CMS accomplishes quality assurance functions under the Social Security Act (the Act) and the Public Health Service Act (for clinical laboratories), working jointly with SAs, Accrediting Organizations (AOs), and contracts with qualified organizations.
The Act mandates the establishment of minimum health and safety standards that must be met by participating providers and suppliers. When significant problems are determined, CMS has legislative authority to impose remedies on the provider or supplier.
If a provider or supplier fails to implement appropriate remedial actions for serious deficiencies, CMS can terminate their Medicare (and Medicaid, when applicable) provider agreements or supplier approval, which also ends federal funding.
For clinical laboratories, failure to correct issues may also result in sanctions, like revoking their Clinical Laboratory Improvement Amendments (CLIA) certificate. Once revoked, the laboratory can no longer perform any human specimen testing.