23 June 2025 This Week in Health Policy for June 23 This week, the House and Senate will be in session. The Senate could begin consideration of its version of the reconciliation bill and committees will hold hearings to continue nominations and appropriations. House Appropriations Committee will hold a hearing to finish the markup of the FY 2026 Food and Drug Administration Bill
House Energy and Commerce Health Subcommittee hearing on "FY 2026 Department of Health and Human Services Budget."
Senate Health, Education, Labor & Pensions Committee will hold a hearing on the "Nomination of Susan Monarez to be Director of the Centers for Disease Control and Prevention, Department of Health and Human Services."
House Ways and Means Health Subcommittee will hold a hearing on "Health at Your Fingertips: Harnessing the Power of Digital Health Data."
Senate Health, Education, Labor & Pensions Committee will hold a hearing on the nominations of several Department of Labor nominees.
House Select Committee on China will hold a hearing on "Algorithms and Authoritarians: Why US AI Must Lead."
Reconciliation update. On Monday (June 16), the Senate Finance Committee released its portion of the budget reconciliation bill. The legislative text includes health care provisions impacting Medicaid, the Affordable Care Act, and more. While the bill includes some of the same provisions as the House-passed bill, it also includes some significant changes to state Medicaid provider taxes and other provisions and completely removes provisions related to health savings accounts and a provision to reform Medicare physician payment, delay disproportionate share hospital payment reductions, and codifying the Trump Administration's proposed ACA program integrity rule. For a list of the health care provisions in the Senate bill, see the attached alert: WCEY Alert - Summary of Health Care Provisions in House and Senate Reconciliation Bills On Friday (June 20), Senate Minority Leader Chuck Schumer (D-NJ) and Sens. Amy Klobuchar (D-MN), Ron Wyden (D-OR) and Jeff Merkley (D-OR) — the ranking members of the Agriculture, Finance and Budget Committees, respectively — sent a letter Friday to Majority Leader John Thune asking that he negotiate with Democrats on health care and food assistance programs rather than forging ahead with changes in a partisan package. While the letter is unlikely to impact negotiations some Senate Republicans also are pushing back against the Senate's changes to the Medicaid provider tax provision. Some provisions also could be removed through the parliamentarian review, also known as the "Byrd Bath." The Senate Finance Committee is expected to begin discussions with the parliamentarian this weekend. Senate Majority Leader John Thune (R-SD) said he's still hoping to send the bill to President Trump's desk by the GOP's self-imposed July 4 deadline. However, that may more realistically be the date by which the bill could pass the Senate, but significant legislative hurdles remain. Whether a Senate bill can be taken up and passed by the House, as-is, remains unclear. House Energy and Commerce Democrats raise questions about MAHA report. On Tuesday (June 17), Reps. Frank Pallone (D-NJ), Diana DeGette (D-CO) and Yvette Clarke (D-NY) sent a letter to HHS Secretary Robert F. Kennedy Jr. asking questions about the validity of information in the Make America Health Again report on children's health. Nominations. On Tuesday (June 17), the Senate voted 57-40 to confirm Gary Andres, a former House Budget Committee staffer, as HHS Assistant Secretary for Legislation. CMS issues final ACA program integrity rule. On Friday (June 20), CMS finalized the Affordable Care Act program integrity rule, which repeals the monthly special enrollment period for individuals with household incomes at or below 150% of FPL and increases income and eligibility verifications for enrollees. The rule also creates a tax credit penalty of $5 for those who are auto re-enrolled in fully subsidized plans without eligibility verification. Several of the provisions, including some of the income verification provisions will sunset in 2026. Click here for a fact sheet. NIH suspends funding for gain-of-function research. On Wednesday (June 18), the National Institutes of Health issued a notice immediately terminating funding and other support for gain-of-function research conducted by "foreign entities in countries of concern or foreign countries where there is no adequate oversight." The agency also will suspend funding and additional support for all other gain-of-function research and has asked researchers who receive NIH funds to identify other projects not yet identified by the agency that fit the category by June 30. The notice was issued in response to President Trump's May 5 executive order on Improving the Safety and Security of Biological Research and NIH said it will not be accepting any exceptions or suspensions. FDA to review all new clinical trials involving human cells conducted in 'hostile' countries. On Wednesday (June 18), the FDA announced it would immediately review new clinical trials that "involve sending American citizens' living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent." FDA said the efforts are intended to address an exception included in the Biden Administration's final rule on bulk sensitive data and address directives included in President Trump's EO on Improving the Safety and Security of Biological Research. Prasad tapped to oversee FDA regulatory and scientific policies. On Wednesday (June 18), FDA Commissioner Marty Makary announced that biologics chief Vinay Prasad has also been named Chief Medical and Scientific Officer and will steer regulatory and scientific policies across the entire agency. FDA unveils new expedited review voucher program. On Tuesday (June 17), the FDA announced a new voucher program, the Commissioner's National Priority Review Voucher, that will allow drug sponsors who "support US national interests" to qualify for a pilot program intended shorten the review process from 10 or 12 months to one or two months. Click here for an FAQ with more details on the program. President Trump says pharma tariffs 'coming soon.' On Tuesday (June 17), President Trump during a return trip from the G7 meeting in Canada reiterated that said pharmaceutical tariffs were coming very soon. CMS releases MA RADV audit methodology for PY 2019. CMS released the methodology for payment year (PY) 2019 risk adjustment data validation (RADV) audits, which includes additional information about the criteria used to select enrollees for audit, submission instructions, and details on how CMS will calculate extrapolated overpayment amounts. CMS in a separate FAQ said it has selected 45 Medicare Advantage contracts for those audits. Gender affirming care. On Wednesday (June 16), the Supreme Court rules 6-3 to uphold a Tennessee law that bans gender-affirming hormone therapies for minors. In the ruling, Justice Clarence Thomas cited a lack of FDA authorization for puberty blockers and cross-sex hormones as a factor. Separate legal challenges to President Trump's executive order on gender affirming care are ongoing. Federal judge rules against NIH grant terminations. On Wednesday (June 16), a federal judge in Massachusetts ruled in two cases that the NIH illegally terminated hundreds of grants related to gender identity and diversity, equity, and inclusion. The judge said the termination process was arbitrary and ordered some of the grants to be restored. Judge blocks public health funding cuts in certain localities. On Tuesday (June 15), U.S. District Judge Christopher Cooper in Washington, D.C., issued a preliminary injunction, requiring the Trump administration to reinstate public health funding in Harris County, Texas; Columbus, Ohio, Nashville, Tennessee, and Kansas City, Missouri, while the case continues.
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