2023-07115.pdf

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 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 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,  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, 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 consider an enrollees need for the services and common waiting times in the community. In particular, the Manual provides examples of appointment wait times for certain primary care services, based on the type of services and level of need: (1) urgently needed services or emergencyimmediately; (2) services that are not emergency or urgently needed, but requires medical attentionwithin 1 week; and (3) routine and preventive carewithin 30 days. The 2022 CMS Behavioral Health Strategy78describes CMS goals to increase and enhance access to equitable behavioral health care services for people with behavioral health care needs. To support these goals, CMS is committed to strengthening our requirements for MA organizations to ensure beneficiaries can access needed behavioral health care services similar to how they access needed physical health services. Therefore, we proposed to codify appointment wait times as standards for primary care services that are the same as the appointment wait times described in the Manual and to extend those standards to behavioral health services. These new standards for minimum appointment wait times would be added to the existing requirement that MA organizations offering coordinated care plans establish written policies for the timeliness of access to care and member services so that MA organizations must have appointment wait times that meet or exceed the minimum standards we proposed here. We proposed that the wait time standards for behavioral health services would apply to both mental health services and substance use disorder services. We remind MA organizations that substance use disorder services include medications for opioid use disorder (MOUD), which is particularly important as opioid-related overdose deaths have spiked during the pandemic,79and we have heard from commenters that beneficiaries have experienced barriers to behavioral health treatment. Proposing to codify these wait time standards as discussed by commenters through our RFI, should reduce access barriers to behavioral health treatment for those who need it; and help ensure access to a robust array of practitioners furnishing behavioral health services, including Opioid Treatment Providers who prescribe medications for opioid use disorder. In addition, the proposal to codify wait time standards for primary care is consistent with the goal to increase VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00055 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222174 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 80https://www.hhs.gov/about/news/2022/06/27/ fact-sheet-hhs-initiative-to-strengthen-primary- health-care-seeking-public-comment.html. 81https://jamanetwork.com/journals/ jamainternalmedicine/fullarticle/2724393. 82https://www.cms.gov/CCIIO/Resources/ Regulations-and-Guidance/Downloads/Final-2023- Letter-to-Issuers.pdf. access to primary care articulated in HHS Initiative to Strengthen Primary Care.80The National Academies for Science, Engineering, and Medicine (NASEM) Report outlined the importance of ensuring that high-quality primary care is available to every individual and family in every community, particularly those that are underserved. After all, access to primary care practitioners, as opposed to any other practitioner type, is associated with decreased mortality.81 We also sought comment on alternative specific appointment wait times standards to apply to MA organizations. For example, we considered, as suggested by a commenter on our RFI, establishing appointment wait time standards that align with those established for qualified health plans, (QHPs) as outlined by CMS in the 2023 Final Letter to Issuers in the Federally- facilitated Exchanges.82The appointment wait time standards for QHPs include: Behavioral health appointments must be available within 10 business days, Primary care (routine) must be available within 15 business days; and Specialty care (non-urgent) must be available within 30 business days. We explained that under this alternative, the wait time requirements would be applicable to primary care and behavioral health specialty types. We solicited comment on whether a more flexible approach would be appropriate, such as requiring MA organizations have specific standards for appointment wait time in their written internal policies, but that CMS require MA plans to meet the specific standards for appointment wait time limits for routine or non-emergency services for only a significant portion (for example, 95