WASHINGTON, D.C. — The Centers for Medicare & Medicaid Services has finalized new regulations aimed at strengthening oversight of healthcare accreditation organizations, responding to concerns that some facilities retained accreditation despite quality and safety deficiencies and that conflicts of interest may have undermined the integrity of the accreditation process.
The final rule affects most CMS-approved accrediting organizations, known as AOs, which conduct inspections of healthcare providers and suppliers participating in Medicare and Medicaid programs. CMS said the changes are intended to improve patient safety, increase accountability and align accreditor practices more closely with government survey standards.
Accrediting organizations play a central role in federal healthcare oversight. More than 9,000 healthcare providers are surveyed annually by CMS-approved accreditors, whose findings can allow facilities to meet Medicare and Medicaid participation requirements without direct state inspections.
CMS cited several concerns that prompted the regulatory changes, including instances where providers retained accreditation after being terminated from Medicare or Medicaid programs for quality and safety issues. The agency also raised concerns about accreditors offering fee-based consulting services to facilities they later inspect, creating potential conflicts of interest.
Federal officials also pointed to inconsistencies between accreditor surveys and inspections conducted by state survey agencies, including cases in which healthcare facilities received advance notice of accreditation surveys, a practice not permitted under CMS policies.
Under the final rule, accrediting organizations will be required to meet standards more closely aligned with those applied to state survey agencies. The regulation also imposes new restrictions on consulting relationships between accreditors and the facilities they oversee.
The rule prohibits accrediting organization owners, surveyors and employees, as well as their immediate family members, from participating in surveys or related activities involving facilities in which they have a financial interest or other relationship.
CMS is also establishing a new direct-observation validation process to evaluate accreditor performance. Organizations receiving unacceptable performance scores will be required to submit corrective action plans that will be publicly reported.
Additional provisions require greater consistency in survey procedures and training requirements across accrediting organizations and state survey agencies.
CMS said the changes are intended to strengthen public trust in the accreditation process while improving transparency and reducing the risk of conflicts that could affect patient care and safety.
The agency currently approves nine accrediting organizations to survey Medicare-certified facilities for deeming purposes. The rule does not apply to organizations that accredit clinical laboratories or certain non-certified suppliers, including advanced diagnostic imaging providers, home infusion therapy providers, diabetes self-management training suppliers and durable medical equipment suppliers.
The final rule follows a proposed rule issued in February 2024 and incorporates public feedback received during the comment period.
The final rule, CMS-3367-FC, is available through the Federal Register at https://www.federalregister.gov/.
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