2023-07115.pdf

or two software developers working at a wage of $92.92/hr will spend a total of 8 hours updating an MA organizations existing provider termination notice template and related systems based on CMSs model. With approximately 697 MA organizations impacted by this change, this results in a total of 5,576 hours (697 MA organizations * 8 hours), at an aggregate cost across all MA organizations of $518,122 (5,576 hours * $92.92/hr). In the proposed rule, we were unable to estimate the burden for the telephonic notice requirement at  422.111(e)(1)(i) and 422.2267(e)(12)(iii) because the number of primary care and behavioral health provider contract terminations an MA organization undergoes in a given contract year is unknown, as are the number of affected enrollees per termination. We did not receive any comments related to our projected burden estimates for this provision, therefore, we are finalizing the proposed burden without change. 5. ICRs Regarding Clarifications of Coverage Criteria for Basic Benefits and Use of Prior Authorization ( 422.101) The following changes be submitted to OMB for approval under control number (09380753) (CMSR267). As explained in section III.E. of this rule, MA plans must comply with national coverage determinations (NCD), local coverage determinations (LCD), and general coverage and benefit conditions included in Traditional Medicare statutes and regulations when making medical necessity determinations. Under this rule, MA plans must follow Traditional Medicare coverage criteria as specified in NCDs, LCD, or Medicare laws (that is, in Medicare statutes and regulations). Additionally, MA organizations may create internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs. This rule also provides that when creating these internal policies, MA organizations must provide in a publicly accessible way: the internal coverage criteria in use and a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination, which includes, when applicable, identifying the general provisions that are being supplemented or interpreted and explaining how the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. We expect that each plan will have new policies that they create annually. We believe that the public accessibility of a plans internal coverage criteria, a summary of evidence that was considered; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria will require 16 hours per contract. We believe this is an adequate estimate of time needed for a business operations specialist to make all postings. Thus the per contract burden is 16 hours at a cost of $1,219 (16 hr * $76.20) and the aggregate burden over 697 contracts is 11,152 hours (697 contracts * 16 hr/contract) at a cost of $849,782 (11,152 hr * $76.20/hr) We invited stakeholder comment on all aspects of this proposal. More specifically, we questioned (1) is our assumption that plans are already complying with the requirement of creating new guidance correct? (2) is our assumption of 16 hours annually sufficient? (3) Are there any other aspects of this proposal or its estimates upon which stakeholders have comments? Comments were received. Some commenters stated that publicly posting a summary of evidence considered during the development of the criteria would require significant administrative effort. However, we did not receive specific comments on our estimates and are therefore finalizing our burden estimates for public posting of guidance as proposed. However, the stakeholder comments of increased administrative burden are consistent with our statement in the preamble and RIA, that due to its complexity and many unknowns we cannot quantify the burden of the requirement to create new policies when existing guidance does not exist. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00190 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222309 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 6. ICRs Regarding Utilization Management (UM) Committee ( 422.137) The following changes will be submitted to OMB for approval under control number 09380964 (CMS 10141) (reference to this package was inadvertently left out of the proposed rule). We are correcting that oversight in this final rule. This rule adds protections to help ensure that beneficiaries maintain access to medically necessary Part A and B services and drugs, while permitting MA plans to use utilization management tools, such as prior authorization. This rule requires that MA plans establish and use a committee (similar to a P&T committee) that reviews UM policies annually to ensure the policies are consistent with current traditional Medicare coverage and guidelines in Medicare statutes and regulations, NCDs, and LCDs. This final rule also requires that the committee review all medical services that require PA and other utilization management policies, at least on an annual basis and to document their findings. Additionally, the committee will be responsible for revising and updating the MA plans utilization management policies as needed. In this rule, 422.137(c)(1) through (4) specifies that the UM committee must clearly articulate and document processes to determine that the committee membership requirements under 422.137(c)(1) through (4) have been met, including the determination by an objective party of whether disclosed financial interests are conflicts of interest and the management of any recusals due to such conflicts. We estimate it would take 1 hour at $76.20/hr for an UM Committee business specialist to perform the tasks enumerated in the previous paragraph and review and retain documentation and information on an annual basis. Additionally, at  422.137(d)(4) and (5) specifies that the 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. We estimate that it will take 2 hours at $76.20/hr for a UM Committee business specialist to capture and retain this required documentation on an annual basis. In aggregate, the burden for 697 MA plans is 2,091 hours (697 plans * 3 hr) at a cost of $159,334 (2,091 hr * $76.20/ hr). We did not receive any comments related to our proposed provisions and projected burden estimates. Consequently, we are finalizing the proposed provisions and burden without change. 7. ICRs Regarding Review of Medical Necessity Decisions by a Physician or Other Health Care Professional With Expertise in the Field of Medicine Appropriate to the Requested Service ( 422.566 and 422.629) The following changes will be submitted to OMB for approval under control number 09380753 (CMSR 267). In section III.G. of this final rule, we are finalizing the proposal to strengthen the current requirement at  422.566(d) and 422.629(k)(3) for who must review an organization determination or an integrated organization determination when the MA organization or AIP expects to issue a partially or fully adverse medical necessity decision. Under this new requirement, the reviewing physician or health care professional must have expertise in the field appropriate to the requested service. This requirement will also apply to coverage denials from section 1876 cost plans and healthcare prepayment plans because  417.600 and 417.840 require those plans to comply with the requirements in the MA regulations regarding organization determinations. As stated in the proposed rule, we do not believe this requirement imposes additional staffing burden on plans. In light of existing review requirements applicable to organization determinations and integrated organization determinations, coupled with the requirements at  422.152 for MA plans (including AIPs) to engage in ongoing quality improvement (including in processing requests for initial or continued authorization of services) and the contract requirement provisions at  422.504, we believe plans already have the requisite expertise in staffing to satisfy this requirement. The requirement that the physician or other appropriate health care professional have expertise in the field appropriate to the requested service may at most result in plans reallocating staff resources in certain cases to ensure that someone with appropriate expertise is reviewing the request; however, we dont believe that this requirement will require additional staffing for MA organizations and AIPs. This requirement is expected to yield savings due to fewer denied organization determinations getting into the appeals process as a result of enhanced medical necessity review by appropriate experts. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00191 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222310 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations To estimate these savings we considered the following: Number of unfavorable pre-service organization determinations: The 2022 CMSR267 reports 1,786,733 (Row C of Table 6) which equals 5.7 percent (Row B), (the percent of unfavorable pre- service organization determinations), times 31,346,194 (Row A) (the total number of pre-service organization determinations.) We re-examined the underlying 2020 MA plan reported data and still believe this to be correct. You can find this computation in rows AC of Table 6. Number of unfavorable pre-service organization determinations that are appealed. The 2022 CMSR267 comes up with 431 per plan or 242,653 appealed pre-service organization determinations. This number appeared excessively low to us. Additionally, this number was derived in the 2022 CMS R267 by taking 5% * 20% * 24,279,575. There is no documentation explaining the percentages or the number. Accordingly, we re-examined the underlying 2020 MA plan data. The aggregate percentage of unfavorable pre- service organization determinations that are appealed is 9 percent (Row D). Using this we calculate 160,806 (Row E) appealed unfavorable decisions (0.09 * 1,786,733). We note that 160,806 is in the ballpark of the 242,795 used in the 2022 CMSR267 package but as noted the documentation for the calculations is not presented and a reexamination of the data gives 160,806. Accordingly, we are correcting that number from the CMSR267 package in the base we use for impact. These calculations are also conveniently summarized in Table 6 in rows CE. Percent of appeals resulting in an overturn: The CMSR267 package uses a figure of 75 percent. However, upon reexamination of the same underlying data we found the percentage to be 81 percent (Row F). We believe the 81 percent is more accurate and are therefore correcting the base figures on which we base our impact. We note that in this Collection of Information Section we are basing all numbers on aggregate percentages from total appeals rather than the approach used in the CMSR 267 package which was based on the per-plan percentage. The process of using per-plan may result in unintended approximations which may account for some of the inaccuracies discovered. Time for a single appeal notification: The CMSR267 package lists 4 hours as the time necessary to totally process an appeal including notification. The amount of time from this 4 hours targeted specifically to notification is not listed in the package. We believe 15 minutes (Row H) (0.25 hr) is an adequate and reasonable allocation of time for notification. This requirement has no impact on the time required for an appeal notification. The calculations are summarized in Table 6 and are summarized as follows. As just explained, according to 2020 MA plan reported data, 1,786,733 (5.7 percent of all 31,346,194 Medicare pre- service organization determination decisions) are unfavorable coverage decisions (the decision is fully or partially unfavorable to the enrollee). Of this universe of unfavorable pre-service organization determinations, 160,806 cases (9 percent * 1,786,733) are appealed and subject to reconsideration by the plan. Of the cases reviewed on appeal, 130,253 cases (81 percent * 160,806 cases) of the reconsiderations resulted in a plan overturning its unfavorable organization determination (Rows AG of Table 6). Thus, the total burden is 32,563 hr (Row I) (130,253 cases * 0.25 hr/case) at a cost of $2,481,317 (Row K) (32,563 hr * $76.20/hr for a business operations specialist). While we dont know with certainty what the reduction in existing denied organization determinations will be under this new requirement, we believe VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00192 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.012</GPH>ddrumheller on DSK120RN23PROD with RULES222311 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations