State Operations Manual (Pub. 100-07), Ch. 1 § 1010
Certification Related Functions of SA
1010 - Certification Related Functions of SA
(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)
The functions that the SAs perform under the agreements in §1864 of the Act are referred
to collectively as the certification process. This includes, but is not limited to:
A. Identifying Potential Participants - The law guarantees to Medicare
beneficiaries that payment will be made for health services furnished in or by
entities that meet stipulated requirements of the Act. Identification includes those
laboratories seeking to participate in the CLIA program.
B. Conducting Investigations and Fact-Finding Surveys - Verifying how well the
health care entities comply with the applicable requirements for nursing facilities
(NFs) and skilled nursing facilities (SNFs), Conditions of Participation (CoPs) for
providers, Conditions for Coverage (CfCs) for most institutional suppliers, or
Conditions for Certification for rural health clinics (RHCs).
C. Certifying and Recertifying - Certifications are periodically sent to the
appropriate Federal or State agencies regarding whether entities, including CLIA
laboratories, are qualified to participate in the programs.
D. Explaining Requirements - Advising providers and suppliers and potential
providers and suppliers in regard to applicable Federal regulations to enable them
to qualify for participation in the programs and to maintain standards of health
care consistent with the CoPs, requirements, CfCs or Conditions for Certification.
Also, as mandated by §§1819(g)(1)(B) and 1919(g)(1)(B) of the Act, States must
conduct periodic educational programs for the staff and residents, and their
representatives, of SNFs and NFs in order to present current regulations,
procedures, and policies.
E. Operating Toll-Free Home Health Hotline - Maintain a toll-free telephone
hotline to collect, maintain, and continually update information on Medicare-
approved HHAs. The hotline is also used to receive complaints and answer
questions about HHAs in the State or locality. See §1864(b) of the Act.
The SA is also authorized to perform numerous other functions under a blanket clause of
its SA agreement, by special agreement, or by statute. These include:
F. Identifying Prospective Payment System (PPS) Excluded Institutions -
Certification information helps in identifying institutions or components of
institutions that meet special requirements qualifying them to be excluded from
the Medicare PPS.
G. Participating on Validation Surveys of Deemed Providers/Suppliers - These
surveys are intended to furnish DHHS and Congress information on the validity of
the survey process of accrediting organizations with CMS-approved Medicare
accrediting programs under which a provider or supplier may be "deemed" to be
in compliance with the applicable CoPs, CfCs, or Conditions for Certification.
Validation surveys include both representative sample surveys as well as
substantial allegations of non-compliance (complaint) surveys.
H. Proficiency Testing - Monitor programs of proficiency testing in laboratories and
contribute laboratory compliance findings to use in the CLIA Laboratory
Certification Program.
I. Direct Data Entry - Enter data from surveys of deemed and non-deemed
providers or suppliers, including revisits, and complaint investigations into CMS
data systems, for example ASPEN Central Office (ACO) or ASPEN Complaint
Incident Tracking System (ACTS). Update information about providers,
suppliers, and CLIA laboratories in the appropriate system when indicated.
J. Nurse Aide Training - Specify and review Nurse Aide Training and Competency
Evaluation Programs (NATCEPs) and/or Nurse Aide Competency Evaluation
Programs (NACEPs). (See §§1819(e)(1) and 1919(e)(1) of the Act.)
K. Nurse Aide Registry (NAR) - Establish and maintain a registry for all individuals
who have satisfactorily completed NATCEP or a NACEP. (See Chapter 4, §4145
of this manual and §§1819(e)(2) and 1919(e)(2) of the Act.)
L. Resident Assessment Instrument (RAI) - Specify a RAI for use in the LTC
facilities participating in Medicare and/or Medicaid. (See Chapter 4, §4145.4 of
this manual.)
M. Records and Reports - Maintain pertinent survey, certification, statistical, or
other records for a period of at least 4 years and make reports in the form and
content as the Secretary may require.
N. Ensure that applicants to be certified as Medicare providers/suppliers have
submitted an enrollment application to the appropriate Medicare Administrative
Contractor (MAC) and that the MAC has recommended the applicant for
enrollment prior to conducting an initial survey.
(NOTE: Approval and certification of hospital organ transplantation centers
have unique features. Transplant centers are not separate providers, but
participate in Medicare on the basis of the existing provider agreement between
the Medicare program and the hospital that houses the transplant center.
Therefore, transplant centers are not eligible to enroll separately. Rather, a
hospital is required to submit a Form CMS 855A to the MAC to add a transplant
center. In accordance with Section 15.5.2.5.C of the Program Integrity Manual,
Publication 100-08: “For purposes of Medicare enrollment, a hospital
transplant center is treated similarly to a hospital sub-unit. If the hospital wishes
to add a transplant center, it must check the “other” box in section 2A2 of the
CMS-855A, write “transplant center” on the space provided, and follow the
standard instructions for adding a sub-unit. Unless CMS indicates otherwise, the
contractor shall process the application in the same manner it would the addition
of a hospital sub-unit; however, no separate enrollment in PECOS need be
created for the transplant center).
(Hospital transplant centers are subject not only to all applicable CoPs in 42
CFR Part 482, Subparts A, B, C and D, but are also subject to the special
transplant CoPs in Subpart E. Even though there is a separate CCN number
issued for each approved transplant center program, this is a function of the
operational design of the CCN fields in the data system supporting Federal
surveys; transplant center CCNs, unlike other CCNs, do not correspond to
separate provider agreements or supplier approvals.)
A hospital seeking initial approval to offer organ transplantation services must not
only submit a CMS-855A to add a transplant center, but must also notify CMS
Central Office of its request. Central Office is responsible for advising SAs (or CMS
contract transplant surveyors, as applicable) if and when to conduct initial transplant
program surveys. Based on the survey findings, transplant programs may be
approved.