evekhm/cms_iom_500 huggingface dataset:
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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
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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
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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
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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
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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
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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 it is reasonable to estimate that 50 percent (Row B) of the existing volume of denials will result in a favorable decision given the enhanced standard of review. In other words, having a physician or other health care professional with expertise in the field of medicine appropriate to the requested service will result in a favorable organization determination decision, thereby reducing the number of cases potentially subject to appeal. In the absence of further information, we believe this a reasonable assumption. We also explicitly note that given that a decision is still unfavorable, even with an expert review, we believe the other percentages (such as the overturn rate and rate of appeals) remains unchanged. Savings: To estimate savings associated with this finalized rulemaking, we note that Table 6 estimates 50 percent of the burden of the current practice and hence the savings is also 50 percent. That is, the numbers in Table 6 in the column with this rules burden estimates are numerically equal to the savings: 16,281 hours (32,563 hr  16,282 hr) and $1,240,688 ($2,481,301  $1,240,688) (Row L). We received no comments on our proposed requirement and burden estimates and are finalizing them as is. 8. ICRs Regarding Strengthening Translation Requirements for Medicare Advantage, Part D, and DSNP Enrollee Marketing and Communication Materials:
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L). We received no comments on our proposed requirement and burden estimates and are finalizing them as is. 8. ICRs Regarding Strengthening Translation Requirements for Medicare Advantage, Part D, and DSNP Enrollee Marketing and Communication Materials: Standing Request for Translated Materials or Materials in Alternate Formats ( 422.2267 and 423.2267) This rule requires that FIDE SNPs, HIDE SNPs, and AIPs translate materials into any languages required by the Medicare translation standard plus any additional languages required by the Medicaid translation standard as specified through their Medicaid capitated contracts. This rule slightly modifies existing policy, so the impact to FIDE SNPs, HIDE SNPs, and AIPs depends upon whether, and to what extent, these plans are already translating materials in ways that would meet this rules requirements. We note that translation requirements vary by State. Therefore, we expect no impact in States where the applicable Medicare and Medicaid translation requirements result in the same outcome. We expect marginal impacts where State requirements result in translation into languages not required by the current MA rules at  422.2267(a)(2) and 423.2267(a)(2). However, even in these States, FIDE SNPs, HIDE SNPs, and AIPs (in combination with their affiliated Medicaid managed care plans) have translators on staff or access them via contractors because of existing Medicare and Medicaid translation requirements. Consistent with our April 15, 2011 final rule (76 FR 21536), (CMS4144F, RIN 0938AQ00), we continue to claim that the Medicare translation requirement is exempt from the requirements of the PRA since the time, effort, and financial resources necessary to comply with this rules translation requirements is a usual and customary business practice (see 5 CFR 1320.3(b)(2)). FIDE SNPs, HIDE SNPs, and AIPs are already required to translate all Medicare materials listed in  422.2267(e) and 423.2267(e) into language(s) required by the Medicare translation standard at  422.2267(a) and meet obligations for translation or interpretation services under 45 CFR 92.101. The requirements we are finalizing as proposed at  422.2267(a)(4)
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the Medicare translation standard at  422.2267(a) and meet obligations for translation or interpretation services under 45 CFR 92.101. The requirements we are finalizing as proposed at  422.2267(a)(4) and 423.2267(a)(4) would require that these Medicare materials also be translated into any additional languages required by Medicaid. Since FIDE SNPs, HIDE SNPs, and AIPs are already translating these Medicare materials for enrollees on their language preferences as part of their usual and customary business practice, the finalized requirements do not establish any new disclosure, information collection, or record keeping requirements. For a full accounting of the translation burden, please see section IX.D.3.b. of this final rule. 9. ICRs Regarding Medicare Advantage (MA) and Part D Communications and Marketing (Subpart V of Parts 422 and 423) The following changes will be submitted to OMB for approval under control number 09381442 (CMS 10837). The control number and expiration date have yet to be issued. The issuance can be monitored at reginfo.gov. The proposed rule mistakenly set out CMS10260 (09381051) as the collection of information requests CMS and OMB identification numbers, respectively. We are correcting that oversight in this final rule. This rule sets forth several changes to the marketing policies in subpart V of parts 422 and 423. Each of these changes will require updates to policies and procedures on the part of a business operations specialist, entailing the addition of a phrase or sentence and, as such, not requiring much time. For this rules reinstatement of the prohibition on MAOs and Part D sponsors marketing outside of their service areas (unless unavoidable), we estimate 30 minutes (0.5 hr) to implement the change to policies and procedures (0.5 hr  $76.20/hr = $38.10). For our reinstatement of the prohibition on sales presentations following educational events, we estimate 15 minutes (0.25 hr) to implement the change to policies and procedures (0.25 hr  $76.20/hr = $19.05). For our reinstatement of the prohibition on distribution and collection of Scope of Appointment and Business Reply Cards by agents at educational events, we estimate
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policies and procedures (0.25 hr  $76.20/hr = $19.05). For our reinstatement of the prohibition on distribution and collection of Scope of Appointment and Business Reply Cards by agents at educational events, we estimate 0.25 hours to implement the change to policies and procedures (0.25 hr.  $76.20/hr = $19.05). For our reinstatement of the prohibition on conducting a sales/ marketing or enrollment meeting with a beneficiary before 48 hours after the beneficiarys initial consent to the meeting (via scope of appointment), we estimate 0.25 hours to implement the change to policies and procedures (0.25 hr  $76.20/hr = $19.05). For the clarification of the requirement of a plan to notify CMS of any agent that fails to adhere to CMS requirements, we estimate 0.5 hours to implement the change to policies and procedures (0.5 hr  $76.20/hr = $38.10). We estimate that this policy change does have burden, however we have no way of estimating the number of agents and frequency of which they will violate CMS requirements. Therefore, we cannot estimate it. For the requirement that agents/ brokers inform beneficiaries that the beneficiaries can obtain complete Medicare information from 1800 MEDICARE, SHIPs, or Medicare.gov, we estimate 12hour to implement the change to policies and procedures (0.5 hr  $76.20/hr = $38.10). For the requirement that agents/ brokers ask a standardized list of questions prior to enrolling the beneficiary in a plan, we estimate 0.5 hours to implement the change to policies and procedures (0.5 hr  $76.20/hr = $38.10). CMS has already developed the questions as part of the Pre-Enrollment Check List. CMS does not require agents/brokers to develop the questions themselves. As the questions were already developed, and the development was by CMS staff, development of the questions does not incur COI burden. For the requirement that agents/ brokers inform beneficiaries of all the plans the agent/broker actually sells, we estimate 0.25 hours to implement the VerDate Sep<11>2014 21:20 Apr
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COI burden. For the requirement that agents/ brokers inform beneficiaries of all the plans the agent/broker actually sells, we estimate 0.25 hours to implement the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00193 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222312 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations change to policies and procedures (0.25 hr.  $76.20/hr. = $19.05). For the changes that clarify the prohibition of the use of the term Medicare or CMSs logos in a way that is misleading or confusing or which misrepresents the plan, we estimate 14 hour to implement the change to policies and procedures (0.25 hr  $76.20/hr = $19.05). Thus, the total one-time burden per contract for these marketing provisions is 3.25 hours (0.5 hr + 0.25 hr + 0.25 hr + 0.25 hr + 0.5 hr + 0.5 hr + 0.5 hr + 0.25 hr + 0.25 hr for the time required to update policies and procedures on the prohibitions of marketing outside the service area, of sales following educational events, of distribution of business cards, as well as the required 48-hour wait time for agents, reporting to CMS delinquent agents, disclosing 800-Medicare, using a standardized list of questions, for agents to notify beneficiaries of all plans they represent, and to avoid misleading use of the Medicare log respectively) at $76.20/hr for a total of $247.65. The aggregate burden across 697 contracts is 2,265 hr (3.25 hr * 697 contracts) at a cost of $172,593 ($76.20/hr * 2,265 hr). 10. ICRs Regarding Medicare Advantage/Part C and Part D Prescription Drug Plan Quality Rating System ( 422.162, 422.164, 422.166, 423.182, 423.184, and
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hr). 10. ICRs Regarding Medicare Advantage/Part C and Part D Prescription Drug Plan Quality Rating System ( 422.162, 422.164, 422.166, 423.182, 423.184, and 423.186) As discussed in section V. of this final rule, this rule adds, removes, and updates certain measures, replaces the current reward factor with a new HEI reward to further incentivize Part C and D plans to focus on improving care for enrollees with specific SRFs, reduces the weight of patient experience/ complaints and access measures, adds a rule for the sub-regulatory removal of Star Ratings measures when a measure steward other than CMS retires the measure, and removes the 60 percent rule that is applied when adjusting Star Ratings for extreme and uncontrollable circumstances (for example, natural disasters like hurricanes or public health emergencies). The HEI is a different way for CMS to analyze existing data and will not increase plan burden. Most of the new measures will be calculated from administrative data and, as such, there will be no increase in plan burden. The other measure-level change we are finalizing in this rule entails moving an existing measure from the display page to Star Ratings, which also will have no impact on plan burden. This rule also sets out a series of technical clarifications related to adjusting Star Ratings for extreme and uncontrollable circumstances and consolidations. The provisions will not change any respondent requirements or burden pertaining to any of CMSs Star Ratings related PRA packages, including: OMB control number 0938 0732 for CAHPS (CMSR246), OMB control number 09380701 for HOS (CMS10203), OMB control number 09381028 for HEDIS (CMS10219), OMB control number 09381054 for Part C Reporting Requirements (CMS 10261), and OMB control number 0938 0992 for Part D Reporting Requirements (CMS10185). Since the provisions will not impose any new or revised information collection requirements or burden, we are not making any changes under any of the aforementioned control numbers. 11. ICRs Regarding the PACE Service Determination Process ( 460.121) The following changes will be submitted to OMB for approval under control number