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.


Califf Confirmation Expected to Slip to January

Senate confirmation of Robert Califf, the President’s nominee to serve as the next Commissioner of Food and Drugs, will likely be pushed to January due to a delay in submitting the necessary paperwork. Califf ’s confirmation hearing before the Senate Health, Education, Labor, and Pensions (HELP) Committee is now expected to take place in mid-December, at the earliest. HELP Committee Chair Patty Murray (D-Wash.) has already endorsed the nominee. Lawmakers’ current focus on government funding, the debt limit, and the Build Back Better reconciliation package make a full floor vote on Califf ’s confirmation before the end of the year increasingly unlikely.

Lawmakers Push for Quick MCIT Replacement

A bipartisan group of more than 60 lawmakers are urging the Centers for Medicare and Medicaid Services (CMS) to quickly propose a replacement for the recently withdrawn Medicare Coverage of Innovative Technology (MCIT) regulation. The group warns that a “permanent withdrawal of the MCIT rule may delay future innovative medical devices and diagnostic tools” and further delay patient access to breakthrough devices. The letter encourages CMS to issue a separate rulemaking to address the MCIT implementation issues raised by the agency while providing for immediate or near-immediate temporary coverage of breakthrough devices.

Dems Urge Treasury to Support International COVID Response

A group of Democrats in the House of Representatives have sent a letter to Treasury Secretary Janet Yellen asking her to approve the issuance of additional Special Drawing Rights (SDRs) by the International Monetary Fund (IMF) to support developing countries in their response to the COVID-19 pandemic. “By further boosting global demand for U.S. exports, assisting in a worldwide economic recovery, easing major spikes in hunger, poverty and disease, and providing financial resources for mass vaccinations abroad at no cost to the United States, a new issuance of 1.5 trillion SDRs remains a vital tool for this administration’s efforts to crush the coronavirus and build back better, both at home and abroad,” the lawmakers states. The letter was signed by Reps. Pramila Jayapal (D-Wash.), Chuy Garcia (D-Ill.), Judy Chu (D-Calif.), Raul Ruiz (D-Calif.), and Joyce Beatty (D-Ohio).

COVID Panel Seeks Interview With Former FDA Commissioner Hahn

House Select Subcommittee on the Coronavirus Chair Jim Clyburn (D-S.C.) is asking former Commissioner of Food and Drugs Stephen Hahn for documents related to his role in the response to the coronavirus pandemic. Clyburn is seeking to understand Trump administration officials’ efforts to “interfere with FDA’s authorization of coronavirus vaccine” and any pressure directed by the former President on the agency. The letter specifically discusses the White House’s push to authorize hydroxychloroquine and convalescent plasma therapy, as well as its support for a herd immunity strategy in response to the coronavirus pandemic.

November 29, 2021: | Page 1 Page 2



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