Healthcare

CMS 2026 Proposed Policy and Technical Changes for Medicare

December 5, 2024

CMS 2026 Proposed Policy and Technical Changes for Medicare

by Sheela Andrews, Pharm D.


On November 26, 2024, CMS issued a proposed rule that would revise the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program (Part D), Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE) with the intent to hold MA and Part D plans more accountable for delivering high-quality coverage so that people with Medicare are connected to the care they need when they need it.

Below is the link to the fact sheet.
Public comments must be submitted no later than January 27, 2025.

CMS.gov Fact Sheet

Key Highlights Include:

Coverage of Anti-Obesity Medications

  • Under current policy, anti-obesity medications are only coverable in Part D if the drug is being used to treat another condition that is a medically accepted indication other than weight loss or weight management (for example, type 2 diabetes or to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight).
  • The proposed rule would permit coverage of anti-obesity medications for the treatment of obesity when such drugs are indicated to reduce excess body weight and maintain weight reduction long-term for individuals with obesity.

Strengthening Prior Authorization and Utilization Management Guardrails

  • CMS will be building upon and enhancing prior regulations and policies related to the use of internal coverage criteria, by defining the phrase “internal coverage criteria,” establishing guardrails to preserve access to benefits, and adding more specific rules about publicly posting internal coverage criteria content on MA organization websites.
  • CMS is proposing an additional four items:
    • Clarify that an enrollee’s further liability to pay for services cannot be determined until an MA organization has made a determination on a request for payment.
    • Modify the definition of an organization determination to clarify that a coverage decision made by an MA organization contemporaneously with when an enrollee is receiving such services, including level of care decisions (such as inpatient or outpatient coverage), is an organization determination subject to appeal and other existing requirements.
    • Strengthen the notice requirements to ensure that a provider who has made a standard organization determination or integrated organization determination request on an enrollee’s behalf, or when it is otherwise appropriate, receives notice of the MA organization’s decision.
    • Changing the reopening rules to eliminate the discretion of an MA organization to reopen an approved authorization for an inpatient hospital admission.

Guardrails for Artificial Intelligence (AI)

  • Revise policies to ensure that the use of AI does not result in inequitable treatment, bias, or both, within the healthcare system, and instead is used to promote equitable access to care and person-centered care for all enrollees.

Format Provider Directories for Medicare Plan Finder (MPF)

  • Medicare Plan Finder does not currently include information on provider networks and instead MA organizations are required to include on their plan websites a PDF or copy of a printable provider directory and a searchable provider directory.
  • The proposed rule will require MA organizations to make provider data directly available on Medicare Plan Finder.

Ensuring Equitable Access to Behavioral Health Benefits Through Section 1876 Cost Plan and MA Cost Sharing Limits

  • CMS is taking steps to improve access to behavioral health care for enrollees by ensuring that MA in-network cost sharing may be no greater than cost sharing in Traditional Medicare for these services.

Promoting Informed Choice through Agent and Broker Requirements on Programs to Help Beneficiaries & Enhanced Review of Marketing & Communications

  • Propose changes to CMS’ definition of “marketing” to increase the number and type of advertisements that are required to be submitted to CMS and subject to review before their use.
  • To further promote informed enrollment decisions, CMS is proposing to expand the number of required topics that an agent or broker must cover before an individual’s enrollment to ensure the individual is educated on important topics and options that may factor into their enrollment decision.

Administration of Supplemental Benefits Coverage Through Debit Cards

  • Provide clarity on the use of MA organization debit cards used to administer supplemental benefits, and for guidance on which plan-covered supplemental benefits can be purchased with their debit card and/or where and how the cards can be used.

MA and Part D Medical Loss Ratio (MLR) Reporting

  • Require that provider incentive and bonus arrangements are tied to clinical or quality improvement standards in order to be included in the MA MLR numerator
  • Require administrative costs to be excluded from quality-improving activities in the MA and Part D MLR numerators
  • Codify the current practice by which MA and Part D MLR reports include a description of how expenses are allocated across lines of business
  • Establish compliance standards for MA and Part D MLR audits. CMS already has the authority to review and audit MA organization and Part D sponsor MLR reports. However, CMS is proposing to regulate the actions they intend to take as a result of audit findings. Specifically, they are setting forth standards for selecting contracts for audit examinations, clarifying compliance actions that will be taken as a result of audit findings, and outlining an appeals process
  • Change Medicare MLR regulations authorizing the release of Part C and Part D MLR data to add exclusions
  • Exclude Medicare Prescription Payment Plan unsettled balances from the MLR
  • Request information on MLR and vertical integration in MA and Part D and,
  • Collect additional details regarding plan expenditures categorized by different provider payment arrangements.

Medicare Prescription Payment Plan

  • Codify the requirements established in the final part one and final part two guidance for 2026 and future years of the Medicare Prescription Payment Plan.
  • Propose an automatic election renewal process that extends a Part D enrollee’s participation in the program for the next calendar year, unless the enrollee opts out.
  • Additionally, CMS solicits comments on a potential requirement for Part D sponsors to effectuate election requests received via phone or web in real-time for 2026 or future years.

Formulary Inclusion and Placement of Generics and Biosimilars

  • CMS clarifies that plan formularies must provide beneficiaries with broad access to generics, biosimilars, and other lower-cost drugs to be compliant.

Promoting Transparency for Pharmacies and Protecting Beneficiaries from Disruptions

  • Require Part D plans (or first tier, downstream, or related entities, such as PBMs, acting on the Part D sponsors’ behalf) to provide contracted pharmacies with information about which Part D plans they are in-network for before open enrollment and on request thereafter.
  • Require Part D sponsors (or first tier, downstream, or related entities, such as PBMs, acting on the Part D sponsors’ behalf) to allow pharmacies to terminate their network contracts without cause after the same notice period that the sponsor is allowed to terminate pharmacy network contracts without cause.

Part D Medication Therapy Management (MTM) Program Eligibility Criteria

  • Proposing to expand the reference to Alzheimer’s disease on the list of core chronic diseases to include other dementias.

Promoting Community-Based Services and Enhancing Transparency of In-Home Service Contractors

  • Entities that provide covered benefits need to be included in an MA organization’s provider directory.

View attachment