November 30, 2020

Volume X, Number 335

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McDermottPlus Check-Up: November 20, 2020

This Week’s Dose

The Administration is working to finalize a series of healthcare-related rules, and Pfizer and Moderna released promising coronavirus (COVID-19) vaccine data. 

Congress

Prospects of Further COVID-19 Relief This Year Remain Dim. House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) sent a letter to Senate Majority Leader Mitch McConnell (R-KY) this week urging him to restart negotiations on a COVID-19 relief package, but the two sides appear no closer to an agreement. Senate Republicans remain committed to the $500 billion plan that Democrats have blocked, while Democratic leadership continues to call for a $2.2 trillion package. In addition to the price tag, disagreements persist on additional aid for state and local governments, liability protections for businesses and unemployment insurance. The Senate adjourned this week ahead of the Thanksgiving holiday, and the House will adjourn next week. Congress will return with just two weeks to reach a government funding deal, leaving a tight timeline if lawmakers wish to accomplish a COVID-19 deal before the end of the year. Also complicating the process is the January runoff election in Georgia that will determine party control of the Senate. Who holds the majority could have a significant impact on the negotiations if lawmakers wait until January to return to the table. 

Administration

HHS Finalizing Key Healthcare Regulations. The Department of Health and Human Services (HHS) published an interim final rule that allows Medicare to pay the “most favored nation” price for Part B drugs, and is expected to publish three other rules in the near term aimed at drug pricing and reforms to outdated fraud and abuse laws. It is likely the Trump Administration will publish the rules today as a final stamp on health policy before the incoming Biden Administration takes over (today is the final day to issue a rule with a 60-day implementation period for it to take effect before Inauguration Day), though the Biden Administration could still reverse the policies. The two drug pricing rules, the most favored nation rule and an expected rule to eliminate drug rebates to health plans and pharmacy benefit managers, represent significant changes and may be contested by stakeholders. Also in the pipeline are two rules that would add safe harbor protections under the federal anti-kickback statute to improve care coordination, and reform the physician self-referral law (Stark Law)

Other

Pfizer and Moderna to Seek FDA Approval for Vaccines. Pfizer applied for emergency use authorization from the Food and Drug Administration (FDA) today, and Moderna plans to do so in the coming weeks, after the pharmaceutical manufacturers each released data showing their COVID-19 vaccines were over 90% effective in late-stage trials. The promising results mean that at least one vaccine could be available to some Americans by the end of the year. Johnson and Johnson and AstraZeneca are also in late-stage trials of their vaccines and could deliver results this year. The Administration has announced that it will begin distributing a vaccine 24 hours after FDA approval, although a vaccine distribution plan has not yet been finalized.  

Quick Hits

  • Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) sent a letter urging the FDA to issue overdue hearing aid regulations required by the Over-the-Counter Hearing Aid Act of 2017.

  • HHS released a request for information on Use of Technology for Chronic Disease Management for Aging Underserved Populations. Comments are due December 22, 2020.

  • FDA issued the first emergency use authorization for an at-home COVID-19 test.

  • FDA announced that it will publicly post its reviews of the scientific data and information supporting the issuance, revision or revocation of emergency use authorization for all drug and biological products, including COVID-19 vaccines.

  • The Center for Medicaid and Medicaid Innovation announced the first cohort of Primary Care First model participants. 

© 2020 McDermott Will & EmeryNational Law Review, Volume X, Number 325
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About this Author

Mara McDermott, McDermott Law Firm, Washington DC, HealthCare Law Executive

Mara is an accomplished health care executive with a deep understanding of federal health care law and policy, including delivery system reform, physician payment and Medicare payment models.

Most recently Mara served as the senior vice president of federal affairs at America’s Physician Groups (formerly the California Association of Physician Groups, CAPG), a professional association representing medical groups and independent practice associations practicing in capitated, coordinated care models. As head of the Washington, DC, office, Mara...

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Kristen O’Brien Healthcare Executive McDermott Consulting
Execusitve

Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts.

Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance.

Kristen recently served as Principal of the Health Industry Policy and Regulatory Practice Group at a law and lobbying...

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Rachel Stauffer, McDermott Law Firm, Washington DC, Health Policy Consultant

Rachel is a highly experienced government relations and legislative affairs strategist and advocate who is informed by a solid foundation of health policy knowledge.

Prior to joining McDermottPlus, Rachel served as the director of policy and government relations for a health IT contractor, where she developed the company’s first strategic plan for government relations. She grew the company’s profile on Capitol Hill by establishing new relationships with key leaders in the federal, state and military health program space. As a result, the company...

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Government Relations Professional and Registered Lobbyist

Emma is a government relations professional and registered lobbyist who supports clients on a range of health policy issues.

As a policy consultant, Emma lobbies and consults with legislators and congressional staff on issues relating to Medicare, Medicaid payment and regulation, and the 340B Drug Pricing Program. She provides analysis of the federal political and regulatory environment, and routinely monitors pertinent Hill activities including congressional hearings, bill markups and think tank events.

Emma graduated...

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