2023-07115.pdf

of the PACE organization when necessary, and in accordance with  460.200(e), and (iii) original documentation of the communication is available to CMS and the SAA upon request. This provision continues to require PACE organizations ensure that these important communications relating to the care, health, or safety of a participant are included in the medical record, but it allows PACE organizations operational flexibility on how these communications are included. PACE organizations would be permitted, under this proposal, to summarize the information in the medical record, as long as the summary is accurate and thorough, and the original documentation of the communication is maintained outside the medical record and is accessible by the PACE organizations employees and contractors as needed, and available to CMS and the SAA upon request. We believe this proposal balances CMS interest in ensuring these communications are safeguarded with PACE organizations interest in ensuring the medical record is usable and that confidential information is protected to the extent possible. A PACE organization would be able to include a summary of the information but could now choose to exclude names or other potentially sensitive information, provided the requirements under proposed  460.210(b)(6)(i) through (iii) are met. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00186 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222305 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations We summarize the comments received on the proposals at  460.200(d)(2) and 460.210(b)(6) and provide our responses to those comments in this section of this rule. Comment: CMS received several comments expressing overwhelming support for our proposals at  460.200(d)(2) and 460.210(b)(6), allowing for more administrative flexibility in how PACE organizations maintain written communications relating to the care, health, or safety of PACE participants. Commenters conveyed their appreciation and believed that the ability to maintain these communications in a more appropriate location will help to safeguard participant anonymity during the grievance process and reduce burden on PACE organizations. Response: CMS appreciates the comments and agrees that this flexibility will safeguard participant anonymity and sensitive information, and help PACE organizations more easily comply with the requirements at the new 460.200(d)(2) to maintain all written communications received in any format from participants or other parties in their original form when the communications relate to a participants care, health, or safety. Comment: CMS received a comment stating that they were not supportive of our proposals at  460.200(d)(2) and 460.210(b)(6) as they believed this flexibility was unnecessary and could lead to confusion and variation amongst the industry regarding practices for medical record access and storage. Response: CMS appreciates the comment, however disagrees that this will lead to variation and confusion in the industry regarding medical record access and storage practices. As described in the proposed rule, when the January 2021 final rule became effective, CMS received concerns from PACE organizations regarding the requirement to maintain original communications in the medical record, due to the challenges associated with maintaining the confidentiality of grievances, and managing the volume of communications in the medical record. Furthermore, PACE organizations indicated that maintaining written communications related to participant grievances in the medical record allows access to the information by all PACE organization staff, thereby jeopardizing the confidentiality of such communications, especially when confidentially is requested by a participant and/or caregiver, and requested that CMS provide clarification on how to adhere to the requirements at the former  460.210(b)(6), while maintaining the confidentiality of participant grievances, as required at  460.120(c)(4). CMS believes that allowing these communications be stored outside of the medical record, when certain conditions are met, balances the need to keep grievance and sensitive information confidential, while appropriately maintaining communications related to participant care, health or safety, as part of the medical record. CMS also points out that PACE organizations may choose to maintain these communications outside of the medical record in a secure location when certain conditions are met, however, they can also choose to maintain the communications in the medical record in accordance with the new  460.200(d)(2). PACE organizations have the option to exercise this flexibility, but are not required to do so. Lastly, CMS believes these changes will be welcomed by the industry. After consideration of the comments received, we are finalizing our proposed changes to  460.200(d)(2) and 460.210(b)(6) without modification. F. Out of Scope Comments and Summary We received comments on the following topics which were out of scope of our proposal and to which we are therefore 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 $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 $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  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 (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