Title of Regulation: 12VAC5-67. Advance Health Care Directive Registry (amending 12VAC5-67-20, 12VAC5-67-30).

Statutory Authority: § 54.1-2995 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 31, 2015.

Effective Date: August 29, 2015.

Agency Contact: Debbie Condrey, Chief Information Officer, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7118, FAX (804) 864-7156, or email debbie.condrey@vdh.virginia.gov.

Basis: Sections 54.1-2994, 54.1-2995, and 54.1-2996 of the Code of Virginia require the State Board of Health to make available a secure online central registry for advance health care directives. Section 54.1-2995 of the Code of Virginia

directs the board to promulgate regulations to carry out the provisions of Article 9 (§ 54.1-2994 et seq.) of Chapter 29 of Title 54.1 of the Code of Virginia. Chapter 715 of the 2014 Acts of Assembly amended § 54.1-2995 to allow legal representatives to submit documents to the registry.

Purpose: To fulfill the statutory mandate to review regulations and to protect the citizens of the Commonwealth, the Virginia Department of Health conducted a periodic review of Advance Healthcare Directive Registry (12VAC5-67) pursuant to Executive Order 14 (2010). As a result of the periodic review, it was noted that the regulations had existing language preventing a physician with a patient who is incapable of communication from searching the registry to determine whether his patient has submitted an advance directive to the registry. This restriction is not required by the Code of Virginia. This regulatory action will protect the health and welfare of Virginians by ensuring that the medical wishes of individuals who have submitted an advance health care directive to the registry are honored if they are incapacitated and unable to manage their own care.

Rationale for Using Fast-Track Process: These amendments update the regulations to reflect (i) current practice and (ii) changes to § 54.1-2995 of the Code of Virginia pursuant to Chapter 715 of the 2014 Acts of Assembly. The department does not expect that this regulatory action will be controversial because the action simply brings the regulatory language into conformity with statutory language and current practice.

Substance: The amendments to (i) 12VAC5-67-20 add language that allows authorized representatives to submit documents to the registry and (ii) 12VAC5-67-30 remove restrictive language that would prevent a physician with a patient who is incapable of communication from searching the registry to determine whether his patient has submitted an advance directive to the registry and insert clarifying language stating physicians have the authority to query the registry for directive information of patients incapable of communication.

Issues: The primary advantages of the regulatory action are greater clarity of the regulations and allowing physicians with patients incapable of communication the ability to search the registry to determine if their patient has submitted an advance directive to the registry. There are no disadvantages to the agency, the public, or the Commonwealth.

Small Business Impact Review Report of Findings: This regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. From § 54.1-2983 of the Code of Virginia, "Any adult capable of making an informed decision may, at any time, make a written advance directive to address any or all forms of health care in the event the declarant is later determined to be incapable of making an informed decision." Documents that may be submitted to the Advance Health Care Directive Registry (Registry) include: 1) a health care power of attorney, and 2) an advance directive. The Board of Health (Board) proposes to amend this regulation to: 1) remove restrictive language that would prevent physicians who have patients who are incapable of communication from searching the Registry to determine whether their patient has submitted an advance directive to the Registry, and 2) insert clarifying language stating that physicians have the authority to query the Registry for directive information of patients incapable of communication. Chapter 715 of the 2014 Acts of Assembly amended the Code of Virginia provisions relating to the Registry by newly allowing a legal representative or designee of the person executing the document to submit the document for filing. The Board also proposes to update this regulation to reflect that change by adding the exact statutory language allowing an authorized representative to submit documents to the Registry.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The proposal to amend regulatory language to make clear that physicians may search the Registry to see if patients who are currently incapable of communication had previously made their wishes clear through an advance directive will be beneficial in that it will increase the likelihood that patients will have their healthcare preferences followed. There is no cost associated with the proposed amendment.

Once Chapter 715 of the 2014 Acts of Assembly was enacted, authorized representatives could submit relevant documents to the Registry. Adding this language to the regulation does not change the law, but reduces the likelihood that someone who only reads the regulation is unaware of this provision. Thus this proposed amendment also is beneficial with no associated cost.

Businesses and Entities Affected. The proposed amendments affect the approximate 34,000 licensed physicians in the Commonwealth and 2,505 individuals who have submitted to the Registry.¹

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments will not significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments will not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments will not significantly affect costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments will not adversely affect small businesses.

Real Estate Development Costs. The proposed amendments will not affect real estate development costs.

Legal Mandate. General: The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order Number 17 (2014). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed regulatory

action would apply,

• the identity of any localities and types of businesses or other entities particularly affected,

• the projected number of persons and employment positions to be affected,

• the projected costs to affected businesses or entities to implement or comply with the regulation, and

• the impact on the use and value of private property.

Small Businesses: If the proposed regulatory action will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

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¹ Data source: Virginia Department of Health

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the results of the analysis performed by the Department of Planning and Budget, specifically, the benefits likely exceed the costs for all proposed changes.

Summary:

The amendments provide that (i) physicians who have patients who are incapable of communication may search the registry to determine whether their patients have an advance directive in the registry and (ii) a legal representative may submit a document for filing in the registry.

12VAC5-67-20. Criteria for submission of an advance directive to the registry.

A. Documents that may be submitted to the registry include:

1. A health care power of attorney.

2. An advance directive created pursuant to Article 8 (§ 54.1-2981 et seq.) of Chapter 29 of Title 54.1 of the Code of Virginia or a subsequent act of the General Assembly.

3. A declaration of an anatomical gift made pursuant to the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia).

B. The document shall be submitted for filing only by the person who executed the document or his legal representative or designee.

C. The person submitting documents to the registry shall be responsible for payment of any fee required by the contracted vendor, public-private partnership, or any other entity through which the department has made the registry available to citizens of the Commonwealth. Fees associated with the registry shall not exceed the direct costs associated with the development and maintenance of the registry and with the education of the public about the availability of the registry.

12VAC5-67-30. Access to the registry.

The person registering documents may specify a legal representative or other persons to have access to such documents. It shall be the responsibility of the person registering to provide all such persons with the information necessary to access the registry. In accordance with patient authorization, health care professionals may have access to the registry Licensed health care providers shall have access to the registry for the purpose of a query for advance directive information on patients who are comatose, incapacitated, or otherwise mentally or physically incapable of communication.