State Operations Manual (Pub. 100-07), Ch. 1 § 1012
Explanation of Certification and Survey
1012 - Explanation of Certification and Survey
(Rev. 1, 05-21-04)
1012A - Meaning of Certification
(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)
Certification is when the SA officially recommends its findings regarding whether health
care entities meet the Act's provider or supplier definitions, and whether the entities
comply with standards required by Federal regulations. State agencies do not have
Medicare determination-making functions or authorities; those authorities are delegated
to CMS’ RO. State agency certifications are the crucial evidence relied upon by the ROs
in approving healthcare entities to participate in Medicare.
(When the RO approves participation in Medicare, it issues the entity a Medicare
provider agreement or supplier approval, and the provider or supplier is then considered
“certified.” (Note that in the case of a health care entity seeking to participate in
Medicare on the basis of accreditation by a CMS-approved Medicare accreditation
program, the accrediting organization (AO) does not “certify” its findings to the RO.
Instead, the AO provides a copy of its survey report, indicates the date of accreditation,
and recommends “deemed status” for the entity. When the RO approves participation,
the provider or supplier is “deemed” to have met the applicable CoPs or CfCs and the
RO issues the entity a Medicare provider agreement or supplier approval. The entity is
then considered “certified” on the basis of the entity’s deemed status.)
Recertification surveys are performed periodically by the SAs, and reaccreditation
surveys are performed periodically by the AOs.
Regardless of whether the survey is conducted for Medicare or Medicaid purposes, the
SA surveys a healthcare entity in exactly the same way to ascertain and certify whether it
meets the applicable Federal health and safety requirements for participation. Except for
nursing homes and entities that participate in both Medicare and Medicaid and where
Federal Medicaid regulations require a healthcare provider to satisfy the Medicare
health and safety standards, CMS’ determination is binding for both programs. For
dually participating nursing homes, regardless of whose decision prevails (CMS’ or the
State’s), that decision is adopted by CMS and applied to the entire facility.
Surveys are necessary for the SA to be able to certify its findings. The law provides
Federal funding for these surveys. SAs may survey many institutions simultaneously for
Medicare, Medicaid, and State licensure purposes, and sometimes for other inspection
programs, so when they do so, the costs are equitably allocated among the programs that
rely upon the survey findings. Accurate accounting of allocation of survey resources is
imperative.
Part of a survey may concern a provider's efforts to prevent environmental hazards due to
contagion, fire, contamination, or structural design and maintenance problems. However,
a survey is not a mere building inspection. Surveys include, among other things,
observation of the manner in which health care services are delivered, or laboratory
services are performed, in order to ascertain that the entity is operating in accordance
with Federal requirements to protect health and safety.
Many aspects of the survey also include scrutinizing the provider's/supplier’s records to
determine whether professional healthcare staff members have been properly noting and
evaluating the progress of the care being provided or managing provider operations with
continuing vigilance. Surveys of SNFs, NFs, HHAs, ESRDs, CMHCs, the psychiatric
hospital special conditions, the hospital transplant program conditions and ICFs/IID are
conducted in accordance with outcome-oriented protocols, which were designed to
concentrate on patient/resident outcomes of care in determining the provider's compliance
with the Federal requirements. For other types of providers/suppliers, surveys may focus
more on compliance with “process-oriented” regulatory requirements.
A provider’s/supplier’s certification generally is not invalidated merely on grounds that
the it has moved a short distance or slightly modified the scope of its services. However,
if a provider or supplier relocates to the extent that it no longer serves the same
community, the provider or supplier has voluntarily ceased to do business and its
Medicare provider agreement or supplier approval must be terminated as a voluntary
termination, effective as of the date it ceased to provide services to its original
community. (See 42 CFR 489.52(b)(3)) The healthcare entity must seek to enroll as an
initial applicant in the Medicare program at its new location. (Note that, for certain
types of providers or suppliers such as critical access hospitals, there are specific
location requirements and even a short move may result in failure to meet all Federal
requirements and involuntary termination of its provider agreement or supplier
approval.)
See 42 CFR §§488.26, 488.330 and 489.52.