The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acquisition" means an expenditure of $600,000 or more that changes the ownership of a medical care facility . It shall also include , including the donation or lease of a medical care facility . An acquisition of a medical care facility shall not include , but excluding a capital expenditure involving the purchase of stock. See 12VAC5-220-120.

"Amendment" means any modification to an application that is made following the public hearing and prior to the issuance of a certificate of public need, and includes including those factors that constitute a significant change as defined in this chapter . An amendment shall not include , but excluding a modification to an application that serves to reduce the scope of a project.

"Applicant" means the owner of an existing medical care facility or the sponsor of a proposed medical care facility project submitting an application that submits an application for a certificate of public need.

"Application" means a prescribed format for the presentation of data and information deemed necessary by the board to determine a public need for a medical care facility project. has the same meaning as ascribed to the term in § 32.1-102.1 of the Code of Virginia.

"Application fees" means fees required for a project application and application for a significant change. Fees shall not exceed the lesser of 1.0% of the proposed capital expenditure or cost increase for the project or $20,000.

"Board" means the State Board of Health.

"Capital expenditure" means any expenditure by or in on behalf of a medical care facility that, under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance, . Such expenditure shall also include including a series of related expenditures during a 12-month period or a financial obligation or a series of related financial obligations made during a 12-month period by or in on behalf of a medical care facility. Capital expenditures need not be made by a medical care facility so long as they are made in on behalf of a medical care facility by any person. See definition of "person."

"Certificate" or "certificate of public need" means a document that legally authorizes a medical care facility project as defined herein and which is issued by the commissioner to the owner of such project. has the same meaning as ascribed to the term "certificate" in § 32.1-102.1 of the Code of Virginia.

"Charity care" has the same meaning as ascribed to the term in § 32.1-102.1 of the Code of Virginia.

"Clinical health service" means a single diagnostic, therapeutic, rehabilitative, preventive or palliative procedure as defined has the same meaning as ascribed to the term in § 32.1-102.1 of the Code of Virginia.

"Commissioner" means the State Health Commissioner who has authority to make a determination respecting the issuance or revocation of a certificate.

"Competing applications" means applications for the same or similar services and facilities that are proposed for the same planning district or planning region, medical service area or statewide, as designated in the State Health Services Plan, and which that are in the same review cycle. See 12VAC5-220-220.

"Completion" means conclusion of construction activities necessary for substantial performance of the contract.

"Construction" means the building of a new medical care facility or the expansion, remodeling, or alteration of an existing medical care facility.

"Construction, initiation of" means that a project shall be considered under construction for the purpose of certificate extension determinations upon the presentation of evidence by the owner of: (i) a signed construction contract; (ii) the completion of short term financing and a commitment for long term (permanent) financing when applicable; (iii) the completion of predevelopment site work; and (iv) the completion of building foundations.

"CT" means computed tomography.

"Date of issuance" means the date of the commissioner's decision awarding a certificate of public need.

"Day" means a calendar day. For purposes of project review, any scheduled deadlines that fall on a weekend or state holiday shall be advanced to the next work day.

"Department" means the Virginia Department of Health.

"Designated medically underserved areas" means (i) areas designated as medically underserved areas pursuant to § 32.1-122.5 of the Code of Virginia; (ii) federally designated Medically Underserved Areas (MUA); or (iii) federally designated Health Professional Shortage Areas (HPSA).

"Ex parte" means any meeting that takes place between (i) any person acting in behalf of the applicant or holder of a certificate of public need or any person opposed to the issuance or in favor of the revocation of a certificate of public need and (ii) any person who has authority in the department to make a decision respecting the issuance or revocation of a certificate of public need for which the department has not provided 10 days written notification to opposing parties of the time and place of such meeting, . An ex parte contact shall not include and excludes a meeting between the persons identified in (i) and staff of the department.

"General hospital" has the same meaning as ascribed to the term in 12VAC5-410-10.

"Good cause" means that (i) there is significant relevant information not previously presented at and not available at the time of the public hearing or, if no public hearing is held, by the close of the public comment period, (ii) there have been significant changes in factors or circumstances relating to the application subsequent to the public hearing or, if no public hearing is held, by the close of the public comment period, or (iii) there is a substantial material mistake of fact or law in the department staff's report on the application or in the report submitted by the health planning agency.

"Gamma knife surgery" means stereotactic radiosurgery, where stereotactic radiosurgery is the noninvasive therapeutic procedure performed by directing radiant energy beams from any source at a treatment target in the head to produce tissue destruction. See definition of "project."

"Health planning region" means a contiguous geographical area of the Commonwealth as defined has the same meaning as ascribed to the term in § 32.1-102.1 of the Code of Virginia.

"Hospital" has the same meaning as ascribed to the term in § 32.1-123 of the Code of Virginia.

"Informal fact-finding conference" means a conference held pursuant to § 2.2-4019 of the Code of Virginia.

"Initiation of construction" means that a project shall be considered under construction for the purpose of certificate extension determinations upon the presentation of evidence by the owner of: (i) a signed construction contract; (ii) the completion of short term financing and a commitment for long term (permanent) financing when applicable; (iii) the completion of predevelopment site work; and (iv) the completion of building foundations.

"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 varying nomenclatures including but not limited to: nursing beds, intensive care beds, minimal or self care beds, isolation 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 a maternity department and beds located in labor or birthing rooms, recovery rooms, emergency rooms, preparation or anesthesia inductor rooms, diagnostic or treatment procedures rooms, or on-call staff rooms are excluded from this definition.

"Medical care facility" means any institution, place, building, or agency as defined has the same meaning as ascribed to the term in § 32.1-102.1 32.1-3 of the Code of Virginia.

"Medical service area" means the geographic territory from which at least 75% of patients come or are expected to come to existing or proposed medical care facilities, the delineation of which is based on such factors as population characteristics, natural geographic boundaries, and transportation and trade patterns, and all parts of which are reasonably accessible to existing or proposed medical care facilities.

"Modernization" means the alteration, repair, remodeling, replacement or renovation of an existing medical care facility or any part thereto, including that which is incident to the initial and subsequent installation of equipment in a medical care facility. See definition of "construction."

"MRI" means magnetic resonance imaging.

"Nursing home" has the same meaning as ascribed to the term in § 32.1-123 of the Code of Virginia.

"Operating expenditure" means any expenditure by or in on behalf of a medical care facility that, under generally accepted accounting principles, is properly chargeable as an expense of operation and maintenance and is not a capital expenditure.

"Operator" means any person having designated responsibility and legal authority from the owner to administer and manage a medical care facility. See definition of "owner."

"Other plans" means any plan(s) which is formally adopted by an official state agency or regional health planning agency and which provides for the orderly planning and development of medical care facilities and services and which is not otherwise defined in this chapter.

"Owner" means any person who has legal responsibility and authority to construct, renovate or equip or otherwise control a medical care facility as defined herein.

"Person" has the same meaning as ascribed to the term in § 32.1-3 of the Code of Virginia. means an individual, corporation, partnership, association or any other legal entity, whether governmental or private. Such person may also include the following:

1. The applicant for a certificate of public need;

2. The regional health planning agency for the health planning region in which the proposed project is to be located;

3. Any resident of the geographic area served or to be served by the applicant;

4. Any person who regularly uses health care facilities within the geographic area served or to be served by the applicant;

5. Any facility or health maintenance organization (HMO) established under § 38.2-4300 et seq. of the Code of Virginia that is located in the health planning region in which the project is proposed and that provides services similar to the services of the medical care facility project under review;

6. Third party payors who provide health care insurance or prepaid coverage to 5.0% or more patients in the health planning region in which the project is proposed to be located; and

7. Any agency that reviews or establishes rates for health care facilities.

"PET" means positron emission tomography.

"Physician's "Physician office" means a place, owned or operated by a licensed physician or group of physicians practicing in any legal form whatsoever, which that is designed and equipped solely for the provision of fundamental medical care, whether diagnostic, therapeutic, rehabilitative, preventive or palliative to ambulatory patients, and which that does not participate in cost-based or facility reimbursement from third party health insurance programs or prepaid medical service plans, excluding pharmaceuticals and other supplies administered in the office. See definition of "medical care facility."

"Planning district" means a contiguous area within the boundaries established by the Department of Housing and Community Development as set forth in § 15.2-4202 of the Code of Virginia, except that for purposes of this chapter, Planning District 23 shall be divided into two planning districts: Planning District 20, consisting of the counties of Isle of Wight and Southampton and the cities of Chesapeake, Franklin, Norfolk, Portsmouth, Suffolk and Virginia Beach; and Planning District 21, consisting of the counties of James City and York and the cities of Hampton, Newport News, Poquoson and Williamsburg.

"Predevelopment site work" means any preliminary activity directed towards preparation of the site prior to the completion of the building foundations, . This includes, but is not limited to, including soil testing, clearing, grading, and extension of utilities and power lines to the site.

"Primary medical care services" means a first-contact, whole-person medical and health services service delivered by broadly trained, generalist physicians, nurses, and other professionals, intended to include, without limitation, including obstetrics/gynecology obstetrics and gynecology, family practice, internal medicine, and pediatrics.

"Progress" means actions that are required in a given period of time to complete a project for which a certificate of public need has been issued. See 12VAC5-220-450, Demonstration of progress.

"Project" means any plan or proposal as defined in § 32.1-102.1 of the Code of Virginia that is subject to Certificate of Public Need approval. action described in subsection B of § 32.1-102.1:3 of the Code of Virginia.

"Public hearing" means a proceeding conducted by a regional health planning agency or the department at which an applicant for a certificate of public need and members of the public may present oral or written testimony in support or opposition to the application that is the subject of the proceeding and for which a verbatim record is made. See subsection A of 12VAC5-220-230 .

"Regional health plan" means the regional plan adopted by the regional health planning agency board.

"Regional health planning agency" means the regional agency as defined in § 32.1-102.1 of the Code of Virginia.

"RFA" means a request for applications.

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

"Schedule for completion" means the timetable that identifies the major activities required to complete a project as identified by the applicant and set forth on the certificate of public need. The timetable is used by the commissioner to evaluate the applicant's progress in completing an approved project.

"Significant change" means any alteration, modification, or adjustment to a reviewable project for which a certificate of public need has been issued or requested following the public hearing which that:

1. Changes the site;

2. Increases the capital expenditure amount authorized by the commissioner on the certificate of public need issued for the project by 10% or more;

3. Changes the service(s) proposed to be offered; or

4. Extends the schedule for completion of the project beyond three years (36 months) from the date of certificate issuance or beyond the time period approved by the commissioner at the date of certificate issuance, whichever is greater. See 12VAC5-220-440 and 12VAC5-220-450.

"Standard review process" means the process utilized in the review of all certificate of public need requests with the exception of:

1. Certain bed relocations as specified in 12VAC5-220-280; or

2. Certain projects that involve an increase in the number of beds in which nursing facility or extended care services are provided as specified in 12VAC5-220-325.

"State Medical Facilities Plan" means the planning document 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 "State Health Services Plan" means the plan as described in § 32.1-102.1 of the Code of Virginia.

"Work day" means any day that is not a Saturday, Sunday, legal holiday, or day that the department is closed. For the purposes of this chapter, any day on which the Governor authorizes the closing of the state government shall be considered a legal holiday.

The Virginia Medical Care Facilities Certificate of Public Need Law, which is codified as Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia, requires the owners or sponsors of medical care facility projects to secure a certificate of public need from the State Health Commissioner prior to initiating such projects. Sections 32.1-102.2 and 32.1-12 of the Code of Virginia direct the Board of Health to promulgate and prescribe such rules and regulations as are deemed necessary to effectuate the purposes of this statute.

The board has promulgated this chapter to set forth an orderly administrative process for making public need decisions.

This chapter is administered by the following:

1. The Board of Health is the governing body of the Virginia Department of Health. The Board of Health has the authority to promulgate and prescribe such rules and regulations as it deems necessary to effectuate the purposes of the Act.

2. The State Health Commissioner is the executive officer of the Virginia Department of Health. The commissioner is the designated decision maker in the process of determining public need under the Act.

All meetings and hearings convened to consider any certificate of public need application shall be open to the public in accordance with the provisions of the Virginia Freedom of Information Act (§ 2.1-340 et seq.) of the Code of Virginia.

Written information including staff evaluations and reports and correspondence developed or utilized or received by the commissioner during the review of a medical care facility project shall become part of the official project record maintained by the Department of Health and shall be made available to the applicant, competing applicant and review bodies. Other persons may obtain a copy of the project record upon request. All records are subject to the Virginia Freedom of Information Act.

This chapter has general applicability throughout the Commonwealth. The requirements of the Virginia Administrative Process Act (§ 9-6.14:1 et seq.) of the Code of Virginia apply to their promulgation.

The commissioner and the board reserve the right to authorize any procedure for the enforcement of this chapter that is not inconsistent with the provisions set forth herein and the provisions of Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

Pursuant to § 32.1-102.12 of the Code of Virginia, the commissioner shall annually report to the Governor and the General Assembly on the status of Virginia's certificate of public need program.

A. Prior to initiating a reviewable medical care facility project the A owner or sponsor person shall obtain a certificate of public need or registration, as required by law, from the commissioner prior to initiating a project by or on behalf of a medical care facility . In the case of an acquisition of an existing medical care facility, the notification requirement set forth in 12VAC5-220-120 shall be met.

B. Projects involving a temporary increase in the total number of beds in an existing hospital or nursing home shall be exempt from the requirement for a certificate, for a period of no more than 30 days, if the commissioner has determined that a natural or man-made disaster has caused the evacuation of a hospital or nursing home and that a public health emergency exists due to a shortage of hospital or nursing home beds.

C. A person shall be exempt from obtaining a certificate of public need for a project that:

1. Relocates up to 10 beds or 10 percent of the beds, whichever is fewer from one existing medical care facility to another existing medical care facility at the same site in any two-year period;

2. Uses up to 10 percent of beds as nursing home beds by a medical care facility that is licensed as a hospital; or

3. Relocates up to 10 beds or 10 percent of the beds, whichever is fewer from one existing medical care facility licensed as a nursing home to any other existing medical care facility licensed as a nursing home in any three-year period that is:

a. Owned or controlled by the same person; and

b. Located within the same planning district or within another planning district out of which at least 10 times the number of beds have been authorized by statute to be relocated from one or more medical care facilities in that other planning district and at least half of those beds have not been replaced.

D. A nursing home shall be exempt from obtaining a certificate of public need when the nursing home is affiliated with a facility that, on January 1, 1982, and thereafter:

1. Operates as a nonprofit institution;

2. Is licensed jointly by the department as a nursing home and by the Department of Social Services as an assisted living facility; and

3. Restricts the admissions such that:

a. Admissions to a facility are only allowed pursuant to the terms of a "life care contract" guaranteeing that the full complement of services offered by a facility are available to a resident as and when needed;

b. Admissions to an assisted living facility unit of a facility are restricted to individuals defined as ambulatory by the Department of Social Services; and

c. Admissions to a nursing home unit of a facility are restricted to an individual who is a resident at the assisted living unit of the facility.

Within 30 days of any person contracting to make, or otherwise legally obligating to make, a capital expenditure for the replacement of medical equipment or otherwise acquiring replacement medical equipment for the provision of services listed in subdivision 7 of the definition of "project" in 12VAC5-220-10, the person shall register in writing such equipment replacement with the commissioner and the appropriate regional health planning agency. Such registration shall be made on forms provided by the department. The registration shall identify the specific unit of equipment to be replaced and the estimated capital cost of the replacement and shall include documentation that the equipment to be replaced has previously been authorized or exempted as allowed by law.

A. A person shall register any capital expenditure for the purchase of new medical equipment for the provision of:

1. Lithotripsy;

2. Stereotactic radiosurgery;

3. Stereotactic radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy X-rays to perform external beam radiation therapy;

4. Obstetrical services;

5. Nuclear imaging services; or

6. Proton beam therapy.

B. A person shall register any capital expenditure for the replacement of medical equipment for the provision of:

1. Cardiac catheterization;

2. CT scanning;

3. MRI scanning;

4. Open heart surgery;

5. PET scanning;

6. Radiation therapy; or

7. Proton beam therapy.

C. The department may not require the registration of replacement medical equipment for the provision of:

1. Lithotripsy;

2. Stereotactic radiosurgery;

3. Nuclear imaging services;

4. Obstetrical services; or

5. Stereotactic radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy X-rays to perform external beam radiation therapy.

D. A person shall submit the registration for the purchase of medical equipment described in subsections A and B of this section in writing:

1. To the commissioner and the appropriate regional health planning agency;

2. At least 30 days before a person is contractually obligated to make a capital expenditure for the purchase of medical equipment;

3. Accompanied by the fee prescribed, if applicable; and

4. On forms available on the department's website that identify:

a. The specific unit of medical equipment to be replaced, if applicable;

b. The specific unit of medical equipment to be purchased;

c. The estimated capital cost of the medical equipment; and

d. If applicable, documentation that the equipment to be replaced has previously been authorized or exempted as allowed by law.

A. At least 30 days before any person contracts to make or is otherwise legally obligated to make a capital expenditure by or on behalf of a medical care facility as defined in this chapter that has not been previously authorized by the commissioner, such expenditure shall be registered in writing with the commissioner. The threshold amount for capital expenditure project registration shall be determined using the formula contained in subsection B of this section. A person shall register in writing with the commissioner at least 30 days before the person is contractually obligated to make a capital expenditure at or on behalf of a:

1. General hospital if the capital expenditure is $5 million or more; and

2. Medical care facility that is not a general hospital if the capital expenditure is between $5 million and the amount established in subsection B of this section.

B. The threshold contained in subsection A of this section shall be adjusted The department shall determine the threshold amount for the registration of capital expenditures prescribed in subdivision A 2 of this section using the formula in this subsection and adjust the threshold annually using the percentage increase listed in the Consumer Price Index for All Urban Consumers (CPI-U) for the most recent year as follows:

A x (1+B)

where:

A = the capital expenditure threshold amount for the previous year

and

B = the percent increase for the expense category "Medical Care" listed in the most recent year available of the CPI-U of the U.S. Bureau of Labor Statistics.

C. The format for registration shall include information concerning the purpose of such expenditure and projected impact that the expenditure will have upon the charges for services. For purposes of registration, the owner shall include any person making the affected capital expenditure. See definition of "project." A person shall submit information concerning:

1. The purpose of the expenditure; and

2. The projected impact that the expenditure will have upon the charges for services.

D. Annually, the department shall (i) publish the threshold amount in the General Notices section of the Virginia Register of Regulations and (ii) post the threshold amount on its website. The department shall annually:

1. Publish the threshold amount in the General Notices section of the Virginia Register of Regulations; and

2. Post the threshold amount on the department's website.

An HMO must obtain a certificate of public need prior to initiating a project. Such HMO must also adhere to the requirements for the acquisition of medical care facilities if appropriate. See definition of "project" and 12VAC5-220-10.

A. Every If a medical care facility subject to the requirements of Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia, other than a nursing home, that is not a medical care facility for which a certificate with conditions imposed pursuant to § 32.1-102.4 F of the Code of Virginia has been issued and that provides charity care, as defined in § 32.1-102.1 of the Code of Virginia, has a certificate of public need with conditions imposed pursuant to subsection B of § 32.1-102.4 of the Code of Virginia and provides charity care, the medical facility shall annually report to the commissioner department annually the amount of charity care provided by submitting that information to the nonprofit organization described in § 32.1-276.4 of the Code of Virginia.

B. No provision of this section shall apply to a nursing home.

In determining whether a public need exists for a proposed project, the applicable requirements of § 32.1-102.2:1 of the Code of Virginia will be considered.

A. Letter of intent. An applicant shall file a letter of intent with the commissioner to request appropriate application forms, and submit a copy of that letter to the appropriate regional health planning agency , .

B. An applicant shall file a letter of intent by the later of :

(i) 1. 30 days prior to the submission of an application for a project included within a particular batch group ; or

(ii) 2. 10 days after the first letter of intent is filed for a project within a particular batch group for the same or similar services and facilities which that are proposed for the same planning district or medical service area. planning region, or statewide, as designated by the State Health Services Plan.

C. The letter shall identify the:

the owner, 1. Owner;

the type 2. Type of project for which an application is requested , and ;

the proposed 3. Proposed scope (size) of the project, including:

a. Number of beds;

b. Number of equipment units; or

c. Number of operating rooms; and

4. location Location of the proposed project.

D. The department shall transmit application forms to the applicant within seven days of the receipt of the letter of intent make the application forms available on its website . A letter of intent filed with the department shall be considered void one year after the date of receipt of such letter. (See 12VAC5-220-310 C.)

B. Application fees. E. The department shall collect application fees for applications that request a certificate of public need. The fee required for an application shall be 1.0% of the proposed expenditure for the project, but not less than $1,000 and no more than $20,000.

No application will be deemed to be complete for review until the required application fee is paid. (See 12VAC5-220-310 C.)

C. Filing application forms. Applications must be submitted at least 40 days F. An applicant shall submit an application to be received by the department no later than 5 p.m. on the 10th day prior to the first day of a scheduled review cycle to be considered for review in the same cycle.

In order to verify the date of the department's and the appropriate regional health planning agency's receipt of the application, the G. An applicant shall transmit the document an application electronically, or prepare in triplicate , two copies to be submitted to the department and one copy to be submitted to the appropriate regional health planning agency and sent by certified mail or a delivery service, return receipt requested, by hand, with a signed receipt to be provided.

H. No application shall be deemed to have been submitted until the required copies have been received by the department and the appropriate regional health planning agency. (See 12VAC5-220-200.)

The applicant shall be notified by the department within 15 days following receipt of the application if additional information is required to complete the application or the application is complete as submitted. No application shall be reviewed until the department has determined that it is complete. To be complete,

A. The department shall consider an application complete if an applicant:

1. Answers all questions must be answered to the satisfaction of the commissioner in an application; and

2. Supplies all requested documents in an application; and

3. Submits the application fee.

supplied, when applicable and the application fee submitted. Additional information required to complete an application shall be submitted to the department and the appropriate regional health planning agency at least five days prior to the first day of a review cycle to be considered complete for review in the same review cycle. (See 12VAC5-220-200.)

B. The department shall notify an applicant within 10 days following receipt of the application if the application is complete as submitted.

C. The department may not review an application until the application is determined to be complete.

A. The department shall review the following groups of completed applications in accordance with the following 190-day scheduled review cycles and the following descriptions of projects within each group, except as provided for in 12VAC5-220-220.

B. Batch Group A includes:

1. The establishment of a general hospital . ;

2. An increase in the total number of general acute care beds in an existing or authorized general hospital . ; and

3. The relocation at the same site of 10 general hospital beds or 10% of the general hospital beds of a medical care facility, whichever is less, from one existing physical facility to another in any two-year period if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

4. 3. The introduction into an existing medical care facility of any new neonatal special care or obstetrical services that the facility has not provided in the previous 12 months.

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category included in Batch Groups B through G, by or in behalf of a general hospital.

C. Batch Group B includes:

1. The establishment of a specialized center, clinic, or portion of a physician's physician office developed for the provision of outpatient or ambulatory surgery or cardiac catheterization services . ;

2. An increase in the total number of operating rooms in an existing medical care facility or establishment of operating rooms in a new facility . ;

3. The introduction into an existing medical care facility of any new cardiac catheterization, open heart surgery, or organ or tissue transplant services that the facility has not provided in the previous 12 months . ;

4. The addition by an existing medical care facility of any medical equipment for the provision of cardiac catheterization . ;

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Group A or Batch Groups C through G, by or in on behalf of a specialized center, clinic, or portion of a physician's physician office developed for the provision of outpatient or ambulatory surgery or cardiac catheterization services . ; and

6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Group A or Batch Groups C through G, by or in on behalf of a medical care facility, that is primarily related to the provision of surgery, cardiac catheterization, open heart surgery, or organ or tissue transplant services.

D. Batch Group C includes:

1. The establishment of a mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts for individuals with substance use disorder, or mental retardation facility. individuals with intellectual disabilities;

2. An increase in the total number of beds in an existing or authorized mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts for individuals with substance use disorder, or mental retardation facility. individuals with intellectual disabilities;

3. An increase in the total number of mental hospital, psychiatric hospital, substance abuse substance use disorder treatment and rehabilitation, or mental retardation beds in an existing or authorized medical care facility that is not a dedicated mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts for individuals with substance use disorder, or mental retardation facility. individuals with intellectual disabilities;

4. The relocation at the same site of 10 mental hospital, psychiatric hospital, substance abuse treatment and rehabilitation, or mental retardation beds or 10% of the mental hospital, psychiatric hospital, substance abuse treatment and rehabilitation, or mental retardation beds of a medical care facility, whichever is less, from one existing physical facility to another in any two-year period if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

5. 4. The introduction into an existing medical care facility of any new psychiatric or substance abuse substance use disorder treatment service that the facility has not provided in the previous 12 months . ;

6. 5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A and B or Batch Groups D/F D through G, by or in on behalf of a mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts for individuals with substance use disorder, or mental retardation facilities. individuals with intellectual disabilities; and

7. 6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A and B or Batch Groups D/F D through G, by or in behalf of a medical care facility, which that is primarily related to the provision of mental health, psychiatric, substance abuse substance use disorder treatment or rehabilitation, or mental retardation services individuals with intellectual disabilities.

E. Batch Group D/F D includes:

1. The establishment of a specialized center, clinic, or that portion of a physician's physician office developed for the provision of computed tomographic (CT) CT scanning, magnetic resonance imaging (MRI) MRI scanning, magnetic source imaging (MSI), positron emission tomographic (PET) or PET scanning, or nuclear medicine imaging, except for the purpose of nuclear cardiac imaging. ;

2. The introduction into an existing medical care facility of any new computed tomography (CT) CT scanning, magnetic resonance imaging (MRI) MRI scanning, magnetic source imaging (MSI), positron emission tomographic (PET) or PET scanning, or nuclear medicine imaging services, except for the purpose of nuclear cardiac imaging that the medical care facility has not provided in the previous 12 months . ;

3. The addition by an existing medical care facility of any equipment for the provision of computed tomography (CT) CT scanning, magnetic resonance imaging (MRI) MRI scanning, magnetic source imaging (MSI), or positron emission tomographic (PET) or PET scanning . ;

4. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A, B, C, E, and G, by or in on behalf of a specialized center, clinic, or that portion of a physician's physician office developed for the provision of computed tomographic (CT) CT scanning, magnetic resonance imaging (MRI) MRI scanning, magnetic source imaging (MSI), positron emission tomographic (PET) or PET scanning , or nuclear medicine imaging, except that portion of a physician's office dedicated to providing nuclear cardiac imaging. ; and

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A, B, C, E, and G, by or in on behalf of a medical care facility, which that is primarily related to the provision of computed tomographic (CT) CT scanning, magnetic resonance imaging (MRI) MRI scanning, magnetic source imaging (MSI), positron emission tomographic (PET) or PET scanning , or nuclear medicine imaging, except for the purpose of nuclear cardiac imaging .

F. Batch Group E includes:

1. The establishment of a medical rehabilitation hospital . ;

2. An increase in the total number of beds in an existing or authorized medical rehabilitation hospital . ;

3. An increase in the total number of medical rehabilitation beds in an existing or authorized medical care facility that is not a dedicated medical rehabilitation hospital . ;

4. The relocation at the same site of 10 medical rehabilitation beds or 10% of the medical rehabilitation beds of a medical care facility, whichever is less, from one existing physical facility to another in any two-year period, if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

5. 4. The introduction into an existing medical care facility of any new medical rehabilitation service that the facility has not provided in the previous 12 months . ;

6. 5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A, B, C, D/F D, F/D , and G, by or in on behalf of a medical rehabilitation hospital . ; and

7. 6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A, B, C, D/F D, F/D , and G, by or in on behalf of a medical care facility, that is primarily related to the provision of medical rehabilitation services.

G. Batch Group D/F F/D includes:

1. The establishment of a specialized center, clinic, or that portion of a physician's physician office developed for the provision of gamma knife surgery, lithotripsy, or radiation therapy, stereotactic radiotherapy other than radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy x-rays to perform external beam radiation therapy, CT scanning, MRI scanning, or PET scanning that the medical care facility has not provided in the previous 12 months . ;

2. Introduction into an existing medical care facility of any new gamma knife surgery, lithotripsy, or radiation therapy services, stereotactic radiotherapy other than radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy x-rays to perform external beam radiation therapy, CT scanning, MRI scanning, or PET scanning that the medical care facility has not provided in the previous 12 months . ;

3. The addition by an existing medical care facility of any medical equipment for the provision of gamma knife surgery, lithotripsy, or radiation therapy, stereotactic radiotherapy other than radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy x-rays to perform external beam radiation therapy, CT scanning, MRI scanning, or PET scanning . ;

4. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project in Batch Groups A, B, C, E, and G, by or in on behalf of a specialized center, clinic, or that portion of a physician's physician office developed for the provision of gamma knife surgery, lithotripsy, or radiation therapy, stereotactic radiotherapy other than radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy x-rays to perform external beam radiation therapy, CT scanning, MRI scanning, or PET scanning . ; and

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project in Batch Groups A, B, C, E, and G, by or in on behalf of a medical care facility, which that is primarily related to the provision of gamma knife surgery, lithotripsy, or radiation therapy, stereotactic radiotherapy other than radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy x-rays to perform external beam radiation therapy, CT scanning, MRI scanning, or PET scanning.

H. Batch Group G includes:

1. The establishment of a nursing home, or intermediate care facility, or extended care facility of a continuing care retirement community by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia . ;

2. The establishment of a nursing home, or intermediate care facility , or extended care facility that does not involve an increase in the number of nursing home facility beds within a planning district . ;

3. An increase in the total number of beds in an existing or authorized nursing home, or intermediate care facility, or extended care facility of a continuing care retirement community by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia . ;

4. An increase in the total number of beds in an existing or authorized nursing home, or intermediate care facility, or extended care facility that does not involve an increase in the number of nursing home facility beds within a planning district . ;

5. The relocation at the same site of 10 nursing home, or intermediate care facility, or extended care facility beds or 10% of the nursing home, intermediate care facility, or extended care facility beds of a medical care facility, whichever is less, from one physical facility to another in any two-year period, if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

6. 5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A through D/F F/D , by or in on behalf of a nursing home, or intermediate care facility, or extended care facility, which that does not increase the total number of beds of the medical care facility . ; and

7. 6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B I of this section and not defined as a project category in Batch Groups A through D/F F/D , by or in on behalf of a medical care facility, that is primarily related to the provision of nursing home , or intermediate care, or extended care services, and does not increase the number of beds of the medical care facility.

B. The capital expenditure threshold referenced in subsection A of this section shall be adjusted I. The department shall determine the threshold amount for capital expenditures prescribed in subsections B through H of this section using the formula in this subsection and adjust this threshold annually using the percentage increase listed in the Consumer Price Index for All Urban Consumers (CPI-U) for the most recent year as follows:

A x (1+B)

where:

A = the capital expenditure threshold amount for the previous year

and

B = the percent increase for the expense category "Medical Care" listed in the most recent year available of the CPI-U of the U.S. Bureau of Labor Statistics.

C. Annually, the J. The department shall annually:

1. (i) publish Publish the threshold amount in the General Notices section of the Virginia Register of Regulations; and

2. (ii) post Post the threshold amount on its website.

A. The commissioner may request the submission of applications for his consideration which that address a specific need for services and facilities as identified in the State Medical Facilities Plan State Health Services Plan . The department shall give notice of such RFA :

1. Give notice of an RFA in a newspaper of general circulation in the locality or the planning district where the specific services or facility is requested . ;

Such notice shall be published 2. Publish the notice at least 120 days prior to the first day of the appropriate review cycle for the type of project being requested . ; and

A 3. Make available upon request a written copy of an RFA shall also be available upon request from the department and the regional health planning agency in the appropriate geographic area .

B. The process for adoption of an RFA by the commissioner for projects listed in § 32.1-102.3:2 A, B, and C of the Code of Virginia are set forth in 12VAC5-220-335.

Applications for the same or similar services which are proposed for the same planning district or medical service area planning region or statewide, as designated in the State Health Services Plan, shall be considered as competing applications by the commissioner. The commissioner shall determine whether an application is competing and shall provide written notification to the competing applicants and the regional health planning agency. The commissioner may, upon the request of an applicant, waive the review schedule requirements of 12VAC5-220-200 in the case of a documented emergency or in cases where, as of the deadline for filing a letter of intent for the otherwise applicable cycle, there are no competing applicants, and the applicant who has filed a letter of intent for a particular project proposes to combine the intended project with another related project for which an application will be filed in a subsequent batch group.

A. Review cycle. At the close of the work day on the tenth day of the month, the department shall provide written notification to applicants specifying the acceptance date and review schedule of completed applications, including the date for any informal fact-finding conference that may be held between the eightieth and ninetieth day of the review cycle. The regional health planning agency shall:

1. Post, or cause to be posted, notice of an application and a summary of the proposed project on the department's website within 10 calendar days following the start of the review cycle, to include:

a. Information about how comments may be submitted; and

b. The date the public comment period expires, which shall be no later than 45 calendar days following the date of the public notice;

conduct no more than two meetings, one of which must be a public hearing conducted by the regional health planning agency board or a subcommittee of the board and

2. Upon notification by the department of the acceptance date of a completed application:

a. Provide written notification of its review schedule to the applicant;

b. Notify by mail the local governing bodies in the planning district that may be affected by the proposed project; and

c. Give notice of the public hearing, if applicable, at least nine days prior to the public hearing, in a newspaper of general circulation in the county or city in which a project is proposed or a contiguous county or city that shall include:

(i) The date, time, and location of the public hearing; and

(ii) The date, time, and location of the meeting where the regional health planning agency will make its final recommendation on an application;

3. Conduct a public hearing in the case of competing applications or in response to a written request by an elected local government representative, a member of the General Assembly, the commissioner, the applicant, or a member of the public;

4. Create a verbatim record of the public hearing that includes any comments of the local governing bodies of the planning district and all other public comments;

5. Maintain the verbatim record for at least one year following the final decision on a certificate of public need application and provide a copy of the verbatim record to the department;

provide 6. Provide applicants with an opportunity, prior to the vote, to respond to any comments made about the project by the regional health planning agency staff, any information in a staff report, the comments of local governing bodies in the health planning district, all other public comments, or comments by those voting in ;

completing its 7. Complete the review and recommendation by the sixtieth 60th day of the review cycle . or other period in accordance with the applicant's request for extension; and

8. Submit the health planning agency's recommendations on the application and the reasons for the recommendations to the department within 10 calendar days after the completion of the review or other period in accordance with the applicant's request for extension.

By the seventieth day of the review cycle, the department shall complete its review and recommendation of an application and transmit the same to the applicants and other appropriate persons. By the seventy-fifth day of the review cycle, the department shall transmit to the applicant and the appropriate other persons its determination whether an informal fact-finding conference is necessary. An informal fact-finding conference shall be held when (i) determined necessary by the department or (ii) requested by any person seeking to be made a party to the case for good cause. Any person seeking to be made a party to the case for good cause shall file, no later than four days after the department has completed its review and recommendation of an application and has transmitted the same to the applicants and to persons who have prior to the issuance of the report requested a copy in writing, written notification with the commissioner, applicants and other competing applicants, and regional health planning agency stating the grounds for good cause and providing the factual basis therefor under oath.

For purposes of this section, "good cause" means that (i) there is significant, relevant information not previously presented at and not available at the time of the public hearing, (ii) there have been significant changes in factors or circumstances relating to the application subsequent to the public hearing, or (iii) there is a substantial material mistake of fact or law in the department staff's report on the application or in the report submitted by the regional health planning agency. See § 32.1-102.6 of the Code of Virginia.

B. Time period for review. The review period shall begin on the first day of the applicable review cycle within which an application is determined to be complete, in accordance with scheduled batch review cycles described in 12VAC5-220-200. If the application is not determined to be complete for the applicable batch cycle within 40 calendar days from the date of submission, the application may be refiled in the next applicable batch cycle.

If the regional health planning agency has not completed its review by the sixtieth day of the review cycle, or such other period in accordance with the applicant's request for extension, and submitted its recommendation within 10 calendar days after the completion of its review, the department shall, on the eleventh day after expiration of the regional health planning agency's review period, proceed as if the regional health planning agency has recommended approval of the proposed project.

In any case in which an informal fact-finding conference is not held, the project record shall be closed on the earlier of (i) the date established for holding the informal fact-finding conference or (ii) the date that the department determines that an informal fact-finding conference is not necessary. See 12VAC5 220-230 A.

In any case in which an informal fact-finding conference is held, a date shall be established for closing of the record that shall not be more than 30 calendar days after the date for holding the informal fact-finding conference.

C. Determination by the commissioner. If a determination whether a public need exists for a project is not made by the commissioner within 45 calendar days of the closing of the record, the commissioner shall notify the applicant or applicants and any persons seeking to show good cause, in writing, that the application or the applications of each shall be deemed approved 25 calendar days after the expiration of such 45-calendar-day period, unless the receipt of recommendations from the person performing as hearing officer permits the commissioner to issue his case decision within that 25-calendar-day period. The validity or timeliness of the aforementioned notice shall not, in any event, prevent, delay or otherwise impact the effectiveness of this section.

In any case when a determination whether a public need exists for a project is not made by the commissioner within 70 calendar days after closing of the record, the application shall be deemed approved and a certificate shall be granted.

If a determination whether a public need for a project exists is not made by the commissioner within 45 calendar days of the closing of the record, any person who has filed an application competing in the relevant batch review cycle or who has filed an application in response to the relevant Request for Applications issued pursuant to 12VAC5-220-355 may, prior to the application being deemed approved, petition for immediate injunctive relief pursuant to § 2.2-4030 of the Code of Virginia, naming as respondents the commissioner and all parties to the case. During the pendency of proceeding, no applications shall be deemed to be approved. In such a proceeding, the provisions of § 2.2-4030 of the Code of Virginia shall apply.

Deemed approvals shall be construed as the commissioner's case decision on the application pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and shall be subject to judicial review on appeal as the commissioner's case decision in accordance with such act.

Any person who has sought to participate in the department's review of such deemed-to-be-approved application as a person showing good cause who has not received a final determination from the commissioner concerning such attempt to show good cause shall be deemed to be a person showing good cause for purposes of appeal of a deemed-to-be-approved certificate.

In any appeal of the commissioner's case decision granting a certificate of public need pursuant to a Request for Applications issued pursuant to § 32.1-102.3:2 of the Code of Virginia, the court may require the appellant to file a bond pursuant to § 8.01-676.1 of the Code of Virginia, in such sum as shall be fixed by the court for protection of all parties interested in the case decision, conditioned on the payment of all damages and costs incurred in consequence of such appeal.

The applicants, and only the applicants, shall have the authority to extend any of the time periods for review of the application, which are specified in 12VAC5-220-230. If all applicants consent to extending any time period in this section, the commissioner, with the concurrence of the applicants, shall establish a new schedule for the remaining time periods.

For purposes of project review, any scheduled deadlines that fall on a weekend or state holiday shall be advanced to the next work day.

D. Regional health planning agency required notifications. Upon notification of the acceptance date of a complete application as set forth in subsection A of this section, the regional health planning agency shall provide written notification of its review schedule to the applicant. The regional health planning agency shall notify the local governing bodies in the planning district, health care providers and specifically identifiable consumer groups who may be affected by the proposed project directly by mail and shall also give notice of the public hearing in a newspaper of general circulation in such county or city wherein a project is proposed or a contiguous county or city at least nine days prior to such public hearing. Such notification by the regional health planning agency shall include: (i) the date and location of the public hearing which shall be conducted on the application except as otherwise provided in this chapter, in the county or city wherein a project is proposed or a contiguous county or city and (ii) the date, time, and place the final recommendation of the regional health planning agency shall be made. The regional health planning agency shall maintain a verbatim record of the public hearing that includes any comments of the local governing bodies of the health planning district and all other public comments. A copy of the verbatim record shall be provided to the department. Such public hearing record shall be maintained for at least a one-year time period following the final decision on a certificate of public need application. See definition of "public hearing."

E. Ex parte contact. After commencement of a public hearing and before a final decision is made, there shall be no ex parte contacts between the State Health Commissioner and any person acting on behalf of the applicant or holder of a certificate or any person opposed to the issuance or in favor of revocation of a certificate of public need, unless written notification has been provided. See definition of "ex parte."

B. If there is no regional health planning agency for the planning district in which a project is proposed, the department shall:

1. Post notice of an application and a summary of the proposed project on the department's website, which shall include:

a. Information about how comments may be submitted; and

b. The date the public comment period expires, which shall be no later than 45 calendar days following the date of the public notice;

2. Notify by mail the local governing bodies in the planning district that may be affected by the proposed project;

3. Give notice of the public hearing, if applicable, at least nine days prior to the public hearing, in a newspaper of general circulation in the county or city in which a project is proposed or a contiguous county or city that shall include:

a. Date, time, and location of the public hearing; and

b. Date, time, and location of the meeting where the department shall make its final recommendation on an application;

4. Conduct a public hearing in the case of competing applications or in response to a written request by an elected local government representative, a member of the General Assembly, the commissioner, the applicant, or a member of the public; and

5. Create a verbatim record of the public hearing that includes any comments of the local governing bodies of the planning district and all other public comments.

A. The review period shall begin on the first day of the applicable review cycle within which an application is determined to be complete, in accordance with scheduled review cycles. If the department determines an application for the applicable review cycle to not be complete within 30 calendar days from the date of submission, the application may be refiled in the next applicable review cycle.

B. The department shall:

1. Provide written notification to an applicant no later than 5 p.m. on the first day of the review cycle that specifies:

a. The acceptance date of the completed application;

b. The review schedule of completed applications; and

c. The date for any informal fact-finding conference, which shall be held between the 80th and 90th day of the review cycle;

2. Complete the review and recommendation of a completed application by the 70th day of the review cycle that ensures:

a. The applicable requirements of subsection B of §32.1-102.3 of the Code of Virginia are considered; and

b. The recommendation is consistent with the most recent applicable provisions of the State Health Services Plan;

3. Notify the applicant and other appropriate persons of the recommendation by the 70th day of the review cycle;

4. Proceed as if the regional health planning agency has recommended approval of a project by the 71st day of the review cycle if the regional health planning agency has not:

a. Completed its review by the 60th day of the review cycle;

b. Completed its review in accordance with an applicant's request for extension, if applicable; or

c. Submitted its recommendation within 10 days after the completion of its review; and

5. Notify the applicant and other appropriate persons by the 75th day of the review cycle its determination whether an informal fact-finding conference is necessary.

C. The department shall hold an informal fact-finding conference if the department determines it to be necessary or if requested by any person seeking to be made a party to the case for good cause.

D. Any person seeking to be made a party to the case for good cause shall provide written notification stating the grounds and factual basis for good cause:

1. No later than four days after the department has completed its review and recommendation of an application and has transmitted the same to the applicant and to persons who have prior to the issuance of the report requested a copy; and

2. To the commissioner, applicants and other competing applicants, and regional health planning agency.

E. If an informal fact-finding conference is not held, the project record shall be closed on the earlier of the date:

1. Established for holding the informal fact-finding conference; or

2. That the department determines that an informal fact-finding conference is not necessary.

F. If an informal fact-finding conference is held, the presiding officer shall establish a date for closing of the project record that shall not be more than 30 calendar days after the date of the informal fact-finding conference.

A. After commencement of a public hearing and before a final decision is made, there shall be no ex parte contacts between the commissioner and any person acting on behalf of the applicant or holder of a certificate or any person opposed to the issuance or in favor of revocation of a certificate of public need, unless written notification has been provided pursuant to § 32.1-102.6 C of the Code of Virginia.

B. In determining whether a public need exists for a proposed project, the commissioner shall:

1. Consider all applicable requirements of subsection B of § 32.1-102.3 of the Code of Virginia; and

2. Ensure the determination is consistent with the most recent applicable provisions of the State Health Services Plan, except as provided in subsections C and D of this section.

C. Upon presentation of appropriate evidence, the commissioner may find that the provisions of the State Health Services Plan are:

1. Not relevant to a rural locality's needs;

2. Inaccurate;

3. Outdated;

4. Inadequate; or

5. Otherwise inapplicable.

D. If the commissioner makes a finding pursuant to subsection C of this section, the commissioner:

1. May issue or approve the issuance of a certificate; and

2. Shall initiate procedures to make appropriate amendments to the State Health Services Plan.

E. The commissioner shall:

1. Provide written notice of the determination to the applicant and the regional health planning agency;

2. Issue the approved schedule and maximum capital expenditure for a project with the certificate of public need, if applicable; and

3. Include the following in the written determination:

a. The reasons for the determination;

b. The factors and bases considered in making the determination;

c. The remedies available for appeal of the determination; and

d. The progress reporting requirements, if applicable.

F. The commissioner may determine a public need exists for a portion of a project. The commissioner shall consult with the applicant prior to making the determination. The consultation may be subject to the ex parte provision of this section.

G. Except as provided in subdivision G 2 of this subsection, the commissioner shall make a determination whether a public need exists for a project no later than 45 days after the closing of the project record.

1. The commissioner shall notify in writing the applicants or any other persons seeking to show good cause that the application, or application of each, shall be deemed approved 25 days after the expiration of the 45-day period, if a case decision is not issued within the 25 days after the 45 days period.

2. If the receipt of recommendations from the presiding officer does not permit the commissioner to make the determination by the 45th day after the closing of the project record but does permit the commissioner to make a determination by the 70th day after the closing of the project record, the commissioner shall notify in writing the applicants or any other persons seeking to show good cause.

3. The commissioner may combine the notices prescribed in subdivisions G 1 and G 2 of this section into a single notice, if applicable.

4. The validity or timeliness of any notice prescribed by this subsection may not, in any event, prevent, delay, or otherwise impact the effectiveness of this section.

H. If the commissioner has not made a determination whether a public need for a project exists by the 45th day of the closing of the project record, any person who has filed an application competing in the relevant review cycle or who has filed an application in response to the relevant RFA may, prior to the application being deemed approved, petition for immediate injunctive relief pursuant to § 2.2-4030 of the Code of Virginia.

1. The person petitioning for immediate injunctive relief shall name as respondents the commissioner and all parties to the case.

2. During the pendency of proceeding, no applications shall be deemed to be approved.

3. The provisions of § 2.2-4030 of the Code of Virginia shall apply to the proceeding.

I. An application shall be deemed approved and a certificate shall be granted if the commissioner does not make a determination whether a public need exists for a project by the 70th day after the closing of the project record.

A. An applicant may extend any of the time periods for review of the application prescribed in 12VAC5-220-230, 12VAC5-220-232, and 12VAC5-220-234. If there are competing applications, the applicants may extend any of the time periods of review of the applications only by mutual consent of all applicants.

B. If a time period for the review of an application has been extended pursuant to subsection A of this section, the commissioner shall establish a new schedule for the remaining time periods.

The A. An applicant shall have the right to may amend an application at any time.

Any B. Except as otherwise provided in this chapter, if a public hearing is held, an amendment which that is made to an application following the public hearing and prior to the issuance of a certificate unless otherwise specified in this chapter shall :

constitute 1. Constitute a new application; and

shall be 2. Be subject to the review requirements set forth in Part V III of this chapter.

C. Except as otherwise provided in this chapter, if no public hearing is held, an amendment that is made to an application following the close of the public comment period and prior to the issuance of a certificate unless otherwise specified in this chapter shall:

1. Constitute a new application; and

2. Be subject to the review requirements set forth in Part III of this chapter.

D. If such amendment is made the applicant amends the application subsequent to the issuance of a certificate of public need, it shall be reviewed in accordance with 12VAC5-220-130.

A. Commissioner's responsibility. Decisions as to approval or disapproval of applications or a portion thereof for certificates of public need shall be rendered by the commissioner. Any decision to issue or approve the issuance of a certificate shall be consistent with the most recent applicable provisions of the State Medical Facilities Plan. However, if the commissioner finds, upon presentation of appropriate evidence, that the provisions of either 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.

Conditions of approval. The commissioner may condition the approval of an application for a project (i) on the agreement by the applicant to provide an acceptable level of care at a reduced rate to indigents, or (ii) on the agreement of the applicant to provide care to persons with special needs, or (iii) upon the agreement of the applicant to facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The terms of such agreements shall be specified in writing prior to the commissioner's decision to approve a project. Any person willfully refusing, failing or neglecting to honor such agreement shall be subject to a civil penalty of $100 per violation per day from the date of receipt from the department of written notice of noncompliance until the date of compliance. Upon information and belief that a person has failed to honor such agreement in accordance with this provision, the department shall notify the person in writing and 15 days shall be provided for response in writing including a plan for immediate correction. In the absence of an adequate response or necessary compliance or both, a judicial action shall be initiated in accordance with the provisions of § 32.1-27 of the Code of Virginia.

B. Notification process-extension of review time. The commissioner shall make a final determination on an application for a certificate of public need and provide written notification detailing the reasons for such determination to the applicant with a copy to the regional health planning agency within the time frames specified in 12VAC5-220-230 B unless authorization is given by the applicant or applicants to extend the time period. Such written notification shall also reference the factors and bases considered in making a decision on the application and, if applicable, the remedies available for appeal of such decision and the progress reporting requirements. The commissioner may approve a portion of a project provided the portion to be approved is agreed to by the applicant following consultation, which may be subject to the ex parte provision of this chapter, between the commissioner and the applicant.

A. The commissioner shall condition the approval of an application for a project on the agreement of the applicant to:

1. Provide care to individuals who are eligible for benefits under:

a. Title XVIII of the Social Security Act (42 U.S.C. § 1395 et seq.);

b. Title XIX of the Social Security Act (42 U.S.C. § 1396 et seq.); and

c. 10 U.S.C. § 1071 et seq.; and

2. Either:

a. Provide a specified level of charity care to indigent persons or accept patients requiring specialized care;

b. Facilitate the development and operation of primary and specialty medical care services in designated medically underserved areas of the applicant's service area; or

c. Both.

B. The commissioner may condition the approval of an application for a project on the agreement of the applicant to:

1. Comply with a schedule for completion; or

2. Comply with a maximum expenditure amount.

C. A certificate of public need holder shall:

1. Develop a financial assistance policy that includes specific eligibility criteria and procedures for applying charity care;

2. Provide the financial assistance policy to a patient at the time of admission, discharge, or at the time services are provided; and with any billing statement sent to an uninsured patient;

3. Post the financial assistance policy conspicuously in a public area of the medical care facility to which the certificate was issued; and

4. Post the financial assistance policy on a website maintained by the certificate holder.

D. The commissioner shall review the conditions imposed on a certificate of public need at least every 3 years. In determining whether a condition imposed on a certificate of public need is appropriate, the commissioner shall consider a change in circumstance of the certificate holder resulting from changes:

1. In the financing or delivery of health care services;

2. To the Commonwealth's program of medical assistance services; and

3. In other specific circumstances of the certificate holder.

E. The commissioner shall specify the conditions for approval in writing prior to the decision to approve a project.

A. A person refusing, failing, or neglecting to comply with the conditions on a certificate of public need shall be subject to a civil penalty of $100 per violation per day until the date of compliance.

B. For the purpose of determining the amount of a civil penalty imposed pursuant to this section, the date that the person began providing services in accordance with the original certificate of public need shall be the date from which the period of non-compliance shall be calculated.

C. The department shall notify a person in writing upon information and belief that a person has refused, failed, or neglected to comply with the conditions on a certificate of public need and the amount of the civil penalty imposed.

D. A person shall, within 15 days of receipt of the department's notification, provide a response in writing to the department that includes a plan for immediate correction.

E. In the absence of an adequate response, necessary compliance, or both, a judicial action shall be initiated in accordance with the provisions of § 32.1-27 of the Code of Virginia.

Capital expenditures A capital expenditure as contained in subdivision 8 of "project" as defined in § 32.1-102.1 subdivision B 8 of § 32.1-102.1:3 of the Code of Virginia or projects that involve relocation at the same site of 10 beds or 10% of the beds, whichever is less, from one existing physical facility to another, when the cost of such relocation is less than $5 million, shall be subject to an expedited review process except when the full review process is requested by the applicant .

A. Obtaining application forms. Application forms for an expedited review The department shall be available from the department upon the request of the applicant make the application forms for an expedited review available on its website . The department shall transmit application forms to the applicant within seven days of receipt of such request.

B. Application fees. The department shall collect an application fees fee pursuant to 12VAC5-220-180 for an applications application that request requests a certificate of public need under the expedited review process. No application will be reviewed until the required application fee is paid as provided in 12VAC5-220-180 B.

C. The department shall consider an application complete if the applicant:

1. Answers all questions on an application;

2. Supplies all requested documents in an application; and

3. Submits the application fee.

D. The department shall notify an applicant within 10 days following receipt of the application if the application is complete as submitted.

E. The department may not review an application until the application is determined to be complete.

C. Filing application forms. F. The department and the regional health planning agency shall:

All 1. Review all expedited review requests for a certificate of public need in accordance with the expedited review process shall be reviewed by the department and the regional health planning agency which shall each forward ; and

2. Submit a recommendation to the commissioner within 40 30 days from the date the submitted application has been deemed complete.

No application for expedited review shall be reviewed until the application form has been received by the department and the appropriate regional health planning agency, has been deemed complete, and the application fee has been paid to the department.

A. Decisions to approve any project under the expedited review process shall be rendered by the The commissioner:

1. Shall render a decision on an application for a project that is determined to meet the criteria for expedited review set forth in 12VAC5-220-280 within 45 days of that determination; and the receipt of such completed request.

2. The commissioner shall approve May approve and issue a certificate for any project which that is determined to meet the criteria for expedited review set forth in 12VAC5-220-280.

B. If the commissioner determines that a project does not meet the criteria for an expedited review set forth in 12VAC5-220-280, the applicant will be notified the commissioner shall notify the applicant in writing of such the determination within 45 days of the receipt of such request determination that the application is complete . In such cases, the department will forward the appropriate forms to the project applicant for use in filing an application for review of a project in the appropriate review cycle in accordance with Part V of this chapter.

C. Any project which that the commissioner determines does not qualify for an expedited review in accordance with 12VAC5-220-280, as determined by the commissioner, shall be exempted from the requirements of 12VAC5-220-180 A and B in subsections A, B, C and E of 12VAC5-220-180 when such the project is filed for consideration in accordance with Part V III of this chapter.

The following categories of projects A project as determined by the State Health Commissioner shall be subject to the nursing home bed review process when they involve that involves an increase in the number of nursing home facility beds in Virginia . (For Continuing Care Retirement Community nursing home beds, see Part V (12VAC5-220-170 et seq.) of this chapter.) shall be subject to the nursing home bed review process if the project:

1. The establishment of Establishes a nursing home , intermediate care facility, or extended care facility, except when such if the nursing home , intermediate care facility, or extended care facility is proposed by a continuing care retirement community and the project is sponsored by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia . ;

2. An increase in Increases the total number of beds in an existing or authorized nursing home , intermediate care facility, or extended care facility, except when if the nursing home , intermediate care facility, or extended care facility is a component of a continuing care retirement community and the project is sponsored by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia . ;

3. An increase in Increases the total number of nursing home beds , intermediate care facility beds, or extended care facility beds in an existing or authorized medical care facility which is not a dedicated nursing home, intermediate care facility, or extended care facility. ; or

4. The introduction Introduces into any an existing medical care facility of any a new nursing home service such as intermediate care facility services, extended care facility services or skilled nursing facility services , except when such if the medical care facility is an existing nursing home as defined in § 32.1-123 of the Code of Virginia.

A. Pursuant to § 32.1-102.3:2 A, B, and C of the Code of Virginia, the commissioner shall periodically issue a Request for Applications (RFA). An RFA the commissioner shall be issued at least issue an RFA annually.

A RFA from project applicants proposing projects which B. An RFA that would result in an increase in the number of nursing home beds are provided shall be based on analyses of the need for increases in the nursing home bed supply in each of Virginia's planning districts district in accordance with the applicable standards included in the State Medical Facilities Plan State Health Services Plan. Such RFAs

C. An RFA shall also include a schedule for the review of applications submitted in response to the RFA which that allows for at least 120 days between the day on which the RFA is issued and the first day of the review cycle for such the applications.

The applicant shall be notified by the department within 15 days following receipt of the application if additional information is required to complete the application or the application is complete as submitted. No application shall be reviewed until the department has determined that it is complete. To be complete, all questions and information items requested on the application must be completely addressed and the application fee submitted. Additional information required to complete an application shall be submitted to the department and the appropriate regional health planning agency at least five days prior to the first day of the review cycle, as specified in the RFA, to be considered in the review cycle.

A. The department shall consider an application complete if an applicant:

1. Answers all questions to the satisfaction of the commissioner in an application;

2. Supplies all requested documents in an application; and

3. Submits the application fee.

B. The department shall notify an applicant within 10 days following receipt of the application if the application is complete as submitted.

C. The department may not review an application until the application is determined to be complete.

A. Review cycle. At the close of the work day on the tenth day of the month, the department shall provide written notification to applicants specifying the acceptance date and review schedule of completed applications, including the date for any informal fact-finding conference that may be held between the eightieth and ninetieth day of the review cycle. The regional health planning agency shall:

1. Post, or cause to be posted, notice of an application and a summary of the proposed project on the regional health planning agency's website to include:

a. Information about how comments may be submitted; and

b. The date the public comment period expires;

conduct no more than two meetings, one of which must be a public hearing conducted by the regional health planning agency board or a subcommittee of the board and

2.Upon notification by the department of the acceptance date of a completed application:

a. Provide written notification of the review schedule to the applicant;

b. Notify by mail the local governing bodies in the planning district that may be affected by the proposed project; and

c. Give notice of the public hearing, if applicable, at least nine days before the public hearing, in a newspaper of general circulation in the county or city in which a project is proposed or a contiguous county or city that shall include:

(i) The date, time, and location of the public hearing ; and

(ii) The date, time, and location of the meeting where the regional health planning agency shall make the final recommendation on an application;

3. Conduct a public hearing in the case of competing applications or in response to a written request by an elected local government representative, a member of the General Assembly, the commissioner, the applicant, or a member of the public;

4. Create a verbatim record of the public hearing that includes any comments of the local governing bodies of the planning district and all other public comments;

5. Maintain the verbatim record for at least one year following the final decision on a certificate of public need application and provide a copy of the verbatim record to the department;

6. provide Provide applicants with an opportunity, prior to the vote, to respond to any comments made about the project by the regional health planning agency staff, any information in a staff report, the comments of local governing bodies in the health planning district, all other public comments, or comments by those voting in;

7. completing Complete its review and recommendation by the sixtieth 60th day of the cycle.; and

8. Submit the health planning agency's recommendations on the application and the reasons for the recommendations to the department within 10 calendar days after the completion of its review or such other period in accordance with the applicant's request for extension.

By the seventieth day of the review cycle, the department shall complete its review and recommendation of an application and transmit the same to the applicants and other appropriate persons. By the seventy-fifth day of the review cycle, the department shall transmit to the applicant and the appropriate other persons its determination whether an informal fact-finding conference is necessary. An informal fact-finding conference shall be held when (i) determined necessary by the department or (ii) requested by any person seeking to be made a party to the case for good cause. Any person seeking to be made a party to the case for good cause shall file, no later than four days after the department has completed its review and recommendation of an application and has transmitted the same to the applicants and to persons who have prior to the issuance of the report requested a copy in writing, written notification with the commissioner, applicants and other competing applicants, and regional health planning agency stating the grounds for good cause and providing the factual basis therefor under oath.

For purposes of this section, "good cause" means that (i) there is significant, relevant information not previously presented at and not available at the time of the public hearing, (ii) there have been significant changes in factors or circumstances relating to the application subsequent to the public hearing, or (iii) there is a substantial material mistake of fact or law in the department staff's report on the application or in the report submitted by the regional health planning agency. See § 32.1-102.6 of the Code of Virginia.

B.Time period for review. The review period shall begin on the first day of the applicable review cycle within which an application is determined to be complete, in accordance with scheduled batch review cycles described in 12VAC5-220-200. If the application is not determined to be complete for the applicable batch cycle within 40 calendar days from the date of submission, the application may be refiled in the next applicable batch cycle.

If the regional health planning agency has not completed its review by the sixtieth day of the review cycle, or such other period in accordance with the applicant's request for extension, and submitted its recommendation within 10 calendar days after the completion of its review, the department shall, on the eleventh day after expiration of the regional health planning agency's review period, proceed as if the regional health planning agency has recommended approval of the proposed project.

In any case in which an informal fact-finding conference is not held, the project record shall be closed on the earlier of (i) the date established for holding the informal fact-finding conference or (ii) the date that the department determines that an informal fact-finding conference is not necessary. See 12VAC5 220-230 A.

In any case in which an informal fact-finding conference is held, a date shall be established for closing of the record that shall not be more than 30 calendar days after the date for holding the informal fact-finding conference.

C. Determination by the commissioner. If a determination whether a public need exists for a project is not made by the commissioner within 45 calendar days of the closing of the record, the commissioner shall notify the applicant or applicants and any persons seeking to show good cause, in writing, that the application or the applications of each shall be deemed approved 25 calendar days after the expiration of such 45-calendar-day period, unless the receipt of recommendations from the person performing as hearing officer permits the commissioner to issue his case decision within that 25-calendar-day period. The validity or timeliness of the aforementioned notice shall not, in any event, prevent, delay or otherwise impact the effectiveness of this section.

In any case when a determination whether a public need exists for a project is not made by the commissioner within 70 calendar days after closing of the record, the application shall be deemed approved and a certificate shall be granted.

If a determination whether a public need for a project exists is not made by the commissioner within 45 calendar days of the closing of the record, any person who has filed an application competing in the relevant batch review cycle or who has filed an application in response to the relevant Request for Applications issued pursuant to 12VAC5-220-355 may, prior to the application being deemed approved, petition for immediate injunctive relief pursuant to § 2.2-4030 of the Code of Virginia, naming as respondents the commissioner and all parties to the case. During the pendency of proceeding, no applications shall be deemed to be approved. In such a proceeding, the provisions of § 2.2-4030 of the Code of Virginia shall apply.

Deemed approvals shall be construed as the commissioner's case decision on the application pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and shall be subject to judicial review on appeal as the commissioner's case decision in accordance with such act.

Any person who has sought to participate in the department's review of such deemed-to-be-approved application as a person showing good cause who has not received a final determination from the commissioner concerning such attempt to show good cause shall be deemed to be a person showing good cause for purposes of appeal of a deemed-to-be-approved certificate.

In any appeal of the commissioner's case decision granting a certificate of public need pursuant to a Request for Applications issued pursuant to § 32.1-102.3:2 of the Code of Virginia, the court may require the appellant to file a bond pursuant to § 8.01-676.1 of the Code of Virginia, in such sum as shall be fixed by the court for protection of all parties interested in the case decision, conditioned on the payment of all damages and costs incurred in consequence of such appeal.

The applicants, and only the applicants shall have the authority to extend any of the time periods for review of the application, which are specified in 12VAC5-220-230. If all applicants consent to extending any time period in this section, the commissioner, with the concurrence of the applicants, shall establish a new schedule for the remaining time periods.

D. Regional health planning agency required notifications. Upon notification of the acceptance date of a complete application as set forth in subsection A of this section, the regional health planning agency shall provide written notification of its review schedule to the applicant. The regional health planning agency shall notify the local governing bodies in the planning district, health care providers and specifically identifiable consumer groups who may be affected by the proposed project directly by mail and shall also give notice of the public hearing in a newspaper of general circulation in such county or city wherein a project is proposed or a contiguous county or city at least nine days prior to such public hearing. Such notification by the regional health planning agency shall include: (i) the date and location of the public hearing which shall be conducted on the application except as otherwise provided in this chapter, in the county or city wherein a project is proposed or a contiguous county or city; and (ii) the date, time and place the final recommendation of the regional health planning agency shall be made. The regional health planning agency shall maintain a verbatim record of the public hearing that includes any comments of the local governing bodies of the health planning district and all other public comments. A copy of the verbatim record shall be provided to the department. Such public hearing record shall be maintained for at least a one-year time period following the final decision on a certificate of public need application. See definition of "public hearing."

B. If there is no regional health planning agency for the planning district in which a project is proposed, the department shall:

1. Post notice of an application and a summary of the proposed project on the department's website, which shall include:

a. Information about how comments may be submitted; and

b. The date the public comment period expires;

2. Notify by mail the local governing bodies in the planning district that may be affected by the proposed project;

3. Give notice of the public hearing, at least nine days before the public hearing, in a newspaper of general circulation in the county or city in which a project is proposed or a contiguous county or city that shall include:

a. The date, time, and location of the public hearing; and

b. The date, time, and location of the meeting where the department shall make the final recommendation on an application; and

4. Conduct a public hearing in the case of competing applications or in response to a written request by an elected local government representative, a member of the General Assembly, the commissioner, the applicant, or a member of the public;

5. Create a verbatim record of the public hearing that includes any comments of the local governing bodies of the planning district and all other public comments.

A. The review period shall begin on the first day of the applicable review cycle within which an application is determined to be complete, in accordance with scheduled review cycles. If the department determines an application for the applicable review cycle to not be complete within 30 calendar days from the date of submission, the application may be refiled in the next applicable review cycle.

B. The department shall:

1. Provide written notification to the applicant no later than 5 p.m. on the first day of the review cycle that specifies:

a. The acceptance date of the completed application;

b. The review schedule of completed applications; and

c. The date for any informal fact-finding conference, which shall be held between the 80th and 90th day of the review cycle;

2. Complete the review and recommendation of a completed application by the 70th day of the review cycle that ensures:

a. All applicable requirements of subsection B of §32.1-102.3 of the Code of Virginia are considered; and

b. The recommendation is consistent with the most recent applicable provisions of the State Health Services Plan;

3. Notify the applicant and other appropriate persons of the recommendation by the 70th day of the review cycle;

4. Proceed as if the regional health planning agency has recommended approval of a project by the 71st day of the review cycle if the regional health planning agency has not:

a. Completed its review by the 60th day of the review cycle;

b. Completed its review in accordance with an applicant's request for extension, if applicable; or

c. Submitted its recommendation within 10 days after the completion of its review; and

5. By the 75th day of the review cycle, notify the applicant and other appropriate persons of the determination whether an informal fact-finding conference is necessary.

C. The department shall hold an informal fact-finding conference if the department determines it to be necessary or if requested by any person seeking to be made a party to the case for good cause.

D. Any person seeking to be made a party to the case for good cause shall provide written notification stating the grounds and factual basis for good cause:

1. No later than four days after the department has completed its review and recommendation of an application and has transmitted the same to the applicant and to persons who have prior to the issuance of the report requested a copy; and

2. To the commissioner, applicants and other competing applicants, and regional health planning agency.

E. If an informal fact-finding conference is not held, the project record shall be closed on the earlier of the date:

1. Established for holding the informal fact-finding conference; or

2. That the department determines that an informal fact-finding conference is not necessary.

F. In any case in which an informal fact-finding conference is held, the presiding officer shall establish a date for closing of the project record that shall not be more than 30 calendar days after the date of the informal fact-finding conference.

A. After commencement of a public hearing and before a final decision is made, there shall be no ex parte contacts between the commissioner and any person acting on behalf of the applicant or holder of a certificate or any person opposed to the issuance or in favor of revocation of a certificate of public need, unless written notification has been provided pursuant to § 32.1-102.6 C of the Code of Virginia.

B. In determining whether a public need exists for a proposed project, the commissioner shall:

1. Consider all applicable requirements of subsection B of § 32.1-102.3 of the Code of Virginia; and

2. Ensure the determination is consistent with the most recent applicable provisions of the State Health Services Plan, except as provided in subsections C and D of this section.

C. Upon presentation of appropriate evidence, the commissioner may find that the provisions of the State Health Services Plan are:

1. Not relevant to a rural locality's needs;

2. Inaccurate;

3. Outdated;

4. Inadequate; or

5. Otherwise inapplicable.

D. If the commissioner makes a finding pursuant to subsection C of this section, the commissioner:

1. May issue or approve the issuance of a certificate; and

2. Shall initiate procedures to make appropriate amendments to the State Health Services Plan.

E. The commissioner shall:

1. Provide written notice of the determination to the applicant and the regional health planning agency;

2. Issue the approved schedule and maximum capital expenditure for a project with the certificate of public need, if applicable; and

3. Include the following in the written determination:

a. The reasons for the determination;

b. The factors and bases considered in making the determination;

c. The remedies available for appeal of the determination; and

d. The progress reporting requirements, if applicable.

F. The commissioner may determine a public need exists for a portion of a project. The commissioner shall consult with the applicant prior to making the determination. The consultation may be subject to the ex parte provision of this section.

G. Except as provided in subdivision G 2 of this subsection, the commissioner shall make a determination whether a public need exists for a project no later than 45 days after the closing of the project record.

1. The commissioner shall notify in writing the applicants or any other persons seeking to show good cause that the application, or application of each, shall be deemed approved 25 days after the expiration of the 45-day period, if a case decision is not issued within the 25 days after the 45 day period.

2. If the receipt of recommendations from the presiding officer does not permit the commissioner to make the determination by the 45th day after the closing of the project record but does permit the commissioner to make a determination by the 70th day after the closing of the project record, the commissioner shall notify in writing the applicants or any other persons seeking to show good cause.

3. The commissioner may combine the notices prescribed in subdivisions G 1 and G 2 of this section into a single notice, if applicable.

4. The validity or timeliness of any notice prescribed by this subsection may not, in any event, prevent, delay, or otherwise impact the effectiveness of this section.

H. If the commissioner has not made a determination whether a public need for a project exists by the 45th day of the closing of the project record, any person who has filed an application competing in the relevant review cycle or who has filed an application in response to the relevant RFA may, prior to the application being deemed approved, petition for immediate injunctive relief pursuant to § 2.2-4030 of the Code of Virginia.

1. The person petitioning for immediate injunctive relief shall name as respondents the commissioner and all parties to the case.

2. During the pendency of proceeding, no applications shall be deemed to be approved.

3. The provisions of § 2.2-4030 of the Code of Virginia shall apply to the proceeding.

I. An application shall be deemed approved and a certificate shall be granted if the commissioner does not make a determination whether a public need exists for a project by the 70th day after the closing of the project record.

A. An applicant may extend any of the time periods for review of the application prescribed in 12VAC5-220-385, 12VAC5-220-388, and 12VAC5-220-392. If there are competing applications, the applicants may extend any of the time periods of review of the applications only by mutual consent of all applicants.

B. If a time period for the review of an application has been extended pursuant to subsection A of this section, the commissioner shall establish a new schedule for the remaining time periods.

A. Commission's responsibility. Decisions as to approval or disapproval of applications or a portion thereof for certificates of public need shall be rendered by the commissioner. Any decision to issue or approve the issuance of a certificate shall be consistent with the most recent applicable provisions of the State Medical Facilities Plan. 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.

The commissioner may condition the approval of an application for a project (i) on the agreement by the applicant to provide an acceptable level of care at a reduced rate to indigents or, (ii) on the agreement of the applicant to provide care to persons with special needs, or (iii) upon the agreement of the applicant to facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The terms of such agreements shall be specified in writing prior to the commissioner's decision to approve a project. Any person willfully refusing, failing or neglecting to honor such agreements shall be subject to a civil penalty of $100 per violation per day from the date of receipt from the department of written notice of noncompliance until the date of compliance. Upon information and belief that a person has failed to honor such agreement in accordance with this provision, the department shall notify the person in writing and 15 days shall be provided for a response in writing including a plan for immediate correction. In the absence of an adequate response or necessary compliance or both, a judicial action shall be initiated in accordance with the provisions of § 32.1-27 of the Code of Virginia.

B. Notification process – extension of review time. The commissioner shall make a final determination on an application for a certificate of public need and provide written notification detailing the reasons for such determination to the applicant with a copy to the regional health planning agency within the time frames specified in 12VAC5-220-385 B unless an authorization is given by the applicants to extend the time period. Such written notification shall also reference the factors and bases considered in making a decision on the application and, if applicable, the remedies available for appeal of such decision and the progress reporting requirements. The commissioner may approve a portion of a project provided the portion to be approved is agreed to by the applicant following consultation, which may be subject to the ex parte provision of this chapter, between the commissioner and the applicant.

The commissioner may condition the approval of an application for a project on the agreement of the applicant to:

1. Comply with a schedule for completion; or

2. Comply with a maximum expenditure amount.

A. Lack of progress. Failure of any The commissioner shall revoke a certificate of public need for:

1. Failure to comply with the requirements of subsection A of § 32.1-102.4; or

2. Willfully or recklessly misrepresenting intentions or facts on obtaining a certificate of public need.

B. The commissioner may revoke a certificate of public need if:

1. A project fails to meet the progress requirements stated in 12VAC5-220-450 shall be cause for certificate revocation , unless the commissioner determines sufficient justification exists to permit variance, considering factors enumerated in 12VAC5-220-450 . ;

B. Failure to report progress. Failure of an 2. An applicant fails to file progress reports on an approved project in accordance with 12VAC5-220-450 shall be cause for revocation, unless, due to extenuating circumstances, the commissioner, in his sole discretion, extends the certificate, in accordance with subsection B of 12VAC5-220-440 . ;

C. Unapproved changes. Exceeding a capital expenditure amount not authorized by the commissioner or not consistent with the schedule of completion shall be cause for revocation. See definition of "significant change" and "schedule of completion."

D. Failure to initiate construction. Failure 3. An applicant fails to initiate construction of the project within two years following the date of issuance of the certificate of public need shall be cause for revocation , unless due to extenuating circumstances the commissioner extends the certificate, in accordance with subsection B of 12VAC5-220-440 . ; or

E. Misrepresentation. Upon determination that an applicant has knowingly misrepresented or knowingly withheld relevant data or information prior to issuance of a certificate of public need, the commissioner may revoke said certificate.

F. Noncompliance with assurances. Failure 4. An applicant fails to comply with the assurances or intentions set forth in the application or written assurances provided at the time of issuance of a certificate of public need shall be cause for revocation .

A. Appeals to a circuit court shall be governed by pursuant to the Virginia Administrative Process Act, § 2.2-4000 et seq. of the Code of Virginia, Article 5 (§ 2.2-4025 et seq.) of Chapter 40 of Title 2.2 of the Code of Virginia and Part Two A of the Rules of the Supreme Court of Virginia.

B. Deemed approvals shall be:

1. Construed as the commissioner’s case decision on the application pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia); and

2. Subject to judicial review on appeal as the commissioner's case decision in accordance with the act.

C. A person who sought to participate as a person showing good cause in the department's review of an application that was deemed approved and who did not receive a final determination from the commissioner concerning their alleged good cause shall be deemed to be a person showing good cause for purposes of an appeal of the deemed approval.

D. In an appeal of the commissioner's case decision granting a certificate of public need pursuant to an RFA issued pursuant to § 32.1-102.3:2 of the Code of Virginia, the court may require the appellant to file a bond pursuant to § 8.01-676.1 of the Code of Virginia:

1. In a sum fixed by the court for protection of all parties interested in the case decision; and

2. Conditioned on the payment of all damages and costs incurred in consequence of such appeal.

Commencing any project without a certificate or a registration required by this chapter shall constitute grounds for refusing to issue a license for such the project.

On petition of the commissioner, the Board of Health or board, the Attorney General, or the circuit court of the county or city where a project is under construction or is intended to be constructed, located, or undertaken shall have jurisdiction to enjoin :

1. any Any project which that is constructed, undertaken, or commenced without a certificate or registration; or to enjoin

2. the The admission of patients to the project ; or or to enjoin

3. the The provision of services through the project.