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 Consider Gun Control Legislation

President Joe Biden is demanding that Congress pass new gun control measures following the killing of 19 children and two teachers during a mass shooting at an elementary school in Uvalde, Texas last week. Senate Majority Leader Chuck Schumer (D-N.Y.) has moved to put two gun background check bills on the Senate calendar but stated that he is not optimistic about their prospects given continued Republican opposition to any firearm restrictions. While most Republicans, including Minority Leader Mitch McConnell (R-Ky.), are not inclined to examine legislative solutions to gun violence, a few GOP senators appeared more open to exploring areas of possible compromise. Sens. Roy Blunt (R-Mo.), Lindsey Graham (R-S.C.), Susan Collins (R-Maine), and Mitt Romney (R-Utah) have highlighted the potential of red flag proposals and efforts to address mental health. Majority Whip Dick Durbin (D-Ill.) confirmed that the chamber will debate and vote on legislation mandating background checks for gun sales following the Memorial Day recess, but there appears little chance for movement in the evenly divided Senate where at least 10 Republican votes would be required to avoid a filibuster. Sen. Joe Manchin (D-W.Va.) has also confirmed that he remains opposed to changing the Senate’s filibuster rules to pass gun restrictions by a simple majority.

COVID-19 Aid Back to Negotiating Table

The senators working to draft the latest package of COVID-19 response funding will return to the negotiating table amidst reports that offsets for the $10 billion agreed to in April have been spent given the delay in taking up the bill. According to a Republican aide, between $2 and $4 billion in funds previously designated as COVID-19 pay-fors have already been spent. Sen. Roy Blunt (R-Mo.), one of the Republicans working to negotiate an agreement, also stated that the overall size of the package may change as the total need has increased over the past two months. The deal has been stalled amidst a disagreement over the administration’s decision to end the Title 42 immigration policy.

Senate FDA Safety and Landmark Advancements Act (FDASLA) Introduced

Bipartisan leadership of the Senate Health, Education, Labor, and Pensions (HELP) Committee introduced legislation last week to reauthorize the Food and Drug Administration’s (FDA) medical product user fee programs for another five years. The introduced bill contains several additions to the discussion draft released earlier this month, including changes to the accelerated approval process that would give the FDA the authority to remove from the market any products that obtained accelerated approval but fail to show a clinical benefit. The FDA would be allowed to require that post-market studies begin before approval is granted. The Senate’s bill also adds a proposal to allow the FDA to require that opioids are dispensed to patients with safe, in-home disposal systems, based on S. 2628. HELP Committee Ranking Member Richard Burr (R-N.C.) stated that the current infant formula shortages and the agency’s response to the crisis may slow the reauthorization of the user fee programs. He said he planned to consider “whether now is the right time to move forward on our user fee negotiations…It may be that finding all the answers to this question is increasingly more important than expediting something that really doesn’t have a finality until the end of this year.” The HELP Committee is currently targeting June 8 for the markup of the must-pass bill. Congress must act on the legislation before the current user fee agreements expire on September 30. The House Energy and Commerce Committee reported out its user fee package on May 18.

Burn Pitt Bill to Get Early June Vote

Senate Majority Leader Chuck Schumer (D-N.Y.) stated that he will bring legislation to support veterans who have been exposed to toxic substances during military deployments to the floor in early June. The expansive bipartisan agreement is based on the Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics (PACT) Act (H.R. 3967), introduced by House Veterans Affairs Committee Chair Mark Takano (D-Calif.). 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.

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