February 19, 2024 This Week in Health Policy for February 19 This Week (February 19 - 23) The House and Senate will be on recess this week for the President's Day holiday. The Senate will next convene at 3:00 p.m. on Monday, February 26. The House is scheduled to be back on February 28. Congress faces government shutdown deadlines on March 1 and March 8. Last Week (February 12 - 16) Health Care Highlights Departments end No Surprises Act IDR extensions. On Friday (February 16), the Departments of Health and Human Services, Labor, and the Treasury (collectively, the Departments) announced that all currently applicable extensions of certain Independent Dispute Resolution (IDR) deadlines, including for initiation of new batched disputes and new single disputes involving air ambulance services, resubmission of improperly batched disputes initiated before August 3, 2023, and selection or reselection of certified IDR entities, will end on March 14, 2024. In addition, initiating parties who submitted a batched dispute before August 3, 2023, and received notification from a certified IDR entity that the dispute was improperly batched will have the standard 4-business-day period to resubmit, instead of the existing 10-business days. Parties will still receive one opportunity to resubmit improperly batched disputes. CMS issues draft part 2 guidance for 'smoothing' program. On Thursday (February 15), the Centers for Medicare & Medicaid Services (CMS) released the second part of draft guidance for the Inflation Reduction Act's Medicare Prescription Payment Plan, which goes into effect in 2025 and allows beneficiaries to pay their out-of-pocket costs as monthly payments through-out the year. The new guidance includes requirement details for Medicare Part D plan sponsors, including those related to outreach and education, pharmacy processes, and operational considerations to ensure beneficiaries and other interested parties know about the program. CMS said it expects to issue final part one guidance in coming weeks. Click here for a fact sheet on the draft part two guidance. Click here for an implementation timeline for the program. HHS announces states participating in postpartum collaborative. On Wednesday (February 14), The Department for Health and Human Services (HHS) announced six states have agreed to participate in a new Postpartum Maternal Health Collaborative designed to examine the challenges of postpartum life and new solutions to improve postpartum mortality. The six states are Iowa, Massachusetts, Maryland, Michigan, Minnesota, and New Mexico. FTC, HHS issue RFI on generic drug shortages. On Wednesday (February 14), the Federal Trade Commission (FTC) and HHS jointly issued a request for information to better understand how the business practices of group purchasing organizations (GPOs) and drug wholesalers may be contributing to generic drug shortages. The RFI includes questions on competition within those industries; contracting practices with pharmacies, hospitals, and other health care providers; and policy ideas on ways to keep drug costs low. Public comments will be open for 60 days at Regulations.gov. Patent office seeks comment on AI guidance. On Tuesday (February 13), the U.S. Patent and Trademark Office published a request for comment on guidance for inventions that are assisted by artificial intelligence. The guidance emphasizes the office's focus on human contributions, saying, "Patent protection may be sought for inventions for which a natural person provided a significant contribution to the invention, and the guidance provides procedures for determining the same." The document will be open for comment for 90 days. ONC designates two new QHINS. On Monday (February 12), the Office of the National Coordinator for Health Information Technology (ONC) designated two additional organizations — CommonWell Health Alliance and Kno2 — as Qualified Health Information Networks (QHINs) that can support health data exchange governed by the Trusted Exchange Framework and Common Agreement (TEFCA). The designation of these two QHINs brings the total number to seven. Judge dismisses first IRA challenge. On Monday (February 12), a federal district judge dismissed a drug industry trade group's legal challenge to halt Medicare drug price negotiations. PhRMA, joined by the National Infusion Center Association and the Global Colon Cancer Association, claimed that the IRA delegated too much authority to HHS and violated drug companies' due process. However, the judge ruled that National Infusion Center Association lacked standing and subject matter jurisdiction to bring the lawsuit. Eight other lawsuits that challenge the constitutionality of the program are ongoing. Hearings, Markups, and Other Committee Activity House Energy and Commerce Subcommittee on Health held a hearing on "Legislative Proposals to Support Patients and Caregivers." On Wednesday (February 14), the Subcommittee voiced support for 19 bipartisan bills, including four supporting Alzheimer's disease patients and family caregivers and several program reauthorizations, including one to reauthorize a grant program to support hospital workers' mental health and well-being.
House Committee on Veterans' Affairs Subcommittee on Health held a hearing on "Artificial Intelligence at VA: Exploring its Current State and Future Possibilities." On Thursday (February 15), the Subcommittee held a hearing to explore how the VA uses AI and how it can be used in the future. The Subcommittee heard testimony from several representatives of the VA and experts in AI.
House Committee on Veterans' Affairs Subcommittee on Technology Modernization held a hearing on "Electronic Health Record Modernization Deep Dive: Can the Oracle Pharmacy Software Be Made Safe and Effective?" On Thursday (February 15), the Subcommittee heard testimony from representatives of the VA, the Veterans Health Administration, and the VA Office of Inspector General. Discussion during the hearing focused on errors and safety concerns related to the VA's electronic health record system, which has been undergoing a years long upgrade process.
House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing on "Assessing America's Vaccine Safety Systems, Part 1." On Thursday (February 15), the Select Subcommittee heard from a panel of witnesses representing the Centers for Disease Control and Prevention (CDC), the FDA's Center for Biologics Evaluation and Research (CEBR), and the Health Resources and Services Administration who spoke about the Biden administration's COVID-19 vaccine programs. The witnesses faced pointed questions from several Republicans on the committee and there was particular discussion around CDC's Vaccine Adverse Event Reporting System (VAERS) and HRSA's Countermeasures Injury Compensation Program.
Reports, Studies, and Journals Kaiser Family Foundation: Medicaid Enrollment and Unwinding Tracker. The tracker provides the latest data on monthly Medicaid disenrollments, renewals, overall enrollment and other key indicators reported by states as they continue through the Medicaid redetermination process. Health Affairs: Nursing Homes Increasingly Rely on Staffing Agencies for Direct Care Nursing. The study examines data to better understand the role of agency staff in nursing home staffing, finances, and quality, as CMS and states consider implementing new nursing staff regulations. Government Accountability Office: VA Health Care: Opportunities Exist to Further Meet Student Veterans' Mental Health Needs. The report provides recommendations for the Veterans Health Administration to better support student veteran' mental health needs.
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