State Operations Manual (Pub. 100-07), Ch. 3 § 3240
Validation Surveys - General
3240 - Validation Surveys - General
(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)
A “deemed” provider or supplier means a provider or supplier which has voluntarily
applied for and has been accredited by a CMS-approved Medicare accreditation program
whose recommendation for deemed status for that provider or supplier has been accepted
by the RO. A list of current CMS-approved Medicare accreditation programs may be
found at: https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/AOContactInformation.pdf
NOTE: For the purposes of this section, the term “Condition” refers to any Condition of
Participation, Condition for Coverage, or Condition for Certification. (See Chapter VI for
discussion of validation surveys for accredited laboratories.)
SAs may not conduct a Medicare survey of a deemed provider or supplier unless
specifically authorized by the RO to do so. Sections 1864(c) and 1865 of the Act provide
the basis for conducting validation surveys of deemed providers and suppliers.
Regulations authorizing such surveys are found in 42 CFR Part 488. The CMS may
require a survey of a deemed provider or supplier to validate the accreditation
organization’s process. These surveys will be conducted on either a representative
sample basis (i.e., representative sample validation survey), or in response to a substantial
allegation of noncompliance (i.e., complaint survey).
A representative sample validation survey is usually a standard or full survey of all
applicable conditions.
A substantial allegation/complaint survey is authorized by the RO in response to a
credible allegation which, if substantiated, would result in a condition-level citation. The
RO advises the SA which conditions are to be assessed for compliance, based on the
nature of the complaint. See Chapter 5, Sections 5100 – 5110 for more information on
substantial allegation survey policies, procedures and timeframes.
The Form CMS 2802 is transmitted from the RO to the SA via the ASPEN Central Office
(ACO) system, for a representative sample validation survey, or via the ASPEN
Complaint Tracking System (ACTS) for a substantial allegation validation survey. The
RO uses this form to:
• authorize the SA to conduct a validation survey of a particular provider/supplier;
• identify the applicable AO(s);
• indicate the type of validation survey to be conducted;
• indicate, when applicable in the case of a representative sample validation survey,
the AO’s survey end-date; and
• in the case of a substantial allegation validation survey, identify the specific
conditions for which the SA must assess compliance.
If a provider or supplier selected for a validation survey (representative sample or
substantial allegation) is found to have one or more condition-level deficiencies, it will no
longer be deemed to meet the Medicare Conditions. The RO advises the provider or
supplier that its deemed status is removed and that it is being placed under SA
jurisdiction. However, no change is made to the provider’s or supplier’s deemed status in
the Automated Survey Process Environment (ASPEN). Instead, the placement of the
provider or supplier under SA jurisdiction is noted under the Deeming tab within the
certification kit in ACO.