On June 12, The Centers for Medicare & Medicaid Services (CMS) issued a final rule revising how the agency conducts oversight of accrediting organizations that ensure that hospitals and other healthcare providers are in compliance with the Medicare Conditions of Participation (CoPs). That said, a bit of background is in order.
Surveyors’ Standards
According to a CMS fact sheet summarizing the final rule, AOs play an important role in determining whether healthcare providers and suppliers participating in Medicare or Medicaid programs meet health and safety requirements. “Each year, CMS-approved AOs survey more than 9,000 healthcare providers for compliance with health and safety requirements.”
For CMS to approve an AO's program, their accreditation standards must meet or exceed the requirements and conditions under the Medicare or Medicaid programs to ensure patients receive quality and safe care. When CMS approves an AO program, the AO can perform surveys in lieu of State Survey Agencies (SAs). By taking on this role, AOs accept a “public trust" responsibility in their oversight of the nation's healthcare providers.
Surveyors’ Shortcomings
While much is expected from these AOs as far as their role in safeguarding public health, CMS has nevertheless identified several concerns about AO performance of its fiduciary duties, such as the following:
- Providers and suppliers retaining their accreditation after they are terminated from Medicare or Medicaid programs for quality and safety concerns.
- Conflicts of interest arising from AOs providing fee-based consulting services to the providers and suppliers they accredit (often just before an accreditation survey), potentially compromising the integrity of the process.
- Inconsistent survey results due to AO standards or practices that differ from those of SAs (e.g., AOs notifying facilities before the date of their onsite surveys, which is against CMS policy).
CMS provides annual Reports to Congress (RTCs) on AO oversight. These RTCs highlight the agency’s concerns about AO performance and outline plans for “correcting deficient AO survey performance, strengthening oversight of AOs, reducing conflicts of interest, and establishing greater consistency in survey processes and standards to improve patient care and ensure safety in participating facilities.” It is out of these corrective plans that this new final rule rises.
Provisions of the Final Rule
The Final Rule includes the following changes to CMS’ AO requirements, which align with CMS’ National Quality Strategy:
- Holding AOs accountable to the same Medicare standards and strengthening comparability of survey processes to those of 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 healthcare facilities they accredit.
- Preventing AO conflicts of interest by prohibiting AO owners, surveyors and other employees, as well as their immediate family members who have an interest in or relationship with a healthcare 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, and from having access to survey records related to that facility.
- Improving AO performance by requiring AOs with unacceptable performance measure scores, determined through a direct observation validation survey by CMS (a new process for monitoring AO performance established as a requirement in this rule), 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 in the final rule are intended to 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 rule will 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 suppliers and suppliers of prosthetics, orthotics, and supplies (DMEPOS).
The American Hospital Association had this to say about the final rule:
To reduce burden on providers, the final rule phases out the use of “look-back” validation surveys, replacing them with direct observation validation surveys in which state agencies accompany AOs on surveys to directly evaluate their work. The rule also implements several policies intended to improve consistency in the survey process, including requiring AOs to match their baseline standards with the CoPs and provide a crosswalk of those standards with the CoPs. It also requires AO surveyors to take the same basic training courses as state agency surveyors and implements several conflict-of-interest policies for AOs, including certain restrictions on fee-based consulting services.
The changes addressed in the final rule will take effect June 16, 2027. To access the Final Rule, (CMS-3367-FC), visit https://www.federalregister.gov/.
