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.


Government Funding Extended through March 11

The Senate cleared a three-week stop gap spending bill (H.R. 6617) on a 65- 27 vote last week, extending government funding through March 11 and giving lawmakers additional time to complete work on a full year government funding package. The continuing resolution (CR) had been previously passed by the House of Representatives and was signed by President Joe Biden on Friday, averting a government shutdown otherwise set to begin February 19. The latest CR extends government funding at FY 2021 levels with very few exceptions. It also extends the temporary designation of fentanyl as a Schedule I controlled substance through March 11. Appropriators have reached an agreement on the framework for an approximately $1.5 trillion full-year omnibus spending bill to fund the federal government for the remainder of the fiscal year. Federal agencies have been operating on temporary CRs since the fiscal year began on October 1, 2021. The appropriations subcommittees charged with drafting the 12 annual appropriations bills have each been given tentative spending limits to work within. Lawmakers are still negotiating whether to attach supplemental spending measures to the omnibus legislation. White House officials have begun urging appropriators to include $30 billion in new spending to combat the COVID-19 pandemic and procure treatments, pediatric vaccines, and variant-specific vaccines. Sen. John Kennedy (R-La.) is also pushing to include disaster relief for Louisiana, Kentucky, New York, and California in the main government funding package. Senate Appropriations Chairman Patrick Leahy (D-Vt.), however, has expressed reservations about attaching any supplementing spending measures to the omnibus bill. Both chambers stand in recess for the Presidents’ Day holiday until the week of February 28.

Dr. Robert Califf Confirmed as FDA Commissioner

The Senate confirmed President Joe Biden’s nominee to lead the Food and Drug Administration (FDA) last week by a vote of 50-46. Republican Sens. Roy Blunt (Mo.), Richard Burr (N.C.), Susan Collins (Maine), Lisa Murkowski (Alaska), Mitt Romney (Utah), and Pat Toomey (Pa.) voted in favor of Dr. Robert Califf, a cardiologist and medical researcher, while Sens. Bernie Sanders (I-Vt.) and Democratic Sens. Richard Blumenthal (Conn.), Maggie Hassan (N.H.), Ed Markey (Mass.), and Joe Manchin (W.Va.) voted in opposition. Califf received far less support than when he was first confirmed as FDA Commissioner during the Obama administration by an 89-4 vote. Throughout his most recent confirmation process Califf faced criticisms regarding his ties to industry, ability to respond to the opioid crisis, and the regulation of abortion drugs. Califf gained the support of several lawmakers by agreeing to an enhanced ethics pledge and to not work for industry for four years after leaving the FDA.

Dr. Califf was officially sworn in on Thursday afternoon. The FDA has been without a confirmed leader since President Biden took office, with acting commissioner Janet Woodcock serving at the helm of the agency. Woodcock will remain at the FDA as principal deputy commissioner. “The FDA is one of our nation’s most critical public health agencies and having a commissioner with Dr. Califf ’s experience and expertise will ensure we are well positioned to combat COVID-19, the opioid crisis, and many other public health challenges,” U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra said in his statement welcoming Dr. Califf back to the FDA and thanking Dr. Woodcock for her leadership. Califf has committed to improving the agency’s accelerated approval pathway, which has been scrutinized in recent months following the approval of Biogen’s Aduhelm, and to launching a comprehensive review of opioid painkillers. The agency is also working to issue new tobacco and e-cigarette regulations.

Senate Passes Several Health Measures and Previews Agenda for Coming Weeks

The Senate confirmed Christi A. Grimm as inspector general of the U.S. Department of Health and Human Services (HHS) last week. The chamber also passed the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 1667) and the John Lewis NIMHD Research Endowment Revitalization Act of 2021 (H.R. 189). Both bills will be sent to the President’s desk for his signature. Senate Majority Leader Chuck Schumer (D-N.Y.) has previewed his priorities for the Senate in the coming weeks, taking procedural steps to set up a vote on the Women’s Health Protection Act of 2021 (H.R. 3755) when the chamber returns the week of February 28. The House-passed legislation would codify Roe v. Wade and is expected to be blocked by Republicans. Other agenda items highlighted by Schumer as priorities include legislation from Sen. Raphael Warnock (D-Ga.) to address the cost of insulin, modeled after the Build Back Better provision to restrict what insured patients pay for insulin to $35 a month, as well as addressing the differences between the House and Senate passed China competition legislation.

Warren, King, Doggett Urge WH to Use March-in-Rights on Pfizer’s Xtandi

Sen. Elizabeth Warren (D-Mass.), Sen. Angus King (I-Maine), and Rep. Lloyd Doggett (D-Texas) have sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra urging him to use existing executive authorities to lower the price of Pfizer’s prostate cancer drug Xtandi. The march-in-rights established by the Bayh-Dole Act would allow the federal government to license a company’s patents to outside manufacturers if the government helped fund the product’s research and development. “Exercising the government’s march-in rights for Xtandi will dramatically lower the price of this life-saving drug for millions of Americans,” the lawmakers write. The U.S. government has never before exercised march-in-rights for a manufacturer’s drug patents.

New COVID Protocols for SOTU as GOP Pushes to Reopen Capitol Complex

All members of Congress will be permitted to attend President Joe Biden’s State of the Union address on March 1, according to a new memo from the Sergeant at Arms. No guests will be allowed to attend. Those in attendance must adhere to COVID-19 health guidelines, including the use of masks, or risk being removed from the event and fined. According to Sens. Chuck Schumer (D-N.Y.) and Dick Durbin (D-Ill.), the President plans to discuss inflation and the economy during his speech.

Sen. Amy Klobuchar (D-Minn.) blocked a resolution introduced by more than half of Senate Republicans to fully reopen the Capitol complex and return to pre-COVID-19 visitor policies. The Capitol has been largely closed to the public since March 2020, with no timeline for reopening. The congressional sergeants-at-arms, in consultation with the Capitol’s attending physician, are responsible for any decisions on changes to the current restrictions.

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