What’s Ahead: This Week
Hearings and Markups –
- Wednesday, January 10
- Senate Homeland Security and Government Affairs Committee, “Harnessing AI To Improve Government Services And Customer Experience.” Additional Information
- Thursday, January 11
- House Veterans Affairs Committee, “Rural Access: Is VA Meeting All Veterans Where They Live?” Additional Information
- House Education and Workforce Committee, Subcommittee on Health, Employment, Labor, and Pensions, “Lowering Costs and Increasing Access to Health Care with Employer-Driven Innovation.” Additional Information
Notable Policy Events –
- Wednesday, January 10
- CMS, “Consumer Assessment of Healthcare Providers and Systems Home and Community-Based Services (HCBS CAHPS) Survey National Community Feedback Call.” Virtual, Free. Additional Information
- CMS, “2024 Health Insurance Marketplace Open Enrollment Period Stakeholder Webinars.” Virtual, Free. Additional Information
- Thursday, January 11
- Bipartisan Policy Center, “Teaming Up: Policies to Support the Integrated Care Workforce.” Virtual, Free. Additional Information
- Thursday, January 11 to Friday, January 12
- Medicare Payment Advisory Commission (MedPAC), “January Public Meeting.” Virtual, Free. Additional Information
Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare & Medicaid–
- On December 18, the HHS Office of Inspector General (OIG) released a toolkit providing information on certain Medicare Advantage diagnosis codes which are at a high risk for being miscoded. HHS intends for Medicare Advantage organizations to use this toolkit to take appropriate measures to prevent, detect, and correct such errors. Toolkit
- Also on December 18, HHS released new data on state Medicaid and CHIP enrollment changes among children and youth since full eligibility renewals restarted earlier this year. HHS Secretary Becerra sent letters to nine states with the highest child disenrollment rates, urging them to adopt additional federal strategies and flexibilities to help prevent children and their families from losing coverage due to red tape. Press Release
- On December 21, HHS released a proposed rule establishing appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria. Comments are due February 25, 2024. Proposed Rule
- On December 22, Sens. Murphy (D-CT) and Tillis (R-N.C.) sent a letter to CMS Administrator Brooks-LaSure raising concerns regarding Medicare Advantage plans’ using prior authorization to deny coverage of medically necessary care at Long-Term Care Hospitals. Press Release Letter
- On December 28, CMS released the latest enrollment figures for Medicare, Medicaid and CHIP. As of September 2023, 66,472,325 people are enrolled in Medicare and 88,414,773 of people are enrolled in Medicaid and CHIP. Enrollment Data
- On December 29, the Government Accountability Office (GAO) released a notice soliciting nominations for appointments to the Medicaid and CHIP Payment and Access Commission (MACPAC), effective May 2024. Letters of nomination and resumes must be submitted by January 25, 2024. Notice
Marketplaces –
- On December 20, HHS announced that more than 19 million consumers were enrolled in 2024 ACA Marketplace coverage. Press Release White House Statement
- On December 21, HHS released a rule finalizing fees associated with use of the Federal Independent Dispute Resolution (IDR) process under the No Surprises Act (NSA). The rule finalizes an administrative fee amount of $115 per party for disputes initiated on or after January 22, 2024. Final Rule
Payment & Delivery System Models –
- On December 20, CMS released a fact sheet highlighting four in-person meetings it hosted to solicit external feedback on promising practices and challenges to address health equity at state and local levels, which will inform the ongoing implementation of the CMS’s Health Equity Initiative. Fact Sheet
- On December 28, CMS released the second evaluation report for the Part D Senior Savings Model. The report found that insulin users experienced increased access, fewer days in the catastrophic phase, and lower total out-of-pocket spending. Evaluation
- On January 4, CMS released the second evaluation report for the ESRD Treatment Choices (ETC) Model, which found that overall transplantation increased in the first two years, but there was no significant increase on transplant waitlisting or living donor transplantation. Evaluation
Public Health Prevention, Preparedness, Surveillance –
- On December 18, Senate HELP Committee Ranking Member Cassidy (R-LA) released a statement highlighting the 115 organizations who have called on Congress to reauthorize the bipartisan Pandemic and All-Hazards Preparedness Act (PAHPA). Press Release
- On January 2, HHS released a report highlighting claims data limitations identified during the COVID-19 Public Health Emergency Health (PHE) and considerations to address these limitations. Report
- On January 3, HHS released a readout of HHS Secretary Becerra’s meeting with long-term care providers to express concerns about low COVID-19 vaccination rates among nursing home residents. Readout
Health IT, Privacy, & Digital Health –
- On December 19, Micky Tripathi, National Coordinator at the Office of the National Coordinator for Health IT (ONC) published a blog on his recent testimony in front of the House Energy & Commerce Committee during a hearing on artificial intelligence (AI). Blog
- Also on December 19, Sen. Markey (D-MA), along with other Senate Democrats, wrote a letter to FDA Commissioner Califf asking the agency to ensure that its new Digital Health Technologies Advisory Committee includes voting members with civil rights, medical ethics, and disability rights backgrounds. Press Release Letter
- On December 20, GAO announced the appointment of five new members to the Health Information Technology Advisory Committee (HITAC). Press Release
- Also on December 20, the National Institute of Standards and Technology (NIST) issued an request for information (RFI), seeking information to assist in carrying out several of its responsibilities under President Biden’s recent Executive Order on Artificial Intelligence. RFI
- On January 3, Rep. Murphy (R-NC) sent a letter to the FDA Commissioner Califf regarding regulatory frameworks for AI in health care. The letter requests the FDA to answer several questions by January 13. Letter Press Release
Mental Health and Substance Use Disorder Policy –
- On December 21, HHS announced guidance recommending that all federal facilities across the nation include overdose reversal medications in their safety stations on site. The recommendation will make life-saving medications, such as naloxone, more readily available. Press Release
Prescription Drugs & Health Innovation –
- On December 19, FDA announced the availability of the draft guidance entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” to clarify how FDA evaluates real-world data (RWD) that can be used in FDA regulatory decision-making for medical devices. Announcement Draft Guidance
- On December 21, FDA announced the availability of a final guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This guidance provides recommendations to sponsors to support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from RWD sources in regulatory submissions. Announcement Final Guidance
- Also on December 21, FDA Commissioner Califf published a blog post on the FDA’s publication of guidance documents to help advance real world evidence. Blog
- Also on December 21, the Congressional Budget Office (CBO) issued a letter in response to an inquiry from House Committee on the Budget Chair Arrington (R-TX) and Rep. Burgess (R-TX) that requested information about the CBO’s analysis and model related to federal policies that affect the development of new drugs in the United States. Letter
- On December 22, FDA announced the availability of a final guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. Announcement Final Guidance
SDOH & Health Equity – On December 20, the Agency for Healthcare Research and Quality (AHRQ) released its 2023 National Healthcare Quality and Disparities Report that presents trends for measures related to access to care, affordable care, care coordination, effective treatment, healthy living, patient safety, and person-centered care. Press Release Executive Summary Report
Health Systems & Health Care Workforce – On December 29, the Health Resources and Services Administration (HRSA) released a notice with complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas as of December 2, 2023. Notice
Miscellaneous –
- On December 18, the Federal Trade Commission (FTC) and Justice Department released the 2023 Merger Guidelines which describe factors and frameworks the agencies utilize when reviewing mergers and acquisitions. Guidelines
- On January 3, AHRQ released a notice soliciting nominations for the U.S. Preventive Services Task Force (USPSTF). Nominations must be received by March 15, 2024 to be considered for appointment to begin in January 2025. Notice
Legislative Activity –
Votes and Committee Activity –
- On December 22, the President signed the National Defense Authorization Act for Fiscal Year 2024 (H.R. 2670) into law. The legislation authorizes appropriations for fiscal year 2024 for military activities of the Department of Defense and for military construction, and for defense activities of the Department of Energy, to prescribe military personnel strengths for such fiscal year. Bill Text Press Release
Introduced Legislation –
- On December 19, Rep. Gallagher (R-WI) introduced the Timely Bills for Patients Act (H.R. 6855), which would ensure timely bills for patients. Bill Text Press Release
- Also on December 19, Rep. Gallagher (R-WI) introduced the Prescription Drug Rebate Reform Act of 2023 (H.R. 6856), which would reform prescription drug pricing and reduce out-of-pocket costs by ensuring consumers benefit from negotiated rebates. Bill Text Press Release
- Also on December 19, Rep. Gallagher (R-WI) introduced the Simplify and Expand Health Savings Account Act (H.R. 6857), which would modernize health savings accounts. Bill Text Press Release
- Also on December 19, Reps. Kelly (R-PA), Clarke (D-NY), Dunn (R-FL), Davis (D-IL), Joyce (R-PA), and Ruiz (D-CA) introduced the Restore Protections for Dialysis Patients Act (H.R. 6860), which would clarify and preserve the breadth of the protections under the Medicare Secondary Payer Act. Press Release
- Also on December 19, Reps. Reschenthaler (R-PA), Kilmer (D-WA), and Van Orden (R-WI) introduced H.R. 6873, which would include information relating to the rate of suicide among covered Reserves in each National Veteran Suicide Prevention Annual Report of the Office Mental Health and Suicide Prevention of the Department of Veterans Affairs. Bill Text Press Release
- Also on December 19, Sens. Murphy (D-CT) and Braun (R-IN) introduced the Opioid Review Act (S. 3557), which would prepare a report that outlines a plan for completing a review of approved opioid analgesic drugs that considers the public health effects of such opioid drugs. Press Release