0938-AU88 202510 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 Strengthening Oversight of Accrediting Organizations (AO), Burden Reduction, and Related Provisions (CMS-3367)

This final rule sets forth a number of provisions to strengthen the oversight of accrediting organizations (AO) by addressing conflicts of interest, establishing consistent standards, processes and definitions, and updating the validation and performance standards systems. 

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No Regulatory 42 CFR 488 42 CFR 489 42 U.S.C. 1302 42 U.S.C. 1395hh Statutory Final 02/15/2027 MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule. Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner. Yes

We seek to strengthen public trust in CMS-approved Accrediting Organization (AO) findings and to promote the health and safety of patients who receive services from Medicare and Medicaid-participating providers accredited by CMS-approved AOs.  When AOs request and receive CMS approval to determine compliance for facilities they accredit and are deemed by CMS to meet federal requirements, they take on a public trust responsibility in their oversight of providers and suppliers across the country. CMS needs to hold these organizations accountable for that responsibility and to eliminate any corporate conflicts of interest. Patients need to be able to rely on the strength of that accreditation to be assured that their health care services will be safe and of high quality. Where there are gaps in that accreditation process, or where quality issues are not fully identified or investigated by the AO, it means that current and future patients may experience unnecessary harm or quality issues.  

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This rule implements changes under 42 U.S.C. 1302 and 1395hh (the Social Security Act).

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In developing the policies contained in this rule, we considered several alternatives affecting AO fee-based consulting and the validation program.  These alternatives will be described in the rule.

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In developing this regulation, we carefully considered its potential effects including both costs and benefits.  The overall benefit of this rule would be to improve CMS’ oversight of the AOs and to improve the overall quality and safety of healthcare.  More specifically, the benefits of this rule include the improvement of the validation process and anticipated reductions in the validation disparity rate, the additional performance measure and the implementation of plans of correction that would help AOs that have low performance measure scores to prepare a plan for how to improve their performance, and the prevention and removal of potential and actual conflicts of interest. We note that the generation of benefits is contingent upon behavior change, which entails costs, as having negligible costs would therefore be anticipated to have minimal benefits.  As we move toward publication, estimates of costs and benefits will be included in the rule.

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The changes to be finalized in this rule are intended to mitigate risks and improve patient care. 

]]> NPRM 02/15/2024 89 FR 11996 NPRM Comment Period End 04/15/2024 Final Action 02/00/2027 No None No No No Michelle Geppi Special Assistant 0938 Centers for Medicare & Medicaid Services CMS 410 786-4844 michelle.geppi@cms.hhs.gov Center for Clinical Standards and Quality, 7500 Security Boulevard, Baltimore MD 21244