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Accrediting Organization Proposed Rule Fact Sheet

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Strengthening CMS Oversight of Accrediting Organizations

Each year, Accrediting Organizations (AOs) with a CMS-approved program survey over 9,000 accredited health care providers and suppliers participating in the Medicare/Medicaid program for compliance with health and safety requirements. These accredited facilities must meet all applicable federal participation requirements and are deemed to meet them through their CMS-approved AO accreditation. The AO’s approved program standards must meet or exceed CMS health and safety standards to ensure the quality of care provided to patients. 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. 

In recent years, CMS has identified several concerns related to AO performance: 

  • Providers and suppliers that have been terminated from the Medicare/Medicaid program but retain accreditation despite significant quality and safety concerns;
  • AOs provide fee-based consulting services to the providers and suppliers they accredit, potentially affecting the integrity of the onsite survey process and decreasing public trust by creating conflicts of interest;
  • Inconsistent survey results due to differing AO standards or practices (such as AOs notifying facilities of the date of their onsite surveys in advance contrary to CMS policies).

CMS’s annual AO oversight Reports to Congress (RTCs) highlight the agency’s significant concerns regarding AO performance that need to be addressed. CMS is committed to improving current deficiencies and strengthening oversight of AOs and establishing greater consistency in survey processes and standards to improve patient care. 

Notice of Proposed Rulemaking

CMS takes its responsibility to ensure the quality and safety of patient care very seriously. We recognize there are opportunities to improve our current AO performance review process, so we can better assess whether AOs are meeting their public-trust obligations.

To fulfill this public-trust mission, CMS released a Notice of Proposed Rulemaking (NPRM) on February 8, 2024 to bolster oversight of AOs and ensure providers meet health and safety standards so that patients can receive high-quality, safe care from our nation’s health care facilities. The most recent AO oversight RTC, the 2021 RTC, covers the 2020 oversight and validation activities for all AOs in fiscal year 2020, as well as those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).     

Provisions of the Proposed Rule 

The changes proposed in the NPRM would strengthen oversight of AOs, reduce conflicts of interest, and strive for enhanced consistency of survey processes, all of which aim to improve patient safety and quality of care. These proposed changes, which align with CMS’s National Quality Strategy, are outlined below:

  • Holding AOs accountable to the same standards as State Survey Agencies (SAs), that also conduct surveys on behalf of CMS.
  • Ensuring that AOs remain independent reviewers by addressing conflicts of interest and placing certain limitations on the fee-based consulting services AOs provide to the health care facilities they accredit.
  • Preventing AO conflicts of interest by prohibiting AO owners, surveyors, and other employees, and as well as their immediate family members that have an interest in or relationship with a health care facility accredited by the AO from participating in surveys, having input into the survey results and involvement in pre- or post-survey  activities of that facility, or from having access to survey records related to that facility.
  • Addressing potential and actual conflicts of interest by requiring AOs to report specific information to CMS about how they will monitor, prevent, and handle conflicts of interest and fee-based consulting services they provide.
  • Improving AO performance by requiring AOs with poor performance to submit a publicly reported correction plan to CMS.
  • Improving consistency and standardization in surveys nationwide by more closely aligning AO survey activity requirements and staff training with those of SAs.

Additional changes proposed in the NPRM would reduce the burden on providers, strengthen survey policies, and increase the transparency of AO practices.

Affected AOs

Currently, CMS has approved nine AOs to survey and accredit Medicare-certified facilities. The changes outlined in the NPRM affect all AOs except those that accredit clinical laboratories and noncertified suppliers, which include suppliers of advanced diagnostic imaging (ADI), home infusion therapy (HIT), and diabetes self-management training (DSMT), as well as durable medical equipment (DME) suppliers and suppliers of durable medical equipment prosthetics, orthotics, and supplies (DMEPOS).

Proposed Changes and Strategic Aims at a Glance

Additional details on the proposed changes in this rule are described in the table below: 

Priority Area

Proposed Changes

Strengthen Oversight

  • Standardize the AO application process to require AO standards to match the Medicare Conditions of Participation (CoPs), CfCs, and Requirements (AOs may still exceed Medicare standards by differentiating in their applications between standards met and those exceeded).
  • Require publicly reported plans of correction in cases of poor AO performance.
  • Update AO hospital accreditation programs to include standards and surveys for the three additional CoPs for psychiatric hospitals.
  • Strengthen and expand evaluation of AO surveyors’ competency in regard to performing surveys.
  • Expand validation programs to include direct-observation surveys.

Enhance Enforcement

  • Require accredited providers or suppliers involuntarily terminated from participation in Medicare or Medicaid and seeking re-entry to remain under the oversight of the SA for a reasonable assurance period, of a length to be determined by CMS, and during this time, prohibit them from obtaining deeming accreditation from a CMS-approved AO.
  • Establish that Medicare would not recognize the deemed status accreditation of a provider or supplier that has been terminated from the Medicare program.
  • Require AOs to submit an agreement (with their initial and renewal applications) to withdraw or revoke the deemed status accreditation of any accredited provider or supplier that has been terminated from the Medicare/Medicaid program within 5 days after being notified of the provider’s or supplier’s termination.
  • Impose consequences for violating conflict-of-interest provisions, including putting AO programs under performance review or terminating AO program approval.

Increase Transparency

  • Prohibit AO owners, surveyors, and other employees from participating in surveys of health care providers in which they have an interest or a relationship (e.g., facilities where they work, have a financial interest, or for which they have consulted).
  • Place certain limitations on the provision of fee-based consulting services by AOs to the health care facilities for which they are currently providing accreditation services.
  • Strengthen AO performance measures and revise the disparity rate calculation methodology used to determine the ability of AOs to correctly identify deficiencies. These new disparity rates would be included in the Annual Report to Congress.
  • Require publicly reportable plans of correction for significant negative AO performance measure findings.

Ensure Health and Safety

  • Fortify AO survey process requirements to align with SA requirements.
  • Require AO surveyors to take the same online basic trainings as SA surveyors.
  • Strengthen survey policies to ensure that surveys by AOs are unannounced.

Reduce Provider Burden

  • Through proposed revision to the validation program, reduce provider burden by reducing look-back validation surveys by 50 percent.

Comment on the NPRM 

Please see the proposed rule to find out how to formally provide comments, which must be submitted by the close of the 60-day comment period, on April 15, 2024. 

When commenting, refer to file code CMS 3367-P.

Please note that fax transmissions won’t be accepted. Submit your comments: 

  • Electronically through Regulations.gov 
  • By regular mail
  • By express or overnight mail

To view the proposed rule, (CMS-3367-P), please visit https://www.federalregister.gov/.
 

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