evekhm/cms_iom_500 huggingface dataset:
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the MA organization must arrange for 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 (see section III.C. of this final rule). Furthermore, it may be necessary for MA organizations to allow care to continue to be furnished on an interim, transitional basis, by providers who have been terminated from the network in order to adequately address continuity of care needs for affected enrollees. This is longstanding CMS guidance from section 110.1.2.2 of Chapter 4 of the MMCM, therefore, we expect MA organizations to be complying with this interpretation and application of the obligations on the MA organization to ensure that its provider network is adequate to furnish medically necessary covered benefits to enrollees.93Lastly, we agree with the commenters concerns that palliative care is appropriate at any age or stage of a serious illness, so our references to the scope of primary care in this final rule include both palliative care and end-of-life care because we believe that both are key elements of primary care. Comment: We received several comments on our proposed changes to  422.2267(e)(12). A commenter opposed requiring MA organizations to include a list of names and phone numbers of alternative in-network providers instead of just a link to the MA organizations current provider directory. Another commenter believed CMS should allow for electronic delivery for written notices if the enrollee opted into electronic communication. Response: We respectfully disagree with these comments on  422.2267(e)(12). We strongly believe that enrollees whose providers are leaving their network unexpectedly should be provided a list of other providers that they may access for continued care. As paragraph (e)(12)(ii)(B) states, MA organizations have the option to supplement this list with a link to their provider directory as well. Regarding the method of delivery of the provider termination notice, we did not propose any changes to our current requirement at  422.2267(e)(12)(i) that the notice be provided in hard copy via U.S. mail, therefore, we decline the suggestion to allow for electronic delivery as the only means for delivering this written notice. MA organizations may send a supplemental
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that the notice be provided in hard copy via U.S. mail, therefore, we decline the suggestion to allow for electronic delivery as the only means for delivering this written notice. MA organizations may send a supplemental notice using electronic delivery if consistent with an enrollees preference. Thus, we are finalizing our proposed changes to  422.2267(e)(12)(i) and (ii)(B) as proposed. Comment: Generally, commenters were supportive of CMSs proposal to consider an enrollee who is impacted by a provider contract termination to be someone who is experiencing an exceptional condition and therefore eligible for the SEP specified in  422.62(b)(26). One commenter proposed that CMS provide MA organizations time to attempt to resolve an enrollees transition needs before informing an enrollee that they may contact 1800MEDICARE to request an SEP. The commenter was concerned that calls to 1800MEDICARE may be classified by CMS as complaints and adversely impact the MA organizations overall Star Rating. Two commenters requested that information on the SEP for exceptional conditions be featured more prominently in CMS publications. We also solicited comment on alternative approaches; specifically, the adoption of a new SEP for this type of provider contract termination, with explicit standards for when termination of a provider from the network should VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00066 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222185 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 94The terms Traditional Medicare and Original Medicare are used interchangeably throughout this section and both mean the Medicare Fee-For-Service program. 95https://oig.hhs.gov/oei/reports/OEI-09-18- 00260.pdf. serve as a basis for SEP eligibility. One commenter requested that CMS expand the SEP for Significant Change in Provider Network at  422.62(b)(23) so that it would be available to any plan enrollee who wishes change plans mid- year in order to continue to
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One commenter requested that CMS expand the SEP for Significant Change in Provider Network at  422.62(b)(23) so that it would be available to any plan enrollee who wishes change plans mid- year in order to continue to see their provider(s). Another commenter requested that CMS create a new SEP for any enrollee whose provider is terminated, stating that such an event is a common, not unique, event that should not need to be reviewed on a case-by-case basis. This commenter requested that the new SEP be three months in length and be available to any enrollee who receives a notice of provider termination sent in accordance with  422.111(e). Another commenter requested that CMS take the position that that any enrollee who has ever received care from a particular provider or facility is eligible for an SEP upon termination of that provider or facility, including an enrollee who attests to having confirmed a providers or facilitys in- network status when making a decision to join the MA plan. One commenter who expressed opposition to offering an SEP to an enrollee who is impacted by a provider contract termination stated that an enrollee should not be eligible for an SEP if other providers are available in the network. Another stated that notifying enrollees of a potential SEP may create confusion when a provider retires and there are other providers available in the network. Response: We appreciate the commenters support for our proposal to consider an enrollee who is impacted by a provider contract termination to be someone who is experiencing an exceptional condition and therefore eligible for the SEP specified in  422.62(b)(26). We also appreciate the response to our solicitation for feedback on alternative approaches, such as the adoption of a new SEP for this type of provider contract termination. We did not propose any changes to the SEPs at  422.62(b)(23) and 422.62(b)(26), so this final rule will not include any changes to these regulations; however, we will consider this feedback in future rulemaking and policy development. Summary of Regulatory Changes We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulations. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed changes to  422.111(e) with the following
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the majority of which reflected support for the regulations. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed changes to  422.111(e) with the following modifications: In proposed regulation text  422.111(e)(1)(i), we are removing the phrase both written and telephonic notice and adding the phrase 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). Thus, we are revising (e)(1)(i) to read as follows: 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), In proposed regulation text  422.111(e)(1)(iii), we are adding the phrase are currently assigned to that primary care provider and to enrollees who and removing the word ever and adding the phrase within the past three years. Thus, we are revising (e)(1)(iii) to read as follows: 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. We are finalizing changes to  422.2267(e)(12) as proposed. E. Utilization Management Requirements: Clarifications of Coverage Criteria for Basic Benefits and Use of Prior Authorization, Additional Continuity of Care Requirements, and Annual Review of Utilization Management Tools ( 422.101, 422.112, 422.137, and 422.138) 1. Introduction A majority of MA plans are coordinated care plans, which is defined at  422.4(a) as a plan that includes a network of providers that are under contract or arrangement with an MA organization to deliver the benefit package approved by CMS. CMS regulations at  422.202(b) require that each MA organization consult with network providers on the
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a plan that includes a network of providers that are under contract or arrangement with an MA organization to deliver the benefit package approved by CMS. CMS regulations at  422.202(b) require that each MA organization consult with network providers on the organizations medical policy, quality improvement programs, medical management procedures, and ensure that certain standards are met. For example, coordinated care plans must ensure that practice guidelines and utilization management guidelines are based on reasonable medical evidence or a consensus of health care professionals in the particular field; consider the needs of the enrolled population; are developed in consultation with contracting physicians; and are reviewed and updated periodically. Further, these guidelines must be communicated to providers and, as appropriate, to enrollees. Coordinated care plans are designed to manage cost, service utilization, and quality by ensuring that only medically necessary care is provided. This is done in part through the use of utilization management tools, including prior authorization, expressly referenced at section 1852(c)(1)(G) and (c)(2)(B) of the Act. These tools are designed to help MA plans determine the medical necessity of services and minimize the furnishing of unnecessary services, thereby helping to contain costs and protect beneficiaries from receiving unnecessary care. Additionally, section 1852(g)(1)(A) of the Act states that MA plans shall have a procedure for making determinations regarding whether an enrollee is entitled to receive a health care service and that such determinations must be made on a timely basis; that provision applies to both prior authorization determinations and to post-service decisions about coverage and payment. In addition, CMS regulations at  422.101(a) and (b) require that MA plans provide coverage of all basic benefits (that is, services covered under Medicare Parts A and B, except hospice care and the cost of kidney acquisitions for transplant) and that MA plans must comply with Traditional Medicare national coverage determinations (NCDs) and local coverage determinations (LCDs) applicable in the MA plans service area.94In recent years, CMS has received feedback from various stakeholders, including patient groups, consumer advocates, providers and provider trade associations that utilization management in MA, especially prior authorization, can sometimes create a barrier to patients accessing medically necessary care. Stakeholder feedback has included concerns about the quality of MA plans prior authorization decisions (for example, coverage denials being made by plan clinicians who
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MA, especially prior authorization, can sometimes create a barrier to patients accessing medically necessary care. Stakeholder feedback has included concerns about the quality of MA plans prior authorization decisions (for example, coverage denials being made by plan clinicians who do not have expertise in the field of medicine applicable to the requested service) and process challenges (for example, repetitive prior approvals for needed services for enrollees that have a previously-approved plan of care). In addition, in April 2022, the Office of the Inspector General (OIG) released a report95titled, Some Medicare VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00067 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222186 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 96https://oig.hhs.gov/oei/reports/OEI-09-18- 00260.pdf, pg. 3. Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care, which summarized the results of a study by the OIG of MA plan denials of requests for prior authorization of services. The OIG found that some prior authorization requests were denied by MA plans, even though the requested services met Traditional Medicare coverage guidelines. In other cases, the OIG found that prior authorization requests were inappropriately denied by MA organizations due to errors that were likely preventable through process or system changes by MA organizations. Citing a concern that such inappropriate denials may prevent or delay beneficiaries from receiving medically necessary care, the OIG recommended that CMS: (1) issue new guidance on the appropriate use of MA organization clinical criteria in medical necessity reviews; (2) update its audit protocols to address the issues related to MA organizations use of clinical criteria and/or examining particular service types; and (3) direct MA organizations to take steps to identify and address vulnerabilities that can lead to manual review errors and system errors.96 CMS understands that utilization management tools are an important means to coordinate care, reduce inappropriate utilization, and promote cost-efficient care. In light
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take steps to identify and address vulnerabilities that can lead to manual review errors and system errors.96 CMS understands that utilization management tools are an important means to coordinate care, reduce inappropriate utilization, and promote cost-efficient care. In light of the feedback we have received from stakeholders and the findings in the OIG report, however, we have concluded that certain guardrails are needed to ensure that utilization management tools are used, and associated coverage decisions are made, in ways that ensure timely and appropriate access to medically necessary care for beneficiaries enrolled in MA plans. We proposed to clarify requirements for the coverage criteria that MA plans use when making medical necessity determinations. We also proposed additional beneficiary protection requirements in order to improve continuity of care and integration of health care services and to increase plan compliance with regards to utilization management policies. Our proposals interpreted and implemented the requirements in section 1852 of the Act regarding the provision and coverage of services by MA plans and were, therefore, proposed under our authority in section 1856 of the Act to adopt standards to carry out the Part C statute and MA program. As originally stated in the June 2000 final rule (65 FR 40207), MA organizations must cover all Part A and B benefits, excluding hospice services and the cost of kidney acquisitions for transplant, on the same conditions that items and services are furnished in Traditional Medicare. This means that MA organizations may not limit coverage through the adoption of policies and procedureswhether those policies and procedures are called utilization management and prior authorization or the standards and criteria that the MA organization uses to assess and evaluate medical necessity when those policies and procedures result in denials of coverage or payment where the Traditional Medicare program would cover and pay for the item or service furnished to the beneficiary. In addition, this means that limits or conditions on payment and coverage in the Traditional Medicare program such as who may deliver a service and in what setting a service may be provided, the criteria adopted in relevant NCDs and LCDs, and other substantive conditionsapply to set the scope of basic benefits as defined in  422.100(c). MA organizations have flexibility to furnish and cover services without meeting all substantive conditions of coverage in Traditional Medicare, but that flexibility is limited to and in the form of supplemental benefits. As stated in the June 2000 final rule, MA organizations flexibility to deliver care using cost-effective approaches should not be construed to mean that Medicare coverage policies do
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Medicare, but that flexibility is limited to and in the form of supplemental benefits. As stated in the June 2000 final rule, MA organizations flexibility to deliver care using cost-effective approaches should not be construed to mean that Medicare coverage policies do not apply to the MA program. If Traditional Medicare covers a service only when certain conditions are met, these conditions must be met in order for the service to be considered part of the Traditional Medicare benefits (that is, basic benefits) component of an MA plan. MA organizations may cover the same service when the conditions are not met, but these benefits would then be defined as supplemental benefits within the scope of  422.100(c)(2) and 422.102 and must be included in the supplemental benefits portion of the MA plans bid. For example, when services are furnished by a type of provider other than the type of provider who may furnish the service in Traditional Medicare, those services are supplemental benefits. We proposed policies that provide less flexibility for MA organizations to deny or limit coverage of basic benefits than provided in the 2000 final rule. However, as provided by section 1852(a)(3) of the Act and reflected in  422.100(c)(2) and 422.102, MA plans may cover benefits beyond what is covered (and when it is covered) under Traditional Medicare by offering supplemental benefits. Our proposal was primarily directed at ensuring that minimum coverage requirements are met and that MA plans do not deny or limit coverage of basic benefits; we were not proposing to limit the scope of permissible supplemental benefits, but our proposal applies certain requirements for the use of utilization management for all covered benefits as discussed in section III.E. of this proposed rule. In this rule, we clarify acceptable cost-effective utilization management approaches for MA organizations to use in the context of the new proposed requirements. These clarifications aim to ensure access to medically necessary care, while maintaining MA organizations ability to apply utilization management that ensures clinically appropriate care. Additionally, we are codifying substantive rules regarding clinical coverage criteria for basic benefits and how they interact with utilization management policies, including revisions to existing regulations and adopting new regulations to ensure that MA enrollees receive the basic benefits coverage to which they are entitled and to ensure appropriate treatment of a benefit as a basic benefit or supplemental benefit for purposes of the bid under  422.254. We solicited comment on whether our proposed regulatory provisions sufficiently address the requirements
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the basic benefits coverage to which they are entitled and to ensure appropriate treatment of a benefit as a basic benefit or supplemental benefit for purposes of the bid under  422.254. We solicited comment on whether our proposed regulatory provisions sufficiently address the requirements and limits that we described in the preamble. The final rules adopted here related to utilization management requirements and limitations, coverage criteria and medical necessity determinations, use of prior authorization and continuity of care requirements for MA plans are additional standards to implement the statutory requirements at section 1852(a) of the Act that MA plans provide to their enrollees (by furnishing directly or through contracted providers, arranging for, or paying for) basic benefits (that is, all Part A and Part B benefits with limited exceptions) and such supplemental benefits the MA plan elects to offer. CMS has authority to adopt standards to carry out the applicable MA provisions in Title XVIII of the Act and to add new contract terms that we find necessary, appropriate, and not inconsistent with the statute in sections 1856(b) and 1857(e) of the Act. In addition, section 1854(a)(5) and (6) of the Act provide that CMS is not obligated to accept every bid submitted and may negotiate with MA organizations regarding the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00068 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222187 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations bid, including benefits. To the extent that these new minimum standards for MA organizations and how they cover benefits would not implement section 1852 of the Act, establish standards to carry out the MA program under section 1856(b) of the Act (which CMS does not concede, as these are important protections to ensure that MA enrollees receive Medicare covered services), or be contract terms that we are authorized to adopt under section 1857(e)(1) of the Act, we believe that our negotiation authority in section 1854(a)(6)(B) of the Act permits creation of minimum coverage requirements. While the rules finalized here do not limit our negotiation authority (which is addressed in
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of the Act, we believe that our negotiation authority in section 1854(a)(6)(B) of the Act permits creation of minimum coverage requirements. While the rules finalized here do not limit our negotiation authority (which is addressed in  422.256), they provide minimum standards for an acceptable benefit design for CMS to apply in reviewing and evaluating bids, in addition to establishing important protections to ensure that enrollees have access to medically necessary items and services that are covered under Part A and Part B. 2. Coverage Criteria for Basic Benefits a. Application of Coverage Criteria In interpreting requirements involving coverage criteria, whether used for prior authorization or post-service payment, CMS has a longstanding policy, discussed in sub-regulatory guidance (section 10.16 of Chapter 4 of MMCM), that MA plans must make medical necessity determinations based on internal policies that include coverage criteria that are no more restrictive than Traditional Medicares national and local coverage policies and approved by a plans medical director. In light of the previously discussed feedback and the OIG recommendation that we issue new guidance on the appropriate use of MA organization clinical criteria in medical necessity reviews, we proposed to codify standards for coverage criteria to ensure that basic benefits coverage for MA enrollees is no more restrictive than Traditional Medicare. Section 1862 of the Act requires original Medicare benefits to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, in order to meet the statutory requirements at section 1852(a)(1) of the Act, which requires MA plans to cover A and B services, MA plan coverage criteria must do the same. We also proposed to amend  422.101(b) and (c) to clarify the obligations and responsibilities for MA plans in covering basic benefits. Section 1852(a)(1) of the Act and CMS regulations at  422.101(a) and (b) require all MA organizations to provide coverage of, by furnishing, arranging for, or making payment for, all items and services that are covered by Part A and Part B of Medicare and that are available to beneficiaries residing in the plans service area. Section 422.101 requires MA organizations to comply with all NCDs; LCDs written by Medicare Administrative Contractors (MACs) with jurisdiction for Medicare claims in the MA organizations or plans service area; and coverage instructions and guidance in