2023-07115.pdf

revising paragraph (e)(4) to read as follows:  417.454 Charges to Medicare Enrollees. * * * * * (e) * * * (4) A COVID19 vaccine and its administration described in section 1861(s)(10)(A) of the Act. PART 422MEDICARE ADVANTAGE PROGRAM 3. The authority citation for part 422 continues to read as follows: Authority: 42 U.S.C. 1302, 1306, 1395w 101 through 1395w152, and 1395hh. 4. Section 422.62 is amended by: a. Removing and reserving paragraph (b)(18); and b. Redesignating paragraph (b)(26) as paragraph (b)(27) and adding new paragraph (b)(26) to read as follows:  422.62 Election of coverage under an MA plan. (b) * * * (26) The individual enrolls in Medicare premium-Part A or Part B using an exceptional condition SEP, as described in 42 CFR 406.27 and 407.23. The SEP begins when the individual submits their application for premium- Part A and Part B, or Part B only, if the individual is already entitled to Part A (or is enrolling in premium-free Part A within the timeframe for use of this SEP), and continues for the first 2 months beyond the premium-Part A and/or Part B entitlement date. The MA plan enrollment is effective the first of the month following the month the MA plan receives the enrollment request. * * * * * 5. Section 422.100 is amended by adding paragraph (n) to read as follows:  422.100 General requirements. * * * * * (n) Digital health education program. MA organizations must establish procedures to identify and offer digital health education to enrollees with low digital health literacy to assist with accessing any medically necessary 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. (1) The MA organization must make information about its digital health literacy screening and digital health education programs available to CMS upon request. Requested information may include, but is not limited to, statistics on the number of enrollees identified with low digital health literacy and receiving digital health education, manner(s) or method of digital health literacy screening and digital health education, financial impact of the programs on the MA organization, evaluations of effectiveness of digital health literacy interventions, and demonstration of compliance with the requirements of this section. (2) [Reserved]. 6. Section 422.101 is amended by: a. Revising paragraph (b)(2); b. Adding paragraph (b)(6); and c. Revising paragraph (c). The revisions and addition read as follows:  422.101 Requirements relating to basic benefits. * * * * * (b) * * * (2) General coverage and benefit conditions included in Traditional Medicare laws, unless superseded by laws applicable to MA plans. This includes criteria for determining whether an item or service is a benefit available under Traditional Medicare. For example, this includes payment criteria for inpatient admissions at 42 CFR 412.3, services and procedures that the Secretary designates as requiring inpatient care under 42 CFR 419.22(n), and requirements for payment of Skilled Nursing Facility (SNF) Care, Home Health Services under 42 CFR part 409, and Inpatient Rehabilitation Facilities (IRF) at 42 CFR 412.622(a)(3). * * * * * (6) MA organizations may create publicly accessible internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs. Current, widely-used treatment guidelines are those developed by organizations representing clinical medical specialties, and refers to guidelines for the treatment of specific diseases or conditions. Acceptable clinical literature includes large, randomized controlled trials or VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00210 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222329 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations prospective cohort studies with clear results, published in a peer-reviewed journal, and specifically designed to answer the relevant clinical question, or large systematic reviews or meta- analyses summarizing the literature of the specific clinical question. (i) Coverage criteria not fully established. Coverage criteria are not fully established when: (A) additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently. The MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services; (B) NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD; or (C) There is an absence of any applicable Medicare statutes, regulations, NCDs or LCDs setting forth coverage criteria. (ii) Publicly accessible. For internal coverage policies, the MA organization must provide in a publicly accessible way the following: (A) The internal coverage criteria in use and a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations; (B) A list of the sources of such evidence; and (C) An explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination. When coverage criteria are not fully established as described in paragraph (6)(i)(A), the MA organization must identify the general provisions that are being supplemented or interpreted and explain how the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. (c) Medical necessity determinations and special coverage provisions(1) Medical necessity determinations. (i) MA organizations must make medical necessity determinations based on all of the following: (A) Coverage and benefit criteria as specified at paragraphs (b) and (c) of this section and may not deny coverage for basic benefits based on coverage criteria not specified in paragraph (b) or (c) of this section. (B) Whether the provision of items or services is reasonable and necessary under section 1862(a)(1) of the Act. (C) The enrollees medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes. (D) Where appropriate, involvement of the organizations medical director as required at  422.562(a)(4). (ii) [Reserved] (2) Exception for qualifying hospital stay. MA organizations may elect to furnish, as part of their Medicare covered benefits, coverage of posthospital SNF care as described in subparts C and D of this part, in the absence of the prior qualifying hospital stay that would otherwise be required for coverage of this care. 7. Section 422.109 is amended by revising the section heading and adding paragraphs (e) and (f) to read as follows:  422.109 Effect of national coverage determinations (NCDs) and legislative changes in benefits; coverage of clinical trials and A and B device trials. * * * * * (e) Clinical trials specified in NCD 310.1. (1) With the exception specified in paragraph (e)(3) of this section, original Medicare is responsible for coverage of MA enrollees participating in CMS-approved clinical trials to include routine costs, as specified in NCD 310.1, and any coverage for the diagnosis or treatment of complications related to the clinical trial. (2) MA enrollees are not charged traditional Medicare Part A and B deductibles for clinical trial coverage. (3) MA plans are responsible for paying the difference between traditional Medicare cost-sharing incurred for qualifying clinical trial items and services and the MA plans in-network cost-sharing for the same category of items and services. (4) An enrollees in-network cost- sharing portion must be included in the MA plans maximum out-of-pocket calculation. (5) MA plans may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by the plan, nor may it create impediments to an enrollees participation in a non-plan-sponsored clinical trial. (f) A and B IDE trials. (1) MA plans are responsible for payment of routine care items and services in CMS- approved Category A and Category B IDE studies that are covered under  405.211(a) of this chapter. (2) MA plans are responsible for coverage of CMS-approved Category B devices that are covered under  405.211(b) of this chapter. 8. Section 422.111 is amended by revising paragraphs (b)(3)(i) and (e) to read as follows:  422.111 Disclosure requirements. * * * * * (b) * * * (3) * * * (i) The number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services; 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; any out-of-network coverage; any point-of-service option, including the supplemental premium for that option; and how the MA organization meets the requirements of  422.112 and 422.114 for access to services offered under the plan. * * * * * (e) Changes to provider network. The MA organization must provide enrollees notice of a termination of a contracted provider, irrespective of whether the termination was for cause or without cause, in accordance with  422.2267(e)(12). The MA organization must make a good faith effort to provide enrollees notice of a for-cause termination of a contracted provider within the timeframes required by this paragraph (e). For all terminations, the MA organization must meet the following requirements: (1) For contract terminations that involve a primary care or behavioral health provider: (i) Provide written notice and make one attempt at telephonic notice to those enrollees identified in paragraph (e)(1)(iii) of this section who have not opted out of calls regarding plan business as described in  422.2264(b), (ii) At least 45 calendar days before the termination effective date, and (iii) To all enrollees who are currently assigned to that primary care provider and to enrollees who have been patients of that primary care or behavioral health provider within the past three years. (2) For contract terminations that involve specialty types other than primary care or behavioral health: (i) Provide written notice, (ii) At least 30 calendar days before the termination effective date, and (iii) To all enrollees who are patients seen on a regular basis by the provider whose contract is terminating. The phrase enrollees who are patients seen on a regular basis by the provider whose contract is terminating means enrollees who are assigned to, currently receiving care from, or have received care within VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00211 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222330 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations the past three months from a provider or facility being terminated. * * * * * 9. Section 422.112 is amended by a. Adding a sentence at the end of paragraph (a)(1)(i); b. Adding paragraph (a)(1)(iii); c. Removing the last sentence of paragraph (a)(3); d. Revising paragraphs (a)(6)(i), (a)(8) and (b)(3); and e. Adding paragraph (b)(8). The additions and revisions read as follows:  422.112 Access to services. (a) * * * (1) * * * (i) * * * The network must include providers that specialize in behavioral health services. * * * * * (iii) 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. * * * * * (6) * * * (i) Timeliness of access to care and member services that meet or exceed standards in this paragraph. The MA organization must continuously monitor access to care and member services and must take corrective action as necessary to ensure that appointment wait times in the provider network comply with these standards. The minimum standards for appointment wait times for primary care and behavioral health services are as follows for appointments: (A) Urgently needed services or emergencyimmediately; (B) Services that are not emergency or urgently needed, but the enrollee requires medical attentionwithin 7 business days; and (C) Routine and preventive care within