2023-07115.pdf

while developing UM policies and procedures, and remind plans that under  422.202(b)(2), MA organizations must communicate information about practice guidelines and UM policies to providers and, when appropriate, to enrollees. Comment: Many commenters stated they would be supportive of requiring an UM committee to ensure, as required by  422.202(b)(2), that an MA organization communicates information about practice guidelines and UM policies to providers and, when appropriate, to enrollees. One commenter suggested amending  422.202(b)(1)(iii) to state MA plan practice guidelines and UM guidelines must be developed in consultation with contracting physicians or practitioners. Response: CMS thanks all commenters for their input. CMS will continue to monitor compliance with the existing obligations under  422.202(b) and with  422.137 as finalized and consider this requirement for future rulemaking. We believe the request to amend  422.202(b)(1)(iii) is outside the scope of this proposal and that the existing requirements on this issue and on incorporating adequate information about clinical practices are sufficient in light of other amendments in this final rule regarding coverage criteria, medical necessity determinations and use of utilization management policies. Comment: Many commenters were supportive of a requirement for the UM committee to have an ongoing or active oversight role in ensuring that decisions made by an MA plan throughout the year are consistent with the final, approved practice guidelines and UM policies. A few commenters expressed concern that this requirement could be administratively burdensome on the UM committee. One commenter suggested that the UM committee be required to engage in internal oversight of plan operations, including randomized audits, assessment of rates of and reasons for denial, and duration of time between denials issued. Another commenter suggested that the UM committee review appealed cases and caseloads to determine whether MA plan operations are complying with the relevant requirements so as to not unduly burden provider, MA plan, and the Office of Medicare Hearings and Appeal resources through unnecessary appeals. Another commenter suggested the UM committee conduct retroactive review of organization determinations throughout the year and assess whether the approved practice guidelines and UM policies are being followed. Another commenter suggested a regulatory revision that would require the UM committee to . . . undertake appropriate diligence and oversight to ensure that the MA plans coverage or medical necessity decisions under any UM policy are consistent with such policy and any revisions to it made by the UM committee. One commenter suggested revising proposed  422.137(d)(1)(i) to read as follows: The services to which the utilization management applies, including the total number of cases or requests reviewed under a specific policy being reviewed, the number of approvals for cases or requests under such policy, the number of denials for cases or requests under such policy, and a review of a subset of patient determinations whose cases were denied under such policy, based on the most recent 6 months of data and information available. Response: CMS appreciates the feedback received and will take it into consideration for future rulemaking. Because MA plans are required to follow the relevant coverage criteria and other requirements pertaining to the use of utilization management adopted in this rule, CMS does not believe it is necessary to require the UM committee to have an ongoing or active oversight role in ensuring that decisions made by an MA plan throughout the year are consistent with the final, approved practice guidelines and UM policies at this time. CMS encourages MA plans to involve the UM committee in such decisions to the extent practicable. Comment: Several commenters expressed concern over how proposed  422.137 will be enforced, as well as who will be responsible for enforcement. One commenter suggested that CMS require regular submission of committee determinations and associated documentation to CMS to allow for CMS audit and oversight. Another commenter suggested CMS conduct ongoing audits throughout the year to ensure decisions made by the MA plan are in line with the final approved guidance from the UM committee Response: CMS currently monitors MA plan compliance through account management activities, complaint tracking and reporting, and auditing activities. These oversight operations alert CMS to any issues with access to care and plan compliance, and CMS may require MA plans to address these matters if they arise. We intend to use these oversight operations to ensure MA organizations comply with the final rule. Further,  422.137(d)(5) requires the UM committee to document in writing the reason for its decisions regarding the development of UM VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00096 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222215 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations policies and make this documentation available to CMS upon request. CMS may request and review such documentation as part of its monitoring and oversight. Comment: CMS solicited comment regarding whether the proposed regulation text sufficiently and clearly establishes the standards and requirements discussed in the proposed rule. A few commenters requested that the regulations should establish a clear process to ensure transparency with stakeholders, including posting detailed meeting minutes and policies to websites, making the composition of the committee available to the public, and mandating regularly scheduled meetings. Additionally, several commenters requested that there be an opportunity for the public to provide input and comment on UM policies and procedures to ensure transparency and clinician engagement. Several commenters suggested that the UM committee be required to meet and/or review and revise UM policies and procedures more frequently than annually. One commenter suggested that the committee be required to revise UM policies and procedures at any time. Another commenter stated that policies should remain active during the review period. A few commenters suggested that the UM committee participate in the development of UM policies and procedures. One commenter suggested that the UM committee conduct quarterly or bi- annual reviews of UM policies and programs and their effects on organizational determinations, patient access and clinical validity. One commenter suggested the committee annually update its list of novel therapies and make available to the public the clinical literature and research linked to treatment criteria. A few commenters suggested that CMS revise the regulatory text to require that the clinical members of the UM committee be appropriately licensed and skilled physicians or other qualified health care providers opposed to practicing physicians. Response: CMS appreciates the feedback received. While  422.137, as proposed and finalized, requires that prior authorization policies and procedures be reviewed and approved at least annually by the UM committee, the regulation does not prescribe the frequency with which the committee is required to meet or prohibit UM committees from reviewing policies more frequently to address changes in clinical guidelines, coverage criteria, or similar considerations. CMS believes there is value is giving flexibility to UM committees to review UM polices more frequently than once a year, and acknowledges that more frequent meetings are likely warranted. The minimum requirement is that the relevant policies be reviewed and approved annually. We intend to take the feedback from commenters into consideration for future policy development. Comment: Several commenters addressed the documentation requirements for the UM committee, including that the UM committee must document in writing the reason for its decisions regarding the development of UM policies and make this documentation available to CMS upon request. Several commenters requested that the regulation establish a clear process to ensure transparency with stakeholders, including posting detailed meeting minutes and policies to websites, and making the composition of the committee available to the public. Commenters also stated that MA plans do not regularly release minutes from P&T meetings in a timely manner, and that when these minutes are released, they do not contain detailed information. Several commenters requested that CMS require UM criteria documents to be publicly posted. One commenter requested that such documents should not be required to contain a detailed summary of each piece of evidence considered or rationale for adopting the policy due to potentially containing proprietary information. Response: CMS thanks commenters for their feedback. As outlined in the preamble, MA organizations must make relevant documentation available to CMS upon request. The documentation should provide CMS with an understanding of the UM committees rationale for their decision, and may include, but is not limited to, information such as meeting minutes outlining issues discussed and any relevant supporting documentation. Supporting documentation could include relevant coverage criteria that comply with  422.101 that was relied on in the decision-making process. As to P&T committee documentation,  422.136(b)(9) requires that MA plan P&T committees document their decisions regarding the development and revision of step therapy programs and to make that documentation available to CMS upon request; we appreciate the commenters concerns that information is not always made available publicly or with regularity. Should an MA organization use a P&T committee to fulfill the requirement of the UM committee, that committee must meet all of the requirements outlined in  422.137, which includes the requirement to make documentation available to CMS upon request. We will consider these comments for future rulemaking. Comment: Many commenters supported implementing a requirement for the UM committee to review all internal coverage criteria used by the MA plan. Some commenters expressed opposition to the proposal and to any requirement that the UM committee review all internal coverage criteria used by the MA plans, citing that many MA plans have separate committees tasked with reviewing UM policies and coverage criteria. One commenter requested clarification as to which policies and procedures the UM committee is required to review. Response: Per  422.137(d), as proposed and finalized, the UM committee is responsible for reviewing UM policies and procedures used by the MA plan(s) served by the committee. The UM Committee must approve only UM policies and procedures that use and are consistent with the relevant coverage criteria that comply with  422.101 and other applicable regulations. In addition, the UM committee is charged with making any needed revisions to such policies and procedures to ensure that the standards in  422.137(d)(1) and (2) are met. Such revisions should be made expeditiously when inconsistencies are identified. Comment: Some commenters requested flexibility in the requirements regarding the composition of the UM committee, specifically the requirement that the committee include various clinical specialties, because of potential operational challenges, including that the conflict of interest requirement be removed. Many commenters requested that specific provider types be explicitly required for the committee, including but not limited to: Nurse practitioners; physical therapists; chiropractors; integrative medicine providers; pharmacists; clinicians with skilled nursing facility experience; nonphysician care team members; and case management professionals. A few commenters suggested that physician committee members be members of the American College of Physician Advisors, board certified through board of medical specialists or American Board of Medical Specialties. Many commenters supported the inclusion of an enrollee representative. One commenter suggested that more than one provider should be free from conflict, and another commenter suggested that members should have to VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00097 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222216 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 116https://www.merriam-webster.com/dictionary/ expert. annually attest to being free from conflict. Response: CMS appreciates the feedback received and will take it into consideration for future rulemaking. We believe the proposed composition requirements are sufficient because they represent a diverse group of medical professionals, with the relevant expertise necessary to fulfil the regulatory requirements. Requiring additional specific provider types or specialties could end up limiting the committee composition, and that there is value in allowing plans the flexibility to determine which providers should be represented. Further,  422.137(c)(4) requires that the committee include members representing various clinical specialties to ensure that a wide range conditions are adequately considered in the development of the MA plans utilization management policies. We believe this requirement will ensure that a diverse range of specialists are represented. Section 422.137(c)(2) requires that at least one physician be independent from the MA plan and free of conflict. We believe this is sufficient because the other requirements for the UM committee clearly establish the parameters in which the UM committee must review and approve UM policies and procedures, and therefore additional independent committee members are not necessary to ensure appropriate decisions are being made. We encourage plans to include an enrollee representative on the UM committee as we believe enrollee representation will add a valuable perspective to the review process. Comment: Many commenters supported having a specialist with expertise in the particular item or service that is subject of the UM policy and procedure under review by the UM committee be involved in that review. A few commenters suggested that there should be specialty-focused subcommittees or workgroups to ensure appropriate expertise is represented. One commenter suggested that the UM committee be required to seek outside assistance when the committee does not have expertise in a certain area. Response: CMS appreciates the feedback received and will take it into consideration as part of future policy development. We believe that the requirements in  422.137(d)(1) and (2) that set the standards for the review by UM committees, including that utilization management policies comply with  422.101(b) (which includes compliance with Traditional Medicare coverage rules and limits on MA plan internal coverage criteria) and that the committee review relevant current clinical guidelines, are sufficient to ensure that appropriate evidence is reviewed and relied upon by the committee during its annual (or more frequent) review of utilization management policies. Therefore, we are not adopting an additional requirement for the UM committee to have specialty focused subcommittees and workgroups. We are not finalizing an additional requirement for participation or involvement by a specific specialty provider or health care provider with expertise related to each individual UM policy. We believe that is unnecessary because, as previously noted, all utilization management policies must comply with  422.101(b), which requires any permissible internal coverage criteria must be based on current evidence in widely used treatment guidelines or clinical literature. 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. Therefore, we do not believe