FQHC – Requirements and Enrollment Process

Federally Qualified Health Centers (FQHC) are safety net providers that primarily provide services typically furnished in an outpatient clinic. FQHC’s are paid based on the FQHC Prospective Payment System (PPS). FQHC Services include Physician services, services and supplies incident-to the services of qualified providers, non-physician provider services, Part B covered drugs furnished with practitioner services, nurse visits to home-bound patients in health provider shortage areas, diabetes management and medical nutrition therapy.

FQHC Requirements

To be certified as an FQHC, an entity must meet one of these requirements:

• Is receiving a grant under Section 330 of the Public Health Service (PHS) Act (42 United States Code Section 254a) or is receiving funding from such a grant and meets other requirements
• Is not receiving a grant under Section 330 of the PHS Act but is determined by the Secretary of the Department of Health & Human Services (HHS) to meet the requirements for receiving such a grant (qualifies as a “FQHC look-alike”) based on the recommendation of the Health Resources and Services Administration
• Was treated by the Secretary of HHS for purposes of Medicare Part B as a comprehensive Federally-funded health center as of January 1, 1990
• Is operating as an outpatient health program or facility of a tribe or tribal organization under the Indian Self-Determination Act or as an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act as of October 1991

For certification as an FQHC, the entity must meet all of these requirements:

• Provide comprehensive services and have an ongoing quality assurance program
• Meet other health and safety requirements
• Not be concurrently approved as a Rural Health Clinic

Medicare Enrollment Process

To participate in the Medicare program as an FQHC, entities must submit to CMS the following:

• A signed and completed application Form CMS-855A Medicare Enrollment Application – Institutional Providers.  Applications must be submitted as follows:
• In the case of applicants that are operated by a tribe or tribal organization, to the jurisdiction H A/B MAC; and
• In the case of all other applicants, to the A/B MAC that covers the State where the applicant facility is located. (Previously all FQHC applications and claims were processed by one national fiscal intermediary. This system is being phased out as CMS implements the MAC contracts, and all new FQHC applications are to be assigned to the applicable MAC, as described above. In the case of a new applicant that is a permanent unit owned and operated by an existing FQHC in a different location in the same state, this could mean that each permanent unit would have a different MAC until the transition to MACs has been completed nationwide. However, accommodations have been made for a set of FQHCs that straddle MAC jurisdiction boundaries to continue filing a consolidated cost report.)
• Two copies of the standard attestation statement, each with an original signature and date.  When countersigned by CMS, this statement serves as the Medicare FQHC agreement.  One signed copy will be returned to the FQHC by CMS. A template attestation statement with instructions may be downloaded from CMS’ Web site at: http://www.cms.hhs.gov/manuals/downloads/som107_exhibit_177.pdf.
• In the case of applicants eligible to be an FQHC on the basis of: 1) receiving a HRSA §330 grant; or 2) receiving funding under a contract with an FQHC receiving a HRSA §330 grant; or 3) FQHC Look-Alike designation, the HRSA Notice of Grant Award to an FQHC or the notice of FQHC Look-Alike designation. The notice must indicate the approved or designated practice location, which must be the same as that reported on the Form CMS 855A;
• Form CMS-588 Electronic Funds Transfer (EFT) Authorization Agreement; Copy of Clinical Laboratory Improvement Act (CLIA) Certificate (if applicable).
  Facilities that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings is considered a laboratory and must meet CLIA requirements. These facilities must apply and obtain a certificate from the CLIA program that corresponds to the complexity of tests performed. Certain types of laboratories and laboratory tests are NOT subject to meeting CLIA requirements. One example would be facilities which serve only as collection stations. A collection station receives specimens to be forwarded to a laboratory performing diagnostics test. Chapter 6, Section 6002 of the State Operations Manual provides additional details regarding laboratories and laboratory tests NOT subject to CLIA requirements. It is the responsibility of the FQHC applicant to review the CLIA requirements and obtain a CLIA certificate if needed. Neither the MAC/FI nor the Regional Office makes a determination as to whether the FQHC applicant must obtain and submit a CLIA certificate; and
• Copy of State License (if applicable).

Before submitting an FQHC enrollment package with the attestation statement, it is important to carefully review the regulations in 42 CFR Part 405 Subpart X, and 42 CFR Part 491.  Submitting the application package is written attestation of compliance with all regulations.  CMS may terminate an agreement with an FQHC if it finds that the FQHC is not in substantial compliance with the Medicare regulator requirements.

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