2023-07115.pdf

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 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 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 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 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 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 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