2023-07115.pdf

preferred languages, health literacy levels, and communication needs.12As indicated by several research studies, language concordance between providers and limited English proficient individuals is associated with better health outcomes, and so better matching patients with providers who speak the same language is expected to improve quality of care and reduce disparities.13CMS believes this important regulatory change would enhance the quality and usability of provider directories, particularly for non-English speaking enrollees searching for providers who speak their preferred language, for limited English proficient individuals, and for those enrollees seeking providers who use ASL themselves or have an ASL interpreter available in their office. This proposed change does not implement, take the place of, or supersede an organizations or providers obligations to take reasonable steps to ensure meaningful access to such programs or activities by limited English proficient individuals and appropriate steps to ensure that communications with individuals with disabilities are as effective as communications with others in such programs or activities, including the provision of oral language assistance services and/or auxiliary aids and services when required by applicable law (section 1557 of the Patient Protection and Affordable Care Act (PPACA) and 45 CFR part 92). We proposed this new requirement for MA provider directories as a standard for implementing and ensuring compliance with section 1852(c)(1)(C) of the Act and as a necessary and appropriate standard to ensure that MA enrollees have the information they need in order to access covered services from an MA plan. This proposal is also consistent with the health equity objectives of CMSs first strategic pillar Advance Equity under the 2022 CMS Strategic Plan.14It supports current CMS efforts to advance health equity by giving enrollees a fair and just opportunity to access health care services regardless of preferred language. Please refer to sections III.A.1. and III.A.2. of this final rule for more extensive discussion of health equity issues in the MA program. To further enhance our requirements for MA provider directories in the area of behavioral health, we also proposed to amend  422.111(b)(3)(i) to add a new required provider directory data element for certain providers who offer medications for opioid use disorder (MOUD). Access to MOUD can be life- saving, but too often, patients do not know how to access this type of care. MA enrollees may have little insight as to which providers can provide MOUD. This problem is especially urgent, as overdose deaths from opioids VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222155 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 15https://www.cdc.gov/nchs/nvss/vsrr/drug- overdose-data.htm. 16https://www.samhsa.gov/medication-assisted- treatment/find-treatment/treatment-practitioner- locator. skyrocketed during the COVID19 pandemic.15Therefore, we proposed to require organizations to identify certain providers in their directories who had obtained a waiver under section 303(g)(2) of the Controlled Substances Act (CSA) (21 U.S.C. 823(g)(2)(B)(i)(ii)) from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) to treat patients with buprenorphine for opioid use disorder and who are listed on SAMHSAs Buprenorphine Practitioner Locator (BPL).16 As we stated in the proposed rule, we believe that this additional MA provider directory data element is important and necessary for ensuring access to behavioral health services for MA enrollees. We further stated that it supports both national and CMS efforts related to behavioral health priorities and strategies, as described in section III.B.1. of this final rule. We also explained our goal that the proposed change would help MA enrollees struggling with opioid use disorder to find providers who could treat them by prescribing MOUD, moving these enrollees further along the path towards long-term recovery. In summary, CMS proposed to add two new requirements to  422.111(b)(3)(i) that organizations must include providers cultural and linguistic capabilities and identify certain providers waived to treat patients with MOUD in their provider directories. We solicited comment on these proposed improvements to the content of MA provider directories. We also refer readers to section III.B.2. of this final rule to review our summary of comments and outcome for our proposal to add prescribers of MOUD as a new specialty type to be subject to MA network adequacy evaluation. We thank commenters for their input on CMSs proposed new MA provider directory requirements. We received the following comments on this proposal, and our response follows: a. Comments on Identifying Providers Cultural and Linguistic Capabilities Comment: Comments on this proposal were largely favorable. Commenters supported allowing enrollees to make informed decisions when choosing providers, making care more accessible and equitable, and sharing information with enrollees in advance as to whether a provider can deliver care that meets their cultural and linguistic needs. Commenters stated that identifying providers cultural and linguistic capabilities in provider directories is crucial for enrollees to ensure that providers are equipped to provide accessible, inclusive, person-centered care. Commenters appreciated the benefit this new requirement would provide for non-English speaking enrollees searching for providers who speak their preferred language, for limited English proficient individuals, and for those enrollees seeking providers who use ASL themselves or have an ASL interpreter available in their office. They believed that enrollees who are treated by providers who speak their same language tend to have better health outcomes, and this change will ensure equity by creating expanded and better-informed access by enrollees to providers who can accommodate their language needs. A commenter praised CMSs use of the HHS OMH definition of CLAS. Another commenter supported the transparency these new elements would provide to enrollees in understanding a providers capabilities and whether these capabilities match the enrollees communication needs. Response: We thank commenters for their support, and we concur that there is added value of requiring organizations to include providers cultural and linguistic capabilities in their provider directories. We are therefore finalizing this first aspect of  422.111(b)(3)(i) as proposed. Comment: Many commenters stressed the importance of provider directory accuracy, but also noted the continued challenge in maintaining accurate provider directories. They stated that there is no easy or systematic way for providers to update their information with all organizations they contract with, and organizations do not have a single source of truth for provider information. Commenters were in favor of a national provider directory and referenced CMSs recent request for information (RFI) titled Request for Information; National Directory of Healthcare Providers & Services (NDH), which appeared in the Federal Register on October 7, 2022 (87 FR 61018). An NDH would be a centralized data hub for provider information that would allow providers to report changes to their information once instead of to each organization with which they contract. Commenters recommended CMS focus provider directory efforts on creating an NDH rather than establishing any new piecemeal requirements that would draw resources away from focusing on an NDH and would have limited value in the interim. Some commenters suggested CMS delay implementation of the proposed requirement for organizations to include providers cultural and linguistic capabilities in their provider directories until an NDH is implemented. Other commenters believed that if CMS does finalize this requirement, CMS should exercise enforcement discretion, provide an audit safe harbor, allow for leniency, and not penalize organizations making a good faith effort to include the new required data elements in their directories, until there is a better long- term solution in place, such as an NDH. Response: We understand commenters concerns regarding the difficulty in maintaining accurate provider directories without a single source of truth for provider data. As stated in our RFI, we understand that the fragmentation of current provider directories requires inefficient, redundant reporting from providers, and an NDH could serve as a centralized data hub for directory and digital contact information containing the most accurate, up-to-date, and validated data in a publicly accessible index. We thank commenters for referencing this RFI and expressing strong support for an NDH. However, CMS is still considering the NDH concept. Consequently, unless and until such a long-term solution to provider directories is adopted, CMS continues to make every effort to improve our policies surrounding provider directories, including this proposal for MA directories. We believe that requiring organizations to include providers cultural and linguistic capabilities in their provider directories is an important improvement that promotes transparency and equitable access to care. Therefore, we are finalizing this first aspect of  422.111(b)(3)(i) as proposed. Regarding comments requesting CMS exercise enforcement discretion, we note that CMS considers a variety of factors when operationalizing policy and taking enforcement action, including an organizations ability to implement policy changes as they establish the processes needed to evaluate effectiveness. Comment: Several commenters indicated that the new proposed provider directory requirements would raise significant issues related to providers. For example, commenters believed provider burden would increase, there would likely be provider abrasion with all organizations separately seeking the same data from providers, and in general there would be a low response rate from providers. A commenter stated that the bottleneck in achieving accurate directories lies with VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222156 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 17https://www.minorityhealth.hhs.gov/Assets/ PDF/TCH%20Resource%20Library_CLAS%20CLC%20CH.pdf. 18The contact year 2024 MA and Section 1876 Cost Plan Provider Directory Model will be available at: https://www.cms.gov/Medicare/Health- Plans/ManagedCareMarketing/MarketngModelsStandardDocumentsandEducationalMaterial. providers who do not provide updated information to organizations, and the proposed additional information may be yet another piece of information organizations and providers are not willing to try hard enough to extract or supply. Another commenter was concerned that compliance would be difficult for organizations without additional requirements to incentivize providers to submit timely and accurate information. Several commenters also recommended that CMS require providers to maintain this data, notify providers of the new requirement, and educate or raise awareness with providers on the importance of keeping this data updated for the organizations with whom they contract. A commenter recommended a robust campaign to educate providers and seek their commitment before implementing this requirement. Another commenter stated that maintaining up-to-date provider directories should be a shared responsibility of providers and health plans. In general, commenters suggested that CMS support providers if this proposal is finalized. Response: We acknowledge that the adoption of this new requirement may result in increased provider burden and abrasion, that providers may have low response rates to organizations, and compliance may be difficult for some organizations. However, organizations must still meet this requirement. We encourage organizations to consider using their contracts with providers to require them to provide this information and keep it updated. The contract between the provider and the organization is a useful tool that organizations have at their disposal to help them meet CMSs new provider directory requirement. At this time, CMS does not have plans to require providers to maintain this specific data, nor to conduct provider education campaigns. It is the responsibility of organizations to do all that they can in their relationships with contracted providers in order to meet  422.111(b)(3)(i) as finalized. Comment: A few commenters suggested that providers may have reservations regarding sharing their cultural and linguistic capabilities, some stating that providers either do not or rarely share this information today. A commenter believed that this data element should be optional for providers to disclose to organizations, acknowledging and respecting concerns with the possible unintended consequences of publicizing this demographic information. Response: We are finalizing this first proposed change to  422.111(b)(3)(i) without modification; therefore, it will not be optional for organizations to include this information in their provider directories. We reiterate that organizations should use their contracts with providers as leverage to require this information be provided to organizations to populate their provider directory. Information on providers cultural and linguistic capabilities in provider directories is critical for enrollees to have when making both provider choices and MA plan choices. Therefore, if a provider refuses to provide their cultural and linguistic capabilities, organizations should document the providers response. CMS will take such responses into consideration when reviewing findings associated with future provider directory reviews. Comment: Some commenters requested additional clarity, examples, and more guidance on how CMS expects organizations to implement this new requirement if finalized. Commenters sought guidance on various topics, such as how to determine a providers cultural and linguistic capabilities, what level of language fluency is sufficient, whether a provider must be a certified translator prior to having a particular language listed, what constitutes a skilled medical interpreter, and what exactly is meant by cultural capabilities. A commenter stated that multiple issues remain to be addressed, including development of objective criteria for certain categories, such as language capability within a providers office. Another commenter questioned whether organizations must identify whether linguistic assistance is available in-person or via telehealth. Response: We appreciate these questions and requests for clarification regarding how to implement this new provider directory requirement and plan to provide additional information through future sub-regulatory guidance. As stated in the proposed rule, cultural and linguistic capabilities refers to the capabilities of a provider (or skilled medical interpreter at the providers office) to deliver CLAS, which are defined by the HHS OMH as services that are respectful of and responsive to individual