TL/DR –
The Biden Administration released a final rule detailing the fees for the Federal Independent Dispute Resolution process under the No Surprises Act. The Food and Drug Administration (FDA) issued several guidances and draft guidances on topics including the use of real-world evidence to support regulatory decision-making for medical devices and the registration and listing of cosmetic product facilities and products. Furthermore, the Centers for Medicare & Medicaid Services (CMS) issued a notice on the charter renewal for the Advisory Committee on Ground Ambulance and Patient Billing (GAPB).
Summary of the Health Care Week in Review
The Biden Administration recently implemented a final rule that outlines the costs for the Federal Independent Dispute Resolution (IDR) process under the No Surprises Act. In addition, the Ways and Means Democrats released additional reports illustrating the U.S. health care system’s role in the climate crisis.
I. Regulations, Notices & Guidance
The FDA and The Department of Health and Human Services (HHS), Labor, and Treasury issued several guidances and final rules on December 18 and 19, 2023. These included guidances on the use of real-world data (RWD) in medical device regulation, cosmetic product facility registrations and product listing submissions, and the Federal Independent Dispute Resolution process. FDA also announced the locations of future guidance document development and posted a list of potential topics for future consideration.
The Centers for Medicare & Medicaid Services (CMS) and FDA also released several notices and final rules on December 20 and 21, 2023. These included the renewal of the charter for the Advisory Committee on Ground Ambulance and Patient Billing, guidance on data standards for drug and biological product submissions containing real-world data, and the final rule on Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.
Additional FDA guidances were released on December 21, 2023, focusing on the use of digital health technologies for remote data acquisition in clinical investigations, the development of drugs and biological products, and the assessment of registries for regulatory decision-making for drug and biological products. HHS and CMS issued additional notices and proposed rules on December 21 and 22, 2023, covering a range of topics including pandemic prevention, appeal rights for certain changes in patient status, and the development of drugs and biological products for rare diseases.
On December 22, 2023, CMS issued a final rule that updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations.
II. Reports, Studies, & Analyses
The Office of Inspector General (OIG) and the Kaiser Family Foundation released reports on December 19, 2023, studying how the Provider Relief Fund (PRF) helped select nursing homes during the COVID-19 pandemic and recent trends in Medicaid outpatient prescription drug utilization and spending.
On December 22, 2023, OIG released a report on Medicare Part B spending on clinical diagnostic laboratory tests in 2022.
III. Other Health Policy News
On December 18, Senator Bill Cassidy (R-LA) released a letter underscoring the urgency of reauthorising the Pandemic and All-Hazards Preparedness Act (PAHPA). On December 18, 2023, the Biden Administration issued a final rule outlining the fees for the Federal IDR process under the No Surprises Act. The final rule establishes new regulations for the administrative fees charged to participate in the Federal IDR process.
On December 19, 2023, House Ways and Means Committee Democrats released additional reports detailing the role the U.S. health system plays in the climate crisis. The report focuses on the health care supply chain and includes a new fact sheet on stakeholder responses related to the environmental impact of pressurized metered dose inhalers.
On December 21, 2023, the Biden Administration announced initiatives to expand access to naloxone in federal facilities nationwide. HHS and the General Services Administration introduced guidelines recommending the inclusion of overdose reversal medications, like naloxone, in safety stations across federal facilities.
On December 22, 2023, the Departments and the Office of Personnel Management announced that they intend to reopen the comment period for the proposed rule entitled, Federal Independent Dispute Resolution (IDR) Operations.
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