Basis for Investigation

5100.1 - Basis for Investigation (Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26) Sections 1864(c) and 1865 of the Social Security Act (the Act) provide the basis for conducting substantial allegation validation – i.e., complaint investigation - surveys of deemed providers/suppliers. Before the SA may conduct a complaint investigation survey at a deemed provider/supplier, it must receive authorization to do so from the CMS location. In accordance with 42 CFR 488.7, the CMS location may authorize a complaint investigation only in response to a “substantial allegation” of noncompliance. A “substantial allegation of noncompliance” is defined at 42 CFR 488.1 as 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 any Medicare condition. In other words, the complaint, if verified and uncorrected at the time of the survey, would result in a condition-level deficiency citation. The SA survey conducted in response to a substantial allegation is one type of validation survey. NOTE: Deemed status is irrelevant for EMTALA complaints. Hospitals and CAHs may not be deemed to be in compliance with EMTALA requirements at 42 CFR 489.24 and the related requirements at 42 CFR 489.20, since these requirements are not part of an approved Medicare hospital or CAH Medicare accreditation program. SAs must refer all EMTALA-related allegations concerning a hospital or CAH to the CMS location, regardless of whether the hospital or CAH is deemed or not. The provisions of Section 5100 do not apply to EMTALA investigations. The SA must notify the CMS location of all complaints/incidents it receives which, if substantiated, would by their manner and degree suggest condition-level noncompliance. The CMS location authorizes the SA to conduct a complaint investigation if it concurs that the nature of the allegation, if it were true and uncorrected, suggests condition-level noncompliance. If the CMS location does not concur that the allegation rises to this level, either the CMS location will change the prioritization of the intake in ACTS to the appropriate level or it will instruct the SA to do so. Regardless of who makes the change in ACTS, the CMS location instructs the SA to refer the complainant to the applicable accrediting organization, following the procedures in section 5100.2 The CMS location communicates its authorization to conduct a complaint investigation of the deemed provider/supplier by completing the applicable Form CMS 2802 (See Exhibit 33) in ACTS, indicating which Conditions of Participation or Conditions for Coverage or Certification are to be investigated by the SA. Absent CMS location authorization, the SA may not conduct a Federal complaint investigation of the deemed provider/supplier. The SA may have authority under State law to conduct its own non-Federal investigation. The CMS location completes the Form CMS 2802 in ACTS even if the SA received an initial verbal authorization from the CMS location to initiate the complaint survey of a deemed provider/supplier. Since ACTS allows the CMS location to authorize a complaint survey electronically it is not necessary for the CMS location to send a signed hard copy of the Form CMS 2802 to the SA via fax or U.S. Postal Service. Once the SA receives the authorization, it may begin its complaint investigation of a deemed provider/supplier. Whether the survey is of one or all Medicare conditions, it will be treated as a complaint survey under ACTS rather than a re-certification survey, since the complaint/incident is the basis for the survey. If the CMS location learns directly of a complaint/incident concerning a deemed provider/supplier, it will review the complaint/incident to assign a priority consistent with Section 5075. If the complaint/incident is found to be a substantial allegation of noncompliance, prioritized for investigation as either immediate jeopardy or non-IJ high, the CMS location authorizes the SA to conduct a complaint investigation or, in a limited number of cases, the CMS location conducts the complaint investigation. There may be occasions during the course of a State-only activity in a deemed provider/supplier when State surveyors observe a situation they believe may constitute IJ or other substantial noncompliance with a Medicare condition. In such circumstances, the State must contact the CMS location by telephone or e-mail, explain the situation, and request authorization to conduct a Federal complaint survey. CMS authorizes the investigation as a complaint validation (i.e., substantial allegation validation) survey if it concurs that there may be condition-level noncompliance. The complaint is entered into ACTS at the earliest possible opportunity.