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.
Highlight of the Week
This week, the White House released the President’s budget request for fiscal year (FY) 2027, and CMS finalized policy and technical changes to Medicare Advantage (MA), the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year (CY) 2027.
Regulations, Notices & Guidance
- On March 30, 2026, the Food and Drug Administration (FDA) released a notice entitled, Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments. Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII), included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have committed to supporting the use of DHTs in drug and biological product development. To inform potential FDA activities in this area, CDER and CBER are requesting information to better understand the opportunities and challenges sponsors and other interested parties face in making innovative use of DHTs in clinical investigations of drugs and biological products.
- On March 31, 2026, the Department of Health and Human Services (HHS) released a notice entitled, Statement of Organization, Functions, and Delegations of Authority; Office of The National Coordinator for Health Information Technology. This reorganization by HHS reverses the actions that created the management title of Assistant Secretary for Technology Policy (ASTP), removes the title and role from HHS’ leadership structure, and restores the Office of the National Coordinator for Health Information Technology (ONC) as a singularly titled office. The roles and responsibilities of the HHS Chief Technology Officer, Office of the HHS Chief Artificial Intelligence Officer, and Office of the HHS Chief Data Officer will no longer be part of ONC.
- On March 31, 2026, FDA released a notice entitled, Filing of Color Additive Petition from the International Association of Color Manufacturers; Request to Amend the Color Additive Regulations to Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride. FDA is announcing they have filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM), proposing that the agency amend the color additive regulations to no longer provide for the use of three specified solvents—methylene chloride, trichloroethylene, and ethylene dichloride—for preparing certain color additives, because these uses have been permanently abandoned.
- On April 1, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Advisory Board on Radiation and Worker Health; Notice of Charter Renewal. CDC is announcing the renewal of the charter of the Advisory Board on Radiation and Worker Health (ABRWH). This charter has been renewed for a two-year period through March 22, 2028.
- On April 2, 2026, the National Institutes of Health (NIH) released a notice entitled, Government-Owned Inventions; Availability for Licensing. The National Institute of Allergy and Infectious Diseases (NIAID) is giving notice of an invention that uses blood plasma with the rare immune disorder CD4 lymphocytopenia (ICL) to find naturally occurring human antibodies. This new approach is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
- On April 2, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Approval of Application by the Accreditation Commission for Health Care Inc. (ACHC) for Continued CMS-Approval of its Hospice Accreditation Program. This notice acknowledges the approval of an application from the Accreditation Commission for Health Care Inc. (ACHC), for continued CMS approval as a national accrediting organization for hospice programs that wish to participate in the Medicare or Medicaid programs.
- On April 2, 2026, CMS released a notice entitled, Medicare and Medicaid Programs: Application from the Accreditation Commission for Health Care Inc. (ACHC) for Continued Approval of its Critical Access Hospital Accreditation Program. This notice announces the decision to approve the ACHC for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.
- On April 2, 2026, HHS released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. HHS is issuing this notice to revise its Statement of Organization, Functions, and Delegations of Authority for the Office of the Secretary (OS). This reorganization removes the Office of the Chief Information Officer (OCIO) from the organizational description for the Office of the Assistant Secretary for Administration (ASA), and establishes the OCIO as a stand-alone organization that reports directly to the HHS Secretary and Deputy Secretary. These changes supersede the OCIO-related organizational language contained in the notice published at 74 FR 57747 on November 9, 2009, and any subsequent amendments, as well as corresponding OCIO references in the ASA Federal Register notice published at 90 FR 3655 on January 10, 2025.
- On April 2, 2026, CMS released a final rule entitled, Medicare Program; Contract Year 2027 and Certain Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program. This final rule revises the Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), and Medicare cost plan regulations to implement changes related to Star Ratings, marketing and communications, drug coverage, enrollment processes, special needs plans (SNPs), and other programmatic areas.
- On April 3, 2026, FDA released a notice entitled, Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation. FDA is announcing an updated data standard requirement for the submission of postmarketing individual case safety report (ICSR) submissions for human drug products, biological products, and drug- or biologic-led combination products to the FDA Adverse Event Monitoring System (AEMS) database via the Electronic Submissions Gateway Next Generation (ESG NextGen). Starting October 1, 2026, postmarketing ICSRs must be reported using the data standards adopted by FDA in the International Council for Harmonisation (ICH) guidance for industry entitled, E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification, which incorporates by reference regional implementation guides.
- On April 3, 2026, CMS released a notice entitled, Medicare Program; Delayed Implementation of Certain Prior Authorization for Select Services for the Wasteful and Inappropriate Services Reduction (WISeR) Model. This notice announces a delay in the implementation of two services from the list of Wasteful and Inappropriate Services Reduction (WISeR) model items and services. CMS is delaying implementation of the WISeR model prior authorization (PA) and pre-payment review processes for Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease (NCD 160.24) and Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis (NCD 150.13).
- On April 3, 2026, CDC released a notice entitled, Advisory Committee on Immunization Practices (ACIP); Notice of Charter Renewal. CDC is announcing that the Advisory Committee on Immunization Practices (ACIP) has been renewed for a two-year period through April 1, 2028.
- On April 3, 2026, CMS released a notice entitled, Notice of Public Data Asset Release Under the Open, Public, Electronic, and Necessary (OPEN) Government Data Act. In accordance with the Open, Public, Electronic, and Necessary Government Data Act (OPEN Act), CMS is announcing the forthcoming release of public data assets in open, machine-readable formats under an open license. These data are intended to support public engagement in identifying and preventing fraud, waste, and abuse, and to promote transparency and accountability. CMS has taken steps to ensure that the release of these data appropriately furthers transparency objectives consistent with the protection of sensitive information.
- On April 3, 2026, CMS released a proposed rule entitled, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027. This rule proposes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. This proposed rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.
- On April 3, 2026, CMS released a proposed rule entitled, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program. This proposed rule would update the PPS rates for inpatient rehabilitation facilities (IRFs) for FY 2027. As required by statute, this proposed rule includes the classification and weighting factors for the IRF PPS’ case-mix groups and a description of the methodologies and data used in computing the PPS rates for FY 2027. It also continues the third year of the three-year phaseout of the rural adjustment, which began in FY 2025. This proposed rule (1) includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; (2) proposes to require all therapy treatments or therapy evaluations to begin within 36-hours from midnight on the day of admission; (3) proposes to require that a patient’s current functional status is documented on the preadmission screening; (4) proposes requirements for the initial Interdisciplinary Team meeting; and (5) includes a request for information (RFI) on potential future IRF PPS payment reform. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program. Furthermore, the proposed rule includes changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP).
- On April 3, 2026, CMS released a proposed rule entitled, Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System – Rate Update. This proposed rule would update the PPS rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This proposed rule would also refine the IPF PPS outlier policy. These changes would be effective for IPF discharges occurring during the FY 2027. CMS is also proposing the implementation of a standardized IPF patient assessment instrument and the removal of two measures used in the Inpatient Psychiatric Facilities Quality Reporting Program.
- On April 3, 2026, CMS released a proposed rule entitled, Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements. This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for FY 2027. This proposed rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index (SSVI), and proposes to require that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this proposed rule would conform regulation text changes to discharge from hospice care regulations, as well as regulation text changes to the face-to-face encounter regulations. The proposed rule also includes RFIs on community palliative care services, the construction of a hospice specific wage index, and the overlap between hospice and medical aid in dying (MAID). Finally, this proposed rule includes changes to the Hospice Quality Reporting Program.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- April 6, 2026: 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.
- April 7, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.
- April 8, 2026: NIH announced a meeting of the National Cancer Advisory Board Ad hoc Working Group on Extramural Research Concepts and Programs. This is a virtual meeting open to the public.
- April 9-10, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a hybrid meeting open to the public.
- April 12, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public.
- **April 16, 2026: CDC announced a meeting of the National Committee on Vital and Health Statistics. This is a virtual meeting open to the public.
- April 17, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a hybrid meeting with some sessions open to the public.
- April 23, 2026: 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.
- April 29, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
- April 30, 2026: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting open to the public.
- May 4-5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
- May 5, 2026: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
- May 7, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting open to the public.
- May 12, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
- May 13, 2026: NIH announced a meeting of the National Institute on Aging. This is an in-person meeting with some sessions open to the public.
- May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
- May 18-19, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
- May 19, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting open to the public.
- May 19, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee. This is a hybrid meeting open to the public.
- May 19, 2026: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting open to the public.
- May 21, 2026: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting open to the public.
- June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
- June 2, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
- June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
- **June 5, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
- June 8-9, 2026: FDA announced a public workshop entitled, Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop. This is a hybrid meeting open to the public.
- June 10-11, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
- June 12, 2026: FDA announced a public hearing related to the Commissioner’s National Priority Voucher (CNPV) Pilot Program. This is a hybrid meeting open to the public.
- June 15, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
- June 15-16, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
- June 29, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
- July 8, 2026: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
- September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
- September 14-15, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
- September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
- September 24, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- November 5, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- December 7-8, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
- December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
Reports, Studies & Analyses
On March 30, 2026, the Congressional Research Service (CRS) released a report entitled, U.S. Health Care Coverage and Spending. The report provides an overview of health insurance coverage and health care spending in the U.S., showing that most Americans remained insured in 2024 while overall health spending continued to account for a significant share of the economy. According to CRS, of the estimated 335 million people living in the U.S. in 2024, about 91.8 percent had some form of health insurance, while 8.2 percent were uninsured. Total health consumption expenditures reached approximately $5.0 trillion, representing 17.2 percent of gross domestic product (GDP). Private health insurance remained the largest source of coverage, with employer‑sponsored and direct‑purchase plans covering nearly 69 percent of the population combined. Medicare covered an estimated 63 million people, or 18.9 percent of the population, while Medicaid and the Children’s Health Insurance Program (CHIP) covered about 69 million individuals, or 20.5 percent. Private insurance accounted for about one‑third of total health care expenditures, followed by Medicare at 22.2 percent and Medicaid and CHIP at 19.1 percent. Hospital care and physician services made up the largest share of spending across coverage types, while Medicaid devoted a higher proportion of its expenditures to long‑term services and supports than other programs.
The report also highlighted recent trends affecting coverage and spending. Out‑of‑pocket spending totaled $557 billion in 2024, or 11 percent of total health care expenditures. The uninsured rate, which declined significantly following implementation of the Affordable Care Act (ACA), increased slightly between 2023 and 2024, a change the report attributes in part to the unwinding of temporary Medicaid and CHIP policies adopted during the COVID‑19 public health emergency. Spending on other health services, including public health and pandemic‑related programs, declined in 2024 after peaking during the pandemic, returning closer to pre‑pandemic levels.
Other Health Policy News
- On March 30, 2026, Senators Jeff Merkley (D‑OR), Bill Cassidy (R‑LA), Tina Smith (D‑MN), and Roger Marshall (R‑KS) sent a letter to CMS Administrator Mehmet Oz urging the agency to work more closely with Congress to address persistent overpayments in the MA program as CMS finalizes MA payment rates for 2027.
The letter points to a recent CMS proposal that would exclude certain diagnoses from risk score calculations beginning in 2027, specifically those derived from chart reviews that are not linked to a clinical encounter. While the Senators welcomed the proposed change, they emphasized that administrative action alone may not be sufficient to fully address the issue. They argued that congressional action, including passage of the bipartisan No Unreasonable Payments, Coding, or Diagnoses for the Elderly (No UPCODE) Act, is needed to curb broader coding practices that inflate MA payments.
In their letter, the Senators outlined several additional policy changes for consideration, such as: (1) excluding diagnoses from health risk assessments and all chart reviews; (2) using two years of diagnostic data rather than one to better capture chronic conditions; and (3) further adjusting risk scores to account for differences in coding patterns between MA and fee-for-service (FFS) Medicare. The Medicare Payment Advisory Commission (MedPAC) estimated that even after existing statutory adjustments, higher coding intensity could increase MA payments by an additional four percent in 2026.
A press release can be found here. The letter can be found here.
- On March 30, 2026, Senator Marsha Blackburn (R-TN), alongside Senator Ron Wyden (D-OR), introduced the Health Workforce Innovation Act. This bill would create a federal grant program to address workforce shortages among allied health professionals, such as medical assistants and pharmacy technicians. This grant program would provide funding for community health centers (CHCs) and rural health clinics to carry out models that educate and train a wide range of allied health professionals. Such training can occur through partnerships with high schools, community colleges, and other entities. These grants can also be used to support new and existing health care ladder programs. The bill states that priority will be given to models that train individuals from underserved and disadvantaged communities and demonstrate the potential to be replicated and scaled. The bill would authorize funds annually for FYs 2027 through 2029 for grantees to carry out these initiatives.
The full bill text can be found here. A one page summary of the bill can be found here. A press release can be found here.
- On March 31, 2026, several House physician-lawmakers, including Representatives Greg Murphy (R-NC), John Joyce (R-PA), Mariannette Miller-Meeks (R-IA), Bob Onder (R-MO), Brad Schneider (D-IL), Tom Suozzi (D-NY), Jimmy Panetta (D-CA), and Kim Schrier (D-WA), introduced a bill entitled, Provider Reimbursement Stability Act, to modernize and update the underlying mechanics of the Medicare Physician Fee Schedule (MPFS) to improve payment stability for physicians and their patients.
The bill would cap annual Medicare MPFS cuts at 2.5 percent, providing a predictable ceiling that would allow clinician practices to budget and plan for future years. It would also give the CMS greater flexibility to consider medical inflation in limited circumstances when setting reimbursement and requires more frequent, accurate updates to practice expense relative value units (RVUs) that contribute to payment calculations. These RVUs would be reviewed at least every five years against real-world practice costs, correcting a long-standing flaw in the system, which has not been updated since its establishment in 1992.
The legislation would also reform MPFS’s “budget neutrality” rule. Currently, any spending increase above a $20 million threshold—set more than three decades ago in the Omnibus Budget Reconciliation Act of 1989 and never adjusted for inflation—must be reduced elsewhere, often through across-the-board cuts. The bill would raise that threshold to $54.3 million and indexes it to medical inflation every five years.
The measure would also reform CMS’s existing utilization forecasts for new billing codes and require CMS to revisit those estimates using real-world data and adjust payments accordingly.
A press release on the bill can be found here.
- On April 3, 2026, the Office of Management and Budget (OMB) released the FY 2027 President’s budget. The budget proposal again pursues several health policies that Congress declined to enact last year. The proposal calls for a 12.5 percent reduction in discretionary funding for HHS, totaling $111.1 billion, and revives plans for a major departmental reorganization alongside funding cuts to several health agencies, including NIH.
While the White House’s topline budget materials focus on health care largely in the context of fraud reduction, the full budget documents outline a proposal to create a new Administration for a Healthy America (AHA). The new entity would consolidate agencies and functions currently housed at HHS, including the Substance Abuse and Mental Health Services Administration (SAMHSA), the Health Resources and Services Administration (HRSA), and portions of CDC, and would prioritize initiatives related to nutrition, food and drug safety, and chronic disease prevention. The Trump Administration says the restructuring would streamline operations and eliminate programs it views as duplicative or misaligned with its policy priorities, while directing funding toward nutrition services, food safety initiatives, and certain public health efforts.
The budget also proposes eliminating or reducing funding for a number of existing programs, including teen pregnancy prevention, sexual health initiatives, harm reduction efforts, and certain behavioral health and preparedness programs. Cuts are proposed across multiple agencies, including NIH, the Agency for Health Research and Quality (AHRQ), and the Administration for Strategic Preparedness and Response (ASPR). The proposal sets the stage for negotiations with lawmakers, who rejected many of these reductions and structural changes during the last appropriations cycle.
More information on the President’s Budget can be found here.
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