evekhm/cms_iom_500 huggingface dataset:
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We explained that a complete estimation of impact from proposed  422.138(a) and (b) cannot be given because we would need detailed knowledge of proprietary plan information on the frequency and specific services for which prior authorization is done in each plan. (As noted in a prior paragraph, proposed  422.138(c) would only codify existing guidance to MA organizations.) We solicited comment from stakeholders on the impact and any additional information that would assist CMS in making an estimation. Some commenters stated that publicly posting a summary of evidence considered during the development of the criteria would require significant administrative effort. However, we did not receive specific comments on our estimates. The stakeholder comments of increased administrative burden are consistent with our statements in the proposed VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00082 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222201 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations rule, that due to its complexity and many unknowns we cannot quantify the burden. We thank commenters for helping inform CMSs policy on the appropriate use of prior authorization and the requirements proposed at  422.138. We summarize the comments and our responses follow. Comment: Some commenters asserted that this proposed rule goes against sections 1852(c)(1)(G) and (c)(2)(B) of the Act, and the MA regulations at  422.4(a)(1)(ii) which reference a MA plans application of utilization management tools, like prior authorization and other procedures used by the organization to control utilization of services and expenditures. Other commenters expressed concern that limiting prior authorization will lead to redundant, unnecessary, and inappropriate care. Response: In the proposed rule, we acknowledged that utilization management tools, including prior authorization, are expressly referenced at section 1852(c)(1)(G) and (c)(2)(B) of the Act, as part of the disclosure obligations of MA organizations. We also stated that section 1852(g)(1)(A) of the Act states that MA organizations shall have a procedure
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and (c)(2)(B) of the Act, as part of the disclosure obligations of MA organizations. We also stated that section 1852(g)(1)(A) of the Act states that MA organizations shall have a procedure for making determinations regarding whether an enrollee is entitled to receive a health care service and that such determinations must be made on a timely basis; that provision applies to both prior authorization determinations and to post-service decisions about coverage and payment. We proposed at  422.138(a) that coordinated care plans may use prior authorization processes for basic benefits and supplemental benefits, to ensure basic benefits are medically necessary based on standards specified in  422.101(c)(1), or to ensure that the furnishing of supplemental benefits is clinically appropriate. Thus, under our proposal and as finalized here, coordinated care plans are still permitted to use prior authorization as a utilization management tool. However, the use of prior authorization is subject to a number of new limitations, which we proposed to ensure that MA enrollees receive the Part A and Part B benefits to which they are entitled. We proposed, and are finalizing, at  422.138(b)(1) through (3) that coordinated care plans may use prior authorization processes only to confirm the presence of diagnoses or other medical criteria that are the basis for coverage determinations for the specific item or service, to ensure basic benefits are medically necessary based on standards specified in  422.101(c)(1), or to ensure that the furnishing of supplemental benefits is clinically appropriate. With regards to supplemental benefits at  422.138(b)(3), we state that MA organizations may use prior authorization to ensure that the furnishing of supplemental benefits is clinically appropriate. The regulation text uses the term clinically appropriate as opposed to medically necessary because while supplemental benefits must be medically necessary based on long standing guidance, certain supplemental benefits (that is, SSBCI) may be non-primarily health related. Thus, a standard based on medical necessity may not always be appropriate and using the term clinically appropriate is more inclusive of SSBCI that may or may not be primarily health related. As discussed in section III.E.2 of this rule, MA plans are still permitted to use additional coverage criteria when Traditional Medicare coverage criteria are not
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appropriate is more inclusive of SSBCI that may or may not be primarily health related. As discussed in section III.E.2 of this rule, MA plans are still permitted to use additional coverage criteria when Traditional Medicare coverage criteria are not fully established to determine medical necessity as specified at  422.101(b)(6). This codifies CMSs existing expectations about the appropriate use of prior authorization and will provide important beneficiary protections that prior authorization processes are not used as a barrier to accessing medically necessary services. Comment: Several commenters thanked CMS for acknowledging prior authorization as an acceptable and useful utilization management tool. Some commenters stated that prior authorization is necessary to manage care and prevent overutilization. Many of these commenters supported CMS codifying that prior authorization policies and procedures for coordinated care plans may only be used to confirm the presence of diagnoses or other medical criteria that are the basis for coverage determinations for the specific item or service, and for basic benefits, to ensure an item or service is medically necessary based on standards specified in  422.101(c)(1). Other commenters suggested that CMS do more to limit the use of prior authorization, in general. For example, some commenters suggested CMS prohibit prior authorization for certain covered services. One commenter suggested CMS require MA plans to exempt providers participating in value-based models from prior authorization requirements. Another commenter requested that CMS require plans to post prior authorization criteria. Others suggested CMS implement greater oversight over prior authorization policies by requiring plans to submit their policies for CMS to review. Response: We thank commenters for their comments and suggestions. As previously stated, CMS believes that prior authorization is an acceptable utilization management tool and authorized under the Medicare Advantage statutory provisions at section 1852(c) and (g)(1)(A) of the Act. However, we also believe that appropriate limitations on the use of these policies is necessary, so we are relying on our authority under section 1856(b) and 1857(e)(1) of the Act to adopt regulatory limitations designed to protect beneficiaries and ensure their access to medically necessary (or clinically appropriate in the case of certain supplemental benefits) covered benefits. Section 1852(a) of the Act requires MA plans to cover basic benefits and authorizes coverage of supplemental benefits. Ensuring access to covered benefits is one of CMSs
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clinically appropriate in the case of certain supplemental benefits) covered benefits. Section 1852(a) of the Act requires MA plans to cover basic benefits and authorizes coverage of supplemental benefits. Ensuring access to covered benefits is one of CMSs policy goals for the MA program and regulating use of prior authorization to ensure that inappropriate barriers to services are not being established supports that policy goal. As to suggestions that CMS do more to prohibit the use of prior authorization, we do not believe that we have authority for a sweeping prohibition on all use of prior authorization. As to prior authorization requirements for specific services, we did not propose such broad limitations and believe that appropriate investigation and study of such a policy is warranted before it could be adopted. Our proposals at  422.138, which we are finalizing, address when and how MA plans may use prior authorization generally, except where prohibited by other rules (for example  422.113). As previously discussed, the proposals at  422.138(b)(1) through (3) were made to limit the use of prior authorization processes only to confirm the presence of diagnoses or other medical criteria that are the basis for coverage determinations for the specific item or service, to ensure basic benefits are medically necessary based on standards specified in  422.101(c)(1), or to ensure that the furnishing of supplemental benefits is clinically appropriate. We are also finalizing, at  422.112(b)(8), that minimum continuity and coordination of care requirements for coordinated care plans include that approval of a prior authorization request for a course of treatment must be valid for as long as medically necessary to avoid disruptions in care, and that prior authorization be prohibited for a minimum 90-day transition period for any active course(s) of treatment when an enrollee has enrolled in an MA plan after starting a course of treatment. In response to the suggestion that CMS require MA plans to exempt providers participating in value-based VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00083 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222202 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 /
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12APR2ddrumheller on DSK120RN23PROD with RULES222202 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 106The scope of that proposed rule is broader than summarized here. models from prior authorization requirements, we note that MA plans determine through negotiations with providers, the terms by which contracted health care providers are paid, and section 1854(a)(6)(B)(iii) of the Act and CMS regulations at  422.256(a)(2)(ii) prohibit CMS from requiring an organization to contract with a particular health care provider or to use a particular price structure for payment under such a contract. MA organizations have the flexibility to, but are not required to, incorporate value- based payment into their payment arrangements with providers, including the terms on which payments are made (for example, whether payment is available if prior authorization procedures have not been met). We consider participation in such payment arrangements to be a contractual matter between organizations and their contracted providers. Given these limitations, we do not believe CMS has the authority to adopt requirements for these contractual arrangements related to payment between MA organizations and contracted providers. As to the comment requesting that CMS require MA plans to make prior authorization criteria publicly available, we do not believe adopting that requirement in this rule is necessary. Currently,  422.111(b)(7) requires MA plans to disclose to enrollees any prior authorization rules and other review requirements that must be met in order to ensure payment for the services. In addition,  422.202(b)(2) requires MA plans that use a network of providers to communicate practice guidelines and utilization management guidelines to providers and, as appropriate, to enrollees. Finally, the proposed rule Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Childrens Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program (Interoperability proposed rule), which appeared in the Federal Register on December 13, 2022, includes proposals to
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Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program (Interoperability proposed rule), which appeared in the Federal Register on December 13, 2022, includes proposals to revise the timelines on which MA organizations make prior authorization decisions, to require use of an application programming interface to identify the covered items and services for which prior authorization is required and related documentation requirements, and for MA organizations to report certain metrics regarding use of prior authorization.106Given that proposed rule is pending and the scope of current requirements for MA organizations, we will continue to monitor this area to determine if additional requirements are necessary. Comment: Some commenters made recommendations regarding PA policies. Many of these commenters suggested CMS require MA plans to implement a number of PA standardizations including timelines, format, and content. Other commenters stated that CMS should standardize prior authorization requirements across all CMS programs. Some commenters requested that CMS establish standards for prior authorization requests in regards to both format and contents. Comments also suggested CMS establish standards regarding timelines for payers to response to requests. Some commenters requested CMS require MA plans to publicly post prior authorization denial rates. Another commenter requested that CMS clarify whether prior authorization policies or procedures that dictate specific definitions of medical diagnoses is considered more restrictive than Traditional Medicare. Response: We thank commenters for their suggestions. Existing regulations governing organization determinations, which include pre-service requests and prior authorization requests, address many of the issues raised by these commenters. Under the rules at  422.572(a)(1) related to an expedited organization determination request for a medical item or service (which could include an item or service subject to prior authorization), the MA organization must make its determination and notify the enrollee (and the physician involved, as appropriate) of its decision, whether adverse or favorable, as expeditiously as the enrollees health condition requires, but no later than 72 hours after receiving the request. For a standard organization determination request for a medical item or service (again, which could include an item or service subject to prior authorization), the rules at  422.568(b)(1) require the MA organization to notify the enrollee of its determination as expeditiously as the enrollees health condition requires, but no later than 14 calendar
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the rules at  422.568(b)(1) require the MA organization to notify the enrollee of its determination as expeditiously as the enrollees health condition requires, but no later than 14 calendar days after the date the organization receives the request for a standard organization determination. Under certain limited circumstances, an MA organization may extend these adjudication timeframes. Existing regulations also specify that when an MA organization denies an organization determination request for an item or service, the denial notice must use approved notice language in a readable and understandable form; state the specific reasons for the denial; inform the enrollee of his or her right to a reconsideration; describe both the standard and expedited reconsideration processes, including the enrollees right to, and conditions for, obtaining an expedited reconsideration and the rest of the appeal process; and comply with any other notice requirements specified by CMS. See  422.568(e) and 422.2267(e)(14) and (e)(16). We did not propose to change the timing requirements for organization determinations. In addition to these existing requirements that apply to organization determinations that involve PA, CMS recently released the Interoperability proposed rule,, which includes proposals to expand access to health information and streamline certain procedures used for prior authorization. The Interoperability proposed rule includes proposals requiring implementation of a HL7Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interface (API) for electronic access to certain information about pending and approved prior authorization requests, including the reason for a denial of a prior authorization request. In addition, there are proposals to require MA organizations to send decisions within 72 hours for expedited (that is, urgent) requests and seven calendar days for standard (that is, non-urgent) requests, and publicly report certain prior authorization metrics. We believe the proposals in the Interoperability proposed rule, if finalized, may address these commenters recommendations. As we continue to monitor the needs of the program, we will consider these comments for future rulemaking. Finally, in response to whether prior authorization policies or procedures that dictate specific definitions of medical diagnoses is considered more restrictive than Traditional Medicare, we consider coverage policies that dictate specific definitions of medical diagnoses to be additional coverage criteria that are only authorized in
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whether prior authorization policies or procedures that dictate specific definitions of medical diagnoses is considered more restrictive than Traditional Medicare, we consider coverage policies that dictate specific definitions of medical diagnoses to be additional coverage criteria that are only authorized in accordance with  422.101(b)(6) as finalized in this rule. We do not VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00084 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222203 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations consider internal coverage criteria authorized under  422.101(b)(6) to be more restrictive than Traditional Medicare when the requirements of that regulation are met. We believe that permitting the use of publicly accessible internal coverage criteria in these limited circumstances and contexts is necessary to promote transparent, and evidence-based clinical decisions by MA plans that are consistent with Traditional Medicare. Additionally, we are finalizing requirements at  422.137 that require MA plans UM committees to review all utilization management procedures used by the MA plan. Under these requirements, UM committees are required to ensure compliance with a number of MA rules, including approving only utilization management policies and procedures that use or impose coverage criteria that comply with the requirements and coverage standards at  422.101(b) and medical necessity criteria at  422.101(c)(1). Comment: Some commenters recommended that CMS clarify how we intend to enforce these new utilization management rules and the prior authorization requirements at new section  422.138. One commenter suggested CMS establish third party reviews of prior authorization denials. Another commenter suggested that CMS develop a process for providers to report when MA organizations are not following these rules. Response: We thank commenters. CMS currently monitors MA organization compliance with this existing policy through account management activities, complaint tracking and reporting, and auditing activities. These oversight operations alert CMS to any issues with access to care, and CMS may require MA plans to address these matters if they arise. CMS intends to continue these oversight operations to ensure MA organizations compliance with the final rule. Comment: Some commenters requested that CMS revise the
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access to care, and CMS may require MA plans to address these matters if they arise. CMS intends to continue these oversight operations to ensure MA organizations compliance with the final rule. Comment: Some commenters requested that CMS revise the proposed good cause language at 422.138(c), stating that the proposed language is too broad and may be interpreted too broadly by plans. Some commenters suggested that CMS should not continue to allow coverage decisions to be reopened under the provisions at  422.616. Another commenter suggested we revise  422.138(c) to state that . . . unless the MAO has evidence of good cause or fraud or similar fault to prevent plans from abusing their authority here. Response: We thank commenters for their comments and suggestions. Under the reopening rules at  422.616(a), an organization determination made by an MA organization is one of the types of decisions that may be reopened and revised by the MA organization under the rules in 42 CFR part 405, subpart I. The application of the reopening rules at  405.980(b) permit an MA organization to, among other reasons, reopen an organization determination within 1 year from the date of the initial determination for any reason; in addition, reopenings are permitted within 4 years for good cause; at any time to where there is reliable evidence that the initial determination was procured by fraud or similar fault; and for other specified reasons. However, under the new provision we proposed at  422.138(c), if an MA organization approved the furnishing of a covered item or service through a prior authorization or pre-service determination of coverage or payment, it may not deny coverage later on the basis of lack of medical necessity. We proposed that if the MA organization has the authority to reopen on the basis of good cause or fraud or similar fault, it may do so consistent with the rules at  422.616 which cross-reference the reopening rules at  405.980. An MA organization may reopen an approved organization determination made through a prior authorization or pre- service determination within 4 years from the date of the organization determination for good cause as defined in  405.986 or at any time if there exists reliable evidence as defined in  405.902 that the organization determination was procured by fraud or similar fault as defined in