The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Board of Health Professions. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

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

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Board of Health Professions, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 18VAC75-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to (i) submit data, views, and arguments, either orally or in writing, to the agency; and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working days prior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

Statutory definitions of words and terms related to the Practitioner Self-Referral Act are established in § 54.1-2410 of the Code of Virginia.

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

"Act" means the Practitioner Self-Referral Act, Chapter 24.1 (§ 54.1-2410 et seq.) of Title 54.1 of the Code of Virginia.

"Applicant" means a practitioner or entity who has applied to the board for an advisory opinion on the applicability of the Act, or for an exception to the prohibitions of the Act.

"Appropriate regulatory board" means the regulatory board within the Department of Health Professions which licenses or certifies the practitioner.

"Board" means the Board of Health Professions.

"Committee" means an informal conference committee of the Board of Health Professions.

"Department" means the Department of Health Professions.

18VAC75-10-10 establishes the guidelines for participation by the public in rulemaking activities of the board.

A. Any practitioner or entity may request an advisory opinion on the applicability of the Act upon completion of an application and payment of a fee.

B. Requests shall be made on an application form prescribed by the board. The request shall contain the following information:

1. The name of the practitioner or entity;

2. Identification of the practitioner or entity and description of the health care services being provided or proposed;

3. The type and amount of existing or proposed investment interest in the entity;

4. A description of the nature of the investment interest and copies of any existing or proposed documents between the practitioner and the entity including but not limited to leases, contracts, organizational documents, etc.; and

5. Certification and notarized signature of the practitioner or principal of the entity requesting the advisory opinion that the information and supporting documentation contained therein is true and correct.

C. The application shall be reviewed for completeness, and the board may request such other additional information or documentation it deems necessary from the practitioner or entity.

D. Upon a determination that a request for an advisory opinion is complete and that it has sufficient information, the board shall notify the practitioner or entity that it will consider its request.

E. At the conclusion of an informal conference, the committee shall issue an advisory opinion to the practitioner or entity, which shall be presented for ratification by the board.

A. A practitioner or entity may request an exception to the prohibitions of the Act upon completion of an application and payment of a fee.

B. Requests shall be made on an application form prescribed by the board. The application shall contain the following information:

1. The name and identifying information of the practitioner or entity;

2. The information and documentation regarding community need and alternative financing as required by § 54.1-2411 B of the Code of Virginia;

3. Certification and notarized signature of the practitioner or principal of the entity requesting the exception that the information contained in the application and supporting documentation is true and correct.

C. The application shall be reviewed for completeness, and the board may request additional information and documentation from the applicant.

D. Upon a determination that an application is complete and that it has sufficient information, the board shall notify the applicant that it will consider the request.

E. At the conclusion of an informal conference, the committee shall issue a decision regarding the request for an exception to the applicant, which shall be presented for ratification by the board.

F. Exceptions to the Act shall be valid for a period of no more than five years.

G. Subject to verification by the board, an exception shall be renewed upon payment of a renewal fee and the receipt of certification from the practitioner or entity that the conditions under which the original exception was granted continue to warrant the exception.

A. An application fee for an opinion on applicability of the Act shall be $500.

B. An application fee for an exception to the Act shall be $1,000.

C. The renewal fee for board approval of exceptions to the Act shall be $250.

The board shall determine violations of prohibitions of the Act on the part of an entity other than a practitioner as defined in § 54.1-2410 of the Code of Virginia in accordance with the provisions of the Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia).

A. Upon receipt of an investigative report of an alleged violation of the Act by a practitioner as defined in § 54.1-2410 of the Code of Virginia, the department, on behalf of the board, shall provide a copy of the report to the appropriate regulatory board within the department as required by subdivision 13 of § 54.1-2510 of the Code of Virginia.

B. Violations of the Act by a practitioner shall be determined by the appropriate regulatory board within the department and shall be subject to disciplinary action by that board in accordance with § 54.1-2412 D of the Code of Virginia.

C. Upon closure of a case involving an alleged violation of the Act by a practitioner, the appropriate regulatory board shall provide a copy of the final order or of the letter of dismissal of the case to the board.

D. The board shall review periodically the disposition of cases involving allegations of violation of the Act by practitioners to ensure the protection of the public and the fair and equitable treatment of health professionals, as authorized by subdivision 11 of § 54.1-2510 of the Code of Virginia.

The provisions of the Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia) shall govern proceedings on questions of violations of the Act.

In accordance with § 54.1-2400 (10) of the Code of Virginia, the board may delegate an informal conference to an agency subordinate to consider an application for an advisory opinion or an exception to the provisions of the Act.

Applications that may be delegated shall be those approved by the chairman and executive director of the board.

A. An agency subordinate authorized by the board to conduct an informal conference may include current or past board members and professional staff or other persons deemed knowledgeable by virtue of their training and experience in the organizational structure of entities providing the health care services identified in the application.

B. The board shall delegate to the executive director the selection of the agency subordinate who is deemed appropriately qualified to conduct a conference based on the qualifications of the subordinate and the type of case being heard.

Application for an Advisory Opinion - Virginia Self-Referral Act (rev. 7/2013)

Application for an Exception to the Prohibitions of the Virginia Practitioner Self-Referral Act (rev. 7/2013)

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

"Board" means the Board of Health Professions.

"Dialysis patient care technician" or "dialysis care technician" means a person who has obtained certification from an organization approved by the board to provide, under the supervision of a licensed practitioner of medicine or a registered nurse, direct care to patients undergoing renal dialysis treatments in a Medicare-certified renal dialysis facility. Such direct care may include, but need not be limited to, the administration of heparin, topical needle site anesthetics, dialysis solutions, sterile normal saline solution, and blood volumizers in accordance with the order of a licensed physician, nurse practitioner or physician assistant.

A. In accordance with Chapter 27.01 (§ 54.1-2729.1 et seq.) of Title 54.1 of the Code of Virginia and this chapter, only those persons who hold certification from an entity approved by the board as prescribed in 18VAC75-40-30 shall:

1. Provide direct patient care in a Medicare-certified renal dialysis facility.

2. Administer medications in accordance with subsection O of § 54.1-3408 of the Code of Virginia.

B. Dialysis patient care technicians or dialysis care technicians shall practice only under the supervision of a licensed practitioner of medicine or a registered nurse.

C. Dialysis patient care technicians or dialysis care technicians shall administer medications only under the orders of a licensed physician, nurse practitioner, or physician assistant and under the direct and immediate supervision of a registered nurse.

D. Persons who do not hold such certification shall not hold the restricted titles or use any other title or term that implies a minimum level of education, training and competence. Unregulated persons shall only perform services relating to the technical elements of dialysis, such as equipment maintenance and preparation of dialyzers for reuse by the same patient.

In order to use the titles of dialysis patient care technician or dialysis care technician or administer medications in a Medicare-certified renal dialysis facility, a person shall hold one of the following certifications:

1. Certified Clinical Hemodialysis Technician (CCHT) by the Nephrology Nursing Certification Commission (NNCC);

2. Certified Hemodialysis Technician (CHT) by the Board of Nephrology Examiners Nursing and Technology (BONENT);

3. Certified in Clinical Nephrology Technology (CCNT) by the National Nephrology Certification Organization (NNCO); or

4. Certification or licensure as a dialysis technician or similar title by another jurisdiction in the United States provided the standards for certification or licensure are substantially equivalent to those in Virginia.