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.
Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.
Week in Review Highlight of the Week:
This week, HHS and DEA postponed the effective date of their buprenorphine telemedicine prescribing rule until 2026 and HHS continued the Biden-era defense of its authority to dictate 340B rebate models.
1. Regulations, Notices & Guidance
- On March 17, 2025, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review. AHRQ is seeking scientific information submissions from the public to inform its review on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. AHRQ notes that access to published and unpublished pertinent scientific information will improve the quality of this review.
- On March 19, 2025, the Food and Drug Administration (FDA) released a notice entitled, Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability. FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) issued to Beckman Coulter, Inc., for the Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. FDA revoked the EUAs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the EUA holder.
- On March 19, 2025, FDA released a notice entitled, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 063. FDA is announcing a publication containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled Modifications to the List of Recognized Standards, Recognition List Number: 063 (Recognition List Number: 063), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
- On March 19, 2025, the Executive Office of the President (EOP) released an executive order (EO) entitled, Achieving Efficiency Through State and Local Preparedness. This EO announces that it is the policy of the Administration that state and local governments should play a more active and significant role in national resilience and preparedness. It directs the creation of a National Resilience Strategy; the review of infrastructure, continuity, and preparedness policies; the development of a National Risk Register to identify, articulate, and quantify risks to national infrastructure; and directs the streamlining of the federal government’s preparedness and continuity functions.
- On March 20, 2025, FDA released a notice entitled, Over-the-Counter Monograph Drug User Fee Program--Facility Fee Rates for Fiscal Year 2025. FDA is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). The notice also includes the OMUFA facility fee rates for FY 2025.
- On March 20, 2025, the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) released a final rule entitled, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients. HHS and DEA are announcing that two final rules related to telemedicine scheduled to become effective on March 21, 2025, the Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients final rules, would be delayed to December 31, 2025. During the comment period following the final rules’ first implementation delay, DEA received 32 comments regarding the delayed effective date. When considering these comments, the Department of Justice (DOJ), which oversees DEA, determined that it was necessary to further postpone the effective dates for the purpose of further reviewing any questions of fact, law, and policy that the rules may raise. In the final rule, the agencies also note that this additional effective date delay will not delay or limit the ability of practitioners covered by the final rules to prescribe via telemedicine because they currently are able to do so pursuant to COVID-19 telemedicine prescribing flexibilities that were extended through December 31, 2025.
- On March 20, 2025, the EOP released an EO entitled, Improving Education Outcomes by Empowering Parents, States, and Communities. This EO directs the Secretary of Education to take all necessary steps to facilitate the closure of the Department of Education, return authority over education to the States and local communities while “ensuring the effective and uninterrupted delivery of services, programs, and benefits on which Americans rely,” and “ensure that the allocation of federal funds to the Department of Education complies with federal law and administration policy” (e.g., not being used to promote diversity, equity, and inclusion (DEI) programs or gender ideology).
- On March 20, 2025, the EOP released an EO entitled, Eliminating Waste and Saving Taxpayer Dollars by Consolidating Procurement. This EO consolidates domestic Federal procurement in the General Services Administration (GSA). Within 60 days of the date of this order, agency heads are required to submit to the GSA Administrator proposals to have the GSA conduct domestic procurement with respect to common goods and services for the agency. Within 90 days of the date of this order, the GSA Administrator is required to submit a comprehensive plan to the Office of Management and Budget (OMB) Director for the GSA to procure common goods and services across the domestic components of the Government. Within 30 days of the date of this order, the OMB Director is required to designate the GSA Administrator as the executive agent for all Government-wide acquisition contracts for information technology (IT). The GSA Administrator must, on an ongoing basis, “rationalize Government-wide indefinite delivery contract vehicles for information technology for agencies across the Government, including as part of identifying and eliminating contract duplication, redundancy, and other inefficiencies.”
- On March 20, 2025, the EOP released a memorandum entitled, Strengthening the Suitability and Fitness of the Federal Workforce. This memorandum delegates the Office of Personnel Management (OPM) Director the authority to make final “suitability determinations” and take “suitability actions” regarding employees in the executive branch based on post-appointment conduct. A suitability action can include a directive by OPM to the head of an executive department or agency to remove an employee who does not meet the suitability criteria defined in OPM’s regulations. It also requires the OPM Director to propose regulations to account for the delegation and to implement appropriate rules and procedures regarding suitability determinations and suitability actions based on post-appointment conduct. Such delegation must not be effective until the completion of this rulemaking.
- On March 20, 2025, the EOP released a memorandum entitled, Stopping Waste, Fraud, and Abuse by Eliminating Information Silos. This memorandum requires that agency heads “take all necessary steps, to the maximum extent consistent with law, to ensure Federal officials designated by the President or Agency Heads (or their designees) have full and prompt access to all unclassified agency records, data, software systems, and information technology systems — or their equivalents if providing access to an equivalent dataset does not delay access — for purposes of pursuing Administration priorities related to the identification and elimination of waste, fraud, and abuse.” This includes “authorizing and facilitating both the intra- and inter-agency sharing and consolidation of unclassified agency records.”
- On March 21, 2025, FDA released a notice entitled, Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Final Rule; Delay of Effective Date. In accordance with the presidential memorandum of January 20, 2025, entitled Regulatory Freeze Pending Review, the effective date of the final rule, entitled Nonprescription Drug Product With an Additional Condition for Nonprescription Use, (ACNU) was originally delayed until March 21, 2025. Additional time is needed for review; therefore, FDA is extending the delay for an additional 60 days.
Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings may be cancelled or postponed. We are continuing to monitor.
** - New addition
- March 27-28, 2025: The Health Resources and Services Administration (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: The Centers for Medicare & Medicaid Services (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 15-16, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
- **April 24, 2025: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with one session 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 5-6, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health. 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, 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.
2. Reports, Studies, & Analyses
- On March 19, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Medicare Administrative Contractors Did Not Consistently Meet Medicare Cost Report Oversight Requirements. OIG examined whether the 12 Medicare Administrative Contractor (MAC) jurisdictions complied with Medicare cost reporting requirements. OIG found that between FY 2019 and 2021, each of the 12 MAC jurisdictions failed to comply with the contract requirements for audit and reimbursement desk review and audit quality (AR-4) for at least one of the three years. Issues included MACs not performing proper reviews, inadequate review of graduate medical education (GME) and indirect medical education (IME) reimbursement, improper review of allocation, grouping, or reclassification of charges to cost centers, improper calculation and reimbursement for nursing and allied health programs, and inadequate review of bad debts. The MACs suggested that some of the causes of this were unclear guidance from CMS, limited feedback on cost report reviews, inadequate training, and staffing issues. As a result, OIG recommended that CMS provide MACs with clearer feedback on Quality Assurance Surveillance Plan (QASP) audits, update the audit program to incorporate revised change requests and Technical Direction’s Letters, and offer MACs additional training and guidance, based on the results of their QASP, and include best practices used by MACs. CMS generally concurred with these recommendations.
3. Other Health Policy News
- On March 19, 2025, CMS published a proposed rule entitled, Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability.
- The proposed rule revises Marketplace standards relating to:
- Past-due premium payments;
- The evidentiary standard HHS uses to assess an agent’s, broker’s, or web-broker’s potential noncompliance with marketplace requirements;
- An individual’s ineligibility for advance payments of the premium tax credit (APTC) due to a failure to file and reconcile their taxes;
- Income eligibility verifications for premium tax credits and cost-sharing reductions;
- Annual eligibility redetermination;
- How automatic re-enrollment works for individuals who may be eligible for APTC;
- The annual open enrollment period;
- Special enrollment periods (SEPs);
- De minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements and for income-based cost-sharing reduction plan variations; and
- The premium adjustment percentage methodology.
- CMS also proposes policies that would exclude Deferred Action for Childhood Arrivals (DACA) recipients from the definition of “lawfully present,” making them ineligible for enrollment in a qualified health plan (QHP) or in insurance affordability programs. The agency also proposes to prohibit issuers of coverage subject to EHB requirements from providing coverage for “sex-trait modification” as an EHB.
- The proposed rule cites President Trump’s January 20, 2025 memorandum entitled, Delivering Emergency Price Relief for American Families and Defeating the Cost-of-Living Crisis, which instructed all executive departments and agencies to “deliver emergency price relief for the American people and to increase the prosperity of the American worker,” noting that health care represents a “substantial portion of a family’s budget” and a “tremendous cost to Federal taxpayers.” In the proposed rule, CMS is proposing several regulatory actions aimed at “strengthening the integrity of the Patient Protection and Affordable Care Act (ACA) eligibility and enrollment systems to reduce waste, fraud, and abuse” in order to provide relief from rising health care costs.
- The full proposed rule can be viewed here.
- On March 17, 2025, HHS filed a cross-motion for summary judgment against drug manufacturers who sued HHS for blocking their proposed rebate model for drugs purchased under the 340B Drug Pricing Program (340B) in the U.S. District Court for the District of Columbia. This filing marks the Trump Administration’s first action regarding 340B and it appears to indicate that the Administration is supportive of HHS’ authority to dictate how the 340B program operates, maintaining an argument from the Biden Administration that all 340B rebate models must be approved by the HHS Secretary. Ultimately, the legality of these arguments is still being determined by the court. The full motion filed by HHS can be viewed here.
4. Additional Alston & Bird Publications
- We have released an advisory on the potential ramifications of HHS rescinding the Richardson Waiver, which can be found here.
- We have also released an advisory on how the Trump Administration’s indirect cost guidance could impact NIH and other grant recipients, which can be found here.
- Finally, we maintain an online tracker for all executive orders issued by the Trump Administration, which is updated daily and can be found here.
View our Health Care Legislative & Public Policy team.
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