September 23, 2024 This Week in Health Policy for September 23 This Week (September 23 - 27) The House and Senate are in session and continuing negotiations to meet a September 30 deadline to extend government funding and other expiring health and non-health programs. The House next week also is scheduled to consider health-related bills, including those on disease research and treatment programs, organ transplantation, data accessibility, Stark law waiver, prescription drug patents, Medicaid, and more. Senate Finance Committee will hold a hearing on "Chaos and Control: How Trump Criminalized Women's Health Care."
Senate HELP Committee will hold a hearing on "Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?"
Senate HELP Committee will hold a hearing on "Reading the Room: Preparing Workers for AI."
Senate HELP Committee will hold a markup of health bills
House Committee on Oversight and Accountability will hold a hearing on "Meddling with Medicare: The Biden-Harris Cover-Up."
Last Week (September 16 - 20) Health Care Highlights >Congress acts on health bills while FY 2025 discussions continue. On Wednesday (September 18), the House failed to advance (in a 202-220 vote) a continuing resolution (CR) through March 28, 2025, that included the partisan SAVE Act bill to ensure only US citizens are registered to vote. House Republican leaders are reportedly preparing a CR into December, without the SAVE Act. Senate Majority Leader Chuck Schumer (D-NY) has taken procedural steps toward consideration of a CR in the event the House doesn't send over a bill that can gain enough Democratic support to pass the Senate. The House and Senate this week also took action on key health bills:
CMS finalizes MDRP Final Rule. On Friday (September 20), the Centers for Medicare and Medicaid Services (CMS) published a final rule aimed at advancing policies to promote the efficient operation of the Medicaid Drug Rebate Program (MDRP). This includes policies to address situations in which manufacturers incorrectly report or misclassify their drugs in the MDRP along with other provisions aimed at enhancing MDRP integrity, greater consistency and accuracy of drug information reporting, timely data collection, and efficient MDRP operations. CMS said it is continuing to review input provided by commenters on the proposed rule which were not finalized, such as the proposal to account for stacking when determining Best Price and the new definitions for "manufacturer" for National Drug Rebate Agreement (NDRA) Compliance Purposes and "vaccine" for MDRP purposes. A fact sheet for the rule can be found here and the rule can be found here . FTC alleges anticompetitive PBM behavior. On Friday (September 20), the Federal Trade Commission (FTC) filed an administrative complaint against the three largest pharmacy benefit managers (PBMs) — Caremark Rx, Express Scripts (ESI), and OptumRx — and their affiliated group purchasing organizations (GPOs). The complaint alleges the companies are engaging in anticompetitive and unfair drug rebate practices that excluded lower priced insulins in favor of higher priced, highly rebated versions, resulting in artificially inflated list prices and higher patient costs. The administrative complaint marks the beginning of a process for the allegations to be heard in a formal hearing by an administrative law judge. HRSA awards multi-vendor organ transplant contracts and funding to support behavioral health services. On Thursday (September 19), the Health Resources and Services Administration (HRSA) announced the first ever multi-vendor contract awards to modernize the Organ Procurement and Transplantation Network (OPTN). The contracts will focus on improving patient safety, support OPTN modernization, increase public engagement in policy development, strengthen patient communications, and improve financial management. HRSA on September 19 also announced $240 million in awards to support mental health and substance use disorder services in more than 400 community health centers. HRSA warns against proposed 340B drug rebate model. On Tuesday (September 17), HRSA sent a letter to Johnson & Johnson warning that the drugmaker's plan to switch disproportionate share hospitals to a rebate model for certain 340B drugs would violate federal law. In the letter, HRSA said it "expects J&J to cease implementation of its rebate proposal immediately" and asked the manufacturer to provide HRSA with an update by September 30. CMS launches pilot to create provider network directory. On Tuesday (September 17), CMS announced it would partner with the state of Oklahoma to build a qualified health plan directory pilot to create a centralized directory for provider information. CMS said the pilot would help inform a National Directory of Healthcare. ICYMI: EY hosts Digital Health on the Hill. On Thursday (September 19), EY held its Digital Health on the Hill event, bringing together industry leaders in digital health and AI to showcase the potential future of digitally enabled health care. The event featured Keynote Speaker Micky Tripathi, who serves as Assistant Secretary for Technology Policy, National Coordinator for Health Information Technology, and Acting Chief Artificial Intelligence Office. Tripathi spoke about ways ONC is working to improve and simplify health data exchange and is thinking about the implications of AI. The event also featured Rep. Mariannette Miller-Meeks (R-IA) who spoke about ways legislators are thinking about digital health and AI regulations, as well as industry panels on the return on investment of digital health and the future of AI in health care delivery. Hearings, Markups, and Other Committee Activity Senate Health, Education, Labor and Pensions (HELP) held an executive session on resolutions of contempt for Steward Health Care CEO Ralph de la Torre. On Thursday (September 19), the Committee unanimously approved resolutions to hold Steward Health Care CEO Ralph de la Torre in contempt for failing to comply with a congressional subpoena to testify before the committee. One resolution seeks civil enforcement of the subpoena and the other refers the matter to the US Attorney for the District of Columbia for criminal contempt. Both resolutions will need to be approved by the full Senate.
House Energy and Commerce Committee held a markup of telehealth and other health care bills. On Wednesday (September 18), the Committee advanced 16 bills, including 11 related to health care, and a children's online data privacy bill. The health bills advanced seek to improve access to Medicaid home and community-based services, improve research into pediatric cancer treatment, extend by two years expiring Medicare telehealth flexibilities, and more. The Telehealth Modernization Act of 2024 (HR 7623) includes a number of offsets including provisions to "delink" PBM compensation from list prices in the Part D market.
House Ways & Means Health Subcommittee held a hearing on "Investing in a Healthier America: Chronic Disease Prevention and Treatment." On Wednesday (September 18), the Subcommittee heard from a panel of witnesses featuring a former senator, academics, providers, and Medicare Advantage plans. During the hearing, discussion centered on the need for legislation to reduce the prevalence of chronic diseases and the role poor nutrition plays. Democrats largely focused on the impact of food deserts and other social causes, while Republicans spoke about the need for more public awareness and incentives to eat healthier food.
Senate Finance Committee held a hearing on "Lower Health Care Costs for Americans: Understanding the Benefits of the Inflation Reduction Act." On Tuesday (September 17), the Committee held a hearing during which they heard testimony from five witnesses on the impact of the Inflation Reduction Act's (IRA) health provisions including the negotiation of Maximum Fair Price (MFP), premium tax credits for the purchase of qualified health insurance and the Medicare Part D demonstration program. Much of the focus at the hearing was on how these provisions have influenced access to affordable health care and innovation in the pharmaceutical industry. There was also some concern expressed at the cost of these provisions.
Senate Judiciary Subcommittee on Human Rights and the Law held a hearing on "How Georgia's Abortion Ban Harms Women: Health Care in Jeopardy." On Monday (September 16), the Subcommittee held a field hearing in Fulton County, Georgia, during which they heard from a panel of patients and an OB/GYN. Discussion at the hearing focused on ways Georgia's 6-week abortion ban is negatively impacting women's health and access to the full spectrum of reproductive care.
Reports, Studies, and Journals Washington Council EY: AI in health care: a regulatory and legislative outlook. The report highlights key regulatory and legislative actions taken on AI and key considerations for developing future AI policy. Federal Trade Commission: A Look Behind the Scenes: Examining the Data Practices of Social Media and Video Streaming Services. The staff report found that major social media and video streaming services engage in consumer surveillance, including the collection of personal and demographic information, that fail to protect children and teens from negative mental health impacts. CMS: Kidney Care Choices (KCC) Model: First Annual Evaluation Report, Performance Year 2022. The report, which provides an overview of the Kidney Care Choices model's first year, showed the model led to increases in home dialysis, home dialysis training, and optimal starts to dialysis, with no significant changes in transplant rates or Medicare Part A and Part B spending. Commonwealth Fund: Mirror, Mirror 2024: A Portrait of the Failing U.S. Health System. The report, which compared 10 countries and cited lack of adequate primary care, consolidation, underinvestment in addressing social issues, ranks the US last on key health care performance measures compared to other high-income countries.
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