SOM Chapter 5 - Page 22
Sections 1864(c) and 1865 of the Social Security Act (the Act) provide the basis for
conducting complaint surveys of deemed providers/suppliers. The SAs should report
poor quality of care or other indications of noncompliance with the Conditions of
Participation (COP)/Conditions for Coverage (CfC) for deemed providers/suppliers to the
RO. The SA refers to the CMS Regional Office (RO) all allegations for deemed
providers/suppliers and all EMTALA allegations for Medicare-participating hospitals.
The RO may authorize the SA to investigate specific areas of the hospital’s operation
related to EMTALA requirements for alleged noncompliance with 42 CFR 489.24 and
the related requirements at 42 CFR 489.20. The SA has responsibility to investigate
whether the conditions are met. Entities and facilities that are subject to the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) are responsible for meeting CLIA
requirements under 42 CFR Part 493.
A substantial allegation of noncompliance refers to a complaint from any of a variety of
sources, including complaints submitted in person, by telephone, through written
correspondence, or in news media articles, that, if substantiated, would have an impact on
the health and safety of patients, and that raises doubts as to a provider’s or supplier’s
compliance with one or more of the COP or CfC.
If the RO learns of a substantial allegation of noncompliance concerning a deemed
provider/supplier, it will review the complaint, to determine if the complaint identifies the
provider/supplier noncompliance with Medicare conditions. If the RO identifies potential
noncompliance, it refers the complaint to the SA for investigation or conducts its own
investigation. If the RO directly receives the allegation , it is responsible for sending the
complainant a letter, which acknowledges the receipt of the complaint and advises the
complainant that an investigation will be initiated. In addition, the RO is responsible for
sending the complainant follow-up letters. These letters may include information
regarding the results of the complaint investigation.
If the SA receives a substantial allegation of noncompliance directly from a complainant
regarding a deemed provider/supplier, it acknowledges receipt of the complaint, and
advises the complainant that an investigation will be initiated when warranted. In this
instance, the RO is not responsible for sending the complainant a letter. The SA forwards
a copy of the acknowledgment letter and the complaint to the RO through the ACTS
system. The SA may not conduct a complaint survey for a deemed provider/supplier
unless it is authorized by the RO. The RO is responsible for determining whether the
complaint identifies an allegation of Medicare noncompliance. If the RO determines that
the complaint does not warrant an investigation by the SA, it sends a copy of the
complaint allegation to the appropriate accreditation organization (AO).
There may be occasions during the course of a state-only activity in a deemed
provider/supplier that state surveyors observe a situation they believe may constitute IJ or
noncompliance with a Medicare condition. In such circumstances, the state should
contact the RO by telephone, explain the situation, and request permission to convert the
survey into a Medicare complaint validation survey. CMS authorizes the investigation as