Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-210).

Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: April 6, 2016.

Effective Date: April 22, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, or erik.bodin@vdh.virginia.gov.

Basis: The regulation is promulgated under the authority of §§ 32.1-12 and 32.1-127 of the Code of Virginia. Section 32.1-12 grants the board the legal authority "to make, adopt, promulgate, and enforce such regulations necessary to carry out the provisions of Title 32.1 of the Code." Section 32.1-127 directs the board to promulgate regulations with minimum standards for the construction and maintenance of hospitals; the operation, staffing, and equipping of hospitals; qualifications and training of staff of hospitals; conditions under which a hospital may provide medical and nursing services to patients in their places of residence; and policies related to infection prevention, disaster preparedness, and facility security.

Purpose: The Centers for Medicare and Medicaid Services (CMS) revised 42 CFR 482.22(b) in 2014 to add § 482.22(b)(4), which permits a hospital that is part of a hospital system consisting of multiple, separately certificated hospitals to participate in a unified, integrated medical staff that the hospital system utilizes for two or more of its member hospitals, in accordance with state law. The Regulations for the Licensure of Hospitals in Virginia is currently written in a manner that can be interpreted to be more restrictive than the federal regulations. This was not the intent and therefore this regulatory action will amend the regulations to remove restrictions that may be interpreted to be more stringent than federal law. This regulatory action will protect the health and welfare of Virginians by ensuring that patients within a hospital setting benefit from the improved efficiency and quality and patient safety made possible through a unified, integrated medical staff.

Rationale for Using Fast-Track Process: These amendments simply ensure that the Commonwealth's regulations are not more restrictive than federal regulations. These amendments have also been prepared with input from stakeholders. Therefore, the department does not expect that this regulatory action will be controversial.

Substance: The amendment to 12VAC5-410-210 clarifies the requirement that each hospital have an organized medical staff by adding language that allows hospitals that are part of a hospital system to have a unified and integrated medical staff and adding a citation for the CFR subsections that specify the requirements of unified and integrated medical staffs.

Issues: The primary advantage to the agency, the Commonwealth, and the public of the proposed regulatory action will be less burdensome regulations. The proposed regulatory action will also lead to improved efficiency and quality and patient safety created through unified and integrated medical staffs. There are no known disadvantages to the agency, the Commonwealth, or the public.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to add a clarifying sentence to this regulation in order to reflect changes to federal regulations.

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

Estimated Economic Impact. This regulation specifies that "Each hospital shall have an organized medical staff responsible to the governing body of the hospital for its own organized governance and all medical care provided to patients." The federal Centers for Medicare and Medicaid Services revised 42 CFR § 482.22 (b) in 2014 to add § 482.22 (b)(4) which permits a hospital that is part of a hospital system consisting of multiple, separately certificated hospitals to participate in a unified, integrated medical staff that the hospital system utilizes for two or more of its member hospitals. In order to clarify that the federal rule applies in the Commonwealth, the Board proposes to add the following sentence to the regulation: "Nothing in this provision shall prevent hospitals which are a part of a hospital system from having a unified and integrated medical staff as permitted by 42 CFR § 482.22 (b) (4)." The proposed addition of clarifying language will not affect any requirements, but will provide a small benefit in that it will reduce potential confusion and associated time wasted in determining how hospitals may be organized.

Businesses and Entities Affected. The proposed amendment pertains potentially affects the 106 licensed hospitals and critical access hospitals within the Commonwealth.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

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

Effects on the Use and Value of Private Property. The proposed amendment is unlikely to significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendment does not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, 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."

Costs and Other Effects. The proposed amendment is unlikely to significantly affect small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendment will not adversely affect small businesses.

Adverse Impacts:

Businesses: The proposed amendment will not adversely affect businesses.

Localities: The proposed amendment will not adversely affect localities.

Other Entities: The proposed amendment will not adversely affect other entities.

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

Summary:

The amendment clarifies that 42 CFR 482.22(b)(4) applies in the Commonwealth of Virginia. 42 CFR 482.22(b)(4) permits a hospital that is part of a hospital system consisting of multiple, separately certificated hospitals to participate in a unified, integrated medical staff that the hospital system utilizes for two or more of its member hospitals.

12VAC5-410-210. Medical staff.

A. Each hospital shall have an organized medical staff responsible to the governing body of the hospital for its own organized governance and all medical care provided to patients. Nothing in this subsection shall prevent hospitals that are a part of a hospital system from having a unified and integrated medical staff as permitted by 42 CFR 482.22(b)(4).

B. The medical staff shall be responsible to the hospital governing board and maintain appropriate standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review, and other appropriate mechanisms.

C. The medical staff, subject to approval by the governing body, shall develop bylaws incorporating details of the medical staff organization and governance, giving effect to its general powers, duties, and responsibilities including:

1. Methods of selection, election, or appointment of all officers and other executive committee members and officers;

2. Provisions for the selection and appointment of officers of departments or services specifying required qualifications;

3. The type, purpose, composition, and organization of standing committees;

4. Frequency and requirements for attendance at staff and departmental meetings;

5. An appeal mechanism for denial, revocation, or limitation of staff appointments, reappointments, and privileges;

6. Delineation of clinical privileges in accordance with the requirements of § 32.1-134.2 of the Code of Virginia;

7. Requirements regarding medical records;

8. A mechanism for utilization and medical care review; and

9. Such other provisions as shall be required by hospital or governmental rules and regulations.

D. A copy of approved medical staff bylaws and regulations and revisions thereto shall be made available to the OLC on request.