evekhm/cms_iom_500 huggingface dataset:
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not responding: (1) The passage of the 117th Congress proposed legislation entitled PACE Plus Act (S. 1162/H.R. 6770), PACE Part D Choice Act (S. 5106/H.R. 4941), and Improving Seniors Timely Access to Care Act (S. 3018/H.R. 3173); and (2) Allowing the PACE program to utilize gift cards in marketing. VII. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information, as defined under 5 CFR 1320.3(c) of the PRAs implementing regulations, is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection requirement should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. On December 27, 2022 (87 FR 79452) we solicited public comment on each of these issues for the following sections of the proposed rule (CMS4201P, RIN 0938AU96) that contained information collection requirements. Such comments were received as indicated under ICR #5 (Regarding [the] Clarifications of Coverage Criteria for Basic Benefits and Use of Prior Authorization) and ICR #11 (Regarding the PACE Service Determination Process) in this rule. This final rule is only finalizing some of the provisions of the proposed rule. The remaining provisions may be finalized in subsequent rulemaking. A. Wage Data 1. Wage Changes For the provisions being finalized in this rule, the proposed rules burden estimates are being carried over without change except that the beneficiarys wage is adjusted from $28.01/hr to
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A. Wage Data 1. Wage Changes For the provisions being finalized in this rule, the proposed rules burden estimates are being carried over without change except that the beneficiarys wage is adjusted from $28.01/hr to $20.71/hr. The adjustment is based on internal review as we changed the source of the wage figure from BLS at $28.01/hr to HHS at $20.71/hr. See Wage for Beneficiaries and ICR #2, in this rule. 2. Private Sector Wages To derive average costs, we are using data from the most current U.S. Bureau of Labor Statistics (BLSs) National Occupational Employment and Wage Estimates for all salary estimates (http:// www.bls.gov/oes/current/oes_ nat.htm). In this regard, Table 5 presents BLS mean hourly wage, our estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and our adjusted hourly wage. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00187 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222306 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations As indicated, except for enrollees, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and other indirect costs vary significantly from employer to employer and because methods of estimating these costs vary widely from study to study. We believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. 3. Wage for Beneficiaries We believe that the cost for beneficiaries undertaking administrative and other tasks on their own time is a post-tax wage of $20.71/hr. The Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices identifies the approach for valuing time when individuals undertake activities on their own time. To derive the costs for beneficiaries, a measurement of the usual weekly earnings of wage and salary workers of
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Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices identifies the approach for valuing time when individuals undertake activities on their own time. To derive the costs for beneficiaries, a measurement of the usual weekly earnings of wage and salary workers of $998, divided by 40 hours to calculate an hourly pre-tax wage rate of $24.95/ hr. This rate is adjusted downwards by an estimate of the effective tax rate for median income households of about 17 percent, resulting in the post-tax hourly wage rate of $20.71/hr. Unlike our private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs since the individuals activities, if any, would occur outside the scope of their employment. B. Information Collection Requirements (ICRs) The following ICRs are listed in the order of appearance within the preamble (see sections II. through VI.) of this final rule. 1. ICRs Regarding Applying DSNP Look-Alike Requirements to Plan Benefit Package Segments ( 422.514) This rule adds a new paragraph at  422.514(g) to clarify that the DSNP look-alike contracting limitations at  422.514(d) through (f) apply to segments of the MA plan. This new paragraph will address instances we have seen since adopting  422.514(d) through (f) where a specific segment of an MA plan looks like a DSNP look- alike and would be subject to the contracting prohibitions in  422.514(d) if the segment were treated as an MA plan. We believe that by applying the DSNP look-alike contracting limitations only at the MA plan level without applying it to segments of plans, our existing regulation has an unintended and unforeseen loophole through which DSNP look-alikes could persist, contrary to the stated objectives in our prior rulemaking. Based on January 2022 Monthly Membership Report data, we expect that this rule will result in three MA plan segments being identified as DSNP look-alikes, and these DSNP look- alikes would likely transition the approximately 3,000 current enrollees into another MAPD plan offered by the same MA organization (or by another MA organization with the same parent organization as the MA organization) using the transition process described in
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look- alikes would likely transition the approximately 3,000 current enrollees into another MAPD plan offered by the same MA organization (or by another MA organization with the same parent organization as the MA organization) using the transition process described in  422.514(e). Based on our analysis of proposed DSNP look-alike transitions for contract year 2023, two DSNP look- alikes in contract year 2022 are proposing to transition a combined total of approximately 7,000 DSNP look- alike enrollees into two new non-SNP MA plan segments, which could create two new DSNP look-alikes for contract year 2023. In the June 2020 final rule (85 FR 33877 through 33880), we estimated each DSNP look-alike would take a one-time effort of 2 hours for a business operations specialist to submit all enrollment changes to CMS necessary to complete the transition process. We also stated that, after the prohibition on D SNP look-alikes was implemented, at most five plans per year would be identified as DSNP look-alikes under  422.514(d) due to meeting the enrollment threshold for dually eligible individuals or operating in a State that will begin contracting with DSNPs or other integrated plans. In association with our June 2020 final rule, the requirement and burden estimates (5 respondents, 5 total responses, and 10 total hours) were approved by OMB under control number 09380753 (CMSR267). This rules clarification under  422.514(g) does not change the transition process nor our currently approved burden estimates. Similarly, the addition of non-SNP MA plan segments to the contracting limitations at  422.514 has no impact on our currently approved burden estimates that at most five plans (including PBP segments) per year would be identified as DSNP look-alikes; therefore, the currently approved number of respondents and burden estimates in control number 09380753 would not change. 2. ICRs Regarding Transitional Coverage and Retroactive Medicare Part D Coverage for Certain Low-Income Beneficiaries Through the LI NET Program ( 423.2500 Through  423.2536) The following changes will be submitted to OMB for approval under control number 09381441
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Part D Coverage for Certain Low-Income Beneficiaries Through the LI NET Program ( 423.2500 Through  423.2536) The following changes will be submitted to OMB for approval under control number 09381441 (CMS 10831). OMB will set out an expiration date upon their approval of this final rules new collection of information request. The issuance of the expiration date can be monitored at reginfo.gov. We did not receive any comments specific to the private sector proposed ICRs and, therefore, are finalizing the proposed private sector requirements and burden estimates as is. As previously indicated under Wage Data, we have adjusted the proposed beneficiary wage resulting in adjusted cost estimates under this final rule. As described in section II.D.2 of this final rule, we expect that some beneficiaries will enroll in LI NET using VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00188 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.011</GPH>ddrumheller on DSK120RN23PROD with RULES222307 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations methods that may entail providing information. Some beneficiaries may enroll in LI NET at the point-of-sale (POS) at a pharmacy because: (1) they are likely eligible for the low-income subsidy (LIS), have immediate need for their prescription, and do not have Part D coverage or (2) present documentation with their LIS status at the pharmacy and do not have Part D coverage. Some beneficiaries submit receipts for reimbursement for claims paid out of pocket; if they are eligible for LI NET they will be retroactively enrolled into the LI NET program by the LI NET sponsor. Another way for beneficiaries to potentially enroll into LI NET is by completing an LI NET application form. To estimate the total burden, we consider the burden for enrollees, pharmacists, and Part D sponsors separately. Each consideration entails counting the number of documents arising from point of sale enrollments, direct reimbursement forms, and LI
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estimate the total burden, we consider the burden for enrollees, pharmacists, and Part D sponsors separately. Each consideration entails counting the number of documents arising from point of sale enrollments, direct reimbursement forms, and LI NET application forms. a. Beneficiaries To estimate the information collection burden for beneficiaries, we have estimated the number of beneficiaries submitting information to LI NET and time related to handling the information. We have not included burden estimates for individuals who would not be providing documentation, such as those CMS automatically enrolls into LI NET, individuals whose eligibility for LI NET is confirmed independently by the LI NET sponsor, or for those who opt not to provide evidence. When enrolling in LI NET at POS, possible forms of evidence for LIS eligibility include but are not limited to, a Medicaid card or a letter from the State or SSA showing LIS or Extra Help status. We estimate that it would take an individual approximately 15 minutes (0.25 hr) to gather supporting documentation. There are 36,722 individuals enrolled in the LI NET demonstration at POS in 2021 who applied at the point of sale. Based on our experience with the LI NET demonstration, we estimate approximately 250 beneficiaries would submit receipts for reimbursement for claims paid out of pocket. These beneficiaries may complete a direct reimbursement request form available online, and return by mail, email, or fax, together with their receipt, to the LI NET sponsor. In the LI NET demonstration, approximately ten beneficiaries per year completed the LI NET application form, which is available online, and returned it to the LI NET sponsor by mail, email, or fax. Thus, in total we expect 36,982 beneficiaries (36,722 at point of sale plus 250 through direct reimbursement plus 10 applying via the LI NET application form) to spend 15 minutes (0.25 hr) resulting in an aggregate burden of 9,246 hours (36,982 enrollees * 0.25 hr) at an aggregate cost of $191,485 (9,246 hr * $20.71/hr). b. Private Sector (Pharmacists) We estimate that it will take 2 minutes (0.0333 hr) for a pharmacy to fax the documentation to the LI NET sponsor.
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hr * $20.71/hr). b. Private Sector (Pharmacists) We estimate that it will take 2 minutes (0.0333 hr) for a pharmacy to fax the documentation to the LI NET sponsor. However, pharmacists will not process the forms of enrollees who use direct reimbursement or the LI NET application form. Thus, pharmacists will only process the 36,722 enrollees at point of sale. Thus, the aggregate burden for pharmacists is 1,223 hours (36,722 enrollees * 0.0333 hr) at an aggregate cost of $147,812 (1,223 hr * $120.86/hr). c. Part D Sponsors The Part D sponsors will process the documents received from all 36,982 enrollees. Part D sponsors are estimated to spend about 2 minutes (0.0333 hr) to process information from point of sale, direct reimbursement requests, and application forms. Thus, the aggregate burden for Part D sponsors is 1,232 hours (36,982 enrollees * 0.0333 hr) at an aggregate cost of $93,878 (1,232 hr * $76.20/hr). 3. ICRs Regarding Adding New Behavioral Health Specialty Types Subject to Network Adequacy Evaluation ( 422.116) The following changes will be submitted to OMB for approval under control number 09381346 (CMS 10636). To ensure that MA enrollees have access to provider networks sufficient to provide covered services, including behavioral health service providers, this rule adds new specialty types that will be subject to network adequacy evaluation under  422.116. This rule adds Clinical Psychology and Clinical Social Work under  422.116(b)(1). However, we are not finalizing our proposed addition of the Prescribers of Medication for Opioid Use Disorder specialty type. Section 1262 of Division FF of the Consolidated Appropriations Act of 2023 (CAA) (Pub. L. 117328) amended section 303(g) of the Controlled Substances Act to remove the statutory requirement for providers to obtain a valid waiver from SAMHSA and the DEA to administer, dispense, or prescribe MOUD. Therefore, we will not be finalizing this portion of our proposal. Because we planned to use
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the statutory requirement for providers to obtain a valid waiver from SAMHSA and the DEA to administer, dispense, or prescribe MOUD. Therefore, we will not be finalizing this portion of our proposal. Because we planned to use SAMHSAs list of waivered providers to populate the Provider Supply file, we are no longer able to accurately track the providers that prescribe medications like buprenorphine in order to create and maintain a network adequacy standard. We have determined that there is no cost for MA organizations in regards to reporting new specialty types to CMS for their network adequacy reviews as this rule requires. However, we have determined that there is a minimal one- time cost for MA organizations to update their policies and procedures associated with this rule. First, regarding reporting the proposed new specialty types to CMS, MA organizations are already conducting ongoing work related to network adequacy reviews that happen during the initial or service area application, or every three years for the triennial review. Further, organizations should already have these specialty provider types within network, as these are services covered by Medicare Part A and B and which are furnished by these specialty types, so there is no burden related to contracting with new provider types. This will only require that the specialty types be added to the Health Services Delivery (HSD) tables during any network adequacy evaluation requested by CMS. As determined by our contractors, the time to conduct tasks related to adding additional specialty types on the HSD tables is negligible. We understand that MA organizations will need to update their policies and procedures related to submission of HSD tables to ensure that the new required behavioral health specialty types are included. We estimate that a business operations specialist working at an hourly wage of $76.20/hr will take 5 minutes (0.0833 hr) for a one-time update of policies and procedures related to this task, at a cost of $6.35 (0.0833 hr * $76.20/hr). The aggregate burden is 62 hours (742 MA contracts * 0.0833) at a cost $4,724 (62 hr. * 76.20/ hr). We did not receive any comments specific to the proposed ICRs and, therefore, are finalizing the proposed requirements and burden estimates as is. 4. ICRs Regarding Enrollee Notification Requirements for Medicare Advantage (MA) Provider Contract
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hr). We did not receive any comments specific to the proposed ICRs and, therefore, are finalizing the proposed requirements and burden estimates as is. 4. ICRs Regarding Enrollee Notification Requirements for Medicare Advantage (MA) Provider Contract Terminations ( 422.111 and 422.2267) The following changes were submitted to OMB for review under control number 09380753 (CMSR 267). VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00189 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222308 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations As described in section III.D. of this final rule, we are revising: (1)  422.111(e) 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; and (2)  422.2267(e)(12) to specify the requirements for the content of the notification to enrollees about a provider contract termination. We are finalizing this provision as proposed with some modifications based on public comment. We are modifying the proposed changes to  422.111(e) by requiring only one telephonic notice attempt to enrollees who have not opted out of plan calls and by specifying a three-year lookback period to determine which enrollees of terminating primary care and behavioral health providers must be notified. However, these modifications have no impact on our proposed burden estimates. This amendment to  422.111(e) and 422.2267(e)(12) impacts MA organizations in terms of the burden required to identify those enrollees who must be notified of provider contract terminations per CMS requirements, to develop and send the required written notices, to develop the scripts for the required telephonic notices, and to make the required enrollee telephone calls. However, CMS does not currently collect data regarding the widely variable number of provider contract terminations an MA organization undergoes in a given contract year, nor the number of enrollees affected by
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notices, and to make the required enrollee telephone calls. However, CMS does not currently collect data regarding the widely variable number of provider contract terminations an MA organization undergoes in a given contract year, nor the number of enrollees affected by each termination. Therefore, in the proposed rule, we did not have information that would have allowed us to estimate the extent of MA provider contract terminations, how many enrollees are affected and need to be notified per  422.111(e), or how the MA program will be impacted as we see the effects of this regulation. Although we solicited comment, we received no comments to help us derive such estimates. The actual direct burden of this provision arises from MA organization staff hours spent, resources purchased, and enrollee notifications provided. MA organizations may also differ in how their spending for the requirements evolves over time as they test strategies and redevelop their approaches to complying with the regulation. Despite our inability to quantify certain burden for this provision, we were able to estimate the one-time burden on MA organizations to update their existing written provider termination notice in compliance with the new required notice content that we are finalizing at  422.2267(e)(12)(ii). We stated in the proposed rule that we expect MA organizations to engage in some routine software development to update their notice template and related systems to incorporate the new requirements, which will be delineated in a provider termination model document developed by CMS staff (thus not incurring COI burden). This proposed model was posted for public review and comment in conjunction with the proposed rules 09380753 ICR. We estimated that one 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
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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