The General Assembly directed the Secretary of Health and Human Resources (SHHR) to “develop recommendations for implementation of [Chapter 297 of the 2020 Acts of Assembly], including any regulatory changes that may be necessary for implementation of this act, and shall report his recommendations to the Governor and the Chairmen of the House Committee on Health, Welfare and Institutions and the Senate Committee on Education and Health by November 1, 2022." The Office of the Secretary of Health and Human Resources (OSHHR) convened two meetings in September of 2022, during which several informational presentations were given and robust debate ensued amongst the assembled stakeholders. OSHHR developed the following recommendations.

RECOMMENDATIONS

Legislative. Implementation of any of the recommendations below would require the General Assembly to either amend the Code of Virginia or to amend Chapter 2 of the 2022 Acts of Assembly, Special Session I (Appropriations Act). The legislative recommendation receiving unanimous support of study contributors is Recommendation 3.

1. The Virginia Department of Health (VDH) should have sufficient resources to monitor compliance.

2. If VDH determines that a hospital is noncompliant with any Virginia hospital price transparency requirement and the hospital fails to submit or comply with an acceptable plan of correction (PoC),(*1) the State Health Commissioner should have the authority to impose civil monetary penalties (CMPs) on a hospital in amounts commensurate with the CMPs for failure to comply with the federal hospital price transparency requirements.

3. If VDH determines that a hospital is noncompliant with any Virginia hospital price transparency requirement and the hospital fails to submit or comply with an acceptable PoC, the State Health Commissioner should have the authority to impose a directed PoC.(*2)

4. In addition to administrative enforcement by VDH, subsection A of Va. Code § 59.1-200 and subsection A of Va. Code 32.1-137.05 should be amended to state that a violation of the Virginia hospital price transparency is a prohibited act under the Virginia Consumer Protection Act of 1977 (§ 59.1-196 et seq. of the Code of Virginia).

Regulatory. Implementation of any of the recommendations below would require the State Board of Health (Board) to initiate one or more regulatory actions under the Virginia Administrative Process Act. The regulatory recommendations receiving unanimous support of study contributors are Recommendations 1, 3, and 7. Recommendation 6 received unanimous support for the provision of notice to a hospital of alleged noncompliance, but did not receive unanimous support for publication of notice. Unanimous support of study contributors on Recommendation 2 is contingent on the U.S. Centers for Medicare and Medicaid Services (CMS) concurring in the determination outpatients hospitals in Virginia to meet the definition of “hospital" in 45 CFR § 180.20.

1. The Board should adopt the federal minimums for machine-readable files found in 45 CFR § 180.50 in its hospital regulations.

2. Outpatient hospitals should be subject to Virginia’s hospital price transparency requirements.

3. Hospitals should be required to display the gross charge, negotiated charge, and discounted cash price in the machine-readable file as U.S. dollars when the charge or cash price has been calculated as a percentage of Medicare or Medicaid rates.

4. “Items and services" should include medication that the hospital customarily provides as part of, or in conjunction with, a service.

5. Hospitals should be required to provide the link to the webpage where their machine-readable files are located to Virginia Health Information (VHI).)(*3)

6. If VDH determines that a hospital is noncompliant with any Virginia hospital price transparency requirement, VDH should provide notice to the hospital of the alleged noncompliance and publish determinations of noncompliance on its website.

7. If VDH determines that a hospital is noncompliant with any Virginia hospital price transparency requirement and after providing notice, VDH should require the hospital to submit an acceptable PoC.

Operational. Implementation of any of the recommendations below would require neither a legislative act nor regulatory action, but require changes to the operations of VDH. The operational recommendation receiving unanimous support of study contributors is Recommendation 1. Recommendation 2 received unanimous support for which agencies would be responsible for compliance monitoring, but did not receive unanimous support for publication of determinations of noncompliance. Unanimous support of study contributors on Recommendations 3 and 7 are contingent on CMS concurring in the determination outpatients hospitals in Virginia to meet the definition of “hospital" in 45 CFR § 180.20.

1. Links to each hospital’s webpage for the machine-readable file should be provided by VHI on each hospital’s already-existing VHI webpage.

2. CMS and VDH should be responsible for compliance monitoring, and VDH should make public determinations of noncompliance.

3. VDH and VHI should compile a list of all currently licensed outpatient hospitals and conduct outreach to each facility in advance of July 1, 2023, but no later than March 30, 2023, to inform the outpatient hospitals of the applicability of Chapter 297 of the 2022 Acts of Assembly to their facility.

4. VHI should publish instructions on its website on how a consumer/patient can view the contents of machine-readable file, including recommended free software to open the file.

5. VDH should be directed to create an off-site inspection process to monitor compliance with Virginia’s hospital price transparency requirement.

6. VDH should report to CMS any hospital that has been subject to enforcement action for failing to meet a Virginia hospital price transparency requirement that is identical or substantially equivalent to a federal hospital price transparency requirement.

7. VDH should not assess compliance of outpatient hospitals with the Virginia hospital price transparency until January 1, 2024.
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(*1) A PoC is developed by the noncompliant health care provider to detail its planned methods to correct violations and date on which such corrections are expected to be completed, all of which is subject to approval by the regulatory body before it can be implemented.
(*2) A directed PoC is developed by the regulatory body instead of the noncompliant health care provider, and details the methods by which the noncompliant health care provider must correct violations and date on which such corrections must be completed.
(*3) VHI is a nonprofit data services organization that VDH has contracted with pursuant to Va. Code §§ 32.1-23.4 and 32.1-276.2 et seq. to collect data for, amongst a number of programs, the prescription drug price transparency program, AllPayer Claims Database, the Patient Level Data System, and service utilization and charity care for the certificate of public need program.