Summary
With Congress in recess this week, we turn our attention to the Biden-Harris Administration, and specifically the recently updated unified agenda. The Administration is planning to engage in multiple rulemaking efforts to advance its health-related priorities. For example, we expect to see more from the Administration this year on its plans for implementing the drug pricing provisions included in the Inflation Reduction Act. We also anticipate additional work on advancing the Administration’s behavioral health integration strategy, which it unveiled last year. Last, the Administration is expected to end the COVID-19 public health emergency (PHE) this year and will begin supporting health care providers, states, and other stakeholders in the unwinding of the various pandemic-related flexibilities and requirements that have been in place since 2020. The Administration will also likely move forward on a variety of efforts to support access to reproductive health, support public health systems, and improve access to equitable care.
Below, we highlight planned activity on the regulatory front in drug pricing, public health, mental health, and coverage and access:
- Drug Pricing: This week, the Center for Medicare and Medicaid Innovation (CMMI) is expected to release a report describing various different alternative payment models it could consider launching to lower prescription drug pricing. The report was required as part of President Biden’s Executive Order last year on lowering prescription drug costs. Beyond this, the Administration will also begin implement aspects of the newly authorized Medicare Drug Price Negotiation Program, as detailed recently by the Centers for Medicare & Medicaid Services (CMS).
- Public Health: The Occupational Safety and Health Administration is expected to soon issue the highly anticipated permanent COVID-19 standard for health care. The final rule arrived at OMB for review on December 7, 2022. Back in June 2021, OSHA implemented an emergency temporary standard (ETS) establishing requirements for employers to protect workers from COVID-19 in health care settings. The ETS remains in effect until superseded by a permanent standard. In September 2023, OSHA plans to propose a standard intended to protect workers from infectious diseases. This broader standard would apply to more settings beyond health care, such as correctional facilities, homeless shelters, drug treatment programs, and occupational settings.
- Mental Health: The Administration will continue to advance its behavioral health integration strategy, which it formally announced last September. This will largely consist of federally-sponsored training programs for mental health professionals, increased compliance with mental health parity requirements, increased health IT interoperability to facilitate communication between mental and physical health providers, and improved quality measures. On the rulemaking front, the Administration has previewed it plans to issue a proposed rule to implement the mental health parity provisions included in the Consolidated Appropriations Act of 2021. The Administration is also aiming to pursue rulemaking intended to improve care for those with substance use disorder (e.g., here and here).
- Coverage & Access: In support of President Biden’s executive orders (January 2021, April 2022), the Administration will continue to use regulatory levers to strengthen Medicaid and the ACA. In response to the decoupling of the Medicaid unwinding period from the COVID-19 Public Health Emergency, CMS plans to issue a final rule modifying state requirements for the temporary 6.2 percentage point FMAP increase. Additionally, CMS plans to issue a final rule in November 2023 intended to streamline the Medicaid and CHIP application and enrollment processes. In April 2023, CMS plans to release proposed rules to improve access to Medicaid and CHIP broadly as well as Medicaid managed care (e.g., here and here).
In addition to the annual notice of benefit and payment parameters for 2024, CMS plans to pursue rulemaking to strengthen protections under the ACA. In April, the Administration plans to propose changes to the regulation of short-term, limited-duration insurance to ensure this type of coverage does not undermine the ACA. CMS is also expected to issue a proposed rule regarding religious and moral exemptions as they relate to coverage of certain preventive services (e.g., reproductive health care).
Lastly, the Administration will issue a slate of rules implementing the No Surprises Act related to independent dispute resolution, provider nondiscrimination requirements, advanced explanation of benefits, air ambulance services.