[Code of Federal Regulations]

[Title 42, Volume 3]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR491.5]



[Page 963-965]

 

                         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 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



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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.

    (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



[[Page 965]]



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]