2023-07115.pdf

when an MA network is not adequate to provide necessary and life- saving care and treatment. Response: We agree that this requirement, which seeks to guarantee access when in-network providers or services are unavailable or inadequate to meet an enrollees medical needs, is particularly beneficial for protecting more vulnerable enrollees, such as those with cancer or rare conditions, and dually eligible enrollees. We thank the commenters for expressing these sentiments and for their support. Comment: A few commenters recommended that, in addition to CMSs existing oversight processes, CMS establish a provider complaint mechanism that would allow providers to report MA organization behavior that potentially violates these requirements. They stated that providers are likely to recognize patterns of enrollees inability to access care through network providers, inappropriate delays in care, and denials from MA organizations, and could therefore raise concerns that could guide heightened enforcement of this requirement. A commenter specifically suggested CMS track MA enrollees appeals of requests for obtaining out-of-network services in order to better identify MA organizations that are not following this rule. Response: We operationally support the ability of providers to submit complaints to CMS regarding MA organization behavior that potentially violates these requirements. Contracted providers are instructed to resolve their complaints directly with the MA organizations since the contract is between the MA organization and the provider. In addition, the definition of organization determination in  422.566(b) includes both an MA organizations refusal to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the MA organization and an MA organizations failure to approve, furnish, arrange for, or provide payment for health care services in a timely manner, or to provide the enrollee with timely notice of an adverse determination, such that a delay would adversely affect the health of the enrollee. MA enrollees, and their providers on their behalf, may file an appeal of organization determinations of this type under subpart M of Part 422. We appreciate any information that providers are willing to share that may help us enforce this requirement. Regarding tracking MA enrollees appeals of requests for obtaining out-of-network services, we currently track this VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00059 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222178 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations information and can use it to identify MA organizations failing to comply with the requirements at  422.112(a)(1)(iii). Comment: A few commenters opposed this proposal. A commenter believed that when CMS requires MA organizations to allow for out-of- network providers to be seen at in- network cost sharing, it limits the MA organizations ability to control utilization, quality, and costs, and build higher performing networks of providers. This commenter further emphasized that out-of-network providers are not required to follow plan treatment protocols and guidelines for care and in some cases do not accept Medicare rates for services, thereby creating clinical and fiscal risk to the enrollee resulting in additional costs for the MA organizations to absorb in the absence of a contract. On the same topic, another commenter requested that CMS clarify that in these circumstances, MA organizations must pay out-of- network providers the traditional Medicare rates for their services, not a discounted rate. Yet another commenter stated that out-of-network providers should not be required to accept in- network reimbursement for their services, and MA organizations should be required to reimburse out-of-network providers at a rate that accurately reflects the services provided. A commenter also stated that they appreciated the intent behind this proposal but noted that it will not meaningfully improve access to medically necessary services. They noted that many MA organizations existing processes for providing access to out-of-network care are fraught with obstacles and unnecessary hurdles, prompting many enrollees to delay or forego needed care. Response: We acknowledge commenters concerns that requiring MA organizations to allow out-of- network providers to be seen at in- network cost sharing limits the MA organizations oversight in the absence of a contract with the providers. Nevertheless, this has been longstanding policy, and we are finalizing  422.112(a)(1)(iii) as proposed. We reiterate the option for MA organizations to enter into a case-by- case agreement or limited contract with the non-contracted provider if they wish to have more control over such things as utilization, quality, treatment protocols, and costs. Alternatively, if the MA organization has another means or mechanism to address the enrollees need for care without contracting with an out-of- network provider to furnish that care, then the applicable regulations do not necessarily prohibit alternate solutions. For example, the MA organization may waive referral or gatekeeper requirements for an enrollee who cannot access in-network primary care providers (PCPs) in a timely manner to get a referral or gatekeeper approval for a specialist visit. In addition, if an MA organization requires its enrollees to obtain a referral in most situations before receiving services from a specialist, specialty care is medically necessary, and the enrollee has not selected a PCP, then the MA organization could assign a PCP for purposes of making the needed referral. To account for situations like these where the enrollee finds the provider and the issue is not about the MA organization not contracting with that provider, but rather authorizing the ability to obtain medically necessary services out-of-networkwe are modifying the regulatory text at  422.112(a)(1)(iii) to read arrange for and cover instead of just arrange for. Regarding comments about reimbursement rates for non-contracted providers, it is true that MA organizations are required to pay non- contracted providers at least what they would have received had they furnished the services in an original Medicare setting, but providers are not obligated to participate in Medicare. This is required by section 1852(k)(1) of the Act and  422.100(b)(2). We note that  422.220(a) prohibits MA organization from paying, directly or indirectly, on any basis, for basic benefits furnished to a Medicare enrollee by a physician (as defined in paragraphs (1), (2), (3), and (4) of section 1861(r) of the Act) or other practitioner (as defined in section 1842(b)(18)(C) of the Act) who has filed with the Medicare contractor an affidavit promising to furnish Medicare- covered services to Medicare beneficiaries only through private contracts under section 1802(b) of the Act with the beneficiaries. In addition,  422.224(a) prohibits MA organizations from paying, directly or indirectly, on any basis, for items or services furnished to a Medicare enrollee by any individual or entity that is excluded by the Office of the Inspector General (OIG) or is included on the preclusion list, defined in  422.2. We reiterate that MA organizations must prioritize meeting CMSs required network adequacy standards, and arranging for care outside of the network, while a responsibility of MA organizations, should not be the norm. Any out-of- network alternative arrangements should only be made in the rare circumstance that an in-network provider or benefit is unavailable or inadequate to meet an enrollees medical needs. Finally, we recognize the commenters concern that many MA organizations existing processes for providing access to out-of-network care are problematic. It is our hope that this regulation will strengthen our requirement that MA organizations ensure adequate access to medically necessary covered benefits and compel MA organizations to reexamine their existing processes and make improvements to fully comply with CMSs requirements. Comment: Some commenters stressed that any alternative arrangements made by MA organizations for enrollees for out-of-network benefits should not substitute for compliance with network adequacy requirements. They suggested that CMS monitor the use of these alternative arrangements and continue oversight of MA organizations to ensure that they meet the network adequacy requirements, consistently provide access to in-network care, and give enrollees access to a variety of in- network and, if necessary, out-of- network, providers and facilities. Response: We agree and again emphasize that any out-of-network alternative arrangements should only be made in the rare circumstance that an in-network provider or benefit is unavailable or inadequate to meet an enrollees medical needs. MA organizations are still required to comply with our network adequacy requirements at  422.112(a)(1)(i) and 422.116, and we will continue our oversight of MA organizations compliance with these requirements through routine network adequacy reviews. Also, as noted in the proposed rule, we will monitor the use of alternative arrangements through account management activities, complaint tracking and reporting, and auditing activities. Comment: A commenter believed that CMS should amend the regulatory text to specify that when an MA organization arranges for medically necessary covered out-of-network benefits, enrollee preferences should be considered. They noted that the enrollee should have options regarding their out- of-network care, and it should be at a setting and location that best fits the enrollees needs and is in their best interests. Response: While we understand the commenters desire to specifically include enrollee preferences in the regulatory text, we believe that the existing regulatory text to meet an enrollees medical needs is sufficient. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00060 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222179 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 84https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. Any out-of-network care that the MA organization arranges for must meet the enrollees medical needs because in- network providers or benefits were unavailable or inadequate to meet the enrollees medical needs. We are therefore finalizing the regulatory text as proposed. Comment: Another comment suggested that CMS require MA organizations to clearly and prominently highlight this requirement in plan materials, including the Explanation of Benefits (EOB). Response: We agree and note that this requirement is already contained in the EOB. We intend to strengthen this language in the next iteration of updates to the model documents. Summary of Regulatory Changes We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulation. 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  422.112(a)(1)(iii) and (3) with slight modification. We are modifying the regulation text as follows. In proposed regulation text  422.112(a)(1)(iii), we are adding the phrase and cover. Thus, we are revising  422.112(a)(1)(iii) to read as follows: 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. D. Enrollee Notification Requirements for Medicare Advantage (MA) Provider Contract Terminations ( 422.111 and 422.2267) As provided in section 1852(d) of the Act and discussed in section 110.1.2.1 of Chapter 4 of the MMCM, MA organizations have considerable discretion to select the providers with whom to contract in order to build high- performing, cost effective provider networks.84This flexibility is also apparent in how CMS is prohibited by section 1854(a)(6)(B)(iii) of the Act from requiring MA organizations to contract with a particular provider. Under our current regulations, MA organizations are able to make changes to these networks at any time during the contract year, as long as they continue to furnish all Medicare-covered services in a non- discriminatory manner, meet established access and availability standards and timely notice requirements, and ensure continuity of care for enrollees. Thus, an MA organization may terminate providers from its network during the plan year, which could impact enrollees who are patients of those providers. CMS requires notification to MA enrollees when a provider network participation contract terminates. Most notably, CMSs disclosure regulations at  422.111(e) require MA organizations to make a good faith effort to provide written notice of a termination of a contracted provider at least 30 calendar days before the termination effective date to all enrollees who are patients seen on a regular basis by the provider whose contract is terminating, irrespective of whether the termination was for cause or without cause. Additionally,  422.111(e) requires that when a contract termination involves a primary care professional, all enrollees who are patients of that primary care professional must be notified. CMS established these enrollee notification requirements at  422.111(e) over 22 years ago in the Medicare Program; Medicare+Choice Program final rule with comment period, which appeared in the Federal Register on June 29, 2000 (65 FR 40170) (hereinafter referred to as the June 2000 final rule). The MA program and its policies have evolved considerably since the inception of  422.111(e). Therefore, CMS proposed to revise this particular disclosure requirement by establishing specific enrollee notification requirements for no-cause and for-cause provider contract terminations and adding specific and more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur. CMS also proposed to revise  422.2267(e)(12) to specify the requirements for the content of the notification to enrollees about a provider contract termination. First, we proposed to clarify the regulatory text at