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.


Robert Califf Nominated as FDA Commissioner

President Joe Biden has selected Robert Califf to serve as commissioner of the Food and Drug Administration (FDA). Califf is a cardiologist and a senior advisor at the Duke Clinical Research Institute. He most recently worked for the life sciences research group Verily and Google Health. He previously served as FDA Commissioner during the last year of President Obama’s term (February 2016-January 2017). Janet Woodcock, former Director of the Center for Drug Evaluation and Research (CDER), has been serving as acting commissioner since January, and the White House faced a legal deadline of mid-November to nominate a permanent commissioner or choose another acting commissioner.

Sens. Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) have expressed opposition to Califf ’s nomination given his ties to the pharmaceutical industry. The lawmakers were joined by Sen. Ed Markey (D-Mass.) in voting against his confirmation in 2016. Markey has said that he is still reviewing Califf ’s record from his earlier time spent at the head of the FDA. Califf was previously confirmed by the Senate in an 89-4 vote. More than sixty of the senators who voted for his confirmation continue to serve in the Senate today. The President has urged the Senate to quickly confirm Califf given the ongoing COVID-19 pandemic.

House Awaits CBO Score of Reconciliation Package

Congress returns from recess this week hoping to make progress on the $1.75 trillion Build Back Better reconciliation package along with other must- pass items before the end of the year. The House of Representatives delayed a vote on the tax and social spending legislation in response to several requests from moderate Democrats to wait for the official Congressional Budget Office (CBO) cost estimate of the bill. CBO has said that it will provide a score for the legislation “as soon as practicable” and has been its score piecemeal through the past week. The reconciliation package is still expected to be modified when it reaches the Senate, both to pass the Senate’s rules for the reconciliation process and to gain the necessary support of every Senate Democrat. Sen. Joe Manchin (D-W.Va.) has already expressed reservations about some of the key provisions of the bill and has called for slowing the pace of negotiations. Democratic leadership have expressed their hope of passing the reconciliation bill before Thanksgiving. Congress also faces several deadlines the week following its Thanksgiving recess, including the expiration of the current continuing resolution (CR) funding the federal government on December 3 and the date by which Congress must formally raise the nation’s debt limit or risk a default. Negotiations on an omnibus appropriations package have stalled, given a disagreement between Democrats and Republicans over topline defense and non-defense spending figures.

Doc Caucus Expresses Concern Re: Surprise Billing Regulation

The GOP Doctors Caucus is urging the Biden administration to revise its proposed regulation to implement the No Surprises Act. The lawmakers argue that the interim final rule (IFR) released on September 30 detailing the parameters of the independent dispute resolution (IDR) process “does not reflect legislation that could have passed Congress or the law as written.” The letter states that major revisions are needed to align with the statute and congressional intent, specifying that “the final law explicitly required an independent entity to consider a broad range of criteria and weigh all relevant factors equally when deciding appropriate payments for out-of-network services.”

Investigation Launched Into Unregulated, Synthetic Nicotine

House Economic and Consumer Policy Subcommittee Chair Raja Krishnamoorthi has sent letters to Next Generation Labs LLC and Puff Bar regarding their manufacturing and sale of synthetic nicotine. Krishnamoorthi asserts that some companies that have been banned by the Food and Drug Administration (FDA) from selling their products plan to switch to the production of synthetic nicotine to avoid regulation. He asks the firms to supply documents and answer a series of questions by November 22.

Upcoming Congressional Hearings and Markups

House Oversight and Reform Committee hearing “Cracking Down on Ransomware: Strategies for Disrupting Criminal Hackers and Building Resilience Against Cyber Threats;” 10:00 a.m.; November 16

House Oversight and Reform Subcommittee on National Security hearing “Invisible Wounds: Preventing Suicide in Our Nation’s Military and Veteran Communities;” 10:00 a.m.; November 17

House Homeland Security Subcommittee on Cybersecurity, Infrastructure Protection & Innovation and Intelligence & Counterterrorism hearing “A Whole-of-Government Approach to Combatting Ransomware: Examining DHS’s Role;” 10:00 a.m.; November 17

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing “U.S. Role in Global COVID-19 Vaccine Equity;” 10:30 a.m.; November 17

House Transportation and Infrastructure Committee hearing “Industry and Labor Perspectives: A Further Look at North American Supply Chain Challenges;” 10:30 a.m.; November 17

House Oversight and Reform Select Subcommittee on the Coronavirus Crisis hearing “Combating Coronavirus Cons and the Monetization of Misinformation;” 2:00 p.m.; November 17

House Veterans’ Affairs Subcommittee on Oversight and Investigations hearing “Modernizing VA’s Medical Supply Chain: Progress Made?” 10:00 a.m.; November 18

Senate Judiciary Committee markup of the Better Cybercrime Metrics Act (S. 2629); 9:00 a.m.; November 18

November 15, 2021: | Page 1 Page 2



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