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.


Drafting of Gun Violence Bill Continues into Weekend

Senate Minority Leader Mitch McConnell (R-Ky.) stated that he is comfortable with the bipartisan gun violence proposal reached by Senate negotiators and that he will support the final legislation if it is in line with the details of the previously released framework. The tentative deal includes measures to make changes to background checks and funding for state red-flag laws, mental health, and school security. Lawmakers have yet to release legislative text or an estimate of the total cost of the bill. Sen. Chris Murphy (D-Conn.), one of the lead negotiators on the package, stated that a vote on the bill could come as early as this week. Sen. John Cornyn (R-Texas), the head GOP negotiator, noted however that there are still unresolved issues surrounding the red-flag law provisions and language to close the ‘boyfriend loophole’. The Senate is scheduled to adjourn late this week for a two-week July 4 recess.

House to Consider ARPA-H, Mental Health Legislation This Week

The House of Representatives plans to consider H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022 on the floor this week. The bill would terminate the special waiver health care providers need to prescribe substance use disorder treatment medication as well as provide more funding for mental health care services and people suffering from drug addiction. The House is also scheduled to consider H.R. 5585, the Advanced Research Projects Agency–Health Act, which would establish the President’s proposed new agency to speed the development of medical breakthroughs. The chamber also plans to vote on H.R. 5407, the Enhancing Mental Health and Suicide Prevention Through Campus Planning Act under suspension of the rules.

Senate Passes Bill to Support Veterans Exposed to Burn Pits

The Senate voted 84-14 to pass a substitute amendment to the House-passed Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics (PACT) Act (H.R. 3967). The legislation would support veterans who have been exposed to toxic substances during military deployments. The bill, introduced by House Veterans Affairs Committee Chair Mark Takano (D-Calif.), will be considered by the House Rules Committee on Tuesday. The bill would increase access to medical care and disability benefits for veterans by establishing presumptions of service connection related to toxic exposure, and by adding 23 burn pit and toxic exposure-related conditions to the VA’s list of service presumptions. It would also mandate more federal research on toxic burn pits. The package would cost $278.5 billion over the next decade. In response to Republican concerns about the total cost of the package, the Senate’s substitute amendment decreased the cost of the bill from $322 billion by reducing the number of veterans eligible for disability compensation and by delaying the bill’s effective date. The legislation is expected to be sent to the President’s desk after a final vote is held in the House of Representatives this week.

HELP Advances User Fee Package

Last week, the Senate Health, Education, Labor, and Pensions (HELP) Committee advanced the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348) reauthorizing medical product user fees at the Food and Drug Administration (FDA) for another five years. The package was approved in a 13-9 vote, with Ranking Member Richard Burr (R-N.C.) joining eight other Republicans in voting against the measure. Ranking Member Burr expressed concern that several amendments adopted during the markup “would kill innovation, placing the entire bill in jeopardy”, likely in response to two amendments adopted related to generic drugs. Additional amendments adopted during the committee markup included provisions to prevent future infant formula shortages, increase transparency around accelerated approval determinations, and allow the FDA to approve predetermined change plans for post-market changes to a medical device during its premarket submission phase. The House already passed its version of the bill (H.R. 7667) on the floor in a 392-28 suspension vote. The current user fee agreements expire at the end of September. HELP Committee Chair Patty Murray (D-Wash.) stated that she would work with Majority Leader Chuck Schumer (D-N.Y.) on the timing for Senate floor consideration of the reauthorization. House Energy and Commerce Chair Frank Pallone (D-N.J.) has expressed confidence that the two chambers will be able to reconcile the differences between the bills without much difficulty.

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