Summary
Democrats appear to be getting close to a compromise on prescription drug pricing reforms – including versions of Medicare drug price negotiation, Part D redesign, inflation rebates that are more moderate than originally proposed in H.R. 3 (WHG summary of the most pertinent drug pricing proposal provisions in the 117th Congress). We could see the House vote on the Build Back Better Act (H.R. 5376; WHG summary), followed by the Senate-approved bipartisan Infrastructure Investment and Jobs Act, as soon as this week.
Still, passage of the Further Surface Transportation Extension Act of 2021 (H.R. 5763) bought Democrats more time to reach a deal on the budget reconciliation package. December 3 is the new expiration date for surface transportation programs at the Department of Transportation. However, Democrats are eager to deliver President Biden a much-needed legislative win. An NBC News poll released yesterday finds 42 percent of Americans approve of President Joe Biden’s job performance, down from 53 percent in April when the Biden Administration was able to tout the then newly enacted American Rescue Plan Act of 2021 (P.L. 117-7).
Additionally, lawmakers will soon need to refocus their attention on fiscal year (FY) 2022 spending bills. The continuing resolution (P.L. 117-43) expires December 3. House and Senate Appropriations Committee leaders are meeting this week to discuss spending levels for FY 2022. In addition, Congress must deal with the debt limit by early December.
COVID-19
Tomorrow, the CDC’s Advisory Committee on Immunization Practices (ACIP) will vote on whether the newly FDA-authorized Pfizer COVID-19 vaccine should be recommend for all children 5 to 11 years or only certain subgroups of children. The vaccine could be available to the public within a few days of CDC making a formal recommendation after the ACIP vote. The Biden Administration is partnering with pediatricians’ offices and other primary cites, children’s hospital systems, pharmacies, school and community-based clinics, and community health centers and rural health clinics to ensure convenient and equitable access to children, according to its operational plan.
The Office of Management and Budget (OMB) has concluded review of regulations requiring COVID-19 vaccinations among health care workers and large employers. We could see both regulations this afternoon.
- Centers for Medicare and Medicaid Services (CMS) interim final rule with comment period would require Medicare and Medicaid facilities – including nursing homes, hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others – to mandate COVID-19 vaccines among workers.
- Occupational Safety and Health Administration (OSHA) emergency temporary standard (ETS) would require large employers (with 100+ employees) to mandate COVID-19 vaccinations or weekly testing.
Medicare Payment Rules
Last week, CMS released the final rule for its calendar year (CY) 2022 end stage renal disease (ESRD) prospective payment system (PPS) (full summary here). This week, we may see the remaining final rules for the CY Medicare payment updates – the Medicare Physician Fee Schedule, the Hospital Outpatient PPS, and the Home Health PPS – which have all cleared review by the OMB. A brief overview of what we may see included in these final rules follows.
- Medicare Physician Fee Schedule (MPFS): CMS may finalize a number of provisions related to telehealth expansion under its current regulatory authorities. Specifically, CMS may make changes that increase beneficiary access to audio-only services for certain conditions, and may extend the timeframe by which CMS will retain temporarily added telehealth services to continue collecting data and study their impact on beneficiary outcomes. Other changes will likely include continued implementation of its MIPS Value Pathways program, as well as continued implementation of certain SUPPORT Act provisions around requirements for the electronic prescribing of controlled substances.
- Hospital Outpatient PPS (HOPPS): CMS may finalize its proposals to increase fines for hospitals that do not publish their list of standard charges (as required by the Hospital Price Transparency final rule). The proposed rule also included a number of changes to the CMS Radiation Oncology model, which we may see finalized in the forthcoming rule as well.
- Home Health PPS: CMS may finalize its proposal to expand the Home Health Value Based Purchasing model to all 50 states, as well as provisions that would make permanent certain COVID-19 waivers related to home health aide supervision and the use of telecommunications for unplanned occurrences.
Nutrition
Tomorrow, a Senate Agriculture Subcommittee will hear from policy experts about “The State of Nutrition in America 2021.” During the COVID-19 pandemic, a slew of nutrition-related flexibilities has been used by the Biden Administration and Congress to strengthen food security within schools, the Supplemental Nutrition Assistance Program (SNAP), the Special Nutrition Program for Women, Infants and Children (WIC), among other programs. Additionally, the Build Back Better Act includes several provisions to further increase accesso to nutrition benefits in schools as well as $140 million to support nutrition programs for Older Americans.