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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. 

Overall Description of Deadline: 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.

Statement of Need:

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.  

Summary of the Legal Basis:

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

Alternatives:

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.

Anticipated Costs and Benefits:

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.

Risks:

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