2023-07115.pdf

12APR2ddrumheller on DSK120RN23PROD with RULES222303 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations regarding their experiences engaging and communicating with participants in different ways during the COVID19 pandemic. In light of that feedback and experience, CMS has determined that allowing the IDT to provide either oral or written notice of service determination request extensions should not adversely impact participants, as both oral and written communication can be an effective means of communication when providing notice of a service determination request extension. Therefore, we proposed to revise the requirement at  460.121(i)(2) to allow the IDT to provide notification either orally or in writing to the participant or their designated representative when the IDT extends the timeframe for a service determination request, as permitted under  460.121(i)(1) (87 FR 79670). Additionally, the proposed rule discussed that allowing the IDT to provide either oral or written notice of service determination request extensions increases operational flexibility for PACE organizations (87 FR 79670). As stated in the proposed rule (87 FR 79670), in order to ensure participants are fully informed of the reason(s) for an extension, CMS would expect oral notice of the service determination request extensions to meet the same requirements as written notice, including the expectations that notices will explain the reason(s) for the delay and be issued as expeditiously as the participants condition requires, but no later than 24 hours after the IDT decides to extend the timeframe. CMS would expect that PACE organizations document the content of oral notifications of service determination request extensions in accordance with  460.121(m). An IDT may choose to provide the extension notification both orally and in writing if it believes that is necessary to ensure the participants understanding. We estimate ongoing burden reduction due to the expected decrease in written notifications of service determination request extensions in favor of oral notification. We discuss and account for the burden reduction resulting from the expected decrease in written notification of service determination request extensions in the Collection of Information Requirements section. We will submit these changes to OMB for approval under control number 09380790 (CMSR244). Comment: All commenters that addressed the proposed change to  460.121(i)(2) supported allowing the IDT to provide either oral or written notice of service determination request extensions. They noted that this provision would increase operational flexibility, which would reduce burden for PACE organizations. Response: We thank the commenters for their support of this provision and are finalizing this requirement as proposed. E. PACE Maintenance of Records ( 460.200 and 460.210) Under sections 1894(b) and 1934(b) of the Act, PACE organizations are required to provide all items and services covered under Medicare and Medicaid, and all additional items and services specified in regulations and determined necessary by the interdisciplinary team to improve and maintain the participants overall health status. Currently, PACE organizations are required to safeguard data and records in accordance with  460.200(d). PACE organizations must also maintain a single comprehensive medical record for each participant in accordance with accepted professional standards ( 460.210(a)(1)). In the February 2020 proposed rule (85 FR 9002), CMS proposed to add a new requirement at  460.200(d)(2) for PACE organizations to maintain in the medical record all written communications received from participants or other parties in their original form when the communications relate to a participants care, health, or safety in accordance with  460.210(b)(6). We explained in that proposed rule that we had found through our monitoring of PACE organizations that they do not always maintain and safeguard important records such as communications related to a participants care from family members, caregivers, and the participants community (85 FR 9134). We stated that maintaining a comprehensive, complete, and accurate medical record allows a PACE organization to remain alert to all information that is relevant to a participants care, health and safety, and to provide appropriate and timely care to the participant (85 FR 9140). Therefore, we also proposed a new requirement at  460.210(b)(6) for PACE organizations to maintain in a participants medical record original documentation of any written communication the PACE organization receives relating to the care, health or safety of a participant, in any format (for example, emails, faxes, letters, etc.) and including, but not limited to (i) communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participants health or safety or both; and (ii) communications from an advocacy or governmental agency such as State-based Adult Protective Services. In the January 2021 final rule, CMS summarized and responded to the comments received on these proposed record maintenance requirements (86 FR 6039 through 6040). We noted that some commenters recommended we allow PACE organizations to maintain original communications outside of the medical record systems, as they believed that maintaining original documentation of any written communication relating to the care, health or safety of a participant in any format in the medical record would compromise the usefulness of the medical record, due to the quantity of information that would be required to be stored (86 FR 6040). Based on these comments, we contemplated allowing original documentation of communications to be summarized in the medical record, so long as PACE organizations maintained the original documentation of the communication in a separate system. Ultimately, we chose not to modify our proposal with the contemplated change of permitting PACE organizations to summarize written communications relating to the care, health, or safety of a participant in the medical record. We did, however, modify our original proposal to allow PACE organizations to maintain in a participants medical record original documentation, or an electronic copy, of any written communication the PACE organization receives relating to the care, health or safety of a participant. In finalizing this provision, we explained that we were not establishing specific requirements governing where affected communications must be stored within a participants medical record. We also explained that PACE organizations may operationalize these requirements in accordance with the capabilities of their medical record systems (86 FR 6040). Participants, their family members, and representatives have a longstanding right to file a grievance expressing dissatisfaction with the delivery of PACE services or the quality of care furnished as part of the PACE benefit package (see  460.112(g)(1) and 460.120). A PACE organization must have a formal written process to evaluate and resolve medical and non- medical grievances by PACE participants ( 460.120(a)). A PACE organizations grievance process must include a written procedure for maintaining the confidentiality of a participants grievance ( 460.120(c)(4)). VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00185 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222304 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations PACE participants routinely file grievances with a PACE organization under the assumption that the details of their grievance will be kept confidential. This is especially important to PACE participants when a grievance involves a particular staff member of the PACE organization (for example, a home care aide, a driver, or a specific member of the interdisciplinary team). PACE organizations have typically maintained confidentiality of this information by only allowing access to the information, that is, the details of the complaint, to a limited number of PACE organization staff and/or by storing this information outside of the medical record in a secure location (for example, a separate electronic application or paper-based system). Since we finalized the January 2021 final rule, PACE organizations have had an opportunity to implement this provision, and we have continued to receive questions related to maintaining original communications in the medical record. These questions and comments indicate that as PACE organizations have begun to operationalize this requirement, they have been challenged with maintaining the confidentiality of grievances and managing the volume of these communications in the medical record. Other inquires include whether it would be permissible for PACE organizations to scan communications and store them electronically in the medical record. In addition to the concerns around maintaining the confidentiality of grievances, PACE organizations have also pointed out that there are instances when written communications sent to the PACE organization by the individuals and entities listed at  460.210(b)(6)(i) and (ii) may contain sensitive information about a PACE participant, their caregivers, and/or family members, and that these communications are often accompanied by a request to keep the information private. For example, information shared with a PACE organization may pertain to a caregivers health, and may have implications for the participants care, and the caregiver may only want the details of this information shared among employees and contractors who need to know the information rather than all individuals with access to the participants medical record. There are also instances when the communications include contents or language that may be inappropriate for inclusion in the medical record, such as vulgar comments directed towards individual PACE staff. PACE organization staff have 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, and have therefore requested clarification from CMS on how to adhere to comply with the requirement in  460.210(b)(6) when the original communication is part of a participant grievance and contains sensitive or confidential information. Sections 1894(f)(3) and 1934(f)(3) of the Act provide authority for the establishment of certain additional beneficiary and program protections applicable to MA and Medicaid managed care programs under prepaid capitation agreements under section 1903(m) of the Act. Sections 1894(b)(2) and 1934(b)(2) of the Act require that the PACE program agreement have written safeguards of the rights of enrolled participants, including a bill of rights and procedures for grievances and appeals, in accordance with regulations and with other Federal and State laws designed for the protection of beneficiaries. This authority allows CMS to implement regulations to ensure that PACE participants rights are protected, including the right to file a grievance anonymously. To uphold participant rights and help PACE organizations to safeguard anonymity to the extent possible during the grievance process and in other circumstances that involve sensitive information, CMS proposed, using the authority at sections 1894(f)(3) and 1934(f)(3) of the Act, to amend the PACE regulations at  460.200(d)(2) and 460.210(b)(6) to allow for more administrative flexibility in how PACE organizations maintain written communications relating to the care, health, or safety of a participant. Specifically, we proposed to amend  460.200(d)(2) to require that a PACE organization must maintain all written communications received in any format (for example, emails, faxes, letters, etc.) from participants or other parties in their original form when the communications relate to a participants care, health, or safety, including, but not limited to, the following: (i) communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participants care, health or safety; and (ii) communications from an advocacy or governmental agency, such as Adult Protective Services. This proposal moves and revises language located at  460.210(b)(6) that requires PACE organizations to maintain original documentation, or an unaltered electronic copy, of any written communication the PACE organization receives relating to the care, health or safety of a participant, in any format. By moving this language to  460.200(d)(2), with the proposed modifications, we retained the requirement for PACE organizations to maintain these important communications in their original form, while removing the requirement that these communications be stored in the participants medical record. At  460.210(b)(6), we proposed to replace the current language with a new requirement that states that original documentation or an unaltered electronic copy, of any written communication as described in  460.200(d)(2), must be maintained in the participants medical record unless the following requirements are met: (i) the medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication, (ii) original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors 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