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December 20, 2021

This Week in Health Policy for December 20

This Week (December 20 - 24)

Due to the Congressional recess, the next This Week in Health will be published when Congress returns in January.

Last Week (December 13 - 17)

Health Care Highlights

Update on Build Back Better health provisions. Late last week, Senate committees released draft text for their portions of the Build Back Better (BBB) Act, including some notable health care changes from the House-passed version of the package. Included in the draft text are changes to:

  • Remove a 12.5% cut to disproportionate share hospital (DSH) payments to hospitals in non-Medicaid expansion states.
  • Eliminate requirements related to skilled nursing facility (SNF) staff-to-patient ratios.
  • Add an additional $3 million in funds to develop Home and Community Based Services (HCBS) quality measures, along with various changes to the use of HCBS funding.
  • Change the permanent expansion of the Money Follows the Person demonstration to begin in 2022, rather than 2023.
  • Require qualified health plans to cover up to three months of services prior to enrollment of low-income people who gain coverage in 2025, to be reimbursed by HHS.
  • Drug pricing changes include:
    • Clarifications for how the maximum fair price for a prescription drug will be determined under the negotiation provisions
    • Excluding plasma-derived products from negotiation
    • Changes aimed at preventing hospitals from getting duplicate 340B discounts under negotiation
    • Modifications to the timeline and baseline to determine how the inflation-based rebates for prescription drugs will be calculated
    • A provision exempting generic drugs from inflationary rebates if they are experiencing supply chain disruptions or it could result in access issues.

Republicans are also expected to challenge several drug pricing provisions for their perceived failure to meet budgetary rules under the reconciliation process. This includes caps on what Americans pay for insulin, inflationary rebate provisions, and new transparency requirements for pharmacy benefits managers (PBMs). Democratic leaders are continuing to make their case to the Senate parliamentarian that those provisions should be retained and have abandoned plans to pass the BBB before their Christmas break as negotiations continue between the White House and moderate Democrat Joe Manchin (D-WV).

HHS releases $9 billion in PRF funding. On Tuesday (Dec. 14), the Department of Health and Human Services (HHS) announced the distribution of approximately $9 billion in Provider Relief Fund (PRF) Phase 4 payments to health care providers who have experienced revenue losses and expenses related to the COVID-19 pandemic. According to the release, the average payment for small providers is $58,000, for medium providers is $289,000, and for large providers is $1.7 million. More than 69,000 providers in all 50 states, Washington, D.C., and eight territories will receive Phase 4 payments.

CDC recommends mRNA vaccines over J&J shot. On Thursday (Dec. 16), all 15 members of the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices voted in favor of recommending messenger RNA (mRNA) vaccines made by Pfizer and Moderna for use in adults over Johnson & Johnson’s shot due to a link to rare but serious blood clots. CDC Director Rochelle Walensky later signed off on the advice, saying: “Today’s updated recommendation emphasizes CDC’s commitment to provide real-time scientific information to the American public. I continue to encourage all Americans to get vaccinated and boosted.”

Biden vaccine mandates continue to be challenged in court. The Biden administration this week asked the U.S. Supreme Court to let their federal vaccine mandate for health care workers take effect in 24 states where lower court orders have blocked the rule while litigation moves forward in cases filed by Republican-led states. A federal district court blocked the Biden administration from enforcing the mandate for health care workers in Texas just hours after an appeals court allowed the rule to resume in around half the U.S. Also this week, a federal judge in Louisiana ruled that Biden’s vaccine mandate for federal contractors should be paused for state employers in Louisiana, Mississippi, and Indiana with contracts with the federal government. Meanwhile, more than 165,000 U.S. government employees have been granted exemptions from and extensions for the Biden administration's COVID-19 vaccine mandate for federal employees.

HHS may need more pandemic funding from Congress. Health and Human Services Secretary Xavier Becerra said this week that the Biden administration may need to ask Congress for more funding to combat the pandemic in wake of the omicron variant, saying the department is making projections to determine potential future costs. He noted, as an example, that the administration has about $10 billion left for COVID-19 testing, but that there's a "strong chance" more will be needed. According to new estimates from HHS, demand for COVID-19 tests in the U.S. could reach 3 million to 5 million tests per day as soon as late January, far outpacing the current level of more than 1.6 million tests.


Senate HELP Committee hearing on nomination of Robert Califf for FDA Commissioner. On Tuesday (Dec. 14), the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the nomination of Dr. Robert Califf to be Commissioner of the Food and Drug Administration (FDA). Ranking Member Richard Burr (R-NC) expressed support along with Democrats on the committee for Califf’s nomination, saying his experience in clinical research and his previous time leading the agency during the Obama administration give him a “unique perspective” to serve at the helm once again. HELP Committee Chair Sen. Patty Murray (D-WA) said she looks forward to working with Califf again “to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first.” If confirmed, Califf will become the first permanent head of the FDA nearly a year into the Biden administration. Support from Republicans will be critical in moving his nomination forward given some Democrats, including Sens. Joe Manchin (D-WV) and Bernie Sanders (I-VT), have already signaled opposition, citing Califf’s history of working closely with the pharmaceutical industry. The HELP Committee hasn’t scheduled a vote on Califf’s nomination, a precursor to a vote in the full Senate.

Reports, Studies, and Journals

Health Affairs: National Health Care Spending In 2020: Growth Driven By Federal Spending In Response To The COVID-19 Pandemic. U.S. health care spending increased 9.7 percent to reach $4.1 trillion in 2020, a much faster rate than the 4.3 percent increase seen in 2019. The acceleration in 2020 was due to a 36.0 percent increase in federal expenditures for health care that occurred largely in response to the COVID-19 pandemic. At the same time, gross domestic product declined 2.2 percent, and the share of the economy devoted to health care spending spiked, reaching 19.7 percent. In 2020 the number of uninsured people fell, while at the same time there were significant shifts in types of coverage.

CIDRAP: Review Uncovers Weak COVID Clinical Practice Guidelines.A new systematic review of 32 clinical practice guidelines (CPGs) for severely ill COVID-19 patients reveals that most were of poor quality, with few reporting funding sources or conflicts of interest, employing a methodologist, describing a search strategy or study selection process, or synthesizing evidence. The review, published in JAMA Network Open, was conducted by a team led by University of Toronto researchers from Dec 14, 2020, to Feb 28, 2021.

The Commonwealth Fund. The U.S. COVID-19 Vaccination Program at One Year: How Many Deaths and Hospitalizations Were Averted? According to this analysis, in the absence of a vaccination program, there would have been approximately 1.1 million additional COVID-19 deaths and more than 10.3 million additional COVID-19 hospitalizations in the U.S. by November 2021.

Kaiser Family Foundation: Medicaid Enrollment Churn and Implications for Continuous Coverage Policies. Among full-benefit beneficiaries enrolled at any point in 2018, 10.3% had a gap in coverage of less than a year. About 4.2% were disenrolled and then re-enrolled within three months and 6.9% within six months.


Contact Information
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