evekhm/cms_iom_500 huggingface dataset:
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in this final rule, are expected to include the costs of compliance in their bids, thus avoiding additional burden, since the cost of complying with any final rule is funded by payments from the government and, if applicable, enrollee premiums. For the insurance plans classified in category Direct Health and Medical Insurance Carriers, NAICS 524114, which include MA plans, Part D sponsors, standalone PDPs, and PACE plans, the plans estimate their costs for the upcoming year and submit bids and proposed plan benefit packages. Upon approval, the plan commits to providing the proposed benefits, and CMS commits to paying the plan either(1) the full amount of the bid, if the bid is below the benchmark, which is a ceiling on bid payments annually calculated from original Medicare data; or (2) the benchmark, if the bid amount is greater than the benchmark. If an MA plan or Part D sponsor bids above the benchmark, section 1854 of the Act requires the MA plan to charge enrollees a premium for that amount. Historically, only 2 percent of plans bid above the benchmark, and they contain roughly 1 percent of all plan enrollees. The CMS threshold for what constitutes a substantial number of small entities for purposes of the RFA is 3 to 5 percent. Since the number of plans bidding above the benchmark is 2 percent, this is not considered substantial for purposes of the RFA. Note that PACE plans while not submitting bids (except for Part D) in the same sense as MA plans, estimate their costs and these amounts are covered by a combination of funding from the Trust Fund and the States in which they operate. The preceding analysis shows that meeting the direct cost of this final rule does not have a significant economic impact on a substantial number of small entities, as required by the RFA. Besides the direct costs, as previously discussed, are certain indirect consequences of these provisions which also create impact. We have already explained that 98 percent of MA plans (including MAPD plans) bid below the benchmark. Thus, their estimated costs for the coming year are fully paid by the Federal Government. However, the government additionally pays the plan a beneficiary rebate amount that is an amount equal to a percentage (between 50 and 70 percent depending on a plans quality rating) multiplied by the amount by which the benchmark exceeds the bid. The rebate is used to provide additional benefits to enrollees in
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amount that is an amount equal to a percentage (between 50 and 70 percent depending on a plans quality rating) multiplied by the amount by which the benchmark exceeds the bid. The rebate is used to provide additional benefits to enrollees in the form of reduced cost-sharing or other supplemental benefits, or to lower the Part B or Part D premiums for enrollees. (Supplemental benefits may also partially be paid by enrollee premiums.) However, as noted previously, the number of plans bidding above the benchmark to whom this burden applies do not meet the RFA criteria of a significant number of plans. It is possible that if the provisions of this rule would otherwise cause bids to increase, plans will reduce their profit margins, rather than substantially change their benefit package. This may be in part due to market forces; a plan lowering supplemental benefits even for 1 year may lose its enrollees to competing plans that offer these supplemental benefits. Thus, it can be advantageous to the plan to temporarily reduce profit margins, rather than reduce supplemental benefits. We note that we do not have definitive data on this. Plans do not report to CMS the strategies behind their bids. More specifically, when supplemental benefits are reduced, we VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00198 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222317 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 171Indeed, see similar discussion in previous regulatory impact analyses: https://www.federalregister.gov/documents/2022/05/09/ 2022-09375/medicare-program-contract-year-2023- policy-and-technical-changes-to-the-medicare- advantage-and and https://www.federalregister.gov/ documents/2022/04/14/2022-07642/medicare- program-maximum-out-of-pocket-moop-limits-and- service-category-cost-sharing-standards. have no way of knowing the cause for this reduction, whether it be new provisions, market forces, or other causes. Notably, it may
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service-category-cost-sharing-standards. have no way of knowing the cause for this reduction, whether it be new provisions, market forces, or other causes. Notably, it may be inappropriate to consider the relevant regulatory impacts (and thus the profit considerations) as temporary because the issuance of a series of regulations sustains the effects.171As a result, changes in benefits packages may be plausible and we requested comment on the assessment of this outcome in association with this final rule. We next examine in detail each of the other stakeholders and explain how they can bear cost. Each of the following are providers (inpatient, outpatient, or pharmacy) that furnish plan-covered services to plan enrollees for: (1) Pharmacies and Drug Stores, NAICS 446110; (2) Ambulatory Health Care Services, NAICS 621, including about two dozen sub-specialties, including Physician Offices, Dentists, Optometrists, Dialysis Centers, Medical Laboratories, Diagnostic Imaging Centers, and Dialysis Centers, NAICD 621492; (3) Hospitals, NAICS 622, including General Medical and Surgical Hospitals, Psychiatric and Substance Abuse Hospitals, and Specialty Hospitals; and (4) SNFs, NAICS 623110. If these providers are contracted with the plan, their aggregate payment for services is the sum of the enrollee cost sharing and plan payments. The rules for non-contracted providers servicing plan enrollees depends on the plan type involved. Non-contracted providers in both MA and MA PD plans are not expected to incur burden from a final rule because the regulations (42 CFR 422.214 and sections 1852(k)(1) and 1866(a)(1)(O) of the Act) require they be paid at least the FFS Rate. PACE must provide only contracted providers to its participants (42 CFR 460.70(a)). Similarly non- contracted pharmacies are a sporadic issue in stand-alone drug plans which are encouraged to limit out of network access to those situations when it is required (42 CFR 423.124). PACE plan participants must obtain services either from the PACE organization of from its contracted providers (42 CFR 470(a)). Consequently, non-contracted providers have no additional cost burden above the already existing burden in original Medicare. Consequently, consistent with our conclusions stated earlier, the Secretary has certified that this
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of from its contracted providers (42 CFR 470(a)). Consequently, non-contracted providers have no additional cost burden above the already existing burden in original Medicare. Consequently, consistent with our conclusions stated earlier, the Secretary has certified that this final rule will not have a significant impact on a substantial number of small entities. D. Anticipated Effects Many provisions of this final rule have negligible impact either because they are technical provisions or are provisions that codify existing guidance. Other provisions have an impact that cannot be quantified or whose estimated impact is zero. Throughout the preamble, we have noted when we estimated that provisions have no impact. Additionally, this Regulatory Impact Analysis discusses several provisions with either zero impact or impact that cannot be quantified. The remaining provisions are estimated in section VIII of this final rule and in this Regulatory Impact Analysis. Where appropriate, when a group of provisions have both paperwork and non- paperwork impact, this Regulatory Impact Analysis cross-references impacts from section VIII. of this final rule in order to arrive at total impact. Additionally, this Regulatory Impact Analysis provides pre-statutory impact of several provisions whose additional current impact is zero because their impact has already been experienced as a direct result of the statute. For further discussion of what is estimated in this Regulatory Impact Analysis, see Tables 13 and 14 and the discussion afterwards. 1. Transitional Coverage and Retroactive Medicare Part D Coverage for Certain Low-Income Beneficiaries Through the LI NET Program ( 423.2500 Through  423.2536) This rule implements section 118 of the CAA, which amends section 1860D 14 of the Act, to establish the Limited Income Newly Eligible Transition (LI NET) Program as a permanent part of Medicare Part D. This will ensure that the transitional drug coverage currently provided to low-income Medicare beneficiaries under the LI NET demonstration will continue indefinitely. Therefore, we anticipate this rule will advance health equity by improving low income individuals access to continuous, affordable health coverage, consistent with Executive Order 13985, issued January 20, 2021, on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. We also believe it will improve the customer service experience of low- income beneficiaries consistent with the goals of the Executive Order 14058, Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government. Using drug cost data from 2021, the CMS Office of the Actuary (OACT) projects
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income beneficiaries consistent with the goals of the Executive Order 14058, Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government. Using drug cost data from 2021, the CMS Office of the Actuary (OACT) projects the following program costs (in millions of dollars) over the next 10 years: We note that OACT has provided cost/savings estimates each year under the LI NET demonstration, and it has not altered its methodology based on the program becoming permanent. Therefore, these projected costs are the same as what the government would have incurred if the demonstration continued. Further, the costs of the payments provided for under the LI NET program will continue, as under the demonstration, to be covered through the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance (SMI) Trust Fund. Also note that we are classifying these payments of the Medicare Trust Fund as transfers from the Trust Fund to the LI NET sponsor. We received no comments on this section and therefore are finalizing this provision without modification. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00199 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.014</GPH>ddrumheller on DSK120RN23PROD with RULES222318 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 172Based on 854 MA, cost, and Part D plan sponsor contracts in the May 2022 Monthly Contract and Enrollment Summary Report. Retrieved from https://www.cms.gov/research- statistics-data-and-systemsstatistics-trends-and- reportsmcradvpartdenroldatamonthly/contract- summary-2022-05. 173Based on the BLS wage information for business operations specialist (code 131199) whose wage we estimate at $76.20 per hour, including fringe benefits and overhead costs (http:// www.bls.gov/oes/current/oes_ nat.htm). 2. 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 provision that a
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nat.htm). 2. 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 provision that a physician or other health professional with expertise in the field of medicine appropriate to the requested service review any decision about medical necessity before an MA plan may issue an adverse organization determination was intended to provide a more meaningful clinical review informed by specific expertise. As stated in the proposed rule, we believe this enhanced level of review will reduce unnecessary appeals, delays in treatment and the potential for adverse outcomes. In the proposed rule, we quantified the expected reduced appeals in the Collection of Information section, quantifying the costs of effects of delay in treatment and consequent possible adverse medical complications is not possible because we lack adequate data. In addition to requesting comment on these effects, we sought feedback on the opportunity cost of medical experts time when reallocated for the purpose of compliance with this provision. We did not receive comments on this impact analysis. We are finalizing this provision without modification. 3. Strengthening Translation Requirements for Medicare Advantage and DSNP Enrollee Marketing and Communication Materials: Require HIDE SNPs and FIDE SNPs To Translate Materials Into the More Stringent of the Medicare or Medicaid Translation Standards ( 422.2267 and 423.2267) a. Standing Request for Translated Materials and Materials in Accessible Formats We proposed to specify in Medicare regulations that MA organizations, cost plans, and Part D sponsors must provide materials to enrollees on a standing basis in an accessible format or any non- English languages that is the primary language of at least 5 percent of the individuals in a plan benefit package service area upon receiving a request for the materials or otherwise learning of the enrollees preferred language. The proposal would also extend to individualized plans of care for special needs plans. Our final rule clarifies existing policy. Therefore, the impact to MA organizations, cost plans, and Part D plan sponsors depends on whether, and to what extent, they currently have processes in place to note an enrollees language preference and need for an alternate format. As described in this section of this final rule, we believe many plans would not incur significant cost from the proposed requirement because plans currently comply with the proposal. Enrollees who need translated materials or materials in an accessible format who are enrolled in MA,
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As described in this section of this final rule, we believe many plans would not incur significant cost from the proposed requirement because plans currently comply with the proposal. Enrollees who need translated materials or materials in an accessible format who are enrolled in MA, cost, or Part D plans that do not currently create a standing request for these materials would likely spend less time contacting their plan to request these materials as a result of this proposal. Any MA, cost, or Part D plan that has not created a standing request for enrollees requiring translated materials or materials in an accessible format would likely reduce their efforts to accept requests and resend the translated materials or materials in an accessible format. CMS received information from Medicare-Medicaid Plans (MMPs) in Ohio and California about their requests for translated materials in 2021 and 2022. We include our assumptions from these discussions, but we sought comment on additional information that may better inform our estimates. Of the five MMPs in Ohio in 2021, only one of the plans accepted standing requests for translated materials or materials in an accessible format. A higher proportion (86 percent) of seven California MMPs that responded had established standing requests due to State oversight ensuring California MMPs followed the State- specific marketing guidance; however, we believe the Ohio MMPs landscape betters represents MA organizations as a whole. Therefore, we estimate that 20 percent or 171172MA organization, cost plan, and Part D plan sponsor contracts are currently accepting standing requests and would not be impacted by this proposal. Therefore, an estimated 80 percent or 683 MA organization, cost plan, and Part D plan sponsor contracts would need to implement this proposed requirement. We believe our analysis of MMP plans, which cover Part C and Part D benefits, also applies to MA organization, cost plan, and Part D plan sponsors. We requested comment on whether MA organization, cost plan, and Part D plan sponsors accept standing requests for translated materials or materials in an accessible format at a greater or lesser extent than MMPs. Based on the information we received from MMPs, we are uncertain if establishing a standing request for translated material or materials in an accessible format will increase or decrease administrative cost for the estimated 683 MA organization, cost plan, and Part D plan sponsor contracts impacted by our proposal. Based on information from MMPs who have implemented a standing request, we believe establishing a process for standing requests would require about 200 hours of business operations specialist173time during the first year or 136,600
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Part D plan sponsor contracts impacted by our proposal. Based on information from MMPs who have implemented a standing request, we believe establishing a process for standing requests would require about 200 hours of business operations specialist173time during the first year or 136,600 hours (200 hr * 683 MA, cost, and Part D contracts) at a cost of $10,408,920 (136,600 hr * $76.20/hr wage for a business operations specialist). We assume that this initial cost would be offset by a reduction in cost for MA organizations, cost plans, and Part D plan sponsors to resend materials in the correct translated or accessible format. We also expect that implementing a standing request process would reduce future costs to MA organizations, cost plans, and Part D sponsors by decreasing rework of sending two sets of information, one in the incorrect language or format and the other in the correct format. However, establishing a standing request for translated material or materials in an accessible format could result in more enrollees requesting to consistently receive these materials at an additional cost to MA organizations, cost plans, and Part D plan sponsors. We requested comment on our assumptions and the potential savings or costs to MA organizations, cost plans, and Part D plan sponsors. b. Require FIDE SNPs and HIDE SNPs and Applicable Integrated Plans To Translate Materials Into the Medicare Translation Standard Plus Additional Medicaid Languages We proposed to require 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. Our final 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 our proposed requirements. We note that translation requirements vary by State. Therefore, we expect no impact in States where the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00200 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222319 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations
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12APR2ddrumheller on DSK120RN23PROD with RULES222319 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 174Extrapolated based on data from CMS4144 F (76 CFR 21549) that estimated 91,623 words for translation of approximately 17 plan materials. 175Mean hourly wage for interpreters and translators, May 2021 retrieved from: https://www.bls.gov/oes/current/oes273091.htm The mean rate of $28.08 was doubled to include fringe benefits and overwork time. 176Translation rates vary widely and also depend on the technical nature of what is translated as well as whether adequate review time is included. The consensus of multiple websources: (i) https://www.proz.com/forum/money_ matters/300163- words_ per_hour.html; (ii) https://www.pactranz.com/translation-times/; (iii) https://www.getblend.com/blog/output-words-per-day/; (iv) https://www.trainingfortranslators.com/2011/01/20/ webinar-question-how-many-words-per-day/ provides ranges from 200 words/hour to 1000 words per hour. We have selected 500 as a reasonable average and invite stakeholder feedback on the reasonableness of this assumption. 177CMS released the contract year 2023 version of this HPMS memorandum titled, Contract Year 2023 Translated Model Materials Requirements and Language Data Analysis on September 23, 2022. This memorandum can be retrieved at: https://www.cms.gov/httpseditcmsgovresearch-statistics- data-and-systemscomputer-data-and- systemshpmshpms-memos-archive/hpms-memos- wk-4-september-19-23. applicable Medicaid 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
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applicable Medicaid 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 translation requirements. For contract year 2022, MA organizations sponsor 292 FIDE SNPs, HIDE SNPs, and AIPs. We expect that some portion of these FIDE SNPs, HIDE SNPs, and AIPs already translate their Medicare materials in ways that meet our proposed requirement, but we do not have a good estimate of how many. While HPMS identifies the Medicare translation requirements for each MA and Part D plan sponsor at the plan level, we do not have a good source of the State-specific Medicaid translation requirements since they differ by State and there is no one source of information outlining these requirements. For purposes of this analysis, we estimate that 75 percent of the FIDE SNPs, HIDE SNPs, and AIPs currently translate their Medicare materials in ways that would meet our proposed requirement and 25 percent or 73 of these FIDE SNPs, HIDE SNPs, and AIPs do not. Section 422.2267(e) requires MA plans to provide 29 materials to current and prospective MA plan enrollees, as applicable and  423.2267(e) requires Part D sponsors to provide an additional 18 materials to current and prospective enrollees for a total of 47 materials. We estimate that the proposed provision would require 73 FIDE SNPs, HIDE SNPs, and AIPs to translate 47 materials into one additional language. On average, we expect these plans to translate materials into one additional language based on our experience with MMPs where, out of nine States, only two States (California and Rhode Island) required translation of materials into additional languages that exceeds the Medicare translation standard. California required MMPs to translate materials into nine additional languages in certain counties and Rhode Island required MMPs to translate materials into two additional languages. Collectively, these 47 materials include an estimated 253,311 words.174At a cost of $56.16/hr,175we estimate a translator could translate 500