evekhm/cms_iom_500 huggingface dataset:
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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. Therefore, we will not be finalizing this portion of our proposal. Because we planned to use SAMHSAs list of waivered providers to populate the Provider Supply file, we will no longer be able to accurately track the providers that prescribe medications like buprenorphine in order to create and maintain a network adequacy standard. In addition, we are not adding OTPs to the facility-specialty type list in  422.116(b)(2). We proposed a combined specialty type called Prescribers of Medication for Opioid Use Disorder, which included OTPs and MOUD Waivered Providers, that allowed us to create meaningful access standards. At this time there is not enough supply of OTPs to create meaningful access standards. As OTPs continue to expand, we will monitor the appropriateness of setting network adequacy standards in future rulemaking. We remind MA organizations that they are required to arrange for and cover the Part B OTP benefit, which may only be furnished by certified OTPs. Therefore, as a practical matter, MA organizations must include certified OTPs in their networks or arrange out-of-network care (at in- network cost sharing) for their enrollees who need OTP benefits. Finally, we thank commenters for their suggestions on alternative standards for this important category of providers, and we will consider all comments in future rulemaking. Comment: Several commenters requested that CMS delay the effective date of the proposal to add new behavioral health specialty types to the network adequacy standards to 2025, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222171 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations indicating that more time would be needed for MA organizations to contract with providers to ensure they are able to meet network
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with RULES222171 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations indicating that more time would be needed for MA organizations to contract with providers to ensure they are able to meet network adequacy standards especially in advance of applying for new or expanded service areas. Response: We appreciate commenters suggestions regarding delaying the effective date of our proposal. However, we believe that our regulations currently provide flexibilities that will assist MA applicants in meeting network adequacy standards. These flexibilities include a 10-percentage point credit for new or expanding service area applicants towards the percentage of beneficiaries residing within time and distance standards for the contracted network in the pending service area, and the ability to utilize a Letter of Intent (LOI) which meets our regulatory requirements, to meet network standards at the time of and for the duration of the application review ( 422.116(d)(7)). In addition, MA organizations are required to provide all medically necessary services to their enrollees; it is our expectation that these organizations already have established relationships with these providers because certain Medicare Part B services are furnished by clinical social workers, as defined in section 1861(hh) of the Act, and clinical psychologist as defined in 42 CFR 410.71(d). Comment: A few commenters requested clarification on the types of social workers that will be allowable to submit for network adequacy review purposes. Response: As detailed in our proposal, commenters may refer to section 1861(hh) of the Act regarding the definition for clinical social worker. Comment: Several commenters supported our proposal to amend the list of health care providers in the existing access to services standards at  422.112(a)(1)(i) to include that the network must also include providers that specialize in behavioral health services. Response: We thank commenters for their support of this proposal. As we previously noted, this amendment will reinforce regulatory requirements for MA plans to provide access to critical behavioral health care services. Comment: Many commenters supported our proposal to add the new behavioral health specialty types to the list of those that receive the 10- percentage point credit ( 422.116(d)(5)) towards the percentage of beneficiaries that reside within published time and distance standards when the plan includes one or more providers that provide
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the list of those that receive the 10- percentage point credit ( 422.116(d)(5)) towards the percentage of beneficiaries that reside within published time and distance standards when the plan includes one or more providers that provide additional telehealth benefits, as defined in  422.135, in its contracted network. Commenters indicated that telehealth is vital in accessing behavioral health services for enrollees. Some commenters requested that CMS provide a credit higher than 10- percentage points, indicating that it would help plans meet network adequacy standards in light of the behavioral health provider shortage. A few commenters did not support the proposal to provide additional credits for these provider types to MA organizations in meeting network standards. Response: In our proposed rule, we noted that Medicare FFS claims data from 2020 shows that telehealth was the second most common place of service for claims with a primary behavioral health diagnosis. Further, we agree with commenters that telehealth is important in continuing to expand access to behavioral health care, and that the credit may encourage MA plans to provide additional telehealth benefits to expand access. We are extending the telehealth credit for the new specialty types consistent with other established credits afforded to MA organizations in meeting network standards. We will continue to monitor the credit and consider whether changes are appropriate in future rulemaking. Based on our review and consideration of the comments received, and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing these provisions with two modifications as follows: We are not finalizing the addition of Prescribers of Medication for Opioid Use Disorder as a specialty type for which we set network adequacy standards. We are finalizing the addition of clinical psychology and clinical social work to the list of provider specialty types at  422.116(b)(1), requiring these new specialty types to be subject to network adequacy standards. Adding time and distance standards and minimum ratios for the two new specialty types to  422.116 to Table 1 to Paragraph (d)(2) and Table 2 to Paragraph (e)(3)(i)(C), respectively, to indicate the standards for the two new specialty types, clinical psychology and clinical social work. Amending  422.112(a)(1)(i) to include that the network must also include providers that
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respectively, to indicate the standards for the two new specialty types, clinical psychology and clinical social work. Amending  422.112(a)(1)(i) to include that the network must also include providers that specialize in behavioral health services. Adding clinical psychology and clinical social work to the list at  422.116(d)(5) that that will receive the 10 percentage point credit if the MA organizations contracted network of providers includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in  422.135, for covered services. 3. Behavioral Health Services in Medicare Advantage (MA) ( 422.112 and 422.113) Care Coordination for Behavioral Health Services. In addition to ensuring that there are specific types of providers in behavioral health specialties accessible in an MA organizations provider network, it is also important for individuals with behavioral health needs to have care coordination available. Care coordination in behavioral health can be broadly described as including the process of assisting an enrollee to access a range of services that will assist in their recovery or improved functioning. Section 1852(d)(1)(A) of the Act requires MA organizations that use a network of providers to make benefits under the plan available and accessible to each individual electing the plan within the plan service area. CMS proposed to further ensure that enrollees have access to behavioral health services by adding behavioral health services to the types of services for which MA organizations that offer MA coordinated care plans must have programs in place to ensure continuity of care and integration of services at  422.112(b)(3). Under 422.112(b)(3), MA organizations must coordinate plan services with community and social services available through contracting or noncontracting providers in the area served by the MA plan, which must be made available for enrollees as part of overall delivery and coordination of services. CMS proposed to revise  422.112(b)(3) to include behavioral health services by adding the phrase , and behavioral health services after the words community-based services at the end of  422.112(b)(3). CMS believes the inclusion of behavioral health care services among the services for which MA organizations must have a care coordination program in place will better ensure enrollee access to such services. Comment: Some commenters requested CMS
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CMS believes the inclusion of behavioral health care services among the services for which MA organizations must have a care coordination program in place will better ensure enrollee access to such services. Comment: Some commenters requested CMS delay the implementation deadline. These commenters expressed concern with MA organizations abilities to secure contracts with providers who will deliver the services. Response: While CMS appreciates the challenges associated with behavioral health care access, MA organizations fundamental responsibility to ensure their enrollees can access Part A and VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222172 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Part B items and services through plan networks, as applicable, remains unchanged with the advent of this provision. We also note that  422.112(a)(3) requires MA organizations to arrange for specialty care outside of the plan provider network when network providers are unavailable or inadequate to meet an enrollees medical needs. MA organizations responsibility to cover all medically necessary care, including behavioral health care, is further discussed in section III.C. of this final rule. Comment: A commenter expressed support for the addition of behavioral health to care coordination services provision, but also requested a list of specific services that should be added in order to comply with the new provision. Response: CMS appreciates the request to specify services applicable to care coordination in behavioral health, and the commenters desire to be thorough, however the codification of a list of specific behavioral health services that require care coordination could inadvertently limit the services offered to an enrollee. Further, the availability of certain types of services could vary based on an enrollees geographic location. Thus, CMS declines to create a list of this nature at this time in order to promote MA organizations flexibility to meet their enrollees needs. We intend this amendment to ensure that MA coordinated care plans consider and address behavioral health conditions and needs of an enrollee when developing and facilitating community and social services for enrollees. Emergency Medical Condition. In addition to proposing care coordination for behavioral health services, CMS proposed to fully codify the
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coordinated care plans consider and address behavioral health conditions and needs of an enrollee when developing and facilitating community and social services for enrollees. Emergency Medical Condition. In addition to proposing care coordination for behavioral health services, CMS proposed to fully codify the agencys interpretation of section 1852(d)(3)(B) of the Act which is used to determine a condition that qualifies as an emergency medical condition for purposes of carrying out the requirements of section 1852(d)(1)(E) of the Act. Section 1852(d)(1)(E) of the Act requires MA organizations to cover, and reimburse a provider for, emergency services without regard to prior authorization or the emergency care providers contractual relationship with the MA organization. An emergency medical condition under  422.113(b)(1)(i) is defined as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in serious jeopardy to the health of the individual or their unborn child, serious impairment to bodily function, or serious dysfunction of any bodily organ or part; this regulatory definition generally mirrors the statutory definition in section 1852(d)(3)(B) of the Act. However, the definition does not explicitly address that its criteria extends to conditions both physical and mental, that is, behavioral, health. CMS interprets the scope of the definition to pertain to both physical and behavioral health conditions when those conditions meet the prudent layperson standard discussed in  422.113(b)(1)(i), consistent with the statute. Accordingly, CMS proposed to amend the regulation by inserting , mental or physical, after the word condition and before the word manifesting. We explained that we intended the proposed revision to ensure that emergency medical conditions are easily interpreted as including both physical and mental health conditions, thereby prohibiting the use of prior authorization as required by the statute and guaranteeing that coverage is provided by the MA organization, consistent with the statute. This ensures that enrollees have access to emergency behavioral health services in parity with access to other medical emergency services. Comment: A commenter requested that CMS specify that the rules pertaining to emergency care in
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the MA organization, consistent with the statute. This ensures that enrollees have access to emergency behavioral health services in parity with access to other medical emergency services. Comment: A commenter requested that CMS specify that the rules pertaining to emergency care in this rule are applicable only to hospital emergency department or free-standing emergency departments. Response: CMS does not dictate the site at which emergency services must be provided. Section 1852(d)(3)(A) of the Act specifies that emergency services are covered inpatient and outpatient services that are furnished by a provider qualified to furnish the inpatient or outpatient services, and are needed to evaluate or stabilize an emergency medical condition. CMS will continue to use this definition in order to determine when services are emergency services. Additionally, CMS notes that urgently needed services, as defined at  422.113(b)(1)(iii), must also be covered by MA plans under  422.113. Urgently needed services are not limited to services from an Emergency Room or Emergency Department and, per  422.112(b)(1)(iii), are covered services provided when an enrollee is temporarily absent from the MA plans service (or, if applicable, continuation) area (or provided when the enrollee is in the service or continuation area but the organizations provider network is temporarily unavailable or inaccessible) when the services are medically necessary and immediately required as a result of an unforeseen illness, injury, or condition and it was not reasonable given the circumstances to obtain the services through the organization offering the MA plan. Comment: A commenter requested that CMS consider a specific set of behavioral health services that meet the prudent layperson standard to further clarify the variations of behavioral health symptoms that necessitate emergency care. Response: We respectfully disagree with this comment. Identifying a specific set of behavioral health services that can or must be used to treat an emergency medical condition in order for the condition (and the corresponding emergency services and post- stabilization services) to be subject to the protections in  422.113 would undermine and inappropriately limit the regulation. Comment: Some commenters suggested that CMS clarify that when an enrollee has an emergency medical condition, MA organizations may not issue denials based on medical necessity. The commenters also pointed out that some MA organizations frequently deny payment for emergency services (for example, those services rendered prior to stabilization) based
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when an enrollee has an emergency medical condition, MA organizations may not issue denials based on medical necessity. The commenters also pointed out that some MA organizations frequently deny payment for emergency services (for example, those services rendered prior to stabilization) based on opinions that such services were not medically necessary, and this practice is variably referred to by MA organizations using terms such as prior authorization, retrospective authorization, retrospective prior authorization, or medical necessity review. Similarly, another commenter offered a scenario when payment for services is denied by an MA organization because the individual, who is stabilized and awaiting evaluation or placement, is provided care that is no longer medically necessary in the opinion of the MA organization. Response: CMS emphasizes here that section 1852(d)(1)(E) of the Act and  422.113(b)(2) require coveragewhich means paymentof emergency services defined under  422.113(b)(1)(ii). Emergency services, under the statute and regulation, are covered inpatient and outpatient services that are furnished by a provider qualified to furnish the services and needed to evaluate or stabilize an emergency medical condition (determined using the prudent layperson standard). Further, emergency services must be covered regardless of the final diagnosis, consistent with  422.113(b)(2)(iii), so the services needed to treat the emergency medical condition as presented therefore may not be retrospectively denied payment by the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00054 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222173 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 77https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. 78https://www.cms.gov/cms-behavioral-health- strategy. 79https://www.cdc.gov/nchs/nvss/vsrr/drug- overdose-data.htm. MA plan. As CMS has explained in Ch 4,
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strategy. 79https://www.cdc.gov/nchs/nvss/vsrr/drug- overdose-data.htm. MA plan. As CMS has explained in Ch 4,  20.3, of the Medicare Managed Care Manual interpreting  422.113, an MA organization is not responsible for the care provided for an unrelated non- emergency problem during treatment for an emergency situation. For example, if the attending physician is treating a fracture, the plan is not responsible for any costs connected with a biopsy of skin lesions performed while treating the fracture. Under  422.113(b)(3), the physician treating the enrollee must decide when the enrollee may be considered stabilized for transfer or discharge, and that decision is binding on the MA organization. The MA organization is financially responsible (consistent with  422.100(b) and 422.214 regarding payment) for post-stabilization services as specified in  422.113(c)(2) and (c)(3). Comment: Some commenters cautioned CMS against defining emergency medical condition with reference to conditions for which an enrollee may receive behavioral health crisis services because emergencies vary from crisis in behavioral health treatment, and referred CMS to the work being done to define behavioral health crisis services by an interagency workgroup organized by the Substance Abuse and Mental Health Services Administration (SAMHSA). Response: CMS believes that the commenter has misinterpreted the goal of this clarification to 422.113(b)(1)(i), which is simply to add mental (behavioral health) to the definition of emergencies to capture mental and physical health emergencies. There is no mention of crisis services in this change, and the scope of behavioral health crisis services is beyond the scope of this regulation. CMS notes that an emergency medical condition is not defined by the types of services used to treat the condition, as the commenters suggested. CMS acknowledges the suggestion of collaboration with SAMHSA as that agency does important work to improve behavioral health crisis care, but notes that it is not related to the content of this regulation. All public comments received on these proposals were generally supportive, including those that requested modifications be made to the final rule. For reasons presented in the proposed rule and our discussion of the public comments,
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that it is not related to the content of this regulation. All public comments received on these proposals were generally supportive, including those that requested modifications be made to the final rule. For reasons presented in the proposed rule and our discussion of the public comments, we are finalizing changes to  422.113 as proposed. 4. Medicare Advantage (MA) Access to Services: Appointment Wait Time Standards ( 422.112) CMS solicited public comment through RFI that appeared in the January 2022 proposed rule regarding the challenges that exist with accessing behavioral health providers for MA enrollees and how to resolve issues with building adequate behavioral health networks within MA plans. The responses to this RFI included requests that CMS consider strengthening network adequacy standards and improving access to care and services for enrollees by establishing requirements for appointment wait times for behavioral health services. We also heard that beneficiaries experience barriers to treatment for behavioral health conditions, including opioid use disorder. Section 1852(d) of the Act requires MA plans that limit coverage using provider networks to make covered benefits available and accessible to enrollees in the plan service area with reasonable promptness and in a manner that assures continuity in the provision of benefits, and that medically necessary care must be available and accessible 24 hours a day and 7 days a week. The MA regulation at  422.112 includes requirements and standards to ensure that MA organizations that offer coordinated care plans, which generally use networks of providers, meet the statutory requirements. Under these rules, MA organizations must ensure that all covered services are made available and accessible to enrollees by the plans designated provider network. Furthermore, MA organizations are required under  422.112(a)(6)(i) to maintain written standards that require timely access to care for enrollees which meet or exceed those established by CMS. Timely access to care and member services within a plans provider network must be continuously monitored to ensure compliance with these standards, and the MA organization must take corrective action as necessary. CMS has provided guidelines for MA organizations in the Medicare Managed Care Manual, Chapter 4, Benefits and Beneficiary Protections, section 110.1.1,77 regarding provider network standards. That guidance includes directions that MA organizations make their timeliness standards known to network providers (which is necessary in order to ensure that providers in the network comply with MA plans written standards) and that the MA organization should