three-dimensional an image of that structure.

"Condition" means the agreed upon qualifications placed on a project by the commissioner when granting a Certificate of Public Need. Such conditions shall direct an applicant to provide a level of care to indigents, accept patients requiring specialized needs, or facilitate the development and operation of primary care services in designated medically underserved areas of the applicant's service area.

"Continuing care retirement community" or "CCRC" means a retirement community consistent with the requirements of Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia. [ CCRCs can have nursing home services available on site or at licensed facilities off site. ]

"COPN" means [ the a ] Medical Care Facilities Certificate of Public Need [ Program as contained for a project as required ] in Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia [ , used to make medical care facilities and services needs decisions ].

[ "COPN program" means the Medical Care Facilities Certificate of Public Need Program implementing Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia. ]

"Continuity of care" means the extent of effective coordination of services provided to individuals and the community over time, within and among health care settings.

"Cost" means all expenses incurred in the production and delivery of health services.

"Department" means the Virginia Department of Health.

"DEP" means diagnostic equivalent procedure, a method for weighing the relative value of various cardiac catheterization procedures as follows: a diagnostic procedure equals 1 DEP, a therapeutic procedure equals 2 DEPs, a same session procedure (diagnostic and therapeutic) equals 3 DEPs, and a pediatric procedure equals 2 DEPs.

"Direction" means guidance, supervision or management of a function or activity.

"General inpatient hospital beds" means beds located in the following units or categories:

1. Medical/surgical units available for the care and treatment of adults not requiring specialized services; and

2. Pediatric units that are maintained and operated as a distinct unit for use by patients younger than 21. Newborn cribs and bassinets are excluded from this definition.

[ "Gamma knife®" means the name of a specific instrument used in stereotactic radiosurgery.

"Health planning district" means the same contiguous areas designated as planning districts by the Virginia Department of Housing and Community Development or its successor. ]

"Health planning region" means a contiguous geographic area of the Commonwealth as designated by the department Board of Health with a population base of at least 500,000 persons, characterized by the availability of multiple levels of medical care services, reasonable travel time for tertiary care, and congruence with planning districts.

"Health system" means an organization of two or more medical care facilities, including but not limited to hospitals, that are under common ownership or control and are located within the same [ health ] planning district, or [ health ] planning region for projects reviewed on a regional basis.

"Hospital" means a medical care facility licensed as a general, community, or special hospital licensed an inpatient hospital or outpatient surgical center by the Department of Health or as a psychiatric hospital licensed by the Department of Mental Health, Mental Retardation, and Substance Abuse Services.

"Hospital-based" means a service operating physically within, connected to a hospital, or on the hospital campus, and legally associated with a hospital.

"ICF/MR" means an intermediate care facility for the mentally retarded.

"Indigent or uninsured" means persons eligible to receive reduced rate or uncompensated care at or below Income Level E as defined in 12VAC5-200-10 of the Virginia Administrative Code any person whose gross family income is equal to or less than 200% of the federal Nonfarm Poverty Level or income levels A through E of 12VAC5-200-10 and who is uninsured.

"Inpatient beds" means accommodations in a medical care facility with [ continuous support services, such as food, laundry, housekeeping, and staff to provide health or health-related services to patients who generally remain in the a medical care facility in excess of 24 hours or longer a patient who is hospitalized longer than 24 hours for health or health related services ]. Such accommodations are known by various nomenclatures including but not limited to: nursing facility, intensive care, minimal or self care, isolation, hospice, observation beds equipped and staffed for overnight use, obstetric, medical/surgical, psychiatric, substance abuse disorder, medical rehabilitation, and pediatric. Bassinets and incubators and beds in labor and birthing rooms, emergency rooms, preparation or anesthesia induction rooms, diagnostic or treatment procedure rooms, or on-call staff rooms are excluded from this definition.

"Intensive care beds" or "ICU" means acute care inpatient beds located in the following units or categories:

1. General intensive care units are those units where patients are concentrated by reason of serious illness or injury regardless of diagnosis. Special lifesaving techniques and equipment are immediately available and patients are under continuous observation by nursing staff;

2. Cardiac care units, also known as Coronary Care Units or CCUs, are units staffed and equipped solely for the intensive care of cardiac patients; and

3. Specialized intensive care units are any units with specialized staff and equipment for the purpose of providing care to seriously ill or injured patients for based on age selected categories of diagnoses, including units established for burn care, trauma care, neurological care, pediatric care, and cardiac surgery recovery . This category of beds, but does not include bassinets in neonatal [ intensive special ] care units.

"Intermediate care substance abuse disorder treatment services" means long-term hospital-based inpatient treatment services that provide structured programs of assessment, counseling, vocational rehabilitation, and social rehabilitation.

"Lithotripsy" means a noninvasive therapeutic procedure of crushing kidney, to (i) crush renal and biliary stones using shock waves. Lithotripsy can also be used to fragment matter such as calcifications or bone, i.e., renal lithotripsy or (ii) [ to ] treat certain musculoskeletal conditions and to relieve the pain associated with tendonitis [ , ] i.e., orthopedic lithotripsy.

"Long-term acute care hospital" or "LTACH" means an inpatient hospital that provides care for patients who require a length of stay greater than 25 days and is, or proposes to be, certified by the Centers for Medicare and Medicaid Services as a long-term care inpatient hospital pursuant to 42 CFR Part 412. [ For the purpose of granting a COPN, the Board of Health pursuant to § 32.1-102.2 A 6 of the Code of Virginia has designated LTACH as a type of extended care facility. ] An LTACH may be either a free standing facility or located within an existing or host hospital.

"Magnetic resonance imaging" or "MRI" means a noninvasive diagnostic technology using a nuclear spectrometer to produce electronic images of specific atoms and molecular structures in solids, especially human cells, tissues and organs.

[ "Medical rehabilitation" means those services provided consistent with 42 CFR 412.23 and 412.24. ]

"Medical/surgical" [ or "med/surge" ] means those services available for the care and treatment of patients not requiring specialized services.

"Minimum survival rates" means the [ lowest base ] percentage of [ those receiving organ transplants transplant recipients ] who survive at least one year or for such other period of time as specified by the United Network for Organ Sharing [ (UNOS) ].

"MRI relevant patients" means the sum of: 0.55 times the number of patients with a principal diagnosis involving neoplasms (ICD-9-CM codes 140-239); 0.70 times the number of patients with a principal diagnosis involving diseases of the central nervous system (ICD-9-CM codes 320-349); 0.40 times the number of patients with a principal diagnosis involving cerebrovascular disease (ICD-9-CM codes 430-438); 0.40 times the number of patients with a principal diagnosis involving chronic renal failure (ICD-9-CM code 585); 0.19 times the number of patients with a principal diagnosis involving dorsopathies (ICD-9-CM codes 720-724); 0.40 times the number of patients with a principal diagnosis involving diseases of the prostate (ICD-9-CM codes 600-602); and 0.40 times the number of patients with a principal diagnosis involving inflammatory disease of the ovary, fallopian tube, pelvic cellular tissue or peritoneum (ICD-9-CM code 614). The applicant shall have discharged all patients in these categories during the most recent 12-month reporting period.

"Neonatal special care" means care for infants in one or more of the three higher service levels designated in 12VAC5-410-440 D 2 12VAC5-410-443 of the Rules and Regulations for the Licensure of Hospitals [ , i.e., a hospital elevates its services from general level normal newborn to intermediate level newborn services, specialty level newborn services, or subspecialty level newborn services ].

"Network" means a group of medical care facilities, including hospitals, or health care systems, legally or operationally associated with one or more hospitals in a planning region.

"Nursing facility" means those facilities or components thereof licensed to provide long-term nursing care.

"Nursing facility beds" means inpatient beds that are located in distinct units of general hospitals that are licensed as long-term care units by the department. Beds in these long-term units are not included in the calculations of inpatient bed need.

"Obstetrical services" means the distinct organized program, equipment and care related to pregnancy and the delivery of newborns in inpatient facilities.

"Off-site replacement" means the relocation of existing beds or services from an existing medical care facility site to another location within the same [ health ] planning district.

"Open heart surgery" means a set of surgical procedures using a heart-lung bypass machine or pump to perform extracorporeal circulation and oxygenation during surgery. This technique is used when the heart must be slowed down to correct congenital and acquired cardiac and coronary artery disease. a surgical procedure requiring the use or immediate availability of a heart-lung bypass machine or "pump." The use of the pump during the procedure distinguishes "open heart" from "closed heart" surgery.

"Operating room" means a room, meeting the requirements of 12VAC5-410-820, in a licensed general or outpatient surgical hospital used solely or principally for the provision of surgical procedures [ , ] excluding endoscopic and cystscopic procedures [ especially those ] involving the administration of anesthesia, multiple personnel, recovery room access, and a fully controlled environment. [ This does not include rooms designated as procedure rooms or rooms dedicated exclusively for the performance of cesarean sections. ]

"Operating room use" means the amount of time a patient occupies an operating room, plus the estimated or actual and includes room preparation and cleanup time.

"Operating room visit" means one session in one operating room in a licensed general an inpatient hospital or outpatient surgical hospital center, which may involve several procedures. Operating room visit may be used interchangeably with "operation" or "case."

[ "Outpatient surgery" "Outpatient" ] means services [ those surgical procedures provided to individuals who are not expected to require overnight hospitalization but who require treatment in a medical care facility exceeding the normal capability found in a physician's office a patient who visits a hospital, clinic, or associated medical care facility for diagnosis or treatment, but is not hospitalized 24 hours or longer ]. [ For the purposes of this chapter, outpatient services surgery refers only to surgical services provided in operating rooms in licensed general inpatient hospitals or licensed outpatient surgical hospitals centers, and does not include surgical services provided in outpatient departments, emergency rooms, or treatment procedure rooms of hospitals, or physicians' offices. ]

"Pediatric" means patients [ younger than ] 18 years of age [ and younger ]. Newborns in nurseries are excluded from this definition.

[ "Pediatric cardiac catheterization" means the cardiac catheterization of patients ] less than 21 years of age [ 18 years of age and younger. ]

"Perinatal services" means those resources and capabilities that all hospitals offering general level newborn services as described in 12VAC5-410-440 D 2 a (1) 12VAC5-410-443 of the Rules and Regulations for the Licensure of Hospitals must provide routinely to newborns.

"PET/CT scanner" means a single machine capable of producing a PET image with a concurrently produced CT image overlay to provide anatomic definition to the PET image. For the purpose of [ grating granting ] a COPN, the Board of Health pursuant to § 32.1-102.2 A 6 of the Code of Virginia has designated PET/CT as a specialty clinical services. A PET/CT scanner shall be reviewed under the PET criteria as an enhanced PET scanner unless the CT unit will be used independently. In such cases, a PET/CT scanner that will be used to take independent PET and CT images will be reviewed under the applicable PET and CT services criteria.

"Physician" means a person licensed by the Board of Medicine to practice medicine or osteopathy in Virginia.

[ "Planning district" means a contiguous area within the boundaries established by the Virginia Department of Housing and Community Development or its successor. ]

"Planning horizon year" means the particular year for which bed or service needs are projected.

"Population" means the census figures shown in the most current series of projections published by the Virginia Employment Commission a demographic entity as determined by the commissioner.

"Positron emission tomography" or "PET" means a noninvasive diagnostic or imaging modality using the computer-generated image of local metabolic and physiological functions in tissues produced through the detection of gamma rays emitted when introduced radio-nuclids decay and release positrons. A PET system includes two major elements: (i) a cyclotron that produces radio-pharmaceuticals and (ii) a scanner that includes a data acquisition system and a computer A PET device or scanner may include an integrated CT to provide anatomic structure definition.

"Primary service area" means the geographic territory from which 75% of the patients of an existing medical care facility originate with respect to a particular service being sought in an application.

"Procedure" means a study or treatment or a combination of studies and treatments identified by a distinct [ ICD9 ICD-9 ] or CPT code performed in a single session on a single patient.

"Quality of care" means to the degree to which services provided are properly matched to the needs of the population, are technically correct, and achieve beneficial impact. Quality of care can include consideration of the appropriateness of physical resources, the process of producing and delivering services, and the outcomes of services on health status, the environment, and/or behavior.

"Qualified" means meeting current legal requirements of licensure, registration or certification in Virginia or having appropriate training, including competency testing, and experience commensurate with assigned responsibilities.

"Radiation therapy" means the treatment of disease with radiation, especially by selective irradiation with x-rays or other ionizing radiation and by ingestion of radioisotopes [ a clinical specialty, including radioisotope therapy, in which ionizing radiation is used for treatment of cancer or other diseases, often in conjunction with surgery or chemotherapy or both. The predominant form of radiation therapy involves an external source of radiation whose energy is focused on the diseased area treatment using ionizing radiation to destroy diseased cells and for the relief of symptoms ]. [ Radioisotope therapy is a process involving the direct application of a radioactive substance to the diseased tissue and usually requires surgical implantation Radiation therapy may be used alone or in combination with surgery or chemotherapy ].

"Relevant reporting period" means the most recent 12-month period, prior to the beginning of the applicable batch review cycle, for which data is available from the Virginia Employment Commission, Virginia Health Information, or other source identified by the department VHI or a demographic entity as determined by the commissioner.

"Rural" means territory, population, and housing units that are classified as "rural" by the Bureau of the Census of the United States Department of Commerce, Economic and Statistics Administration.

"State medical facilities plan" or "SMFP" means the planning document adopted by the Board of Health that includes, but is not limited to (i) methodologies for projecting need for medical facility beds and services; (ii) statistical information on the availability of medical facility beds and services; and (iii) procedures, criteria and standards for the review of applications for projects for medical care facilities and services "SMFP" means the state medical facilities plan as contained in Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia used to make medical care facilities and services needs decisions.

"Stereotactic radiosurgery" or "SRS" means [ a noninvasive one session therapeutic procedure for precisely locating diseased points within the body using an external, a 3-dimensional frame of reference the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume ]. A stereotactic instrument is attached to the body and used to localize precisely an area in the body by means of coordinates related to anatomical structures. [ An example of a stereotactic radiosurgery instrument is a Gamma Knife® unit. Stereotactic radiotherapy means more than one session is required. One SRS procedure equals three standard radiation therapy procedures SRS may be delivered in a single session or in a fractionated course of treatment up to five sessions ].

[ "Stereotactic radiotherapy" or "SRT" means more than one session of stereotactic radiosurgery. ]

"Study" or "scan" means the gathering of data during a single patient visit from which one or more images may be constructed for the purpose of reaching a definitive clinical diagnosis.

"Substance abuse disorder treatment services" means services provided to individuals for the prevention, diagnosis, treatment, or palliation of chemical dependency, which may include attendant medical and psychiatric complications of chemical dependency. Substance abuse disorder treatment services are licensed by the Department of Mental Health, Mental Retardation and Substance Abuse Services.

"Supervision" means to direct and watch over the work and performance of others.

"The center" means the Center for Quality Health Care Services and Consumer Protection.

"Use rate" means the rate at which an age cohort or the population uses medical facilities and services. The rates are determined from periodic patient origin surveys conducted for the department by the regional health planning agencies, or other health statistical reports authorized by Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia.

"VHI" means the health data organization defined in § 32.1-276.4 of the Code of Virginia and under contract with the Virginia Department of Health.

Statutory Authority

§ 32.1-12 and, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from VR355-30-100 § 1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-20. Preface. Responsibility of the department. (Repealed.)

Virginia's Certificate of Public Need law defines the State Medical Facilities Plan as the "planning document adopted by the Board of Health which shall include, but not be limited to, (i) methodologies for projecting need for medical facility beds and services; (ii) statistical information on the availability of medical facility beds and services; and (iii) procedures, criteria and standards for the review of applications for projects for medical care facilities and services." (§ 32.1-102.1 of the Code of Virginia.)

Section 32.1-102.3 of the Code of Virginia states that, "Any decision to issue or approve the issuance of a certificate (of public need) shall be consistent with the most recent applicable provisions of the State Medical Facilities Plan; provided, however, if the commissioner finds, upon presentation of appropriate evidence, that the provisions of such plan are not relevant to a rural locality's needs, inaccurate, outdated, inadequate or otherwise inapplicable, the commissioner, consistent with such finding, may issue or approve the issuance of a certificate and shall initiate procedures to make appropriate amendments to such plan."

Subsection B of § 32.1-102.3 of the Code of Virginia requires the commissioner to consider "the relationship" of a project "to the applicable health plans of the board" in "determining whether a public need for a project has been demonstrated."

This State Medical Facilities Plan is a comprehensive revision of the criteria and standards for COPN reviewable medical care facilities and services contained in the Virginia State Health Plan established from 1982 through 1987, and the Virginia State Medical Facilities Plan, last updated in July, 1988. This Plan supersedes the State Health Plan 1980‑‑1984 and all subsequent amendments thereto save those governing facilities or services not presently addressed in this Plan.

A. Sections 32.1-102.1 and 32.1-102.3 of the Code of Virginia requires the Board of Health to adopt a planning document for review of COPN applications and that decisions to issue a COPN shall be consistent with the most recent provisions of the State Medical Facilities Plan.

B. The commissioner is the designated decision maker in the process of determining public need.

C. The center is a unit of the department responsible for administering the COPN program under the direction of the commissioner.

D. The regional health planning agencies assist the department in determining whether a certificate should be granted.

E. The center's COPN staff is available to answer questions and provide technical assistance throughout the application process.

F. In developing or revising standards for the COPN program, the board adheres to the requirements of the Administrative Process Act and the public participation process. The department, acting for the board, solicits input from applicants, applicant representatives, industry associations, and the general public in the development or revision of these criteria through informal and formal comment periods and may hold public hearings, as appropriate.

G. If, upon presentation of appropriate evidence, the commissioner finds that the provisions of this chapter are not relevant to a rural locality's needs, or are inaccurate, outdated, inadequate or otherwise inapplicable, he may issue or approve the issuance of a certificate and shall initiate procedures to make appropriate amendments to this chapter.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-100 § 2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-30. Guiding principles in certificate of public need the development of project review criteria and standards.

[ A. ] The following general principles will be used in guiding the implementation of the Virginia Medical Care Facilities Certificate of Public Need (COPN) Program and have served serve as the basis for the development of the review criteria and standards for specific medical care facilities and services contained in this document:

1. The COPN program will give preference to requests that encourage medical care facility and service development approaches which can document improvement in that improve the cost-effectiveness of health care delivery. Providers should strive to develop new facilities and equipment and use already available facilities and equipment to deliver needed services at the same or higher levels of quality and effectiveness, as demonstrated in patient outcomes, at lower costs is based on the understanding that excess capacity [ and or ] underutilization of medical facilities are detrimental to both cost effectiveness and quality of medical services in Virginia.

2. The COPN program will seek seeks to achieve a balance between appropriate the levels of availability and access to medical care facilities and services for all the citizens of Virginia of Virginia's citizens and the need to constrain excess facility and service capacity the geographical [ dispersion distribution ] of medical facilities and to promote the availability and accessibility of proven technologies.

3. The COPN program will seek [ seeks ] to achieve economies of scale in development and operation, and optimal quality of care, through establishing limits on the development of specialized medical care facilities and services, on a statewide, regional, or planning district basis [ promotes to promote ] the development and maintenance of services and access to those services by every person who needs them without respect to their ability to pay.

4. The COPN program will give preference to [ seeks ] to promote the development and maintenance of needed services which are accessible to every person who can benefit from the services regardless of their ability to pay [ encourages to encourage ] the conversion of facilities to new and efficient uses and the reallocation of resources to meet evolving community needs.

5. The COPN program will promote the elimination of excess facility and service capacity. The COPN program will promote the promotes the elimination and conversion of excess facility and service capacity to meet identified needs discourages the proliferation of services that would undermine the ability of essential community providers to maintain their financial viability. The COPN program will not facilitate the survival of medical care facilities and services which have rendered superfluous by changes in health care delivery and financing.

Statutory Authority

§ 32.1-12 and, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from VR355-30-100 § 3, eff. July 1, 1993; amended, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-40. General application filing criteria.

A. In addition to meeting the applicable requirements of the State Medical Facilities Plan this chapter, applicants for a Certificate of Public Need shall provide include documentation in their application that their proposal project addresses the applicable 20 considerations requirements listed in § 32.1-102.3 of the Code of Virginia.

B. Facilities and services shall be provided in locations that meet established zoning regulations, as applicable The burden of proof shall be on the applicant to produce information and evidence that the project is consistent with the applicable requirements and review policies as required under Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

C. The department shall consider an application complete when all requested information, and the application fee, is submitted on the form required. If the department finds the application incomplete, the applicant will be notified in writing and the application may be held for possible review in the next available applicable batch review cycle The commissioner may condition the approval of a COPN by requiring an applicant to: (i) provide a level of care at a reduced rate to indigents, (ii) accept patients requiring specialized care, or (iii) facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The applicant must actively seek to comply with the conditions place on any granted COPN.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-50. Project costs.

The capital development and operating costs for providing services should be comparable to similar services in the health planning region The capital development costs of a facility and the operating expenses of providing the authorized services should be comparable to the costs and expenses of similar facilities with the health planning region.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-60. Preferences When competing applications received.

In the review of reviewing competing applications, preference [ consideration will preference may ] be given [ to ] applicants [ the when an ] applicant who:

1. Who have Has an established performance record in completing projects on time and within the authorized operating expenses and capital costs;

2. Whose proposals have Has both lower direct construction costs and cost of equipment capital costs and operating expenses than their his competitors and can demonstrate that their cost his estimates are credible;

3. Who can demonstrate a commitment to facilitate the transport of patients residing in rural areas or medically underserved areas of urban localities to needed services, directly or through coordinated efforts with other organizations;

4. Who can 3. Can demonstrate a consistent compliance with state licensure and federal certification regulations and a consistent history of few documented complaints, where applicable; or

5. Who can 4. Can demonstrate a commitment to enhancing financial accessibility to services through the provision of documented charity care, exclusive of bad debts and disallowances from payers, and services to Medicaid beneficiaries serving [ their his ] community or service area as evidenced by unreimbursed services to the indigent and providing needed but unprofitable services, taking into account the demands of the particular service area.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-70. Emerging technologies [ Prorating of mobile service volume requirements Calculation of utilization of services provided with mobile equipment ].

Inasmuch as the SMFP cannot contemplate all possible future applications and advances in the regulated technologies, these future applications and technological advances will be evaluated based on emerging national trends and evidence in the peer review literature. Until such time as the SMFP can be updated to reflect changes, emerging technologies should be registered with the center following 12VAC5-220-110 of the Virginia Administrative Code.

[ A. The required minimum service volumes for the establishment of services and the addition of capacity for mobile services shall be prorated on a "site by site" basis based on the amount of time the mobile services will be operational at each site using the following formula:

A. The minimum service volume of a mobile unit shall be prorated on a site-by-site basis reflecting the amount of time that proposed mobile units will be used, and existing mobile units have been used, during the relevant reporting period, at each site using the following formula:

B. [ This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the service has been achieved as described in the applicable service section The average annual utilization of existing and approved CT, MRI, PET, lithotripsy, and catheterization services in a health planning district shall be calculated for such services as follows:

Y = the sum of the minimum service volume of each mobile site in the health planning district with the minimum services volume for each such site prorated according to subsection A of this section.

C. This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the services has been achieved as described in the applicable service section. ]

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-80. Institutional need When institutional expansion needed.

A. Notwithstanding any other provisions of this chapter, consideration will be given to the commissioner may grant approval for the expansion of services at an existing medical care facilities facility in a [ health ] planning districts district with an excess supply of such services when the proposed expansion can be justified on the basis of facility-specific utilization a facility's need having exceeded its current service capacity to provide such service or on the geographic remoteness of the facility.

B. If a facility with an institutional need to expand is part of a network health system, the underutilized services at other facilities within the network should be relocated health system should be reallocated, when appropriate, to the facility within the planning district with the institutional need when possible to expand before additional services are approved for the applicant. However, underutilized services located at a health system's geographically remote facility may be disregarded when determining institutional need for the proposed project.

C. This section is not applicable to nursing facilities pursuant to § 32.1-102.3:2 of the Code of Virginia.

D. Applicants shall not use this section to justify a need to establish new services.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-90. Compliance with the terms of a condition.

A. The commissioner may condition the approval of a COPN to provide care to Virginia's indigent population, patients with specialized needs, or the medically underserved.

B. The applicant shall actively seek to provide opportunities to offer the conditioned service directly to indigent or uninsured persons at a reduced rate or free of charge to patients with specialized needs, or by the facilitation of primary care services in designated medically underserved areas.

C. If the direct provision of the conditioned services does not fulfill the terms of the condition, the center may determine the applicant to be in compliance with the terms of the condition when:

1. The applicant is part of a facility or provider network and the facility or provider network has provided reduced rate or uncompensated care at or above the regional standard; or

2. The applicant provides direct financial support for community based health care services at a value equal to or greater than the difference between the terms of the condition and the amount of direct care provided.

Such direct financial support shall be in addition to, and not a substitute for, other charitable giving chosen by the applicant.

D. Acceptable proof for direct financial support is a signed receipt indicating the number or amount of services or other support provided and dollar value of that service or support. Applicants providing direct financial support for community based health care services should render that support through one of the following organizations:

1. The Virginia Association of Free Clinics;

2. The Virginia Health Care Foundation; or

3. The Virginia Primary Care Association.

E. Applicants shall demonstrate compliance with the terms of a condition for the previous 12-month period. The written condition report shall be certified or affirmed by the applicants and filed with the center. Such report shall include, but is not limited to, the:

1. Facility or service name and address;

2. Certificate number;

3. Facility or service gross patient revenues;

4. Dollar value of the charity care provided, excluding bad debts and disallowances from payers; and

5. Number of individuals served by the direct provision of care or a receipt from one of the allowable organizations listed in subsection D of this section.

Part II
Diagnostic Imaging Services

Article 1
Criteria and Standards for Computed Tomography

12VAC5-230-100. Accessibility 12VAC5-230-90. Travel time.

CT services should be within 30 minutes driving time one way, under normal conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-110 12VAC5-230-100. Need for new fixed site [ or mobile ] service.

A. No CT service should be approved at a location that is within 30 minutes driving time one way of:

1. A service that is not yet operational; or

2. An existing CT unit that has performed fewer than 3,000 scans during the relevant reporting period.

B. A. No new fixed site [ or mobile ] CT service or network shall should be approved unless all existing fixed site CT services or networks in the [ health ] planning district performed an average of 4,500 CT scans per machine during the relevant reporting period. [ 10,000 7,400 ] procedures per existing and approved CT scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing [ fixed site ] providers in the [ health ] planning district [ below 10,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of CT scanners in such [ health ] planning district.

C. Consideration may be given to new CT services proposed for sites located beyond 30 minutes driving time one way of existing facilities that do not meet the 4,500 scans per machine criterion if the proposed sites are in rural areas B. [ Existing ] CT scanners [ to be ] used solely for simulation with radiation therapy treatment shall be exempt from [ the utilization criteria of ] this article [ when applying for a COPN. In addition, existing CT scanners used solely for simulation with radiation therapy treatment may be disregarded in computing the average utilization of CT scanners in such health planning district ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-120 12VAC5-230-110. Expansion of existing fixed site service.

Proposals to increase the number of CT scanners in expand an existing medical care facility's CT service or network may through the addition of a CT scanner should be approved only if when the existing service or network services performed an average of 3,000 CT scans [ 10,000 7,400 ] procedures per scanner for the relevant reporting period. The commissioner may authorize placement of a new unit at the applicant's existing medical care facility or at a separate location within the applicant's primary service area for CT services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the [ health ] planning district [ below 10,000 procedures ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-120. Adding or expanding mobile CT services.

A. Proposals for mobile CT scanners shall demonstrate that, for the relevant reporting period, at least 4,800 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing CT providers in the [ health ] planning district [ below 10,000 procedures for fixed site scanners or 4,800 procedures for mobile scanners ].

B. Proposals to convert [ authorized ] mobile CT scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, at least 6,000 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing CT providers in the [ health ] planning district [ below 10,000 procedures for fixed site scanners or 4,800 procedures for mobile scanners ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-130. Staffing.

Providers of CT services should be under the direct supervision of one or more board-certified diagnostic radiologists direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-140. Space.

Applicants shall provide documentation that:

1. A suitable environment will be provided for the proposed CT services, including protection against known hazards; and

2. Space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

Article 2
Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-150. Accessibility. 12VAC5-230-140. Travel time.

MRI services should be within 30 minutes driving time one way, under normal conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-160 12VAC5-230-150. Need for new fixed site service.

A. No new fixed site MRI services shall should be approved unless all existing fixed site MRI services in the [ health ] planning district performed an average of 4,000 scans per machine 5,000 procedures per existing and approved fixed site MRI scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site MRI providers in the [ health ] planning district [ below 5,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of MRI scanners in such [ health ] planning district.

B. Consideration may be given to new MRI services proposed for sites located beyond 30 minutes driving time one way of existing facilities that do not meet the 4,000 scans per machine criterion of the prospered sites are in rural areas.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-170 12VAC5-230-160. Expansion of services fixed site service.

Proposals to expand an existing medical care facility's MRI services through the addition of a new scanning unit of an MRI scanner may be approved if when the existing service performed at least 4,000 scans an average of 5,000 MRI procedures per existing unit scanner during the relevant reporting period. The commissioner may authorize placement of the new unit at the applicant's existing medical care facility, or at a separate location within the applicant's primary service area for MRI services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the [ health ] planning district [ below 5,000 procedures ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-170. Adding or expanding mobile MRI services.

A. Proposals for mobile MRI scanners shall demonstrate that, for the relevant reporting period, at least 2,400 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing MRI providers in the [ health ] planning district [ below 2,400 procedures for mobile scanners ].

B. Proposals to convert [ authorized ] mobile MRI scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, 3,000 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing MRI providers in the [ health ] planning district [ below 5,000 procedures for fixed site scanners and 2,400 procedures for mobile scanners ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-180. Staffing.

MRI machines services should be under the direct, on-site supervision of one or more board-certified diagnostic radiologists direct supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-190. Space.

Applicants should provide documentation that:

1. A suitable environment will be provided for the proposed MRI services, including shielding and protection against known hazards; and

2. Space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

Article 3
Magnetic Source Imaging

12VAC5-230-200 12VAC5-230-190. Policy for the development of MSI services.

Because Magnetic Source Imaging (MSI) scanning systems are still in the clinical research stage of development with no third-party payment available for clinical applications, and because it is uncertain as to how rapidly this technology will reach a point where it is shown to be clinically suitable for widespread use and distribution on a cost-effective basis, it is preferred that the entry and development of this technology in Virginia should initially occur at or in affiliation with, the academic medical centers in the state.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4
Positron Emission Tomography

12VAC5-230-210 12VAC5-230-200. Accessibility Travel time.

The service area for each proposed PET service shall be an entire planning district PET services should be within 60 minutes driving time one way under normal conditions of 95% of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4
Positron Emission Tomography

12VAC5-230-220 12VAC5-230-210. Need for new fixed site service.

A. Whether the applicant is a consortium of hospitals, a hospital network, or a single general hospital, at least 850 new PET appropriate cases should have been diagnosed in the planning district. If the applicant is a hospital, whether free-standing or within a hospital system, 850 new PET appropriate cases shall have been diagnosed and the hospital shall have provided radiation therapy services with specific ancillary services suitable for the equipment before a new fixed site PET service should be approved for the [ health ] planning district.

B. If the applicant is a general hospital, the facility shall provide radiation therapy services and specific ancillary services suitable for the equipment, and have reported at least 500 new courses of treatment or at least 8,000 treatment visits in the most recent reporting period No new fixed site PET services should be approved unless an average of 6,000 procedures [ preexisting per existing ] and approved fixed site PET scanner were performed in the [ health ] planning district during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site PET providers in the [ health ] planning district [ below 6,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of PET units in such [ panning health planning ] district.

Note: For the purposes of tracking volume utilization, an image taken with a PET/CT scanner that takes concurrent PET/CT images shall be counted as one PET procedure. Images made with PET/CT scanners that can take PET or CT images independently shall be counted as individual PET procedures and CT procedures respectively, unless those images are made concurrently.

C. If the applicant is a consortium of general hospitals or a hospital network, at least one of the consortium or network members shall provide radiation therapy services and specific ancillary services suitable for the equipment, and have reported at least 500 new PET appropriate patients.

D. Future applications of PET equipment shall be evaluated based on review of national literature.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-230. Additional scanners. 12VAC5-230-220. Expansion of fixed site services.

No additional PET scanners shall be added in a planning district unless the applicant can demonstrate that the utilization of the existing PET service was at least 1,200 PET scans for a fixed site unit and that the proposed new or expanded service would not reduce the utilization after for existing services below 850 PET scans for a fixed site unit. The applicant shall also provide documentation that he project complies with 12VAC50-230-240. Proposals to increase the number of PET scanners in an existing PET service should be approved only when the existing scanners performed an average of 6,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing fixed site providers in the [ health ] planning district [ below 6,000 procedures ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-230. Adding or expanding mobile PET or PET/CT services.

A. Proposals for mobile PET or PET/CT scanners [ shall should ] demonstrate that, for the relevant reporting period, at least 230 [ procedures were performed PET or PET/CT appropriate patients were seen ] and that the proposed mobile unit will not significantly reduce the utilization of existing providers in the [ health ] planning district [ below 6,000 procedures for the fixed site PET providers or 230 procedures for the mobile PET providers ].

B. Proposals to convert [ authorized ] mobile PET or PET/CT scanners to fixed site scanners should demonstrate that, for the relevant reporting period, at least 1,400 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing providers in the [ health ] planning district [ below 6,000 procedures for the fixed site PET or 230 procedures of the mobile PET providers ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-240. Staffing.

PET services should be under the direction of a physician who is a board certified radiologist or supervision of one or more qualified physicians. Such physician physicians shall be a designated [ or ] authorized user [ users of isotopes used for PET ] by the Nuclear Regulatory Commission or licensed by the Office Division of Radiologic Health of the Virginia Department of Health, as applicable.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 5
Noncardiac Nuclear Imaging Criteria and Standards

12VAC5-230-250. Accessibility Travel time.

Noncardiac nuclear imaging services should be available within 30 minutes driving time one way, under normal driving conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-260. Introduction of a service Need for new service.

Any applicant proposing to establish a medical care facility for the provision of noncardiac nuclear imaging, or introducing nuclear imaging as a new service at an existing medical care facility, shall provide documentation that No new noncardiac imaging services should be approved unless the service can achieve a minimum utilization level of:

(i) 650 scans 1. 650 procedures in the first 12 months of operation, ;

(ii) 1,000 scans 2. 1,000 procedures in the second 12 months of services, and (iii) 1,250 scans service in the second 12 months of operation service; and

3. The proposed new service would not significantly reduce the utilization of existing providers in the [ health ] planning district.

Note: The utilization of an existing service operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of noncardiac nuclear imaging services in such [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-270. Staffing.

The proposed new or expanded noncardiac nuclear imaging service shall should be under the direction of a board certified physician or supervision of one or more qualified physicians a designated [ or ] authorized user [ users of isotopes licensed ] by the Nuclear Regulatory Commission or the Office Division of Radiologic Health of the Virginia Department of Health, as applicable.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part III
Radiation Therapy Services

Article 1
Radiation Therapy Services

12VAC5-230-280. Accessibility Travel time.

Radiation therapy services should be available within 60 minutes driving time one way, under normal conditions, for of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-290. Availability Need for new service.

A. No new radiation therapy service [ shall should ] be approved unless:

(i) existing 1. Existing radiation therapy machines located in the [ health ] planning district were used for at least 320 cancer cases and at least performed an average of 8,000 [ treatment visits procedures per existing and approved radiation therapy machine ] for in the relevant reporting period; and

(ii) it can be reasonably projected that the 2. The new service will perform at least 6,000 5,000 procedures by the third second year of operation without significantly reducing the utilization of existing radiation therapy machines within 60 minutes drive time one way, under normal conditions, such that less than 8,000 procedures will be performed by an existing machine providers in the [ health ] planning district.

B. The number of radiation therapy machines needed in a primary service area [ health ] planning district will be determined as follows:

where:

1. The population is projected to be at least 75,000 150,000 people three years from the current year as reported in the most current projections of the Virginia Employment Commission a demographic entity as determined by the commissioner;

2. The "cancer incidence rate" is based on as determined by data from the Statewide Cancer Registry;

3. 60% is the estimated number of new cancer cases in a [ health ] planning district that are treatable with radiation therapy; and

4. 320 is 100% utilization of a radiation therapy machine based upon an anticipated average of 25 [ treatment visits procedures ] per case.

C. Consideration will be given to the approval of Proposals for new radiation therapy services located at a general hospital at least less than 60 minutes driving time one way, under normal conditions, from any site that radiation therapy services are available if the applicant can shall demonstrate that the proposed new services will perform at least an average of 4,500 [ treatment ] procedures annually by the second year of operation, without significantly reducing the utilization of existing machines located within 60 minutes driving time one way, under normal conditions, from the proposed new service location [ providers services ] in the [ health ] planning [ region district ].

D. Proposals for the expansion of radiation therapy services should not be approved unless all existing radiation therapy machines operated by the applicant in the planning district have performed at least 8,000 procedures for the relevant reporting period.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-300. Statewide Cancer Registry Expansion of service.

Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia

Proposals to [ increase expand ] radiation therapy services should be approved only when all existing radiation therapy [ machines services ] operated by the applicant in the [ health ] planning district have performed an average of 8,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers [ below 8,000 procedures ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-310. Staffing Statewide Cancer Registry.

Radiation therapy services shall be under the direction of a physician board-certified in radiation oncology Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-320. Equipment, patient care; support services Staffing.

In addition to the radiation therapy machine, the service should have direct access to:

1. Simulation equipment capable of precisely producing the geometric relations of the equipment to be used for treatment of the patient;

2. A computerized treatment planning system;

3. A custom block design and cutting system; and

4. Diagnostic, laboratory oncology services

Radiation therapy services should be under the direction or supervision of one or more qualified physicians [ . Such physicians shall be ] designated [ or ] authorized [ users of isotopes licensed ] by the Nuclear Regulatory Commission or the Division of Radiologic Health of the Virginia Department of Health, as applicable.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Criteria and Standards for Stereotactic Radiosurgery

12VAC5-230-330. Availability; need for new service Travel time.

No new services should be approved unless (i) the number of procedures performed with existing units in the planning region average more than 350 per year and (ii) it can be reasonably projected that the proposed new service will perform at least 250 procedures in the second year of operation without reducing patient volumes to existing providers to less than 350 procedures Stereotactic radiosurgery services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of a [ health ] planning [ district region using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-340. Statewide Cancer Registry Need for new service.

Facilities shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

A. No new stereotactic radiosurgery services should be approved unless:

1. The number of procedures performed with existing units in the [ health ] planning region averaged more than 350 per year [ in the relevant reporting period ]; and

2. The proposed new service will perform at least 250 procedures in the second year of operation without significantly reducing the utilization of existing providers in the [ health ] planning region [ below 350 treatments ].

B. [ Consideration Preference ] may be given to a [ project that incorporates ] tereotactic radiosurgery service incorporated within an existing standard radiation therapy service using a linear accelerator when an average of 8,000 [ treatments procedures ] during the relevant reporting period [ were performed and the applicant can demonstrate that the volume and cost of the service is justified and utilization of existing services in the health planning region will not be significantly reduced ].

C. [ Consideration Preference ] may be given to a [ project that incorporates a ] dedicated Gamma Knife® [ incorporated ] within an existing radiation therapy service when:

1. At least 350 Gamma Knife® appropriate cases were referred out of the region in the relevant reporting period; and

2. The applicant can demonstrate that:

a. An average of 250 procedures will be preformed in the second year of operation; [ and ]

b. Utilization of existing services in the [ health ] planning region will not be significantly reduced [ below 350 treatments per year; and. ]

[ c. The cost is justified. ]

D. [ Consideration Preference ] may be given to [ a project that incorporates ] non-Gamma Knife® [ SRS ] technology [ incorporated ] within an existing radiation therapy service when:

1. The unit is not part of a linear accelerator;

2. An average of 8,000 radiation [ treatments procedures ] per year were performed by the existing radiation therapy services;

3. At least 250 procedures will be performed within the second year of operation; and

4. Utilization of existing services in the [ health ] planning region will not be significantly reduced [ below 350 treatments ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-350. Staffing Expansion of service.

The proposed new or expanded stereotactic radiosurgery services shall be under the direction of a physician who is board-certified in neurosurgery and a radiation oncologist with training in stereotactic radiosurgery

Proposals to increase the number of stereotactic radiosurgery services should be approved only when all existing stereotactic radiosurgery machines in the [ health ] planning region have performed an average of 350 procedures [ per existing and approved unit ] for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers in the [ health ] planning region [ below 350 procedures ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part IV
Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-360. Accessibility Statewide Cancer Registry.

Adult cardiac catheterization services should be accessible within 60 minutes driving time one way, under normal conditions, for 95% of the population of the planning district Facilities [ with stereotactic radiosurgery services ] shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-370. Availability Staffing.

A. No new fixed site cardiac catheterization laboratory should be approved unless:

1. All existing fixed site cardiac catheterization laboratories located in the planning district were used for at least 960 diagnostic-equivalent cardiac catheterization procedures for the relevant reporting period; and

2. It can be reasonably projected that the proposed new service will perform at least 200 diagnostic equivalent procedures in the first year of operation, 500 diagnostic equivalent procedures in the second year of operation without reducing the utilization of existing laboratories in the planning district to less than 960 diagnostic equivalent procedures at any of those existing laboratories.

B. Proposals for the use of freestanding or mobile cardiac catheterization laboratories shall be approved only if such laboratories will be provided at a site located on the campus of a general or community hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform 200 diagnostic equivalent procedures in the first year of operation, 350 diagnostic equivalent procedures in the second year of operation without reducing the utilization of existing laboratories in the planning district to less than 960 diagnostic equivalent procedures at any of those existing laboratories.

C. Consideration may be given for the approval of new cardiac catheterization services located at a general hospital located 60 minutes or more driving time one way, under normal conditions, from existing laboratories, if it can be projected that the proposed new laboratory will perform at least 200 diagnostic-equivalent procedures in the first year of operation, 400 diagnostic-equivalent procedures in the second year of operation without reducing the utilization of existing laboratories located within 60 minutes driving time one way, under normal conditions, of the proposed new service location.

D. Proposals for the addition of cardiac catheterization laboratories shall not be approved unless all existing cardiac catheterization laboratories operated in the planning district by the applicant have performed at least 1,200 diagnostic-equivalent procedures for the relevant reporting period, and the applicant can demonstrate that the expanded service will achieve a minimum of 200 diagnostic equivalent procedures per laboratory in the first 12 months of operation, 400 diagnostic equivalent procedures in the second 12 months of operation without reducing the utilization of existing cardiac catheterization laboratories in the planning district below 960 diagnostic equivalent procedures.

E. Emergency cardiac catheterization services shall be available within 30 minutes of admission to the facility.

F. No new or expanded pediatric cardiac catheterization services should be approved unless the proposed service will be provided at a hospital that:

1. Provides open heart surgery services, provides pediatric tertiary care services, has a pediatric intensive care unit and provides neonatal special care or has a cardiac intensive care unit and provides pediatric open heart surgery services; and

2. The applicant can demonstrate that each proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation.

G. Applications for new or expanded cardiac catheterization services that include nonemergent interventional cardiology services should not be approved unless emergency open heart surgery services are available within 15 minutes drive time in the hospital where the proposed cardiac catheterization service will be located.

Stereotactic radiosurgery services should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part IV
Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-380. Staffing Travel time.

A. Cardiac catheterization services should have a medical director who is board-certified in cardiology and clinical experience in the performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. All physicians who will be performing cardiac catheterization procedures should be board-certified or board-eligible in cardiology and clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric catheterization services, each physician performing pediatric procedures should be board-certified or board-eligible in pediatric cardiology, and have clinical experience in performing physiologic and angiographic procedures.

C. All anesthesia services should be provided by or supervised by a board-certified anesthesiologist.

In the case of pediatric catheterization services, the anesthesiologist should be experienced and trained in pediatric anesthesiology.

Cardiac catheterization services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-390. Accessibility Need for new service.

Open heart surgery services should be available 24 hours per day 7 days per week and accessible within a 60 minutes driving time one way, under normal conditions, for 95% of the population of the planning district.

A. No new fixed site cardiac catheterization [ laboratory service ] should be approved for a [ health ] planning district unless:

1. Existing fixed site cardiac catheterization [ laboratories services ] located in the [ health ] planning district performed an average of 1,200 cardiac catheterization DEPs [ per existing and approved laboratory ] for the relevant reporting period; [ and ]

2. The proposed new service will perform an average of 200 DEPs in the first year of operation and 500 DEPs in the second year of operation; and

3. The utilization of existing services in the [ health ] planning district will not be significantly reduced.

B. Proposals for mobile cardiac catheterization laboratories should be approved only if such laboratories will be provided at a site located on the campus of an inpatient hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform an average of 200 DEPs in the first year of operation and 350 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the [ health ] planning district below 1,200 procedures.

C. [ Consideration Preference ] may be given [ for to a project that locates ] new cardiac catheterization services [ located ] at an inpatient hospital that is 60 minutes or more driving time one way under normal conditions from existing [ laboratories services ] if the applicant can demonstrate that the proposed new laboratory will perform an average of 200 DEPs in the first year of operation and 400 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-400. Availability Expansion of services.

A. No new open heart services should be approved unless:

1. The service will be made available in a general hospital with established cardiac catheterization services that have been used for at least 960 diagnostic equivalent procedures for the relevant reporting period and have been in operation for at least 30 months;

2. All existing open heart surgery rooms located in the planning district have been used for at least 400 open heart surgical procedures for the relevant reporting period; and

3. It can be reasonably projected that the proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without reducing the utilization of existing open heart surgery programs in the planning district to less than 400 open heart procedures performed at those existing services.

B. Notwithstanding subsection A of this subsection, consideration will be given to the approval of new open heart surgery services located at a general hospital more than 60 minutes driving time one way, under normal conditions, from any site in which open heart surgery services are currently available if it can be projected that the proposed new service will perform at least 150 open heart procedures in the first year of operation; and 200 procedures in the second year of operation without reducing the utilization of existing open heart surgery rooms to less than 400 procedures per room within 2 hours driving time one way, under normal conditions, from the proposed new service location.

Such hospitals should also have provided at least 960 diagnostic-equivalent cardiac catheterization procedures during the relevant reporting period on equipment that has been in operation at least 30 months.

C. Proposals for the expansion of open heart surgery services should not be approved unless all existing open heart surgery rooms operated by the applicant have performed at least:

1. 400 adult-equivalent open heart surgery procedures in the relevant reporting period when the proposed facility is within two hours driving time one way, under normal conditions, of an existing open heart surgery service; or

2. 300 adult-equivalent open heart surgery procedures in the relevant reporting period when the applicant proposes expanding services in excess of two hours driving time, under normal conditions, of an existing open heart surgery service.

D. No new or expanded pediatric open heart surgery services should be approved unless the proposed new or expanded service is provided at a hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed at least 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides neonatal special care.

Proposals to increase cardiac catheterization services should be approved only when:

1. All existing cardiac catheterization laboratories operated by the applicant's facilities where the proposed expansion is to occur have performed an average of 1,200 DEPs [ per existing and approved laboratory ] for the relevant reporting period; and

2. The applicant can demonstrate that the expanded service will achieve an average of 200 DEPs per laboratory in the first 12 months of operation and 400 DEPs in the second 12 months of operation without significantly reducing the utilization of existing cardiac catheterization laboratories in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-410. Staffing Pediatric cardiac catheterization.

A. Open heart surgery services should have a medical director certified by the American Board of Thoracic Surgery in cardiovascular surgery with special qualifications and experience in cardiac surgery.

In the case of pediatric open heart surgery, the medical director shall be certified by the American Board of Thoracic Surgery in cardiovascular surgery and experience in pediatric cardiovascular surgery and congenital heart disease.

B. All physicians performing open heart surgery procedures should be board-certified or board-eligible in cardiovascular surgery, with experience in cardiac surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitably trained board-certified or board-eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. There should also be present at least one board-certified or board-eligible anesthesiologist with experience in open heart surgery.

In the case of pediatric open heart surgery services, each physician performing and assisting with pediatric procedures should be board-certified or board-eligible in cardiovascular surgery with experience in pediatric cardiovascular surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitably trained board-certified or board-eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. All pediatric procedures should include a board-certified anesthesiologist with experience in pediatric anesthesiology and pediatric open heart surgery.

No new or expanded pediatric cardiac catheterization services should be approved unless:

1. The proposed service will be provided at an inpatient hospital with open heart surgery services, pediatric tertiary care services or specialty or subspecialty level neonatal special care;

2. The applicant can demonstrate that the proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation; and

3. The utilization of existing pediatric cardiac catheterization laboratories in the [ health ] planning district will not be reduced below 100 procedures per year.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part V
General Surgical Services

12VAC5-230-420. Accessibility Nonemergent cardiac catheterization.

Surgical services should be available within 30 minutes driving time one way, under normal conditions, for 95% of the population of the planning district.

Proposals to provide elective interventional cardiac procedures such as PTCA, transseptal puncture, transthoracic left ventricle puncture, myocardial biopsy or any valvuoplasty procedures, diagnostic pericardiocentesis or therapeutic procedures should be approved only when open heart surgery services are available on-site in the same hospital in which the proposed non-emergent cardiac service will be located.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-430. Availability Staffing.

A. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a planning district, exclusive of Level I and Level II Trauma Centers dedicated to the needs of the trauma service, dedicated cesarean section rooms, or operating rooms designated exclusively for open heart surgery, will be determined as follows:

ORV = the sum of total operating room visits (inpatient and outpatient) in the planning district in the most recent five years for which operating room utilization data has been reported by Virginia Health Information; and

POP = the sum of total population in the planning district in the most recent five years for which operating room utilization data has been reported by Virginia Health Information, as found in the most current projections of the Virginia Employment Commission.

PROPOP = the projected population of the planning district five years from the current year as reported in the most current projections of the Virginia Employment Commission.

AHORV = the average hours per general purpose operating room visit in the planning district for the most recent year for which average hours per general purpose operating room visit has been calculated from information collected by Virginia Health Information.

FOR = future general purpose operating rooms needed in the planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room that is available 40 hours per week, 50 weeks per year.

B. Projects involving the relocation of existing general purpose operating rooms within a planning district may be authorized when it can be reasonably documented that such relocation will improve the distribution of surgical services within a planning district by making services available within 30 minutes driving time one way, under normal conditions, of 95% of the planning district's population.

A. Cardiac catheterization services should have a medical director who is board certified in cardiology and has clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. Cardiac catheterization services should be under the direct supervision or one or more qualified physicians. Such physicians should have clinical experience in performing physiologic and angiographic procedures.

Pediatric catheterization services should be under the direct supervision of one or more qualified physicians. Such physicians should have clinical experience in performing pediatric physiologic and angiographic procedures.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VI
General Inpatient Services

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-440. Accessibility Travel time.

Acute care inpatient facility beds A. Open heart surgery services should be within 30 60 minutes driving time one way, under normal conditions, of 95% of the population of a the [ health ] planning district [ using mapping software as determined by the commissioner ].

B. Such services shall be available 24 hours a day, seven days a week.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-450. Availability Need for new service.

A. Subject to the provisions of 12VAC5-230-80, no new inpatient beds should be approved in any planning district unless:

1. The resulting number of beds does not exceed the number of beds projected to be needed, for each inpatient bed category, for that planning district for the fifth planning horizon year;

2. The average annual occupancy, based on the number of beds, is at least 70% (midnight census) for the relevant reporting period; or

3. The intensive care bed capacity has an average annual occupancy of at least 65% for the relevant reporting period, based on the number of beds.

A. No new open heart services should be approved unless:

1. The service will be available in an inpatient hospital with an established cardiac catheterization service that has performed an average of 1,200 DEPs for the relevant reporting period and has been in operation for at least 30 months;

2. Open heart surgery [ programs services ] located in the [ health ] planning district performed an average of 400 open heart and closed heart surgical procedures for the relevant reporting period; and

3. The proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without significantly reducing the utilization of existing open heart surgery [ programs services ] in the [ health ] planning district [ below 400 open and closed heart procedures ].

B. No proposal to replace or relocate inpatient beds to a location not contiguous to the existing site should be approved unless:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The beds to be replaced experienced an average annual utilization of 70% (midnight census) for general inpatient beds and 65% for intensive care beds in the relevant reporting period;

4. The number of beds to be moved off site is taken out of service at the existing facility; and

5. The off-site replacement of beds results in: (i) a decrease in the licensed bed capacity; (ii) a substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or (iii) generally improved operating efficiency in the applicant's facility or facilities.

B. [ Consideration Preference ] may be given to [ a project that locates ] new open heart surgery services [ located ] at an inpatient hospital more than 60 minutes driving time one way under normal condition from any site in which open heart surgery services are currently available [ when and ]:

1. The proposed new service will perform an average of 150 open heart procedures in the first year of operation and 200 procedures in the second year of operation without significantly reducing the utilization of existing open heart surgery rooms within two hours driving time one way under normal conditions from the proposed new service location below 400 procedures per room; and

2. The hospital provided an average of 1,200 cardiac catheterization DEPs during the relevant reporting period in a service that has been in operation at least 30 months.

C. For proposals involving a capital expenditure of $5 million or more, and involving the conversion of underutilized beds to medical/surgical, pediatric or intensive care, consideration will be given to a proposal if: (i) there is a projected need in the category of inpatient beds that would result from the conversion; and (ii) it can be demonstrated that the average annual occupancy of the beds to be converted would reach the standard in subdivisions B 1, 2 and 3 for the bed category that would result from the conversion, by the first year of operation.

D. In addition to the terms of 12VAC5-230-80, a need for additional general inpatient beds may be demonstrated if the total number of beds in a given category in the planning district is less than the number of such beds projected as necessary to meet demand in the fifth planning horizon year for which the application is submitted.

E. The number of medical/surgical beds projected to be needed in a planning district shall be computed as follows:

1. Determine the projected total number of medical/surgical and pediatric inpatient days for the fifth planning horizon year as follows:

a. Add the medical/surgical and pediatric inpatient days for the past three years for all acute care inpatient facilities in the planning district as reported in the Annual Survey of Hospitals;

b. Add the projected planning district population for the same three year period as reported by the Virginia Employment Commission;

c. Divide the total of the medical/surgical and pediatric inpatient days by the total of the population and express the resulting rate in days per 1,000 population;

d. Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in thousands) for the fifth planning horizon year.

2. Determine the projected number of medical/surgical and pediatric beds that may be needed in the planning district for the planning horizon year as follows:

a. Divide the result in subdivision E 1 d of this subsection by 365;

b. Divide the quotient obtained by 0.80 in planning districts in which 50% or more of the population resides in nonrural areas or 0.75 in planning districts in which less than 50% of the population resides in nonrural areas.

3. Determine the projected number of medical/surgical and pediatric beds that may be established or relocated within the planning district for the fifth planning horizon year as follows:

a. Determine the number of medical/surgical and pediatric beds as reported in the inventory;

b. Subtract the number of beds identified in subdivision E 1 from the number of beds needed as determined in subdivision E 2 b of this subsection. If the difference indicated is positive, then a need may exist for additional medical/surgical or pediatric beds. If the difference is negative, then no need for additional beds exists.

F. The projected need for intensive care beds shall be computed as follows:

1. Determine the projected total number of intensive care inpatient days for the fifth planning horizon year as follows:

a. Add the intensive care inpatient days for the past three years for all inpatient facilities in the planning district as reported in the annual survey of hospitals;

b. Add the planning district's projected population for the same three-year period as reported by the Virginia Employment Commission;

c. Divide the total of the intensive care days by the total of the population to obtain the rate in days per 1,000 population;

d. Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in thousands) for the fifth planning horizon year to yield the expected intensive care patient days.

2. Determine the projected number of intensive care beds that may be needed in the planning district for the planning horizon year as follows:

a. Divide the number of days projected in subdivision F 1 d of this subsection by 365 to yield the projected average daily census;

b. Calculate the beds needed to assure with 99% probability that an intensive care bed will be available for unscheduled admissions.

3. Determine the projected number of intensive care beds that may be established or relocated within the planning district for the fifth planning horizon year as follows:

a. Determine the number of intensive care beds as reported in the inventory.

b. Subtract the number of beds identified in subdivision F 3 a of this subsection from the number of beds needed as determined in subdivision F 2 b of this subsection. If the difference is positive, then a need may exist for additional intensive care beds. If the difference is negative, then no need for additional beds exists.

G. No hospital should relocate beds to a new location if underutilized beds (less than 85% average annual occupancy for medical/surgical and pediatric beds), when the relocation involves such beds, and less than 65% average annual occupancy for intensive care beds when relocation involves such beds, are available within 30 minutes of the site of the proposed hospital.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VII
Nursing Facilities

12VAC5-230-460. Accessibility Expansion of service.

A. Nursing facility beds should be accessible within 60 minutes driving time one way, under normal conditions, to 95% of the population in a planning region.

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. Preference will be given to proposals that improve geographic access and reduce travel time to nursing facilities within a planning district

Proposals to [ increase expand ] open heart surgery services shall demonstrate that existing open heart surgery rooms operated by the applicant have performed an average of:

1. 400 adult equivalent open heart surgery procedures in the relevant reporting period [ of if ] the proposed increase is within one hour driving time one way under normal conditions of an existing open heart surgery service; or

2. 300 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed service is in excess of one hour driving time one way under normal conditions of an existing open heart surgery service in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-470. Availability Pediatric open heart surgery services.

A. No planning district shall be considered to have a need for additional nursing facility beds unless (i) the bed need forecast in that planning district (see subsection D of this section) exceeds the current inventory of beds in that planning district and (ii) the estimated average annual occupancy of all existing Medicaid-certified nursing facility beds in the planning district was at least 93% for the most recent two years following the first year of operation of new beds, excluding the bed inventory and utilization of the Virginia Veterans Care Center.

B. No planning district shall be considered to have a need for additional beds if there are unconstructed beds designated as Medicaid-certified.

C. Proposals for expanding existing nursing facilities should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 93% in the most recent year for which bed utilization has been reported to the department.

Exceptions will be considered for facilities that operated at less than 93% average annual occupancy in the most recent year for which bed utilization has been reported when the facility has a rehabilitative or other specialized care focus that results in a relatively short average length of stay, causing an average annual occupancy lower than 93% for the facility.

D. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85) where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP64 = The population aged 0 to 64 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP69 = The population aged 65 to 69 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP74 = The population aged 70 to 74 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP79 = The population aged 75 to 79 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP84 = The population aged 80 to 84 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP85+ = The population aged 85 and older projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

Planning district bed need forecasts will be rounded as follows:

The above applies, except in the case of a planning district that has two or more nursing facilities, has had an average annual occupancy rate in excess of 93% for the most recent two years for which bed utilization has been reported to the department, and has a forecasted bed need of 15 to 29 beds. In such a case, the bed need for this planning district will be rounded to 30.

E. No new freestanding nursing facilities of less than 90 beds should be authorized. Consideration will be given to new freestanding facilities with fewer than 90 nursing facility beds when such facilities can be justified on the basis of a lack of local demand for a larger facility and a maldistribution of nursing facility beds within a planning district.

F. Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities will be considered when:

1. The total number of new or additional beds plus any existing nursing facility beds operated by the continuing care provider does not exceed 10% of the continuing care provider's total existing or planned independent living and adult care residence;

2. The proposed beds are necessary to meet existing or reasonably anticipated obligations to provide care to present or prospective residents of the continuing care facility;

3. The applicant agrees in writing not to seek certification for the use of such new or additional beds by persons eligible to receive Medicaid;

4. The applicant agrees in writing to obtain the resident's written acknowledgement, prior to admission, that the applicant does not serve Medicaid recipients and that, in the event such resident becomes a Medicaid recipient and is eligible for nursing facility placement, the resident will not be eligible for placement in the CCRC's nursing facility unit;

5. The applicant agrees in writing that only continuing care contract holders who have resided in the CCRC as independent living residents or adult care residents will be admitted to the nursing facility unit after the first three years of operation.

G. The construction cost of proposed nursing facilities should be comparable to the most recent cost for similar facilities in the same health planning region. Consideration should be given to the current capital cost reimbursement methodology utilized by the Department of Medical Assistance Services.

H. Consideration should be given to applicants proposing to replace outdated and functionally obsolete facilities with modern nursing facilities that will result in the more cost efficient delivery of health care services to residents in a more aesthetically pleasing and comfortable environment. Proponents of the replacement and relocation of nursing facility beds should demonstrate that the replacement and relocation are reasonable and could result in savings in other cost centers, such as realized operational economies of scale and lower maintenance costs.

No new [ or expanded ] pediatric open heart surgery service should be approved unless the proposed new [ or expended ] service is provided at an inpatient hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed an average of 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides specialty or subspecialty neonatal special care.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VIII
Lithotripsy Services

12VAC5-230-480. Accessibility Staffing.

A. The waiting time for lithotripsy services should be no more than one week Open heart surgery services should have a medical director who is board certified in cardiovascular or cardiothoracic surgery by the appropriate board of the American Board of Medical Specialists.

In the case of pediatric cardiac surgery, the medical director should be board certified in cardiovascular or cardiothoracic surgery, with special qualifications and experience in pediatric cardiac surgery and congenital heart disease, by the appropriate board of the American Board of Medical Specialists.

B. Lithotripsy services should be available within 30 minutes driving time in urban areas and 45 minutes driving time one way, under normal conditions, for 95% of the population of the health planning region Cardiac surgery should be under the direct supervision of one or more qualified physicians.

Pediatric cardiac surgery services should be under the direct supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part V
General Surgical Services

12VAC5-230-490. Availability Travel time.

A. Consideration will be given to new lithotripsy services established at a general hospital through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, provided the hospital has referred at least two patients per week, or 100 patients annually, for the relevant reporting period to other facilities for lithotripsy services.

B. A new service may be approved at the site of any general hospital or hospital-based clinic or licensed outpatient surgical hospital provided the service is provided by:

1. A vendor currently providing services in Virginia;

2. A vendor not currently providing services who can demonstrate that the proposed unit can provide at least 750 procedures annually at all sites served; or

3. An applicant who can demonstrate that the proposed unit can provide at least 750 procedures annually at all sites to be served.

C. Proposals for the expansion of services by existing vendors or providers of such services may be approved if it can be demonstrated that each existing unit owned or operated by that vendor or provider has provided a minimum of 750 procedures annually at all sites served by the vendor or provider.

D. A new or expanded lithotripsy service may be approved when the applicant is a consortium of hospitals or a hospital network, when a majority of procedures will be provided at sites or facilities owned or operated by the hospital consortium or by the hospital network.

Surgical services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part IX
Organ Transplant

12VAC5-230-500. Accessibility Need for new service.

A. Organ transplantation services should be accessible within two hours driving time one way, under normal conditions, of 95% of Virginia's population. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a [ health ] planning district, exclusive of [ procedure rooms, ] dedicated cesarean section rooms, operating rooms designated exclusively for cardiac surgery, procedures rooms or VDH-designated trauma services, shall be determined as follows:

Where:

ORV = the sum of total inpatient and outpatient general purpose operating room visits in the [ health ] planning district in the most recent [ three five ] years for which general purpose operating room utilization data has been reported by VHI; and

POP = the sum of total population in the [ health ] planning district as reported by a demographic entity as determined by the commissioner, for the same [ three year five-year ] period as used in determining ORV.

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

AHORV = the average hours per general purpose operating room visit in the [ health ] planning district for the most recent year for which average hours per general purpose operating room visits have been calculated as reported by VHI.

FOR = future general purpose operating rooms needed in the [ health ] planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room available 40 hours per week, 50 weeks per year.

B. Providers of organ transplantation services should facilitate access to pre- and post-transplantation services needed by patients residing in rural locations by establishing part-time satellite clinics Projects involving the relocation of existing [ general purpose ] operating rooms within a [ health ] planning district may be authorized when it can be reasonably documented that such relocation will [ : (i) ] improve the distribution of surgical services within a [ health ] planning district by making services available within 30 minutes driving time one way under normal conditions of 95% of the planning district's population; (ii) result in the provision of the same surgical services at a lower cost to surgical patients in the health planning district; or (iii) optimize the number of operations in the health planning district that are performed on an outpatient basis ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-510. Availability Staffing.

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Proposals to expand existing transplantation programs shall demonstrate that existing organ transplantation services comply with all applicable Medicare program coverage criteria. Surgical services should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VI
Inpatient Bed Requirements

12VAC5-230-520. Minimum utilization; minimum survival rate; service proficiency; systems operations Travel time.

A. Proposals to establish or expand organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number of transplants required by organ system is:

Performance of minimum transplantation volumes does not indicate a need for additional transplantation capacity or programs.

B. Preference will be given to expansion of successful existing services, either by enabling necessary increases in the number of organ systems being transplanted or by adding transplantation capability for additional organ systems, rather than developing additional programs that could reduce average program volume.

C. Facilities should demonstrate that they will achieve and maintain minimum transplant patient survival rates. Minimum one-year survival rates, listed by organ system, are:

D. Proposals to add additional organ transplantation services should demonstrate at least two years successful experience with all existing organ transplantation systems.

E. All physicians that perform transplants should be board-certified by the appropriate professional examining board, and should have a minimum of one year of formal training and two years of experience in transplant surgery and post-operative care.

Inpatient beds should be within 30 minutes driving time one way under normal conditions of 95% of the population of a [ health ] planning district [ using a mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part X
Miscellaneous Capital Expenditures

12VAC5-230-530. Purpose Need for new service.

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other parts of the SMFP addressing changes in bed or service capacity used in the COPN review process.

A. No new inpatient beds should be approved in any [ health ] planning district unless:

1. The resulting number of beds for each bed category contained in this article does not exceed the number of beds projected to be needed for that [ health ] planning district for the fifth planning horizon year; and

2. The average annual occupancy based on the number of beds in the [ health ] planning district for the relevant reporting period is:

a. 80% at midnight census for medical/surgical or pediatric beds;

b. 65% at midnight census for intensive care beds.

B. For proposals to convert under-utilized beds that require a capital expenditure of $15 million or more, consideration may be given to such proposal if:

1. There is a projected need in the applicable category of inpatient beds; and

2. The applicant can demonstrate that the average annual occupancy of the converted beds would meet the utilization standard for the applicable bed category by the first year of operation.

For the purposes of this part, "underutilized" means less than 80% average annual occupancy for medical/surgical or pediatric beds, when the relocation involves such beds and less than 65% average annual occupancy for intensive care beds when relocation involves such beds. 

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-540. Project need Need for medical/surgical beds.

All applications involving the expenditure of $5 million dollars or more by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

The number of medical/surgical beds projected to be needed in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for the medical/surgical beds for the [ health ] planning district using the formula:

BUR = (IPD/PoP) x 1,000

Where:

BUR = the bed use rate for the [ health ] planning district.

IPD = the sum of total inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient day data has been reported by VHI; and

PoP = the sum of total population [ greater than ] 18 years of age [ and older ] in the [ health ] planning district for the same [ three five ] years used to determine IPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of medical/surgical beds needed for the [ health ] planning district in five years from the current year using the formula:

ProBed = ((BUR x ProPop)/365)/0.80

Where:

ProBed = The projected number of medical/surgical beds needed in the [ health ] planning district for five years from the current year.

BUR = the bed use rate for the [ health ] planning district determined in subdivision 1 of this section.

ProPop = the projected population [ greater than ] 18 years of age [ and older ] of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of medical/surgical beds that are needed in the [ health ] planning district for the five planning horizon years as follows:

NewBed = ProBed – CurrentBed

Where:

NewBed = the number of new medical/surgical beds that can be established in a [ health ] planning district, if the number is positive. If NewBed is a negative number, no additional medical/surgical beds should be authorized for the [ health ] planning district.

ProBed = the projected number of medical/surgical beds needed in the [ health ] planning district for five years from the current year determined in subdivision 2 of this section.

CurrentBed = the current inventory of licensed and authorized medical/surgical beds in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-550. Facilities expansion Need for pediatric beds.

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion are inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

The number of pediatric beds projected to be needed in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for pediatric beds for the [ health ] planning district using the formula:

PBUR = (PIPD/PedPop) x 1,000

Where:

PBUR = The pediatric bed use rate for the [ health ] planning district.

PIPD = The sum of total pediatric inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient days data has been reported by VHI; and

PedPop = The sum of population under [ 19 18 ] years of age in the [ health ] planning district for the same [ three five ] years used to determine PIPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of pediatric beds needed to the [ health ] planning district in five years from the current year using the formula:

ProPedBed = ((PBUR x ProPedPop)/365)/0.80

Where:

ProPedBed = The projected number of pediatric beds needed in the [ health ] planning district for five years from the current year.

PBUR = The pediatric bed use rate for the [ health ] planning district determined in subdivision 1 of this section.

ProPedPop = The projected population under [ 19 18 ] years of age of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of pediatric beds needed within the [ health ] planning district for the fifth planning horizon year as follows:

NewPedBed – ProPedBed – CurrentPedBed

Where:

NewPedBed = the number of new pediatric beds that can be established in a [ health ] planning district, if the number is positive. If NewPedBed is a negative number, no additional pediatric beds should be authorized for the [ health ] planning district.

ProPedBed = the projected number of pediatric beds needed in the [ health ] planning district for five years from the current year determined in subdivision 2 of this section.

CurrentPedBed = the current inventory of licensed and authorized pediatric beds in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-560. Renovation or modernization Need for intensive care beds.

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent three-year period.

The projected need for intensive care beds in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for ICU beds for the [ health ] planning district using the formula:

ICUBUR = (ICUPD/Pop) x 1,000

Where:

ICUBUR = The ICU bed use rate for the [ health ] planning district.

ICUPD = The sum of total ICU inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient day data has been reported by VHI; and

Pop = The sum of population [ greater than ] 18 years of age [ or older for adults or under 18 for pediatric patients ] in the [ health ] planning district for the same [ three five ] years used to determine ICUPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of ICU beds needed for the [ health ] planning district, including bed availability for unscheduled admissions, five years from the current year using the formula:

ProICUBed = ((ICUBUR x ProPop)/365)/0.65

Where:

ProICUBed = The projected number of ICU beds needed in the [ health ] planning district for five years from the current year;

ICUBUR = The ICU bed use rate for the [ health ] planning district as determine in subdivision 1 of this section;

ProPop = The projected population [ greater than ] 18 years of age [ or older for adults or under 18 for pediatric patients ] of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of ICU beds that may be established or relocated within the [ health ] planning district for the fifth planning horizon planning year as follows:

NewICUB = ProICUBed – CurrentICUBed

Where:

NewICUBed = The number of new ICU beds that can be established in a [ health ] planning district, if the number is positive. If NewICUBed is a negative number, no additional ICU beds should be authorized for the [ health ] planning district.

ProICUBed = The projected number of ICU beds needed in the [ health ] planning district for five years from the current year as determined in subdivision 2 of this section.

CurrentICUBed = The current inventory of licensed and authorized ICU beds in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-570. Equipment Expansion or relocation of services.

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

A. Proposals to relocate beds to a location not contiguous to the existing site should be approved only when:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The number of beds to be moved off-site is taken out of service at the existing facility;

4. The off-site replacement of beds results in:

a. A decrease in the licensed bed capacity;

b. A substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or

c. Generally improved operating efficiency in the applicant's facility or facilities; and

5. The relocation results in improved distribution of existing resources to meet community needs.

B. Proposals to relocate beds within a [ health ] planning district where underutilized beds are within 30 minutes driving time one way under normal conditions of the site of the proposed relocation should be approved only when the applicant can demonstrate that the proposed relocation will not materially harm existing providers.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XI
Medical Rehabilitation

12VAC5-230-580. Accessibility Long-term acute care hospitals (LTACHs).

Comprehensive inpatient rehabilitation services should be available within 60 minutes driving time one way, under normal conditions, of 95% of the population of the planning region.

A. LTACHs will not be considered as a separate category for planning or licensing purposes. All LTACH beds remain part of the inventory of inpatient hospital beds.

B. A LTACH shall only be approved if an existing hospital converts existing medical/surgical beds to LTACH beds or if there is an identified need for LTACH beds within a [ health ] planning district. New LTACH beds that would result in an increase in total licensed beds above 165% of the average daily census for the [ health ] planning district will not be approved. Excess inpatient beds within an applicant's existing acute care facilities must be converted to fill any unmet need for additional LTACH beds.

C. If an existing or host hospital converts existing beds for use as LTACH beds, those beds must be delicensed from the bed inventory of the existing hospital. If the LTACH ceases to exist, terminates its services, or does not offer services for a period of 12 months within its first year of operation, the beds delicensed by the host hospital to establish the LTACH shall revert back to that host hospital.

If the LTACH ceases operation in subsequent years of operation, the host hospital may reacquire the LTACH beds by obtaining a COPN, provided the beds are to be used exclusively for their original intended purpose and the application meets all other applicable project delivery requirements. Such an application shall not be subject to the standard batch review cycle and shall be processed as allowed under Part VI (12VAC5-220-280 et seq.) of the Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations.

D. The application shall delineate the service area for the LTACH by documenting the expected areas from which it is expected to draw patients.

E. A LTACH shall be established for 10 or more beds.

F. A LTACH shall become certified by the Centers for Medicare and Medicaid Services (CMS) as a long-term acute care hospital and shall not convert to a hospital for patients needing a length of stay of less than 25 days without obtaining a certificate of public need.

1. If the LTACH fails to meet the CMS requirements as a LTACH within 12 months after beginning operation, it may apply for a six-month extension of its COPN.

2. If the LTACH fails to meet the CMS requirements as a LTACH within the extension period, then the COPN granted pursuant to this section shall expire automatically.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-590. Availability Staffing.

A. The number of comprehensive and specialized rehabilitation beds needed in a health planning region will be projected as follows:

((UR x PROJ. POP.)/365)/.90

Where UR = the use rate expressed as rehabilitation patient days per population in the health planning region as reported in the most recent "Industry Report for Virginia Hospitals and Nursing Facilities" published by Virginia Health Information; and

PROJ.POP. = the most recent projected population of the health planning region three years from the current year as published by the Virginia Employment Commission.

B. No additional rehabilitation beds should be authorized for a health planning region in which existing rehabilitation beds were utilized at an average annual occupancy of less than 90% in the most recently reported year.

Preference will be given to the development of needed rehabilitation beds through the conversion of underutilized medical/surgical beds.

C. Notwithstanding subsection A of this section, the need for proposed inpatient rehabilitation beds will be given consideration when:

1. The rehabilitation specialty proposed is not currently offered in the health planning region; and

2. A documented basis for recognizing a need for the service or beds is provided by the applicant.

Inpatient services should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VII
Nursing Facilities

12VAC5-230-600. Staffing Travel time.

Medical rehabilitation facilities should have full-time medical direction by a physiatrist or other physician with a minimum of two years experience in the proposed specialized inpatient medical rehabilitation program.

A. Nursing facility beds should be accessible within 30 minutes driving time one way under normal conditions to 95% of the population in a [ health ] planning district [ using mapping software as determined by the commissioner ].

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. [ Consideration will Preference may ] be given to proposals that improve geographic access and reduce travel time to nursing facilities within a [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XII
Mental Health Services

Article 1
Psychiatric and Substance Abuse Disorder Treatment Services

12VAC5-230-610. Accessibility Need for new service.

A. Acute psychiatric, acute substance abuse disorder treatment services, and intermediate care substance abuse disorder treatment services should be available within 60 minutes driving time one way, under normal conditions, of 95% of the population.

B. Existing and proposed acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment service providers shall have established plans for the provision of services to indigent patients which include, at a minimum: (i) the minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients; (ii) the minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation; (iii) the minimum number of unreimbursed patient days to be provided to local community services boards; and (iv) a description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

C. Proposed acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment service providers shall have formal agreements with their identified community services boards that: (i) specify the number of charity care patient days that will be provided to the community service board; (ii) describe the mechanisms to monitor compliance with charity care provisions; (iii) provide for effective discharge planning for all patients, including return to the patients place of origin or home state if not Virginia; and (iv) consider admission priorities based on relative medical necessity.

D. Providers of acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment services serving large geographic areas should establish satellite outpatient facilities to improve patient access, where appropriate and feasible.

A. A [ health ] planning district should be considered to have a need for additional nursing facility beds when:

1. The bed need forecast exceeds the current inventory of beds for the [ health ] planning district; and

2. The average annual occupancy of all existing and authorized Medicaid-certified nursing facility beds in the [ health ] planning district was at least 93%, excluding the bed inventory and utilization of the Virginia Veterans Care Centers.

Exception: When there are facilities that have been in operation less than three years in the [ health ] planning district, their occupancy can be excluded from the calculation of average occupancy if the facilities [ has had ] an annual occupancy of at least 93% in one of its first three years of operation.

B. No [ health ] planning district should be considered in need of additional beds if there are unconstructed beds designated as Medicaid-certified. This presumption of ‘no need' for additional beds extends for three years [ or the date on the certificate, whichever is longer, for the unconstructed beds from the issuance date of the certificate ].

C. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85)

Where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP64 = The population aged 0 to 64 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP69 = The population aged 65 to 69 projected for the [ health ] planning district three years from the current year as most recently published by the a demographic program as determined by the commissioner.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP74 = The population aged 70 to 74 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP79 = The population aged 75 to 79 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP84 = The population aged 80 to 84 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP85+ = The population aged 85 and older projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

[ Planning Health planning ] district bed need forecasts will be rounded as follows:

Exception: When a [ health ] planning district has:

1. Two or more nursing facilities;

2. Had an average annual occupancy rate in excess of 93% for the most recent two years for which bed utilization has been reported to VHI; and

3. Has a forecasted bed need of 15 to 29 beds, then the bed need for this [ health ] planning district will be rounded to 30.

D. No new freestanding nursing facilities of less than 90 beds should be authorized. However, consideration may be given to a new freestanding facility with fewer than 90 nursing facility beds when the applicant can demonstrate that such a facility is justified based on a locality's preference for such smaller facility and there is a documented poor distribution of nursing facility beds within the [ health ] planning district.

E. When evaluating the [ capital ] cost of a project, consideration may be given to projects that use the current methodology as determined by the Department of Medical Assistance Services.

F. [ Consideration Preference ] may be given to [ proposals to projects that ] replace outdated and functionally obsolete facilities with modern facilities that result in the more cost-efficient resident services in a more aesthetically pleasing and comfortable environment.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-620. Availability Expansion of services.

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROJ.POP. = the projected population of the planning district five years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-80, no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

However, consideration will be given to the addition of acute psychiatric or acute substance abuse disorder beds by existing medical care facilities in planning districts with an excess supply of beds when such additions can be justified on the basis of facility-specific utilization or geographic remoteness, i.e., driving time of 60 minutes or more, one way under normal conditions, to alternate acute care facilities. If the facility with the institutional need for beds is part of a hospital network, underutilized beds at the other facilities within the network should be relocated to the facility with the institutional need if possible.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.80

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROJ.POP. = the projected population of the planning district five years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

E. Preference will be given to the development of needed acute psychiatric and intermediate substance abuse disorder treatment beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and to have contractual agreements to serve populations served by Community Services Boards, whether through conversion of underutilized general hospital beds or development of new beds.

F. The number of intermediate care substance disorder abuse treatment beds needed in a planning district with existing intermediate care substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the planning district expressed as the average intermediate care substance abuse disorder treatment patient days per population reported for the most recent three-year period; and

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

G. Subject to the provisions of 12VAC5-230-80, no additional intermediate care substance abuse disorder treatment beds should be authorized for a planning district with existing intermediate care substance abuse disorder treatment beds if the existing inventory of such beds is greater than the need identified. No beds in facilities operated by DMHMRSAS will be included in the inventory of intermediate care substance abuse disorder beds.

However, consideration will be given to the addition of intermediate care substance abuse disorder treatment beds by existing medical care facilities in planning districts with an excess supply of beds when such addition can be justified on the basis of facility-specific utilization or geographic remoteness, i.e., driving time of 60 minutes or more one way under normal conditions, to alternate acute care facilities. If the facility with the institutional need for beds is part of a hospital network, underutilized beds at the other facilities within the network should be relocated to the facility with the institutional need if possible.

H. No existing intermediate care substance abuse disorder treatment beds should be relocated from one site to another unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing intermediate care substance abuse disorder treatment providers to continue to provide historic levels of service to indigent patients.

I. The number of intermediate care substance abuse disorder treatment beds needed in a planning district without existing intermediate care substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average intermediate care substance abuse disorder treatment patient days per population reported for the most recent three-year period;

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

J. Preference will be given to the development of needed intermediate care substance abuse disorder treatment beds through the conversion of underutilized general hospital beds.

Proposals to increase existing nursing facility bed capacity should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 93% in the relevant reporting period as reported to VHI.

Note: Exceptions will be considered for facilities that operated at less than 93% average annual occupancy in the most recent year for which bed utilization has been reported when the facility [ has a rehabilitative or other specialized care program causing a short average length of stay resulting in offers short stay services causing ] an average annual occupancy lower than 93% for the facility.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Mental Retardation

12VAC5-230-630. Availability Continuing care retirement communities.

The establishment of new ICF/MR facilities should not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility.

6. The proposed new facility is consistent with the current DMHMRSAS Comprehensive Plan and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities (CCRC) will be considered when:

[ 1. The facility is registered with the State Corporation Commission as a continuing care provider pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia; ]

[ 1. 2. ] The [ total ] number of [ new or additional beds plus any existing ] nursing facility beds [ operated by the continuing care provider does not exceed 20% of the continuing care provider's total existing or planned independent living and adult care residence requested in the initial application does not exceed the lesser of 20% of the continuing care retirement community's total number of beds that are not nursing home beds or 60 beds ];

[ 2. 3. ] The [ proposed beds are necessary to meet existing or reasonably anticipated obligations to provide care to present or prospective residents of the continuing care facility number of new nursing facility beds requested in any subsequent application does not cause the continuing care retirement community's total number of nursing home beds to exceed 20% of its total number of beds that are not nursing facility beds ]; and

[ 3. The applicant certifies that :

a. The CCRC has, or will have, a qualified resident assistance fund and that the facility will not rely on federal and state public assistance funds for reimbursement of the proposed beds;

b. The continuing care contract or disclosure statement, as required by § 38.2-4902 of the Code of Virginia, has been filed with the State Corporation Commission and that the commission has deemed the contract or disclosure statement in compliance with applicable law; and

c. Only continuing care contract holders residing in the CCRC as independent living residents or adult care residents or who is a family member of a contract holder residing in a non-nursing facility portion of the CCRC will be admitted to the nursing facility unit after the first three years of operation.

4. The continuing care retirement community has established a qualified resident assistance policy. ]

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-640. Continuity; integration Staffing.

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary. Nursing facilities shall be under the direction or supervision of a licensed nursing home administrator and staffed by licensed and certified nursing personnel qualified as required by law. 

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VIII
Lithotripsy Service

12VAC5-230-650. Acceptability Travel time.

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations of the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services. Lithotripsy services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the health planning region [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XIII
Perinatal Services

Article 1
Criteria and Standards for Obstetrical Services

12VAC5-230-660. Accessibility Need for new service.

Obstetrical services should be located within 30 minutes driving time one way, under normal conditions, of 95% of the population in rural areas and within 30 minutes driving time one way, under normal conditions, in urban and suburban areas.

A. [ Consideration Preference ] may be given to [ a project that establishes ] new renal or orthopedic lithotripsy services [ established ] at a new facility through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, [ provided and ] the facility has referred at least two appropriate patients per week, or 100 appropriate patients annually, for the relevant reporting period to other facilities for either renal or orthopedic lithotripsy services.

B. A new renal lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 750 renal lithotripsy procedures annually.

C. A new orthopedic lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 500 orthopedic lithotripsy procedures annually.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-670. Availability Expansion of services.

A. Proposals to establish new obstetrical services in rural areas should demonstrate that obstetrical volumes within the travel times listed in 12VAC5-230-660 will not be negatively affected.

B. Proposals to establish new obstetrical services in urban and suburban areas should demonstrate that a minimum of 2,500 deliveries will be performed annually by the second year of operation and that obstetrical volumes of existing providers located within the travel times listed in 12VAC5-230-660 will not be negatively affected.

C. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service will be given preference over the addition of new services or the expansion of single service providers.

A. Proposals to [ increase expand ] renal lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 750 procedures annually at all sites served by the vendor or provider.

B. Proposals to [ increase expand ] orthopedic lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 500 procedures annually at all sites served by the vendor or provider.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-680. Continuity Adding or expanding mobile lithotripsy services.

A. Perinatal service capacity should be developed and sized to provide routine newborn care to infants delivered in the associated obstetrics service, and shall have the capability to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The application should identify the primary and secondary neonatal special care center nearest the proposed service and provide travel time one way, under normal conditions, to those centers.

A. Proposals for mobile lithotripsy services should demonstrate that, for the relevant reporting period, at least 125 procedures were performed and that the proposed mobile unit will not reduce the utilization of existing machines in the [ health ] planning region.

B. Proposals to convert a mobile lithotripsy service to a fixed site lithotripsy service should demonstrate that, for the relevant reporting period, at least 430 procedures were performed and the proposed conversion will not reduce the utilization of existing providers in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Neonatal Special Care Services

12VAC5-230-690. Accessibility Staffing.

Neonatal special care services should be located within an average of 45 minutes driving time one way, under normal conditions, in urban and suburban areas of hospitals providing general-level newborn services. Lithotripsy services should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part IX
Organ Transplant

12VAC5-230-700. Availability Travel time.

A. Existing neonatal special care units located within the travel times listed in 12VAC5-230-660 should achieve 65% average annual occupancy before new services can be added to the planning region Organ transplantation services should be accessible within two hours driving time one way under normal conditions of 95% of Virginia's population [ using mapping software as determined by the commissioner ].

B. Preference will be given to the expansion of existing services rather than the creation of new services Providers of organ transplantation services should facilitate access to pre and post transplantation services needed by patients residing in rural locations be establishing part-time satellite clinics.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-710. Neonatal services Need for new service.

The application should identify the service area, levels of service, and capacity of the current general-level newborn service hospitals to be served within the identified area.

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Performance of minimum transplantation volumes as cited in 12VAC5-230-720 does not indicate a need for additional transplantation capacity or programs.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-720. Transplant volumes; survival rates; service proficiency; systems operations.

A. Proposals to establish organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number transplants of required by organ system is:

Note: Any proposed pancreas transplant program must be a part of a kidney transplant program that has achieved a minimum volume standard of 30 cases per year for kidney transplants as well as the minimum transplant survival rates stated in subsection B of this section.

B. Applicants shall demonstrate that they will achieve and maintain at least the minimum transplant patient survival rates. Minimum one-year survival rates listed by organ system are:

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-730. Expansion of transplant services.

A. Proposals to [ increase expand ] organ transplantation services shall demonstrate at least two years successful experience with all existing organ transplantation systems at the hospital.

B. [ Consideration will Preference may ] be given to [ expanding successful existing services through increases in a project expanding ] the number of organ systems being transplanted [ at a successful existing service ] rather than developing new programs that could reduce existing program volumes.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-740. Staffing.

Organ transplant services should be under the direct supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part X
Miscellaneous Capital Expenditures

12VAC5-230-750. Purpose.

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other service specific parts addressed elsewhere in this chapter.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-760. Project need.

All applications involving the expenditure of $15 million or more by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-770. Facilities expansion.

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion is inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-780. Renovation or modernization.

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent five-year period.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-790. Equipment.

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XI
Medical Rehabilitation

12VAC5-230-800. Travel time.

Medical rehabilitation services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-810. Need for new service.

A. The number of comprehensive and specialized rehabilitation beds shall be determined as follows:

((UR x PROPOP)/365)/ [ .85 .80 ]

Where:

UR = the use rate expressed as rehabilitation patient days per population in the [ health ] planning district as reported by VHI; and

PROPOP = the most recent projected population of the [ health ] planning district five years from the current year as published by a demographic entity as determined by the commissioner.

B. Proposals for new medical rehabilitation beds should be considered when the applicant can demonstrate that:

1. The rehabilitation specialty proposed is not currently offered in the [ health ] planning district; and

2. There is a documented need for the service or beds in the [ health ] planning district.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-820. Expansion of services.

No additional rehabilitation beds should be authorized for a [ health ] planning district in which existing rehabilitation beds were utilized with an average annual occupancy of less than [ 85% 80% ] in the most recently reported year.

[ Exception: Consideration Preference ] may be given to [ expanding a project to expand ] rehabilitation beds [ through the conversion of by converting ] underutilized medical/surgical beds.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-830. Staffing.

Medical rehabilitation facilities should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XII
Mental Health Services

Article 1
Acute Psychiatric and Acute Substance Abuse Disorder Treatment Services

12VAC5-230-840. Travel time.

Acute psychiatric and acute substance abuse disorder treatment services should be available within 60 minutes driving time one way under normal conditions of 95% of the population [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-850. Continuity; integration.

A. Existing and proposed acute psychiatric and acute substance abuse disorder treatment providers shall have established plans for the provision of services to indigent patients that include:

1. The minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients;

2. The minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation;

3. The minimum number of unreimbursed patient days to be provided to local community services boards; and

4. A description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

B. Proposed acute psychiatric and acute substance abuse disorder treatment providers shall have formal agreements with the appropriate local community services boards or behavioral health authority that:

1. Specify the number of patient days that will be provided to the community service board;

2. Describe the mechanisms to monitor compliance with charity care provisions;

3. Provide for effective discharge planning for all patients, including return to the patient's place of origin or home state if not Virginia; and

4. Consider admission priorities based on relative medical necessity.

C. Providers of acute psychiatric and acute substance abuse disorder treatment serving large geographic areas should establish satellite outpatient facilities to improve patient access where appropriate and feasible.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-860. Need for new service.

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a [ health ] planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the [ health ] planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-70, no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a [ health ] planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

[ Consideration Preference ] may also be given to the addition of acute psychiatric or acute substance abuse beds dedicated for the treatment of geriatric patients in [ health ] planning districts with an excess supply of beds when such additions are justified on the basis of the specialized treatment needs of geriatric patients.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a [ health ] planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the health planning region in which the [ health ] planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

E. Preference [ will may ] be given to the development of needed acute psychiatric beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and that have contractual agreements to serve populations served by community services boards, whether through conversion of underutilized general hospital beds or development of new beds.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Mental Retardation

12VAC5-230-870. Need for new service.

The establishment of new ICF/MR facilities with more than 12 beds shall not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility;

6. The proposed new facility will have a maximum of 20 beds and is consistent with any plan of the Department of Mental Health, Mental Retardation and Substance Abuse Sservices and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-880. Continuity; integration.

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-890. Compliance with licensure standards.

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations for the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XIII
Perinatal [ and Obstetrical ] Services

Article 1
Criteria and Standards for Obstetrical Services

12VAC5-230-900. Travel time.

Obstetrical services should be located within 30 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-910. Need for new service.

[ A. ] No new obstetrical services should be approved unless the applicant can demonstrate that, based on the population and utilization of current services, there is a need for such services in the [ health ] planning district without [ significantly ] reducing the utilization of existing providers in the [ panning health planning ] district.

[ B. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service should be given preference over establishing new services or expanding single service providers. ]

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-920. Continuity.

A. Perinatal service capacity, including service availability for unscheduled admissions, should be developed to provide routine newborn care to infants delivered in the associated obstetrics service, and shall be able to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The proposal shall identify the primary and secondary neonatal special care center nearest the proposed service shall provide transport one-way to those centers.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-930. Staffing.

Obstetric services should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Neonatal Special Care Services

12VAC5-230-940. Travel time.

A. Intermediate level neonatal special care services should be located within 30 minutes driving time one way under normal conditions of hospitals providing general level new born services [ using mapping software as determined by the commissioner ].

B. Specialty and subspecialty neonatal special care services should be located within 90 minutes driving time one way under normal conditions of hospitals providing general or intermediate level newborn services [ using mapping software as determined by the commissioner ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-950. Need for new service.

[ A. ] No new level of neonatal service shall be offered by a hospital unless that hospital has first obtained a COPN granting approval to provide each such level of service.

[ B. Preference will be given to the expansion of existing services, rather than to the creation of new services. ]

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-960. Intermediate level newborn services.

A. Existing [ neonatal special care units providing ] intermediate level newborn services as designated in 12VAC5-410-443 [ , located within 30 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new intermediate level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing intermediate Intermediate ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of six bassinets [ , stations or beds ].

C. No more than four bassinets [ , stations and beds ] for intermediate level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-970. Specialty level newborn services.

A. Existing [ neonatal special care units providing ] specialty level newborn services as designated in 12VAC5-410-443 [ located within 90 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new specialty level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing specialty Specialty ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets [ , stations or beds. A station shall equal one bed ].

C. No more than four bassinets [ , stations and beds ] for specialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

D. Proposals to establish specialty level [ neonatal special care ] services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing specialty level [ neonatal special care newborn service ] providers located within the travel time listed in 12VAC5-230-940 will not be [ significantly ] reduced.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-980. Subspecialty level newborn services.

A. Existing [ neonatal special care units providing ] subspecialty level newborn services as designated in 12VAC5-410-443 [ located within 90 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new subspecialty level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing subspecialty Subspecialty ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets [ , stations or beds. A station shall equal one bed ].

C. No more than four bassinets [ , stations and beds ] for subspecialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

D. Proposals to establish subspecialty level [ neonatal special care newborn ] services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing subspecialty level [ neonatal special care newborn ] providers located within the travel time listed in 12VAC5-230-940 will not be [ significantly ] reduced.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-990. Neonatal services.

The application shall identify the service area and the levels of service of all the hospitals to be served by the proposed service.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-1000. Staffing.

All levels of neonatal special care services should be under the direction or supervision of one or more qualified physicians as described in 12VAC5-410-443.

Statutory Authority

§ 32.1-12, 32.1-102.1, 32.1-102.2, and 32.1-102.3 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 240
GENERAL ACUTE CARE SERVICES (REPEALED)

Part I
Definitions

12VAC5-240-10. Definitions. (Repealed.)

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acute inpatient facility beds" means any beds included in the definitions of "general medical/surgical beds" and "intensive care beds."

"Acute care inpatient facility" means any hospital, ambulatory surgical center providing overnight accommodations, or other medical care facility which provides medical care and distinct housing of patients whose length of stay averages at most 30 days.

"Department" means the Virginia Department of Health.

"General medical/surgical beds" means acute care inpatient beds located in the following units or categories:

1. General medical/surgical units that are organized facilities and services (excluding those for newborns) available for the care and treatment of patients, not requiring specialized services; and

2. Pediatric units that are organized facilities and services maintained and operated as a distinct unit for regular use by inpatients below the age of 15. Newborn cribs and bassinets are excluded from this definition.

"Inpatient beds" means accommodations within a medical care facility with continuous support services (such as food, laundry, housekeeping) and staff to provide health or health-related services to patients who generally remain in the medical care facility in excess of 24 hours. Such accommodations are known by various nomenclatures including but not limited to; nursing facility beds, intensive care beds, minimal or self care beds, insolation beds, hospice beds, observation beds equipped and staffed for overnight use, and obstetric, medical surgical, psychiatric, substance abuse, medical rehabilitation and pediatric beds including pediatric bassinets and incubators. Bassinets and incubators in the maternity department and beds located in labor and birthing rooms, emergency rooms, preparation or anesthesia inductor rooms, diagnostic or treatment procedure rooms, or on-call staff rooms are excluded from this definition.

"Intensive care beds" means acute inpatient beds that are located in the following units or categories:

1. General intensive care units (ICU) means those units in which patients are concentrated, by reason of serious illness or injury, without regard to diagnosis. Special lifesaving techniques and equipment are immediately available, and patients are under continuous observation by nursing staff specially trained and selected for the care of this class of patient;

2. Cardiac care units (CCU) means special units staffed and equipped solely for the intensive care of cardiac patients;

3. Specialized intensive care units (SICU) means any units with specialized staff and equipment for the purpose of providing care to seriously ill or injured patients for selected categories of diagnoses. Examples include units established for burn care, trauma care, neurological care, pediatric care, and cardiac surgery recovery. This category of beds does not include neonatal intensive care units; and

4. Progressive care units (PCU) means any units which have been established to care for seriously ill or injured patients who do not require the continuous level of care available in an intensive care unit but whose conditions require monitoring at a level which is generally not available in a general medical/surgical bed.

"Licensed bed" means those inpatient care beds licensed by the department's Office of Health Facilities regulation.

"Nursing facility beds" means inpatient beds which are located in distinct units of acute inpatient facilities which are licensed as long-term care units by the department. Beds in these long-term units are not included in the calculations of acute inpatient bed need.

"Off-site replacement" means the movement of existing beds off of the existing site of an acute care inpatient facility.

"Planning horizon year" means the particular year for which beds are projected to be needed.

"Relevant reporting period" means the most recent 12-month period, prior to the beginning of the Certificate of Public Need application's review cycle, for which data is available and acceptable to the department.

"Skilled nursing units (SNF)" means those units which provide patient care at a level of care below that normally required in an acute care setting and greater than that of an intermediate care nursing facility. Although such units often have lengths of stays of less than 30 days, they are considered nursing facility beds and are excluded in calculations of acute care inpatient bed need.

"Staffed beds" means that portion of the licensed or approved beds that are immediately available to be occupied. Beds which are not available due to lack of staffing or renovation are excluded from this category.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-101 § 1.1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-240-20. Accessibility. (Repealed.)

Acute care inpatient facility beds should be within 30 minutes driving time, under normal conditions, of 90% of the population of a planning district.

Providers of acute care inpatient facility services serving rural areas should facilitate the transport of patients residing in rural areas to needed medical care facilities and services, directly or through coordinated efforts with other organizations. Preference will be given in the review of competing applications to applicants who can document a commitment to development of transportation resources for rural populations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-101 § 2.1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-240-30. Availability. (Repealed.)

A. Need for new service.

1. No new acute inpatient care beds should be approved in any planning district unless the resulting number of licensed and approved beds in a planning district does not exceed the number of beds projected to be needed, for each acute inpatient bed category, for that planning district for the fifth planning horizon year.

2. Notwithstanding the need for new acute inpatient care beds above, no proposals to increase the general medical/surgical and pediatric bed capacity in a planning district should be approved unless the average annual occupancy, based on the number of licensed beds in the planning district where the project is proposed, is at least 85% for the relevant reporting period.

3. Notwithstanding the need for new acute inpatient beds above, no proposals to increase the intensive care bed capacity in a nonrural area should be approved unless: (i) the average annual occupancy rate, based on the number of licensed beds in the nonrural area where the project is proposed, is at least 65% for the relevant reporting period; or (ii) for hospitals in rural areas, the number of beds projected to be needed to provide 99% probability that adequate bed capacity will exist for all unscheduled admissions, exceeds the number of licensed beds projected for the fifth planning horizon year.

B. Off-site replacement of existing services.

1. No proposal to replace acute care inpatient beds off-site, to a location not contiguous to the existing site, should be approved unless: (i) off-site replacement is necessary to correct life safety or building code deficiencies; (ii) the population served by the beds to be moved will have reasonable access to the acute care beds at the new site, or the population served by the facility to be moved will generally have comparable access to neighboring acute care facilities; and (iii) the beds to be replaced experienced an average annual utilization of 85% for general medical/surgical beds and 65% for intensive care beds in the relevant reporting period.

2. The number of beds to be moved off-site must be taken out of service at the existing facility.

3. The off-site replacement of beds should result in a decrease in the licensed bed capacity of the applicant facility(ies) or substantial cost savings, cost avoidance, consolidation of underutilized facilities, or in other ways improve operation efficiency, or improvements in the quality of care delivered over that experienced by the applicant facility(ies).

C. Alternative need for the conversion of underutilized licensed bed capacity. For proposals involving a capital expenditure of $1 million or more, and involving the conversion of underutilized licensed bed capacity to either medical/surgical, pediatric or intensive care, consideration will be given to the approval of the project if: (i) there is a projected need for the category of acute inpatient care beds that would result from the conversion; and (ii) it can be reasonably demonstrated that the average annual occupancy of the beds to be converted would reach the standard in subdivision B 1 of this section for the bed category that would result from the conversion, by the first year of operation.

D. Computation of the need for general medical/surgical and pediatric beds.

1. A need for additional acute care inpatient beds may be demonstrated if the total number of licensed and approved beds in a given category in the planning district where the proposed project will be located is less than the number of such beds that are projected as potentially necessary to meet demand in the fifth planning horizon year from the year in which the application is submitted.

2. The number of licensed and approved general medical/surgical beds will be based on the inventory presented in the most recent edition of the State Medical Facilities Plan or amendment thereof, and may also include subsequent reductions in or additions to such beds for which documentation is available and acceptable to the department. The number of general medical/surgical beds projected to be needed in the planning district shall be computed using the following method:

a. Determine the projected total number of general medical/surgical and pediatric inpatient days for the fifth planning horizon year as follows:

(1) Sum the medical/surgical and pediatric unit inpatient days for the past three years for all acute care inpatient facilities in the planning district as reported in the Annual Survey of Hospitals;

(2) Sum the planning district projected population for the same three-year period as reported by the Virginia Employment Commission;

(3) Divide the sum of the general medical/surgical and pediatric unit inpatient days by the sum of the population and express the resulting rate in days per 1,000 population;

(4) Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in 1,000s) for the fifth planning horizon year.

b. Determine the projected number of general medical/surgical and pediatric unit beds which may be needed in the planning district for the planning horizon year as follows:

(1) Divide the result in subdivisions D 2 a (4) (number of days projected to be needed) by 365;

(2) Divide the quotient obtained by 0.85 in planning districts in which 50% or more of the population resides in nonrural areas and 0.75 in planning districts in which less than 50% of the population resides in nonrural areas.

c. Determine the projected number of general medical/surgical and pediatric beds which may be established or relocated within the planning district for the fifth planning horizon year as follows:

(1) Determine the number of licensed and approved medical/surgical and pediatric beds as reported in the inventory of the most recent edition of the State Medical Facilities Plan, available data acceptable to the department;

(2) Subtract the number of beds identified in subdivision 2 a of this subsection from the number of beds needed as determined in subdivision 2 b (2) of this subsection. If the difference indicated is positive, then a need may be determined to exist for additional general medical/surgical or pediatric beds. If the difference is negative, then no need shall be determined to exist for additional beds.

E. Computation of need for distinct pediatric units.

1. Beds used to form pediatric units must be taken from the inventory of general medical/surgical beds of a facility if need for additional such beds cannot be demonstrated.

2. Should a hospital desire to establish or expand a distinct pediatric unit within its licensed bed capacity, the following methodology shall be used to determine the appropriate size:

a. Determine the utilization of the individual hospital's inpatient days by persons under 15 years of age:

(1) Sum the general medical/surgical (including pediatric unit) inpatient days for the past three years for all patients under 15 years of age from hospital discharge abstracts;

(2) Sum the planning district projected population for the 0 to 14 age group for the same three-year period as reported by the Virginia Employment Commission;

(3) Divide the sum of the general medical/surgical days by the sum of the population and express the resulting rate in days per 1,000 population;

(4) Multiply the days per 1,000 population rate by the projected population age 0 to 14 for the planning district (expressed in 1,000s) for the fifth planning horizon year to yield the projected pediatric patient days;

(5) Divide the patient days by 365 to yield the projected average daily census (PADC);

(6) Calculate the number of beds needed to assure that adequate bed capacity will exist with a 99% probability for an unscheduled pediatric admission using the following formula:

Number of pediatric beds allowable = PADC + 2.33%V(501) %VPADC

F. Computation of need for intensive care beds.

1. The number of licensed and approved intensive care beds will be based on the inventory presented in the most recent edition of the State Medical Facilities Plan or amendment thereof, and may also include subsequent reductions in or additions to such beds for which documentation is available and acceptable to the department.

2. The number of intensive care beds projected to be needed in the planning district shall be computed using the following method:

a. Determine the projected total number of intensive care inpatient days for the fifth planning horizon year as follows:

(1) Sum the intensive care inpatient days for the past three years for all acute care inpatient facilities in the planning district as reported in the annual survey of hospitals;

(2) Sum the planning district projected population for the same three-year period as reported by the Virginia Employment Commission;

(3) Divide the sum of the intensive care days by the sum of the population and express the resulting rate in days per 1,000 population;

(4) Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in 1,000s) for the fifth planning horizon year to yield the expected intensive care patient days.

b. Determine the projected number of intensive care beds which may be needed in the planning district for the planning horizon year as follows:

(1) Divide the number of days projected in subdivision 2 a (4) of this subsection by 365 to yield the projected average daily census (PADC);

(2) Calculate the beds needed to assure with 99% probability that an intensive care bed will be available for the unscheduled admission:

Number of pediatric beds allowable = PADC + 2.33%V(501) %VPADC

c. Determine the projected number of intensive care beds which may be established or relocated within the planning district for the fifth planning horizon year as follows:

(1) Determine the number of licensed and approved intensive care beds as reported in the inventory of the most recent edition of the State Medical Facilities Plan, an amendment thereof, or the inventory after subsequent documented reductions or additions have been determined by the department.

(2) Subtract the number of licensed and approved beds identified in subdivision 2 c (1) of this subsection from the number of beds needed as determined in subdivision 2 b (2) of this subsection. If the difference indicated is positive, then a need may be determined to exist for additional intensive care beds. If the difference is negative, then no need shall be determined to exist for additional beds.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-101 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-240-40. Continuity; system coordination for intensive care beds. (Repealed.)

A. All proposals to establish or expand general intensive care beds or cardiac care beds should provide written policies and agreements providing for transfer of patients to specialized units outside of their facility.

B. All proposals to establish or expand specialized intensive care units should provide agreements with all hospitals in their primary and secondary service areas for the transfer of only those patients requiring specialized care to their units.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-101 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-240-50. Cost. (Repealed.)

A. Use of underutilized beds.

1. For proposals that have a capital cost of $1 million or more, preference shall be given to applications which propose to expand intensive care or pediatric units through the conversion of existing underutilized general medical/surgical beds, or to the expansion of general medical/surgical beds through the conversion of underutilized specialty beds.

2. No hospital should relocate beds to a new location if underutilized beds (less than 85% average annual occupancy for medical/surgical and pediatric beds and less than 65% average annual occupancy for intensive care beds) are available within ten miles of the proposed site of the applicant hospital.

B. Reasonable construction cost.

1. The cost per square foot of new construction as well as renovation to the existing facility should be consistent with state and regional costs for similar facilities and patient units.

2. Preference will be given to those proposals which identify the major source of capital as accumulated reserves.

C. Operating cost and charges.

1. The applicant should demonstrate that projected operating costs and charge structure will be comparable or less than similar facilities operating in the same planning district.

2. For projects involving an off-site replacement of beds, the applicant should, in addition to the above standard, demonstrate that the operating costs and charge structure of the proposed facility shall be comparable to, or less than continued operations at the existing facility.

3. Preference should be given to those facilities which have consistently demonstrated the highest levels of charity care as a percent of total patient revenues as reported to the Virginia Health Services Cost Review Council.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-101 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-240-60. Quality; accreditation and compliance with chapters. (Repealed.)

A. The applicant should provide assurances that the proposed facility or units will be designed, staffed, and operated in compliance with applicable state licensure chapters.

B. The applicant should agree to apply for accreditation with the Joint Commission on Accreditation of Healthcare Organizations or other appropriate accreditation organization.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-101 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 250
PERINATAL SERVICES (REPEALED)

Part I
Definitions

12VAC5-250-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Basic obstetrical services" means the distinct, organized inpatient facilities, equipment and care related to pregnancy and the delivery of newborns.

"Basic perinatal services" means those minimal resources and capabilities that all hospitals offering obstetrical services must provide routinely to newborns. The basic services are defined, in Appendix J, specifically by the Virginia Perinatal Services Advisory Board in its "Guidelines for Neonatal Special Care."

"Department" means the Virginia Department of Health.

"Neonatal special care" means care for infants in one or more of the eight patient categories identified by the Perinatal Services Advisory Board in its "Guidelines for Neonatal Special Care."

"Regional neonatal services" (often referred to as Level III neonatal intensive care) means those minimal resources and capabilities available to provide care for all (with the exception of providing invasive cardiac evaluation) of the eight neonatal categories specified in the "Guidelines for Neonatal Special Care" developed by the Perinatal Services Advisory Board. A regional neonatal services provider has accepted at least 10 neonatal transfers from less comprehensive settings within the past twelve months and is certified by Medicaid as rendering extensive neonatal care under Item 6 of Attachment 4.19-A to the State Plan for Medical Assistance.

For the purposes of defining extensive neonatal care, a recognized intensive care unit is defined as a unit which meets the following criteria:

1. It qualifies for reimbursements as an "intensive care unit" under the Medicare principles of reimbursement (see HIM-15, Section 2202.7);

2. It is designated or eligible as a regional perinatal center pursuant to Amendment Number 5 to the Virginia State Health Plan 1980-1984 on perinatal care adopted September 19, 1984, by the Statewide Health Coordinating Council, effective November 15, 1984;

3. It is operating in a manner consistent with the Statewide Perinatal Services Plan, developed by the Statewide Perinatal Services Advisory Council of the Commonwealth of Virginia, dated May 1983 (revised 1984); and

4. It is in conformance with all guidelines for Level III facilities identified in Guidelines for Perinatal Care issued by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (1992).

"Regional obstetric services" means those minimal resources and capabilities to handle the different complications identified in "Guidelines Concerning Maternal Transfer" adopted by the Perinatal Services Advisory Board. A regional obstetric services provider has accepted at least 10 maternal transfers from less comprehensive settings within the past 12 months.

"Regional perinatal center" ("RPC") means a comprehensive obstetric, perinatal and neonatal program serving the Perinatal Service Area as defined by the Department and the Perinatal Services Advisory Board and recognized unofficially as the referral center. The RPC has (i) the capability to handle the different complications identified in "Guidelines Concerning Maternal Transfer" adopted by the Perinatal Services Advisory Board; (ii) the capability to provide care for all (with the possible exception of providing invasive cardiac evaluation when other arrangements are made) of the eight neonatal categories, and applicable standards of special requirements for capabilities, personnel, and equipment, specified in the "Guidelines for Neonatal Special Care" developed by the Perinatal Services Advisory Board; and (iii) accepted at least 10 maternal or neonatal transfers from less comprehensive settings within the past 12 months. Two hospitals within a region may serve as the "regional perinatal center" for that region where one provides the "regional obstetric services" and the other provides the "regional neonatal services."

Regional perinatal centers have not been officially designated in Virginia. The department and the Perinatal Board have divided the Commonwealth into seven perinatal services areas and recognize, unofficially, the following hospitals as regional perinatal centers:

Region I (Southwest)...None designated

Region II (Western)...Community Hospital of Roanoke Valley

Region III (Southside)...Virginia Baptist Hospital

Region IV (Piedmont)...University of Virginia

Region V (Northern)...Fairfax Hospital

Region VI (Central)...Medical College of Virginia

Region VII (Eastern)...Children's Hospital of the King's Daughters/Sentara Norfolk General Hospital.

"Transfer agreement" means a formal agreement between a hospital's obstetrics and neonatal services and a regional perinatal center specifying (i) which categories of maternal and neonatal patients may be served at the local hospital; (ii) the categories, circumstances and protocols for transferring maternal and neonatal patients to the regional perinatal center; and (iii) the reciprocal circumstances and procedures under which such patients may be transferred back to the referring hospital.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards for Obstetrical Services

12VAC5-250-20. Acceptability; patient education. (Repealed.)

Obstetrical service providers should offer an array of family planning and related maternal and child health education programs that are readily accessible to current and prospective patients.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-30. Accessibility; travel time; financial considerations. (Repealed.)

A. Consistent with minimum size and use standards delineated below, basic obstetrical services should be available within one hour average travel time of 95% of the population in rural areas and within 30 minutes average travel time in urban and suburban areas.

B. Obstetrical and related services should be open to all without regard to ability to pay or payment source.

C. Providers of obstetrical facility services serving rural areas should facilitate transport of patients residing in rural areas to needed obstetrical facility services, directly or through coordinated efforts with other organizations. Preference will be given in the review of competing applications to applicants who can demonstrate a commitment to the development of transportation resources for rural populations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-40. Availability; service capacity; occupancy; consolidation of services. (Repealed.)

A. Obstetrical services should be located and sized to ensure that there is 95% probability of there being an empty obstetrics bed in the planning district at any given time.

B. Proposals to establish new obstetrical services or expand existing obstetrical services in rural areas should demonstrate that they will perform a minimum of 1,000 deliveries by the second year of operation or expansion and that obstetrical patient volumes of existing providers will not be negatively affected.

C. Proposals to establish new obstetrical services or expand existing obstetrical services in urban and suburban areas should demonstrate that they will perform a minimum of 3,000 deliveries annually by the second year of operation or expansion and that obstetrical program volumes of existing providers will not be negatively affected.

D. Average annual occupancy of licensed obstetric beds in a planning district should be at the highest attainable level consistent with the above service capacity standard.

E. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service will be given preference over the addition of new services or the expansion of single service providers.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-50. Continuity. (Repealed.)

A. Regional Perinatal Center affiliation.

Facilities seeking to expand existing obstetrical services should affiliate and coordinate their service program with the Regional Perinatal Center.

B. Transfer agreements for high-risk patients.

1. Obstetrical services providers should maintain written transfer agreements with a regional perinatal center specifying the circumstances and procedures under which high-risk maternal patients and newborn infants will be transported to the regional perinatal center and returned to the referring hospital.

2. Written plans and protocols should demonstrate that more than 95% of extremely low birth-weight infants (less than 1,500 grams) and more than 80% of low birth-weight infants (less than 2,000 grams) will be delivered at the regional perinatal center.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-60. Cost. (Repealed.)

A. The total cost of providing necessary obstetrical services to a community is a function of the number, size, location and relative efficiency of the programs providing care. Preference will be given to proposals which reduce or minimize the aggregate costs of providing obstetrical services to a community.

B. Obstetrical unit costs (cost per delivery or per patient day of care) tend to be a function of program size and efficiency.

Preference will be given to proposals which demonstrate the ability to provide care at a unit cost below the median and mean unit cost in their perinatal service area.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-70. Quality standards; data collection. (Repealed.)

A. The standards and requirements established by the Virginia Perinatal Services Advisory Council and the Virginia Department of Health will be utilized as guidance in the evaluation of the ability of proposed and existing providers of regional neonatal services (neonatal intensive care) to provide quality care.

B. Proposals to expand existing services or to add new obstetrical services must demonstrate that they will provide infant and maternal mortality and morbidity data, and program and unit cost and charge data, as requested by the Department of Health.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 2.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part III
Criteria and Standards for Neonatal Special Care Services

12VAC5-250-80. Accessibility; travel time; payment. (Repealed.)

A. Basic perinatal services should be available as an intrinsic element of inpatient obstetrics programs. Neonatal special care services should be located within an average driving time of 45 minutes in urban and suburban areas.

B. Perinatal service areas identified by the Virginia Perinatal Services Advisory Council and the Virginia Department of Health should have one designated or recognized regional neonatal service (often referred to as a Level III neonatal intensive care unit). These services should be located within one and one-half hours driving time of 95% of the population to be served.

C. Neonatal service and related services should be open to all without regard to ability to pay or payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 3.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-90. Availability; service capacity. (Repealed.)

A. Basic perinatal services capacity should be developed and sized to provide routine newborn care to infants delivered in the associated obstetrics service, and should have the capability to stabilize and prepare for transport those infants requiring the specialized care available in a regional perinatal center.

B. Regional perinatal centers should have regional neonatal services (intensive care units) containing a minimum of 15 stations or beds.

C. No more than four neonatal special care bassinets and regional neonatal service beds per 1,000 live births should be established in each perinatal service area.

D. Neonatal special care units should achieve 85% average annual occupancy.

E. Preference will be given to the expansion of existing regional perinatal centers, rather than the creation of new programs, unless extraordinary circumstances require consideration of the development of a second regional perinatal center.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 3.2, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-100. Neonatal services; continuity; agreements; follow-up care. (Repealed.)

A. Regional neonatal service programs should develop and maintain formal agreements with the obstetrics programs in the region governing the transport, admission and return transport of patients to those hospitals.

B. Regional neonatal service programs should develop and maintain educational programs designed to encourage the delivery of high risk births in the regional perinatal centers, as well as the transport and back transport of newborns requiring neonatal special care.

C. Regional neonatal service providers should provide appropriate outpatient neonatal follow-up care for patients at risk for problems related to prematurity or intensive care nursery stays, such as developmental delays.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 3.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-110. Cost; regionalization; levels of care. (Repealed.)

A. Each perinatal region should have only one regional perinatal center unless responsibilities are shared by a hospital providing regional obstetrical services and a hospital providing regional neonatal services.

The regional perinatal center should have responsibility for establishing transfer agreements that provide for quality care of maternal and neonatal patients.

More than one hospital should be authorized to operate as a regional perinatal center only if the existing perinatal center does not meet its responsibility to provide care to most categories of patients, to accept transfers and referrals, and comply with the requirements to be certified by Medicaid as a neonatal intensive care unit.

B. Hospitals should be authorized to provide additional levels of care only when it has been demonstrated that regional system costs would not increase and that the quality of care would not be reduced or jeopardized.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 3.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-250-120. Quality. (Repealed.)

A. The standards and requirements established by the Virginia Perinatal Services Advisory Council and the Virginia Department of Health will be utilized as guidance in the evaluation of the ability of proposed and existing providers of regional neonatal services (neonatal intensive care) to provide quality care.

B. All referral regional neonatal services should be provided in the recognized regional perinatal center.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-102 § 3.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-250) (Repealed.)

Guidelines for Perinatal Care, Third Edition, American Academy of Pediatrics and American College of Obstetricians and Gynecologists, 1992.

Guidelines Concerning Maternal Transfer, Statewide Perinatal Services Plan, May, 1988.

Guidelines for Neonatal Special Care, Statewide Perinatal Services Plan, May, 1988.

CHAPTER 260
CARDIAC SERVICES (REPEALED)

Part I
Definitions

12VAC5-260-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Adult catheterization" means the cardiac catheterization of patients 15 years of age or older.

"Adult open heart surgical procedure" means the performance of an open heart surgical procedure on a patient 15 years of age or older.

"Capacity, cardiac catheterization laboratory or room" means that 1,200 diagnostic equivalent procedures have been performed in the dedicated (not shared with other services) cardiac catheterization laboratory or room on an annual basis. One PTCA or other therapeutic procedure is valued at two diagnostic equivalent procedures; one pediatric catheterization procedure is valued at two diagnostic equivalent procedures; and all other procedures are valued at one diagnostic equivalent procedure.

"Capacity, open heart surgery room or suite" means that 500 adult-equivalent procedures have been performed in the open heart surgery room or suite on an annual basis. One pediatric open heart surgery procedure is valued at two adult procedures.

"Cardiac catheterization" means a procedure performed in a cardiac catheterization room or laboratory whereby a flexible tube is inserted into the patient's body, usually through an extremity blood vessel, and advanced under fluoroscopic guidance into the heart chambers to perform a hemodynamic, electrophysiologic or angiographic examination of the left or right heart chamber, or coronary arteries. Therapeutic intervention in a coronary artery may also be performed using cardiac catheterization. By this definition, a cardiac catheterization does not include a simple right heart catheterization for monitoring purposes as might be done in an electrophysiology laboratory, pulmonary angiography as an isolated procedure, or cardiac pacing through a right electrode catheter. This definition does include angiographic procedures to evaluate the coronary arteries, and aortic root injections to examine the degree of aortic root regurgitation or deformity of the aortic valve.

"Cardiac catheterization procedure" means a single episode of cardiac catheterization.

"Cardiac" or "cardiovascular surgeon" means a surgeon who is eligible or certified in cardiovascular surgery by the American Board of Thoracic Surgery.

"Cardiac surgery room or suite" means a physically identifiable room or suite adequately staffed and equipped for the performance of open heart and closed heart surgery and extracorporeal bypass.

"Cardiac surgery intensive care unit" means a specially designated unit where cardiac vascular surgical patients are held for post-operative care which is not a part of an existing intensive care unit.

"Cardiac surgery team" means the designated specialists, including cardiovascular surgeons and support personnel, who consistently work together in the performance of open heart surgery.

"Cardiovascular surgical procedure" means any surgical procedure dealing with the heart, coronary arteries, and great vessels.

"Cardiovascular surgical service" means the programs, equipment, and staff dealing with the surgery of the heart, coronary arteries, and great vessels.

"Closed heart surgery" means any cardiovascular surgical procedure(s) which does not include the use of a heart-lung bypass machine.

"Comprehensive cardiac services program" means a cardiac services program which provides a full range of clinical services associated with the treatment of cardiovascular disease including community outreach, emergency treatment of cardiovascular illnesses, noninvasive diagnostic imaging modalities, diagnostic and interventional cardiac catheterization, open heart surgery, and cardiac rehabilitation services. Community outreach and cardiac rehabilitation services may be provided through arrangements with other agencies and facilities located within the same jurisdiction or planning district. All other components of a comprehensive cardiac catheterization services program must be provided within a single facility.

"Dedicated cardiac catheterization laboratory or room" means a laboratory or room which is staffed and operated solely for the provision of cardiac catheterization and which has the equipment required to perform angiographic and physiologic catheterization procedures.

"Department" means the Virginia Department of Health.

"Diagnostic cardiac catheterization procedure" means a cardiac catheterization procedure performed for the purpose of detecting and identifying defects in the great arteries or veins or the heart structure or abnormalities in the heart structure.

"Expanded cardiac catheterization service" means the addition or conversion of a laboratory or room to be dedicated to cardiac catheterization procedures and the purchase of additional equipment specially designed to perform cardiac catheterizations.

"Expanded open heart surgery service" means the addition, through new construction, conversion or renovation of space, of a operating room or suite to be used solely for open heart surgery.

"Extracorporeal circulation bypass" means the circulation of blood outside the body as through a heart-lung machine for carbon dioxide-oxygen exchange.

"Open heart surgery" means a highly specialized set of surgical procedures which utilize a heart-lung bypass machine (or "pump") to perform extracorporeal circulation and oxygenation during surgery. This technique is used when the heart must be slowed down to perform necessary surgery to correct congenital and acquired cardiac and coronary artery disease. The use of the "pump" during the procedure distinguishes "open heart" from "closed heart" surgery.

"Pediatric catheterization" means the cardiac catheterization of patients under 15 years of age with congenital heart disease.

"Pediatric open heart surgery" means the performance of an open heart surgical procedure on a patient younger than 15 years of age.

"Percutaneous transluminal coronary angioplasty (PTCA)" means an interventional cardiac catheterization procedure that is therapeutic in nature and used to treat coronary artery disease. In PTCA, a balloon-tipped catheter is placed in a disease artery and the balloon is inflated to compress the plaque blocking the artery. This definition shall also include, for computational purposes, the use of laser-tipped catheters, rather than balloon-tipped catheters, to eliminate or reduce the plaque blocking arteries.

"Pump procedures" means the use in surgery of a heart-lung bypass machine to perform the work of the heart and lungs. Included in these procedures are myocardiac revascularization, aortic and mitral valve replacement, ventricular aneurysm repairs, pulmonary valvouplasity, and other procedures utilizing a cardiac pump.

"Relevant reporting period" means the most recent 12 month period, prior to the beginning of the Certificate of Public Need Application's review cycle, for which data are available and acceptable to the department.

"Special procedures laboratory" or "room with a cardiac catheterization service" means a laboratory or room which is not dedicated exclusively to performing cardiac catheterization but is also utilized for other procedures not directly related to cardiac catheterization, yet which has the equipment, staff and support services required to provide cardiac catheterization and in which such cardiac catheterizations are routinely performed. A room or laboratory defined in this section is to be counted in the inventory of cardiac catheterization rooms.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards for Cardiac Catheterization Services

12VAC5-260-20. Acceptability; consumer participation. (Repealed.)

A. The waiting time for elective procedures should be less than two weeks. Emergency cardiac catheterization services should be available 24 hours a day, seven days a week.

B. Providers with cardiac catheterization services will provide a program of patient and family education regarding the nature of the patient's heart/circulatory disease and available methods of diagnosis and treatment of the patient and family in the management of the problem.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-30. Accessibility; financial considerations. (Repealed.)

A. Adult cardiac catheterization services should be accessible within a one hour driving time, under normal conditions, for 90% of Virginia's population.

B. Cardiac catheterization services should be accessible to all patients in need of services without regard to their ability to pay or the payment source.

C. Providers of cardiac catheterization services serving rural areas should facilitate the transport of patients residing in rural areas to needed cardiac catheterization services, directly or through coordinated efforts with other organizations. Preference will be given in the review of competing applications to applicants who can demonstrate a commitment to the development of transportation resources for rural populations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-40. Availability; need for new services; alternatives. (Repealed.)

A. Need for new service. No new cardiac catheterization service should be approved unless (i) all existing cardiac catheterization laboratories located in the planning district in which the proposed new service will be located where used for at least 960 diagnostic-equivalent cardiac catheterization procedures for the relevant reporting period; and (ii) it can be reasonably projected that the proposed new service will perform at least 200 diagnostic equivalent procedures in the first year of operation, 500 diagnostic equivalent procedures in the second year of operation, and 800 diagnostic equivalent procedures in the third year of operation without reducing the utilization of existing laboratories in the planning district such that less than 960 diagnostic equivalent procedures are performed at any of those existing laboratories.

B. Mobile cardiac catheterization service. Proposals for the use of freestanding or mobile cardiac catheterization services should only be approved if such services will be provided at a site located on the campus of a general/community hospital and complies with all applicable sections of the state medical facilities plan as determined by the department.

C. Alternative need for new services in rural areas. Notwithstanding the standards for approval of new cardiac catheterization services outlined above, consideration will be given to the approval of new cardiac catheterization services which will be located at a general hospital located 60 minutes or more driving time, under normal conditions, from any site at which cardiac catheterization services are available if it can be reasonably projected that the proposed new services will perform at least 200 diagnostic-equivalent procedures in the first year of operation, 400 diagnostic-equivalent procedures in the second year of operation, and 600 diagnostic-equivalent procedures in the third year of operation without reducing the utilization of existing laboratories located within 60 to 70 minutes driving time, under normal conditions, from the proposed new service location.

D. Need for expanded service. Proposals for the expansion of cardiac catheterization services should not be approved unless all existing cardiac catheterization laboratories operated by the applicant have performed at least 1,200 diagnostic-equivalent cardiac catheterization procedures for the relevant reporting period, and it can be reasonably demonstrated that the expanded cardiac catheterization service will achieve a minimum of 200 diagnostic equivalent procedures per laboratory to be added in the first 12 months of operation, 400 diagnostic equivalent procedures in the second 12 months of operation, and 600 procedures per laboratory in the third year of operation, without reducing the utilization of existing cardiac catheterization laboratories in the planning district below 960 diagnostic equivalent procedures.

E. Replacement.

1. Proposals for the replacement of existing cardiac catheterization services should not be approved unless the equipment to be replaced has been in service for at least five years and; (i) in the case of providers located within 60 minutes driving time, under normal conditions, of alternative cardiac catheterization services, the equipment to be replaced has been used in the performance of at least 960 diagnostic-equivalent cardiac catheterization procedures in the relevant reporting period; or (ii) in the case of providers located beyond 60 minutes driving time, under normal conditions, of alternative cardiac catheterization services, the equipment to be replaced has been used in the performance of at least 600 diagnostic-equivalent cardiac catheterization procedures in the relevant reporting period.

2. Additionally, all proposals for replacement of cardiac catheterization services should comply with all applicable sections of this state medical facilities plan component, as determined by the department.

F. Emergency availability. Cardiac catheterization services should be available for emergency cardiac catheterization within 30 minutes or less at all times.

G. Pediatric services. No new or expanded pediatric cardiac catheterization services should be approved unless the proposed new or expanded service will be provided at: (i) a hospital that also provides open heart surgery services, provides pediatric tertiary care services, has a pediatric intensive care unit and provides neonatal special care; or (ii) a hospital that is a regional perinatal center, has a cardiac intensive care unit and provides open heart surgery services; and it can be reasonably demonstrated that each proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation, 200 pediatric cardiac catheterization procedures in the second year of operation and 400 pediatric cardiac catheterization procedures in the third year of operation.

H. Emergency availability of open heart surgery. No application for new, expanded, or replacement cardiac catheterization services which includes the provision or potential provision of PTCA, transseptal puncture, transthoracic left ventricular puncture, or myocardial biopsy services should be approved unless emergency open heart surgery services are, or will be available on-site at all times at the same hospital at which the proposed new, expanded, or replacement cardiac catheterization service will be located.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 2.3, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-50. Continuity; coordination. (Repealed.)

A. Coordination of services. Any application for new or expanded cardiac catheterization services should provide written assurances that the applicant presently has, or will have, a signed coordination agreement (including transportation), with a hospital providing open heart surgery services, such that continuity of patient care will be maintained when transfer is necessary, and that the procedures done at the applicant's laboratory will not be routinely repeated at the surgical facility.

B. Discharge planning procedures and follow-up care.

1. All cardiac catheterization services should have written procedures and policies for discharge planning and follow-up care for the patient and family which are part of the institution's overall discharge planning program.

2. All cardiac catheterization services should presently have, or will have, established protocols for referring physicians and the cardiac surgical service to assure adequate post-operative diagnostic evaluation for cardiac surgical patients.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-60. Cost; alternatives. (Repealed.)

A. Less costly alternatives. Existing or proposed providers of cardiac catheterization services should document to the satisfaction of the department access to a full range of less serious, noninvasive, cardiac diagnostic procedures at the facility where cardiac catheterization services are or will be provided. At a minimum, these shall include the following:

1. Nuclear medicine.

2. Echocardiography.

3. Pulmonary function testing.

4. Stress testing.

5. Electrocardiography.

6. Cardiac chest X-ray.

B. Cost and charges.

1. The usual and customary charge to the patient for cardiac catheterization services should be commensurate with cost.

2. The average charge to the patient for cardiac catheterization services should be comparable to the average charges of other cardiac catheterization providers in the planning district and/or health planning region.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-70. Quality; staffing; patient care and support services. (Repealed.)

A. Staffing.

1. Cardiac catheterization services should have a medical director who is board certified in cardiology with subspecialty training in cardiovascular radiology, and experienced in the performance of physiologic and angiographic procedures. In the case of pediatric cardiac catheterization services, the medical director should be board certified in pediatric cardiology.

2. All physicians on staff who will be performing cardiac catheterization procedures should be board certified or board eligible in cardiology, and experienced in the performance of physiologic and angiographic procedures. In addition to the cardiologist who performs the procedure, there should be another suitably trained board eligible cardiologist immediately available on-site to provide assistance. In the case of pediatric catheterization services, each physician performing pediatric procedures should be board certified or board eligible in pediatric cardiology, and have clinical experience in performing physiologic and angiographic procedures.

3. All anesthesia services should be provided by, or supervised by, a board certified anesthesiologist, and in the case of pediatric catheterization services, the anesthesiologist should also be experienced and trained in pediatric anesthesiology.

4. If cardiac catheterization services include PTCA services, each physician who performs PTCA procedures should perform the equivalent of one PTCA procedure per week or 52 per year. The minimum training standard for such physician should be performance of at least 125 PTCA procedures, of which 75 were as the primary operator with satisfactory outcomes. Continued performance of PTCA shall be dependent upon the demonstration of success and compilation rates which meet expected standards.

5. The staffing pattern for each team performing cardiac catheterizations should be composed of the following nonphysical personnel:

a. One RN nurse with special training and current experience in critical care of cardiac patients, cardiovascular medication and catheterization equipment.

b. At least three technicians with current specialized training in cardiac care who are capable of performing the duties of a radiologic technologist, cardiopulmonary technician, monitoring and recording technician, and darkroom technician.

6. In addition to the team physician, at least two members of the team should be trained in cardiopulmonary resuscitation.

7. Each team should have the capability to treat immediately the possible complications of cardiac catheterization, such as anaphylaxis and cardiac arrhythmias.

8. All cardiac catheterization laboratories should have access to a medical social worker to counsel those patients and families who need assistance with financial and emotional problems prior to and following catheterization.

B. Patient care and support services.

1. Facilities providing cardiac catheterization services should have the following services:

a. Intensive care unit;

b. Laboratory and pathology services (hematology, pulmonary function, blood gasses and blood bank);

c. Anesthesiology, including inhalation therapy;

d. Radiology;

e. Cardiac arrest and surgical team (rapid mobilization should be possible at all times);

f. Maintenance and monitoring equipment;

g. Electrocardiography and testing services to include stress testing and continuous cardiogram monitoring;

h. Echocardiography services; and

i. Microbiology laboratory.

2. Cardiac catheterization laboratories should be competent to provide a range of both angiographic (angiocardiography, coronary arteriography) and hemodynamic and physiologic (measurement of cardiac output, intracardiac pressure) studies.

3. Facilities providing cardiac catheterization services should have the capability to diagnose and treat vascular occlusions and serious hemorrhages which may result from cardiac catheterization.

C. Clinical proficiency. All physicians with cardiac catheterization laboratory privileges should demonstrate the maintenance of proficiency in this procedure by the successful performance of an adequate number and type of cardiac catheterization procedures within a laboratory-specified time period that is equivalent to 150 adult-equivalent procedures per year.

D. Team clinical proficiency - mobile services. Each team (see 12VAC5-260-70) providing cardiac catheterization services in a mobile unit should perform at least 150 diagnostic-equivalent procedures per year, as a team, on the site of the mobile unit.

E. Accreditation and compliance with chapters. Cardiac catheterization services should meet the accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations, and comply with the applicable chapters of the Virginia Department of Health's Bureau of Radiological Health.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 2.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part III
Criteria and Standards for Open Heart Surgery

12VAC5-260-80. Acceptability; consumer participation. (Repealed.)

A. The waiting time for elective open heart surgery procedures should be less than one month.

B. Providers of open heart surgery should provide a program of patient and family education regarding the nature of the patient's heart disease, and which attempts to assure the family and the patient's joint compliance in the post-operative management of the patient.

The patient and his family should be fully informed and involved in the decision-making regarding the open heart surgery.

C. Providers of open heart surgery services should have in place a mechanism for identifying travel and housing problems for patients and their families, particularly in rural areas, and provide assistance in making arrangements for these services for those patients and their families who may need them during the period of surgery and post-operative management.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 3.1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-90. Accessibility; travel time; financial considerations. (Repealed.)

A. Open heart surgery services should be accessible within a two hour driving time, under normal conditions, for 90% of Virginia's population.

B. Open heart surgery services should be accessible to all patients in need of the services without regard to their ability to pay.

C. Open heart surgery service should be available for operation at least eight hours a day for five days a week. Emergency open heart surgery and cardiac catheterization capability should be available 24 hours a day, seven days a week.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 3.2, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-100. Availability; need for the new service; alternatives. (Repealed.)

A. Need for the new service. No new open heart services should be approved unless: (i) the service is to be made available in a general hospital which has established cardiac catheterization services that have been used for the performance of at least 960 diagnostic-equivalent procedures for the relevant reporting period and has been in operation for at least 30 months; (ii) all existing open heart surgery rooms located in the planning district in which the proposed new service will be located have been used for at least 400 adult-equivalent open heart surgical procedures for the relevant reporting period; and (iii) it can be reasonably projected that the proposed new service will perform at least 150 adult-equivalent procedures in the first year of operation, 250 adult-equivalent procedures in the second year of operation, and 400 adult-equivalent procedures in the third year of operation without reducing the utilization of existing open heart surgery programs in the planning district such that less than 400 adult-equivalent open heart procedures are performed at those existing laboratories.

B. Alternative need for new services in rural areas. Notwithstanding the standards for approval of new open heart services outlined above, consideration will be given to the approval of new open heart surgery services which will be located at a general hospital located more than two hours driving time, under normal conditions, from any site at which open heart surgery services are available if it can be reasonably projected that the proposed new service will perform at least 150 adult-equivalent open heart procedures in the first year of operation, 225 adult-equivalent procedures in the second year of operation, and 300 adult-equivalent procedures in the third year of operation without reducing the utilization of existing open heart surgery rooms within a 120-150 minute driving time, under normal conditions, from the proposed new service location below 400 adult-equivalent open heart surgical procedures per room. Such hospitals should also have provided at least 760 diagnostic-equivalent cardiac catheterization procedures during the relevant reporting period on equipment which has been in operation at least 30 months.

C. Need for expanded service. Proposals for the expansion of open heart surgery services should not be approved unless all existing open heart surgery rooms operated by the applicant have performed at least 400 adult-equivalent open heart surgery procedures in the relevant reporting period if the facility is within two hours driving time, under normal conditions, of an existing open heart surgery service, or at least 300 adult-equivalent open heart surgery procedures in the relevant reporting period if the facility that proposes expanded services is in excess of two hours driving time, under normal conditions, of an existing open heart surgery service.

Additionally, all proposals for the expansion of open heart surgery services should comply with all applicable sections of this State Medical Facilities Plan component, as determined by the department.

D. Replacement. Proposals for the replacement of existing open heart surgery services should not be approved unless the equipment to be replaced has been in operation for at least 30 months; and (i) in case of providers located within two hour's driving time, under normal conditions, of alternative open heart surgery services, the open heart surgery equipment to be replaced has been used in the performance of at least 400 adult-equivalent procedures in the relevant reporting period; or (ii) in the case of providers located beyond two hour's driving time, under normal conditions, of alternative open heart surgery services, the open heart surgery room to be replaced has been used in the performance of at least 300 adult-equivalent procedures in the relevant reporting period.

Additionally, all proposals for the replacement of open heart surgery services should comply with all the applicable sections of the State Medical Facilities Plan component, as determined by the department.

E. Pediatric services. No new, expanded or replacement pediatric open heart surgery service should be approved unless the proposed new, expanded or replacement service is provided at a hospital that: (i) has cardiac catheterization services which have been in operation for 30 months and that have been used in the performance of at least 200 pediatric cardiac catheterization procedures for the relevant reporting period, provides pediatric tertiary care services, has pediatric intensive care services and provides neonatal special care; or (ii) is a regional perinatal center and has a cardiac intensive care unit.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 3.3, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-110. Continuity; coordination. (Repealed.)

A. Coordination of services. Any application for new, expanded or replacement open heart surgery services should provide written assurances satisfactory to the department that the applicant presently has, or will have, a signed referral agreement with other community hospitals and physicians to receive referrals for open heart surgery.

B. Discharge planning procedures and follow-up care. All open heart surgery services should have written protocols for discharge planning and follow-up care for the patient and family which are part of the institution's overall discharge planning program.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 3.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-120. Cost; alternatives. (Repealed.)

A. Less costly alternatives. The applicant should provide documentation satisfactory to the department that shared services and consolidation arrangements for open heart surgery have been investigated and found less advantageous in terms of cost, quality, accessibility, availability, and continuity of care.

B. Cost and charge.

1. The usual and customary charge to the patient for open heart surgery services should be commensurate with cost.

2. The average charge to the patient for the proposed open heart surgery service will be comparable to or less than the average charges of other open heart surgery providers in the planning district and the health planning region.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 3.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-260-130. Quality; staffing; patient care and support services. (Repealed.)

A. Staffing.

1. Open heart surgery services should have a medical director who is certified by the American Board of Thoracic Surgery in cardiovascular surgery with special qualification and experience in cardiac surgery. In the case of pediatric open heart surgery, the medical director shall be certified by the American Board of Thoracic Surgery in cardiovascular surgery, and experienced in pediatric cardiovascular surgery and congenital heart disease.

2. All physicians on staff who will be performing open heart surgery procedures should be board certified or board eligible in cardiovascular surgery, with experience in cardiac surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitable trained board certified or board eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. There should also be at least one board certified or board eligible anesthesiologist with experience in open heart surgery. In the case of pediatric open heart surgery services, each physician performing and assisting with pediatric procedures should be board certified or board eligible in cardiovascular surgery with experience in pediatric cardiovascular surgery. All pediatric procedures should include a board certified anesthesiologist with experience in pediatric anesthesiology and pediatric open heart surgery.

3. The staffing pattern for each team performing open heart surgical procedures should be composed of at least the following nonphysician personnel:

a. One certified registered nurse anesthetist;

b. One or more circulating nurses or scrub nurses trained cardiac surgical procedures; and

c. At least three technicians with current specialized training in cardiac care, two of which are certified pump technicians, and the third capable of performing the duties of operating room technician;

4. Post-operatively, the cardiac surgical intensive care unit should provide 24-hour nursing coverage with at least one registered nurse per patient during the first 24 hours and one for every two patients for the second 24 hours for adult and pediatric cases.

5. There should be at least two cardiovascular surgeons, at least one of whom is board certified and the other at least board eligible, on the staff of a hospital with a cardiac surgical program, and one of whom should be immediately available at all times; pediatric open heart surgery programs should have two similarly qualified surgeons experienced and trained in pediatric cardiovascular surgery, one of which should be immediately available at all times.

6. A clinical board certified or eligible cardiologist should be on staff as a member of the surgical team responsible for the medical management of patients, and the selection, assisted by the cardiovascular surgeon, of suitable candidates for surgery.

7. Optimally, on a rotating basis, physician members (a thoracic or cardiovascular surgeon or trainee or a surgical residents with experience in cardiovascular surgery) of the surgical team should be physically present at all times that the patient is in the hospital.

8. Back-up personnel in cardiology, anesthesiology, pathology thoracic surgery and radiology should be immediately available.

9. A medical social worker should be available to all cardiovascular surgery programs.

10. Twenty-four hour a day coverage should be arranged for the operation of the extra-corporeal pump oxygenator.

11. All members of the physician and nurse team involved in the care of cardiovascular surgical patients should be proficient in cardiopulmonary resuscitation.

B. Patient care support services.

1. Facilities providing open heart surgery services should have the following:

a. Non-invasive cardiographics lab, (including electrocardiography, stress testing services, phonocardiography, and echocardiography);

b. Laboratory and pathology services (hematology, pulmonary function, blood gasses and blood bank);

c. Medicine (cardiology, hematology, nephrology, and infectious disease);

d. Anesthesiology including inhalation therapy;

e. Radiology (including a diagnostic nuclear medicine laboratory);

f. Neurology;

g. Microbiology laboratory;

h. Cardiac catheterization services including diagnostic and interventional/therapeutic cardiac catheterization capabilities;

i. Cardiac surgical intensive care unit with at least four beds;

j. Social services;

k. Cardiac rehabilitation services and community outreach and education programs available through the facility on-site or at locations off-site but in reasonable proximity to the patient population;

l. Emergency room staffed 24-hours a day for cardiac emergencies; and

m. Maintenance and equipment services.

C. Clinical proficiency. All physicians with open heart surgery privileges should demonstrate the maintenance of proficiency in this procedure by the successful performance of an adequate number and type of open heart surgical procedures within a specified time period in accordance with acceptable professional standards.

D. Team clinical proficiency. Each open heart surgical team (same individuals) should work together regularly and frequently (preferably four to five times a week) and maintain an adequate caseload to assure clinical proficiency, equivalent to at least 150 open heart surgical procedures per year.

E. Accreditation and compliance with chapters. Open heart surgery services should meet the accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-103 § 3.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 270
GENERAL SURGICAL SERVICES (REPEALED)

Part I
Definitions

12VAC5-270-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Ambulatory (outpatient) surgical services" are surgical services provided to individuals who are not expected to require inpatient (overnight) hospitalization but who require treatment in a medical environment exceeding the normal capability found in a physician's office. For the purposes of these chapters, ambulatory surgical services refers only to surgical services provided in operating rooms in licensed general hospitals or licensed outpatient surgical hospitals, and does not include surgical services safely and appropriately provided in outpatient departments, emergency rooms, or treatment rooms of hospitals, or in physicians' offices.

"Ambulatory surgical operating room" means an operating room in a licensed general or outpatient surgical hospital, which is intended to be used solely or principally for the provision of ambulatory surgical services.

"Inpatient surgical operating room" means an operating room in a licensed general hospital, which is intended to be used solely or principally for the provision of surgery to individuals requiring inpatient (overnight) hospitalization.

"Inpatient surgical services" are surgical services provided to individuals who are expected to require inpatient (overnight) hospitalization.

"Licensed facilities" are surgical facilities licensed as general hospitals or outpatient surgical hospitals in accordance with the Rules and Regulations for the Licensure of Hospitals in Virginia (12VAC5-410-10) of the Virginia Department of Health.

"Operating room capacity" means 1,600 available service hours per operating room per year. This is based on 80% utilization of an operating room that is available 40 hours per week, 50 weeks per year.

"Operating room use" means the amount of time that a patient occupies an operating room, plus estimated or actual preparation and cleanup time.

"Operating room visit" means one session in one operating room in a licensed general hospital or outpatient surgical hospital, which may involve several procedures. Operating room visit may be used interchangeably with "operation."

"Population" means population figures shown in the most current series of population projections published by the Virginia Employment Commission.

"Surgical services" means the provision of surgery to inpatients or outpatients (ambulatory) patients in licensed general or outpatient (ambulatory) surgical hospitals (centers).

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-104 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-270-20. Acceptability. (Repealed.)

Self-referral - Surgical services providers should comply with all applicable federal and state statutes governing the ability of physicians to refer patients to facilities in which they have an ownership interest.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-104 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-270-30. Accessibility; travel time; financial. (Repealed.)

Surgical services should be available within a maximum driving time, under normal conditions, of 30 minutes for 90% of the population of a planning district.

Surgical services should be accessible to all patients in need of services without regard to their ability to pay or the payment source.

Providers of surgical services serving rural areas should facilitate the transport of patients residing in rural areas to needed surgical services, directly or through coordinated efforts with other organizations. Preference will be given in the review of competing applications to applicants who can demonstrate a commitment to the development of transportation resources for rural populations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-104 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-270-40. Availability; need. (Repealed.)

A. Need.

The combined number of inpatient and ambulatory surgical operating rooms needed in a planning district will be determined as follows:

1. CSUR = ORV/POP

Where CSUR is the current surgical use rate in a planning district as calculated in the above formula;

ORV is the sum of total operating room visits (inpatient and outpatient) in the planning district in the most recent three consecutive years for which operating room utilization data has been reported by the Virginia Center for Health Statistics; and

POP is the sum of total population in the planning district in the most recent three consecutive years for which operating room utilization data has been reported by the Virginia Center for Health Statistics, as found in the most recent published projections of the Virginia Employment Commission.

2. PORV = CSUR * PROPOP

Where PORV is the projected number of operating room visits in the planning district three years from the current year; and

PROPOP is the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

3. FORH = PORV * AHORV

Where FORH is future operating room hours needed in the planning district three years from the current year; and

AHORV is the average hours per operating room visit in the planning district for the most recent year for which average hours per operating room visit as been calculated from information collected by the Virginia Department of Health.

4. FOR = FORH/1600

Where FOR is future operating rooms needed in the planning district three years from the current year.

No additional operating rooms should be authorized for a planning district if the number of existing or authorized operating rooms in the planning district is greater than the need for operating rooms identified using the above methodology. New operating rooms may be authorized for a planning district up to the net need identified by subtracting the number of existing or authorized operating rooms in the planning district from the future operating rooms needed in the planning district, as identified using the above methodology.

Consideration will be given to the addition of operating rooms by existing medical care facilities in planning districts with an excess supply of operating rooms, based on the methodology outlined above, when such addition can be justified on the basis of facility-specific utilization or geographic remoteness (driving time of 45 minutes or more, under normal conditions, to alternative surgical facilities).

B. Relocation. Projects involving the relocation of existing operating rooms within a planning district may be authorized when it can be reasonably documented that such relocation will: (i) improve the distribution of surgical services within a planning district; or (ii) result in the provision of the same surgical services at a lower cost to surgical patients in the planning district; or (iii) optimize the number of operations in the planning district which are performed on an ambulatory basis.

C. Ambulatory surgical facilities. Preference will be given to the development of needed operating rooms in dedicated ambulatory surgical facilities developed within general hospitals or as freestanding centers owned and operated by general hospitals.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-104 § 2.3, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-270-50. Cost; charges. (Repealed.)

Preference among competing applications to provide surgical services identified as needed in a planning district will be given to applicants who can reasonably document that the costs of providing services and the charges for these services will be less than the average costs and charges for comparable services provided in the planning district or health planning region in which the project is to be located, consistent with the other standards of this plan component.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-104 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-270-60. Quality; accreditation/licensure. (Repealed.)

A. Surgical services providers should meet all applicable accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations or the Association for Accreditation of Ambulatory Health Centers and licensure standards of the Department of Health.

B. Existing and proposed providers of surgical services should document the availability of physicians who are board-certified or board-eligible in appropriate surgical specialties.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-104 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 280
ORGAN TRANSPLANTATION SERVICES (REPEALED)

Part I
Definitions

12VAC5-280-10. Definitions. (Repealed.)

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Department" means Virginia Department of Health.

"Donor organ/organ system" means an organ/organ system retrieved from a cadaver or living donor, and processed under appropriate rules and protocols, for the purpose of surgical transplantation into a recipient selected in accordance with established guidelines and protocols.

"Medicare requirements" means those clinical, certification and administrative requirements and standards set by the Centers for Medicare and Medicaid Services (CMS) of the United State Department of Health and Human Services to establish eligibility for Medicare program reimbursement.

"Minimum survival rates" means the lowest percentage of those receiving transplants who survive at least one year or for such other periods of times as specified by the department. Minimum survival rates not specified in these standards shall be established by the department as experience permits.

"Minimum utilization" means the number of transplants expected to be performed annually. Minimum utilization requirements not specified in these standards shall be established by the department as experience permits.

"Organ/organ system" means any of the number of clinically distinct components of the human body containing tissues performing a function for which it is especially adapted. Distinct organ/organ systems include, but are not limited to, kidney, heart, heart/lung, liver, and pancreas.

"Organ transplantation" means a set of medical procedures performed to remove surgically a defined diseased or nonfunctioning organ/organ system from a patient and replace it with a healthier functioning donor organ/organ system.

"Satellite clinic" means a scheduled program of outpatient services for pre- and post-transplant patients, or both, conducted at a site remote from the facility in which the organ transplant surgical services are provided that allows patients to obtain outpatient services associated with organ transplantation closer to their city or county of residence.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 1.1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-280-20. Acceptability; consumer participation. (Repealed.)

Providers of organ transplantation services should provide a program of patient and family education regarding the nature of the patient's organ disease and the treatment of the patient and family in the management of the organ pre- and post-transplantation.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-280-30. Accessibility; travel time; access to available organs. (Repealed.)

A. Organ transplantation services, of any type, should be accessible within two hours driving time, under normal conditions, of 95% of Virginia's population.

B. Providers of organ transplantation services should demonstrate to the satisfaction of the department that they have clearly defined patient/organ recipient policies based solely on medical criteria.

C. Providers of organ transplantation services should facilitate access to pre- and post-transplantation services needed by patients residing in distant locations by establishing part-time satellite clinics.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-280-40. Availability; regionalization of services; conditional approval; HCFA medicare requirements. (Repealed.)

A. There should be no more than one transplantation program for each organ system in a health planning region.

B. Approval of organ transplantation programs shall be conditioned upon a facility's meeting both minimum volume and survival standards. Failure to meet these standards within two years of initiation of the service may be cause for revocation of the certificate of public need.

C. 1. Proposals to establish new transplantation services should demonstrate compliance with all Medicare program coverage criteria within two years of the initiation of the program.

2. Proposals to expand existing transplantation programs should demonstrate that existing organ transplantation services comply with all applicable federal Health Care Financing Administration criteria for Medicare program coverage.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-280-50. Continuity of care; discharge planning procedures and follow-up care. (Repealed.)

A. Providers of organ transplantation services should have written procedures and policies for discharge planning and follow-up care for the patient and family which are part of the institution's overall discharge planning program.

B. Providers of organ transplantation services should have established protocols for referring physicians and the organ transplantation service to assure adequate post-operative diagnostic evaluation for transplant patients.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-280-60. Cost and charges. (Repealed.)

The total cost (direct and indirect) for providing all organ transplantation services should be comparable to other similar service providers in the health planning region and the state.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-280-70. Quality; minimum utilization; minimum survival rate; service proficiency; staffing; systems operations; support services. (Repealed.)

A. 1. Proposals to establish, expand or replace organ transplantation services should demonstrate that a minimum number of transplants will be performed annually. The minimum number required by organ system is:

2. Successful transplantation programs are expected to perform substantially larger numbers of transplants annually. Performance of minimum transplantation volumes does not necessarily indicate a need for additional transplantation capacity or programs.

3. Preference will be given to expansion of successful existing services, either by enabling necessary increases in the number of organ systems being transplanted or by adding transplantation capability for additional organ systems, rather than developing other programs that could reduce average program volume.

B. 1. Facilities should demonstrate that they will achieve and maintain minimum transplant patient survival rates. Minimum one year survival rates, listed by organ system, are:

2. Survival rates beyond one year should be consistent with the Medicare program requirements, or with applicable professional society recommended standards acceptable to the department where there are no Medicare criteria.

C. Proposals to add additional organ transplantation services should demonstrate at least two years successful experience with all existing organ transplantation systems.

D. 1. All physicians that perform transplants should be board certified by the appropriate professional examining board, and should have a minimum of one year of formal training and two years of experience in transplant surgery and post-operative care.

2. Organ transplantation services should have a complete team of surgical, medical and other specialists, with at least two years experience in the proposed organ transplantation system.

E. 1. Providers of organ transplantation services should document that they participate in a regional and national organ donor network. The facility should have written policies and procedures governing organ and tissue procurement.

2. Providers of organ transplantation services should have an ongoing approved medical education program.

3. Providers of organ transplantation services should collect and submit to the department transplantation program operating statistics, including patient and procedure volumes, mortality data and program cost and charges.

F. Providers of organ transplantation services should demonstrate that they have direct and immediate access to a histocompatibility testing laboratory that meets the American Society for Histocompatibility and Immunogenetics (ASHI) standards.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-105 § 2.6, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-280) (Repealed.)

Accreditation Standards, Guidelines and Checklist for American Society for Histocompatability and Immunogenetics, March, 1995.

CHAPTER 290
PSYCHIATRIC AND SUBSTANCE ABUSE TREATMENT SERVICES (REPEALED)

Part I
Definitions

12VAC5-290-10. Definitions. (Repealed.)

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acute psychiatric services" are inpatient psychiatric services provided at the hospital level of care that have a reported inpatient average length of stay of 90 days or less.

"Acute substance abuse treatment services" are inpatient substance abuse treatment services provided at the hospital level of care, exemplified by medical detoxification, treatment of the medical and psychiatric complications of chemical dependency, and continuous nursing services.

"Inpatient psychiatric services" are acute psychiatric services provided through distinct inpatient units of medical care facilities or through free-standing psychiatric hospitals. Inpatient psychiatric beds are licensed by the Department of Mental Health, Mental Retardation, and Substance Abuse Services (DMHMRSAS). "Psychiatric services" are services provided to individuals for the prevention, diagnosis, treatment, and/or palliation of psychiatric disorders.

"Inpatient substance abuse treatment services" are substance abuse treatment services provided through distinct inpatient units of medical care facilities or through free-standing inpatient substance abuse treatment facilities. Inpatient substance abuse treatment beds are licensed by the Department of Mental Health, Mental Retardation, and Substance Abuse Services (DMHMRSAS).

"Intermediate care substance abuse treatment services" are inpatient substance abuse treatment services provided at the residential level of care, exemplified by sub-acute (nonhospital) detoxification services and structured programs of assessment, counseling, vocational rehabilitation, and social rehabilitation.

"Long term psychiatric services" are inpatient psychiatric services provided at the hospital level of care which have a reported inpatient average length of stay in excess of 90 days. These services have traditionally been provided in facilities operated by the DMHMRSAS and, in that case, have not been subject to certificate of public need requirements.

"Satellite clinic" means a scheduled program of outpatient services for patients requiring psychiatric or substance abuse treatment following discharge from an inpatient program conducted at a site remote from the facility in which the inpatient services are provided that allows patients to obtain needed outpatient services for their psychiatric illness or substance abuse, or both, closer to their city or county of residence.

"Substance abuse treatment services" are services provided to individuals for the prevention, diagnosis, treatment, or palliation of chemical dependency that may include attendant medical and psychiatric complications of chemical dependency.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 1.1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-290-20. Acceptability; channels for consumer participation. (Repealed.)

Psychiatric and substance abuse providers should have programs of patient and family education regarding the nature of the patient's illness and ongoing needs and the patient and family's role in achieving treatment and rehabilitation objectives.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-290-30. Accessibility; travel time; financial considerations. (Repealed.)

A. Acute psychiatric, acute substance abuse treatment, and intermediate care substance abuse treatment services should be available within a maximum driving time, under normal conditions, of 60 minutes one-way for 95% of the population.

B. 1. Acute psychiatric, acute substance abuse treatment, and intermediate care substance abuse treatment services should be accessible to all patients in need of services without regard to their ability to pay or the payment source.

2. Existing and proposed acute psychiatric, acute substance abuse treatment, and intermediate care substance abuse treatment service providers should have established plans for the provision of services to indigent patients which include, at a minimum: (i) the number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients; (ii) the number of Medicaid-reimbursed patient days to be provided (unless the existing or proposed facility is ineligible for Medicaid participation); (iii) the number of unreimbursed patient days to be provided to local community services boards; and (iv) a description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days. The definition of indigent person used in the indigent patient service plan should be consistent with the definition of charity care used by Virginia's Indigent Care Trust Fund.

3. Proposed acute psychiatric, acute substance abuse treatment, and intermediate care substance abuse treatment service providers should have formal agreements with community services boards in their identified service area which: (i) specify the number of charity care patient days which will be provided to the community service board; (ii) provide adequate mechanisms for the community services board to monitor compliance with charity care provisions; and (iii) provide for effective discharge planning for all patients (to include the return of patients to their place of origin/home state if other than Virginia).

C. Providers of acute psychiatric, acute substance abuse treatment, and intermediate care substance abuse treatment services serving large geographic areas should establish satellite outpatient facilities to improve patient access, where appropriate and feasible.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-290-40. Availability; treatment beds; combined need; intermediate care. (Repealed.)

A. 1. The combined number of acute psychiatric and substance abuse treatment beds needed in a planning district with existing acute psychiatric or acute substance abuse treatment beds or both will be determined as follows:

[(UR * PROJ.POP.)/365]/.90

Where UR = the use rate of the planning district expressed as the average acute psychiatric and acute substance abuse treatment patient days per population reported for the most recent three year period; and

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

2. No additional acute psychiatric or acute substance abuse treatment beds should be authorized for a planning district with existing acute psychiatric or acute substance abuse treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology. For purposes of this methodology, no beds in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services shall be included in the inventory of psychiatric or substance abuse beds.

3. No additional acute psychiatric or acute substance abuse treatment beds should be authorized for a planning district in which the combined inventory of existing acute psychiatric and acute substance abuse treatment beds, exclusive of beds located in medical care facilities or medical care facility units of 20 or fewer beds, were utilized at an average annual occupancy of less than 85% in the most recently reported year.

4. No additional acute psychiatric or acute substance abuse treatment beds should be authorized as additions to existing facilities with more than 20 acute psychiatric or acute substance abuse treatment beds or both unless the average annual occupancy of those existing beds was 90% or higher in the most recently reported year.

5. No existing acute psychiatric or acute substance abuse treatment beds should be authorized to relocate from one site to another unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

6. The combined number of acute psychiatric and acute substance abuse treatment beds needed in a planning district without existing acute psychiatric or acute substance abuse treatment beds will be determined as follows:

[(UR * PROJ.POP.)/365]/OE

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average acute psychiatric and substance abuse treatment patient days per population reported for the most recent three year period;

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission; and

OE = an occupancy expectation of .90 if the projected average daily census for the planning district is greater than 20 and an occupancy expectation of .80 if the projected average daily census for the planning district is 20 or less.

7. Preference will be given to the development of needed acute psychiatric and substance abuse treatment beds through the conversion of unutilized general hospital beds. Preference will also be given to the development of needed acute psychiatric and substance abuse beds which demonstrate a willingness to accept persons under temporary detention orders (TDO) and those with specific contractual agreements for public/private partnerships to serve populations served by Community Services Boards.

B. 1. The number of intermediate care substance abuse treatment beds needed in a planning district with existing intermediate care substance abuse treatment beds will be determined as follows:

[(UR * PROJ.POP.)/365]/.90

Where UR = the use rate of the planning district expressed as the average intermediate care substance abuse treatment patient days per population reported for the most recent three year period; and

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

2. No additional intermediate care substance abuse treatment beds should be authorized for a planning district with existing intermediate care substance abuse treatment beds if the existing inventory of such beds is greater than the need identified using the above methodology. For purposes of this methodology, no beds in facilities operated by DMHMRSAS will be included in the inventory of intermediate care substance abuse beds.

3. No additional intermediate care substance abuse treatment beds should be authorized for a planning district in which the combined inventory of existing intermediate care substance abuse treatment beds, exclusive of beds located in medical care facility units of 20 or fewer beds, were utilized at an average annual occupancy of less than 85% in the most recently reported year.

4. No additional intermediate care substance abuse treatment beds should be authorized as additions to existing facilities with more than 20 intermediate care substance abuse treatment beds unless the average annual occupancy of those existing beds was 90% or higher in the most recently reported year.

5. No existing intermediate care substance abuse treatment beds should be authorized to relocate from one site to another unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing intermediate care substance abuse treatment providers to continue to provide historic levels of service to indigent patients.

6. The number of intermediate care substance abuse treatment beds needed in a planning district without existing intermediate care substance abuse treatment beds will be determined as follows:

[(UR * PROJ.POP.)/365]/OE

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average intermediate care substance abuse treatment patient days per population reported for the most recent three year period;

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission; and

OE = an occupancy expectation of .90 if the projected average daily census for the planning district is greater than 20 and an occupancy expectation of .80 if the projected average daily census for the planning district is 20 or less.

7. Preference will be given to the development of needed intermediate care substance abuse treatment beds through the conversion of unutilized general hospital beds.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-290-50. Continuity; integration. (Repealed.)

Psychiatric and substance abuse treatment services should be coordinated to insure linkages among all available levels and settings of service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-290-60. Cost and charges. (Repealed.)

Preference will be given to applicants who can reasonably document that the costs of providing services and the charges for these services will be less than the average costs and charges for comparable services provided in the planning district or health planning region or both in which the project is to be located, consistent with the other standards of these chapters.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-290-70. Quality; accreditation and compliance with chapters. (Repealed.)

Psychiatric and substance abuse treatment providers should meet all applicable accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations and licensure standards of the Department of Mental Health, Mental Retardation, and Substance Abuse Services.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-106 § 2.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 300
MENTAL RETARDATION SERVICES (REPEALED)

Part I
Definitions

12VAC5-300-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Intermediate care facility/mental retardation (IFC/MR)" is a facility, licensed by the Department of Mental Health, Mental Retardation, and Substance Abuse Services (DMHMRSAS) in which care is provided to mentally retarded individuals who are not in need of skilled nursing care, but who need more intensive training and supervision than would be available in a rooming, boarding home, or group home; such facilities must comply with Title XIX standards, provide health or rehabilitative services, and provide active treatment to clients toward the achievement of a more independent level of functioning.

"Mental retardation facilities" are facilities which provide services to mentally retarded individuals. The only classification of mental retardation facility subject to certificate of public need (COPN) requirements is the intermediate care facility/mental retardation (ICF/MR).

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-300-20. Accessibility; financial considerations. (Repealed.)

Mental retardation facilities and services should be accessible to all patients in need of services without regard to their ability to pay or payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-300-30. Availability; need. (Repealed.)

The establishment of new ICF/MR facilities should not be authorized unless the following conditions are met:

1. Alternatives to the service proposed to be provided by the new ICF/MR are not available in the area to be served by the new facility;

2. There is a documented source of resident referrals for the proposed new facility;

3. The applicant can identify the manner in which the proposed new facility fits into the continuum of care for the mentally retarded;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility.

6. The proposed new facility is consistent with the current DMHMRSAS Comprehensive Plan and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-300-40. Continuity; integration. (Repealed.)

A. Mental retardation facilities should be coordinated to insure linkages among all available levels and settings of service.

B. Each facility should have a written plan for cooperation with other public and private organizations, such as schools, social service agencies, and community service boards, to ensure that each resident under its care will receive comprehensive care.

C. Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-300-50. Quality. (Repealed.)

Mental retardation facilities should meet all applicable licensure standards of the Department of Mental Health, Mental Retardation, and Substance Abuse Services.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-300-60. Acceptability; size, channels for consumer; participation. (Repealed.)

A. The maximum size of a proposed new ICF/MR should be four beds.

B. Mental retardation facilities should have programs of resident and family education regarding the nature of the resident's disability and ongoing needs and the resident's and family's role in achieving treatment plan objectives.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-300-70. Cost and charges. (Repealed.)

A. The total costs for providing mental retardation facility services should not significantly exceed the total costs of other similar service providers in the Commonwealth. In no case should the cost for Medicaid funded ICF/MRs exceed the cost of state operated ICF/MRs.

B. The charges established for the provision of mental retardation facility services should be commensurate with costs and should not significantly exceed the charges established by other similar service providers in the Commonwealth.

C. Preference will be given to applicants who can reasonably document that the costs of providing services and the charges for these services will be less than the average costs and charges for comparable services provided in the planning district or health planning region or both in which the project is to be located, consistent with the other standards of these chapters.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-107 § 2.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 310
MEDICAL REHABILITATION SERVICES (REPEALED)

Part I
Definitions

12VAC5-310-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Comprehensive inpatient medical rehabilitation services" means medical rehabilitation services provided through inpatient departments of general acute care hospitals or through free-standing medical rehabilitation hospitals which are organized on an interdisciplinary basis to provide both inpatient and outpatient services for a range of physical disabilities. Only medical care facilities which are dedicated to comprehensive inpatient medical rehabilitation and are excluded, in their entirety, under the Medicare prospective payment system or medical care facilities which have distinct comprehensive inpatient medical rehabilitation units which are excluded under the Medicare prospective payment system are considered to provide comprehensive inpatient medical rehabilitation.

"Medical rehabilitation services" means services provided to individuals who are primarily physically disabled for the restoration of normal form and function after injury or illness. The objective of these restorative services is self-sufficiency and a return to suitable gainful employment in the shortest possible time or both. Medical rehabilitation services do not include services provided to individuals whose primary disability is psychiatric illness or substance abuse. However, medical rehabilitation services includes mental health services needed by individuals whose disability is primarily physical in nature. The medical rehabilitation services subject to certificate of public need review are comprehensive inpatient medical rehabilitation services and specialized inpatient medical rehabilitation.

"Specialized inpatient medical rehabilitation services" means medical rehabilitation services provided through inpatient departments of general acute care hospitals or through free-standing medical rehabilitation hospitals which are organized on an interdisciplinary basis to: (i) provide both inpatient and outpatient services to a specific category of physically disabled patients, such as spinal cord injured or brain injured patients, or (ii) provide a specialized category of inpatient and outpatient rehabilitation services, such as chronic pain management. Only medical care facilities which are dedicated to specialized inpatient medical rehabilitation and are excluded, in their entirety, under the Medicare prospective payment system or medical care facilities which have distinct specialized inpatient medical rehabilitation units which are excluded under the Medicare prospective payment system are considered to provide specialized inpatient medical rehabilitation.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-310-20. Acceptability; channels of consumer participation. (Repealed.)

Medical rehabilitation services should have programs of patient and family education regarding the nature of the patient's rehabilitation prognosis and ongoing needs and the patient and family's role in achieving rehabilitation objectives.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-310-30. Accessibility; travel time; financial considerations. (Repealed.)

A. Comprehensive inpatient rehabilitation services should be available within a maximum driving time, under normal conditions, of 60 minutes for 95% of the population.

B. Medical rehabilitation services should be accessible to all patients in need of services without regard to their ability to pay.

C. Providers of comprehensive medical rehabilitation services should facilitate access to outpatient medical rehabilitation services for discharged patients residing in remote or rural areas, directly or through the establishment of referral links with general hospitals or other appropriate organizations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-310-40. Availability; need. (Repealed.)

The number of comprehensive and specialized rehabilitation beds needed in a health planning region will be projected as follows:

[(UR * PROJ. POP.)/365]/.85

Where UR = the use rate expressed as rehabilitation patient days per population in the health planning region as reported in the most recent published Beds and Utilization annual report of the Virginia Center for Health Statistics; and

PROJ.POP. = the most recent projected population of the health planning region three years from the current year as published by the Virginia Employment Commission.

No additional rehabilitation beds should be authorized for a health planning region in which existing rehabilitation beds were utilized at an average annual occupancy of less than 90% in the most recent reported year.

Preference will be given to the development of needed rehabilitation beds through the conversion of unutilized hospital beds.

The need for proposed specialized inpatient rehabilitation services will be given consideration beyond the formulated need standard when: (i) the rehabilitation specialty proposed is not currently offered in the health planning region; and (ii) a reasonably documented basis for recognizing a need for the service is provided by the applicant.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-310-50. Continuity; integration. (Repealed.)

Medical rehabilitation services should be coordinated to insure linkages among all available levels and settings of rehabilitation service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-310-60. Cost. (Repealed.)

The total costs for providing medical rehabilitation services should not significantly exceed the total costs of other comparable service providers in the Commonwealth.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-310-70. Quality; staffing and services. (Repealed.)

A. Medical rehabilitation facilities should provide the following staff categories:

1. Full-time medical direction by a physiatrist or other physician with a minimum of two years of experience in a comprehensive or specialized inpatient medical rehabilitation program;

2. Intensive skilled rehabilitation nursing care with nursing supervision provided by a nurse with a minimum of two years of experience in a comprehensive or specialized inpatient medical rehabilitation program;

3. Physical therapy;

4. Occupational therapy;

5. Speech/language pathology;

6. Psychology;

7. Social services counseling; and

8. Discharge planning.

B. Medical rehabilitation facilities shall provide or make formal arrangements for the provision of the following services, as appropriate:

1. Audiology;

2. Drivers education;

3. Orthotics;

4. Prosthetics;

5. Rehabilitation engineering;

6. Respiratory therapy;

7. Therapeutic recreation; and

8. Vocational rehabilitation.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-108 § 2.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 320
DIAGNOSTIC IMAGING SERVICES (REPEALED)

Part I
Definitions

12VAC5-320-10. Definitions. (Repealed.)

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Board certified diagnostic radiologist" means a physician certified by the American Board of Radiology, in diagnostic radiology or in diagnostic radiology with special competence in nuclear radiology.

"Body study" means a study of a part of the body other than the head.

"Computed tomography (CT)" means the construction of images through the detection and computer analysis of numerous X-ray beams directed through a part of the body.

"Contrast" or "contrast medium" means a substance that is strongly imaged and that, when ingested by or injected into a patient, increases the difference in image brightness between parts of the patient's body containing the substance and those where it is absent.

"Cyclotron" means a nuclear accelerator which is used to generate the radiopharmaceuticals which are injected into the patient so that computerized images can be generated through the use of a PET scanner to provide physiological and biochemical information about the patient. Cyclotrons are of two types: positive ion and negative ion.

"Department" means the Virginia Department of Health (VDH).

"Dual study" means a study consisting of two parts: one with contrast and the other without.

"Head equivalent computed tomogram (HECT)" means a relative workload value for CT studies where: a head study without contrast equals 1.00, a head study with contrast equals 1.25, a dual head study equals 1.75, a body study without contrast equals 1.50, a body study with contrast equals 1.75; and a dual body study equals 2.75.

"Head study" means a study of the head.

"HECTs attributable to current patient mix" means 1.45 times the following sum: 3.03 times the number of patients with a principal diagnosis involving neoplasms (ICD-9-CM codes 140-239), plus 3.00 times the number of patients with a principal diagnosis involving cerebrovascular disease (ICD-9-CM codes 430-438), plus 1.35 times the number of patients with a principal diagnosis involving other diseases of the digestive system (ICD-9-CM codes 570-579), plus 1.23 times the number of patients with a principal diagnosis involving dorsopathies (ICD-9-CM codes 720-724). All such patients in these categories shall have been discharged by the applicant during the most recent 12-month reporting period.

"Hospital" means an institution licensed by the department as a general, community, or special hospital but does not include those facilities licensed as freestanding ambulatory surgery centers.

"Hospital-based" means operating physically within or connected to a hospital, or legally associated with or physically associated with one or more hospitals.

"Magnetic resonance imaging (MRI)" means the construction of images through the detection and computer analysis of minute changes in magnetic properties of atomic particles within a strong magnetic field in response to the transmission of selected radiofrequency pulse sequences. Magnetic resonance imaging uses the magnetic spin properties of certain atomic nuclei to visualize and analyze body tissues.

"Magnetic resonance spectroscopy" means the use of the magnetic spin properties of certain atomic nuclei to perform chemical analyses of tissues.

"Mobile" means periodically relocated among more than one site of operation.

"MRI relevant patients" means the sum of: 0.55 times the number of patients with a principal diagnosis involving neoplasms (ICD-9-CM codes 140-239); 0.70 times the number of patients with a principal diagnosis involving diseases of the central nervous system (ICD-9-CM codes 320-349); 0.40 times the number of patients with a principal diagnosis involving cerebrovascular disease (ICD-9-CM codes 430-438); 0.40 times the number of patients with a principal diagnosis involving chronic renal failure (ICD-9-CM code 585) or 0.19 times the number of patients with a principal diagnosis involving dorsopathies (ICD-9-CM codes 720-724); 0.40 times the number of patients with a principal diagnosis involving diseases of the prostate (ICD-9-CM codes 600-602); and 0.40 times the number of patients with a principal diagnosis involving inflammatory disease of the ovary, fallopian tube, pelvic cellular tissue or peritoneum (ICD-9-CM code 614). All such patients in these categories shall have been discharged by the applicant during the most recent 12-month reporting period.

"Network" means a group of institutions sharing an MRI or CT scanning unit.

"Nuclear medicine imaging service" means the provision of nuclear medicine imaging capabilities at a site at which one or more single or multi-head Anger camera devices are available.

"Nuclear medicine procedure" means a complete examination involving one or more imaging procedures which are billed as a unit using one CPT-4 code.

"PET study or scan" means the gathering of data during a single patient visit from which one or more images may be constructed of a single anatomical region of the patient's body.

"PET system" means a PET service which includes two major elements: a cyclotron which produces the radiopharmaceuticals, and a PET scanner which includes a data acquisition system and a computer.

"Physician" means a person licensed by the Virginia State Board of Medicine to practice medicine or osteopathy.

"Positron emission tomography" or "PET" means a non-invasive diagnostic technology which enables the body's physiological and biochemical processes to be observed through the use of positron emitting radiopharmaceuticals which are injected into the body and whose interaction with body tissues and organs is able to be pictured through a computerized positron transaxial reconstruction tomography scanner. The radiopharmaceuticals are positron emitting isotopes which usually include carbon-11, oxygen-15, nitrogen-13, and fluorine-18 (i.e., fluorine dexyglucose or FDG).

"Relevant reporting period" means the most recent 12-month period, prior to the beginning of the certificate of public need application's review cycle, for which data are available and acceptable to the department.

"Single photon emission computed tomography" or "SPECT" means a non-invasive diagnostic technique involving the injection or ingestion of a single-photon emitting radionuclide, prepared as a radiopharmaceutical, which is imaged at 180 to 360 degrees by a single or multiple crystal detector which detects the emitted gamma rays; the instrument, with the aid of a computer, creates 3-dimensional images from the data, displaying them as transaxial slices, as angled slices, as a 3-dimensional image, or as a functional image of the contained information.

Currently, there are SPECT instruments available using one, two, three, or four Anger single-crystal camera devices (often called "heads") or using an array of multiple-crystal detectors. Some of these devices are intended for a particular part of the human anatomy, such as the head or the heart, while others are more versatile by virtue of an expanding diameter of rotation. Many of these instruments are created for multiple purposes, such as SPECT and planar whole body bone imaging, and all of them will permit planar imaging.

Clinically SPECT appears to be most useful for the study of cardiovascular disease, bone imaging, and disorders of the brain such as cerebrovascular disease, epilepsy, and dementia. There is a general trend in nuclear medicine today to use Tc-99m for as many of the examinations as possible because of its ready on-site availability from a generator, the lack of waste because of decay of unused doses, and the adaptation of the Anger camera instruments to the gamma-ray energy of Tc-99m.

It should be noted that SPECT is the only instrument being used in certain kinds of imaging: cardiac imaging with Tc-99m sestamibi and Tc-99m teboroxime, brain perfusion studies performed with Tc-99m HMPAO, liver hemangioma studies performed with Tc-99m labeled red cells and tumor imaging in the head, abdomen, and pelvis for comparison with CT and MRI anatomic images. Since SPECT technology does not require a cyclotron to produce radiopharmaceuticals, this technology is substantially less expensive than a complete PET system.

"SPECT procedure" means a complete examination involving one or more SPECT rotations, and perhaps some planar imaging, which is billed as a unit using one CPT-4 code.

"SPECT rotation" means one pass of the SPECT instrument around the patient leading to a single set of transaxial images and the possible formation of 3-dimensional images from other angles than transaxial.

"SPECT service" means the provision of SPECT scanning capabilities at a site at which one or more single or multi-head SPECT scanners are available.

"SPECT study or scan" means the gathering of data during a single patient visit from which one or more images may be constructed of a single anatomical region of the patient's body.

"Study" or "scan" means the gathering of data during a single patient visit from which one or more images may be constructed of a single anatomical region for the purpose of reaching a definitive clinical diagnosis.

"Under development" means currently authorized through the state's certificate of public need program but not yet operational, or exempted by the Commissioner of Health per provisions of § 32.1-102.11 of the Code of Virginia.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 1.1, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards for Computed Tomography (CT)

Article 1
Acceptability

12VAC5-320-20. Consumer acceptance of services offered. (Repealed.)

The patient or his family or both should be fully informed and involved in decision making regarding CT service and diagnostic information that is being provided.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.1, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Accessibility

12VAC5-320-30. Location. (Repealed.)

A. CT services should be within 30 minutes driving time, under normal conditions, of 95% of the population.

B. Preference will be given to CT service proposals located at a general hospital.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-40. Financial considerations; ability to pay. (Repealed.)

CT services should be accessible to all patients in need of such services without regard to their ability to pay or the payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.3, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 3
Availability

12VAC5-320-50. Need for new service. (Repealed.)

A. Preference will be given to proposals involving the provision of full-body CT scanning rather than units which can perform only CT head scans.

B. No CT service should be approved at a site which is within 30 minutes driving time of: (i) a COPN approved or exempted CT service that is not yet operational; or (ii) an existing CT unit that has performed fewer than 3,500 HECTs or 3,000 combined CT head and body scans during the relevant reporting period.

C. A proposed new CT service may be approved if: (i) in the case of a proposed stationary, hospital-based service, the applicant provides diagnostic-specific hospital discharge data for the relevant reporting period that is acceptable to the department which demonstrates that the HECTs attributable to the patient mix of the hospital where the proposed CT is to be located equates to at least 3,500 HECTs; or (ii) in the case of a proposed nonhospital-based service, the applicant demonstrates that the number of outpatient studies performed by other CT services on the applicant's patients during the relevant reporting period is at least 3,500 HECTs or 3,000 combined CT head and body scans.

Consideration will be given to approval of CT services that project fewer than 3,500 HECTs or 3,000 combined CT head and body scans when such services are proposed for sites located beyond 30 minutes driving time of any existing CT facilities.

D. No new, nonhospital-based CT service or network may be approved unless all existing CT services or networks in the planning district, whether hospital-based, nonhospital-based, mobile or fixed, performed an average of at least 5,000 HECTs or 4,500 combined CT head and body scans per machine during the relevant reporting period.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.4, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-60. Expansion of existing service. (Repealed.)

Proposals to increase the number of CT scanners in an existing hospital-based CT system or network may be approved only if the existing service or network performed an average of at least 5,000 HECTs per existing fixed or mobile scanner in the system or 4,500 combined CT head and body scans for the relevant reporting period.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.5, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-70. Replacement of existing equipment. (Repealed.)

A. Proposals to replace equipment for CT services may be approved if the unit has been in operation for at least five consecutive years and the unit performed at least 5,000 HECTS or 4,500 combined CT head and body scans for the relevant reporting period.

B. Notwithstanding subsection A of this section, consideration will be given to proposals to replace equipment which has been in operation for less than five consecutive years or has been utilized to perform less than 5,000 HECTs or 4,500 combined CT head and body scans if the applicant can reasonably demonstrate that such replacement is in substantial compliance with these standards, and that such replacement is necessary to achieve comparability and competitiveness with existing providers of CT services in the planning district where the replacement is proposed, and the applicant can demonstrate that the equipment to be replaced was fully utilized, given the type of equipment, the mode of service, or the area served, for the relevant reporting period. Such replacement will not qualify for expedited review under Part VI of the Virginia Medical Care Facilities COPN Rules and Regulations (12VAC5-220-10 et seq.).

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.6, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4
Continuity of Care

12VAC5-320-80. Coordination of service. (Repealed.)

Providers of CT services should provide courtesy privileges to qualified physicians for use by their patients who are expected to be treated on an outpatient basis.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.7, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 5
Cost

12VAC5-320-90. Cost and charges. (Repealed.)

The total costs (direct and indirect) for providing CT services should be comparable to other similar service providers in the planning district.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.8, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 6
Quality

12VAC5-320-100. Staffing. (Repealed.)

A. Providers of CT services should be under the direct, on-site supervision of one or more physicians with documented formal training in the production and interpretation of cross-sectional computed tomography images.

B. CT services should be staffed by qualified and experienced technologists consistent with the types and volumes of computer tomography services offered.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.9, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-110. Space. (Repealed.)

A. Applicants for certificates of public need should document to the satisfaction of the department that (i) an appropriate environment will be provided for the proposed CT services, including protection against radiant energy and other known hazards; and (ii) adequate space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

B. Applicants for certificates of public need should document to the satisfaction of the department that the proposed CT service's physical relationship to the applicant's other diagnostic imaging services will be logical and practical with respect to transportation and staff activity patterns.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 2.10, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part III
Criteria and Standards for Magnetic Resonance Imaging (MRI)

Article 1
Acceptability

12VAC5-320-120. Consumer acceptance of services offered. (Repealed.)

The patient or his family or both should be fully informed and involved in decision making regarding MRI service and diagnostic information that is being provided.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.1, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Accessibility

12VAC5-320-130. Location. (Repealed.)

A. MRI services should be within 45 minutes driving time, under normal conditions, of 95% of the population.

B. Preference will be given to MRI service proposals involving provision of services within a general hospital.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.2, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-140. Financial. (Repealed.)

MRI services should be accessible to all patients in need of such services without regard to their ability to pay or the payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.3, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 3
Availability

12VAC5-320-150. Need for new service. (Repealed.)

A. Preference will be given to applications that intend to provide hospital-based MRI services.

B. No MRI service should be approved at a site that is within 45 minutes driving time of: (i) a COPN approved or exempted MRI service that is not yet operational; or (ii) an existing MRI service that has performed fewer than 3,500 MRI scans or at least 3,000 MRI scans excluding those performed on behalf of the applicant during the relevant reporting period.

Consideration will be given to approval of proposed MRI services that project less than full utilization of MRI equipment when such services are proposed for sites located beyond 45 minutes driving time of any existing MRI facilities.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.4, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-160. Alternative need for new MRI service. (Repealed.)

A. Notwithstanding 12VAC5-320-150, consideration will be given to proposals that are hospital based and can reasonably demonstrate that for the relevant reporting period: (i) the number of MRI relevant patients among all Virginia hospitals committed to use the proposed MRI service exceeds 1,600; (ii) at least 4,000 HECTs or a combined 3,000 head and body CT scans were performed during the relevant reporting period on patients from each hospital committed to use the proposed MRI service; and (iii) the proposed MRI service will be under the operational control of at least one hospital with at least 800 MRI relevant patients for the relevant reporting period.

B. In the case of proposals for nonhospital-based MRI services, the applicant must reasonably demonstrate, using data available and acceptable to the department, that at least 4,000 HECTs or a combined total of at least 3,000 head and body CT scans were performed on patients referred by the applicant to other providers of CT services during the relevant reporting period.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.5, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-170. Expansion of services. (Repealed.)

Proposals to expand existing MRI services through the addition of a new scanning unit may be approved if (i) the existing service performed at least 4,000 scans per existing unit during the relevant reporting period, and (ii) the average utilization of all existing MRI units in the planning district was at least 4,000 for the relevant reporting period.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.6, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-180. Mobile services. (Repealed.)

Consideration shall be given to proposals for new MRI units to be operated at more than one site if the applicant demonstrates that, compared with a single MRI unit located at a hospital or freestanding site relatively central to the proposed service location, the proposed mobile arrangement would serve the target population more efficiently and effectively overall in terms of the following factors:

1. Travel time from a majority of the proposed sites to a centrally located fixed or hospital-based unit exceeds 45 minutes;

2. Improved geographic access for the population outweighs the clinical advantages of providing the MRI service at a hospital or freestanding fixed site, which could handle higher Tesla strength and more sophisticated hardware and software; and

3. Based upon the number of MRI relevant patients who would have originated from each of the proposed sites for the relevant reporting period, that the total costs resulting from otherwise unnecessary extended lengths of stay for inpatients awaiting MRI services would have been shorter if the mobile service had been available at each of the proposed sites 2.5 days per week than the total costs which would have been incurred had those patients been transferred to the closest available fixed MRI location.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.7, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-190. Replacement of existing equipment. (Repealed.)

A. Proposals to replace equipment for the provision of MRI services may be approved if the service has been in operation for at least five consecutive years and the unit being replaced or upgraded performed at least 4,000 scans during the relevant reporting period.

B. Notwithstanding subsection A of this section, consideration will be given to proposals to replace MRI equipment which has been in operation for less than five consecutive years or has been utilized to perform less than 4,000 scans if the applicant can reasonably demonstrate that such replacement is in substantial compliance with these standards, and that such replacement is necessary to achieve comparability and competitiveness with existing providers of MRI services in the planning district where the replacement is proposed and the applicant can demonstrate that the equipment to be replaced was fully utilized, given the type of equipment, the mode of service, or the area served, for the relevant reporting period. Such replacement will not qualify for expedited review under Part VI of the Virginia Medical Care Facilities COPN Rules and Regulations (12VAC5-220-10 et seq.).

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.8, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4
Continuity of Care

12VAC5-320-200. Coordination of service. (Repealed.)

Providers of MRI services should provide courtesy privileges to qualified physicians for use for their patients who are expected to be treated on an outpatient basis.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.9, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 5
Cost

12VAC5-320-210. Cost. (Repealed.)

The total costs (direct and indirect) for providing MRI services should be comparable to other similar service providers in the planning district.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.10, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 6
Quality

12VAC5-320-220. Staffing. (Repealed.)

A. Providers of MRI services should provide assurances and a description of the proposed operating arrangement which shows that the production and interpretation of all images made by MRI machines will be under the direct, on-site control and supervision of one or more board certified diagnostic radiologists with training and experience in the interpretation of CT images, who have at least 60 hours of documented instruction in magnetic resonance imaging physics, instrumentation and the interpretation and clinical application of MRI images prior to the initiation of the service. This standard does not preclude the involvement of other staff judged qualified by an appropriate governing board.

B. MRI services should be staffed by technologists qualified and experienced in the operation and maintenance of MRI equipment during all hours of operation of the MRI service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.11, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-230. Space. (Repealed.)

A. Applicants for certificates of public need should document to the satisfaction of the department (i) that an appropriate environment will be provided for the proposed MRI services, including protection against radiant energy and other known hazards; (ii) that adequate space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

B. Applicants for certificates of public need should document to the satisfaction of the department that the proposed MRI service's physical relationship to the applicant's other diagnostic imaging services will be logical and practical with respect to transportation and staff activity patterns.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 3.12, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part IV
Magnetic Source Imaging (MSI)

12VAC5-320-240. Policy for the development of MSI services. (Repealed.)

Because Magnetic Source Imaging (MSI) scanning systems are still in the clinical research stage of development with no third party payment available for clinical applications, and because it is uncertain as to how rapidly this technology will reach a point where it is shown to be clinically appropriate for widespread use and distribution on a cost-effective basis, it is the policy of the Commonwealth of Virginia that the entry and development of this technology in the state should initially occur at, or in affiliation with, the academic medical centers in the state. Regional consortiums of hospitals in affiliation with academic medical centers could also be one possible approach to the initial distribution of this technology in the Commonwealth.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 4.1, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-250. Potential clinical applications of MSI technology. (Repealed.)

Magnetic Source Imaging (MSI) is quite different from conventional imaging and electro-diagnostic techniques. Specifically, while computerized tomography (CT) scanning and magnetic resonance imaging (MRI) generally provide anatomical information, which is to say information about physiological structure, they cannot provide specific information about physiological function. Conversely, the nuclear medicine technologies of single-photon emission computed tomography (SPECT) and positron emission tomography (PET) are both used to study function (though SPECT can apparently be used to clarify the relationship between anatomical structures in some instances), but the information provided by these two technologies is biochemical in nature rather than bioelectrical in nature. Both SPECT and PET scanning require that radioisotopes be injected or ingested into the patient in order to perform the study.

Traditionally, the nuclear technique for measuring bioelectrical activity of the brain has been electroencephalography (EEG), and the technique for measuring bioelectrical activity in the heart has been electrocardiography (ECG). Both EEG and ECG have the virtue that they can provide good temporal resolution, which is to say that they can measure bioelectrical activity that occurs in milliseconds. However, both techniques generally have poor spatial (locational) resolution since the surface electrodes used for EEGs and ECGs, when placed on the patient's body surface, record only a general view of the brain and heart. This is because the detected bioelectrical currents are substantially distorted by the tissues that intervene between the bioelectrical current sources and the recording electrodes. The only way the spatial resolution problems of EEG and ECG can be overcome is to have the electrodes surgically implanted in the patient with direct contact to brain or heart tissue. Such implantations put the patient at some risk and are quite costly.

In contrast, both the SPECT and PET technologies have the advantage of providing good spatial resolution, though PET seems to be superior in this regard, but they are weak in terms of temporal resolution. Moreover, as noted, both of these technologies provide biochemical rather than bioelectrical information.

It is believed that MSI will ultimately play as large a role in the diagnosis and treatment of patients with functional disease as CT and MRI now play in the management of patients with pathologies that disrupt normal physiological structure. Where CT and MRI are quite helpful in facilitating diagnoses as well as assessing treatment responses to pathologies that leave structural lesions, MSI's potential clinical usefulness lies in its ability to noninvasively image diseases that cannot be visualized by anatomic imaging methods.

Thus, the MSI technology can potentially provide noninvasively similar, if not better information than can be gained by EEG and ECG only when electrodes are surgically implanted in heart or brain tissue at some risk to the patient. The literature suggests that, with the relatively recent development of MSI units with expanded arrays of magnetic signal detectors or channels (presently the most sophisticated units have 37 detectors), it is possible to get both excellent temporal resolution (in terms of milliseconds) and excellent spatial resolution (in terms of millimeters) without the problem of surgical intervention.

Consequently, MSI appears to have the potential clinical ability to assess the extent and type of neural damage resulting from a stroke, and such information can be helpful in estimating a patient's potential for recovery from the stroke. Also, MSI may be a way to confirm the occurrence of a transient ischemic attack (TIA) which is often the first warning sign of a stroke.

Another very important potential of MSI is providing presurgical functional brain mapping which could help neurosurgeons to avoid damaging vital regions of the brain during tumor or lesion surgery. Presently, brain mapping occurs during the course of the surgery itself, and this prolongs the surgery which adds both to the patient's risk and to the surgery's cost. In this regard, a good deal of the neurological work that has been done with MSI has apparently focused on the evaluation of patients with medically intractable epilepsy since, by being able to locate regions of epileptogenic tissue, valuable information is gained which can be helpful in determining if surgical treatment is feasible. Notably, a major potential of PET technology is also in the area of partial complex epilepsy and being able to locate lesions for surgical intervention.

In the area of cardiology, MSI potentially can locate noninvasively and quickly the site of arrhythmogenic tissue in the heart at an accuracy level which could enable surgical intervention to remove the tissue. Such intervention might be through open heart surgery or catheter ablation. This potential of MSI is important because national data indicate that approximately two-thirds of all sudden cardiac deaths are caused by arrhythmias rather than by coronary occlusions. Historically, PTCA (percutaneous transluminal coronary angioplasty) and CABG (coronary artery bypass graft surgery) have been used to rectify occluded coronary artery problems that have either been detected/located prior to a myocardial infarction through cardiac catheterization or are the result of, and in response to, a myocardial infarction.

National data indicate that many of those who survive myocardial infarctions each year are left with disturbances in electrical condition in the heart tissue and are, consequently, at risk of sudden cardiac death caused by cardiac arrhythmias. Where the PET technology can be used to determine the size and extent of an infarction and the extent of tissue damage around the area of the infarction, as well as to distinguish viable from nonviable tissue, only MSI can noninvasively determine if disturbances in electrical conduction in heart tissue have occurred.

Additionally, MSI may also potentially be clinically useful in monitoring incipient rejection of a transplanted heart on a noninvasive basis. Preliminary tests seem to indicate that MSI procedures are at least as sensitive as the standard biopsy method used presently for this purpose. Notably, PET scanning can also be potentially helpful in evaluating metabolism in transplanted organs which can indicate selective rejection of tissue.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 4.2, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-260. MSI technology described. (Repealed.)

MSI relies on ultra-sensitive, low-noise amplifiers called SQUIDS (superconducting quantum interference devices) to detect changes in the minute magnetic fields associated with nerve activity in the body. Processes that force ions to flow across an electrically charged membrane are essential to the normal functioning of the brain, heart, and neuromuscular systems. Consequently, disorders of these organs affect their electrical activity, and detection of these changes in electrical activity can often be detected and amplified so that they can provide diagnostic information for potential treatment of the patient.

Apparently, the development of the very sophisticated 37 detector MSI units has enabled MSI to move from a basic research tool to a clinical research tool. Earlier MSI studies which used units with fewer detectors resulted in exams sometimes lasting as long as two to three hours which was too long to be suitable for many patients. With the 37 detector units recording simultaneously from an area of 20 centimeters in diameter, the new sophisticated systems can apparently gather enough data to complete an exam in less than 10 minutes.

The temporal resolution problems experienced by both SPECT and PET scanning technologies, noted earlier, are perhaps best understood when it is remembered that most brain processes occur in a one to ten millisecond time frame. Thus, even with a one minute PET acquisition, much brain activity can be obscured. In other words, the temporal resolution problem limits the sensitivity of SPECT and PET scanning for detecting abnormalities that are bracketed by normal activity and last for only short periods of time.

Notably, because the magnetic fields being measured are so small, the major engineering requirement for MSI units has been to screen out noise in the forms of both magnetic and radio-frequency interference. Thus, the instruments are constructed using nonmagnetic materials and isolated in shielded rooms. MSI units are basically built using the same principles required to contain the strong magnetic fields needed for MRI scanners. Thus, about half the cost for MSI systems comes from building the shielded rooms. Moreover, the entire assembly must be built on an isolated foundation so that the measured signals remain undisturbed by building vibrations.

One article describes the MSI scanning process as follows:

"Both the SQUIDs and the magnetic field sensors (gradiometers) they monitor must be immersed in liquid helium within a cylindrical, thermally isolated cryogenic container called a dewar. During an exam, the patient lies on a table and the sensor end of the dewar is brought within a few millimeters of the heart or body. The gradiometers then transmit the magnetic signals they detect to the SQUIDs which then convert the magnetic signals into corresponding electrical ones. Following amplification, filtering, and digitizing, computer processing of the SQUID electrical signals results in raw data that appear similar to those obtained by EEG and ECG. Further processing produces topographic "field maps" of the distribution and time evolution of the nerve activity being examined. The MSI information can also be superimposed on anatomic images such as those obtained by MRI." (Source: Diagnostic Imaging, March 1990, p. 131.)

Finally, the literature indicates that the cost for the 37 detector MSI units is presently in the $2-3 million range and that less than 10 MSI units of all types are located at facilities within the United States. Units are also presently located in Japan and Germany. Additionally, it is anticipated that, as with other technologies such as MRI, PET, SPECT, and CT, the capital costs associated with MSI units will decrease as the technology evolves and distribution of the units becomes more widespread.

(Note: Source for all information contained in 12VAC5-320-250 and 12VAC5-320-260 were articles which appeared in Diagnostic Imaging, January 1991, pp. A74-76; Diagnostic Imaging, March 1990, pp. 124-132; and information provided by Biomagnetic Technologies, Inc., of San Diego, CA.)

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 4.3, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part V
Criteria and Standards for Positron Emission Tomography (PET)

Article 1
Acceptability

12VAC5-320-270. Consumer acceptance of services offered. (Repealed.)

The patient or his family or both should be fully informed and involved in decision making regarding the service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.1, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Accessibility

12VAC5-320-280. Service area. (Repealed.)

The service area for each proposed PET service should be either an entire regional health planning area designated by the state, or an area with a population of at least 1.5 million people.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.2, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-290. Hours of operation. (Repealed.)

The PET service should be available for clinical operation at least eight hours a day, five days a week.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.3, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-300. Location of service. (Repealed.)

A. The PET service should be located, if possible, at a site which would allow the shortest driving time and distance one way for approximately 75% of the service area's population.

B. Preference will be given to a proposed PET service which is jointly owned and operated by a consortium of hospitals in the regional health planning area and which is located at a general or community hospital which also provides a full range of tertiary services.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.4, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 3
Availability

12VAC5-320-310. Service capacity. (Repealed.)

At least 1,500 PET scans should be performed annually by a single-scanner PET service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.5, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-320. Projecting demand for service. (Repealed.)

A. If the applicant for a proposed new PET service is a consortium of hospitals, the applicant shall provide on a hospital-specific basis documentation satisfactory to the department which indicates that the sum of thallium stress tests performed by the hospitals in the consortium for the most relevant reporting period was at least equal to 28% of the total number of inpatient and outpatient nuclear medicine procedures reported by all of the hospitals in the consortium for that same period, and that 50% of that number would be equivalent to at least 1,500 PET scans annually.

B. If the applicant for a proposed new PET service is an individual hospital, the applicant shall provide documentation satisfactory to the department which indicates that the total number of thallium stress tests performed by the hospital for the most relevant reporting period was at least equivalent to 28% of the total number of inpatient and outpatient nuclear medicine procedures reported by the hospital for that same period, and that 50% of that number would be equivalent to at least 1,500 PET scans annually. The hospital shall also provide open heart surgery services and document that for the most relevant reporting period its per room volume of open heart surgery services complies with standards and criteria specified in the Cardiac Services section of the State Medical Facilities Plan (12VAC5-260-10 et seq.).

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.6, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-330. Minimum utilization. (Repealed.)

The applicant shall provide documentation satisfactory to the department that it can achieve a minimum utilization level of 900 PET scans in the first 12 months of operation of the service, of 1,200 PET scans in the second 12 months of operation of the service, and of 1,500 PET scans in the third 12 months of operation of the service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.7, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-340. Additional scanners. (Repealed.)

No additional PET scanner shall be allowed to be added in a regional health planning area or in a service area having at least 1.5 million people until such time as it is demonstrated that the utilization of the existing single-scanner PET service was at least 1,500 PET scans for the most relevant reporting year and that the proposed new service would not reduce the utilization of the existing service below 1,500 PET scans per year. The applicant shall also provide documentation satisfactory to the department that it complies with 12VAC5-320-310 and 12VAC5-320-320.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.8, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-350. Replacement of service. (Repealed.)

An application to replace or upgrade an existing PET service may be approved when the hardware/software for the existing PET service has been in operation for at least five consecutive years. However, if the proposed replacement or upgrade would also add a new service capability or application that the existing PET service has not provided in the past, then the department may determine that such a replacement or upgrade constitutes the addition of a new service and that the application shall be reviewed as a proposed new service.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.9, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4
Continuity

12VAC5-320-360. Coordination of services. (Repealed.)

A. In order to facilitate close multi-hospital coordination and close interdisciplinary cooperation, preference in review of applications for a proposed new PET service will be given to applications which are consortiums of hospitals located within a designated regional health planning area.

B. If an applicant for a proposed new PET service is a single hospital, that hospital should provide documentation for the most relevant reporting period that it has provided open heart surgery services at a utilization level consistent with the criteria and standards stated in the Cardiac Services section of the State Medical Facilities Plan (12VAC5-260-10 et seq.).

C. If an applicant for a proposed new PET service is a single hospital, that hospital should provide documentation that referral arrangements exist with other hospitals and physicians to receive referrals for patients who potentially could benefit from PET scanning services, particularly those patients who are either nonemergent candidates for open heart surgery or PTCA procedures and those patients with a diagnosis of partial complex epilepsy for whom surgical intervention is being considered.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.10, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 5
Cost

12VAC5-320-370. Less costly alternatives. (Repealed.)

A. Any individual hospital that is an applicant for a proposed new PET service should provide documentation satisfactory to the department that shared service arrangements, such as consortiums with other area hospitals, have been investigated and found less advantageous in terms of accessibility, availability, continuity, cost, and quality.

B. Any individual hospital or consortium of hospitals in a regional health planning area that is an applicant for a proposed new PET service should provide documentation that other lower cost technology alternatives to PET scanning, such as SPECT scanning, have been investigated and found to be less advantageous in terms of accessibility, availability, continuity, cost and quality.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.11, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-380. Financial access. (Repealed.)

Any applicant for proposed new PET service should provide documentation that the services shall be accessible to all patients in need of service regardless of the ability to pay or payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.12, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 6
Quality

12VAC5-320-390. Staffing. (Repealed.)

A. A proposed new PET service should be under the medical direction of a physician who is board certified in nuclear medicine or nuclear radiology or trained and licensed in nuclear cardiology and has additional documented experience and training in PET technology including radiochemistry. Such physician should be licensed by the Nuclear Regulatory Commission to possess radiopharmaceuticals and perform diagnostic procedures employing radiopharmaceuticals in human beings.

B. Additional staff for a proposed new clinical PET service should include at a minimum the following staff:

1. A radiochemist trained at the master's or Ph.D. level in radiochemistry or radiopharmacy who also has a background in PET physics or radiochemistry and experience in radiopharmaceutical production.

2. A nuclear medicine technologist with training on-site or off-site in cyclotron operation and radiopharmaceutical production, and who will work under direction and supervision of the medical director.

3. Two radiological technologists with documented training in radiology, nuclear medicine, or MRI/CT scanning and who are able to provide support in the areas of PET imaging system operation, patient preparation for PET studies, and image analysis and processing.

4. Such administrative staff as shall be necessary to handle billing and other clerical functions.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 5.13, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VI
Criteria and Standards for Single Photon Emission Computed Tomography (SPECT)

Article 1
Acceptability

12VAC5-320-400. Consumer acceptance of services offered. (Repealed.)

The patient or his family or both should be fully informed and involved in decision making regarding the service and specifically the type of diagnostic information which is being provided.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.1, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Accessibility

12VAC5-320-410. Location. (Repealed.)

A. SPECT services should be available within 45 minutes driving time, under normal driving conditions, of 95% of the population.

B. Preference will be given to SPECT service proposals involving provision of service within a general hospital.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.2, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-420. Financial considerations; ability to pay. (Repealed.)

SPECT scanning services should be accessible to all persons in need of such services without regard to their ability to pay or the payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.3, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 3
Availability

12VAC5-320-430. Introduction of SPECT as a new service. (Repealed.)

Any applicant establishing a specialized center, clinic, or portion of a physician's office for the provision of SPECT or introducing SPECT as a new service at an existing medical care facility which has not previously provided nuclear medicine imaging services should provide documentation satisfactory to the department that it can achieve a minimum utilization level of 650 SPECT scans in the first 12 months of operation of the service, and 1,000 such procedures in the second 12 months of services if the imaging unit would be a single-head device; or that it can achieve a minimum utilization level of 1,000 SPECT scans in the first 12 months of operation of the service, 1,250 such procedures in the second 12 months of operation, and 1,500 such procedures in the third 12 months of operation if the imaging unit would be a multi-head device.

Consideration will be given to the approval of proposed nuclear medicine imaging services that project utilization below that outlined in the preceding paragraph when such services are proposed for sites located beyond 45 minutes driving time of any existing nuclear medicine imaging facilities.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.4, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-440. Additional scanners. (Repealed.)

No additional nuclear medicine imaging systems should be added to an existing SPECT service until the utilization of the applicant's existing imaging unit(s) for the relevant reporting period is equivalent to at least 1,000 SPECT procedures per unit per year for a single-head scanning unit and 1,500 SPECT procedures per year per unit for a multi-head scanning unit.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.5, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-450. Replacement of existing equipment. (Repealed.)

A. An application to replace equipment for the provision of SPECT nuclear medicine imaging services may be approved when the existing SPECT equipment has been in operation for at least five consecutive years and utilization of the replaced equipment was at least 1,000 SPECT procedures for a single-head scanning unit and 1,500 SPECT procedures for a multi-head scanning unit in the relevant reporting period.

B. An application to replace non-SPECT nuclear imaging equipment with SPECT nuclear medicine imaging equipment may be approved when the existing nuclear medicine imaging equipment has been in operation for at least five consecutive years and utilization of the replaced equipment was at least 500 procedures.

C. Notwithstanding subsection A of this section, consideration will be given to proposals to replace SPECT equipment which has been in operation for less than five consecutive years or has been utilized to perform less than 1,000 SPECT procedures for a single-head scanning unit and 1,500 SPECT procedures for a multi-head scanning unit if the applicant can reasonably demonstrate that such replacement is in substantial compliance with these standards, and that such replacement is necessary to achieve comparability and competitiveness with existing providers of SPECT services in the planning district where the replacement is proposed, and the applicant can demonstrate that the equipment to be replaced was fully utilized, given the type of equipment, the mode of service, or the area served, for the relevant reporting period. Such replacement will not qualify for expedited review under Part VI of the Virginia Medical Care Facilities COPN Rules and Regulations (12VAC5-220-10 et seq.).

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.6, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4
Cost

12VAC5-320-460. Comparability of charges. (Repealed.)

The total costs for providing SPECT service should be comparable to the costs for similar service providers in the planning district.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.7, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 5
Quality

12VAC5-320-470. Medical director. (Repealed.)

A. The proposed new, expanded, or replacement SPECT service should be under the medical direction of a physician who is board certified or board eligible in nuclear medicine or nuclear radiology or trained and licensed in nuclear cardiology, and has additional documented experience and training in SPECT technology. Such physicians should be licensed by the Nuclear Regulatory Commission to possess radiopharmaceuticals and perform diagnostic procedures employing radiopharmaceuticals in human beings.

B. Any neurologist involved in the performance or interpretation of SPECT studies should have verifiable credentials which indicate that all of the training and education requirements pertaining to the 1990 "Performance/Interpretation Qualifications" statement of the American Academy of Neurology for SPECT have been, or are being, complied with.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.8, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-320-480. Additional staff. (Repealed.)

SPECT services should be staffed by technologists qualified and experienced in the operation and routine maintenance of nuclear medical imaging systems during all hours of operation of the SPECT services.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-109 § 6.9, eff. July 1, 1993; amended, Virginia Register Volume 10, Issue 20, eff. July 27, 1994; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 330
LITHOTRIPSY SERVICES (REPEALED)

Part I
Definitions

12VAC5-330-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Biliary ESWL" or "gallstone ESWL" means a noninvasive procedure that uses shock waves produced outside the body to fragment biliary stones, or gallstones.

"Capacity" means that a single ESWL machine or unit has been used to perform 1,7500 procedures annually.

"Department" means the Virginia Department of Health.

"ESWL procedure" means a single noninvasive procedure, during a single visit, using ESWL.

"Extracorporeal shock wave lithotripsy (ESWL)" means a noninvasive procedure that uses shock waves produced outside the body to fragment matter, such as stones that occur in the kidney or upper urinary tract (renal stones).

"Relevant reporting period" means the most recent 12 month period, prior to the beginning of the Certificate of Public Need application's review cycle, for which data are available and acceptable to the department.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards

12VAC5-330-20. Acceptability; waiting time; consumer participation. (Repealed.)

A. The waiting time for elective ESWL procedure should be less than two weeks.

B. Providers of ESWL services should provide a program of patient education regarding the nature and extent of the stones and the available methods of diagnosis and treatment of the patient in the management of the stone.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-330-30. Accessibility; financial considerations. (Repealed.)

ESWL services should be accessible to all patients in need of services without regard to their ability to pay or the payment source.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 2.2, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-330-40. Availability; need for new services; expanded or replaced. (Repealed.)

A. No new ESWL service should be approved through the acquisition of ESWL equipment unless the total number of ESWL procedures performed in the Health Planning Region during the relevant reporting period, divided by the number of ESWL machines approved to operate in the Health Planning Region, exceeds 1,750.

B. Notwithstanding the standards for approval of new ESWL services outlined above, consideration will be given to the approval of new ESWL services established at a general hospital through lease of equipment of an existing mobile service approved to operate in Virginia, if the hospital where the new service will be located has referred at least six patients per month or 72 patients annually, for the relevant reporting period, to other facilities for ESWL procedures.

C. Proposals for the expansion of existing ESWL services through the acquisition of additional ESWL equipment should not be approved unless the number of ESWL procedures performed by that existing service during the relevant reporting period divided by the number of ESWL machines operated by the existing service exceeds 2,000.

D. 1. Proposals for replacement of ESWL equipment should not be approved unless the equipment to be replaced has been in service five years and has performed at least 1,7500 ESWL procedures for the relevant reporting period.

2. Additionally, all proposals for the replacement of ESWL equipment should comply with all applicable sections of this State Medical Facilities Plan component, as determined by the department.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 2.3, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-330-50. Continuity; coordination of services. (Repealed.)

Facilities providing ESWL services should provide courtesy privileges to qualified physicians for use for their patients who are expected to be treated on an outpatient basis.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 2.4, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-330-60. Cost comparability. (Repealed.)

The total costs (direct and indirect) of providing ESWL services should be comparable to the costs of other ESWL services providers in the health planning region of the Commonwealth.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-330-70. Quality; staffing. (Repealed.)

A. Each ESWL procedure should be under the direct supervision of a urologist who is board certified or board eligible and who is trained in ESWL.

B. All ESWL services should be staffed with technologists qualified and trained in ESWL procedures.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-110 § 2.6, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

CHAPTER 340
RADIATION THERAPY SERVICES (REPEALED)

Part I
Definitions

12VAC5-340-10. Definitions. (Repealed.)

The following words and terms, when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Capacity" means that a megavoltage radiation therapy unit has been used to treat 320 cancer patients or to perform 8,000 treatment visits on an annual basis.

"Course of treatment" means a patient therapy program designed to result in the delivery of a prescribed overall dose of radiation, which is typically divided into a number of treatment fractions delivered during a series of treatment visits to the radiation therapy facility.

"Department" means Virginia Department of Health.

"Gamma knife" or "gamma unit" means a stereotactic radiosurgical instrument with cobalt 60 sources arrayed in a semicircular arc so that they may be very precisely focused and the radiation dose may be very precisely distributed, permitting treatment in neurosurgical cases where the site is inaccessible or otherwise unsuitable for other invasive methods.

"Gamma knife procedure" means a single treatment of a patient using the unit. One procedure is performed per patient.

"Megavoltage radiation therapy units" means the machine, including linear accelerators and Cobalt-60 teletherapy units, used ot generate radiation with an energy range of 2-50 megavolts, or millions of electron volts (MeV).

"Orthovoltage radiation therapy units" means the machine used to generate x-rays with an energy range of 200-400 kilovolts. Although these machines have been largely replaced by megavoltage radiation therapy units, they are sometimes used for treatment of deep-seated tumors.

"Radiation therapy" means a clinical specialty in which ionizing radiation is used for treatment of cancer, often in conjunction with surgery or chemotherapy or both of these treatment methods. The predominant form of radiation therapy involves an external source of radiation whose energy is focused on the diseased area.

"Radioisotope therapy" means a process that involves the direct application of a radioactive substance to the diseased tissue and usually requires surgical implantation.

"Relevant reporting period" means the most recent 12 month period, prior to the beginning of the Certificate of Public Need application's review cycle, for which data are available and acceptable to the department.

"Stereotactic radiosurgery" means a noninvasive therapeutic procedure in which narrow beams of radiant energy are directed at the treatment target in the head so as to produce tissue destruction, using computerized tomography (CT), radiography, magnetic resonance imaging (MRI), and angiography for localization.

"Superficial radiation therapy units" means the machine used to generate x-rays with an energy range of 85-180 kilovolts and used to treat lesions on the surface or just below the skin.

"Treatment fraction" means a single portion of the overall prescribed dose of radiation for a radiation therapy patient.

"Treatment visit" or "procedure" means a single procedure performed to deliver an amount of radiation to the radiation therapy patient.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-111 § 1.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part II
Criteria and Standards for Megavoltage Radiation Therapy Services

12VAC5-340-20. Acceptability; consumer participation. (Repealed.)

Providers of radiation therapy services should provide a program of patient and family education regarding the nature of the patient's cancer and the available methods of diagnosis and treatment, and the medical, clinical, technical, psycho-social, financial, and nutritional aspects of the patient's condition and the family's role in caring for the patient.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-111 § 2.1, eff. July 1, 1993; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-340-30. Accessibility; time; financial considerations. (Repealed.)

A. 1. Radiation therapy services should be available within the institution, on a regularly scheduled basis, for a minimum of 40 hours a week.

2. Convenient hours of operation should be provided for the benefit of outpatients (early morning hours, lunch hours, evening hours, weekends).

B. Radiation therapy services should be available within one hour normal driving time, under normal conditions, for 95% of the population.

C. Radiation therapy services should be accessible to all patients in need of services without regard to their ability to pay or the payment source.

D. Providers of radiation therapy services serving rural areas should facilitate the transport of patients residing in rural areas to needed radiation therapy services, directly or through coordinated efforts with other organizations. Preference will be given in the review of competing applications to applicants who can demonstrate a commitment to the development of transportation resources for rural populations.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from VR355-30-111 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-340-40. Availability; need for new service; expanded; replacement of service. (Repealed.)

A. 1. No new radiation therapy service should be approved unless: (i) existing radiation therapy machines located in the health planning region in which the proposed new service is to be located were used for at least 320 cancer cases and at least 8,000 treatment visits for the relevant reporting period; and (ii) it can be reasonably projected that the new service will be used for 240 cancer patients and will perform at least 6,000 procedures by the third year without reducing the utilization of existing radiation therapy machines in the health planning region such that less than 8,000 procedures will be performed by any existing machine.

2. The number of megavoltage radiation therapy machines needed in a health planning region will be determined as follows:

where:

the population is that projected for three years from the current year and is at least 150,000 (population data will be the most recently available from the Virginia Employment Commission);

Cancer incidence rates are those for the applicant's proposed service area, are specific to Virginia, and are based on data from the Virginia Tumor Registry, or the American Cancer Society;

45% is used to estimate the number of new cancer cases in a given area that are treatable with radiation therapy; and

320 is the 100% utilization of a radiation therapy machine.

B. Notwithstanding the standards for approval of new radiation therapy services outlined above, consideration will be given to the approval of new radiation therapy services which will be located at a general hospital located 60 minutes or more driving time, under normal conditions, from any site at which radiation therapy services are available if it can be reasonably projected that the proposed new services will perform at least 6,000 treatment procedures by the third year of operation, without reducing the utilization of existing machines located within 60 to 70 minutes driving time, under normal conditions, from the proposed new service location.