evekhm/cms_iom_500 huggingface dataset:
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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
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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
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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
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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
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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
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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
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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. Digital Health Education for Medicare Advantage (MA) Enrollees Using Telehealth ( 422.100) Telehealth has become an increasingly popular and important tool in providing access to health care, especially during the COVID19 Public Health Emergency (PHE). For the purposes of this section of this final rule, we are using the term telehealth benefits very broadly to encompass covered services that are furnished to the enrollee (that is, the patient) in a different location than where the provider is located. There are multiple categories of covered benefits where this circumstance is present, with additional criteria or requirements applying to different categories of covered benefits when the enrollee and provider are not in the same place at the time the service is furnished. Under the MA program, there are various requirements and options for coverage of telehealth benefits. When original Medicare covers telehealth benefits, such as services described in section 1834(m) of the Act and  411.78, MA organizations must cover those telehealth benefits as basic benefits, as defined in  422.100(c). If an MA organization wishes to offer telehealth benefits that go beyond the scope of the original Medicare telehealth benefits that must be covered by every MA plan, MA organizations have the option to offer Additional Telehealth Benefits (ATBs) and/or supplemental telehealth benefits. Section 1852(m) of the Act and  422.135 outline the requirements for ATBs, which are generally services for which benefits are available under Medicare Part B but which are not payable under section 1834(m) of the Act, and the services are furnished when the patient and the physician or practitioner are not in the same location. ATBs may be included in the bid and treated as basic benefits when the requirements of  422.135 are met. If an MA organization wishes to offer telehealth benefits that are not covered by original Medicare and are not within the scope of
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ATBs may be included in the bid and treated as basic benefits when the requirements of  422.135 are met. If an MA organization wishes to offer telehealth benefits that are not covered by original Medicare and are not within the scope of  422.135, then the MA organization may choose to offer them as supplemental benefits. The requirements for MA supplemental benefits are set forth at section 1852(a)(3) of the Act and  422.100(c) and 422.102. An MA organizations bid must accurately reflect the covered telehealth service, whether it is covered as an ATB or a supplemental benefit. In addition, during the COVID19 PHE, MA organizations have been required to account for the various waivers, amendments to regulations, and other guidance published by CMS, with regard to telehealth benefits. In using the term telehealth benefits here, we mean to include all of these various categories of covered benefits. In the regulation text we are finalizing in this rule, we use the phrase covered benefits that are furnished when the enrollee and the provider are not in the same location using electronic exchange, as defined in  422.135 as a means to encompass all of the potential covered benefits included in our broad use of the term telehealth benefits. As defined in  422.135, electronic exchange means electronic information and telecommunications technology, which we believe is broad enough to include telecommunications and technologies permitted for covered Part B services under section 1834(m) of the Act and implementing regulations as well as MA ATBs and other supplemental benefits. In recent years, CMS has seen a significant increase in the offering of telehealth benefits in the MA program. Almost 99 percent of MA plans offered some form of telehealth benefits in contract year 2022, either in the form of ATBs or supplemental telehealth benefits. This is a 16 percent increase since contract year 2018 and a 9 percent increase since contract year 2020, which was the first year MA organizations were permitted to offer ATBs. ATB offerings alone have increased by approximately 39 percent since their inception 2 years ago. The total number of MA enrollees who have access to MA telehealth benefits of any kind has risen from approximately 89 percent in contract year 2018 to nearly 100 percent in contract year 2022. While the supply and demand of
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2 years ago. The total number of MA enrollees who have access to MA telehealth benefits of any kind has risen from approximately 89 percent in contract year 2018 to nearly 100 percent in contract year 2022. While the supply and demand of telehealth has clearly grown in recent years, there is evidence that barriers to accessing telehealth leave room to improve health equity in telehealth. The regulatory changes we are finalizing here, taken together, are an attempt to improve health equity in telehealth and are consistent with both E.O. 13985 and CMSs first strategic pillar Advance VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222159 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 23https://www.whitehouse.gov/briefing-room/ presidential-actions/2021/01/20/executive-order- advancing-racial-equity-and-support-for- underserved-communities-through-the-federal- government/. 24https://www.cms.gov/cms-strategic-plan . 25https://www.cms.gov/pillar/health-equity . 26https://telehealth.hhs.gov/providers/health- equity-in-telehealth/. 27https://pubmed.ncbi.nlm.nih.gov/33325524/ ; https://pubmed.ncbi.nlm.nih.gov/32703737/ . 28https://telehealth.hhs.gov/providers/health- equity-in-telehealth/. 29https://nnlm.gov/guides/intro-health-literacy . 30https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC8464820/.
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. 30https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC8464820/. 31https://nces.ed.gov/pubs2018/2018161.pdf . 32https://www.aarp.org/research/topics/ technology/info-2022/2022-technology-trends-older- americans.html. 33https://www.telehealthequitycoalition.org/ improving-digital-literacy-to-improve-telehealth- equity.html. 34https://www.jmir.org/2021/7/e27682/ . 35https://www.pewresearch.org/fact-tank/2021/ 09/10/americans-with-disabilities-less-likely-than- those-without-to-own-some-digital-devices/. 36https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC5878361/. 37https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4799429/. 38https://academic.oup.com/jamia/article/27/12/ 1949/5899728. 39https://jamanetwork.com/journals/jama/ article-abstract/2426088. 40https://www.sciencedirect.com/science/article/ pii/S0738399114001876. 41https://www.cdc.gov/pcd/issues/2020/20 _0130.htm. Equity under the 2022 CMS Strategic Plan.23 24For purposes of this provision, we are using CMSs definition of health equity, which is included in section III.A.1. of this final rule.25In developingour digital health education programpolicy, we were guided by HHSsdefinition of health equity intelehealth as meaning the opportunityfor everyone to receive the health