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CMS Proposed Rules

1. Centers for Medicare & Medicaid Services 42 CFR Parts 417, 422, 423, and 460

CMS–4208–P RIN 0938–AV40

1.1. Purpose

The primary purpose of this proposed rule is to amend the regulations for theMedicare Advantage (Part C) program, Medicare Prescription Drug Benefit (PartD) program, Medicaid program, Medicare cost plan program, and Programs of All-Inclusive Care for the Elderly (PACE). This proposed rule includes a number of new policies that would improve these programs for contract year 2026 as well as codify existing Part C and Part D subregulatory guidance.

We note that, as with previous rules, the new marketing and communications policies in this rule are proposed to be applicable for all contract year 2026 marketing and communications, beginning October 1, 2025. However, to operationalize the proposed Format Provider Directories for Medicare Plan Finder provision at § 422.111(m), we anticipate that 2025 plan year directory data will need to be made available online for testing purposes in the summer of 2025, and 2026 plan year data would need to be available online on October 1, 2026. Therefore, we propose an applicability date of July 1, 2025, for this provision.

1.2. Number 5 Key Provision: Promoting Informed Choice—Format Provider Directories for Medicare Plan Finder

CMS is proposing to require MA provider directory data, as required under § 422.111(b)(3)(i) be submitted for use to populate Medicare Plan Finder (MPF). In addition, CMS is proposing to require MA organizations to attest that this information is accurate and consistent with data submitted to comply with CMS’s MA network adequacy requirements at 422.116(a)(1)(i) when it is submitted to CMS for the purpose of incorporating into MPF. The proposed regulatory changes would further promote informed beneficiary choice and transparency found in online resources, empowering people with Medicare to make informed choices about their coverage. In addition, the proposal will help ensure that provider directory information, including the provider’s cultural and linguistic capabilities, which are currently required for MA provider directories, and are especially important to underserved communities, will be more readily available when considering an MA plan.

Cost This proposed changes will not affect the Medicare Trust Fund. The paperwork burden is half a million dollars annually.

1.3. Number 17 Key provision: Promoting Community-Based Services and Enhancing Transparency of In-Home Service Contractors

CMS has become aware that some entities that provide covered benefits may not be included in an MA organization’s provider directory. These concerns relate to safety and a lack of transparency regarding supplemental benefit service providers and their access to an enrollee’s home, as well as ensuring individuals know which providers are deeply rooted within the communities they serve. This is particularly of concern when the enrollee may not have information about who may have access to their home, personally identifiable information (PII), or protected health information (PHI). As such, to strengthen beneficiary protections and transparency, CMS propose to:

  1. codify definitions of community-based organizations (CBOs), in-home or athome supplemental benefit providers and direct furnishing entities.
  2. require plans to identify, within the provider directory, which providers and direct furnishing entities meet the proposed definition of a CBO.
  3. require plans to identify in-home or athome supplemental benefit providers and direct furnishing entities, including those that provide a hybrid of service (both in-home or at-home, and in-office services), either through a subset list within the provider directory or through a separate list comprising in-home or athome supplemental benefit providers and direct furnishing entities.
  4. clarify existing policy by stating that all direct furnishing entities must be included within the provider directory.

Cost CMS does not expect that these proposed regulary changes will have an impact on the Medicare Trust Fund.

1.3.1. CMS Propose to define community-based organization (CBOs) in requlation 422.2

This definition would provide clarity to plans when adding the new proposed CBO notation to their provider directories regarding which direct furnishing entities are CBOs. This proposed definition is taken from the Calendar Year 2023 Medicare Physician Fee Schedule proposed rule (87 FR 46102) cited previously. We propose to define CBOs as “public or private not-for-profit entities that provide specific services to the community or targeted populations in the community to address the health and social needs of those populations.” We noted in the Calendar Year 2023 Medicare Physician Fee Schedule proposed rule that these CBOs may include:

  • community-action agencies,
  • housing agencies,
  • area agencies on aging,
  • centers for independent living,
  • aging and disability resource centers
  • or other non-profits that apply for grants or contract with health care entities to perform social services.

They may receive grants from other agencies in the U.S. Department of Health and Human Services, including:

  • Federal grants administered by the Administration for Children and Families (ACF),
  • Administration for Community Living (ACL),
  • the Centers for Disease Control and Prevention (CDC),
  • the Substance Abuse and Mental Health Services Administration (SAMHSA),
  • or state-funded grants to provide social services.

We solicit comment on this proposed definition, and whether this definition would be sufficiently broad enough to include all locally based organizations with whom an enrollee may wish to engage. We may consider finalizing revisions to this definition based on the comments received.

1.3.2. CMS Propose to include new regulation test at 422.111(b)(3)(i)(C) requiring plans to include in their provider directory easily identifiable notation indiccation direct furnishing entities that are CBOs.

Plans must include in their provider directories easily identifiable notations, filters, or other distinguishing features to indicate providers and direct furnishing entities that are community- based organizations (CBOs) (as defined in § 422.2).

CMS are interested in encouraging more engagement from both plans and enrollees with organizations invested in the community and local economy and wish to provide enrollees the ability to more easily identify and engage with CBOs. CMS also wish to encourage plans, to the extent possible, to engage with local businesses and vendors when determining which entities to contract with. As we noted in the Calendar Year 2025 Medicare Physician Fee Schedule proposed rule (89 FR 61875), local businesses and CBOs, “know the populations they serve and their communities and may have the infrastructure or systems in place to help coordinate supportive services that address social determinants of health or serve as a source from which ACOs can receive information regarding community needs.” While CMS is prohibited from requiring plans to contract with specific providers under section 1854(a)(6)(B)(iii) of the Act and § 422.256(a)(2)(i), we strongly encourage plans to engage with CBOs given evidence indicating that providers who coordinate care with CBOs to address health related social needs (HRSNs) (for example, housing, transportation, care management, etc.) can positively influence health outcomes. Therefore, we wish to strongly encourage collaboration of this kind. We further note that this complies with our regulation at § 422.112(b)(3) requiring coordinated care plans to coordinate MA plan services with community and social services generally available in the area served by the MA plan. Plans may contract with CBOs to provide benefits – including supplemental benefits – that are compliant with the statutory and regulatory requirements. For example, a plan could elect to offer a meal or food and produce supplemental benefit (so long as the benefit meets the requirements of § 422.100(c)(2) and other requirements for supplemental benefits) and pay a CBO for furnishing the covered benefit. We understand that in some areas there may be a limited number of CBO providers, and so we encourage plans to continue engaging with CBOs. Plans including a notation within the provider directory identifying an entity that is a CBO would increase enrollee awareness of these types of entities. This could lead to more enrollees choosing to receive items and services from CBOs that are more familiar with their community, can better coordinate supportive services, and can further address their community needs.

1.3.3. Burden associate with these requirement

  1. First, the proposed addition of the CBO notation in the provider directory would likely involve minimal burden given that plans must also include a notation or filter for other types of entities. With our proposed CBO definition, it should take little time for plans to identify their contracted CBOs and websites to add a notation to the listings for these entities in their provider directory. The proposed addition of direct furnishing entity listings should also create minimal burden since this is a clarification of existing policy and plans may already include all direct furnishing entities in their provider directories currently. There should therefore be few plans that need to make adjustments to their current provider directory due to the new proposed regulation text clarifying this requirement. We also expect if commenters believe that a subset list of in-home or at-home supplemental benefit providers is a satisfactory method to identify these providers, then there would be minimal burden associated as plans already must maintain an updated provider list as required by regulation. However, should commenters believe that the creation of a separate list for in-home and at-home supplemental benefit providers be prudent, we would likewise expect a low associated burden. As discussed, this list would be a subgroup of the current provider directory and include only in-home or at-home supplemental benefit providers,and, as previously noted, plans should already have information regarding which organizations fall under the proposed definition for an in-home or at-home supplemental benefit provider.

1.3.4. Propose Summary

  1. codify definitions of CBOs and in-home or at-home supplemental benefit providers and direct furnishing entities;
  2. require plans to identify, within the provider directory, which providers and direct furnishing entities meet the proposed definition of a CBO;
  3. require plans to identify in-home or at-home supplemental benefit providers and direct furnishing entities, including those that provide a hybrid of services (both in-home or at-home, and in-office services), either through a subset list within the provider directory or through a separate list comprising in-home or at-home supplemental benefit providers and direct furnishing entities;
  4. clarify existing policy by stating that all direct furnishing entities must be included within the provider directory.

1.4. Format Medicare Advantage (MA) Organizations' Provider Directories for Medicare Plan Finder (422.111 and 422.2256) Section III P

CMS continues to take steps to improve the usability of Medicare Plan Finder, strengthen oversight of plan marketing materials, and require agents and programs share information intended to ensure enrollees are able to make informed choices about their Medicare, Medicare Advantage, and Part D coverage. Policymakers, MedPAC, and other researchers have raised concerns about the increase in the number of plans having a detrimental impact on choice and competition, leading to confusion and difficulty for beneficiaries as they compare plans and choose an option.

Plans differ on multiple dimensions, including covered services, premiums, service-specific cost-sharing, and provider networks, and evidence shows that too much choice complexity, particularly on financial dimensions, hinders beneficiaries’ ability choose a plan that best meets their needs. Moreover, even modest increases in the number of options can further impair consumer choice, reduce enrollment, and can lead to premium increases. On the other hand, facilitating plan comparison shopping through reduced complexity can lead to improved plan selection and more effective competition. CMS continues to consider opportunities to support consumer choice as part of broader efforts to strengthen the MA program.

To reiterate, it is important that, when Medicare beneficiaries are exploring their options, they have the information they need to make the best choice for their needs. When deciding between Traditional Medicare and MA, one key factor is that CMS requires MA plans to have a provider network. Provider directories allow beneficiaries and their caregivers to weigh Medicare options and decide if a certain provider network meets their needs, such as to check if their existing physicians are in the network, what other contracted providers are available to deliver other medical care, amongst a myriad of other factors. As the landscape of MA has evolved, CMS has implemented rules, and made modifications to those rules, to ensure that people with Medicare and the trusted individuals they rely on to aid in their decision making, have the information necessary to make decisions about their Medicare options, including many of the required materials and disclaimers found under § 422.2267(e), as well as the requirements under § 422.2265(b) and (c) that certain content and materials are made available on the MA organization’s website.

422.2267 Required materials and content (e)(11) Provider Directory This is a model communications material through which plans must provide the information under § 422.111(b)(3). The Provider Directory must:

  1. Be provided to current enrollees of the plan by October 15 of the year prior to the applicable year.
  2. Be provided to new enrollees within 10 calendar days from receipt of CMS confirmation of enrollment or by last day of month prior to effective date, whichever is later.
  3. Be provided to current enrollees upon request, within three business days of the request.
  4. Be updated any time the MA organization becomes aware of changes.
  • (A) Updates to the online provider directories must be completed within 30 days of receiving information requiring update.
  • (B)
    1. Updates to hardcopy provider directories must be completed within 30 days.
    2. Hard copy directories that include separate updates via addenda are considered up-to-date.

422.2265 Websites (b) Required content MA organization's website must include

  1. A toll-free customer service number, TTY number, and days and hours of operation.
  2. A physical or Post Office Box address.
  3. A PDF or copy of a printable provider directory.
  4. A provider directory searchable by every element required in the model provider directory, such as name, location, specialty.
  5. When applicable, a searchable pharmacy directory combined with a provider directory.
  6. Information on enrollees' and MA organizations' rights and responsibilities upon disenrollment. MA organizations may either post this information or provide specific information on where it is located in the Evidence of Coverage together with a link to that document.
  7. A description of and information on how to file a grievance, request an organization determination, and an appeal.
  8. Prominently displayed link to the Medicare.gov electronic complaint form.
  9. Disaster and emergency policy consistent with § 422.100(m)(5)(iii).
  10. A Notice of Privacy Practices as required under the HIPAA Privacy Rule (45 CFR 164.520).
  11. For PFFS plans, a link to the PFFS Terms and Conditions of Payment.
  12. For MSA plans, the following statements:
  • “You must file Form 1040, US Individual Income Tax Return,' along with Form 8853, Archer MSA and Long-Term Care Insurance Contracts' with the Internal Revenue Service (IRS) for any distributions made from your Medicare MSA account to ensure you aren't taxed on your MSA account withdrawals. You must file these tax forms for any year in which an MSA account withdrawal is made, even if you have no taxable income or other reason for filing a Form 1040. MSA account withdrawals for qualified medical expenses are tax free, while account withdrawals for non-medical expenses are subject to both income tax and a fifty (50) percent tax penalty.”
  • “Tax publications are available on the IRS website at http://www.irs.gov or from 1-800-TAX-FORM (1-800-829-3676).”
  1. Instructions on how to appoint a representative including a link to the downloadable version of the CMS Appointment of Representative Form (CMS Form-1696).
  2. Enrollment instructions and forms.

422.2265 Websites (c) Required posted materials MA organization's website must provide access to the following materials, in a printable format, within the timeframes specified in paragraphs (c)(1) and (2) of this section.

  1. The following materials for each plan year must be posted on the website by October 15 prior to the beginning of the plan year:
  • Evidence of Coverage.
  • Annual Notice of Change (for renewing plans).
  • Summary of Benefits.
  • Provider Directory.
  • Provider/Pharmacy Directory.
  1. The following materials must be posted on the website throughout the year and be updated as required:
  • Prior Authorization Forms for physicians and enrollees.
  • When applicable, Part D Model Coverage Determination and Redetermination Request Forms.
  • Exception request forms for physicians (which must be posted by January 1 for new plans).
  • CMS Star Ratings document, which must be posted within 21 days after its release on the Medicare Plan Finder.

1.4.1. MA Provider directory propose

CMS believe that additional regulatory changes are now required to allow the agency to ensure that CMS is leveraging technological methods to streamline the beneficiary experience so that beneficiaries have the information they need to make the best choice for their needs, including MA provider directories. CMS proposes to make changes that will allow MA provider directories to be viewable on Medicare Plan Finder (MPF) for the 2026 Annual Enrollment Period (AEP). In addition, to ensure the accuracy of the data being submitted, we propose to require MA organizations to attest to the accuracy of the provider directory data being submitted. In total, we believe these proposed changes will result in an advancement of informed beneficiary choice and transparency benefitting people with Medicare, while also promoting robust competition within the Medicare market, aligned with the President’s July 2021 Executive Order on Promoting Competition in the American Economy.

1.4.2. MA Provider directory access

422.111 Disclosure requirements (b) Content plan Description (3) Access (i) The number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services; each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office; any out-of-network coverage; any point-of-service option, including the supplemental premium for that option; and how the MA organization meets the requirements of §§ 422.112 and 422.114 for access to services offered under the plan.

1.4.2.1. 422.112 Access to Service

(a) Rules for coordinated care plans

  1. Provider Network
  2. PCP panel
  3. Specialty care
  4. Service area expansion
  5. Credentialed providers
  6. written standards
  7. Hours of operation
  8. Ensuring equitable access to MA Services Ensure that services are provided in a culturally competent manner and to promote equitable access to all enrollees, including the following:
  • People with limited English proficiency or reading skills.
  • People of ethnic, cultural, racial, or religious minorities.
  • People with disabilities.
  • People who identify as lesbian, gay, bisexual, or other diverse sexual orientations.
  • People who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex.
  • People living in rural areas and other areas with high levels of deprivation.
  • People otherwise adversely affected by persistent poverty or inequality
  1. Ambulance services, emergency and urgently needed services, and post-stabilization care services coverage
  2. Prevailing patterns of community health care delivery

(b) Continuity of care.
MA organizations offering coordinated care plans must ensure continuity of care and integration of services through arrangements with contracted providers that include—

  1. Policies that specify under what circumstances services are coordinated and the methods for coordination;
  2. Offering to provide each enrollee with an ongoing source of primary care and providing a primary care source to each enrollee who accepts the offer;
  3. Programs for coordination of plan services with community and social services generally available through contracting or noncontracting providers in the area served by the MA plan, including nursing home and community-based services, and behavioral health services; and
  4. Procedures to ensure that the MA organization and its provider network have the information required for effective and continuous patient care and quality review, including procedures to ensure that—
  • The MA organization makes a “best-effort” attempt to conduct an initial assessment of each enrollee's health care needs, including following up on unsuccessful attempts to contact an enrollee, within 90 days of the effective date of enrollment;
  • Each provider, supplier, and practitioner furnishing services to enrollees maintains an enrollee health record in accordance with standards established by the MA organization, taking into account professional standards; and
  • There is appropriate and confidential exchange of information among provider network components.
  1. Procedures to ensure that enrollees are informed of specific health care needs that require follow-up and receive, as appropriate, training in self-care and other measures they may take to promote their own health; and
  2. Systems to address barriers to enrollee compliance with prescribed treatments or regimens.
  3. With respect to drugs for which payment as so prescribed and dispensed or administered to an individual may be available under Part A or Part B, or under Part D, MA-PD plans must coordinate all benefits administered by the plan and—
  • Establish and maintain a process to ensure timely and accurate point-of-sale transactions; and
  • Issue the determination and authorize or provide the benefit under Part A or Part B or as a benefit under Part D as expeditiously as the enrollee's health condition requires, in accordance with the requirements of subpart M of this part and subpart M of part 423 of this chapter, as appropriate, when a party requests a coverage determination.

  • With respect to basic benefits, policies for using prior authorization that at a minimum include that for enrollees undergoing an active course of treatment— (A) Approval of a prior authorization request for a course of treatment must be valid for as long as medically necessary to avoid disruptions in care, in accordance with applicable coverage criteria, the individual patient's medical history, and the treating provider's recommendation; and

    (B) A minimum 90-day transition period for any active course(s) of treatment when an enrollee has enrolled in an MA plan after starting a course of treatment, even if the service is furnished by an out-of-network provider. This includes enrollees new to a plan and enrollees new to Medicare. The MA organization must not disrupt or require reauthorization for an active course of treatment for new plan enrollees for a period of at least 90 days.

  • For purposes of this paragraph (b)(8), the following definitions apply: (A) Course of treatment means as a prescribed order or ordered course of treatment for a specific individual with a specific condition is outlined and decided upon ahead of time with the patient and provider. A course of treatment may but is not required to be part of a treatment plan.

    (B) Active course of treatment means a course of treatment in which a patient is actively seeing the provider and following the course of treatment.

(c) Essential hospital.
An MA regional plan may seek, upon application to CMS, to designate a noncontracting hospital as an essential hospital as defined in section 1858(h) of the Act under the following conditions:

  1. The hospital that the MA regional plan seeks to designate as essential is a general acute care hospital identified as a “subsection(d)” hospital as defined in section 1886(d)(1)(B) of the Act.
  2. The MA regional plan provides convincing evidence to CMS that the MA regional plan needs to contract with the hospital as a condition of meeting access requirements under this section.
  3. The MA regional plan must establish that it made a “good faith” effort to contract with the hospital to be designated as an essential hospital and that the hospital refused to contract with it despite its “good faith” effort. A “good faith” effort to contract will be established to the extent that the MA regional plan can show it has offered the hospital a contract providing for the payment of rates in an amount no less than the amount the hospital would have received had payment been made under section 1886(d) of the Act.
  4. The MA regional plan must establish that there are no competing Medicare participating hospitals in the area to which MA regional plan enrollees could reasonably be referred for inpatient hospital services.
  5. The hospital that is an essential hospital under this paragraph provides convincing evidence to CMS that the amounts normally payable under section 1886 of the Act (and which the MA regional plan has agreed to pay) will be less than the hospital's actual costs of providing care to the MA regional plan's enrollee.
  6. If CMS determines the requirements in paragraphs (c)(1) through (c)(5) of this section have been met, it will make payment to the essential hospital in accordance with section 1858(h)(2) of the Act based on the order in which claims are received, as limited by the amounts specified in section 1858(h)(3) of the Act.
  7. If CMS determines the requirements in paragraphs (c)(1) through (c)(4) of this section have been met, (and if they continue to be met upon annual renewal of the CMS contract with the MA organization offering the MA regional plan), then the hospital designated by the MA regional plan in paragraph (c)(1) of this section shall be “deemed” to be a network hospital to that MA regional plan based on the exception in paragraph (a)(1)(ii) of this section and normal in-network inpatient hospital cost sharing levels (including the catastrophic limit described in § 422.101(d)(2)) shall apply to all plan members accessing covered inpatient hospital services in that hospital.

1.4.2.2. 422.114 Access to services under an MA private fee-for-service plan

(a) Sufficient access (b) Freedom of choice (c) Contracted network

1.4.2.3. The Interoperability and Patient Access final rule (85 FR 25633)** became effective on June 30, 2020, and requires MA organizations, beginning on January 1, 2021, to make standardized information about their provider networks accessible through a Provider Directory Application Programming Interface (API) that conforms with CMS/HHS technical standards at § 422.119(c). The Interoperability and Patient Access final rule, also included in § 422.120 that the Provider Directory API must be accessible via a public-facing digital endpoint on the MA organization's website to ensure that this information is viewable and accessible to prospective and current enrollees as well as third-party application developers, who can create services to help patients find providers for care and treatment.

422.199 Access to and exchange of health data and plan information (a) Application Programming Interface to support MA enrollees (c) Technical requirements conform with 45 CFR 170.215(a)(1),(b)(1)(i), (c)(1), and (e)(1)

1.4.2.1.1. 170.215 Application Programming Interface Standards

(a) API base standard. The following are applicable for purposes of standards-based APIs. (1) Standard. HL7® Fast Healthcare Interoperability Resources (FHIR®) Release 4.0.1 (incorporated by reference, see § 170.299).

1.4.2.1.2. 422.120 Access to published provider directory information.

(a) An MA organization must implement and maintain a publicly accessible, standards-based Application Programming Interface (API) that is conformant with the technical requirements at § 422.119(c), excluding the security protocols related to user authentication and authorization and any other protocols that restrict the availability of this information to particular persons or organizations, the documentation requirements at § 422.119(d), and is accessible via a public-facing digital endpoint on the MA organization's website.

(b) The API must provide a complete and accurate directory of

  1. The MA plan's network of contracted providers, including names, addresses, phone numbers, and specialties, updated no later than 30 calendar days after the MA organizations receives provider directory information or updates to provider directory information; and

  2. For an MA organization that offers an MA-PD plan, the MA-PD's pharmacy directory, including the pharmacy name, address, phone number, number of pharmacies in the network, and mix (specifically the type of pharmacy, such as “retail pharmacy”) updated no later than 30 calendar days after the MA organization receives pharmacy directory information or updates to pharmacy directory information.

(c) This section is applicable beginning January 1, 2021.