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On April 3, 2026, the White House released its fiscal year 2027 (FY 27) budget request for the Department of Health and Human Services (HHS) and the HHS budget in brief. The budget requests $111.1 billion in discretionary budget authority for HHS for 2027, a $15.8 billion, or 12.5 percent decrease, from the 2026 enacted level. This memo focuses on discretionary budget authority rather than program-level funding to distinguish between the president’s request and mandatory funding sources.
The next step in the budget process is for Congress to consider the request. This will involve HHS Secretary Kennedy coming to Congress to testify before the House and Senate Appropriations Committees as well as committees with jurisdiction over health care policy, such as the House Energy and Commerce Committee, the House Ways and Means Committee, the House Education and Workforce Committee, the Senate Finance Committee, and the Senate Committee on Health, Education, Labor, and Pensions. Congress had significant difficulty passing FY 26 appropriations bills. We foresee similar problems in passing FY 27 funding as well.
OVERVIEW
Like the president’s FY 26 budget request, this budget request calls for a reorganization of HHS by establishing the Administration for a Healthy America (AHA). This new agency would combine the General Departmental Management (GDM), Office of the Assistant Secretary for Health (OASH), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and several centers and programs from the Centers for Disease Control and Prevention (CDC). The administration argues that the creation of this new agency will help prioritize programs to improve nutrition and food and drug quality and safety, prevent chronic disease, and save approximately $5 billion.
The budget request calls for reductions in discretionary budget authority for the following agencies: the Administration for Children, Families, and Communities (ACFC) (-$6.8 billion), the Administration for Strategic Preparedness and Response (ASPR) (-$365 million), Advanced Research Projects Agency for Health (ARPA-H) (-$555 million), the Food and Drug Administration (FDA) (-$48 million), the CDC (-$484 million), the National Institutes of Health (NIH) (-$3.4 billion), and the Office of Inspector General (OIG) (-$20 million).
In contrast, the administration calls for an increase in funding for the Centers for Medicare and Medicaid Services (CMS) program integrity measures (+$35 million) and for the Indian Health Services (IHS) (+$1.1 billion). Please see the table below, which provides an agency-by-agency comparison of the FY 27 budget request compared to the FY 26 budget request, along with links to relevant congressional justification documents.
| Agency | FY 27 Discretionary Budget Authority Request (in Millions of $) |
Change from Enacted FY 26 Budget (in Millions of $) |
| Administration for a Healthy America | 14,673 | +14,673[1] |
| Administration for Children, Families, and Communities | 28,680 | -6,856 |
| Administration for Strategic Preparedness and Response | 3,337 | -365 |
| Advanced Research Projects Agency for Health | 945 | -555 |
| Centers for Medicare and Medicaid Services: Program Integrity | 976 | +35 |
| Centers for Medicare and Medicaid Services: Program Management | 3,700 | -437 |
| Food and Drug Administration | 3,306 | -48[2] |
| Centers for Disease Control and Prevention | 5,280 | -484 |
| HHS Office of Inspector General | 175 | -20 |
| Indian Health Service | 9,094 | +1,109 |
| National Institutes of Health[3] | 41,164 | -3,480 |
[1] The President’s FY 26 budget requested $14,058,000,000, which was not enacted.
[2] The proposed budget includes a net increase of $232 million, which is due to an increase in user fees, not the total discretionary budget authority.
[3] As of April 6, the NIH has yet to publish its congressional justification document, but this link goes to the NIH Office of Budget.
ADMINISTRATION FOR A HEALTHY AMERICA (AHA)
The AHA is a proposed new agency that would combine GDM, OASH, HRSA, SAMHSA, and several CDC centers and programs. The organization would include the following components: Primary Care, Maternal and Child Health, Mental and Behavioral Health, HIV/AIDS, Health Workforce, Policy, and Research and Oversight, which includes the Surgeon General. The budget request eliminates several existing programs within each agency that would be incorporated into the AHA. These include the following:
From HRSA: Healthy Start, Early Hearing Detection and Intervention, Emergency Medical Services for Children, Ryan White Part F, Ryan White Special Projects of National Significance, Rural Hospital Flexibility Grants, State Offices of Rural Health, Rural Hospital Stabilization, Rural Hospital Provider Assistance Program, Family Planning, Congressionally directed spending projects, and 14 workforce programs, including some nursing workforce programs and Medical Student Education.
From CDC: All Chronic Disease Prevention and Health Promotion activities except for Cancer Prevention and Control programs and Alzheimer’s Disease, and the following Injury Prevention and Control programs: Youth Violence Prevention, Adverse Childhood Experiences, Firearm Injury and Mortality Prevention Research, Elderly Falls, Drowning, Other Injury Prevention Activities, and Injury Control Research Centers.
From SAMHSA: Mental Health Awareness Training; Healthy Transitions; Infant and Early Childhood Mental Health; Mental Health Children and Family Programs; Consumer and Family Network Grants; Mental Health System Transformation; 5cProject LAUNCH; Primary and Behavioral Health Care Integration Programs; Mental Health Crisis Response Partnership Program; Homelessness Prevention; Mental Health Criminal and Juvenile Justice Programs; Assertive Community Treatment for Individuals with Serious Mental Health Illness; Homelessness Technical Assistance; Minority AIDS; Seclusion and Restraint; Minority Fellowship Program; Tribal Behavioral Health Grants; Interagency Task Force on Trauma-Informed Care; Eating Disorder Identification, Treatment, and Recovery; Children and Family Programs; Strategic Prevention Framework; Sober Truth on Preventing Underage Drinking; Drug Abuse Warning Network, and Congressionally-directed spending projects.
From GDM and OASH: Office of Population Affairs, Teen Pregnancy Prevention, Secretary’s Minority HIV/AIDS Fund, Kidney X, Stillbirth Task Force, and Sexual Risk Avoidance.
The budget also includes investments across AHA to align with Secretary Kennedy’s Make America Healthy Again Initiative. These include:
- $316 million for rural-focused grant programs and technical assistance, including $145 million for the Rural Communities Opioid Response Program
- $19 million for the Prevention Innovation Program for Tribal Communities to support tribes, tribal organizations, and urban Indian health organizations
- $20 million for the Chronic Care Telehealth Centers for Excellence Program and $8 million for the Telehealth Nutrition Services Network Grant Program
- $6.8 billion in discretionary funding to provide substance abuse prevention, treatment, and recovery services, as well as support for mental health services
- $4.6 billion for a new Behavioral Health Innovation Block Grant, which consolidates the Community Mental Health Services Block Grant, Substance Use Prevention, Treatment, and Recovery Services Block Grant, and the State Opioid Response program
- $80 million for the Behavioral Health and Substance Disorder Resources for Native Americans Grant Program
- $788 million in discretionary funding for health workforce programs focused on strengthening the workforce in rural and underserved areas and supporting behavioral health training, including $130 million in discretionary funding for the National Health Service Corps
- $923 million in discretionary funding for maternal and child health programs formerly managed by HRSA
ADMINISTRATION FOR CHILDREN, FAMILIES, AND COMMUNITIES (ACFC)
The FY 27 budget request recommends combining the Administration for Children and Families (ACF) and the Administration for Community Living (ACL) into one agency: the ACFC. The FY 27 budget request calls for the elimination of the following programs: Community Services Block Grant programs, Chronic Disease Self-Management Education, Senior Medicare Patrol Program, University Centers for Excellence in Developmental Disabilities, Developmental Disabilities Projects of National Significance, Limb Loss Resource Center, the Paralysis Resource Center, Area Agencies on Aging, the National Center for Benefits Outreach Enrollment, and the White House Conference on Aging. It includes the following funding for programs administered through ACFC:
- $54 million to support tribal elders through nutrition and caregiver support programs formerly administered by the ACL
- $414 million for the Home and Community-Based Supportive Services program
- $55 million for the State Health Insurance Assistance Program
ADMINISTRATION FOR STRATEGIC PREPAREDNESS AND RESPONSE (ASPR)
The FY 27 budget request for ASPR aims to streamline and simplify federal and state funding tools, protect against natural and man-made health threats, and promote domestic manufacturing of critical medicines. The FY 27 budget request provides the following to ASPR:
- $1.8 billion for medical countermeasure research and development through programs administered by the Biomedical Advanced Research and Development Authority (BARDA)
- $327 million, an increase of +$325 million above FY 26, in no-year funding to support procurement, storage, and annual operational costs of the Strategic Active Pharmaceutical Ingredient Reserve
- $1 billion in flat funding for the Strategic National Stockpile
ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)
The FY 27 budget request is organized around five themes: 1) Addressing Chronic Disease; 2) America-Made Manufacturing and Rural Access; 3) Proactive Approaches to Healthy WellBeing; 4) Healthcare Security, Efficiency, and Transparency; and 5) American Leadership in Frontier Health Technologies. Specifically, the FY 27 budget request includes several goals within these categories, including:
- To create the Treating Hereditary Rare Diseases with in Vivo Precision Genetic Medicines (THRIVE) program to develop integrated platform technologies to accelerate precision treatments for diseases at the genetic level
- To transform manufacturing technologies, processes, and business models for domestic medical products and ensure scalable manufacturing for personalized therapies and critical medical supplies
- To continue investing in Artificial Intelligence (AI)/Machine Learning (ML) to track and remediate toxins and AI and longitudinal data approaches to determine root causes of chronic diseases
- To develop biohybrid systems to restore full function to damaged or diseased tissues, real-time identification and visualization of neural circuits, and quantum imaging technologies
CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)
Program Integrity
The FY 27 budget request includes a number of requests and initiatives intended to strengthen efforts to ensure program integrity within CMS. These include the following:
- $976 million for the Health Care Fraud and Abuse Control (HCFAC) Program, which includes $740 million for the CMS, $138 million for the U.S. Department of Justice, and $98 million for the HHS OIG
- A planned ramp-up of oversight of Medicaid programs through expanded audits and investigations, and establishing new processes to support law enforcement and recover the overpayment of funds
Program Management
The FY 27 budget request also includes funding for CMS program management, which administers programs such as Medicare and Medicaid. This includes the following:
- $811 million to carry out operational needs and beneficiary rights guaranteed by Original Medicare (Parts A & B)
- $385 million for the National Medicare Education Program
- $112 million for Medicare Parts C & D administrative needs to support rulemaking, information technology systems, and timely appeals
- $155 million for Medicaid and CHIP administrative operations, including $25 million for CMS to explore investing in a scalable and modernized Medicaid system and tools to support state systems with the goal of improving transparency in and access to Medicaid data
- $487 million for the Survey and Certification program to improve oversight frequency of health care facilities
- $21 million for the 340B program, +$8 million above FY 26, to increase oversight of the program. As in the FY 26 budget request, the FY 27 budget request recommends moving the 340B program from HRSA to CMS
- Calls to re-platform Original Medicare claims processing using a commercial claims processing system
- Calls to invest in core digital infrastructure to modernize Medicare.gov, strengthen and validate
- CMS-managed provider identity and directory services, and improve CMS’s internal data processing, security, and information-sharing capabilities
FOOD AND DRUG ADMINISTRATION (FDA)
The FY 27 budget request seeks to advance the Make America Healthy Again (MAHA) agenda by supporting food and medical product safety, strengthening foreign and domestic inspection capacities, reducing tobacco-related harm, and maintaining facilities and infrastructure. The budget proposes the reorganization of the National Center of Toxicology Research to the CDC’s National Center for Chemicals and Toxins. Additionally, the FY 27 includes the following for the FDA:
- $2 million to upgrade centralized process systems with AI/ML capabilities
- $466 million and $632 million for reviews of medical devices and human drugs, respectively
- $9 million to establish the FDA PreCheck Program to strengthen domestic pharmaceutical manufacturing
Although the FY 27 budget request proposes a decrease in discretionary spending, there is a proposed net increase in total FDA spending due to higher user fees, which support product reviews and regulatory oversight.
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
The budget request for FY 27 aims to refocus CDC on its core mission and foundational capacities, including data, surveillance, laboratory science, and global preparedness. The budget includes flexibility to move funding between CDC accounts through the Secretary’s transfer authority. The reasoning for this is to allow the CDC to address emerging issues or emergencies. The budget prioritizes funding for the Infection and Prevention Control Initiative and the Healthy and Safe Food Initiative.
- $1 billion to establish the National Center for Chemicals and Toxins
- $107 million (+$33 million) for the Health and Safe Food Initiative
- $219 million (+22 million) for the Infection Prevention Control Initiative
- $45 million to support an innovative biothreat detection system
- $260 million for a Public Health Infrastructure and Capacity grant to address gaps in core public health capacity and infrastructure at the state, tribal, territorial, and local levels
- $963 million for the discretionary immunization and respiratory diseases program
The budget also includes two legislative proposals: 1) to authorize CDC to set data reporting requirements to public health entities to improve capacity to detect and respond to public health threats, monitor and evaluate distribution of medical countermeasures and critical supplies, and connect communities with resources and services; and 2) to allow non-competitive conversion of fellows to employees to retain a highly skilled workforce.
HHS OFFICE OF THE INSPECTOR GENERAL (OIG)
The HHS OIG is currently focused on large-scale financial recoveries and addressing vulnerabilities in Medicaid and Medicare. The budget request proposes a 3% decrease for HHS-OIG from FY 26, reflecting a government-wide Inspector General budget reduction. The FY 27 budget request includes the following:
- $84 million in discretionary funding for Public Health and Human Services Oversight
- $98 million in discretionary funding for Health Care Fraud and Abuse Control
INDIAN HEALTH SERVICE (IHS)
In the FY 27 budget request, the administration aims to strengthen its commitment to improving tribal health and well-being through strategic investment. Specifically, the FY 27 budget request calls for the following at IHS:
- $5.5 billion for direct health care services
- $84 million to fund staffing and operating costs for 5 newly constructed health care facilities
- $287 million to continue the transition to a new electronic health record system
- $191 million to construct facilities on the IHS Healthcare Facilities Construction Priority List
- $538 million for maintenance and improvement, medical equipment, and Facilities and Environmental Health Support programs
NATIONAL INSTITUTES OF HEALTH
The budget request for FY 27 focuses on 2 research priorities: ending the chronic disease epidemic and understanding the biomarkers for aging and disease. The budget proposes to consolidate the National Institute of Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism into the National Institute of Substance Use and Addiction Research. The budget also proposes the elimination of the following:
- National Center for Complementary and Integrative Health
- Fogarty International Center
- National Institute on Minority Health and Health Disparities
The budget will continue the 15% cap on indirect costs. Budget priorities are laid out below:
- $60 million in integrative chronic disease research
- $25 million to advance the understanding of causal biomarkers of aging and disease
- $60 million to scale and further operationalize the Real-World Data Platform
- $515 million in the Office of the Director’s Common Fund to support new program concepts related to cutting-edge research to cure diseases
On April 2, 2026, the Centers for Medicare & Medicaid Services (CMS) released a final rule that will revise the Medicare Advantage (MA) Program, the Medicare Prescription Drug Benefit Program (Part D), and the Medicare Cost Plan Program for Contract Year 2027 (PY27). A CMS fact sheet can be found here. The regulation is effective June 1, 2026, and will be applicable to MA and Part D coverage beginning January 1, 2027.
MA & Part D: Updates to Star Ratings
The Medicare Advantage (MA) and Part D Star Ratings program evaluates plan performance on a 1-to-5-star scale across up to 43 measures for MA-PD contracts, 33 for MA-only, and 12 for Part D, covering categories like outcomes, intermediate outcomes, process, patient experience, and access. Ratings are based on CMS administrative data, enrollee surveys, and plan-submitted information. These ratings influence quality bonus payments (QBPs) for MA plans (up to 5-10% added to benchmarks for 4+ star plans), beneficiary rebates (50–70%), marketing rules, and the way consumers are presented plan options in the Medicare Plan Finder.
In keeping with the Trump administration’s effort to deemphasize equity programs, the final rule eliminates the Biden-era Excellent Health Outcomes for All reward (formerly the Health Equity Index or HEI). This reward—finalized in the 2023 final rule for implementation in PY 2027—was intended to incentivize high measure-level performance among enrollees with specific social risk factors (SRFs), such as dual eligibility for Medicare and Medicaid, receipt of the low-income subsidy, or disability. For PY 2027, the Biden-era reward would have given plans an HEI score ranging from -1 to 1 based on a subset of measures, and those plans with positive HEI scores would have received a bonus added to their overall Star Rating (0.4 for the top third, 0.267 for the middle third, and 0.133 for the bottom third). CMS finalized this provision exactly as proposed, removing the HEI/Excellent Health Outcomes for All reward while retaining the historical reward factor (which similarly rewards plans but emphasizes improvement efforts in clinical care, outcomes, and patient experience across the entire patient population). The change applies beginning with the 2027 Star Ratings.
Continuing the administration’s deregulation theme, the final rule removes 11 of the 12 measures that were proposed for removal, starting from the 2027 measurement year. Removals take effect for the 2028- or 2029-Star Ratings, depending on the measure. CMS finalized these 11 removals exactly as proposed, with the sole modification that it did not finalize the proposed removal of the Diabetes Care – Eye Exam (Part C) measure (which will remain in the Star Ratings program). The measures removed under the final rule are:
- Plan Makes Timely Decisions about Appeals (Part C, 2029)
- Reviewing Appeals Decisions (Part C, 2029)
- SNP Care Management (Part C, 2029)
- Call Center – Foreign Language Interpreter and TTY Availability (Part C, 2028)
- Call Center – Foreign Language Interpreter and TTY Availability (Part D, 2028)
- Complaints about the Health/Drug Plan (Parts C and D, 2029)
- Medicare Plan Finder Price Accuracy (Part D, 2029)
- Statin Therapy for Patients with Cardiovascular Disease (Part C, 2028)
- Members Choosing to Leave the Plan (Parts C and D, 2029)
- Customer Service (Part C, 2029)
- Rating of Health Care Quality (Part C, 2029)
Additionally, CMS finalized two technical updates to the Star Ratings program. CMS is adding a new Part C Depression Screening and Follow-Up measure to address behavioral health gaps. The new measure begins with the 2027 measurement year and will first affect the 2029 Star Ratings. CMS also finalized a technical clarification (originally proposed in the CY 2026 rule) regarding contract consolidations. This clarification specifies how enrollment-weighted measure scores are calculated when a surviving or consumed contract lacks data for a particular measure due to the consolidation (changes applicable to the 2027 Star Ratings).
As finalized, these changes will, in the aggregate, have the practical effect of increasing QBPs to plans. Simulations using 2025 Star Ratings data (accounting for changes implemented in the 2026 Star Ratings) show 63% of contracts with no change in overall rating, 13% increasing by half a star, and 24% decreasing by half a star. Four percent of contracts would gain QBP eligibility, and three percent would lose QBP eligibility. The shifts in Star Rating status are projected to result in an $18.56 billion net increase in Medicare Trust Fund spending over the 2027–2036 window (0.21% of MA payments). This is higher than the $13.18 billion estimate that appeared in the proposed rule (the difference is attributable to retaining the Diabetes Care – Eye Exam measure). Much of that increase is still expected in PYs 2028 and 2029.
MA: Operational Reforms
Per President Trump’s executive order (EO) #14192 (“Unleashing Prosperity through Deregulation”), the final rule includes several reforms intended to reduce the regulatory burden on plans and, therefore, the marginal operational costs passed on to beneficiaries by those plans. CMS finalized all the following changes exactly as proposed:
- Exempting account-based plans from creditable coverage disclosures: Currently, group health plans, including account-based arrangements such as Health Reimbursement Arrangements (HRAs), Flexible Spending Accounts (FSAs), and Health Savings Accounts (HSAs), must disclose their creditable prescription drug coverage status to CMS and Medicare-eligible individuals. CMS finalized the amendment to exclude these plans, as they do not directly offer drug coverage but only reimburse expenses. In practice, this eliminates redundant paperwork for about 7,049 entities (mostly HR managers), saving approximately 585 hours and $90,266 annually.
- Rescinding mid-year notices for unused supplemental benefits: MA organizations must mail individualized mid-year notices by July 31 detailing unused supplemental benefits from the Evidence of Coverage. CMS finalized the complete rescission of this requirement. Practically, this reduces administrative burdens, yielding annual savings of $1.36 million in printing/mailing, plus prevented one-time costs of approximately $499,000 for system updates.
- Eliminating health disparities activities in MA quality improvement programs: Under § 422.152(a)(5), MA organizations must incorporate activities to reduce health disparities into their Quality Improvement (QI) programs. CMS finalized the removal of this requirement.
- Eliminating health equity requirements for MA Utilization Management (UM) Committees: Current rules at § 422.137(c)(5) require a health equity expert on UM Committees, and §§ 422.137(d)(6)–(7) mandate annual health equity analyses of prior authorizations. CMS finalized the rescission of these provisions. In practice, this streamlines committee operations by saving about 6,040 hours and $814,000 annually in data aggregation and posting, enabling focus on core UM functions.
- Waiving the LI NET call center hours requirement: The Limited Income Newly Eligible Transition (LI NET) program currently requires toll-free call centers to be open from 8 a.m. to 8 p.m. in all regions. CMS finalized the amendment to limit hours to 8 a.m.–7 p.m. ET, Monday–Friday. This adjustment accounts for low call volumes and 24/7 pharmacy support, saving $800,000–$1 million annually in operational costs.
- Removing restrictions on the time and manner by which beneficiaries can have conversations with licensed agents and brokers: Current regulations impose specific timing restrictions on beneficiary outreach, including a 12-hour delay requirement between educational events and marketing events in the same location and a 48-hour waiting period between completion of a Scope of Appointment form and a personal marketing appointment. CMS finalized the removal of these timing restrictions (along with the related prohibition on collecting Scope of Appointment forms at educational events). This change provides greater flexibility for plans, agents, and beneficiaries while preserving core consumer protections.
MA: Supplemental Benefits and Seriously Ill Beneficiary Supplemental Coverage Items (SSBCI)
Continuing its focus on reducing regulatory burden while clarifying allowable supplemental benefits, CMS finalized several targeted reforms to supplemental benefits and SSBCI administration. CMS finalized these provisions largely as proposed (with only minor technical refinements):
- Cannabis clarification: CMS refined the regulatory language to state more precisely that cannabis products that are illegal under applicable State or Federal law are not allowable as SSBCI.
- Public posting of SSBCI eligibility criteria: CMS finalized the requirement that MA organizations publicly post their plan-developed objective eligibility criteria for SSBCI on their website to increase transparency for beneficiaries.
- Debit card rules for supplemental benefits: CMS codified and clarified requirements for administering supplemental benefits through debit cards, including real-time electronic verification at the point of sale and limiting cards to the specific plan year. CMS did not finalize the proposed prohibition on marketing the dollar value of supplemental benefits on the debit card itself.
MA: Special Enrollment Period Reforms
The MA program currently includes a Special Enrollment Period (SEP) for enrollees affected by a “significant” provider network change, such as terminations of providers or facilities, where significance is determined, case by case, by CMS and the MA organization based on factors like the scale of the termination. Affected enrollees – those assigned to, receiving care from, or who received care within the past three months from the terminated provider – can switch MA plans or disenroll to Original Medicare, but only if notified of eligibility. MA organizations must send termination notices, but these do not always include detailed SEP information, and separate notifications may be required for eligibility. CMS guidance (but not rules) requires that certain other SEPs, such as those for CMS sanctions, contract violations, or exceptional circumstances, receive CMS approval.
In the PY 2027 proposed rule, CMS proposed to modify the SEP for provider terminations by renaming it from “Significant Change in Provider Network” and eliminating the “significant” determination requirement, making eligibility automatic for affected enrollees upon any no-cause provider or facility termination. The SEP would begin in the month of eligibility notification and last for two additional calendar months, usable once per network change, with MA organizations assessing eligibility via beneficiary attestations rather than solely through 1-800-MEDICARE. Termination notices would be enhanced to include mandatory details on SEP eligibility, start/end dates, Annual Enrollment Period (AEP), MA Open Enrollment Period (MA-OEP), Medigap guaranteed issue rights, and impacts on employer/union coverage.
CMS did not finalize these proposed modifications to the provider termination SEP. The existing “Significant Change in Provider Network” SEP remains unchanged. CMS acknowledged broad stakeholder interest in the topic but stated it will continue to consider the extent to which rulemaking may be appropriate in this area.
Separately, CMS proposed codifying the requirement for prior CMS approval of certain SEPs at §§ 422.66(g), 423.32(k), and 423.36(g), mandating that MA organizations obtain approval via CMS-operated mechanisms (e.g., 1-800-MEDICARE, Online Enrollment Center, or notices) before transmitting elections for specified SEPs like contract violations or sanctions. CMS finalized this provision exactly as proposed. The final rule adds explicit language to the affected SEP provisions in §§ 422.62(b) and 423.38(c) and corresponding limitations in §§ 422.66(g), 423.32(k), and 423.36(g) to require CMS approval prior to use of these SEPs. This codifies longstanding policy and guidance without adding new burden.
MA: Requests for Information (RFIs)
CMS includes several RFIs in the PY27 Proposed Rule to gather public input on enhancing the Medicare Advantage program. The Final Rule included the following commentary from CMS regarding stakeholder feedback and the agency’s reaction to the responses…
- Dually Eligible Individual Enrollment Growth in C-SNPs and I-SNPs: CMS sought comments on the significant growth in dually eligible individuals enrolling in chronic condition special needs plans (C-SNPs) and institutional special needs plans (I-SNPs) rather than dual eligible special needs plans (D-SNPs). Stakeholders expressed strong concerns about care fragmentation and recommended requiring State Medicaid Agency Contracts and D-SNP-like integration rules for plans with high dual enrollment. CMS will consider the feedback received for potential future rulemaking.
- Future Directions in Medicare Advantage Risk Adjustment: CMS solicited input on modernizing the MA program through risk adjustment, including leveraging AI and alternative data sources for next-generation models to promote data transparency, quality improvement, competition, taxpayer savings, and fraud reduction. Stakeholders supported greater data transparency and alignment with Original Medicare data, while stressing privacy protections. CMS will consider the feedback for possible future rulemaking or demonstration projects.
- Future Directions in Medicare Advantage Star Ratings: CMS requested feedback on simplifying and streamlining the Star Ratings program, including reducing timelines from measure development to implementation and shortening the lag between measurement years and payment application. Stakeholders supported simplification but many opposed broad measure removals due to potential impacts on oversight of SNPs. CMS will consider the input for potential future rulemaking.
- Quality Bonus Payments in Medicare Advantage: CMS sought information to refine the Quality Bonus Payment structure and its impact on rebates, including options to shorten new-measure implementation timelines and delink bonuses from MA bids. Stakeholders provided input on refining the structure to better balance quality incentives with cost containment. CMS will consider these comments for future policy development.
- Well-Being and Nutrition: CMS solicited input on tools and policies to improve overall health, happiness, and life satisfaction in MA, including emotional well-being, social connections, self-care, and nutrition strategies. Stakeholders offered ideas for expanding supplemental benefits related to food, housing, and social connections to support prevention and wellness. CMS will consider the feedback received for potential future rulemaking.
- Marketing and Communications Oversight: CMS sought comments on modernizing agent/broker regulations and marketing requirements, including redefining the TPMO definition, modifying translation thresholds, and revising testimonial standards. Stakeholders offered broad support for burden-reducing changes such as adjustments to disclaimers and retention periods. CMS will consider the feedback for potential future rulemaking.
- Other Medicare Advantage Program Areas: CMS solicited input on deregulation and simplification across various MA aspects, such as updating medical loss ratio calculations, streamlining network adequacy reviews, and revising SNP Model of Care requirements. Stakeholders expressed widespread support for further deregulation and streamlining to reduce administrative burden. CMS will consider the comments for future efforts to streamline the program.
Part D: Implementing Certain Provisions of the Inflation Reduction Act (IRA) of 2022
The IRA significantly redesigned the Medicare Part D benefit to lower beneficiary costs, including eliminating the coverage gap phase, reducing the annual out-of-pocket (OOP) threshold starting at $2,000 (with annual indexing based on per capita Part D costs or CPI-U), and removing enrollee cost sharing in the catastrophic phase (setting it to $0 after the OOP threshold is met). It also terminated the Coverage Gap Discount Program (CGDP) and replaced it with the Manufacturer Discount Program (MDP). The IRA granted CMS temporary authority to implement these changes through sub-regulatory program instructions and guidance through 2026. CMS finalized the codification of these reforms in the Contract Year 2027 final rule.
- CMS finalized the termination of the CGDP as proposed. The CGDP (under which manufacturers provided 70% discounts on applicable drugs for non-LIS beneficiaries in the coverage gap) technically terminated on January 1, 2025, but continues to handle discounts and reconciliations for drugs dispensed before that date. The final rule permanently sunsets the program.
- CMS finalized the establishment of a new Subpart AA to codify the MDP for 2027 and beyond largely as proposed. Manufacturers must enter agreements covering all labeler codes for applicable drugs and provide 10% discounts in the initial coverage phase and 20% in the catastrophic phase (calculated on negotiated price including dispensing fees, taxes, and units), with phase-ins for specified manufacturers (based on 2021 Part D spending ≥1% or 2.5% for LIS/non-LIS) and small manufacturers (one drug ≥80% of expenditures). The final rule includes detailed rules on aggregation, acquisitions, terminations, audits, disputes, and civil penalties, with only minor technical refinements from the proposal.
- CMS finalized the codification of OOP changes for 2027 and beyond exactly as proposed by revising § 423.100 to limit “coverage gap” definitions to 2006–2024, amending § 423.104(d)(4) for pre-2025 applicability, eliminating the initial coverage limit post-2024 (§ 423.104(d)(3)(iii)), setting the reduced OOP threshold at $2,000 for 2025 and indexing it annually (§ 423.104(d)(5)(iii)(G)–(H)), and confirming $0 cost sharing in the catastrophic phase (§ 423.104(d)(5)(i)).
In addition to the core IRA codifications described above, CMS finalized several related technical and operational updates to Part D program rules. These include clarifications to true-out-of-pocket (TrOOP) calculations, specialty-tier cost-sharing rules, reinsurance payment methodologies, and implementation details for the Selected Drug Subsidy. CMS finalized all these technical provisions exactly as proposed.
GLP-1 regulation policy continues to be a hot topic in Washington. In May 2025, we wrote about the benefits and costs of expanding patient access to GLP-1 medications. Now a year later, the Trump administration continues its balancing act between increasing individual access to GLP-1 medications while simultaneously providing strong oversight for the popular medications. This blog will explore ways that the administration is managing these priorities.
Expanding Patient Access
President Trump has sought to expand patient access through GLP-1 regulation policy in a couple of key ways. First, his administration entered into Most-Favored-Nation pricing agreements for Ozempic, Wegovy, and Zepbound, the most common brands for US patients to address concerns about the costs of these drugs. These deals can be found on the TrumpRx website, along with over 50 other medications, and are accessed through printable drug manufacturer coupons that can be redeemed at pharmacies at the time of purchase or directly from the drug manufacturer’s website.
The Trump administration has also acted through the Centers for Medicare and Medicaid Services (CMS) to increase access for Medicare and Medicaid beneficiaries through the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model. State Medicaid agencies have the option to opt-into the program, which allows CMS to negotiate pricing and coverage terms of GLP-1 medications, as early as May 2026. Medicare beneficiaries will have access through Part D benefits beginning in January 2027.
Medicare is also offering a GLP-1 payment demonstration beginning in July 2026 that will operate outside of Part D coverage to allow earlier access until the BALANCE Model is implemented.
Addressing Safety Concerns
The Trump administration has also pursued GLP-1 regulation policy to address possible safety concerns through the Food and Drug Administration (FDA). In February 2026, Commissioner Martin Makary issued a statement announcing that the FDA intends to restrict the use of GLP-1 active pharmaceutical ingredients (APIs) that are being used in non-FDA approved formulations by compounding pharmacies. In March 2026, the FDA issued an import alert for GLP-1 APIs due to concerns that drugs made with these products may be adulterated, and therefore unsafe for patients to take.
The FDA is also examining how companies are marketing their GLP-1 medications. In March 2026, warning letters were sent to telehealth companies for alleged misleading claims that their compounded formulas are equivalent to FDA-approved formulas.
There was also a spotlight shone on Novo Nordisk, the maker of Ozempic, for failure to follow Adverse Drug Events (ADEs) reporting guidelines. The investigation revealed Novo Nordisk did not have proper written procedures and did not report ADEs to the FDA in an appropriate amount of time. ADE tracking is one way the FDA evaluates the safety of drugs currently on the market.
What is the end goal?
So, over the past 6 months, GLP-1 regulation policy has created more access to GLP-1 medications, either through self-pay options, or through Medicare and Medicaid. At the same time, the FDA has tightened oversight, especially for compounding pharmacies. While increasing access and ensuring safety are not inherently in conflict with each other, the ongoing balancing act creates questions about how patients will be impacted.
For example, the US experienced a GLP-1 medication shortage when more patients began taking the medications. It was during the shortage that compounding pharmacies began to make and distribute GLP-1 medications. However, now that the shortage was resolved, the FDA is once again restricting compounding of GLP-1s, and voices within the compounding industry have claimed that the policy will cause yet another shortage.
Conclusion
We expect President Trump to tout actions taken to increase low-cost access to GLP-1 medications as part of his strategy to highlight his actions to bring down health care costs. At the same time, the administration will need to ensure efforts to address patient access and efforts to ensure patient safety are seen as striking just the right balance.
The Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) plays a central role in identifying health care waste, fraud, and abuse. They provide oversight and recommendations to improve HHS programs, including Medicare and Medicaid.
As part of the effort, OIG has developed its Top Unimplemented Recommendations list to highlight the efforts that could produce the most substantial savings. This list of ready-made proposals would be a good place for the Trump administration to start if they are looking for more wins ahead of the November midterms.
Cracking down on Medicaid fraud has emerged as a key priority for the Trump administration in 2026, and OIG has already made several recommendations to strengthen the program. So, what moves could the Trump administration make in the future?
This blog outlines specific recommendations aligned with the Trump administration’s priorities for Medicaid, as well as the barriers to implementing these recommendations.
Recovering Medicaid Overpayments
Currently, OIG estimates that the Centers for Medicare and Medicaid Services (CMS) has not recovered over $1 billion in Medicaid overpayments. These overpayments have been found through audits conducted over the past 25 years and include multiple reporting periods. The overpayments have yet to be recovered as CMS does not have set time frame for resolving overpayment issues, does not have a verification process to ensure that states follow guidance, and does not retain documentation to support recovered overpayments.
Kimberly Brandt, CMS’s Deputy Administrator and COO, told the Energy and Commerce Oversight Subcommittee at a March 17 hearing that CMS is looking to move towards a “stop and cop” enforcement strategy as opposed to a “pay and chase” strategy, which would prevent money from being lost to fraud, rather than trying to recover it after the fact. While this change in strategy could be helpful in reducing future overpayments, CMS would still need to take additional actions to recover previous overpayments.
Reviews of Prior Authorization Denials
Prior authorization reform has been gaining traction on both sides of the aisle over the past few years. In 2023, HHS-OIG flagged the high rate of prior authorization denials for Medicaid Managed Care Organizations (MCOs), raising concerns that enrollees are not receiving all medically necessary health care services.
To address these concerns, OIG has recommended that CMS:
- Require states to review the appropriateness of prior authorizations
- Require states to collect data on MCO prior authorization decisions
- Issue guidance to states on use of MCO data for oversight
- Require external medical reviews of upheld MCO prior authorization denials
- Work to identify MCOs that may be issuing inappropriate denials
The Medicaid and CHIP Payment and Access Commission (MACPAC) has also made similar recommendations in the past. In their March 2024 Report to Congress, the Commission recommended that states establish an independent, external medical review process and for CMS to update regulations to require states to collect and report data on denials and appeal outcomes.
These actions could be enticing for the administration because they are reforms the president could point to as examples of action to address concerns about health care access and increase transparency.
Barriers to Implementation
Despite these seemingly straightforward recommendations to address health care waste, fraud, and abuse, implementation is not without challenges.
Pushback could come from stakeholders. For example, states could be unsupportive of new federal mandates that impact Medicaid administration, especially if they come with increased costs and administrative burden. States are also required to balance their budgets, which could make it more difficult to recover overpayments in the wake of Medicaid funding changes from the One Big Beautiful Bill Act or proposed increased program oversight. Additionally, MCOs are unlikely to be supportive of additional oversight over their decision-making processes, with the push back that it will increase administrative burden and delay care. Patient groups may also worry that increased enforcement will lead to improper denials or delays in getting care for enrollees.
The administration would also likely face opposition from Democratic lawmakers and potentially from more moderate Republicans. During consideration of the One Big Beautiful Bill Act, we saw moderate Republicans looking to demonstrate concerns about the impact of certain policies on access to care for Medicaid enrollees. More recently, Democratic members have raised concerns that the Trump administration is unfairly targeting Democratic states in its search to uproot health care waste, fraud, and abuse.
So, what happens now?
HHS-OIG’s recommendations are a starting point to address health care waste, fraud, and abuse. The Trump administration is reviewing some of the recommendations from the list, with an update expected in August. However, a key question is can the administration persuading sell the anti-fraud efforts as also effective in addressing health care affordability concerns. The answer to that question could have implications for who controls Congress next year.