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, former President Donald Trump won the 2024 presidential election, and in the 119th Congress, Republicans will potentially control both chambers.
I. Regulations, Notices & Guidance
- On November 4, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas. This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) in a designated status as of October 15, 2024. The lists are available here.
- On November 7, 2024, the Centers for Medicare and Medicaid Services (CMS) released a notice entitled, Medicare, Medicaid, Children’s Health Insurance Program, Private Health Insurance Program; Health Equity Advisory Committee; Establishment & Nomination Request. This notice announces the establishment of the CMS Health Equity Advisory Committee and solicits nominations for members to be appointed to the committee by the Director of the CMS Office of Minority Health. The committee is established to advise and make recommendations to CMS on the identification and resolution of systemic barriers to accessing CMS programs that hinder quality of care for beneficiaries and consumers. The committee will focus on health disparities in underserved communities, which are populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, such as, but not limited to, Black, Latino, Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality as defined in the Executive Order, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.
- On November 8, 2024, CMS released a notice entitled, Medicare and Medicaid Programs; Approval of Application by the American Association for Accreditation of Ambulatory Surgery Facilities, for Continued CMS Approval of its Ambulatory Surgical Center (ASC) Accreditation Program. This notice acknowledges the approval of an application by the American Association for Accreditation of Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
- On November 8, 2024, CMS released a notice entitled, Medicare and Medicaid Programs; Approval of Application by Community Health Accreditation Partner (CHAP) Inc. for Continued CMS-Approval of its Hospice Accreditation Program. This notice acknowledges the approval of an application by Community Health Accreditation Partner Inc., for continued CMS-approval as a national accrediting organization for its hospice programs that wish to participate in the Medicare or Medicaid programs.
- On November 8, 2024, CMS released a notice entitled, Medicare Program; CY 2025 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. This notice announces the inpatient hospital deductible, and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2025 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2025, the inpatient hospital deductible will be $1,676. The daily coinsurance amounts for CY 2025 will be as follows: $419 for the 61st through 90th day of hospitalization in a benefit period; $838 for lifetime reserve days; and $209.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
- On November 8, 2024, CMS released a notice entitled, Medicare Program; CY 2025 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This notice announces Medicare’s Hospital Insurance Program (Medicare Part A) premium for uninsured enrollees in calendar year (CY) 2025. This premium is paid by enrollees aged 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the "uninsured aged") and by certain individuals with disabilities who have exhausted other entitlement. The monthly Medicare Part A premium for the 12 months beginning January 1, 2025, for these individuals will be $518. The premium for certain other individuals as described in this notice will be $285.
- On November 8, 2024, CMS released a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2025. This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2025. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2025, and the income related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts.
Event Notices
November 12, 2024: The National Institutes of Health (NIH) announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a hybrid meeting open to the public.
November 14, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting that is open to the public.
November 14, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
November 15, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting to discuss implementation of the Executive Order to establish the Artificial Intelligence (AI) in Healthcare Safety Program. This is a virtual meeting open to the public.
November 20, 2024: AHRQ announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is an in-person meeting open to the public.
November 20, 2024: CDC announced a meeting of the Board of Scientific Counselors, Office of Readiness and Response. This is a virtual meeting open to the public.
November 20, 2024: The Food and Drug Administration (FDA) announced a meeting to discuss proposed recommendations for the reauthorization of the Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) for fiscal years (FYs) 2026 through 2030. This meeting is open to the public.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This meeting is open to the public.
November 22, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a hybrid meeting open to the public.
December 2-3, 2024: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
December 3, 2024: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis. This is a virtual meeting open to the public.
December 3, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention’s Drug Testing Advisory Board. This is a virtual meeting open to the public.
December 4, 2024: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open for public comment.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
December 9, 2024: NIH announced a briefing on the National Academies of Science, Engineering, and Medicine’s (NASEM) Assessment of NIH Research on Women’s Health. This is a hybrid meeting open to the public.
December 11, 2024: CDC announced a meeting of the Lead Exposure and Prevention Advisory Committee. This is a virtual meeting open to the public.
December 12, 2024: NIH announced a meeting of the Advisory Committee to the Director, National Institutes of Health. This is a hybrid meeting open to the public.
December 12, 2024: FDA announced a hearing of the Vaccines and Related Biological Products Advisory Committee. This is a virtual 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.
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.
II. Reports, Studies, & Analyses
- On November 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) released a report entitled, Not All Selected Hospitals Complied With the Hospital Price Transparency Rule. In this audit, OIG found that nearly half of sampled hospitals (46 percent) failed to fully comply with CMS's Hospital Price Transparency Rule, which mandates that hospitals publicly post their standard charges. Out of 100 hospitals reviewed, 37 were noncompliant, with 34 missing requirements for machine-readable files and 14 lacking consumer-friendly displays of “shoppable” services. OIG recommended CMS enhance enforcement, clarify “shoppable services,” and develop training, especially for smaller hospitals. CMS agreed with all recommendations and has already implemented some corrective actions.
- On November 1, 2024, the Congressional Budget Office (CBO) released a cost analysis entitled, S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act. S. 3679 would reauthorize the appropriation of $45 million each year from 2025 through 2029 for HRSA to support the mental health and wellness of healthcare professionals and provide grants for those purposes. In 2024, HRSA allocated $25 million for those activities. Based on historical spending patterns for those activities and assuming the appropriation of the authorized amounts, CBO estimates that implementing those provisions would cost $181 million over the 2025-2029 period.
- On November 1, 2024, CBO released a cost analysis entitled, S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024. S. 3765 would reauthorize the appropriation of $24.3 million each year from 2025 through 2029 for HRSA to provide grants to support the expansion and improvement of emergency medical services for children who need treatment for trauma or critical care. In 2024, HRSA allocated $24 million for those activities. Based on historical spending patterns for those activities and assuming the appropriation of the authorized amounts, CBO estimates that implementing the bill would cost $94 million over the 2025-2029 period and $26 million after 2029.
III. Other Health Policy News
- On November 5, 2024, former President Donald Trump was elected President again. Votes continue to be counted in Nevada and Arizona, but with 295 electoral college votes, he well exceeds the 270 required to win the presidency. Although not all congressional races have been decided, Republicans gained the majority in the U.S. Senate and appear to be on track to retain the majority in the U.S. House of Representatives.
- If the House remains in Republican hands, a unified congressional majority will significantly strengthen President-elect Trump’s ability to advance his policy priorities. Broadly, President-elect Trump campaigned on expanding consumer choice in the market, reducing regulatory burden, and bolstering economic growth. Specifically related to health care, he pledged to replace the Affordable Care Act (ACA) with a superior alternative, grant states greater flexibility related to Medicaid, and reform multiple federal agencies, including the CDC, FDA, and NIH.
- The 118th Congress must still complete its work for remainder of the year, including extending appropriations and numerous expiring health programs beyond December 20, 2024, when the current Continuing Resolution (CR) expires. Notably, certain telehealth provisions are set to expire at the end of the year, along with public health extenders for Community Health Centers (CHCs), Teaching Health Center Graduate Medical Education (THGME), and National Health Service Corps (NHSC). Many Republican leaders are anticipating stronger legislative control in the 119th Congress, which could impact how the current Congress addresses these priorities, whether through passage of an extensive healthcare package during the “lame duck” legislative session, or through a “skinnier” CR package to extend funding into 2025.
- On November 5, 2025, the Department of Health and Human Services (HHS) announced the anniversary of the Task Force on Maternal Mental Health and highlighted significant strides in addressing maternal mental health issues through federal programs and policies. The task force has prioritized expanding screenings for maternal mental health conditions and has rolled out the National Maternal Mental Health Hotline, a 24/7 resource providing critical support to mothers facing mental health challenges. Additionally, partnerships across agencies have bolstered data collection efforts aimed at identifying and addressing disparities, particularly among underserved communities. Looking ahead, HHS is dedicated to advancing community resources, improving training for healthcare providers, and supporting further policy initiatives to enhance maternal mental health care nationwide. This includes a focus on expanding accessible support structures within communities and strengthening the healthcare workforce’s capabilities to address maternal mental health issues. As maternal mental health remains a priority, the task force’s efforts align with broader objectives to ensure comprehensive support and care for mothers across the United States. The press release is available here.
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