September 16, 2024 This Week in Health Policy for September 16 This Week (September 16 - 20) The House and Senate are in session and working to meet a September 30 deadline to extend government funding and other expiring health and non-health programs. In the House, lawmakers are scheduled to consider bills related to chronic disease coverage, Medicaid, and telehealth for mental health services. Several committees also have noticed health care hearings and the House Energy and Commerce Committee is expected to have a markup including health care legislation. Senate HELP Committee will hold an executive session on resolutions of contempt for Steward Health Care CEO Ralph de la Torre
Senate Judiciary Committee will hold a mark up of legislation related to patent eligibility
House Ways & Means Health Subcommittee will hold a hearing on "Investing in a Healthier America: Chronic Disease Prevention and Treatment."
House Veterans' Affairs Subcommittee on Health will hold a hearing on "Dial 988 +1: Examining the Operations of the Veterans Crisis Line."
Senate Finance Committee will hold a hearing on "Lower Health Care Costs for Americans: Understanding the Benefits of the Inflation Reduction Act."
Senate Judiciary Subcommittee on Privacy, Technology, and the Law will hold a hearing on "Oversight of AI: Insiders' Perspectives."
Senate Judiciary Subcommittee on Human Rights and the Law will hold a hearing on "How Georgia's Abortion Ban Harms Women: Health Care in Jeopardy."
Last Week (September 9 - 13) Health Care Highlights Congress returns from recess. On Monday (September 9), Congress returned from the August recess for a short pre-election work period focused, primarily, on extension of items expiring on September 30: government funding, farm bill programs, and flood insurance. A continuing resolution (CR) of government funding until after the elections with short-term extensions of certain expiring items is expected, after House Republicans first try to advance a bill with their priorities. Lawmakers are currently negotiating which items to address, including certain extenders for hospital programs, and more. House approves BIOSECURE Act. On Monday (September 9), the House voted 306-81 to pass the BIOSECURE Act (HR 8333), which would prohibit health care companies from using federal funding to purchase or obtain biotechnology equipment or services from certain China-based biotechnology companies deemed a national security threat. The House-advanced version was amended in committee to include an extended phase-in period for existing contracts, allowing them to remain exempt from the prohibitions until January 1, 2032. The pathway to enactment remains unclear, but supporters are considering attaching the bill to must-pass vehicles, such as the National Defense Authorization Act, for passage after the November elections. House Republicans issue RFI on drug supply chain. On Tuesday (September 10), a group of House Republicans issued an request for information on strengthening and enhancing domestic medical supply chains. The RFI includes questions on obstacles to onshoring and diversifying supply chains, the timeframe needed to diversify supply chains, and details on specific elements of the supply chain that are dependent on suppliers in "foreign adversary countries." Responses are due by October 4. Health care in the presidential debate. On Tuesday (September 10), Democratic presidential nominee Vice President Kamala Harris and Republican presidential nominee former President Donald Trump met in their first, and likely only, presidential debate. The debate touched on several health care topics:
See WCEY’s latest publication: "2024 Elections and Health Policy" HHS issues final mental health parity rule. On Monday (September 9), the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (the Departments) issued a final rule to update regulations implementing the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The final rule amends certain provisions of MHPAEA regulations and adds new rules that aim to strengthen requirements and timeframes regarding nonquantitative treatment limitations (NQTL), which are restrictions insurers can place on health benefits, such as prior authorization or step therapy protocols. Under the final rule, plans and issuers, including previously exempted self-funded state and local health plans, must evaluate and revise their NQTLs based on the new requirements. Most provisions apply generally to group health plans and health insurance issuers that offer group health insurance coverage starting on the first day of the first plan year beginning on or after January 1, 2025. However, the Department said the meaningful benefits standard, the prohibition on discriminatory factors and evidentiary standards, the relevant data evaluation requirements, and the related requirements in the provisions for comparative analyses, will apply on the first day of the first plan year beginning on or after January 1, 2026. Click here for a fact sheet. CMS publishes new information on MPPP. On Friday (September 13), CMS published a new fact sheet and other public resources with information for consumers on the Medicare Prescription Payment Plan (MPPP), which allows Medicare Part D beneficiaries who opt-in to spread their out-of-pocket drug costs across the calendar year starting in 2025. HHS awards $14M to boost domestic API production. On Friday (September 13), HHS awarded $14 million to the API Innovation Center (APIIC), a St. Louis-based nonprofit, to modernize the manufacturing capacities of several sites within APIIC's network with the goal of improving domestic production of key starting materials and active pharmaceutical ingredients (APIs) used in essential medications. CDC publishes Rural Public Health Strategic Plan. On Thursday (September 12), the Centers for Disease Control and Prevention (CDC) released its Rural Public Health Strategic Plan for FY 2024 — 2029. The plan aims to improve the health of rural communities by improving collaboration among federal agencies, advancing innovative solutions, and expand rural public health resources. HHS issues proposed rule to streamline organ transplants for people with HIV. On Thursday (September 12), HHS issued a proposed rule that would update requirements for kidney or liver transplants from an HIV-positive donor to another HIV-positive patient. The rule aims to streamline the process, removing existing clinical research and institutional review board requirements. HHS updates research misconduct regulations. On Thursday (September 12), HHS issued a final rule to update decades-old policies on research misconduct. The rule includes provisions to streamline institutional responsibilities in misconduct proceedings, extends the timeline for institutional inquiries from 60 to 90 days, provides a clear appeals process, and more. FDA issues strategy document for innovative manufacturing technologies. On Wednesday (September 11), the FDA unveiled a strategy document detailing its plans related to innovative manufacturing technologies. In the document, FDA said it plans to finalize guidance to implement the Advanced Manufacturing Technology Designation Program by December 29, 2024, and by December 31, 2026, FDA said it will update guidance on Center for Drug Evaluation and Research's Emerging Technology Program and issue a report on the Emerging Technology Team's activities. HHS awards $68M for suicide prevention. On Tuesday (September 10), HHS awarded $68 million in grants for suicide prevention and mental health care programs, including those in educational settings, such as colleges and universities. ICYMI: Health Care Highlights from August Recess Court upholds CMS Stark law guidance. On Friday (August 30), a district court dismissed the Community Oncology Alliance's lawsuit challenging a CMS Frequently Asked Questions document that prohibits physicians from dispensing drugs in locations outside of their office, including mailing drugs to the patients' home. FDA publishes draft guidance on medical device PCCPs. On August 22, FDA issued draft guidance on predetermined change control plans (PCCPs) for medical devices that require premarket approval or premarket notification. Similar to the FDA's proposed PCCP approach for AI/ML-enabled devices, FDA said manufacturers of applicable medical devices could submit planned device modifications without having to seek additional FDA authorizations if those updates are in line with the PCCP. FDA included several examples of modifications medical device manufacturers, including mobile medical app makers, could include in PCCPs. Federal judge strikes down FTC noncompete ban. On August 20, a federal district court judge in Texas struck down the Federal Trade Commission's (FTC) rule banning most non-compete agreements. The decision, which blocks the policy nationwide, cites the Supreme Court's recent Loper Bright decision to argue the FTC lacks the authority to issue "substantive rules regarding unfair methods of competition." The ruling contrasts with a Pennsylvania district court's decision to uphold the policy and is expected to be appealed. The FTC's ban was scheduled to take effect on September 4. CMS publishes data report on NSA complaints and violations. On August 20, CMS released the latest report on complaints and enforcement actions taken by the agency related to title XXVII of the Public Health Service (PHS) Act, which includes the No Surprises Act's (NSA) surprise billing and price transparency provisions. As of June 30, CMS has received 16,073 complaints of which it has closed 12,700 with 400 resulting in PHS violations. CMS said 10,300 NSA complaints were filed against providers, facilities, and air ambulance providers, while 1,777 complaints were filed against non-federal governmental plans and issuers. HHS awards grants to support access to HIV medication. On August 20, HHS' Health Resources and Services Administration (HRSA) announced it is awarding about $1.4 billion to states through the AIDS Drug Assistance Program to help low-income patients cover costs related to HIV medication costs, including copays and coinsurance. HHS celebrates IRA provisions to lower drug costs. On August 16, the Biden administration commemorated the second anniversary of the Inflation Reduction Act (IRA) becoming law and highlighted provisions of the law that have gone into effect, including a $35 cap on Medicare covered insulin products, access to no-cost vaccines for those with Part D, cap on out-of-pocket drug costs in the catastrophic coverage phase (to be followed next year by a $2,000 OOP cap for the Part D benefit), the Medicare inflation rebate program, and more. On August 15, HHS published the list of Maximum Fair Prices (MFP) for the first 10 Medicare Part D drugs that are subject to the IRA's Medicare Drug Price Negotiation Program, which are set to take effect beginning January 1, 2026. CMS unveils prices for first 10 negotiated drugs. On August 15, CMS published the list of MFPs for the first 10 Medicare Part D drugs that are subject to the Medicare Drug Price Negotiation Program created under the IRA. The prices will go into effect beginning January 1, 2026. HHS estimates the negotiations would generate $6 billion in savings, though actual savings won't be known until the drug prices take effect in 2026. CMS will select up to 15 additional drugs covered under Part D for negotiation for 2027 by February 1, 2025. As CMS moves ahead with its implementation of the Medicare Drug Price Negotiation Program, several drugmakers, as well as the US Chamber of Commerce, PhRMA, the National Infusion Center Association, and the Global Colon Cancer Association, have raised concerns about the long-term effect on the incentives to develop new medicines and filed lawsuits to halt the program. However, initial rulings have largely sided with the administration. Click here for a fact sheet. CMS shares information on future PrEP coverage changes. On August 13, CMS published additional information to help pharmacies and other affected parties to begin preparing for the expected transition of coverage, from Medicare Part D to Medicare Part B, for Pre-exposure Prophylaxis (PrEP) antiretroviral drugs to prevent HIV. CMS said it expects the final National Coverage Determination (NCD) will be released in late September 2024. CMS issues final coverage with evidence development guidance. On August 7, CMS issued final guidance on Medicare coverage with evidence development (CED) in which the agency reiterates its authority to require patients to enroll in clinical trials as part of national coverage restrictions for certain FDA-approved drugs, such as those approved through FDA's accelerated approval pathway. In response to concerns that CED can delay patients' access to innovative treatments, CMS said it believes "CED can expedite earlier beneficiary access to new items and services while improving the likelihood of positive patient outcomes." Hearings, Markups, and Other Committee Activity Senate Health, Education, Labor and Pensions (HELP) hearing on "Examining the Bankruptcy of Steward Health Care: How Management Decisions Have Impacted Patient Care." On Thursday (September 12), the Committee held a hearing during which lawmakers heard testimony from a panel of witnesses, including two nurses that worked at Steward-owned hospitals in Massachusetts and local government representatives from Louisiana where a Steward-owned hospital is closing. The committee issued a subpoena to hear testimony from Steward Health Care System CEO Ralph de la Torre, however Dr. de la Torre did not appear before the committee. In response, Chairman Bernie Sanders (I-Vt) and Ranking Member Bill Cassidy (R-LA) said they will be asking the committee to report a resolution to authorize civil enforcement and criminal contempt proceedings against Dr. de la Torre, requiring compliance with the subpoena. Both Chair Sanders and ranking member Cassidy pledged to follow up and hold Dr. de la Torre accountable for the care provided at Steward-owned hospitals and the negative impact on hospital workers and the community. Much of the witness discussion focused on poor conditions under which workers at Steward-owned facilities were required to provide care and the patients who were negatively impacted by those conditions. Witnesses and lawmakers also sought additional clarity and transparency into the financial arrangement between private equity, health care facilities, and real estate insurance trusts.
House Veterans Affairs Subcommittee on Economic Opportunity Oversight held a hearing on " Evaluating Mental Health Support Programs for Separating Servicemembers." On Tuesday (September 10), the Subcommittee held a hearing during which members discussed ways the Department of Defense and the VA can better work together to provide mental health support for separating servicemembers.
House Energy and Commerce Oversight and Investigations Subcommittee held a hearing on "A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network Act Implementation." On Wednesday (September 11), the Subcommittee held a hearing during which they heard from a panel of witnesses representing transplant surgeons and advocacy groups on the implementation of the Securing the US Organ Procurement and Transplantation Network Act and the challenges that remain.
House Budget Committee held a hearing on "Congress and the Congressional Budget Office: Examining Ways to Improve CBO." On Wednesday (September 11), the Committee heard testimony from CBO Director Phillip Swagel and discussed the House-passed Preventive Health Savings Act, which would require CBO, if requested by Congress, to estimate the impact of legislation focused on preventive health care over a 30-year period. Members also discussed issues with past CBO analyses and ways to improve CBO's process, including creating a more organized schedule for CBO reports and auditing certain CBO models to assess and improve accuracy.
House Education and the Workforce Committee held a hearing on "ERISA's 50th Anniversary: The Value of Employer Sponsored Health Benefits." On Tuesday (September 10), the Subcommittee held a hearing commemorating the Employee Retirement Income Security Act's (ERISA) 50th Anniversary. During the hearing, lawmakers heard from a panel of witnesses representing employee benefits groups and consumers as well as research organizations focused on employee benefits and small businesses. During the hearing, lawmakers and witnesses expressed support for ERISA, discussed its role in the US health care system and ways to build upon and strengthen it.
House Education and the Workforce Committee held a markup of health-related bills. On Wednesday (September 11), the Committee advanced two health care bills and one Congressional Review Act (CRA) resolution to the full House. The bills advanced aim to address anti-competitive contract terms between provider facilities and insurers and to prohibit provider facilities from charging additional facility fees for telehealth visits furnished by a health care provider located at the facility. The committee also advanced a CRA resolution to block a Biden administration final rule that rescinds a Trump-era 2018 rule that would have expanded the types of employers who could create Association Health Plans (AHPs). The 2018 rule was vacated in court and never implemented.
House Judiciary Subcommittee held a hearing on "The Role of Pharmacy Benefit Managers." On Wednesday (September 11), the Subcommittee held a hearing during which members heard from a panel of witnesses representing researchers and analysts. During the hearing, members and witnesses discussed the highly concentrated PBM market with members and witnesses raising concerns about vertical integration among PBMs, insurers, and pharmacies and discussing the need for increased transparency.
Reports, Studies, and Journals Government Accountability Office: Behavioral Health: Information on Cost-Sharing in Medicare and Medicare Advantage. The report, which examined behavioral health benefits in both Medicare and Medicare Advantage, found both programs are required to cover basic benefits for behavioral health treatment, and plans in both programs imposed cost-sharing for those benefits in 2024. March of Dimes: Nowhere to Go: Maternity Care Deserts Across the US. The report highlights the growing number of US counties that lack access to obstetrical care and examines policies that could improve access by integrating midwives into the health care system and reducing obstacles to opening and maintaining birth centers. Kaiser Family Foundation: KFF Health Tracking Poll September 2024: Harris v. Trump on Key Health Care Issues. The report finds that 38% of voters name the economy and inflation as their most important issue headed into the November elections. Twenty percent of Democratic voters want Vice President Kamala Harris to focus on general health care costs, while 45% of Republican voters want former President Donald Trump to prioritize health care costs in his campaign. Depart of Treasury. Nearly 50 Million Americans Have Been Covered Through Affordable Care Act Health Insurance Marketplaces Since 2014. The report showed nearly 50 million Americans have been enrolled in a health plan purchased through the ACA's marketplaces since they launched in January 2014, with enrollment reaching an all-time high of 20.8 million in 2024.
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