Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, Congress continued to work to avert an impending government shutdown, and Senators announced the launch of the MAHA Caucus.
I. Regulations, Notices & Guidance
- On December 16, 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) released a final rule entitled, Health Data, Technology, and Interoperability: Protecting Care Access. This final rule finalized certain proposals from the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability Proposed Rule (HTI-2 Proposed Rule) and in doing so, supports the access, exchange, and use of electronic health information. Specifically, this final rule revises two existing information blocking exceptions and establishs an additional reasonable and necessary activity that does not constitute information blocking referred to as the Protecting Care Access Exception. This final rule is effective on December 17, 2024.
- On December 16, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee.
- CDC is seeking nominations for membership on the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC, consisting of up to 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses), and practice settings (academic, clinical, public health), and includes a consumer representative. Nominations for membership on CLIAC must be received no later than July 1, 2025.
- On December 16, 2024, CDC released a notice entitled, Expansion of NIOSH B Reader Certification Eligibility; Request for Information. The B Reader Program, administered by CDC’s National Institute for Occupational Safety and Health (NIOSH), is seeking information from experts in occupational respiratory health surveillance and radiology, nurse practitioners, physician assistants, workers exposed to mineral dust; and unions representing such workers, industry and other parties interested in allowing nurse practitioners and physician assistants to be eligible to take the NIOSH B Reader examination and become certified B Readers if they successfully pass the examination.
- On December 16, 2024, CDC released a final rule entitled, Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins. This rule finalizes updates to the Department of Health and Human Services’ (HHS) list of select agents and toxins that could pose a severe threat to public health and safety. These updates were proposed along with other changes to the select agent and toxin regulations, which will be addressed in a separate regulatory action. The U.S. Department of Agriculture (USDA) is making parallel regulatory changes.
- On December 17, 2024, the National Institutes of Health (NIH) released a notice entitled, The National Institutes of Health Public Access Policy. The 2024 NIH Public Access Policy implements additional steps to accelerate free public access to scholarly publications resulting from the research that NIH supports, building upon NIH’s work towards providing public access to research results.
- On December 18, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Impact of Healthcare Worker Safety and Wellness: A Systematic Review. AHRQ is seeking scientific information submissions from the public to inform AHRQ’s review entitled, Impact of Healthcare Worker Safety and Wellness: A Systematic Review, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On December 19, 2024, CDC released a notice entitled, Hazardous Drugs: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 and Final Reevaluation Determinations for Liraglutide and Pertuzumab. The National Institute for Occupational Safety and Health (NIOSH) announced the publication of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, as well as final reevaluation determinations removing the drugs liraglutide and pertuzumab from the NIOSH List of Hazardous Drugs in Healthcare Settings.
- On December 19, 2024, CDC released a notice entitled, Notice of Award of a Sole Source Cooperative Agreement to Fund Secretaria Ejecutiva del Consejo de Ministros de Salud de Centroamerica y Republica Dominicana (SE-COMISCA). CDC announced the award of approximately $5,000,000, with an expected total funding of approximately $25,000,000 over a 5-year period, to SE-COMISCA. The award will build upon previous efforts by the CDC in collaboration with Ministries of Health of Central America and the Dominican Republic (SE-COMISCA) to target increased capacity at the national and subnational level to implement and achieve outbreak/epidemic/pandemic control in line with U.S. Government and CDC strategy.
- On December 19, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
- On December 20, 2024, FDA released a final rule entitled, Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. FDA is issuing this final rule updating the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This final rule revises the requirements for when the term “healthy” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that are particularly useful as the foundation of a nutritious diet that is consistent with dietary recommendations.
- On December 20, 2024, FDA released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. The FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) has modified its organizational structure. The new organizational structure was approved by the Secretary of HHS on November 19, 2024.
Event Notices
January 7, 2025: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
January 7, 2025: The Small Business Administration (SBA) announced a meeting of the National Women’s Business Council. This is an in-person meeting open to the public.
January 13, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
January 16, 2025: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
January 23, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting with one session open to the public.
January 23, 2025: HRSA announced a meeting of the Secretary’s Advisory Council on Blood Stem Cell Transplantation (ACBSCT). This is a virtual meeting open to the public.
January 27, 2025: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
January 28, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is an in-person meeting open the public.
January 28, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is an in-person meeting open to the public.
February 5, 2025: FDA announced a joint public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This is a hybrid meeting open to the public.
March 5-6, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
March 27-28, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
April 3, 2025: NIH announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
April 10-11, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
April 30, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
May 14, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
June 3-4, 2025: FDA announced a public workshop entitled “FY 2025 Generic Drug Science and Research Initiatives Workshop.” This is a hybrid workshop open to the public.
August 6-7, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
December 4-5, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
II. Reports, Studies, & Analyses
- On December 17, 2024, the Government Accountability Office (GAO) released a report titled Opioid Use Disorder Grants: Opportunities Exist to Improve Data Collection, Share Information, and Ease Reporting Burden. The report examined the Substance Abuse and Mental Health Services Administration’s (SAMHSA) management of the State and Tribal Opioid Response grant programs, which have distributed over $8 billion to states and Tribes since fiscal year 2018 to address the opioid crisis. According to the report, while the grants have funded vital prevention, treatment, and harm reduction services, SAMHSA could improve its processes to enhance program effectiveness. The report found that SAMHSA does not collect data on the actual subrecipients of grant funds, which limits its ability to evaluate how the grants are used. Additionally, grant recipients reported challenges in accessing lessons learned from other programs, and tribal recipients noted that administrative burdens hinder participation in the Tribal Opioid Response program. GAO recommended that SAMHSA implement plans to collect subrecipient data, improve data sharing, and assess ways to reduce administrative burdens for Tribes. SAMHSA and HHS concurred with these recommendations.
- On December 18, 2024, the Kaiser Family Foundation (KFF) released a report titled Hospital Margins Rebounded in 2023, But Rural Hospitals and Those With High Medicaid Shares Were Struggling More Than Others. The report analyzed hospital financial performance from 2018 through 2023, focusing on operating margins, which measure profitability from patient care and operations. According to the report, aggregate operating margins improved from 2.7 percent in 2022 to 5.2 percent in 2023, while total margins increased from 2.3 percent to 6.4 percent. However, both measures remained below pre-pandemic levels, and financial challenges persisted for certain hospital types. The report found that rural hospitals and those with high Medicaid shares faced below-average operating margins in 2023, particularly small rural hospitals and facilities with Medicare rural designations. In contrast, hospitals with higher commercial reimbursement rates and for-profit hospitals reported stronger financial performance and approximately 39 percent of hospitals had negative operating margins, underscoring continued financial pressures.
- On December 19, 2024, the RAND Corporation released a report titled Telehealth Visits in Health Centers Serving Low-Income Patients in California: Final Results from the Connected Care Accelerator Initiative (2022–2024). This report analyzed telehealth use among Federally Qualified Health Centers (FQHCs), which provide primary and limited specialty care to nearly 30 million low-income patients nationwide, within the state of California. The study focused on trends in in-person, video, and audio-only visits between September 2022 and August 2024, capturing the transition following the end of the COVID-19 public health emergency (PHE) in May 2023. The report found that telehealth remained a significant modality for delivering care, accounting for about 25 percent of primary care visits and 50 percent of behavioral health visits during the study period. However, the share of telehealth visits declined over time. For primary care, video visits decreased from 8.9 percent in September 2022 to 5.4 percent in August 2024, while audio-only visits dropped from 19.5 percent to 17.3 percent. Most health centers continued to offer in-person, video, and audio-only options, ensuring flexibility in care delivery. Despite the sustained use of telehealth, disparities persisted. Patients preferring English were disproportionately represented among those accessing video visits, especially for behavioral health, where they accounted for 80.1 percent of video visits but only 66.6 percent of all unique patients. RAND concluded that these findings highlight telehealth’s potential to expand access while underscoring the need to address inequities in its implementation.
III. Other Health Policy News
- On Tuesday, December 17, 2024, congressional leaders released text of a government funding package that was expected to be voted on later in the week. On Thursday afternoon, Congress released another potential funding agreement, but neither deal has garnered enough support to pass Congress. Currently, the federal government is operating under a continuing resolution (CR) that runs through December 20, 2024, and unless Congress passes appropriation bills or another CR by that date, the government will shut down.
- The legislative package released on Tuesday included another CR to fund the government through March 14, 2025, and included numerous health care provisions related to physician payment, including a 2.5 percent boost to the Medicare Physician Fee Schedule (PFS) conversion factor for 2025—which would mitigate, but not eliminate—the scheduled 2.83 percent cut to Medicare PFS payments next year. Other provisions included a one-year extension of the 1.0 floor of the work geographic practice cost index (GPCI) and a one-year extension of incentive payments for clinicians participating in advanced alternative payment models (APMs) under the Medicare Quality Payment Program (QPP). Additionally, the legislation waived the requirements of the Pay-As-You-Go (PAYGO) Act of 2010 that would have otherwise resulted in a mandatory four percent reduction in Medicare payments starting in 2025, and essentially waives the budgetary impact of prior enacted legislation that also would have triggered the PAYGO requirements.
- The proposed CR also included provisions to extend expiring Medicare policies and programs, including two-year extensions of COVID-19 era telehealth flexibilities and a five-year extension of the Medicare Acute Hospital Care at Home (AHCAH) program. Also included were reauthorizations of expiring public health programs including a five-year reauthorization of the Teaching Health Center Graduate Medical Education (THCGME) program, a two-year reauthorization of the National Health Service Corps (NHSC), two years of funding for Community Health Centers (CHCs) and the Special Diabetes Programs, a five-year reauthorization of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, a two-year reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), and a five-year reauthorization of programs under the Dr. Lorna Breen Health Care Provider Protection Act.
- However, by Wednesday evening the deal had been pulled from consideration as President-elect Trump and tech billionaire Elon Musk expressed opposition to the bill. President-elect Trump criticized the size of the package and noted the absence of an extension of the debt limit, which is set to expire early next year.
- On Thursday, December 19, 2024, House Republicans released a scaled back legislative package that included a CR funding the government through March 14, 2025, and a suspension of the debt limit until 2027. The bill also included extensions of expiring health care policies and programs, such as telehealth flexibilities, the AHCAH Program and the 1.0 work GPCI floor, through March 31, 2025. Expiring public health programs including the THCGME program, NHSC, CHCs, and the Special Diabetes Program also would be extended through March 31, 2025. Notably absent from the legislation was any relief to address the impending 2.83 percent cut to the PFS.
- This scaled back package failed to pass the House on Thursday evening. Despite support for the bill from President-elect Trump, 38 Republicans voted against the bill alongside 197 Democrats, while two Democrats and 172 Republicans voted in support.
- With the government scheduled to shutdown at the end of December 20, 2024, Congress has limited options. House Republicans are planning to bring a third proposal to a vote, consisting of a CR through March 14, 2025, and $110 billion in disaster aid, without a suspension of the debt limit. It is unclear at the time of drafting this summary how this proposal addresses the above health care provisions or whether it will successfully pass.
- On December 19, 2024, Senator Roger Marshall (R-KS) announced the creation of the Make America Healthy Again (MAHA) Caucus, which will focus on addressing chronic disease prevention and improving overall health outcomes across the United States. The caucus includes Senators Rick Scott (R-FL), Tommy Tuberville (R-AL), Cynthia Lummis (R-WY), and Ron Johnson (R-WI), and will prioritize improving access to preventive care, promoting better nutrition through a ‘Food is Medicine’ approach, and expanding primary care services, particularly in underserved areas. A key component of the caucus’s agenda is increasing access to affordable, nutrient-dense foods and improving education about the health impacts of diet, including processed foods. The caucus also emphasizes the importance of supporting community health centers, expanding telehealth services, and encouraging direct primary care (DPC) models to reduce healthcare costs and improve access to care. Additionally, the MAHA Caucus advocates for regenerative agriculture practices to enhance food quality and soil health, with the goal of improving long-term public health. A key priority of the caucus is shifting healthcare resources toward prevention rather than treatment, particularly by promoting non-pharmaceutical solutions to address chronic diseases. The MAHA Caucus plans to work closely with Robert F. Kennedy Jr., President-elect Trump’s nominee for Secretary of HHS, to advance these initiatives and drive legislative action. A press release with more information is available here.
- On December 18, 2024, Senators Michael Bennet (D-CO) and Roger Marshall (R-KS) introduced the No Surprises Act Enforcement Act to strengthen the enforcement mechanisms of the 2020 No Surprises Act (NSA). The original law protects patients from unexpected out-of-network medical bills, but has faced implementation challenges. The new bill seeks to address these gaps by increasing penalties for non-compliance with statutory payment deadlines, creating parity in penalties for all parties, and enhancing reporting requirements to ensure transparency in dispute resolutions between insurers and providers.
- The legislation responds to ongoing concerns about delayed payments and enforcement issues that undermine the intent of the NSA. It aims to ensure fair and timely resolution of disputes, protecting patients from financial harm while holding both insurers and providers accountable. The bill has bipartisan, bicameral support, with Representatives Greg Murphy (R-NC), Raul Ruiz (D-CA), John Joyce (R-PA), Kim Schrier (D-WA), and Jimmy Panetta (D-CA) introducing companion legislation, H.R. 9572, the Enhanced Enforcement of Health Coverage Act in the House. The Senate bill text is available here. A press release with more information is available here. The House bill is available here.
- On December 19, 2024, Senators Bill Cassidy (R-LA), Catherine Cortez Masto (D-NV), John Cornyn (R-TX), and Michael Bennet (D-CO) introduced a bipartisan draft bill to modernize the Medicare graduate medical education (GME) program. This legislation seeks to address the projected shortage of nearly 140,000 physicians by 2036, including 68,020 primary care doctors and 42,130 psychiatrists. By reforming GME funding and training, the proposal aims to increase the physician workforce and improve access to care, particularly in rural and underserved areas and builds on the Medicare GME Working Group’s policy proposals first outlined earlier this year. The draft legislation includes several key provisions: expanding Medicare-funded residency slots in high-need areas and specialties, supporting rural hospitals in establishing and maintaining residency training programs, and improving federal data collection to better allocate GME funding and address workforce gaps. Additionally, the Senators are seeking public input on the proposal through January 31, 2025, including feedback on the fair distribution of residency slots, flexibility for rural hospitals, and the creation of a GME Policy Council to guide future allocations. The draft text is available here. A press release with more information is available here.
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