CMS Rule for CY 2026 Highlights AI, Behavioral Health, Anti-Obesity Drug Coverage, and More | Epstein Becker Green
Medicare Proposes Sweeping Changes for 2026, including Coverage of Weight-Loss Drugs
Washington, D.C. – In a move that could substantially impact millions of Americans, the Centers for Medicare & Medicaid Services (CMS) has proposed sweeping changes to Medicare Advantage and Part D plans for 2026. The proposed rule, released in December 2024, tackles a wide range of issues, from the use of artificial intelligence in healthcare to expanding coverage for weight-loss medications.
One of the most notable proposals would require Medicare Part D plans and Medicaid programs to cover anti-obesity medications (AOMs) for beneficiaries with obesity, starting in 2025. This landmark change is estimated to provide coverage for an additional 3.4 million Part D enrollees and four million Medicaid beneficiaries, potentially increasing Medicare and Medicaid spending by billions over the next decade.
the proposed rule also addresses the growing use of artificial intelligence (AI) in healthcare. Recognizing the potential for bias in AI systems, CMS is proposing new guidelines to ensure these tools are used responsibly and equitably.
“We want to make sure that AI is used in a way that benefits all patients, regardless of their background,” said a CMS spokesperson. “These proposed guidelines are a step towards ensuring that AI is used ethically and effectively in Medicare.”
Other key proposals in the 2026 rule include:
Broadened marketing definitions: CMS aims to expand its oversight of Medicare Advantage and Part D marketing materials and activities to protect beneficiaries from misleading or deceptive practices.
Limits on supplemental benefit marketing: The rule proposes restrictions on the marketing of supplemental benefits and the use of debit cards, aiming to prevent confusion and ensure clarity for beneficiaries.
Improved access to behavioral health services: CMS is proposing measures to ensure equitable access to mental health and substance abuse treatment for all Medicare beneficiaries.
Enhanced provider directory accuracy: The rule seeks to improve the accuracy and completeness of Medicare Advantage provider directories, making it easier for beneficiaries to find in-network providers.* Star Ratings improvements: CMS is proposing changes to the Star Ratings system, which measures the quality of Medicare Advantage and Part D plans, to make it more obvious and meaningful for beneficiaries.
The proposed rule is now open for public comment until January 27, 2025. CMS will carefully review all comments before finalizing the rule later in 2025.This proposed rule represents a meaningful step towards modernizing Medicare and ensuring that it meets the evolving needs of america’s seniors and people with disabilities.
Medicare Coverage for Weight-Loss Drugs Could Expand Under Proposed Rule
Millions of Americans with obesity could gain access to potentially life-changing weight-loss medications under a proposed rule change from the Centers for medicare & Medicaid Services (CMS). The proposal, unveiled in the 2026 Proposed Rule, marks a significant shift in CMS policy and reflects the evolving medical understanding of obesity as a chronic disease.
Currently, Medicare Part D, the prescription drug benefit for seniors and people with disabilities, excludes coverage for drugs primarily used for weight loss. However,the new proposal seeks to reinterpret this exclusion,allowing coverage for medications specifically designed to treat obesity.
This change aligns with CMS’s initial stance when Part D was implemented in 2005. At that time, CMS acknowledged that weight-loss agents could be covered for treating morbid obesity, recognizing it as a distinct medical condition.
Despite this early position, CMS has consistently maintained that anti-obesity medications (AOMs) are excluded from Part D coverage when used for weight management. This stance was reaffirmed in March 2024, even as newer, highly effective aoms like Ozempic, Wegovy, and Mounjaro gained popularity.
The proposed rule change comes as obesity rates continue to rise in the U.S., posing a significant public health challenge.
“This proposal recognizes the serious health implications of obesity and aims to provide Medicare beneficiaries with access to effective treatment options,” said a CMS spokesperson.
The proposal, however, draws a clear line between coverage for obesity and general weight loss. Individuals classified as “overweight” but not “obese” would not be eligible for coverage under the proposed rule.
CMS is actively seeking public feedback on potential unintended consequences of this distinction, notably the possibility of beneficiaries intentionally gaining weight to qualify for coverage.
Expanded Oversight of Medicare Advantage Marketing
Along with the AOM coverage proposal, the 2026 Proposed Rule also includes measures to strengthen oversight of marketing practices within Medicare Advantage (MA) and Part D plans.
CMS proposes to expand the scope of marketing materials subject to review,aiming to identify and address potentially misleading or deceptive advertising more effectively. This move comes in response to growing concerns about aggressive marketing tactics employed by some MA plans.
The agency also proposes new regulations on the administration of supplemental benefits, ofen provided through debit cards.These regulations aim to increase transparency and ensure that supplemental benefits are used appropriately, aligning with the Biden administration’s focus on responsible use of MA program funds.
The 2026 Proposed Rule is currently open for public comment, allowing stakeholders and individuals to provide feedback on these significant policy changes.
Medicare Proposes Major Changes to Mental Health Coverage, Sparking Debate
Millions of americans on Medicare Advantage plans could see significant changes to their mental health coverage under a new proposal from the Centers for Medicare & Medicaid Services (CMS). The 2026 Proposed Rule aims to address disparities in access to behavioral health services, particularly for disadvantaged communities hit hard by the COVID-19 pandemic.
The proposal comes in response to data showing that a significant portion of medicare Advantage (MA) plans charge higher cost-sharing rates for mental health and substance use disorder services compared to traditional Medicare. CMS found that between 23 and 25 percent of MA plans impose higher costs for mental health specialty services,while 42 to 71 percent exceed traditional Medicare cost-sharing for outpatient substance use disorder services. This translates to potentially higher out-of-pocket expenses for enrollees seeking vital mental health care.
Under the proposed rule, MA and Cost Plans would be required to set in-network cost-sharing for behavioral health services at or below traditional Medicare levels, starting January 1, 2026. CMS is seeking public comment on the proposed start date, the possibility of a transition period, and the potential impact on plans’ ability to maintain actuarial equivalence with traditional medicare.The proposal has sparked debate among stakeholders. Health plans may raise concerns about the financial implications and actuarial challenges of aligning cost-sharing with traditional Medicare levels. They may also question the precedent of restricting plan discretion in benefit design.
On the other hand,mental health professionals and providers could offer insights into how these changes might improve service delivery and patient access. They may highlight the potential benefits of reducing financial barriers to care, particularly for vulnerable populations.
The potential for unintended consequences is also a key consideration. Some stakeholders may express concerns about potential shifts in plan design or provider network composition that could indirectly affect health plan availability for patients with behavioral health conditions.
CMS is encouraging all interested parties to submit comments on the proposed rule by the deadline. The agency will carefully consider all feedback as it finalizes the rule, aiming to strike a balance between affordability, access, and sustainability in Medicare Advantage mental health coverage.
Medicare advantage Plans Face New Requirements for In-Home Service Provider Data
Medicare Advantage (MA) plans are facing new requirements to increase transparency around in-home service providers, a move aimed at boosting safety and empowering beneficiaries.
The Centers for Medicare & Medicaid Services (CMS) proposed rule would require MA plans to submit detailed provider directory data to Medicare Plan Finder (MPF), making it publicly accessible for the first time. This includes data about in-home service providers, such as their community ties, service capabilities, and whether they offer in-home, in-office, or hybrid services.
The proposal, set to take effect July 1, 2025, comes in response to concerns about safety and transparency surrounding in-home services. CMS aims to give beneficiaries more control over who enters their homes by providing comprehensive information about potential providers.
Challenges for plans and Providers
While CMS believes the changes will be minimal for plans, the new requirements pose significant operational challenges. Plans will need to invest in robust data collection and directory management systems to accurately categorize and tag providers across multiple dimensions.
In-home service providers, particularly smaller ones and community-based organizations (CBOs), may face increased administrative burdens in ensuring their information is accurately represented. This could lead to barriers to entry or participation in MA networks, potentially reducing the diversity of available service providers.
Stakeholder Feedback Sought
CMS is seeking public comment on the proposed rule, encouraging stakeholders to weigh in on several key issues.
Providers and plans may argue that the proposed definitions are too broad or lack precision, potentially creating compliance ambiguities. Advocates for in-home services could support the transparency goals while suggesting refinements to the definition of CBOs to ensure more comprehensive representation of local providers.
Commenters may also request phased implementation to allow plans and providers sufficient time to adapt to the new requirements or seek clarification on the specific technological and administrative mechanisms needed for compliance.
Star Ratings System Under review
In addition to the provider directory changes, CMS is also considering updates to the Part C and Part D Star Ratings system, which measures plan quality and determines quality bonus payments.
CMS is exploring the use of a Universal Foundation of quality measures, a core set of measures aligned across CMS programs, and is seeking ways to streamline the measurement set to improve the impact of the Star Ratings program.
The agency plans to solicit comments on these proposed changes through the 2026 Advance notice and Rate Declaration process.
CMS Proposes Changes to Medicare advantage Star Ratings, Seeks Public Input
Washington, D.C. – The Centers for Medicare & Medicaid Services (CMS) has unveiled proposed changes to the Medicare Advantage (MA) Star ratings system, aiming to enhance the program’s focus on quality care and beneficiary experience. The proposed rule,published in the Federal Register on [Date],invites public comment on several key updates slated for implementation in the 2028 Star Ratings,based on 2026 data.
Among the proposed changes are the addition of new quality measures, including:
Initiation and Engagement of Substance Use Disorder Treatment (IET): This composite measure, focusing on timely access to and engagement with treatment for substance use disorders, would be a significant addition to the Star Ratings.
Initial Opioid Prescribing for Long duration (IOP-LD): This preventative measure aims to curb long-term opioid use and overdose risk by addressing initial prescription practices.CMS is also proposing updates to existing measures, such as expanding the age range for the Breast Cancer Screening measure to include women aged 40 to 49. Additionally, the agency is proposing changes to measures related to the timeliness of appeals decisions.
Furthermore, CMS is considering removing the “guardrail” policy, which limits year-to-year fluctuations in measure-specific thresholds used to determine Star Ratings. This change, initially proposed in December 2022, is intended to reflect the increased stability achieved through the implementation of a new outlier deletion policy.
“These proposed changes reflect CMS’s ongoing commitment to ensuring that the Star Ratings system accurately reflects the quality of care provided by MA plans,” said [Name and Title of CMS Official, if available]. “We encourage all stakeholders to review the proposed rule and provide their valuable feedback.”
the public comment period for the proposed rule closes on January 27, 2025. Comments can be submitted electronically at [Link to Regulations.gov] or by mail as specified in the proposed rule.
New Federal Rule Aims to Boost Transparency in Healthcare Pricing
Hospitals and insurers will soon be required to disclose more detailed pricing information to consumers under a new federal rule finalized by the Biden administration.
The rule, announced by the Centers for Medicare & Medicaid Services (CMS), aims to empower patients to make more informed decisions about their healthcare by providing them with clear and accessible pricing data.
“For too long, americans have been left in the dark about the true cost of their healthcare,” said CMS Administrator Chiquita brooks-LaSure. “This rule is a major step towards increasing price transparency and giving patients the information they need to be active participants in their own care.”
What’s Changing?
The new rule expands on existing transparency requirements by mandating that hospitals disclose prices for a wider range of services, including common procedures and diagnostic tests.
Insurers will also be required to provide consumers with personalized cost estimates for specific services, taking into account their individual plan benefits and out-of-pocket costs.
empowering Patients
The goal of these changes is to empower patients to shop around for healthcare services and compare prices from different providers.
“This rule will help patients understand the costs associated with their care before they receive it,” said Brooks-lasure. “this can help them make more informed decisions about their treatment options and potentially save money.”
Industry Response
The healthcare industry has expressed mixed reactions to the new rule. Some hospitals and insurers have voiced concerns about the administrative burden of complying with the new requirements. Others have welcomed the increased transparency, arguing that it will ultimately benefit patients.
The rule is set to take effect in phases, with hospitals required to begin disclosing prices for certain services by January 1, 2024. insurers will have until July 1, 2024, to comply with the new personalized cost estimate requirements.
The Biden administration hopes that these changes will lead to a more competitive and transparent healthcare market, ultimately resulting in lower costs for consumers.