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.


VP Harris and Others Test Positive for COVID-19

Vice President Kamala Harris has tested positive for COVID-19. While she was not experiencing symptoms, after consulting with her physicians, Harris was prescribed Pfizer Inc.’s Paxlovid COVID-19 therapy. In accordance with the administration’s test-to-treat initiative, the White House recently moved to permit all pharmacies to order the COVID-19 therapy pill to increase access to the treatment as the supply of the drug increases. Harris is not considered to have been in close contact with President Joe Biden. She is the highest-ranking administration official to report being infected. Sens. Ron Wyden (D-Ore.) and Chris Murphy (D-Conn.) also reported that they had tested positive for coronavirus last week. These recent cases impacted confirmation votes in the evenly divided Senate where Harris serves as the tie-breaking president. The chamber was expected to vote on Federal Reserve and Federal Trade Commission nominations, but the votes were postponed due to the absence of the COVID positive Democrats. It was also recently reported that Sen. Michael Bennet (D-Colo.), Rep. Maxine Waters (D-Calif.) and White House Communications Director Kate Bedingfield had tested positive for COVID-19. While Bedingfield had a socially distanced meeting with President Biden earlier in the week, she was not considered a close contact to the President as defined by the Centers for Disease Control and Prevention.

Democrats Seek to Tie COVID Relief to Ukraine Aid

Lawmakers continue to negotiate a COVID-19 response package containing an additional $10 billion in funding for testing, treatment, and vaccines. Senate Democrats are pushing to combine the COVID bill with a $33 billion aid package for Ukraine. How leadership will proceed remains unclear, given disagreements over tying Title 42 restrictions to the package. The Biden administration recently announced that it will rescind the policy, which allows the White House to restrict immigration based on public health concerns, by May 23. That decision has been challenged in court, with a federal judge in Louisiana issuing a temporary restraining order against the phasing out of Title 42. Only the Senate will be in session this week. The House of Representatives stands in a one-week district work period and is scheduled to return on May 10.

Manchin Seeks to Revive Reconciliation Bill to Address Inflation

After a meeting with Senate Majority Leader Chuck Schumer (D-N.Y.) last week, Sen. Joe Manchin (D-W.Va.) stated that he is open to using the budget reconciliation process to pass legislation to address soaring inflation, and that the bill should also include proposals to lower the cost of prescription drugs. Manchin was the sole Democratic holdout responsible for stalling the $2 trillion Build Back Better reconciliation package last year. While Schumer characterized his meeting with Manchin as “preliminary and good” and stated that conversations will continue, many are still skeptical that an agreement can be reached on a reconciliation bill. Although Manchin has expressed support for tax changes and deficit reduction measures, Sen. Kyrsten Sinema (D-Ariz.) stands strongly opposed to raising the corporate tax rate. Other Democrats, including Sens. Amy Klobuchar (D-Minn.) and Ron Wyden (D-Ore.), have told reporters in recent weeks that they are nearing an agreement on a domestic policy package that includes climate change measures and provisions to reduce inflation and drug prices, but there is currently no timetable for passage.

Lawmakers Push to Prioritize Medicaid Expansion

Sen. Raphael Warnock (D-Ga.) and Rep. Carolyn Bourdeaux (D-Ga.) spearheaded a letter to congressional leadership last week about the importance of including Medicaid expansion in any future reconciliation package. The lawmakers assert that the Medicaid gap “results in preventable suffering, death, and tragedy, and the costs of care when it’s too late are inevitably born by the public...It is bad public health policy, and it is bad fiscal policy.” The letter was signed by 29 other lawmakers. Twelve states in the nation have yet to expand their Medicaid programs.

Healthy Future Task Force Releases Set of Treatment Recommendations

The Treatment Subcommittee of the GOP’s Healthy Future Task Force has released its key findings and policy solutions to promote new life-saving cures and lower drug costs. The Healthy Future Task Force was created by House Minority Leader Kevin McCarthy (R-Calif.) in June 2021 to examine strategies to modernize the American health care system and lower costs, keep Americans healthy, develop better therapies, and cures, and provide Americans with more health care choices. The Treatment Subcommittee’s plan recommends:

  • Passage of H.R. 19, the Lower Costs, More Cures Act;
  • Building off bipartisan proposals that allow for innovations in paying for curative therapies;
  • Offering incentives for health plans to share drug discounts with patients directly at the pharmacy counter;
  • Speeding up the Food and Drug Administration approval process to bring more treatments to patients quickly;
  • Expanding and speeding up Medicare coverage for breakthrough drugs and devices;
  • Giving seniors access to new, innovative blood tests to diagnose cancers earlier;
  • Banning the use of quality-adjusted life years from all coverage and payment decisions;
  • Making clinical trials more widely available;
  • Incentivizing domestic medical manufacturing of therapies and therapeutics to prepare for the next pandemic;
  • Promoting sufficient supply of testing and personal protective equipment; and
  • Ensuring secure access to critical ingredients for medicine.

Burr Stresses Need for FDA Accountability in UFA Hearing

The Senate Health, Education, Labor, and Pension Committee held its second hearing on the latest reauthorization of the user fee agreements negotiated between the Food and Drug Administration (FDA) and medical industry. During the hearing last week, panel members heard from the heads of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. Ranking Member Richard Burr (R-N.C.) stressed the need for the agency to be held accountable for meeting the terms of its commitments in the user fee programs. Burr noted that the FDA missed 12 out of 14 user fee goals in the new drug program related to product development meetings with sponsors, only reviewed 50% of biosimilars applications on time, and was three months late in finalizing a medical device user fee agreement.

In related news, Senate Majority Whip Dick Durbin (D-Ill.) is pushing to include his bipartisan Dietary Supplement Listing Act (S. 4090) in the must-pass user fee legislation. The bill aims to improve dietary supplement oversight to better identify potentially harmful ingredients and health impacts. The legislation would require manufacturers to list their products with the FDA and report information on ingredients, directions for use, safety warnings, and claims about health and function. Manufacturers and distributors of the 50,000 to 80,000 dietary supplements available in the U.S. are not currently required to register their products and ingredients with the FDA. In its FY 2023 budget request, the agency proposed requiring an annual listing of supplement products and asked Congress to clarify its authority over dietary supplements. The user fee agreements must be reauthorized before the current agreements expire on September 30.

May 2, 2022: | Page 1 Page 2



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