2023-07115.pdf

specialists, hospitals, skilled nursing facilities, home health agencies, ambulatory clinics and other providers. In response to the RFI in the January 2022 proposed rule, we received comments emphasizing the importance of network adequacy and ensuring adequate access to behavioral health providers in MA plans. Stakeholders responses to the RFI suggested that CMS expand the network adequacy time and distance standards for MA plans beyond those that we currently review through our network adequacy evaluations. Commenters suggested that we expand the standards to include other outpatient behavioral health physicians and health professionals, including those that treat substance use disorders (SUDs), as part of our evaluation of MA plan networks in order to better meet MA enrollees needs in accessing behavioral health care. Even though over one million Medicare beneficiaries had a diagnosis of Opioid Use Disorder (OUD) and more than fifty thousand experienced an overdose in 2021, fewer than 1 in 5 of these Medicare beneficiaries with a diagnosis of OUD receive treatment for their OUD.71Current standards of care for OUD include treatment through three Food and Drug Administration (FDA) approved medications (buprenorphine, naltrexone and methadone), along with other services to provide the best approach to treating SUD. Enrollees can access Medications for Opioid Use Disorder (MOUD) in various settings including in Opioid Treatment Programs (OTPs) and, at the time of the December 2022 proposed rule proposal, through qualified practitioners (physicians, nurse practitioners, physician assistants, etc.) who have obtained a waiver through SAMHSA to dispense these medications in office settings. CMS is committed to ensuring that MA enrollees have access to provider networks sufficient to provide covered services, including access to behavioral health service providers. Medicare fee- for-service claims data for 2020 shows that for certain outpatient behavioral health services, the top provider specialty types to provide services to beneficiaries included psychiatrists, clinical social workers, nurse practitioners, and clinical psychologists. OTPs had the largest number of claims for SUD in this same time period. Therefore, we proposed to strengthen our network adequacy requirements for MA plans as it relates to behavioral health in three ways. First, we proposed to add three new provider specialty types to the list at  422.116(b)(1) to make them subject to the time, distance and minimum number requirements in our network adequacy evaluation: (1) clinical psychology, (2) clinical social work, and (3) one category called Prescribers of Medication for Opioid Use Disorder that includes two specialty types: providers with a waiver under section 303(g)(2) of the Controlled Substances Act (CSA) and OTPs. Most of these new specialty types are defined the same way as they are used for the original Medicare program in section 1861(hh) of the Act (defining clinical social worker),  410.71(d) (defining clinical psychologist), and section 1861(jjj)(2) of the Act (defining Opioid Treatment Program). Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)(G)(ii)) establishes which providers have a waiver and we do not believe a definition in the MA regulations at 42 CFR part 422 is necessary. Our current regulations, at  422.116(a)(2), specify that an MA plan must meet maximum time and distance standards and contract with a specified minimum number of each provider and facility-specialty type. Therefore, as part of the proposed changes to our list of provider specialty types under  422.116(b)(1), we proposed base time and distance standards and minimum number of in-person providers in each county type for each new specialty type as follows: VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222169 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 72Counties with extreme access considerations (CEAC). 73https://bhw.hrsa.gov/data-research/projecting- health-workforce-supply-demand/behavioral- health. 74https://pecos.cms.hhs.gov/pecos/ login.do#headingLv1. 75https://www.samhsa.gov/medication-assisted- treatment/find-treatment/treatment-practitioner- locator. 76https://data.cms.gov/provider-characteristics/ medicare-provider-supplier-enrollment/opioid- treatment-program-providers. Maximum Time and Distance Standards: Minimum Ratios: In the proposed rule titled Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly proposed rule which appeared in the Federal Register on February 18, 2020 (85 FR 9002) (hereinafter referred to as the February 2020 proposed rule), we explained how CMS developed the base time and distance standards and the minimum provider requirements used in  422.116 (85 FR 9094 through 9103). CMS established the current base time and distance standards for the provider and facility types listed in  422.116 by mapping the various specialty types practice locations from the National Provider and Plan Enumeration System (NPPES) National Provider Identifier (NPI) file to the Medicare beneficiary locations from CMS enrollment data. We further explained that we then tested different options for combinations of beneficiary coverage percentages and maximum travel distances to determine what was feasible and practical for the majority of counties given the trade-off between beneficiary coverage and travel distance. The travel time standards were calculated according to the average driving speeds in each of the ZIP code types (urban, suburban, rural) that beneficiaries would traverse between their homes and the provider locations (85 FR 9097). Other than the use of the different and more recent data sources that are identified in this preamble, we followed the same analysis and steps to develop the time and distance standards that we proposed to apply to the new behavioral health specialty types. Further, we explained in the February 2020 proposed rule how CMS determines the minimum number requirement for all provider specialty types. By multiplying the minimum ratio by the number of beneficiaries required to cover, dividing the resulting product by 1,000, and rounding up to the next whole number. This is reflected in  422.116(e)(2)(i) and (e)(3); the current regulation text addresses how the number of beneficiaries required to cover is calculated and will apply to the proposed new provider specialty types. The minimum ratio is the number of providers required per 1,000 beneficiaries. We developed the minimum ratios that currently appear in  422.116 using various data sources, including, Medicare fee for-service claims data, American Medical Association (AMA) and American Osteopathic Association (AOA) physician workforce data, US Census population data, National Ambulatory Medical Care Survey data, and AMA data on physician productivity. In developing the proposal here to add new specialty types subject to network adequacy evaluation, we conducted additional research to inform appropriate minimum ratio requirements. We reviewed utilization data among FFS Medicare beneficiaries for the proposed specialty types for 2019 through 2021. We reviewed literature on the prevalence of behavioral health disorders among Medicare beneficiaries and existing models for projecting the needed behavioral health workforce such as the Health Resources and Services Administrations (HRSA) Health Workforce Simulation Model,73to inform estimates of the potential demand for behavioral health services. We also reviewed data on the potential supply of behavioral health providers, that is, Medicare-enrolled providers in the Provider Enrollment, Chain, and Ownership System (PECOS),74the list of practitioners waivered to provide buprenorphine for the treatment of OUD published by SAMHSA,75and the list of OTP providers enrolled in Medicare published by CMS.76We also sought clinical consultation regarding the types of behavioral health providers that treat VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.006</GPH> ER12AP23.007</GPH>ddrumheller on DSK120RN23PROD with RULES222170 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Medicare beneficiaries, the service locations in which beneficiaries typically use behavioral health care, and typical patterns of care for accessing medication treatment for opioid use disorder, that is, the use of office-based and OTP-based care. Other than the use of different and more recent data sources as identified in this preamble, we followed the same analysis and steps to develop the proposed minimum provider ratios for these new specialty types. Second, in order to reinforce regulatory requirements for MA plans on their responsibility to provide access to critical behavioral health care services, we proposed 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. Finally, to encourage increased access to telehealth providers in contracted MA networks,  422.116(d)(5) provides that for certain specialties, MA plans may receive a 10-percentage point credit towards the percentage of beneficiaries that reside within published time and distance standards when the plan includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in  422.135, in its contracted network. Medicare FFS claims data shows that telehealth was the second most common place of service for claims with a primary behavioral health diagnosis in 2020. As noted previously, the top provider specialty types to provide certain outpatient behavioral services to beneficiaries in that year included psychiatrists, clinical social workers, nurse practitioners, and clinical psychologists. Additionally, previous input from stakeholders discussed the importance of access to telehealth services specific to behavioral health in expanding access to care. Based on these considerations, we also proposed to add all the new behavioral health specialty types to the list at  422.116(d)(5) of the specialty types that that will receive the 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. We solicited comment on this proposal. Comment: We received numerous comments that were supportive of our proposal to add the three new behavioral health specialty types to the list at  422.116(b)(1), requiring these new specialty types be subject to network adequacy evaluation. Commenters noted that expanding the MA network adequacy standards to include the new specialty types would positively impact access to behavioral health providers for enrollees. Response: We thank commenters for their input on this proposal. CMS is committed to ensuring access to provider networks for MA enrollees is sufficient. Adding behavioral health specialty types to our network adequacy standards to supplement the current specialties (psychiatry and inpatient psychiatric facility services) will further strengthen network adequacy requirements for MA plans and enhance access for enrollees. Comment: We also received several comments that opposed the proposal to add the new behavioral health specialty types to the network adequacy evaluation, mainly citing concerns with shortages of behavioral health providers that could hinder the ability for MA plans to meet network adequacy standards. A few commenters suggested that we set the network standards for behavioral specialty types to mirror the network standards for the primary care specialty type. Response: We used current data and followed the established steps to develop the time and distance standards and minimum ratios included in the proposal for the new behavioral health specialty types. Consistent with our established practice, the network adequacy standards for the specialty types we are finalizing in this rule are set such that MA organizations are able to meet them based on the current supply and distribution of behavioral health providers. We also remind commenters that CMS provides annual updates (422.116(a)(4)(ii)) to the Provider Supply file, which identifies available providers and facilities with office locations and specialty types that can be utilized as a supplemental tool for identifying appropriate providers. Further, an MA plan may request an exception to network adequacy criteria under our exceptions process (422.116(f)), when providers or facilities are not available for the MA plan to meet the network adequacy criteria as shown in the Provider Supply file for the year for a given county and specialty type, and the MA plan has contracted with other providers and facilities that may be located beyond the limits in the time and distance criteria, but are currently available and accessible to most enrollees, consistent with the local pattern of care. Comment: Many commenters noted that the Consolidated Appropriations Act, 2023 eliminated the SAMHSA required waiver to prescribe medication for treatment of OUD, and therefore suggested that CMS not finalize the new behavioral health Prescribers of Medication for Opioid Use Disorder requirement as part of our network adequacy standards. Additionally, a few commenters indicated that while the waiver requirement was no longer in effect, CMS should maintain a network adequacy standard specifically for OTPs or develop alternative standards for all prescribers of medication for opioid use disorder. Response: We acknowledge that 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