December 4, 2023 This Week in Health Policy for December 4 This Week (December 4 - 8) The House this week could vote on two health care bills — The TRANQ Research Act, a measure on fentanyl research and the Elizabeth Dole Home Care Act, a measure on veterans' care — under suspension of the rules, meaning the bill would require a two-thirds vote to pass. The House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee also are expected to schedule legislative markups of health care bills for next week but were not noticed before publishing. Other committee activity includes: Senate Finance Committee will hold a hearing on "Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective."
Last Week (November 27 - December 1) Health Care Highlights Biden admin updates on No Surprises Act's IDR process amid legal uncertainty. On Tuesday (November 28), the Departments of Health and Human Services (HHS), Labor and Treasury released new FAQs detailing how certified independent dispute resolution (IDR) entities may determine whether a dispute is appropriately batched amid a flurry of legal activity and industry uncertainty. The FAQs were issued in response to court rulings that vacated regulatory provisions requiring batched services to be billed with the same service code, in addition to specific batching rules for air ambulances. The FAQs aim to provide guidance to IDR entities in the time before a newly proposed rule to update those provisions is effective. The Departments are currently working to re-open the Federal IDR portal for all batched disputes and single air ambulance disputes following a pause. They aim to do so by mid-December and plan to grant extensions to applicable IDR deadlines. Relatedly, on Wednesday (November 29) CMS said health care providers and insurers initiating a payment dispute through January 16 will have 10 business days to select a certified IDR entity after initiating the dispute. Parties also will have 20 business days to initiate new single and bundled disputes that would have been due between August 3, 2023 through November 3, 2023. HHS takes steps to bolster medical supply chain. On Monday (November 27), HHS announced that President Biden plans to issue a Presidential Determination that will give HHS the authority under the Defense Production Act to take actions to bolster the medical supply chain. Specifically, the determination will enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that the President has deemed essential to national defense. HHS also plans to designate a new supply chain resilience and shortage coordinator to improve critical medical product and food supply chains and address shortages. Appeals court reinstates Trump-era Title X rules. On Thursday (November 30), the 6th U.S. Circuit Court of Appeals ruled 2-1 to strike down some of the Biden administration's rules for the Title X family planning program and to reinstate Trump-era policies that require clinics to maintain "strict physical and financial separation" of abortion care and other reproductive health care. The ruling applies only to clinics in Ohio. North Carolina becomes 40th state to expand Medicaid. On Friday (December 1), North Carolina's Medicaid expansion took effect, making nearly 600,000 North Carolina residents with annual incomes below $20,120 eligible for Medicaid coverage. In announcing the news, HHS "strongly" urged the remaining 10 states to expand their Medicaid programs under the Affordable Care Act. ICYMI: Health Care News From November 20-24 FDA issues COVID-19 drug development guidance. On Wednesday (November 22), the FDA issued final guidance on the development of drugs for the treatment and prevention of COVID-19, including guidelines to ensure diverse populations are enrolled in clinical trials. FTC updates investigative practices related to AI products. On Tuesday (November 21), the Federal Trade Commission (FTC) voted to approve an omnibus resolution that related to how the agency will investigate AI-related products and services. Among other things, the resolution will allow one commissioner to issue a subpoena and authorizes the use of compulsory process in nonpublic investigations related to AI products. HHS updates exchange plan selection data. On Tuesday (November 21), the Biden administration announced about 4.6 million people have selected a health plan on the federal or state-based exchanges since the 2024 open enrollment period began on November 1, including 920,000 people who are new to the exchanges. The figures represent plan selection activity through November 18 for the 32 states using HealthCare.gov, and through November 11 for the District of Columbia and the 17 states with state-based Marketplaces. Click here for a fact sheet. FDA cracks down on drug ads. On Tuesday (November 21), the FDA issued a final rule that requires radio and TV ads for prescription drugs to provide information on side effects and contraindications in a more consumer-friendly manner. FDA said it could place limits on selling methods for drugs that fail to comply with the rules. Hearings, Markups, and Other Committee Action House Energy & Commerce Subcommittee on Health held a hearing on "Understanding How AI is Changing Health Care." On Wednesday (November 29), the Subcommittee held a hearing on the potential benefits and risks AI poses to the health care industry and the regulatory framework needed to protect patients and allow for innovation. During the hearing, lawmakers heard testimony from a panel of health care providers and AI experts. Throughout the hearing lawmakers and witnesses discussed the importance of implementing appropriate oversight and guardrails to address ethical considerations like biases in algorithms and practical considerations like data security and user consent. Lawmakers and witnesses also spoke about the nuances between different types of AI and their use cases and the need for AI to remain a supporting tool in health care that is overseen by humans.
House Budget Committee held a hearing on "Examining the Need for a Fiscal Commission Reviewing H.R. 710, H.R. 5779, and S. 3262." On Wednesday (November 29), the Committee held a hearing to discuss three bipartisan legislative proposals that would create fiscal commissions tasked with addressing the federal budget deficit. During the hearing, there was bipartisan agreement on the need to address the budget, debt, and interest payments in an expedited manger to preserve the Medicare and Social Security Trust Funds. However, not all lawmakers agreed creating a new commission was the best approach.
House Energy & Commerce Subcommittee on Oversight and Investigations held a hearing on "Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season." On Thursday (November 30), the subcommittee held a hearing on rebuilding public trust at the CDC following the COVID-19 pandemic. During the hearing, lawmakers heard testimony from CDC Director Mandy Cohen who fielded questions from lawmakers on the guidance the CDC issued during the pandemic and called for more work to improve transparency at the agency.
Reports, Studies, and Journals HHS Office of Inspector General: Semiannual Report to Congress. The report highlights OIG activities identifying significant risks, problems, abuses, deficiencies, and more for the 6-month period that ended September 30. Health Affairs: Medicare Care Choices Model Improved End-Of-Life Care, Lowered Medicare Expenditures, And Increased Hospice Use. A study found enrollees in the Medicare Care Choices Model were 15 percentage points less likely to receive an aggressive life-prolonging treatment at the end of life and spent more than five more days at home than beneficiaries who received standard care. Government Accountability Office: End-Stage Renal Disease: CMS Plans for Including Phosphate Binders in the Bundled Payment. The report examines CMS' plans to add "phosphate binders" to bundled payments for dialysis organizations in 2025 and proposal to monitor the changes' impact. ———————————————
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