2023-07115.pdf

Care.80The National Academies for Science, Engineering, and Medicine (NASEM) Report outlined the importance of ensuring that high-quality primary care is available to every individual and family in every community, particularly those that are underserved. After all, access to primary care practitioners, as opposed to any other practitioner type, is associated with decreased mortality.81 We also sought comment on alternative specific appointment wait times standards to apply to MA organizations. For example, we considered, as suggested by a commenter on our RFI, establishing appointment wait time standards that align with those established for qualified health plans, (QHPs) as outlined by CMS in the 2023 Final Letter to Issuers in the Federally- facilitated Exchanges.82The appointment wait time standards for QHPs include: Behavioral health appointments must be available within 10 business days, Primary care (routine) must be available within 15 business days; and Specialty care (non-urgent) must be available within 30 business days. We explained that under this alternative, the wait time requirements would be applicable to primary care and behavioral health specialty types. We solicited comment on whether a more flexible approach would be appropriate, such as requiring MA organizations have specific standards for appointment wait time in their written internal policies, but that CMS require MA plans to meet the specific standards for appointment wait time limits for routine or non-emergency services for only a significant portion (for example, 95 percent) of appointments. The proposal for mandatory standards for minimum wait times for MA enrollees is intended to ensure that MA enrollees are able to access covered services and that MA organizations meet their obligations under section 1852(d) of the Act to make covered benefits available and accessible to enrollees in the plan. Section 1856(b) of the Act authorizes the adoption of standards that are consistent with and to carry out the Part C statute. We are also considering requiring new and expanding service area applicants to attest to their ability to provide timely access to care consistent with the CMS standards for appointment wait time we would add to  422.112(a)(6)(i). We would implement a new application requirement by adding a new attestation to our Part CMedicare Advantage and 1876 Cost Plan Expansion Application that specifically addresses requirements at  422.112(a)(6)(i). Such an attestation would not be reflected in a specific regulation, however, because we believe the requirement at  422.501(c)(2), that an applicant thoroughly describe how the entity and MA plan meet, or will meet, all the requirements described in this part, permits CMS to use an attestation to support the ability of an MA organization to comply with performance requirements. Adequate access to services for MA enrollees is a key consideration. We solicited comment on our proposal, including whether one or more of the previously described sets of standards for wait time would more effectively address our goals of ensuring that MA organizations are meeting timely access standards for primary care and behavioral health services for enrollees, supporting parity between behavioral health and physical health services, and strengthening our requirements for MA organizations to ensure beneficiary protections in access to care. In addition, we solicited comment on whether a specific standard limit for appointment wait times for emergency or urgently needed services is duplicative of the mandatory coverage and access requirements in  422.113. Comment: We received many comments in support of our proposal to codify, as requirements, the example standards for appointment wait times for primary care and extend them to behavioral health. Response: We thank commenters for their support regarding this proposal. Codifying the standards for appointment wait times and extending them to behavioral health will support our goals of reducing barriers to behavioral health treatment and to supporting parity with physical health. It also underscores the importance of access to timely primary care. As adopted, these new wait time standards for behavioral health services apply to both behavioral health services and substance use disorder services. Comment: We received several comments that did not support our proposal to codify standards for appointment wait times and apply them to both primary care and behavioral health. Commenters citied challenges with behavioral health provider shortages and associated burden with implementing specific wait times with providers in MA networks that may dissuade providers from contracting with MA plans. Further, some commenters indicated that maintaining strict wait times could also discourage MA plans from expanding their service areas, impacting enrollee access. In addition, commenters expressed interest in allowing MA plans to maintain the flexibility in establishing wait times afforded in Chapter 4 of the Medicare Managed Care Manual, and delaying implementation of this proposal. Response: As indicated in our proposed rule, codifying the standards for appointment wait times for primary care and extending them to behavioral health will support our goals for parity, and will help strengthen beneficiary protections in access to care. We are committed to ensuring that MA enrollees are able to access covered services and that MA organizations meet their obligations under section 1852(d) of the Act to make covered benefits available and accessible to enrollees in the plan. Comment: Some commenters requested clarity on evaluation criteria and mechanisms for monitoring MA organizations compliance standards of appointment wait times. Additionally, some requested that CMS provide opportunities for stakeholders to comment on such mechanisms. Response: CMS will use existing mechanisms to monitor and investigate complaints related to access concerns. This includes monitoring the Complaint Tracking Module (CTM) and working with regional office account managers to resolve issues with the MA organizations. In addition,  422.504(m) sets forth CMS approach to issuing compliance actions for failure of an MA organization to comply with the terms of its contract (which incorporates a requirement for MA organizations to comply with regulations in 42 CFR part 422). CMS may issue compliance actions when it determines that an MA organization is out of compliance by applying the performance standards in the applicable statute or regulation or, if there is not already a specific statutory or regulatory standard, CMS may determine that an MA organization is out of compliance when its performance represents an outlier relative to the performance of other MA organizations. Comment: One commenter indicated that establishing standards for appointment wait times could impact implementation of certain integrated care models, such as Collaborative Care, indicating that these models would not consider wait times. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00056 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222175 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 83https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. Response: While we believe the commenter may be referring to the Psychiatric Collaborative Care Model, CMS lacks sufficient information from this comment to explain what the impact of this policy is on such initiatives. The regulatory change to  422.112 applies to MA coordinated care plans. Comment: In response to our proposal, several commenters requested that CMS align our standards for appointment wait time consistent with those standards established for the Qualified Health Plans or by the National Committee for Quality Assurance (NCQA). For example, commenters stated that aligning our standards with recognized NCQA standards would provide consistency for stakeholders; commenters also requested that CMS consider a standard for behavioral health services of 10 business days in alignment with Qualified Health Plans. Response: We thank commenters for their input regarding alternative standards for appointment wait times. While we have decided to finalize the specific wait time standards as proposed, we have decided to clarify that our appointment wait time standards will be based on business days which is the approach adopted for the Qualified Health Plans that aligns with NCQA in basing the standards for appointment wait times on business days. The final regulation text refers to business days. Comment: A few commenters requested that CMS consider different approaches to finalizing appointment wait time standards. For example, establishing separate standards for appointment wait times for mental health and substance use disorder, implementing a pilot program and conducting additional analysis or studies related to appropriate appointment wait times. Response: We appreciate the commenters suggestions regarding the standards for appointment wait times. The standards that we are finalizing in this final rule were previously established through our sub regulatory guidance in section 110.1.1, Chapter 4 of the Medicare Managed Care Manual. Our approach, supports parity between behavioral health and physical health services for enrollees and strengthens our requirements to ensure that MA organizations are meeting timely access standards for these covered services. Comment: We received a few mixed comments regarding our comment solicitation and considerations on implementing the requirement that MA organizations meet the final wait time standard for at least 95 percent of appointments, and on implementing an attestation within the MA application for applicants to attest to meeting the final standards. For example, some commenters agreed that a 95% threshold for compliance would be an appropriate standard for MA organizations to meet regarding wait times. Conversely, one commenter did not agree to the 95% threshold indicating that any failure to meet wait time standards would fail to ensure access to care. Response: We thank commenters for their input and we will monitor and reevaluate these standards if necessary, for future rulemaking. After consideration of the comments and for the reasons outlined in the proposed rule and our response to comments, we are finalizing the proposed revisions to  422.112(a)(6)(i) substantially as proposed but with a modification to clarify that the standards are based on business days. C. Medicare Advantage (MA) Network Adequacy: Access to Services ( 422.112) Section 1852(d)(1)(A) of the Act establishes that an MA organization offering an MA plan may select the providers from whom the benefits under the plan are provided so long as the organization makes such benefits available and accessible to each individual electing the plan within the plan service area with reasonable promptness and in a manner that assures continuity in the provision of benefits. This is generally implemented at  422.112(a), which provides that an MA organization that offers an MA coordinated care plan may specify the networks of providers from whom enrollees may obtain services if the MA organization ensures that all covered services are available and accessible under the plan. The regulation also includes specific additional requirements for MA organizations offering coordinated care plans related to the availability and accessibility of coverage. In addition, the statute and regulation apply these requirements to all benefits covered by the plan, including both basic and supplemental benefits. More specifically, section 1852(d)(1)(D) of the Act requires an MA organization to provide access to appropriate providers, including credentialed specialists, for medically necessary treatment and services, as a condition of the MA organization limiting coverage to a specified network of providers. CMS implemented this statutory requirement at  422.112(a)(1)(i), which provides that the MA organization offering a coordinated care plan must maintain and monitor a network of appropriate providers that is supported by written agreements and is sufficient to provide adequate access to covered services to meet the needs of the population served. In addition,  422.112(a)(3) requires that the MA organization provide or arrange for necessary specialty care and arrange for specialty care outside of the plans provider network when network providers are unavailable or inadequate to meet an enrollees medical needs. Historically, CMS has interpreted these statutory and regulatory requirements to mean that in the event an in-network provider or service is unavailable or inadequate to meet an enrollees medical needs, the MA organization must arrange for any medically necessary covered benefit outside of the plan provider network at in-network cost sharing for the enrollee. For example, if an enrollee needs OTP services but there is no in-network OTP available, then the MA organization must arrange for the enrollee to go to an out-of-network OTP at in-network cost sharing. In our view, furnishing access out of network with higher cost sharing when the MA plans network is inadequate or otherwise does not address the medically necessary benefit required by an enrollee is not consistent with section 1852(d)(1) of the Act. Enrollees should not bear a financial burden because of the inadequacy of the MA plans network. This interpretation is reflected in CMS guidance in section 110.1.1 of Chapter 4 of the MMCM,83 and CMS has routinely emphasized this interpretation to MA organizations about their obligations whenever the need arises, for example, when an MA organization is undergoing a network change due to a provider termination. Therefore, MA organizations are familiar with the policy and should be applying it in the routine course of operations within their MA plans. It is important that MA organizations ensure adequate access to medically necessary covered benefits for enrollees when the plan network is not sufficient by both arranging or covering the out-of-network benefits and only charging in-network cost sharing for those out-of-network benefits. To reflect this important and well-established enrollee protection in the MA program, we proposed to amend  422.112(a)(1) and (a)(3) to more clearly state the scope of the MA organizations VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00057 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222176 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations obligation to ensure adequate access to medically necessary covered benefits. Currently, the regulation text at  422.112(a)(3) does not fully account for the scope of an MA organizations obligations when medically necessary benefits are only accessible out of network in two key ways. First, the regulation text refers to specialty care only, not all medically necessary covered benefits. This oversight does not align with the statutory requirement at section 1852(d)(1)(D) of the Act, which states broadly that the organization must provide access to appropriate providers,