Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


President Signs Short-Term Increase to Debt Limit

The House of Representatives voted last week to raise the debt ceiling until December 3. The debt limit bill was previously passed by the Senate and signed into law by President Joe Biden on Thursday. It would increase the nation’s borrowing ability by $480 billion. In absence of the legislation, the government would have breached its borrowing limit and defaulted on its debt obligations around October 18. While the bill prevents an immediate crisis, it sets the stage for another partisan fight over raising the debt limit to coincide with the current deadline to fund the federal government for fiscal year (FY) 2022.

Biden Expected to Nominate FDA Commissioner in Coming Weeks

Former Commissioner of the Food and Drug Administration (FDA) Robert Califf, MD has emerged as a leading candidate to be nominated to run the agency. President Biden must nominate someone by mid-November for Janet Woodcock to remain in the role of acting Commissioner beyond that time. Califf is a cardiologist and a senior advisor at the Duke Clinical Research Institute. He served as FDA Commissioner during the last year of President Obama’s term (February 2016-January 2017). At that time, he was confirmed by the Senate 89-4. More than sixty of the senators who voted for his confirmation serve in the Senate today.

Reconciliation Negotiations Ongoing

Democrats continue to negotiate what will be included in their multitrillion- dollar social spending package that is expected to be passed via the budget reconciliation process before the end of the year. Lawmakers are working to reduce the total size of the $3.5 trillion package because of opposition to the topline spending figure by Sens. Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.). Manchin and Sinema, however, have yet to make a formal counter proposal on either the size of the package or what they want removed from the bill.

Democrats are expected to coalesce around a plan totaling approximately $2 trillion. House Speaker Nancy Pelosi (D-Calif.) indicated last week that the bill’s current drug pricing provisions are likely to be scaled back. Rep. Scott Peters (D-Calif.), one of the holdouts against the party’s signature Medicare drug pricing negotiation proposal, has confirmed that talks remain at an impasse. Peters supports an alternative proposal that would not impose an excise tax on drug manufacturers that do not comply with Medicare price negotiations and would only subject drugs whose patents have expired to the negotiation process.

The proposed Medicare expansion plan is also being considered for removal. With a cost of $350 billion, the addition of hearing, dental, and vision care to the Medicare benefit may be cut to trim the bill to a size acceptable to Senate holdouts. Manchin has expressed opposition to Medicare expansion unless the bill also addresses the program’s long-term solvency. Senate Budget Committee Chair Bernie Sanders (I-Vt.), however, has characterized the inclusion of Medicare expansion as non-negotiable, a sentiment echoed by the House Congressional Progressive Caucus.

Both the Senate and the House return from recess this week, working toward an unofficial end of the month deadline to reach an agreement on the reconciliation package. The current surface transportation funding extension expires on October 31 – when lawmakers hope to pass the $550 billion bipartisan infrastructure framework (BIF). Progressives, however, are standing by their demand that the BIF and reconciliation bills move forward in tandem.

DeGette, Upton Prepare to Introduce Cures 2.0 This Week

Representatives Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) are expected to officially introduce their Cures 2.0 legislation this week. They aim to pass the bill, a follow up to their 2016 landmark 21st Century Cures Act, before the end of the year. The bill will include provisions to increase telehealth flexibility, speed the development of cutting-edge treatments, improve clinical trial diversity, increase pandemic preparedness, and authorize the Advanced Research Projects Agency for Health (ARPA-H).

More than Half of Congress Urges House Leaders to Act on Impending Medicare Cuts

Nearly 200 national and state organizations supported a bipartisan effort in Congress led by Representatives Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN) to write House Speaker Nancy Pelosi and Minority Leader Kevin McCarthy urging action before the end of the year to mitigate Medicare provider cuts. 247 bipartisan Members of Congress co-signed the letter – more than half of the U.S. House of Representatives. The proposed 2022 Medicare Physician Fee Schedule (MPFS) would eliminate a one-time increase of 3.75% provided in 2021 in response to the COVID-19 public health emergency (PHE). The moratorium on the 2% Medicare sequester is also set to expire at the end of the year. Passage of the American Rescue Plan and pay-as-you-go requirements may necessitate additional payment cuts of up to 4% next year.

Lawmakers Push to Expand Global Access to Vaccine Technology

Abicameral group of 12 Democrats is urging the Biden administration to expand global COVID-19 vaccine access and manufacturing capabilities by sharing Moderna’s vaccine technology. The lawmakers argue that the company’s contract with the U.S. “may give the federal government legal authority to access and share the ingredient list and manufacturing instructions for Moderna’s COVID-19 vaccine.” The letter was signed by Senators Elizabeth Warren (D-Mass.), Jeff Merkley (D-Ore.), Tammy Baldwin (D-Wis.), Brian Schatz (D-Hawaii), Tina Smith (D-Minn.), and Sherrod Brown (D-Ohio) and Representatives Pramila Jayapal (D-Wash.), Jan Schakowsky (D-Ill.), Lloyd Doggett (D-Texas), Mark Pocan (D-Wis.), Maxine Waters (D-Calif.), and Raja Krishnamoorthi (D-Ill.).

Warren, Grassley Look to Speed Hearing Aid Rulemaking

Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) have sent a letter urging the Food and Drug Administration (FDA) to advance regulations related to over-the-counter (OTC) hearing aids. Warren and Grassley authored the Over-the- Counter Hearing Aid Act passed in 2017 to remove outdated regulations preventing hearing aids from being made available over the counter. The proposed rule to implement the law cleared Office of Management and Budget (OMB) review earlier this month. The letter states that such regulations are necessary to increase access to less expensive hearing devices. The lawmakers ask the agency to issue its proposed rule by November 6, in keeping with President Joe Biden’s Executive Order on Promoting Competition in the American Economy.

Budget Chair Yarmuth Announces Retirement

House Budget Committee Chair John Yarmuth (D-Ky.) has announced that he will not be seeking reelection. Yarmuth was first elected to the House of Representatives in 2006. He stated that he plans to spend his remaining time in office building upon the American Rescue Plan. Morgan McGarvey, Kentucky’s State Senate Democratic leader, has announced that he will run for Yarmuth’s seat representing the state’s 3rd congressional district.

FDA Panel Approves J&J, Moderna Boosters

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend authorizing a booster dose of the Johnson & Johnson COVID-19 vaccine last week. The Advisory Committee unanimously supported the authorization of a second J&J dose as soon as two months after the primary dose for individuals aged 18 and older. The recommendation will be considered by the FDA, which is expected to make a formal decision about a J&J booster in the coming days. The panel also voted to recommend a booster of the Moderna vaccine for individuals 65 and older along with younger individuals at high risk because of a medical condition or their job – the same population currently eligible for a Pfizer-BioNTech booster.

October 18, 2021: | Page 1 Page 2



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