An agreement to raise the debt limit passes the Senate. National Institutes of Health Director, Francis Collins, announces plans to step down from the nation’s top medical research agency.

CONGRESS

Senate Reached Debt Limit Compromise to Temporarily Avoid Default

After failing to achieve a bipartisan solution to raise or waive the debt limit, Democrats this week considered pursuing procedural maneuvering to limit the filibuster (a procedural mechanism that requires 60 votes to end debate on a bill and proceed to a vote on its passage), which would have broad impact on Senate procedures going forward. Partially out of concern this move could prove successful, Senate Minority Leader Mitch McConnell offered a proposal for a temporary debt limit increase until early December. Senate Majority Leader Chuck Schumer and McConnell ultimately landed on a $480 billion debt limit increase. McConnell was able to convince 11 Republicans (including him) to vote for cloture (to end debate), which permitted Democrats to then pass the debt limit increase with a simple majority (i.e., Democrats only voting in favor). This also kept Republicans from having to technically endorse the increase. The House is expected to pass the temporary increase in a special session on October 12, 2021. Overall, this now sets up December 3 as the likely deadline for a combined debt limit and government funding showdown, as the continuing resolution currently funding government expires on that date as well.

ADMINISTRATION

Francis Collins Announced Resignation as Director of the National Institutes of Health (NIH)

Collins has headed the nation’s top medical research body since 2009 after 26 years directing the National Human Genome Research Institute, where he led the Human Genome Project launched under President Clinton. His research has been instrumental in understanding the key mechanisms of many genetic diseases, and he oversaw several cutting-edge research projects during his tenure as director. Collins has also played a vital role in overseeing medical research and advising on the COVID-19 response. With Collins’ imminent departure, President Biden will have another high-profile and important healthcare role to fill alongside the head of the U.S. Food and Drug Administration (FDA), which remains leaderless. The next NIH director will not only inherit the Institutes’ historic massive research portfolio and heightened role in pandemic preparedness and response, but also in potentially shaping the Advanced Research Projects Agency for Health (ARPA-H)—a new agency championed by President Biden to drive innovative medical research thinking for diseases like cancer and neurodegenerative disorders. According to the agency’s release, Collins will conclude his role at NIH by the end of the year.

Pfizer and BioNTech Requested Emergency Use Authorization of COVID-19 Vaccine for Younger Children

If granted, this would be the first vaccine approved for emergency use in children ages 5-12. Pfizer’s COVID-19 vaccine (Comirnaty) is the only vaccine to have earned full FDA approval for a two-dose regimen in individuals 16 years and older. It currently has an emergency use authorization (a designation that allows marketing before full FDA approval) for a two-dose regimen in individual 12 years and older, as well as for a third dose booster for certain populations. The increase in COVID-19 cases due to the delta variant has seen more children contracting COVID-19, particularly as they have returned to school. Accordingly, authorization of a highly effective vaccine for this population could help curb community transmission. Pfizer is continuing to study populations as young as 6 months to expand the emergency use authorization. The FDA will convene its Vaccines and Related Biologic Products Advisory Committee on October 26 to review the request and vote on a recommendation.

M+ RESOURCES

• Federal agencies announced Sept. 30 the latest interim final rules implementing the No Surprise Act. At issue is the part of the regulation that lays out the independent dispute resolution process used when there is a disagreement between providers and payers over the fair price for out-of-network services. Eric Zimmerman, Kristen O’Brien, and Katie Waldo breakdown the latest IFR and important issues in the dispute resolution process.

QUICK HITS

• Representatives Neal and Brady, the Chair and Ranking Republican on the House Ways & Means Committee, sent a strongly worded letter to the Secretaries of the three Departments responsible for issuing regulations implementing the No Surprises Act. The letter critiques certain policy decisions included in an Interim Final Rule issued last week that implements aspects of the law.

• Kentucky, Maine and New Mexico launch state-based health insurance marketplaces for 2022 coverage year.

• Office of Civil Rights issued guidance on the Health Insurance Portability and Accountability Act and its application to COVID-19 vaccination records in the workplace.

• HHS awarded more than $2 billion to support HIV care across America in 2021.

• After legal challenges, Missouri proceeds with Medicaid expansion, adding more that 275,000 new enrollees.

NEXT WEEK’S DIAGNOSIS

Congress will continue to negotiate the terms of the reconciliation package. The Senate is in recess beginning next week and the House will return for one day to vote on the debt limit increase.