Summary
COVID-19
The Biden Administration faces a crucial week, as President Biden and top health officials try to ensure public confidence in the administration’s COVID-19 response, especially as the Centers for Disease Control and Prevention (CDC) faces harsh criticism over its new isolation and quarantine guidelines for the general population and schools. The President is scheduled to deliver remarks on the pandemic response on Thursday. Ahead of his speech, we could see the Departments of Health and Human Services (HHS), Labor, and Treasury issue guidance clarifying how individuals who purchase rapid, over-the-counter (OTC) COVID-19 tests can seek reimbursement from their private health insurer. January 15 is the Administration’s self-imposed deadline for this guidance, according to an announcement made in December and reiterated by Biden last week.
Tomorrow, the Senate Committee on Health, Education, Labor and Pensions (HELP) will question top health officials about the Biden-Harris Administration’s response to rising COVID-19 cases fueled by the Omicron variant. The panel features Dr. Rochelle Walensky, Director of the CDC; Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health; Dr. Janet Woodcock, Acting Commissioner of the Food and Drug Administration (FDA); and Dawn O’Connell, Assistant Secretary for Preparedness and Response. They last appeared before the Senate HELP Committee in early November – when the U.S. was seeing a downward trend in cases, hospitalizations, and deaths after the Delta surge over the summer.
With the new reality settling in that COVID-19 is not going away – and negotiations over the Build Back Better bill on pause – we could see lawmakers refocus their energy on legislation to bolster the federal COVID-19 response. Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) may soon release their highly anticipated bipartisan pandemic preparedness bill. According to a plan outlined in April 2021, the legislation would include highly needed resources and strategies to strengthen public health infrastructure and medical capacity, countermeasure development, and medical supply chains.
FDA
On Wednesday, the Senate HELP Committee will consider the nomination of Dr. Robert Califf to serve as the FDA Commissioner. Dr. Califf led the FDA during the last year of the Obama Administration and was confirmed with strong, bipartisan support in 2016 (89-4-7). We anticipate Dr. Califf will clear the Senate HELP Committee and be approved by the full Senate, despite some opposition from lawmakers – including Sens. Joe Manchin (D-WV) and Bernie Sanders (I-VT) – over his ties to the pharmaceutical industry. At his confirmation hearing in December, Dr. Califf said his priorities would be:
- Strengthening the FDA’s emergency preparedness and response infrastructure;
- Protecting consumers and patients (e.g., systematic approaches to evaluating benefits and risks of medical products, ensuring food safety, protecting kids from tobacco products, and reducing overdose deaths); and
- Modernization and innovation.
Medicare
Later this week, the Medicare Payment Advisory Commission will review and vote on draft Medicare fee-for-service (FFS) payment updates for the March 2022 Report to Congress. Commissioners will also discuss the following:
- A congressionally requested report on a new value-incentive program for post-acute care (due March 15, 2022);
- A status report on dual-eligible special needs plans;
- A status report on the Medicare prescription drug program (Part D); and
- A multi-track population-based payment model with administratively updated benchmarks (as part of their work on streamlining and harmonizing advanced alternative payment models).