[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR491.5] [Page 962-964] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 491_CERTIFICATION OF CERTAIN HEALTH FACILITIES--Table of Contents Subpart A_Rural Health Clinics: Conditions for Certification; and FQHCs Conditions for Coverage Sec. 491.5 Location of clinic. (a) Basic requirements. (1) An RHC is located in a rural area that is designated as a shortage area. (2) An FQHC is located in a rural or urban area that is designated as either a shortage area or an area that has a medically underserved population. (3) Both the RHC and the FQHC may be permanent or mobile units. (i) Permanent unit. The objects, equipment, and supplies necessary for the provision of the services furnished directly by the clinic or center are housed in a permanent structure. (ii) Mobile unit. The objects, equipment, and supplies necessary for the provision of the services furnished directly by the clinic or center are housed in a mobile structure, which has fixed, scheduled location(s). (iii) Permanent unit in more than one location. If clinic or center services are furnished at permanent units in more [[Page 963]] than one location, each unit is independently considered for approval as a rural health clinic or for approval as an FQHC. (b) Exceptions. CMS will not disqualify an RHC approved for Medicare participation located in an area that no longer meets the definition of a shortage or rural area, if it determines that the RHC has established that it is essential to the delivery of primary care services that otherwise are not available in the geographic area served by the RHC. An RHC no longer located in a rural area must have a valid shortage area designation (underserved area or population) and meet the criteria set forth in paragraphs (b)(2)(i), (b)(2)(ii), or (b)(2)(iii) of this setion. The RHC that is no longer located in a rural area must also establish that it is essential to the delivery of primary care for patients residing in a rural area by demonstrating that at least 51 percent of the clinic's patients reside in an adjacent nonurbanized area. (1) Essential provider exception criteria. In order to make the final decision to grant an exception as an essential provider under this section, CMS will: (i) Grant an exception to one or more RHCs in a given service area if CMS determines the clinics each meet the criteria set forth in paragraphs (b)(2)(ii) or (b)(2)(iii) of this section. (ii) Use the following criteria in determining distances corresponding to 30 minutes travel time: (A) Under normal conditions with primary roads available within 20 miles. (B) In areas with only secondary roads available within 15 miles. (C) In flat terrain or in areas connected by interstate highways within 25 miles. (2) Conditions for exception. To receive an exception, the RHC must meet one of the following conditions: (i) Sole community provider. The RHC is the only participating primary care provider within 30 minutes travel time. For purposes of this exception, a participating primary care provider means an RHC, an FQHC, or a physician practicing in either general practice, family practice, or general internal medicine that is actively accepting and treating Medicare beneficiaries and low-income patients (Medicaid beneficiaries and the uninsured, regardless of their ability to pay). (ii) Major community provider. The RHC has Medicare and low-income patient (Medicaid and uninsured) utilization rates equal to or above 51 percent or low-income patient utilization rates equal to or above 31 percent. The RHC is also actively accepting and treating a major share of Medicare, Medicaid, and uninsured patients (regardless of their ability to pay) compared to other participating RHCs that are within 30 minutes travel time; or, if the clinic is the only participating RHC within 30 minutes travel, the RHC is actively accepting and treating a major share of Medicare, Medicaid, and uninsured patients (regardless of their ability to pay) compared to other participating primary care providers. (iii) Specialty clinic. The RHC (located within 30 minutes travel time) is the sole or major source of pediatric or OB/GYN services for Medicare (where applicable), Medicaid, and uninsured patients (regardless of their ability to pay) and is actively accepting and treating these patients. Only clinics that exclusively provide pediatric or OB/GYN services can receive an exception under this test. A specialty clinic is also an RHC that is the sole source of mental health services, as defined in Sec. 405.2450. For purposes of meeting this test, mental health services must be furnished onsite to clinic patients. Clinics applying as a major source of pediatric or OB/GYN services must have low-income patient (Medicaid and uninsured) utilization rates equal to or above 31 percent. (iv) Extremely rural community provider. The RHC is actively accepting and treating Medicare, Medicaid, and uninsured patients (regardless of their ability to pay) and is located in a frontier county (less than six persons per square mile) or in a level 8 or level 9 nonmetropolitan county using urban influence codes as defined by the U.S. Department of Agriculture. (c) Criteria for designation of rural areas. (1) Rural areas are areas not delineated as urbanized areas in the last census conducted by the Census Bureau. [[Page 964]] (2) Excluded from the rural area classification are: (i) Central cities of 50,000 inhabitants or more; (ii) Cities with at least 25,000 inhabitants which, together with contiguous areas having stipulated population density, have combined populations of 50,000 and constitute, for general economic and social purposes, single communities; (iii) Closely settled territories surrounding cities and specifically designated by the Census Bureau as urban. (3) Included in the rural area classification are those portions of extended cities that the Census Bureau has determined to be rural. (d) Requirements specific to FQHCs. An FQHC approved for participation in Medicare must meet one of the following criteria: (1) Furnish services to a medically underserved population. (2) Be located in a medically underserved area, as demonstrated by an application approved by PHS. Cross Reference: See 42 CFR 110.203(g) (41 FR 45718, Oct. 15, 1976) and 42 CFR Part 5 (42 FR 1586, Jan. 10, 1978). [43 FR 5375, Feb. 8, 1978. Redesignated at 50 FR 33034, Aug. 16, 1985, and amended at 57 FR 24982, June 12, 1992; 61 FR 14658, Apr. 3, 1996; 68 FR 74816, Dec. 24, 2003]