evekhm/cms_iom_500 huggingface dataset:
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As part of this analysis, we took into account solicited stakeholder input on aspects of the proposal and its impact requested in the NPRM. The regulation requires a PA approval to be valid for as long as medically necessary pursuant to 422.101(c), to avoid disruptions in care . In combination with the requirements to limit when MA plans may deny coverage (or use internal coverage criteria that are not used in Traditional Medicare), this will limit an MA organizations ability to approve only part of what a provider has ordered or prescribed. In addition, the finalized requirements would minimize repetitive PA requirements for enrollees on an appropriate, chronic, stable therapy. It would be qualitatively beneficial for the enrollee. The finalized regulation establishes a minimum 90-day transition period when an enrollee switches to a new plan, or switches from FFS to an MA plan (including new MA plan members who are also new to Medicare as well) for any ongoing courses of treatment so that treatment may not be subjected to prior authorization. This was adopted from similar transition periods in Part D; we believe it is appropriate to align the transition period and scope with the current transition requirements in Part D. We lack adequate data to quantify this provision. Qualitatively, it may result, in certain cases, in more cost to plans; but the proposal is beneficial to the enrollee. The proposed regulation requires MA organizations to establish a committee (similar to a P&T committee), led by a plans Medical Director, that reviews utilization management policies annually and keeps current of Medicare statutes and regulations, LCDs and NCDs. This is beneficial for the enrollee. It was modeled on similar committees used for Part B step therapy programs and by Part D plans. Its major effect is to ask plans to review their utilization management policies. We re-emphasize that we are not able to fully quantify all of these and the discussion of reasons is discussed in the preamble. 2. Medicare Advantage/Part C and Part D Prescription Drug Plan Quality Rating System ( 422.162, 422.164, 422.166, 423.182, 423.184, and 423.186) As an alternative to our proposal to have a tiered health equity index reward, we considered a non-tiered approach. We proposed a tiered HEI reward structure based on the percentage of enrollees in each contract who have the specified social
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As an alternative to our proposal to have a tiered health equity index reward, we considered a non-tiered approach. We proposed a tiered HEI reward structure based on the percentage of enrollees in each contract who have the specified social risk factors (SRFs). We proposed that contracts that have percentages of enrollees with any of the specified SRFs in a given year that are greater than or equal to one-half of the contract-level median percentage of enrollees with the specified SRFs up to, but not including, the contract-level median would qualify for one-half of the HEI reward. Contracts that have percentages of enrollees with any of the specified SRFs greater than or equal to the contract-level median would qualify for the full HEI reward. We have also considered and solicited comment on an alternative non-tiered HEI reward structure, where all contracts with percentages of enrollees with any of the specified SRF greater than or equal to one-half of the contract- level median would qualify for the full HEI reward. Both the tiered and non- tiered HEI reward structures align with our goal of not rewarding contracts that may do well among enrollees with SRFs but serve very few enrollees in this population, although the tiered HEI reward structure goes further in aligning with these goals. The non-tiered HEI reward structure aligns better with the goal of ease of use and understanding for contracts and other stakeholders. Although the non-tiered approach would slightly increase the mean HEI reward, it does not impact the number of contracts qualifying for the reward. We received a few comments related to the tiered versus non-tiered approach summarized in Section V. of this rule. Most commenters did not comment on the tiered versus non-tiered approach and supported the HEI reward as proposed. For the reasons set forth in the proposed rule and our responses to the related comments summarized in Section V of this rule, we are finalizing the HEI reward as proposed without modification. F. Accounting Statement and Table The following Table 14 summarizes costs and transfers by provision. As required by OMB Circular A4 (available at https://obamawhitehouse.archives.gov//circulars_ a004_ a-4/), in Table 13, we have prepared an accounting statement showing the costs and transfers associated with the
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(available at https://obamawhitehouse.archives.gov//circulars_ a004_ a-4/), in Table 13, we have prepared an accounting statement showing the costs and transfers associated with the provisions of this final rule for calendar years 2024 through 2033. Table 13 is based on Table 14 which lists transfers and costs by provision and year. Tables 13 and 14 are expressed in millions of dollars with costs listed as positive numbers and transfers of savings (reduction in dollar spending) to the Medicare Trust Fund listed as a savings. As can be seen, the net annualized cost of this rule is about $2 million per year. This cost is offset by a reduction in dollar spending (savings) to the Medicare Trust Fund of about $0.35 billion per year. Minor seeming discrepancies in totals in Tables 13 reflects use of underlying spreadsheets, rather than intermediate rounded amounts. A breakdown of these costs of this final rule by provision may be found in Table 14. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00207 Fmt 4701 Sfmt 4725 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.020</GPH>ddrumheller on DSK120RN23PROD with RULES222326 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations The following Table 13 summarizes costs, and transfers by provision and year and forms a basis for the accounting Table 13. In Table 14, costs are expressed as positive numbers while savings to the Medicare Trust Fund (reduced dollar spending) are expressed as negative numbers. All numbers are in millions. The costs in this table are true costs reflecting increased consumption of services and goods. However, the savings (reduced dollar spending) to the Medicare Trust Funds reflect a transfer from MA plans, Part D sponsors, and enrollees, who increase their spending, to the Trust Fund. Table 14 combines related provisions. For example, all PACE provisions in the COI summary table are combined into one-line item. Similarly, all provisions dealing with prior authorization have been combined into one-line item in the summary table. Table 14, also combines the three provisions with transfers: The Star Ratings provisions reduce spending by the Trust Fund
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are combined into one-line item. Similarly, all provisions dealing with prior authorization have been combined into one-line item in the summary table. Table 14, also combines the three provisions with transfers: The Star Ratings provisions reduce spending by the Trust Fund (TF) to MA plans; the low-income NET provision and the expansion of low-income subsidy provision both increase dollar spending by the TF to cover assistance through the LI NET sponsors to low-income beneficiaries who would otherwise have to pay for Prescription Drugs. Since the aggregate transfer over all three provisions is a reduction in dollar spending, Table H6, lists this transfer as a savings. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00208 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222327 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations BILLING CODE 412001C VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00209 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.021</GPH>ddrumheller on DSK120RN23PROD with RULES222328 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations G. Conclusion As indicated in Table 13 the finalized provisions of this rule in aggregate reduce dollar spending of the Medicare Trust Fund by $4.0 billion over 10 years, with the Star Ratings provisions being the primary driver of savings. Contrastively, the aggregate paperwork burden of this rule is small, in aggregate, $17.1 million over 10 years. Except for 2024, the annual cost is $0.3 million. The major driver of costs are the translation requirements, which although taking place in 2025, will probably be prepared for by most plans in 2024. Over an infinite horizon the aggregate costs of this rule expressed in 2016 dollars is $0.8 million per year. In accordance with requirements, this major rule has been reviewed by OMB. Chiquita
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prepared for by most plans in 2024. Over an infinite horizon the aggregate costs of this rule expressed in 2016 dollars is $0.8 million per year. In accordance with requirements, this major rule has been reviewed by OMB. Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on March 29, 2023. List of Subjects 42 CFR Part 417 Administrative practice and procedure, Grant programshealth, Health care, Health Insurance, Health maintenance organizations (HMO), Loan programshealth Medicare, and Reporting and recordkeeping requirements. 42 CFR Part 422 Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements. 42 CFR Part 423 Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Incorporation by reference, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements. 42 CFR Part 460 Aged, Citizenship and naturalization, Civil rights, Health, Health care, Health records, Individuals with disabilities, Medicaid, Medicare, Religious discrimination, Reporting and recordkeeping requirements, Sex discrimination. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV and the Department of Health and Human Services amends 45 CFR part 170 as set forth below: PART 417HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS Subpart KEnrollment, Entitlement, and Disenrollment Under Medicare Contract 1. The authority citation for part 417 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395hh, and 300e, 300e5, and 300e9, and 31 U.S.C. 9701. 2. Section 417.454 is amended by 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
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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:
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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:
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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
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(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
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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,