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.


Senate to Vote on Abortion After Leaked Supreme Court Draft Opinion to Overturn Roe v. Wade

A draft Supreme Court opinion that would overturn the 1973 Roe v. Wade ruling was leaked to Politico last week. The draft majority opinion was written by Justice Samuel Alito and has preliminary support from four other Republican-appointed justices – Clarence Thomas, Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett. The decision was drafted in February, and it is unclear whether there have been changes made since. This marks the first time in modern Supreme Court history that a draft opinion was leaked before its publication, and Chief Justice John Roberts announced that he has asked the Supreme Court’s marshal to investigate the source of the leak. The court is scheduled to rule on the case by July, considering a Mississippi law that would ban abortion after 15 weeks of pregnancy except in medical emergencies or severe fetal abnormalities.

If the opinion is finalized, each state would determine if abortion is legal within its borders. Senate Majority Leader Chuck Schumer (D-N.Y.) and House Speaker Nancy Pelosi (D-Calif.) issued a joint statement characterizing the decision as one that “would go down as…one of the worst and most damaging decisions in modern history.” President Joe Biden urged lawmakers to enshrine Roe v. Wade into law, as the White House has limited executive authority on this topic, and Schumer stated that the Senate will hold a vote to codify abortion rights. Democrats, however, have not outlined a clear strategy to accomplish this. Certain Democrats have called on the leadership to end the chamber’s 60-vote threshold known as the filibuster for the purposes of protecting access to abortion, but certain supporters of abortion rights, including Sens. Kyrsten Sinema (D-Ariz.), Susan Collins (R-Maine), and Lisa Murkowski (R-Alaska), oppose changes to the 60-vote threshold. And it appears unlikely that Democrats have the votes necessary to pass an abortion bill even by a simple majority. Earlier this year, a House-passed bill to codify abortion rights was blocked on a 46-48 Senate vote with Sen. Joe Manchin (D-W.Va.) siding with Republicans. A Senate vote on abortion legislation is tentatively set for Wednesday.

Subcommittee to Markup UFA Package

Last week, the bipartisan leadership of the House Energy and Commerce Health Subcommittee released their legislative package to reauthorize the Food and Drug Administration (FDA) medical product user fee programs for the next five years. The Food and Drug Amendments of 2022 (H.R.7667) was officially introduced on Friday, and the Health Subcommittee is expected to mark up the package on Wednesday, followed by full committee consideration next week. The bill would reauthorize the Prescription Drug User Fee Act, the Generic Drug User Fee Act, the Biosimilar User Fee Act, and the Medical Device User Fee Act. It also contains provisions to improve the FDA’s accelerated approval pathway, increase clinical trial diversity, strengthen generic drug competition, and support the medical supply chain through FDA’s inspections programs. The bill would specifically permit the FDA to remove any drugs that obtain accelerated approval from the market but fail to complete required post-market studies or fail to show a clinical benefit. The FDA would also be given the authority to require that manufacturers submit diversity action plans to incorporate diverse populations in their clinical trials. Lawmakers aim to have the package sent to the President for his signature by August. Current user fee authorizations expire on September 30. The legislative text of the reauthorization bill can be found here and a section-bysection can be found here.

E&C Leadership Introduce Mental Health and Substance Use Disorder Legislation

The House Energy and Commerce Subcommittee on Health will consider a bipartisan package of mental health legislation aimed at addressing the rising number of suicides and overdose deaths in the U.S. this week. H.R. 766, the Restoring Hope for Mental Health and Well-Being Act of 2022 package includes provisions to

  • Establish a behavioral health crisis coordinating office within the Substance Abuse and Mental Health Services Administration (SAMHSA) and require the office to convene partners and provide technical assistance to improve access to crisis care annually;
  • Reauthorize the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances and the Youth and Family TREE programs;
  • Reauthorize the Garrett Lee Smith Memorial Act Suicide Prevention Program; the Maternal Mental Health Screening and Treatment Grant Program; grants to support American Indian and Alaska Native communities with mental health and substance use disorder prevention, treatment, and recovery services; and the Behavioral Health Workforce Education and Training Program;
  • Require self-funded, non-federal governmental plans to comply with mental health parity laws;
  • Improve the integration of evidence-based behavioral health care into primary care settings for the treatment of mental health and substance use disorders;
  • Reauthorize the Pediatric Mental Health Care Access Grant Program; and
  • Direct SAMHSA to assess flexibilities provided to opioid treatment programs during the COVID-19 pandemic and increase access to treatment services.
The legislative text is available here and a section-by-section can be found here.

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