May 28, 2024 This Week in Health Policy for May 27 This Week (May 27 - 31) Both the House and Senate are out of session this week for the Memorial Day recess. Last Week (May 20 - 24) Health Care Highlights New bipartisan House caucus focuses on obesity. On Thursday (May 23), Reps. Vern Buchanan (R-FL), chair of the House Ways & Means Committee’s health subcommittee, and Gwen Moore (D-WI) announced the new bipartisan Congressional Prevention Health and Wellness Caucus, which plans to examine potential savings related to obesity prevention and to introduce legislation aimed at the prevention, research and treatment of obesity. FTC, DOJ launch joint inquiry into serial acquisitions. On Thursday (May 23), the Federal Trade Commission (FTC) and the Department of Justice’s (DOJ) Antitrust Division issued a joint request for information related to serial acquisitions and roll-up strategies that have led to consolidation that has harmed competition. The RFI seeks information on acquisitions across of sectors and industries, including health care, and is meant to complement their recent RFI on consolidation in health care markets. Appeals court sides with drug manufacturers in latest 340B contract pharmacy case. On Tuesday (May 21), a federal appeals court ruled that drug manufacturers can limit the number of contract pharmacies that covered entities can use to distribute discounted drugs. The ruling marks the second appeals court that has upheld the contractual limits between contract pharmacies and covered entities. A third appeal is still pending before the Seventh Circuit. CMS unveils new option for individuals to file EMTLA complaints. On Tuesday (May 21), CMS announced a new pathway for individuals to file an Emergency Medical Treatment and Labor Act (EMTLA) complaint directly with the agency. The new option on CMS.gov is the latest in a series of new resources from the Biden administration to improve education and promote patient access to emergency medical care. NIH seeks to use On Tuesday (May 21), the National Institutes of Health (NIH) published a first-of-its-kind policy proposal outlining ways to use its licensing process to advance equitable and affordable access to drugs, vaccines, devices and treatments. The proposal, which applies to products developed from NIH-owned invention, was issued along with a request for information on the topic. NIH is seeking feedback on the proposal through July 21. CMS will not include ‘stacking’ proposal in final Medicaid Drug Rebate program proposed rule. Last Wednesday (May 15), CMS announced that it does not plan to finalize the “stacking” proposal included in the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (MDRP) proposed rule. In the proposed rule, CMS suggested it would update the regulations for the determination of best price to clarify that the manufacturer must stack cumulative discounts, rebates, or other arrangements for a single transaction to determine a final price realized by the manufacturer for a drug. However, in response to comments, CMS said it does not plan to include the proposal in the final rule and instead, will collect additional information from manufacturers related to best price stacking methodologies to better understand and inform future rulemaking. The rule has been at under OMB review since March 22. Sen. Paul seeks to overturn FDA rule on lab-developed tests. On Friday (May 17), Sen. Rand Paul (R-KY) filed a resolution under the Congressional Review Act (CRA) to overturn the Food and Drug Administration’s (FDA) final rule on laboratory-developed tests (LDTs). Industry experts do not believe the effort will be successful because the rule was finalized before the CRA’s “lookback period” begins. Hearings, Markups, and Other Committee Activity House Energy & Commerce Innovation, Data, and Commerce (IDC) Subcommittee held a markup of two data privacy bills. On Thursday (May 23), the House Energy and Commerce Innovation, Data, and Commerce (IDC) Subcommittee advanced a draft federal privacy bill, the American Privacy Rights Act (ARPA), which would limit the type of data that companies can collect and use and allow a private right of action for sharing of sensitive data without consent, along with the Kids Online Safety Act (H.R. 7891), which would require social media companies and other online platforms to prevent and mitigate the spread of harmful content. Both bills advanced by voice vote to the full committee. The latest draft of ARPA notably includes some provisions from the Children Online Privacy Protection Act (COPPA), which were not included in the initial draft. However, some members felt the bill still does not go far enough to protect children.
Senate HELP Committee held an executive session on several health care bills. On Thursday (May 23), the Committee advanced six bills that would reauthorize health care programs, including the Dr. Lorna Breen Health Care Provider Protection Act, which allocates funding to support health care workers access mental health and substance use disorder treatment services, and the BOLD Infrastructure for Alzheimer's Act, which funds research into Alzheimer’s treatments.
House Ways and Means Health Subcommittee held a hearing on “The Collapse of Private Practice: Examining the Challenges Facing Independent Medicine.” On Thursday (May 23), the Subcommittee held a hearing during which lawmakers discussed the challenges facing independent providers and potential policy solutions. The Subcommittee heard from a panel of witnesses representing academics and independent practice providers. During the hearing, witnesses spoke about the need to improve Medicare reimbursement for primary care and address misaligned incentives, including expanding site-neutral payments to remove incentives driving industry consolidation, reforming the quality payment program and increasing federal regulators’ authority to address anticompetitive practices.
House Budget Committee held a hearing on “Breaking Up Health Care Monopolies: Examining the Budgetary Effects of Health Care Consolidation.” On Thursday (May 23), the Committee held a hearing during which they discussed how health care consolidation impacts federal budgets and health care spending. During the hearing, the panel heard from a panel of witnesses representing academics, the Congressional Budget Office, and patient advocates. Witnesses all spoke favorably about policies to correct misaligned incentives driving consolidation in health care, including expanding site-neutral payments and strengthening price transparency.
Senate Finance Committee held a hearing on “Front Lines of the Fentanyl Crisis: Supporting Communities and Combating Addiction through Prevention and Treatment.” On Thursday (May 23), the Committee held a hearing during which members discussed ways to improve access to community prevention and treatment services for substance use disorders, particularly fentanyl. The Committee heard from a panel of witnesses representing addiction treatment centers, academics, and providers.
House Energy and Commerce Health Subcommittee held a hearing on “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices." On Wednesday (May 22), the House Committee on Energy and Commerce Health Subcommittee held a hearing entitled, “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices.” Three center directors at the FDA provided witness testimony. The hearing centered on the efforts of the FDA to promote medical innovation, particularly for rare diseases, while also ensuring patient safety. There was notable concern from some on the committee over delays in drug and device review time and how the FDA can continue to meet its performance metrics, as well as discussion on a slew of other issues including: drug shortages and strengthening of the medical supply chain; the use and approval of artificial intelligence in drug and device development; the accelerated approval pathway and new rule on laboratory developed test, and more. Dr. Cavazzoni, head of the FDA’s drug center, also noted that the delayed guidance on diversity of clinical trials will be out in a matter of days.
Senate Judiciary Committee held a hearing on “Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market.” On Tuesday (May 21, 2024), the Committee held a hearing during which discussion centered on the rise in cost of prescription drugs, the current patent system, and biotech innovations in health care. Lawmakers heard testimonies from a panel of witnesses, representing PhRMA, academics, providers and patients.
Senate HELP Subcommittee on Primary Health and Retirement Security held a hearing on “Feeding a Healthier America: Current Efforts and Potential Opportunities for Food is Medicine.” On Tuesday (May 21), the Subcommittee held a hearing during which they discussed policies to support food is medicine initiatives and improve Americans’ access to healthier food. The Subcommittee heard from a panel of witnesses representing providers, academics, and food nutrition programs.
Reports, Studies, and Journals Congressional Research Service: Litigation Continues Over Use of Contract Pharmacies in 340B Drug Discount Program. The report provides an overview of ongoing litigation related the 340B Drug Discount Program and covered entities’ ability to use contract pharmacies to distribute discounted drugs. Health Affairs: Physician Group Practices Accrued Large Bonuses Under Medicare’s Bundled Payment Model, 2018-20. The study finds that physician practices who participated in the Bundled Payments for Care Improvement Advanced Model (BPCI-A) earned $421 million in incentive payments from 2018 to 2020 and suggests additional policy changes such as improving target price accuracy and refining participation rules. CBO: Monthly Budget Review: April 2024. The report provides an overview of the federal budget deficit, showing that preliminary outlays for Medicare and Medicaid from October 2023 to April 2024 totaled $818 billion. The report shows Medicare outlays increased by 10% due to increased benefit payments to Medicare Advantage plans, while Medicaid outlays decreased by 1% as the redetermination process continues.
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