2023-07115.pdf

an off-label Part B drug when an on-label drug is available. Response: We thank commenters for expressing their comments and concerns. To clarify, the utilization management policies discussed in this rule do not limit MA organizations ability to use step therapy for Part B drugs when it is permitted under  422.136. Under this final rule, certain utilization management processes, such as clinical treatment guidelines that require an item or service (that is not a Part B drug) to be furnished prior to receiving the requested item or service, would violate  422.101(b) and (c), and thus, those utilization management processes are prohibited unless it is specified within the applicable NCD or LCD or Medicare statute or regulation when Traditional Medicare coverage criteria are fully established. When Traditional Medicare coverage criteria are not fully established under VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00085 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222204 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 107https://www.kff.org/medicare/issue-brief/over- 35-million-prior-authorization-requests-were- submitted-to-medicare-advantage-plans-in-2021/. 108https://www.healthaffairs.org/doi/full/ 10.1377/hlthaff.2021.01054. 109https://www.cms.gov/files/zip/2021-parts-c- and-d-reporting-requirements-puf-not-incl-part-d- mtm-data.zip. 110https://www.cms.gov/files/zip/2021-reporting- requirements-puf-tech-specs.zip.  422.101(b)(6)(i), this final rule permits utilization management policies as part of an internal coverage policy when the current evidence in widely used treatment guidelines or clinical literature expressly supports the use of such utilization management policies and the MA organization complies with policies at  422.101(b)(6). We believe there are a number of differences between step therapy for Part B drugs and guidelines for non- drug items and services that require another item or service be furnished prior to receiving the requested item or service. From a clinical standpoint, there tends to be more than one drug that has demonstrated success in treating a certain disease or condition, and also there are generic alternatives, which is somewhat different than other Part A and B services. Additionally, as discussed in the proposed rule, we believe that  422.136 can put MA organizations in a stronger position to negotiate lower pharmaceutical prices with drug manufacturers, reducing the cost sharing and potentially other out of pocket costs like premiums or costs for other benefits for MA enrollees. Reducing drug costs for beneficiaries remains a top concern of CMS. Additionally, as stated in the 2019 rule (84 FR 23856), MA plans have been and remain subject to the MA regulations and must comply with national and applicable local coverage determinations. Step therapy protocols for part B drugs cannot be stricter than an NCD or LCD with specified step therapy requirements. We believe that this interpretation of  422.136 is consistent with this rule. We acknowledge the concerns about the potential for step therapy programs for Part B drugs to deviate from existing clinical guidelines and peer-reviewed supporting evidence, but believe that  422.136 adequately addresses this. Per  422.136(b)(5), the P&T committee used by an MA plan to review and approve its Part B step therapy programs must base clinical decisions on the strength of scientific evidence and standards of practice, including assessing peer- reviewed medical literature, pharmacoeconomic studies, outcomes research data, and other such information as the P&T committee determines appropriate. Similarly, we believe existing MA regulations adequately address disclosure of Part B step therapy policies to beneficiaries before enrollment. Per  422.136(a)(2), MA organizations must have policies and procedures to educate and inform providers and enrollees of any Part B step therapy program used by the MA plan. Per  422.111(b)(2), MA plans are required to disclose accurate information about benefits coverage, including applicable conditions and limitations on benefits coverage. MA plans that apply step therapy to Part B drugs must disclose that Part B drugs may be subject to step therapy requirements in the plans Annual Notice of Change (ANOC) (when initially adopted or subsequently changed) and Evidence of Coverage (EOC) documents as part of their obligations under  422.111 (84 FR 23854). As to the recommendation that CMS prohibit MA plans from requiring an off-label Part B drug when an on- label is available, we did not propose this additional limitation to the existing rule at  422.136(c). Step therapy for Part B drugs regulations at  422.136(c), state that an MA plan may include a drug supported only by an off-label indication in step therapy protocols only if the off-label indication is supported by widely used treatment guidelines or clinical literature that CMS considers to represent best practices. This type of substantive change in the regulation would require additional rulemaking; we may consider this issue as part of future policy development but currently believe that the reasons for adopting  422.136(c) are sufficient (See 84 FR 23855 and 23863). Finally, in response to this recommendation that we adopt certain Part D oversight methods and apply them to Part B drug step therapy programs, we did not propose any changes to  422.136, thus we cannot finalize any of these recommendations in this rule. However, we will continue to monitor step therapy for Part B drug programs in MA and will consider these recommendations in any future rulemaking on this subject. Comment: Some commenters expressed concerns about the OIG report. One commenter stated that the study only looked at 250 denials during a short time period and thus was not enough to indicate a complete understanding of the use and impact of prior authorization in Medicare Advantage. This commenter also asserted that a Kaiser Family Foundation (KFF) study,107which used CMS data, presented different findings from the OIG report and thus does not demonstrate a problem with prior authorization in MA. Another commenter stated that the OIG report stated that among payment requests that were denied, 18 percent met Medicare coverage rules and MAO billing rules and that most of the payment denials in their sample were caused by human and system processing errors. This commenter asserted that the findings of the report were based on human error and that as the proposal does not focus on issues related to human error, it will have a limited impact. Another commenter stated that the OIG report highlighted a small percentage of denials and thus CMS proposals based on the report will have a limited impact. Response: We thank commenters for their comments. The OIG report found that, among the prior authorization requests that MA organizations denied, 13 percent met Traditional Medicare coverage rules and that these services likely would have been approved for these beneficiaries under Traditional Medicare. This is an important finding and we believe that modification of MA coverage rules is appropriate and necessary to ensure MA enrollees have access to Part A and B services as required by the Medicare statute. In response to the comment that the OIG report was too limited to make any broad statements about MA, we note that a Health Affairs study108came to similar conclusions and similarly found that 15 percent of denials were tied to additional plan coverage criteria. Thus, we do not believe that the OIGs findings, as detailed in their report, are isolated. With respect to the differences between the KFF and OIG studies, we note that different data and methods were used. The KFF study analyzed data from the CMS 2021 Parts C and D Reporting Requirements Public Use File (PUF).109These data represent a contract-level reporting of, among other things, all Part C Organization Determinations and Reconsiderations for the 2021 coverage year. In other words, these data are reported at a high level and only account for the number of appeals for each contract that are at a particular stage in the appeals process.110As KFF noted in their presentation regarding the data limitations, Medicare Advantage insurers are not required to indicate the reason a denial was issued in the reporting to CMS, such as whether the service was not deemed medically necessary, insufficient documentation was provided, or other requirements for coverage (such as trying a more basic VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00086 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222205 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 111https://www.kff.org/medicare/issue-brief/over- 35-million-prior-authorization-requests-were- submitted-to-medicare-advantage-plans-in-2021/. 112https://oig.hhs.gov/oei/reports/OEI-09-18- 00260.pdf. 113https://oig.hhs.gov/oei/reports/OEI-09-18- 00260.pdf. 114https://oig.hhs.gov/oei/reports/OEI-09-18- 00260.pdf. service first) were not met.111Thus, the CMS Reporting Requirements in the PUF do not account for more granular and detailed data that one would find in the full case record for each determination, including medical records and a medical necessity review conducted by a physician. By contrast, the OIG study did include reviews by health care coding experts and the clinical reviews by physicians from the case records studied.112Therefore, we believe the OIG study presents appropriate and sufficient evidence regarding the reasons for MA coverage denials and how they differ from coverage policy in Traditional Medicare. In response to the assertion that the OIG report found that denials were based on human error, we note that the OIG report stated that among the payment requests that MAOs denied, 18 percent met Traditional Medicare coverage rules but that many of the payment denials in their sample were caused by human error during manual claims-processing reviews as well as system processing errors. This statement was made in regards to payment denials, not prior authorization requests. Prior authorization requests and payment requests are not the same as described by OIG in the report.113 Prior authorization requests are made to receive authorization for certain services before the MAO will provide coverage and payment where payment requests are made to receive reimbursement for services that the providers have already delivered to beneficiaries.114The OIG report attributed human errors to payment requests specifically and we do not believe that is a basis to dismiss the totality of the OIG report findings and the concerns raised about whether MA plans are furnishing, arranging for, and paying for Part A and B benefits for their enrollees. Finally, while we believe the OIG findings are significant, even if only a few MA organizations are using more restrictive criteria than used in Traditional Medicare, it is important to codify clearer rules on how coverage of Part A and B benefits must be covered and furnished in the MA program 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. Comment: We received some comments requesting that CMS delay the implementation date of all the UM related provisions in this rule, including the new prior authorization requirements at  422.138. These commenters requested that CMS delay the implementation date to 2026 to better align with the requirements in the Interoperability rule (87 FR 76238). Response: We thank commenters for their suggestions. We believe that many coordinated care plans are already using prior authorization to confirm diagnoses or other medical criteria, to determine medical necessity of basic benefits, and to ensure the clinical appropriateness of supplemental benefits as proposed at the new  422.138(b)(1) through (3). Therefore, we do not believe that these requirements present such burden that they should be delayed. In regards to basic benefits, these requirements state that prior authorization may only be used to confirm diagnosis or other medical criteria that are the basis for coverage determinations for the specific item or service and to ensure that an item or service is medically necessary based on the new standards specified in  422.101(c)(1). However, we believe providing further clarification to coordinated care plans on how Parts A and B benefits should be covered and furnished, including the appropriate role or prior authorization, is necessary. We believe it is important to implement these rules as soon as possible. After careful consideration of all comments received, and for the reasons set forth in the final rule and in our responses to the related comments in sections III.E.3 of this final rule, we are adopting the new regulation at  422.138 substantially as proposed with minor modifications to clarify the text. Specifically, we are including that prior authorization processes include all policies and procedures used in prior authorization unless otherwise noted. 4. Continuity of Care In addition to the requirements of section 1852(d) of the Act,  422.112(b) requires MA organizations that offer coordinated care plans to ensure continuity of care and integration of services through arrangements with contracted providers. Requirements in  422.112(b)(1) through (b)(7) detail specific arrangements with contracted providers by which MA coordinated care plans are to ensure effective continuity and integration of health care services for their enrollees. This includes requiring MA coordinated care plans to have policies and procedures that provide enrollees with an ongoing source of primary care, programs for coordination of plan services with community and social services, and procedures to ensure that the MA coordinated care plan and its provider network have the information required for effective and continuous patient care and quality review. a. Stakeholder Feedback Stakeholders have communicated to CMS that MA coordinated care plans prior authorization processes sometimes