2023-07115.pdf

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 cultural health beliefs and practices, preferred languages, health literacy levels, and communication needs.17For purposes of  422.111(b)(3)(i) as finalized, this definition cultural and linguistic capabilities applies; therefore, organizations should take this under consideration when determining a providers cultural and linguistic capabilities. The manner in which organizations do so is at their discretion, so long as the requirement at  422.111(b)(3)(i) is met. We are not being prescriptive in exactly how this information must be displayed in provider directories. The provider directory is a model communications material which, per  422.2267(c), is created by CMS as an example of how to convey enrollee information. When drafting this required communications material, organizations must: (1) accurately convey the vital information in the required material to the enrollee, although the organization is not required to use the CMS model material verbatim; and (2) follow CMSs order of content, when specified (see  422.2267(c)(1) and (2)). We will be updating the MA and Section 1876 Cost Plan Provider Directory Model upon finalization of this rule to incorporate the new requirement in  422.111(b)(3)(i), and we anticipate providing additional guidance and examples to organizations within that model to explain how organizations might display providers cultural and linguistic capabilities in their directories. Organizations should reference the forthcoming contract year 2024 model document.18Also, for purposes of meeting the requirement in  422.111(b)(3)(i) to identify languages offered by the provider or at the providers location, a provider does not need to be a certified translator prior to having a particular language listed because we expect that enrollees choosing that provider because they speak their native language will not need translation services if the enrollee and provider speak the same language. Regarding what constitutes a skilled medical interpreter, the interpreter must be trained and certified in medical interpreting, especially when working in a clinical setting. As to the question about whether organizations must identify whether linguistic assistance is available in-person or via telecommunications, the current provider directory model requires organizations to notate providers who offer services exclusively via telehealth, so if a provider is identified as such and the organization also identifies the providers linguistic capabilities, then it would be clear to the enrollee that that provider offers linguistic assistance VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222157 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 19The current MA and Section 1876 Cost Plan Provider Directory Model is located at: https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/MarketngModelsStandardDocumentsandEducationalMaterial. 20The current MA and Section 1876 Cost Plan Provider Directory Model is located at: https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/MarketngModelsStandard. 21The 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. exclusively via telecommunications technology and not in-person.19Section 422.111(b)(3)(i) does not currently require organizations to identify all providers who offer services via telehealth, but if an organization chooses to identify providers who offer telehealth services, then the provider notation must also identify the providers linguistic capabilities, per the new requirement at  422.111(b)(3)(i) which we are finalizing here. It is the organizations choice as to whether to distinguish if that linguistic assistance is available in-person, via telecommunications, or both. Comment: Several commenters stated concern that this requirement would increase burden on both organizations and providers. A commenter stated that it may require upgrades and investments in existing systems that could potentially require organizations to terminate contracts and change vendors, and also would require significant data pulls from network providers to populate the additional required elements in directories. Response: We reiterate that per control number 09380753 (CMSR 267) currently approved by OMB, the update and maintenance of the provider directory is part of the usual and customary normal business activities of organizations and as such is exempt from PRA by 5 CFR 1320.3(b)(2). Organizations that do not currently collect data on their contracted providers cultural and linguistic capabilities may do so by using the same means and methods by which they already collect other information from contracted providers for inclusion in provider directories. We expect that organizations should only have to make minimal updates to their existing processes related to provider directories, such as a template, related software, and the added data points for providers. Comment: A few commenters suggested that CMS require additional data elements in provider directories through regulatory codifications at  422.111(b)(3)(i). Some suggestions included: whether a provider is accepting new patients, provider specialty granularity, provider sub- specialty, provider telehealth capabilities, average wait time to secure a new patient appointment, hospital affiliation, and accessibility of provider offices and medical diagnostic equipment (for example, availability of ramps, elevators, and accessible medical equipment). Response: We thank commenters for their suggestions to amend  422.111(b)(3)(i) to also require organizations to include these various additional data elements in provider directories. We re-emphasize that some of these data elements are already required, as stated in the proposed rule and in the MA and Section 1876 Cost Plan Provider Directory Model.20As for the data elements that are not currently required, we will carefully consider these additions as we update the MA and Section 1876 Cost Plan Provider Directory Model for contract year 2024 and as we contemplate future rulemaking on provider directory requirements.21 Comment: Commenters requested greater specificity regarding CMSs oversight and compliance monitoring, stating that the language proposed (periodic online provider directory reviews, as CMS deems necessary) is ambiguous and does not provide transparency into the regularity in which CMS will be monitoring organizations. They suggested that CMS provide specific timelines regarding the monitoring of these new requirements, the process by which directory information will be verified, and the frequency of CMS follow-up with organizations to monitor directory accuracy. A commenter stated that CMS may wish to consider using its contracts with organizations and Medicares conditions of participation to reduce the cost of providing information, such that organizations and providers might be more amenable to following the requirements as proposed. Another commenter stressed that CMS oversight, including secret shopper surveys, is necessary to monitor the accuracy of provider directories. They stated that the track record of provider directories in giving accurate and current information has been dismal and unlikely to improve significantly without strong monitoring by CMS. Response: Nothing in the proposed rule changed our compliance authority, therefore, we are not making any changes to our provider directory compliance oversight at this time. Regarding the suggestion that CMS make use of its contracts with organizations and provider conditions of participation, we are not making any changes to these regulations at this time, but may consider changes in the future. We note that  422.504(a)(4) already requires that in the contract between the MA organization and CMS, the MA organization agrees to disclose information to beneficiaries in the manner and the form prescribed by CMS as required under  422.111. This longstanding contract provision is binding on the organization and requires all organizations to comply with  422.111, inclusive of  422.111(b)(3)(i) as finalized in this rule. We agree with commenters about the importance of oversight and strong monitoring of provider directory accuracy, and we intend to continue these activities to ensure organizations are complying with  422.111(b)(3)(i). b. Comments on Identifying MOUD- Waivered Providers Comment: Regarding our proposal for  422.111(b)(3)(i)requiring organizations to identify certain providers waived to treat patients with MOUD in their provider directoriesa majority of commenters pointed to recently enacted legislation that has made our proposal moot. Section 1262 of Division FF of the Consolidated Appropriations Act of 2023 (CAA) (Pub. L. 117328) amended section 303(g) of the Controlled Substances Act to remove the statutory requirement for providers to obtain a valid waiver (commonly referred to as an X- Waiver) from SAMHSA and the DEA to administer, dispense, or prescribe MOUD. Since the waiver has been eliminated, now any licensed provider can treat patients with MOUD without a waiver. Therefore, commenters explained, identifying providers with the waiver in provider directories is not necessary, as providers no longer need to possess the special waiver in order to prescribe MOUD. Accordingly, most commenters recommended CMS not finalize this aspect of the proposal, a few commenters requested CMS clarify in the final rule how the proposal aligns with the legislation, and some commenters presented alternatives. Alternative approaches offered by commenters included requiring organizations to still identify providers from whom enrollees can receive MOUD treatment, identify addiction specialists, or identify Opioid Treatment Programs (OTPs). Response: We are aware that the CAA of 2023 was enacted after the proposed rule was published, and we thank commenters for alerting us of this VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222158 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 22The current MA and Section 1876 Cost Plan Provider Directory Model is located at: https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/MarketngModelsStandard. important legislative change that has a significant impact on how we finalize the second aspect of our provider directory proposal. After careful consideration of all comments received, we have decided to not finalize our proposal to require organizations to include in their provider directories notations for MOUD-waivered providers who are listed on SAMHSAs Buprenorphine Practitioner Locator. Of those who commented on the elimination of the X-waiver, the majority suggested we withdraw this aspect of our proposal, therefore, that is the approach we are taking. We appreciate the alternatives presented by some commenters, and we will consider including in our guidance on best practices for provider directories that organizations identify providers who have expertise in treating patients with OUD. This guidance would cover a wide variety of providers and facilities, including MOUD-prescribers, addiction specialists, and OTPs. If we choose to pursue such guidance, it would appear in the MA and Section 1876 Cost Plan Provider Directory Model, which CMS updates and releases annually.22 Comment: Several commenters opposed our proposal to require organizations to identify MOUD- waivered providers in their provider directories. A commenter stated that there is currently no industry standard for organizations to collect and document information on the status of provider MOUD waivers. They also expressed concerns that including this information in provider directories would cause enrollee confusion, as most enrollees would not understand this designation nor how to factor it into their provider selection. Another commenter believed that it would be challenging for organizations to identify and confirm that providers have the waiver. Response: We agree with commenters concerns surrounding potential implementation of this requirement. As noted previously, we are not finalizing this second aspect of our proposal for  422.111(b)(3)(i) based on the majority of comments recommending such course of action in alignment with the CAA of 2023 provision. c. Summary of Regulatory Changes We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulation. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed change to  422.111(b)(3)(i) to require organizations to include in their provider directories each providers cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the providers office. We are not finalizing our proposal to require organizations to include in their provider directories notations for MOUD-waivered providers. 4.