0938-AV44 202410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Interoperability Standards and Prior Authorization for Drugs (CMS-0062)

This rule would propose new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plans (QHPs) offered on the Federally-facilitated Exchanges (FFEs) to streamline processes for the prior authorization for certain drugs.  We are developing this rule, in part, based on the significant number of public commenters who responded to the CMS Interoperability and Prior Authorization proposed rule (87 FR 76238) urging CMS to expand the proposed prior authorization policies to include drugs.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 42 CFR 422 42 CFR 431 42 CFR 438 42 CFR 457 45 CFR 156 42 U.S.C. 1395hh Yes

This proposed rule furthers CMS efforts to reduce administrative burden on providers and allow them to spend more time on patient care. The proposals increase appropriate electronic access to health care data, while keeping that information safe and secure by utilizing the latest standards adopted by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology. The proposals build on the CMS Interoperability and Prior Authorization final rule by expanding the types of prior authorizations that could be conducted electronically to include those for drugs. Based on public comments received on the CMS Interoperability and Prior Authorization proposed rule (87 FR 76238), we expect patients and providers will overwhelmingly support the addition of drugs to our prior authorization policies and the increased alignment across Medicare, Medicaid, CHIP and Marketplace coverage.

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The policies in this proposed rule are intended, where possible, to address disparities in standards and processes for prior authorization for drugs across Medicare Advantage, Medicaid, CHIP and QHPs offered on the FFEs. The statutory authority for these proposals is contained in the Social Security Act (42 U.S.C. 1302 and 1395hh).

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In this proposed rule, we continue to build on the efforts from the CMS Interoperability and Patient Access final rule (85 FR 25510) and the CMS Interoperability and Prior Authorization final rule (89 FR 8758) to advance interoperability, improve care coordination, empower patients with access to their data, and improve prior authorization processes. When we excluded prior authorizations for drugs from the CMS Interoperability and Prior Authorization proposed rule, we received significant public feedback that we should reconsider that decision with future rulemaking. Those comments and engagements with industry experts over the past two years support our conclusions that the alternative of continuing to exclude drugs would leave significant burden on patients and providers.

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We expect this rule will not be significant under section 3(f)(1). This rule proposes updates to the Application Programming Interfaces (APIs) already required by previous rules, proposes to require standards that were previously recommended, and proposes standards for the electronic prior authorization of drugs that are already required or being implemented across the country. We acknowledge that business processes would need to be updated for these payers, but we do not believe these costs would exceed the section 3(f)(1) threshold.

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None. These policies are natural continuations of the policies finalized in the CMS Interoperability and Prior Authorization final rule. Adding certain drugs to the prior authorization requirements and data availability would close a gap in our current requirements.

]]> NPRM 03/00/2025 No Federal State No No No Alexandra Mugge Director & Chief Health Informatics Officer, Health Informatics and Interoperability Group 0938 Centers for Medicare & Medicaid Services CMS 410 786-4457 alexandra.mugge@cms.hhs.gov Office of Healthcare Experience and Interoperability, MS: C5-02-00, 7500 Security Boulevard, Baltimore MD 21244