COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

In Tuesday's Report: Panel discusses the impact of the U.S. election on COVID-19 response, Trump administration issues IFR implementing “Most Favored Nation” model, AstraZeneca announces vaccine efficacy, Pfizer applies for FDA EUA, and Biden supports larger COVID-19 relief legislation.

Publisher's note: Due to the Thanksgiving holiday in the United States, we will not be publishing on Thursday, 26 November, and on our next bi-weekly newsletter “COVID-19 resources for life sciences and health care companies” will be distributed on 4 December 2020. Happy holidays!

Tuesday, 24 November 2020

  • U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug pricing reform efforts. These actions will create opportunities for companies in the life sciences and health care space, who may find more ways to partner with the government under the Biden administration. Read more here: Election 2020 Snapshot: Helping our life sciences and health care clients make sense of the U.S. election results. Our team recently explored these issues in greater detail in a panel discussion, which is now available to view on-demand, and the presentation materials are available for download here. (Authored by Alice Valder Curran)

  • The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On Monday afternoon, President-elect Joe Biden was informed that the Trump administration would begin the formal transition process, according to a letter from Administrator Emily Murphy. President-elect Biden's transition team pushed back on a report that he would favor a smaller coronavirus relief deal even if it meant ceding on Democratic demands. A transition spokesperson disputed the report, saying Biden “fully supports” the large deal congressional Democrats have passed and continue to push. AstraZeneca said Monday that clinical trials showed its COVID-19 vaccine has an average efficacy of 70 percent and some trials showing 90 percent efficacy. Treasury Secretary Steven Mnuchin announced 19 Nov. that he will not extend the Federal Reserve’s emergency lending programs created under the CARES Act. Health and Human Service Secretary Alex Azar announced that Pfizer/BioNTech filed for emergency Food and Drug Administration (FDA) approval for its COVID-19 vaccine on Friday. Read about these and other updates here: 19 Nov.; 20 Nov.; 23 Nov. (Authored by Ivan Zapien)

  • Last week, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test Medicare reimbursement based on international reference prices. Comments are due no later than January 26, 2021. Initially, the Model will focus on approximately 50 Medicare Part B drugs or biologicals (collectively, drugs) with the highest spending during the preceding year, with additional drugs potentially added in subsequent years without removing a commensurate number of drugs. Part B payment will be made for such drugs based on an “MFN Price” that reflects the lowest per capita Gross Domestic Product (GDP) adjusted price of any non-US member country of the Organisation for Economic Co-Operation and Development (OCED) with a GDP per capita of at least 60 percent of the United States. However, drugs subject to an EUA or approved for treating COVID-19 are categorically excluded from the MFN Model’s drug list. Read more here. (Authored by Stuart Langbein and Beth Halpern)

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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