evekhm/cms_iom_500 huggingface dataset:
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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 09380790 (CMSR 244). Section 460.121 currently includes the service determination process PACE organizations are required to follow and only allows PACE organizations to notify participants and/or their representatives of service determination extensions in writing. Per the burden estimate currently approved by OMB (CMSR244), we estimate the burden of the current extension notification requirements at  460.121 to be 2,350 hours and $140,812 in aggregate. As discussed in section VI.E. of this final rule, we are finalizing our proposal to allow PACE organizations to notify the participant or their designated representative either orally or in writing when the PACE organization extends the timeframe for making a service determination. We expect that PACE organizations will prefer to provide oral notification more frequently than written notification, because oral notification is less time consuming. This belief is further supported by commenters on this proposal, who unanimously agreed the proposed change would reduce burden for PACE organizations. Due to PACE organizations preference for oral notification over written notification and the 45 minutes per response reduction in burden oral notification offers, we estimate that the proposed change will reduce the burden of the extension notification requirements at  460.121. To estimate the decreased burden, we considered: (1) the annual number of extension notifications; (2) the estimated proportions of extension notifications that are provided orally or in writing; and (3) the estimated time required to complete oral and written notification. First, we reviewed extended service determination requests (SDRs) from 2019 through 2021 and found that there were 6,564 total extended SDRs nationally (3,942 in 2019 + 773 in 2020 + 1,849 in 2021). Then we averaged the number of extended SDRs from 2019 2021 to calculate 2,188 extended SDRs annually (6,564 total extended SDRs/3 years), which is about 15 extended SDRs per PACE organization annually (2,188 extended SDRs annually/149 PACE organizations). Secondly, we estimate, based on our experience with audits of similar areas of PACE requirements where PACE organizations have an option of oral or written notification, that 80 percent of extension notifications
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extended SDRs annually/149 PACE organizations). Secondly, we estimate, based on our experience with audits of similar areas of PACE requirements where PACE organizations have an option of oral or written notification, that 80 percent of extension notifications will be provided orally, at 15 minutes per notification, and 20 percent will be provided in writing at 1 hour per notification. The hourly wage for notification by an MSW in both cases is $59.92/hr. In aggregate, the new burden is 875 hours ((2,188 extension notifications * 0.2 written notifications * 1 hr) + (2,188 extension notifications * 0.8 oral notifications * 0.25 hr)) at a cost of $52,430 (875 hours * $59.92/hr). Thus, the aggregate annual time and cost savings for the change is minus 1,475 hours (2,350 hours under current provisions minus 875 hours as documented in the pending OMB package) and minus $88,382 ($140,812 cost under current provisions minus $52,430 under the pending OMB package). Additionally, at the individual service determination request extension level, PACE organizations that choose to provide oral notification instead of written notification will save minus 0.75 hours and $44.94 per extension notification. We did not receive any comments related to our proposed provisions and burden estimates. Consequently, we are finalizing them without change. 12. ICRs Regarding Safeguarding Data and Records and Medical Record Requirements ( 460.200 and 460.210) PACE organizations are currently required to retain original communications related to a participants care, health, or safety in the medical record. In this proposal, we are removing the requirement that these communications be stored in the participants medical record, provided certain conditions are met. Therefore, our burden estimates include costs incurred related to staff (1) training; (2) software development; (3) file cabinets for document storage; and (4) updating/ VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00194 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222313 Federal Register / Vol. 88, No. 70 / Wednesday, April
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E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222313 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations maintaining the organizations policies and procedures. Training: We estimate that a PACE organization will spend 40 hours at a cost of $2,916 (40 hours  $72.90/hr) for a compliance specialist to establish training materials. In aggregate, we estimate a one-time burden of 5,960 hours (40 hours  149 POs) at a cost of $434,484 (5,800960 hours  $72.90/hr). Software development: We estimate that PACE organizations will spend 40 hours at a cost of $4,654 (40 hours  $116.34/hr) for a software developer to make the appropriate software updates. In aggregate, we estimate a one-time burden of 5,960 hours (40 hours  149 POs) at a cost of $693,386 (5,960 hours  $116.34/hr). Storage: We estimate that a PACE organization will spend a total of $300 (2  $150/each) for 2 four-drawer locking file cabinets. In aggregate, we estimate a one-time non-labor cost of $44,700 ($300  149 POs). Update policies and procedures: We estimate that PACE organizations will spend 10 hours at a cost of $729 (10 hours  $72.90/hr) for a compliance specialist to update and maintain related policies and procedures. In aggregate, we estimate a one-time burden of 1,490 hours (10 hours  149 POs) at a cost of $108,621 (1,490 hours  $72.90/hr). The aggregate of this provision is a one-time impact of 13,410 hours (5,960 hours (training materials) + 5,960 hours (software development) + 1,490 hours (policy updates) at a cost of $1,282,191 ($434,484 (training materials) + $693,386 (software updates) + $44,700 (nonlabor purchase of storage) + $108,621 (policy updates).)
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($434,484 (training materials) + $693,386 (software updates) + $44,700 (nonlabor purchase of storage) + $108,621 (policy updates).) These changes will be submitted to OMB for approval under control number 09380790 (CMSR244). Since PACE organizations are already required to retain original communications related to a participants care, health, or safety, and to make these communications accessible to CMS and the SAA upon request, this proposal does not impose any new information collection requirements for PACE organizations. 13. ICRs Regarding Expanding Eligibility for Low-Income Subsidies Under Part D of the Medicare Program ( 423.773 and 423.780) In this rule, we revise the Part D LIS income and resource standards at  423.773 to expand eligibility for the full benefit to individuals who currently have the partial benefit and make a coordinating change in  423.780. This will change the level of assistance that an individual could qualify for in paying their Part D premiums, copays and deductibles. While there will be no change in the number of individuals eligible for the Part D LIS, it will create a transition of people from partial subsidy status to full subsidy status. The burden associated with determining eligibility for the Part D LIS is the time and effort for States or SSA to verify the income and resources and report eligibility to beneficiaries and CMS annually. Most individuals who qualify for the Part D LIS do so because they qualify for Medicaid or other assistance in their State. The burden for States to determine and report eligibility is currently approved by OMB under control number 09380467 (CMSR74) at 54 respondents, 3,241 annual responses, a variable amount of time per response, and 1,082 estimated annual hours. We did not receive any comments related to our proposed provisions and burden estimates. Consequently, we are not making any changes to any of the requirements or burden estimates that are currently approved by OMB under control number 09380467. C. Summary of Information Collection Requirements and Associated Burden Estimates BILLING CODE 412001P VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00195 Fmt
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C. Summary of Information Collection Requirements and Associated Burden Estimates BILLING CODE 412001P VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00195 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222314 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations BILLING CODE 412001C VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00196 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.013</GPH>ddrumheller on DSK120RN23PROD with RULES222315 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations VIII. Regulatory Impact Analysis A. Statement of Need The primary purpose of this final rule is to amend the regulations for the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) programs, and Programs of All- Inclusive Care for the Elderly (PACE). This final rule, besides codifying existing Part C and Part D sub-regulatory guidance also includes a number of new policies from the Bipartisan Budget Act (BBA) of 2018, the Consolidated Appropriations Act, 2021 (CAA), and the Inflation Reduction Act of 2022 (IRA), that would improve these programs. B. Overall Impact We examined the impact of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), Executive Order 13272 on Proper Consideration of Small Entities in Agency Rulemaking (August 13, 2002), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (March 22, 1995; Pub. L. 1044), Executive Order 13132 on Federalism (August 4, 1999), the
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of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (March 22, 1995; Pub. L. 1044), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f)(1) of Executive Order 12866 defines a significant regulatory action as an action that is likely to result in a rule: (1) having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities ; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the Presidents priorities, or the principles set forth in the Executive Order. Based on our estimates, OMBs Office of Information and Regulatory Affairs has determined this rulemaking is significant per section 3(f)(1) as measured by having an annual effect of $100 million or more in any 1 year, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking. Section 202 of UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2022, that threshold is approximately $177 million. This final rule is not anticipated to have an unfunded effect on State, local, or Tribal governments, in the aggregate, or on the private sector of $177 million or more.
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In 2022, that threshold is approximately $177 million. This final rule is not anticipated to have an unfunded effect on State, local, or Tribal governments, in the aggregate, or on the private sector of $177 million or more. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this final rule does not impose any substantial costs on State or local governments, preempt State law or have federalism implications, the requirements of Executive Order 13132 are not applicable. If regulations impose administrative costs on reviewers, such as the time needed to read and interpret this final rule, then we should estimate the cost associated with regulatory review. There are currently 795 contracts (which includes MA, MAPD, and PDP contracts), 55 State Medicaid Agencies, and 300 Medicaid MCOs. We also expect a variety of other organizations to review (for example, consumer advocacy groups, major PBMs). We expect that each organization will designate one person to review the rule. A reasonable maximal number is 2,000 total reviewers. We note that other assumptions are possible. Using the BLS wage information for medical and health service managers (code 119111), we estimate that the cost of reviewing this final rule is $115.22 per hour, including fringe benefits, overhead, and other indirect costs (http://www.bls.gov/oes/current/ oes_nat.htm). Assuming an average reading speed, we estimate that it will take approximately 19 hours for each person to review this final rule. For each entity that reviews the rule, the estimated cost is therefore $2,200 (19 hours  $115.22). Therefore, we estimate that the maximum total cost of reviewing this final rule is $5.3 million ($2,200  2,000 reviewers). However, we expect that many reviewers, for example pharmaceutical companies and PBMs, will not review the entire rule but just the sections that are relevant to them. We expect that on average (with fluctuations) 10 percent of the rule will be reviewed by an individual reviewer; we therefore estimate the total cost of reviewing to be $0.5 million. Note that this analysis assumes one reader per contract. Some alternatives
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We expect that on average (with fluctuations) 10 percent of the rule will be reviewed by an individual reviewer; we therefore estimate the total cost of reviewing to be $0.5 million. Note that this analysis assumes one reader per contract. Some alternatives include assuming one reader per parent organization. Using parent organizations instead of contracts will reduce the number of reviewers. However, we believe it is likely that review will be performed by contract. The argument for this is that a parent organization might have local reviewers assessing potential region-specific effects from this final rule. In accordance with the provisions of Executive Order 12866, this final rule was reviewed by OMB. C. Impact on Small Businesses Regulatory Flexibility Analysis (RFA) The RFA, as amended, requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. We proposed a wide range of policies in the proposed rule. These policies codify, modify, and update current guidance governing MA organization bid requirements. This rule has several affected stakeholders. They include: (1) MA organizations such as HMOs, local and regional PPOs, MSAs, PFFS and Part D sponsors, PACE plans, and Stand Alone Part D plans (PDP) (2) providers, including institutional providers, outpatient providers, clinical laboratories, and pharmacies; and (3) enrollees. Some descriptive data on these stakeholders are as follows: Pharmacies and Drug Stores, NAICS 446110, have a $30 million threshold for small size with 88 percent of pharmacies, those with under 20 employees, considered small. Direct Health and Medical Insurance Carriers, NAICS 524114, have a $41.5 million threshold for small size, with 75 percent of insurers having under 500 employees meeting the definition of small business. Several Medicare Advantage plans (about 3040 VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00197 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222316 Federal Register / Vol. 88, No. 70 /
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4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222316 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations percent) are not-for-profit resulting in a small entity status. Ambulatory Health Care Services, NAICS 621, including about 2 dozen subspecialties, including Physician Offices, Dentists, Optometrists, Dialysis Centers, Medical Laboratories, Diagnostic Imaging Centers, have a threshold ranging from $8 to $35 million (Dialysis Centers, NAICD 621492, have a $41.5 million threshold). Almost all firms are big, and this also applies to sub-specialties. For example, for Physician Offices, NAICS 621111, receipts for offices with under 9 employees exceed $34 million. Hospitals, NAICS 622, including General Medical and Surgical Hospitals, Psychiatric and Substance Abuse Hospitals, Specialty Hospitals have a $41.5 million threshold for small size, with half of the hospitals (those with between 20500 employees) considered small. Skilled Nursing Facilities (SNFs), NAICS 623110, have a $30 million threshold for small size, with half of the SNFs (those with under 100 employees) considered small. We are certifying that this FC does not have a significant economic impact on a substantial number of small entities. To explain our position, we explain certain operational aspects of the Medicare program. Each year, MA plans, including Part D sponsors, submit a bid for furnishing Part A and B benefits and the entire bid amount is paid by the government to the plan if the plans bid is below an administratively set benchmark. If the plans bid exceeds that benchmark, the beneficiary pays the difference in the form of a basic premium (note that a small percentage of plans bid above the benchmark, whereby enrollees pay basic premium, thus this percentage of plans is not significant as defined by the RFA and as justified in this section of this rule). The costs of stand-alone Part D plans, PDPs, is also covered by the Medicare Trust Fund. PACE plans have their costs covered by both the Medicare Trust Fund as well as the States they negotiate
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justified in this section of this rule). The costs of stand-alone Part D plans, PDPs, is also covered by the Medicare Trust Fund. PACE plans have their costs covered by both the Medicare Trust Fund as well as the States they negotiate with. MA plans and Part D Sponsors can also offer enhanced benefits, that is, benefits not covered under Original Medicare. These enhanced benefits are paid for through enrollee premiums, extra government payments or a combination. Under the statutory payment formula, if the bid submitted by an MA plan (including Part D sponsors) for furnishing Part A and B benefits is lower than the administratively set benchmark, the government pays a portion of the difference to the plan in the form of a rebate. The rebate must be used to provide supplemental benefits (that is, benefits not covered under Original Medicare) and or/lower beneficiary Part B or Part D premiums. Some examples of these supplemental benefits include vision, dental, and hearing, fitness and worldwide coverage of emergency and urgently needed services. To the extent that the governments payments to plans for the bid plus the rebate exceeds costs in Original Medicare, those additional payments put upward pressure on the Part B premium which is paid by all Medicare beneficiaries, including those in Original Medicare who do not have the additional health services available in many MA plans. Part D plans, including MAPD plans, submit bids and those amounts are paid to plans through a combination of Medicare funds and beneficiary premiums. In addition, for enrolled low- income beneficiaries, Part D plans receive special government payments to cover most of premium and cost sharing amounts those beneficiaries would otherwise pay. Thus, the cost of providing services by these insurers is funded by a variety of government funding and in some cases by enrollee premiums. As a result, MA plans, Part D plans, Prescription Drug Plans, and PACE plans are not expected to incur burden or losses since the private companies costs are being supported by the government and enrolled beneficiaries. This lack of expected burden applies to both large and small health plans. Small entities that must comply with MA regulations, such as those 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