TITLE 12. HEALTH

STATE BOARD OF HEALTH

Fast-Track Regulation

Title of Regulation: 12VAC5-391. Regulations for the Licensure of Hospice (amending 12VAC5-391-370).

Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: May 7, 2025.

Effective Date: May 22, 2025.

Agency Contact: Val Hornsby, Policy Analyst, Virginia Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 875-1089, FAX (804) 527-4502, or email val.hornsby@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia gives the State Board of Health the responsibility to promulgate and enforce such regulations as may be necessary to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-162.5 of the Code of Virginia requires the board to adopt regulations governing the activities and services provided by hospices as may be necessary to protect the public health, safety, and welfare, including requirements for (i) the qualifications and supervision of licensed and nonlicensed personnel; (ii) the standards for the care, treatment, health, safety, welfare, and comfort of patients and families served by the program; (iii) the management, operation, staffing, and equipping of the hospice program or hospice facility; (iv) clinical and business records kept by the hospice or hospice facility; (v) procedures for the review of utilization and quality of care; and (vi) minimum standards for design and construction.

Purpose: This regulation is being amended due to the changes to § 32.1-162.5 of the Code of Virginia, which requires the board to promulgate regulations for the licensure of hospices in order to protect the health, safety, and welfare of citizens receiving care in hospices.

Rationale for Using Fast-Track Rulemaking Process: This action is expected to be noncontroversial and therefore appropriate for the fast-track rulemaking process because it is being used to conform the regulation to statute, and no new requirements are being developed beyond what is mandated by statute.

Substance: The amendments require hospices to have a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of any religious denomination or sect during public health emergencies related to communicable diseases.

Issues: The primary advantage to the public, the agency, and the Commonwealth is that the regulation will be in compliance with statute. There are no disadvantages to the public, the agency, or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

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 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. Pursuant to a legislative mandate, the State Board of Health (board) proposes to amend this regulation to require all licensed hospices to establish a protocol allowing patients to receive visits from the clergy of any religious denomination or sect during a declared public health emergency related to a communicable disease of public health threat.

Background. This regulatory action is a result of a legislative mandate from Chapter 525 of the 2021 Acts of Assembly, Special Session I.² This mandate amended §§ 32.1-127, 32.1-162.5, and 63.2-1732 of the Code of Virginia pertaining to the regulations of hospitals, nursing homes, certified nursing facilities, assisted living facilities, and hospices. For these regulations, the board is required to include that during a declared public health emergency, related to a communicable disease of public health threat, each facility must establish a protocol allowing patients and residents to receive visits from a rabbi, priest, minister, or clergy of any religious denomination or sect. The mandate allows the protocol to restrict the frequency and duration of visits, require visits to be conducted virtually using interactive audio or video technology, and require the person visiting a patient under this protocol to comply with all reasonable requirements of the facility adopted to protect the health and safety of the person, patients, and staff of the facility. According to Virginia Department of Health (VDH), this legislative mandate occurred as a result of complaints received from the public during the COVID-19 pandemic. However, while VDH received numerous complaints about being unable to visit family and friends in hospitals and nursing homes, only a single complaint concerned denial of access to clergy.

Estimated Benefits and Costs: The proposed changes to the regulatory text are identical to the requirements established in the legislative mandates with the exception of some formatting and technical differences.³ Thus, any costs associated with implementing the mandated changes result from the legislation rather than these regulations. However, VDH has not identified any costs. Although the benefits are not quantified, VDH asserts that access to clergy provide spiritual support during end-of-life care, can improve patient well-being by alleviating or reducing anger, fear, or depression, and both patients and their family members can receive assistance in processing grief before, during, and after death. Federal regulations for hospices that are certified to participate in Medicare and Medicaid already require that visitation with clergy be facilitated, and that an infection control program be in place to protect visitors from communicable diseases (42 CFR 418.60 and 418.64(d)(3)(iii)); every licensed hospice in Virginia is certified, so they are already required to adhere to these requirements.⁴ Therefore, the changes being made by this regulatory action have no direct or indirect cost or benefit because Chapter 525 does not change the substance of any existing requirements that hospices are meeting. Because hospices are already required to allow visitation with clergy, and they are already required to comply with the Code of Virginia even in the absence of these regulations, the main impact of the proposed changes is to conform the regulatory text to the amended section of the Code of Virginia and eliminate a potential source for confusion among the regulated entities and the public about the requirements (e.g., obligations and rights regarding visitations during a public health emergency).

Businesses and Other Entities Affected. The proposed changes apply to 147 licensed hospices. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁵ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. The proposed changes do not introduce any new requirements beyond those already mandated by the Code of Virginia. Thus, no adverse impact on any entity is indicated.

Small Businesses⁶ Affected.⁷ According to VDH, 20 of the licensed hospices are estimated to meet the definition of "small business." However, the proposed amendments to the regulatory text do not adversely affect small businesses.

Localities⁸ Affected.⁹ The proposed amendments to the regulatory text do not introduce costs for local governments.

Projected Impact on Employment. The proposed amendments to the regulatory text do not appear to affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments to the regulatory text do not appear to affect the use and value of property or the real estate development costs.

_____________________________

¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² https://lis.virginia.gov/cgi-bin/legp604.exe?212+ful+CHAP0525.

³ According to VDH, this regulatory package was first prepared as an exempt action under § 2.2-4006 A 4 a of the Code of Virginia, which requires regulations to be filed with the Registrar within 90 days of the law's effective date. Because the action was not filed within the required timeframe due to personnel changes in the Office of the Commissioner, the regulatory action does not qualify as an exempt action.

⁴ ORM Economic Impact Document.

⁵ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁶ Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁷ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) 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, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) 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 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁸ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The State Board of Health concurs with the Department of Planning and Budget's economic impact analysis.

Summary:

Pursuant to Chapter 525 of the 2021 Acts of Assembly, Special Session I, the amendment requires each hospice facility to establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of any religious denomination or sect when there is a declared public health emergency related to a communicable disease of public health threat.

12VAC5-391-370. Spiritual counseling and bereavement services.

A. The hospice program shall provide for the delivery of spiritual counseling and bereavement services that reflect the family's needs and desires and are delivered according to the overall plan of care.

B. Spiritual counseling may be provided through a working arrangement with individual clergy, clergy associations, and other religious programs in the community or by clergy employed by the hospice program.

C. The hospice program shall provide bereavement services to the family for a minimum of one year after the patient's death.

D. The hospice program shall maintain a list of individuals who provide spiritual and bereavement services. The list shall be made available, upon request to patients, families, hospice program employees, and contractors.

E. Arrangements for and delivery of spiritual counseling and bereavement services shall be documented in the patient's record.

F. During a declared public health emergency related to a communicable disease of public health threat, each hospice facility shall establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of a religious denomination or sect. Such protocol shall be consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with an executive order, order of public health, department guidance, or other applicable federal or state guidance having the effect of limiting visitation.

1. The protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology.

2. The protocol may require the person visiting a patient pursuant to this subsection to comply with all reasonable requirements of the hospice facility adopted to protect the health and safety of the person, patients, and staff of the hospice program.