Quality, Safety & Oversight - Certification & Compliance

The Social Security Act (the Act) mandates the establishment of minimum health and safety and standards that must be met by providers and suppliers participating in the Medicare and Medicaid programs.  These standards are found in the 42 Code of Federal Regulations.  The Secretary of the Department of Health and Human Services has designated CMS to administer the standards compliance aspects of these programs. 

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed.  The CLIA regulations are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements. Medicare is a Federal insurance program providing a wide range of benefits for specific periods of time through providers and suppliers participating in the program. The Act designates those providers and suppliers that are subject to Federal health care quality standards. The Federal Government makes payment for services through designated Medicare Administrative Contractors (MACs)  to the providers and suppliers.

• Providers, in Medicare terminology, include patient care institutions such as hospitals, critical access hospitals, hospices, nursing homes, and home health agencies. 
• Suppliers are agencies for diagnosis and therapy rather than sustained patient care, such as laboratories, clinics, and ambulatory surgery centers. 

Medicaid is a State program that provides medical services to clients of the State public assistance program and, at the State's option, other needy individuals.  When services are furnished through institutions that must be certified for Medicare, the institutional standards must be met for Medicaid as well. 

In general, the only types of institutions participating solely in Medicaid are (unskilled) Nursing Facilities, Psychiatric Residential Treatment Facilities, and Intermediate Care Facilities for Individuals with Intellectual Disabilities.  Medicaid requires Nursing Facilities to meet virtually the same requirements that Skilled Nursing Facilities participating in Medicare must meet.  Intermediate Care Facilities for Individuals with Intellectual Disabilities must comply with special Medicaid standards.

State Survey Agencies, under agreements between the State and the Secretary, carry out the Medicare certification process.  The State Survey Agency is also authorized to set and enforce standards for CLIA and Medicaid.  (The State Survey Agency may partially re-delegate the functions to local agencies.)

To improve efficiency in the enrollment process for Medicare-participating certified providers and suppliers, CMS began transitioning certain certification enrollment functions performed by the CMS Locations to CMS’ Center for Program Integrity (CPI) Provider Enrollment and Oversight Group (PEOG) and the MACs.

The transition of certification enrollment work commenced with voluntary terminations on July 27, 2020.  The second implementation consisted of the transition of the Federally Qualified Health Center (FQHC) initial enrollments on March 22, 2021.

The Change of Ownership (CHOW), changes of information or administrative updates, relocations, and initial enrollment work will transition throughout CY2022.  This work applies to the following Medicare-participating facilities:

• Ambulatory Surgical Centers (ASCs);
• Community Mental Health Centers (CMHCs);
• Comprehensive Outpatient Rehabilitation Facilities (CORFs);
• End-Stage Renal Disease (ESRD) Facilities;
• Federally Qualified Health Centers (FQHCs);
• Home Health Agencies (HHAs);
• Hospices;
• Hospitals;
• Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (OPT/OSP);
• Portable X-Ray (PXR); and,
•  Skilled Nursing Facilities (SNF).

This transition work does not apply to the following Medicaid-participating facilities:

• Psychiatric Residential Treatment Facilities (PRTFs);
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID); and
• Nursing Facilities (NFs).

This transition also does not apply to Organ Procurement Organizations (OPOs) and Religious Nonmedical Health Care Institutions (RNHCIs), which are managed by the CMS Locations.  In addition, the transition does not apply to CLIA laboratories.