Title of Regulation: 12VAC5-67. Advance Health Care Directive Registry (adding 12VAC5-67-10, 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: October 26, 2011.

Effective Date: November 15, 2011.

Agency Contact: Kimberly S. Barnes, Policy Analyst, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7661, or email kim.barnes@vdh.virginia.gov.

Basis: Section 54.1-2995 of the Code of Virginia authorizes the Board of Health to adopt regulations to carry out the responsibility of the Department of Health to make available a secure online central registry for advance health care directives.

Purpose: The regulation will implement a central online registry accepting the submission by citizens of advance directives. An advance directive is a legally enforceable document that divulges and explains an individual's intentions regarding the continuation of medical care in the event of the individual's inability to make decisions as the need arises. The goal of the regulation is to effectively administer the registry to allow restricted access to such documents so that citizens' wishes regarding their intentions can be made available to hospitals and other providers of health care services, relatives, and others as needed and authorized. The regulation is essential to protect the welfare of citizens because it will allow a central and secure means for providers of health care services to quickly and accurately identify and understand a patient's wishes regarding the provision and continuation of health care services.

Rationale for Using Fast-Track Process: This regulation is expected to be noncontroversial. No opposition was voiced during the adoption of the enabling legislation during the 2008 Session of the General Assembly.

Substance: This regulation establishes the criteria for submission of an advance health care directive to the registry including the specific documents that may be submitted. This regulation also specifies the individuals authorized to submit such information.

Issues: This regulation allows a Virginia citizen to file an advance health care directive to a registry accessible to selected family members or friends and health care treatment professionals.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapters 301 and 696 of the 2008 Acts of Assembly, the Board of Health (Board) proposes to establish regulations to govern the Advance Health Care Directive Registry.

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

Estimated Economic Impact. Section 54.1-2995 D of the Code of Virginia directs the Board to promulgate regulations to (i) determine who may access the registry, (ii) ensure that registry users are annually reminded of which documents they have registered, and (iii) address fees for filing a document with the registry. For (i), the proposed regulations state that 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.

For (ii), the proposed regulations state that the department shall ensure that the contracted vendor, public-private partnership, or any other entity through which the department has made the registry available to citizens of the Commonwealth annually contacts persons who have registered documents to remind them of which documents they have registered.

For (iii), the proposed regulations state that 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. According to the Department of Health, Microsoft and Univel have agreed to maintain the registry for no charge.

The optional use of the registry is established by statute. The proposed regulations help enable the use of the optional registry with no burdensome requirements. Thus, the benefits of the proposed regulations exceed the costs.

Businesses and Entities Affected. Healthcare providers and all Virginians who may wish to keep records in the Advance Health Care Directive Registry are potentially affected.

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

Projected Impact on Employment. The proposed regulations are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed regulations help enable the optional beneficial use of private records.

Small Businesses: Costs and Other Effects. The proposed regulations are unlikely to significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed regulations are unlikely to significantly affect small businesses.

Real Estate Development Costs. The proposed regulations are unlikely to significantly affect real estate development costs.

Legal Mandate. 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 Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation 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. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The agency concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

Chapters 301 and 696 of the 2008 Acts of Assembly require the board to establish a secure online central registry for advance health care directives. The regulation describes the documents that may be submitted to the Advance Health Care Directive Registry, allows fees to be charged by a vendor with whom the Department of Health contracts to implement the registry, and specifies who is allowed to access documents in the registry.

CHAPTER 67
ADVANCE HEALTH CARE DIRECTIVE REGISTRY

12VAC5-67-10. General provisions.

A. In accordance with Article 9 (§ 54.1-2994 et seq.) of Chapter 29 of Title 54.1 of the Code of Virginia and this chapter, the Department of Health shall make available to the public an Advance Health Care Directive Registry by (i) contracting with a vendor, (ii) publicizing the availability of an existing registry maintained by another entity, or (iii) entering into a public-private partnership.

B. The department shall ensure that the contracted vendor, public-private partnership, or any other entity through which the department has made the registry available to citizens of the Commonwealth annually contacts persons who have registered documents to remind them of which documents they have registered.

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.

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.