evekhm/cms_iom_500 huggingface dataset:
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for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed changes to  422.112(a)(1)(iii) and (3) with slight modification. We are modifying the regulation text as follows. In proposed regulation text  422.112(a)(1)(iii), we are adding the phrase and cover. Thus, we are revising  422.112(a)(1)(iii) to read as follows: Arrange for and cover any medically necessary covered benefit outside of the plan provider network, but at in-network cost sharing, when an in-network provider or benefit is unavailable or inadequate to meet an enrollees medical needs. D. Enrollee Notification Requirements for Medicare Advantage (MA) Provider Contract Terminations ( 422.111 and 422.2267) As provided in section 1852(d) of the Act and discussed in section 110.1.2.1 of Chapter 4 of the MMCM, MA organizations have considerable discretion to select the providers with whom to contract in order to build high- performing, cost effective provider networks.84This flexibility is also apparent in how CMS is prohibited by section 1854(a)(6)(B)(iii) of the Act from requiring MA organizations to contract with a particular provider. Under our current regulations, MA organizations are able to make changes to these networks at any time during the contract year, as long as they continue to furnish all Medicare-covered services in a non- discriminatory manner, meet established access and availability standards and timely notice requirements, and ensure continuity of care for enrollees. Thus, an MA organization may terminate providers from its network during the plan year, which could impact enrollees who are patients of those providers. CMS requires notification to MA enrollees when a provider network participation contract terminates. Most notably, CMSs disclosure regulations at  422.111(e) require MA organizations to make a good faith effort to provide written notice of a termination of a contracted provider at least 30 calendar days before the termination effective date to all enrollees who are patients seen on a regular basis by the provider whose contract is terminating, irrespective of whether the termination was for cause or without cause. Additionally,  422.111(e) requires that when a contract termination involves a primary care professional, all enrollees who are
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basis by the provider whose contract is terminating, irrespective of whether the termination was for cause or without cause. Additionally,  422.111(e) requires that when a contract termination involves a primary care professional, all enrollees who are patients of that primary care professional must be notified. CMS established these enrollee notification requirements at  422.111(e) over 22 years ago in the Medicare Program; Medicare+Choice Program final rule with comment period, which appeared in the Federal Register on June 29, 2000 (65 FR 40170) (hereinafter referred to as the June 2000 final rule). The MA program and its policies have evolved considerably since the inception of  422.111(e). Therefore, CMS proposed to revise this particular disclosure requirement by establishing specific enrollee notification requirements for no-cause and for-cause provider contract terminations and adding specific and more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur. CMS also proposed to revise  422.2267(e)(12) to specify the requirements for the content of the notification to enrollees about a provider contract termination. First, we proposed to clarify the regulatory text at  422.111(e) regarding whether the provider contract termination was for cause or without cause. The regulation currently requires that the MA organization must make a good faith effort to notify enrollees at least 30 calendar days before the termination effective date, irrespective of whether the termination was for cause or without cause. This last clause does not consider  422.202(d)(4), which outlines the timeframe requirement for suspension or termination of an MA organizations contract with a provider. An MA organization and a contracted provider are required by  422.202(d)(4) to provide at least 60 days written notice to each other before terminating the contract without cause. We stated in the proposed rule that consequently, because MA organizations are provided at least a 60-day notice of any no-cause provider contract termination, MA organizations should be able to timely meet a CMS established enrollee notification requirement that provides the MA organization a period of time that is less than 60 days to notify enrollees of the no-cause provider contract termination. Provider contract terminations that are for-cause, however, do not have an equivalent notification requirement as exists at
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the MA organization a period of time that is less than 60 days to notify enrollees of the no-cause provider contract termination. Provider contract terminations that are for-cause, however, do not have an equivalent notification requirement as exists at  422.202(d)(4) for MA organizations and contracted providers, which means that for-cause provider contract terminations could potentially occur with little notice or without any notice at all. In this case, it may not always be possible for the MA organization to notify enrollees in a reasonable amount of time before the provider contract termination effective date. Thus, we proposed to preserve the phrase good faith effort for enrollee notifications for for-cause provider contract terminations regarding the proposed timeframes. We proposed that the good faith effort standard would apply to the timing component for for-cause provider contract terminations. However, we proposed to remove good faith effort for no-cause provider contract terminations. We stated in the proposed rule that we believe when an MA organizations contracted provider network changes, these enrollee notifications are essential for updating enrollees who are patients of the terminating providers. If an enrollees provider is terminated from their network during the contract year, the enrollee must be notified so that they can decide how to proceed with the care they are receiving from that provider. By limiting the good faith effort standard to the timing of for-cause provider contract terminations, we stated that our proposal would make it clear that issuing the notification to enrollees is a requirement that all MA organizations must follow without exception, but in the case of for-cause provider contract terminations, MA organizations must make a good faith effort to notify enrollees of the termination within the proposed timeframes. Next, we proposed to add new provisions to  422.111(e) to address provider contract terminations that involve behavioral health providers. For purposes of this proposal, CMS considered various specialty types (both providers and facilities) as fitting the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222180 Federal Register /
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00061 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222180 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 85https://www.cms.gov/cms-behavioral-health- strategy. 86https://jamanetwork.com/journals/ jamanetworkopen/fullarticle/2785383. 87https://bmchealthservres.biomedcentral.com/ articles/10.1186/s12913-017-2719-9. 88https://www.aafp.org/pubs/fpm/issues/2021/ 0500/p3.html#fpm20210500p3-b1. 89https://www.who.int/health-topics/primary- health-care#tab=tab_ 1. category of behavioral health providers so long as the treatment they furnish to enrollees is about behavioral health; these included but were not limited to psychiatrists, clinical social workers, clinical psychologists, inpatient psychiatric facilities, outpatient behavioral health clinics, and OTPs. As noted in section III.B.1. of this final rule, behavioral health is a top priority of both CMS and the broader administration. Specifically, CMSs goal is to improve access to behavioral health services and improve outcomes for people with behavioral health care needs. The CMS Behavioral Health Strategy seeks to remove barriers to care and services.85To support these policy goals, using a behavioral health perspective, in the proposed rule, we reexamined the MA enrollee notification requirements when a provider contract termination occurs at  422.111(e). According to a recent study, because of the ongoing nature of patient/ provider relationships, when a provider leaves a plans network, there is a potential disruption to the patients treatment plan; this disruption could be especially problematic in the case of behavioral health treatment because this treatment may be longer in duration than that of physical health, and providers and patients are likely to need more time to develop mutual trust.86 Trusting relationships and continuity in the relationship between the patient and provider have shown
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the case of behavioral health treatment because this treatment may be longer in duration than that of physical health, and providers and patients are likely to need more time to develop mutual trust.86 Trusting relationships and continuity in the relationship between the patient and provider have shown to be central for behavioral health recovery, therefore, breaks in these relationships tend to cause patient stress, anxiety, and generally less opportunity to contribute to their treatment plan.87Thus, ensuring continuity of care in these situations becomes even more critical. As a consequence, sufficient enrollee notification is needed when a behavioral health provider leaves an MA network. We believe that affected enrollees need ample time to make decisions that may determine the trajectory of their behavioral health treatment. They may wish to continue seeing the terminated provider with whom they have already established a secure, comfortable relationship (potentially with higher out-of-network cost sharing), they may switch to a new provider in the network (forcing them to start a new relationship), or they may choose to stop treatment altogether (which could be detrimental to their health or perhaps fatal in the case of patients with suicidal ideation). Regardless of what action the enrollee takes, however, the enrollee needs to know that their behavioral health provider is leaving their plans network prior to the contract termination date. A similar case is made for terminating primary care providers both due to the fact that behavioral health services are often offered by primary care providers and the foundational role primary care providers play in an individuals overall health. According to the American Academy of Family Physicians, up to 75 percent of primary care visits include aspects of behavioral health.88Primary care is foundational because it integrates services to meet the patients health needs throughout a lifetime, including key elements such as health promotion, disease prevention, treatment, rehabilitation, palliative care, and end- of-life care.89Furthermore, CMS believes that the importance of a patients relationship with their primary care provider is likely higher in managed care situations, such as MA, where referrals to specialists are often dependent on the primary care provider. Therefore, similar to behavioral health, continuity of care is essential, and sufficient enrollee notification is needed when a primary care provider leaves an MA network. For these reasons, we proposed more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur. We expected positive impacts associated with improving communication about provider terminations from MA networks, including
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primary care provider leaves an MA network. For these reasons, we proposed more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur. We expected positive impacts associated with improving communication about provider terminations from MA networks, including providing more time to MA enrollees with behavioral health conditions to make informed decisions about the future of their behavioral health treatment after their provider leaves their network. We stated in the proposed rule that enrollee benefits would result from increased enrollee protections when unexpected primary care and behavioral health network changes occur, and we also expected to see benefits for providers and facilities who keep their patients informed if they are leaving their MA plans network. To address the previously detailed concerns surrounding unexpected changes in MA primary care and behavioral health provider networks, we proposed to add specific enrollee notification requirements for these types of provider contract terminations. Our proposal had three key aspects. We first proposed to add behavioral health providers to the current requirement at  422.111(e) that all enrollees who are patients of a terminating primary care provider must be notified (not just those enrollees who are patients seen on a regular basis by the terminating provider, which is the case for all other specialty types), and expand the scope of this requirement to refer to all enrollees who have ever been patients of these terminating primary care or behavioral health providers (not just current patients). We proposed that this addition would be reflected at proposed new paragraph (e)(1)(iii). Next, at proposed new paragraph (e)(1)(ii), we proposed to require MA organizations to provide notice to enrollees at least 45 calendar days before the termination effective date for contract terminations that involve a primary care or behavioral health provider, which is longer than the 30-day standard for all other specialty types. Finally, we proposed to require both written and telephonic notice for contract terminations that involve a primary care or behavioral health provider at new proposed paragraph (e)(1)(i), while only written notice would be required for all other specialty types. We proposed that both types of notice would need to be provided at least 45 calendar days before the termination effective date. For the telephonic notice, we proposed that the first telephone call be made to the enrollee at least 45 calendar days in advance. We proposed that the MA organization would be required to continue attempting to reach the enrollee by telephone to provide notice of the termination of
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notice, we proposed that the first telephone call be made to the enrollee at least 45 calendar days in advance. We proposed that the MA organization would be required to continue attempting to reach the enrollee by telephone to provide notice of the termination of the provider from the network. We did not propose a specific number of attempts required by the MA organization when they reach out to the enrollee by telephone and the call goes unanswered, but we solicited comment from MA organizations on how many telephonic attempts they believe are reasonable in this circumstance (for example, 15, 610, 1115). To help inform our proposal, we requested qualitative feedback based on any MA organizations actual experience providing enrollees telephonic notice of primary care and behavioral health provider contract terminations. In the proposed rule, we stated that these proposed requirements for MA organizations providing enrollees notice of primary care and behavioral health provider contract terminations are intended to raise the standards for the stability of enrollees primary care and VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222181 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 90https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. 91https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. behavioral health treatment. We also stated that if finalized, these requirements would require MA organizations to notify all current enrollees who have ever been patients of the primary care or behavioral health provider or providers leaving their plans network (regardless of whether these enrollees are patients currently seen on a regular basis, as that standard is established in proposed new paragraph (e)(2)(iii)), give enrollees more notice (and therefore more time) to decide how to proceed with their course of treatment, and provide enrollees with two different means by which they receive the notice from their MA
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(e)(2)(iii)), give enrollees more notice (and therefore more time) to decide how to proceed with their course of treatment, and provide enrollees with two different means by which they receive the notice from their MA organization. We stated that these strengthened enrollee notification requirements for primary care and behavioral health provider contract terminations would generally increase enrollee protections when MA network changes occur. As discussed earlier, continuity of care is essential, especially for both primary care and behavioral health, and consequently, adequate communication to enrollees is vital when network changes occur so that patients of any terminating primary care or behavioral health providers can decide how to proceed with their course of treatment. By receiving adequate notice of the terminations, enrollees will be able to make an informed decision on how to proceed with their care and have more time to potentially locate and establish a relationship with a new provider. Thus, enrollees are protected from any undue harm that may result from an unexpected provider contract termination involving their primary care or behavioral health provider (for example, sudden lack of medication, psychotic episodes, suicide). We stated in our proposed rule that the proposed enrollee notification requirements are a positive step in the context of our policy for MA provider contact terminations. We proposed that MA organizations would continue to be required to provide written notice at least 30 days before the termination effective date of a termination of a contracted provider that is not a primary care or behavioral health provider to all enrollees who are patients seen on a regular basis by the terminating provider. We also proposed to codify at  422.111(e)(2)(iii) a definition of the phrase enrollees who are patients seen on a regular basis by the provider whose contract is terminating. CMS currently has sub- regulatory guidance in section 110.1.2.3 of Chapter 4 of the MMCM that defines this term as enrollees who are assigned to, currently receiving care from, or have received care within the past three months from a provider or facility being terminated, also called affected enrollees.90As this guidance has been in place since 2016, and based on various MA organization inquiries we have received asking how CMS defines regular basis, we believed the majority of MA organizations have come to adopt this CMS standard and use it routinely as they determine which enrollees to notify when provider contract terminations occur, in order to comply with
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defines regular basis, we believed the majority of MA organizations have come to adopt this CMS standard and use it routinely as they determine which enrollees to notify when provider contract terminations occur, in order to comply with  422.111(e). Therefore, we proposed to codify this definition at proposed  422.111(e)(2)(iii). We proposed that the requirements for contract terminations that involve specialty types other than primary care or behavioral health (written notice only, at least 30 calendar days before the termination effective date, and to all enrollees who are patients seen on a regular basis by the provider whose contract is terminating) would be set forth at new proposed  422.111(e)(2). This would provide a clear distinction for MA organizations between CMSs enrollee notification requirements for contract terminations that involve a primary care or behavioral health provider (at new proposed paragraph (e)(1)) and all other provider contract terminations. We reiterate that the beginning proposed revised regulatory text at  422.111(e) also distinguished between no-cause and for-cause provider contract terminations, with the former scenario prompting a requirement for MA organizations to provide the enrollee notifications and the latter requiring MA organizations to make a good faith effort to notify enrollees within the required timeframes. Regardless, whenever an MA organization notifies enrollees about a provider contract termination (whether it is with or without cause), CMS proposed that MA organizations must follow these new requirements outlined at proposed paragraphs (e)(1) and (2). Finally, regarding the content of the provider termination notice, CMSs regulation at  422.2267(e)(12) currently provides that the Provider Termination Notice is a required model communications material through which MA organizations must provide the information required under  422.111(e). CMS has provided additional guidance regarding the content of the provider termination notice in section 110.1.2.3 of Chapter 4 of the MMCM.91Similar to the definition of affected enrollees, these best practices have been in our guidance since 2016, thus we believe the majority of MA organizations likely already follow them as they develop the content of their provider termination notices. Therefore, we proposed to codify the best practices for provider termination notices at
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these best practices have been in our guidance since 2016, thus we believe the majority of MA organizations likely already follow them as they develop the content of their provider termination notices. Therefore, we proposed to codify the best practices for provider termination notices at  422.2267(e)(12). Specifically, we proposed to make these requirements for the content of MA organizations provider termination notices and also require MA organizations to include additional pieces of information in the notice. First, at proposed  422.2267(e)(12)(ii)(A), we proposed that the provider termination notice must inform the enrollee that the provider will no longer be in the network and the date the provider will leave the network. We modeled this proposed regulatory text after the established precedent for the equivalent notice requirement for the Non-renewal Notice model communications material as provided at  422.2267(e)(10)(ii)(A) (we refer readers to section III.I. of this final rule for our amendment to paragraph (e)(10) to make the Non- renewal Notice a standardized communications material). Next, we proposed to codify a requirement to include the information currently described in the best practices guidance in Chapter 4 of the MMCM at proposed  422.2267(e)(12)(ii)(B), (C), and (E), specifically: names and phone numbers of in-network providers that the enrollee may access for continued care (this information may be supplemented with information for accessing a current provider directory, including both online and direct mail options) (at proposed paragraph (e)(12)(ii)(B)); how the enrollee may request a continuation of ongoing medical treatment or therapies with their current provider (at proposed paragraph (e)(12)(ii)(C)); and the MA organizations call center telephone number, TTY number, and hours and days of operation (at proposed paragraph (e)(12)(ii)(E)). For proposed paragraph (e)(12)(ii)(B) and (C), we proposed to use the same description for the relevant content that is currently found in CMSs guidance in Chapter 4 of the MMCM. However, for proposed paragraph (e)(12)(ii)(E), instead of using the existing Chapter 4 language