Quality, Safety & Oversight - Regulations, Certification & Compliance

The Social Security Act (the Act) mandates the federal government establish 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 Title 42 Code of Federal Regulations. The Act designates those providers and suppliers that are subject to federal health care quality standards. The Secretary of the Department of Health and Human Services (HHS) has designated CMS to administer the standards compliance aspects of the Medicare and Medicaid programs. 

Medicare, a federal insurance program providing a wide range of benefits for specific periods of time through providers and suppliers participating in the program. The federal government makes payment for services through designated Medicare Administrative Contractors (MACs) to the providers and suppliers.

• Providers include patient care institutions like hospitals, critical access hospitals (CAHs), hospices, nursing homes, and home health agencies (HHAs). 
• Suppliers are agencies for diagnosis and therapy rather than sustained patient care, such as laboratories, clinics, and ambulatory surgery centers (ASCs). 

Medicaid is a state program that provides medical services to clients of a state’s public assistance program and, at the state's option, others in need. 

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 that participate only in Medicaid are (unskilled) nursing facilities (NFs), psychiatric residential treatment facilities (PRTFs) and intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs). Medicaid requires nursing facilities to meet virtually the same requirements that skilled nursing facilities participating in Medicare must meet. ICF/IIDs must meet special Medicaid standards.

CLIA

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all testing laboratories to ensure the accuracy, reliability, and timeliness of patient test results, no matter where the test was performed. The CLIA regulations are based on the complexity of the test method; so the more complicated the test, the more stringent the requirements.  

State Survey Agencies

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

To make the enrollment process more efficient for Medicare-participating certified providers and suppliers, CMS transitioned 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 started 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:

• ASCs
• Community Mental Health Centers (CMHCs)
• Comprehensive Outpatient Rehabilitation Facilities (CORFs)
• End-Stage Renal Disease (ESRD) facilities
• FQHCs
• 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)
• SNFs

This transition work doesn’t apply to the following Medicaid-participating facilities:

• PRTFs
• ICF/IIDs
• 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.

The Medicare Conditions of Participation, Conditions for Coverage & Requirements 

The Medicare Conditions of Participation, Conditions for Coverage and Requirements for SNFs and NFs are sets of requirements for acceptable quality in operating health care entities. There’s a set of conditions (or requirements for SNFs and NFs) for each type of provider or supplier subject to certification. In addition to each condition (or requirement for SNFs and NFs) there’s a group of related quality standards, with the condition or requirement expressed in a summary lead sentence or paragraph characterizing the quality or result of operations all the subsidiary standards are directed to. The SA ascertains, by a survey conducted by qualified health professionals, whether and how each standard is met. 

The Interpretive Guidelines interpret and clarify the conditions (or requirements for SNFs and NFs). The Interpretive Guidelines merely define or explain the relevant statute and regulations and don’t impose any requirements that aren’t otherwise in statutes or regulations.

Surveys

Each provider type is surveyed according to the appropriate protocols based on the substantive requirements in the statute and regulations to see if a citation of non-compliance is appropriate. Deficiencies are based on a violation of the statute or regulations, which, in turn, are based on observations of the providers' performance or practices. 

While an institution may fail to comply with 1 or more of the subsidiary standards in any given survey, it can’t participate in Medicare unless it meets each and every condition or attains substantial compliance with SNF and NF requirements.