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, the Senate passed a budget resolution targeting border security, energy, and defense spending, and the Department of Justice has indicated that it will continue the Biden Administration's defense of prohibitions on preventative care cost-sharing.
I. Regulations, Notices & Guidance
Note: For many Executive Office of the President (EOP) actions, the stated day reflects when the action was submitted to the Federal Register, not when it was first released by the White House.
- On February 18, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October through December 2024. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
- On February 18, 2025, EOP released a notice of Executive Order 14212 entitled, Establishing the President’s Make America Healthy Again Commission. This EO establishes the President’s Make America Healthy Again (MAHA) Commission, chaired by the Secretary of the Department of Health and Human Services (HHS). The MAHA Commission is tasked with investigating and addressing the root causes of poor health outcomes, with an initial focus on childhood chronic diseases. The MAHA Commission will produce an assessment within 100 days and develop a strategy within 180 days based on its findings.
- On February 18, 2025, EOP released a memorandum entitled, Reciprocal Trade and Tariffs. This memorandum establishes the President’s Reciprocal Trade and Tariffs Committee, chaired by the U.S. Trade Representative. The President’s Reciprocal Trade and Tariffs Committee is tasked with reviewing and recommending policies to ensure fair and reciprocal trade practices. It will include representatives from various federal agencies, including the Departments of Commerce, State, and Treasury.
- On February 19, 2025, EOP released a notice of Executive Order 14214 entitled, Keeping Education Accessible and Ending COVID-19 Vaccine Mandates in Schools. This EO mandates that discretionary federal funds should not support any educational institution that requires COVID-19 vaccination for in-person attendance. It directs the Secretary of Education to issue guidelines to schools and universities regarding their legal obligations related to parental authority, religious freedom, disability accommodations, and equal protection under the law. Additionally, within 90 days, the Secretary of Education, in consultation with the HHS Secretary, must provide a plan to end COVID-19 school mandates, including a list of non-compliant institutions and any proposed legislation.
- On February 20, 2025, CMS released a notice entitled, Medicare and Medicaid Programs; Application from the Accreditation Commission for Health Care Inc. for Continued Approval of its Home Health Agency Accreditation Program. This notice announces CMS’ decision to approve the Accreditation Commission for Health Care Inc. (ACHC) for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs.
- On February 20, 2025, CMS released a notice entitled, Medicare and Medicaid Programs: Approval of Application from the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS-approval of its Outpatient Physical Therapy (OPT) Accreditation Program. This notice acknowledges the approval of an application from the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for continued recognition as a national accrediting organization for Outpatient Physical Therapy programs that wish to participate in the Medicare or Medicaid programs.
- On February 21, 2025, CMS released a notice entitled, Notice of Hearing: Reconsideration of Disapproval Idaho Medicaid State Plan Amendment (SPA) 24-0015. This notice announces an administrative hearing to be held on April 2, 2025, by way of video or in-person, to reconsider CMS’ decision to disapprove Idaho’s Medicaid SPA 24-0015. Requests to participate in the hearing as a party must be received by the presiding officer within 15 days of the notice’s publication in the Federal Register, which is scheduled for February 24, 2025.
- On February 21, 2025, EOP released a notice of Executive Order 14215 entitled, Ensuring Accountability for All Agencies. This EO applies new restrictions on the actions of independent agencies, including requiring independent agencies to submit proposed and final significant regulatory actions to the Office of Information and Regulatory Affairs (OIRA) for review, as well as submit strategic plans to the Director of the Office of Management and Budget (OMB) for approval prior to finalization. It also requires independent agencies to establish positions for White House liaisons within their agency to facilitate policy coordination with the White House Domestic Policy Council and the White House National Economic Council. The EO directs the OMB Director to establish performance standards and management objectives for independent agencies and report on their performance and efficiency, while also granting the OMB Director the authority to review and adjust the agencies' budgets to align with the President’s policies and priorities.
- On February 21, 2025, EOP released a notice of Executive Order 14216 entitled, Expanding Access to In Vitro Fertilization. This EO directs the Assistant to the President for Domestic Policy to submit policy recommendations within 90 days to protect in vitro fertilization (IVF) access and reduce the out-of-pocket and health plan costs for the treatments. The EO also calls for the removal of unnecessary statutory or regulatory burdens that may exacerbate the cost of IVF treatments. These policy recommendations would be due to the President on or before May 19, 2025.
Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings have been cancelled or postponed. We are continuing to monitor.
February 25, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
February 25, 2025: The Food and Drug Administration (FDA) announced a public workshop entitled, Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development. This is a virtual workshop open to the public.
February 26-28, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
March 5, 2025: The Department of Veterans’ Affairs (VA) announced a meeting of the Rehabilitation Research and Development Service (RR&D) Scientific Merit Review Board. This is a virtual meeting, partially open to the public.
March 5, 2025: VA announced a meeting of the National Research Advisory Council (NRAC). This is a virtual meeting open to the public.
March 5-6, 2025: The Health Resources & Services Administration (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.
March 27-28, 2025: FDA announced a public workshop entitled, Optimizing Pregnancy Registries. This is an in-person workshop open to the public.
April 2, 2025: CMS announced a hearing to reconsider its decision to disapprove Idaho’s Medicaid State Plan Amendment, numbered 24-0015. This is a hybrid hearing open to the public.
April 3, 2025: The National Institutes of Health (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 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, Fiscal Year (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 NACNEP. This is a hybrid meeting open to the public.
August 8, 2025: HRSA announced a meeting of ACTPCMD. This is a hybrid meeting open to the public.
September 11-12, 2025: HRSA announced a meeting of the COGME. This is a hybrid meeting open to the public.
December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
II. Hearings & Markups
- On February 20, 2025, the Senate Judiciary Committee held a hearing entitled, Business meeting to consider S.331, to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances. S.331 was amended, but a final vote on whether to report S.331 favorably was delayed until February 27, 2025.
III. Reports, Studies, & Analyses
- On February 18, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Not All Medicare Enrollees Are Continuing Treatment for Opioid Use Disorder. OIG found that only about 40 percent of Medicare enrollees who began treatment with buprenorphine for opioid use disorder continued their treatment. Those who did continue treatment had better outcomes, including lower mortality rates. However, only one-third of the enrollees who began buprenorphine treatment received at least one behavioral therapy service, which can increase the chance that a patient continues buprenorphine treatment. Additionally, few enrollees received other services aimed at ensuring that they continue buprenorphine treatment, such as care coordination services. OIG recommended that CMS educate both providers and enrollees about available services, assess and adjust payment codes for office-based treatments, and inform emergency department providers about Medicare payments for initiating opioid use disorder treatments. CMS concurred with all of these recommendations.
- On February 18, 2025, OIG released a report entitled, Colorado Made Capitation Payments to Managed Care Organizations After Enrollees’ Deaths. OIG identified 127,874 capitation payments totaling over $7.8 million that were made to Managed Care Organizations (MCOs) for enrollees whose date of death was not recorded in the State agency’s eligibility system, but who did have a date of death recorded in the Social Security Administration’s (SSA) death master file prior to the payment period. A random sampling of these payments found that about 90 percent were indeed made after the enrollee’s death in the preceding payment period, accounting for a total of over $6.7 million. In addition, OIG found almost 39,000 unallowable capitation payments that Colorado made on behalf of deceased enrollees even though their dates of death were accurately recorded in the State’s eligibility system. This issue resulted in an estimated $3.8 million in unallowable payments. Colorado also incorrectly reported over $2.2 million in other Medicaid expenditures to CMS. OIG recommended that Colorado refund an estimated $6.0 million to the federal government and implement corrective actions, some of which Colorado has agreed to or already started.
IV. Other Health Policy News
HHS Issues New Guidance on Definitions of Biological Sex and Rescinds Biden-Era Guidance on Gender-Affirming Care
- On February 19, 2025, HHS issued guidance in response to EO 14168, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government,” addressing sex-based definitions, asserting that there are only two sexes, male and female. The guidance defines “sex” as “a person’s immutable biological classification as either male or female,” “male” as a person “of the sex characterized by a reproductive system with the biological function of producing sperm,” and “female” as a person “of the sex characterized by a reproductive system with the biological function of producing eggs (ova).”
- The following day, February 20, 2025, the HHS Office for Civil Rights (OCR) rescinded previous guidance on gender-affirming care in response to EO 14187, “Protecting Children from Chemical and Surgical Mutilation.” This rescinded guidance, issued in March 2022, had interpreted civil rights and health information privacy laws as providing protections against discrimination based on gender identity and supporting gender-affirming care as a civil right.
- Of note, the provisions of EO 14168 and EO 14187 that would condition or withhold federal funding based on the fact that a healthcare entity or health professional provides gender affirming medical care to a patient under the age of 19 or otherwise “promote gender ideology” is subject to a temporary restraining order in the U.S. District Court for the District of Maryland (case number: 8:25-cv-00337).
- Additionally, the provisions of EO 14187 that would (1) condition or withhold federal funding based on the fact that a healthcare entity or health professional provides gender affirming medical care to a patient under the age of 19; and (2) direct the Attorney General to prioritize “enforcement of protections against female genital mutilation” are subject to a temporary restraining order in the U.S. District Court, Western District Court of Washington at Seattle (case number 2:25-cv-00244).
- The HHS guidance can be viewed here, and the OCR’s memorandum rescinding previous guidance can be viewed here.
Congress Begins Budget Reconciliation Process
- Last week, both the House of Representatives and the Senate began the process of budget reconciliation, the process by which large changes to spending and tax policy can be implemented under an expedited timeline. This first step consists of the Budget Committee in each chamber holding a mark-up on their respective budget resolution, which is used to set topline spending levels for each congressional committee. The budget resolution is then voted upon by the full chamber. After passage of the resolution, each committee then submits a package of legislation within their jurisdiction that adjusts federal spending and revenues to meet the budget resolution’s targets.
- Notably, the Senate Budget Committee, chaired by Senator Lindsey Graham (R-SC), and House Budget Committee, chaired by Representative Jodey Arrington (R-TX-19) have released significantly different resolutions. The Senate’s resolution focuses primarily on border security, defense, and energy spending, and accounts for about $340 billion in spending increases. The House’s resolution includes $1.5 trillion in spending cuts, $4.5 trillion in tax cuts, and a $4 trillion debt limit extension. This is reflective of the opposing viewpoints the House and Senate Republicans have had on how to approach reconciliation, with the Senate Republicans favoring two bills while House Republicans favor just one. A second Senate resolution featuring larger tax and spending cuts is expected at a later date.
- The House resolution also includes instructions for the House Committee on Energy and Commerce to propose legislation under its jurisdiction that would reduce federal spending by $880 billion over the next ten years. This is widely expected to come in the form of cuts to Medicaid spending, but Energy and Commerce Chairman Brett Guthrie (R-KY-02) has yet to announce how and to what degree those cuts will take shape.
- The Senate passed its budget resolution in the early morning of February 21, 2025, while the House is expected to vote on its resolution on February 25, 2025.
DOJ Continues Defense of Cost-Sharing Prohibitions in Braidwood SCOTUS Case
- On February 18, 2025, the Department of Justice (DOJ) indicated in its filing to the Supreme Court of the United States (SCOTUS) that it intends to continue the Biden Administration’s defense of the Affordable Care Act’s (ACA) mandate requiring most private insurers to cover preventative services without cost-sharing in the case Braidwood v. Becerra. Specifically, the case questions the constitutionality of the U.S. Preventive Services Task Force’s (USPSTF) role in determining covered services. The plaintiffs argue that USPSTF members are “principal officers” who were not properly appointed, but DOJ argues that USPSTF members are “inferior officers”, as evidenced by their ability to be removed “at-will”, and that their decisions are reviewed by an appropriately appointed “principal officer.”
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