Arizona Rural Health Clinic Designation Manual - Arizona Center for ...

Arizona Rural Health Clinic
Designation Manual
August 2008
Version 3
This publication is made possible with partial funding from:
U.S. Department of Health and Human Services
Health Resources and Services Administration
Offi ce of Rural Healh Policy
Rural Hospital Flexibility Program

Table of Contents
Introduction.............……………....…………………………..............…….………3
I. An Introduction to Rural Health Clinics............................................................4
A. Background Information ……......….………………...…….............4
B. Rural Health Clinics in Arizona......................................................... 7
C. Number of Rural Health Clinics in the United States.........................9
D. Frequently Asked Questions………… .....……….….......................10
E. Steps to Becoming a Certified Rural Health Clinic….......................14
II. Licensing and Certification Requirements.......................................................16
A. State Licensing…....…………………….…..........…………….......16
B. Interpretive Guidelines for Rural Health..………..........…...……....17
C. See Addendum:Regulatory Guide: RHC/FQHC Proposed Rule...…28
D. Preparing for the Certification Inspection…..……….......…............29
E. 30 Most Common RHC Survey/Certification Deficiencies...............36
F. RHC Cost Report...............................................................................39
G. Important Resources.........................................................................44
III. Appendices.......................................................................................................46
A. Important Contact Information…...........................…………..….....46
B. Definitions for Rural Health Clinic Designation................……..….49
C. Federal Primary Care HPSAs in Arizona…..........……...........….....51
D. Federal MUAs in Arizona….……………………………................54
E. Licensing Forms….………………….……………………..............56
F. Certification Forms………………………..……………...........…....69
G. Rural Health Clinic Survey Report…..............……………..............82
Cover photo taken by Alison Hughes.

Community Environment & Policy
1295 Martin Avenue
Phone (520) 626-3589 PO Box 245210
FAX (520) 626-8009 Tucson, Arizona 85724
Rural Health Office
Introduction
This is the third version of the Arizona Rural Health Clinic Designation Manual. Since the first
manual was published in 2004, ten new rural health clinics received the designation in Arizona and
others have designations pending. Hopefully the popularity of the designation can be attributed
to some extent on the resource value of this document, as it was distributed to all eligible clinics
shortly after its first publication.
The contents of this document will help rural clinics assess whether or not the Rural Health Clinic
(RHC) designation is fiscally advantageous. It also provides a step-by-step guide to the application
process for the designation. The document is made possible with funding support from the Arizona
Rural Hospital Flexibility (Flex) Grant Program located in the Rural Health Office.
Rural Health Clinics have proliferated throughout the country since 1977 when Congress passed
the Rural Health Clinic Act. The purpose of the Rural Health Clinics program is to encourage and
stabilize the provision of out-patient primary care in underserved rural areas through the use of
physicians, nurse practitioners, physician assistants and certified nurse midwives.
According to the National Association of Rural Health Clinics, there are currently over 3,000
designated RHC’s in 47 states serving over seven million people. The small number of RHCs in
Arizona was in part the result of lack of information about the designation’s existence, but also in
part because of the excellent work accomplished by the Arizona Association of Community Health
Centers to develop a strong network of CHCs in the state. To find out more about the difference
between a CHC and an RHC, please refer to the Arizona Rural Health Resource Manual published
by the Arizona Rural Health Office: http://www.rho.arizona.edu/Resources/resource_manual.
aspx
I wish to acknowledge the work of Leila Barraza, MPH, in preparing the original document. She
has dedicated many hours and commitment to its preparation that it might contribute, in some
small way, to improving the health of people who live in rural and remote areas of Arizona.
Alison Hughes, MPA
Director, Flex Program
Rural Health Office
Mel and Enid Zuckerman College of Public Health
August, 2008
3

I. An Introduction to Rural Health Clinics
A. Background Information
What is a certified Rural Health Clinic
Rural Health Clinics (RHCs) provide primary healthcare services in medically underserved areas
and are certified under Medicare. Rural Health Clinics also receive an enhanced reimbursement
rate from Medicare and Medicaid.
What is required to be certified as a Rural Health Clinic
To be certified as a Rural Health Clinic (RHC), a clinic must:
• Be located in a non-urbanized area as determined by the U.S. Bureau of the Census;
• Be located in a federally designated Medically Underserved Area (MUA), a federally
designated Health Professional Shortage Area (HPSA), or in an area designated as
underserved by the state’s Governor;
• Provide outpatient primary care services and basic laboratory services;
• Employ at least one midlevel practitioner (Nurse Practitioner, Certified Nurse Midwife,
or Physician Assistant) who is on-site and available to see patients at least 50 percent of
the time the clinic is open;
• Meet health and safety requirements imposed by Medicare and Medicaid;
• Must have a physician on staff who provides medical supervision, direction, and consultation;
the physician must be present on-site at least one day every two weeks and avail
able by telecommunication for assistance at all times.
Clinic Ownership:
Clinic ownership can be private, non-profit, or public.
Provider-Based vs. Independent Rural Health Clinics:
• Provider-based Rural Health Clinics are owned and operated by any entity defined by the
Medicare statute as a “provider” (hospital, home health agency, or skilled nursing facility).
The reimbursement for Provider-based RHCs is handled by the provider associated with the RHC.
Provider-based Rural Health Clinics that are owned by a hospital with less than 50 beds are exempt
from the per-visit reimbursement cap. The criteria for a facility being defined as “Provider-based”
are not specific to the RHC program and apply to any department that seeks to be designated as
4

A. Background Information (con’t)
Provider-based. The criteria for Provider-based facilities are available online at: www.cms.hhs.
gov/transmittals/downloads/a03030.pdf.
• Independent RHCs are clinics not designated as Provider-based. An Independent RHC
can be owned and operated by a hospital. Unless the hospital applies for and receives approval for
the clinic as Provider-based, it will be considered an Independent RHC. In addition to hospitals,
independent RHCs can also be owned by physicians, physician assistants, nurse practitioners,
certified nurse midwives, skilled nursing facilities, home health agencies, for-profit cooporations,
not-for-profit corporations, or government entities. Independent RHCs are reimbursed through an
RHC fiscal intermediary.
Sources: National Association of Rural Health Clinics, RHC Technical Assistance, RHC Basics: Part II, http://www.
narhc.org/home/RHC.php; Rural Assistance Center, Rural Health Clinics, http://www.raconline.org/info_guides/
clinics/rhc.php; U.S. Department of Health and Human Services, Health Resources and Services Administration,
Office of Rural Health Policy, Starting a Rural Health Clinic: A How-To Manual, http://ruralhealth.hrsa.gov/RHC/
RHCmanual.htm.
Rural Health Clinics Act- PL 95-210: An Overview
The following is an overview, from the National Association of Rural Health Clinics, of the requirements
clinics must meet in order to become certified as a Rural Health Clinic (available
online at: http://www.narhc.org/home/RHC.php).
The purpose of the Rural Health Clinics program is to encourage and stabilize the provision of out-patient
primary care in underserved rural areas through the use of physicians, physician assistants (PAs) , nurse
practitioners (NPs) and certifi ed nurse midwives (CNMs).
1. Location - Rural Health Clinics must be located in communities that are both “rural” and “underserved.”
For purposes of the Rural Health Clinics Act, the following defi nitions apply to these terms:
-Rural Areas - Census Bureau designation as “Non-urbanized”
-Shortage Area - a federally designated Health Professional Shortage Area, a federally designated Medically
Underserved Area or an Area designation by the state’s Governor as underserved.
2. Physical Plant
-May be permanent or mobile
-Has a preventive maintenance program
-Has non-medical emergency procedures
3. Staffi ng
-One or more physicians
-One or more PAs, NPs or CNMs
-PA, NP or CNM must be on-site and available to see patients 50% of the time the clinic open for patients.
4. Provision of Services
•Each Rural Health Clinic must be capable of delivering out-patient primary care services.
•The Clinic must maintain written patient care policies:
-Developed by a physician, physician assistant or nurse practitioner, and one health practitioner
who is not a member of the clinic staff
5

A. Background Information (con’t)
-Describes the services provided directly by the clinic’s staff or through arrangement
-Provide guidelines for medical management of health problems; and,
-Provide for annual review of the policies
-Direct Services (must be provided by clinic staff)
•Provide diagnostic and therapeutic services that are commonly furnished in a physician’s offi ce
•Provide basic laboratory services (6 tests)
-Chemical examinations of urine
-Hemoglobin or Hematocrit
-Blood sugar
-Examination of stool specimens for occult blood
-Pregnancy test
-Primary culturing for transmittal
•Provide Emergency Services
-First response to common life-threatening injuries and acute illnesses
-Has available drugs used commonly in life-saving procedures
•Services Provided through Arrangement (may be provided by individuals other than clinic staff)
-In-patient hospital care
-Specialized physician services
-Specialized diagnostic and laboratory services
-Interpreter for foreign language if indicated
-Interpreter for deaf and devices to assist communication with blind
5. Patient Health Records
•Record System Guided by Written Policies and Procedures
•Designated Professional Staff Member Responsible for Maintaining Records
•Records must include the following information
-Identification data
-Physicians’ orders
-Physical exam fi ndings
-Consultative fi ndings
-Social data
-Diagnostic and laboratory reports
-Consent forms
-Medical history
-Health status assessment
-Signatures of the physician or other health care professionals
•Protection of Record Information Policies
-Maintenance of confi dentiality, safeguards against loss, destruction or unauthorized use
-Written policies and procedures govern use and removal and release of information
-Written patient consent is required for release
6

B. Rural Health Clinics in Arizona (as of 8/2008)
1) Bouse Medical Clinic
Location: 44031 East Pulmosa Road
Bouse, AZ 92885
Mailing Address: Same as above
Phone: (928) 512-1777
Fax: (928) 849-3460
Year of Certification:
Type of Clinic: Provider-Based
Hospital Affiliation: La Paz Regional Hospital
2) Community Health Care of Douglas, Inc
Location: 2174 West Oak Avenue
Douglas, AZ 85607
Mailing Address: Same as above
Phone: (520) 805-5880
Fax: (520) 805-4187
Year of Certification: 2007
Type of Clinic: Provider-Based
Hospital Affiliation: Southeast Arizona
Medical Center
3) Copper Queen Medical Associates- Bisbee
Location: 101 Cole Avenue
Bisbee, Arizona 85603
Mailing Address: Same as Above
Phone: (520) 432-2042
Fax: (520) 432-2098
Year of Certification: 2004
Type of Clinic: Provider-Based
Hospital Affiliation: Copper Queen Community
Hospital
4) Copper Queen Medical Associates- Douglas
Location: 100 East 5th Street
Douglas, Arizona 85607
Mailing Address: Same as Above
Phone: (520) 364-7659
Fax: (520) 364-8541
Year of Certification: 2004
Type of Clinic: Provider-Based
Hospital Affiliation: Copper Queen Community
Hospital
5) Greasewood Clinic
Location: Off Route 15
Greasewood, AZ
Mailing Address: P.O. Box 457
Ganado, AZ 86505
Phone: (928) 654-3208
Fax: (928) 654-3478
Year of Certification: 1999
Type of Clinic: Provider-Based
Hospital Affiliation: Sage Memorial Hospital
6) La Paz Medical Services, Quartzsite
Location: 150 East Tyson Road
Quartzsite, AZ
Mailing Address: P.O. Box 4618
Quartzsite, AZ 85359
Phone: (928) 927-8747
Fax: (928) 927-8748
Year of Certification: 2004
Type of Clinic: Provider-Based
Hospital Affiliation: La Paz Regional Hospital
7) Palominas Hereford Rural Health Clinic
Location: 10524 East Highway 92
Palomias, AZ 85615
Mailing Address: Same as above
Phone: (520) 366-0300
Fax: (520) 432-1724
Year of Certification: 2008
Type of Clinic: Provider-Based
Hospital Affiliation: Copper Queen Community
Hospital
8) Pleasant Valley Community Medical Center
Location: 288 Tewkbury
Young, AZ 85554
Mailing Address: Same as Above
Phone: (928) 462-3435
Fax: (928) 462-6644
Year of Certification: 1995
Type of Clinic: Independent
Hospital Affiliation: Cobre Valley Community
Hospital
9) Regional Center for Border Health/San Luis
Walk-In Clinic
Location: 1896 East Babbitt Lane, Suite D
San Luis, Arizona 85349
Mailing Address: Same as Above
7

B. Rural Health Clinics in Arizona (con’t)
Phone: (928) 722-6112
Fax: (928) 722-6113
Year of Certification: 2004
Type of Clinic: Independent
Hospital Affiliation: N/A
10) Sage Outpatient Clinic
Location: Ganado, AZ
Mailing Address: P.O. Box 457
Ganado, AZ 86505
Phone: (928) 755-4640
Fax: N/A
Year of Certification: 2000
Type of Clinic: Provider-Based
Hospital Affiliation: Sage Memorial Hospital
11) Sulphur Springs Medical Center
Location: 900 W Scott Street
Willcox, Arizona 85643
Mailing Address: Same as Above
Phone: (520) 384-4421
Fax: (520) 384-4645
Year of Certification: 2004
Type of Clinic: Provider-Based
Hospital Affiliation: Northern Cochise Community
Hospital
12) Sunsites Medical Clinic
Location: 225 Frontage Road
Pearce, Arizona 85625
Mailing Address: P.O. Box 186
Pearce, Arizona 85625
Phone: (520) 826-1088
Fax: (520) 826-1089
Year of Certification: 2004
Type of Clinic: Provider-Based
Hospital Affiliation: Northern Cochise Community
Hospital
13) Superior Clinic
Location: 14 N Magma Ave.
Superior, AZ 85273
Mailing Address: Same as Above
Phone: (520) 689-2423
Fax: (520) 689-5237
Year of Certification: 2005
Type of Clinic: Provider-Based
Hospital Affiliation: Cobre Valley Community Hospital
14) Tri-Valley Medical Center
Location: 39726 Harquahala Road
Salome, AZ 85348
Mailing Address: Same as Above
Phone: (928) 859-3460
Fax: (928) 859-3475
Year of Certification: 2006
Type of Clinic: Provider-Based
Hospital Affiliation: La Paz Regional Hospital
15) Wickenburg Hospital Clinic
Location: 520 Rose Lane
Wickenburg, AZ 85390
Mailing Address: Same as above
Phone: (928) 684-5421
Fax: (928) 684-5081
Year of Certification:
Type of Clinic: Provider-Based
Hospital Affiliation: Wickenburg Community
Hospital
16) Wide Ruins Clinic
Location: Wide Ruins, AZ
Mailing Address: P.O. Box 457
Ganado, AZ 86505
Phone: (928) 652-3231
Fax: N/A
Year of Certification: 1997
Type of Clinic: Provider-Based
Hospital Affiliation: Sage Memorial Hospital
Source: Arizona Department of Health Services, Division
of Licensing Services, Office of Medical Facilities
8

C. Number of Rural Health Clinics in the United States, 2004 1
Total # of Clinics
United States 3,599
Alabama 64
Alaska 6
Arizona 2 15
Arkansas 72
California 343
Colorado 35
Connecticut 0
Delaware 0
District of Columbia 0
Florida 152
Georgia 95
Hawaii 1
Idaho 44
Illinois 197
Indiana 51
Iowa 129
Kansas 168
Kentucky 115
Louisiana 56
Maine 49
Maryland 0
Massachusetts 0
Michigan 156
Minnesota 72
Mississippi 137
Missouri 271
Montana 41
Nebraska 89
Nevada 6
New Hampshire 18
New Jersey 0
New Mexico 11
New York 9
North Carolina 109
North Dakota 59
Ohio 17
Oklahoma 42
Oregon 44
Pennsylvania 42
Puerto Rico 0
Rhode Island 1
South Carolina 95
South Dakota 54
Tennessee 40
Texas 344
Utah 14
Vermont 18
Virgin Islands 0
Virginia 55
Washington 109
West Virginia 63
Wisconsin 62
Wyoming 18
1
Source: Centers for Medicare and Medicaid Services,
Standard Online Survey and Certification Reporting
System (OSCAR), Report 10. Accessed through: http://
www.statehealthfacts.org.
2
According to the Arizona Department of Health Services,
Division of Licensing Services, Office of Medical
Facilities Licensing, Arizona has 15 certified Rural
Health Clinics in as of 2008.
9

D. Frequently Asked Questions
Q: What are the benefits of being certified as a RHC
A: RHCs receive enhanced Medicare and Medicaid reimbursement. Medicare visits are reimbursed
based on allowable costs and Medicaid visits are reimbursed under the cost-based Prospective
Payment System (PPS). Since certified RHCs are reimbursed on a cost-based reimbursement,
as opposed to a fee-for-service reimbursement, RHC certification can increase revenues. RHCs
may see improved patient flow through the utilization of NPs, PAs and CNMs, as well as more
efficient clinic operations.
Q: How do I know if becoming certified as a RHC could be financially beneficial for my clinic
A: Experts say that a good rule of thumb to follow is if at least thirty-five to forty percent of your
patients are combined Medicare and Medicaid patients, then becoming a certified RHC could be
financially beneficial to your clinic.
Q: How does a certified RHC differ from a Federally Qualified Health Center (FQHC)
A: Federally Qualified Health Centers are organizations that receive grants under section 330 of
the Public Health Service Act. FQHCs must be open at least 32 hours per week, whereas RHCs
have no minimum hours per week requirement. In addition, a for-profit clinic cannot be a FQHC
but can be certified as an RHC. Unlike RHCs, FQHCs must be governed by a board of directors.
FQHCs are required to provide mental health and substance abuse services, dental services, transportation
services required for sufficient patient care, hospital and specialty care; RHCs are not
required to provide these services.
Q: Do I need a separate building to have an RHC
A: No. An RHC can be in a stand-alone building, a part of another building or a mobile unit.
Q: What types of services do RHCs provide
A: RHCs must provide outpatient primary care services and basic laboratory services. They can
also offer other services such as mental health services and vision services, however, such services
may not be reimbursed based on allowable costs.
Q: If a location loses its shortage designation, is it possible to remain a Rural Health Clinic
A: Rural Health Clinics located in rural areas that are no longer designated as medically underserved
may apply for an exception. Proposed criteria for allowing an exception are spelled out in
the Federal Register notice Medicare Program; Rural Health Clinics: Amendments to Participation
Requirements and Payment Provisions; and Establishment of a Quality Assessment and Performance
Improvement Program; Final Rule (see section II.C. Important Update from the National
Rural Health Clinic Association regarding the details and status of this CMS Final Rule).
Q: Are there special staffing requirements for RHCs
A: RHCs must employ at least one nurse practitioner (NP), physician assistant (PA), or certified
nurse midwife (CNM). The NP, PA, or CNM must be on-site and available to see patients at least
50% of the time the clinic is open. RHCs must have a physician present on-site and available to
see patients at least one day every two weeks, unless greater on-site availability is required by state
10

D. Frequently Asked Questions (con’t)
law or state regulatory mechanism governing PA, NP or CNM practice.
Q: What is the per visit upper payment limit for RHCs for 2008
A: For CY 2008, the Medicare RHC upper payment limit per visit is $75.63. Provider-based clinics
that are owned by a hospital with less than 50 beds are exempt from this per visit reimbursement
cap. For more information, visit the Centers for Medicare and Medicaid Services at: www.
cms.hhs.gov .
Q: How does Medicare reimburse RHCs
A: Certified Rural Health Clinics receive an interim payment rate throughout the clinic’s fiscal
year, which is reconciled at the end of the fiscal year through cost reporting. The interim payment
rate is determined by taking total allowable costs for RHC services divided by allowable visits
provided to RHC patients receiving core RHC services. RHC staff should understand traditional
Medicare regulations for coding and documentation as well as unique RHC billing requirements.
Q: How does Arizona reimburse RHCs for Medicaid
A: AHCCCS, Arizona’s Medicaid program, recognizes RHC services. The state reimburses RHCs
under one of two different methodologies. The first is a prospective payment system. Under this
methodology, for fiscal year 2001, the state calculated a per encounter rate based on an average of
100 percent of the reasonable costs furnished in FY 1999 and FY 2000. For each succeeding year,
this per encounter baseline rate is then increased by the Medicare Economic Index factor. The
second rate setting methodology (the Alternative Payment Methodology) requires a rebase of the
PPS rate every three years, and the physician services component of the CPI is used to inflate the
rate during the interim years. The clinic must agree to this methodology, and the payment to the
clinic must at least equal the payment under a prospective payment system.
The Arizona reimbursement methodology can be downloaded at:
http://www.azahcccs.gov/PlansProviders/FQHC_RHC/FQHC_RHC.asp
Q: How is an RHC encounter defined
A: An encounter is defined as a face-to to-face visit between a recognized provider (i.e., physician,
PA, NP, CNM, or mental health provider) and a Medicare beneficiary for a medically necessary
reason. Clinics receive the RHC rate for Medicare patients for every encounter.
Q: What is the difference between a UPIN and a PIN
A UPIN (Unique Provider Identification Number) is a six-character alphanumeric identifier assigned
to all Medicare physicians, medical groups and non-physician practitioners. A PIN (Provider
Identification Number) is a unique number issued by payers to each provider to identify that
provider as a credentialed and approved provider. This number is also known as a Medicare billing
number.
11

D. Frequently Asked Questions (con’t)
Q: Can our doctors, during RHC time, treat patients at a residential care facility and assisted living
care facility and be reimbursed Can our doctors do house calls and get paid
A: If the medical provider treats patients in a Skilled Nursing Facility (SNF) (100-day Part A bed)
in a nursing home, those services are billed to Part B, and cannot be included in Part A encounters
like other nursing home visits. Only those patients in the 100-day Part A bed have to be billed to
Part B. The rest of the nursing home visits are billed thru Part A as a regular RHC encounter, at the
RHC encounter rate. Any time Part B is billed for a service provided, you must also “carve out”
the associated cost of that service from the RHC cost report. Certainly, medical providers can still
provide treatment for patients in a residential care facility, if that is the patient’s place of residence,
and it is handled the same as a house call or home visit billed to Part A as an encounter. There are
three places of service where the medical provider can bill as an RHC encounter. They are:
1) In the Rural Health Clinic
2) In a nursing home (not a 100-day Part A stay) or other medical facility
3) In the patient’s place of residence or at the scene of an accident.
Q: Can our clinic at a satellite location offer health services outside of the RHC
A: No. The Medicare program makes payments to the RHC for covered RHC services when provided
to a patient at the clinic, skilled nursing facility or other medical facility, the patient’s place
of residence, or elsewhere (i.e., at the scene of an accident).
Q: How would the organizational relationships between a RHC and Critical Access Hospital
(CAH) operate
A: The RHC and CAH programs are two separate programs and have different participation criteria.
If the facilities follow the individual criteria for their respective programs, then the two
programs could co-exist. A CAH could be the owner of a certified RHC and operate the RHC
as either a provider-based or independent clinic. From an economic standpoint, the CAH would
be well advised to compare the payments for the clinic if operated as an RHC or as an outpatient
department of the CAH. CAH outpatient payments are typically better than outpatient payments
for traditional hospitals.
Q: We are an RHC all day. For Medicare patients regarding CPT coding, can we use minutes vs.
time spent with the patient
A: Time cannot be a factor when deciding to code up or down. Coding depends on history, examination,
and the medical decision needed. For example, one patient may take 30 minutes but have
nothing wrong with them while another patient may be seen for only a few minutes before they
are sent to the emergency room. Coding depends on the medical decision-making, not the amount
of time.
Q: If you make rounds at the nursing home and you see a patient who is on hospice, can you bill
it as an RHC visit
A: If the hospice patient receives services from you that are unrelated to the patient’s terminal condition,
then you can then bill the visit to the RHC. However, if you are adjusting pain medications
or providing supportive care, then you must bill hospice.
12

D. Frequently Asked Questions (con’t)
Q: Regarding supplies, in order to be covered in the RHC, what must the supply or service be
A: The supply or service must be of a type that would be furnished in a physician’s office; a type
that is commonly provided without charge or included in the RHC’s bill; and a type that is provided
as incidental to the service of the physician, nurse practitioner, physician assistant, clinical
social worker, certified midwife, or clinical psychologist.
Q: Are RHCs subject to “incident to” regulations as it relates to the provision of services by the
midlevel provider
A: No. The physician does not need to be present in the facility when a midlevel provider sees the
patient and midlevel providers can see patients new to the clinic.
Q: Do I have to log every flu and pneumoccal shot including non-Medicare patients
A: No. There is no requirement to log other payer types, however, the total flu and total pneumoccal
shots provided are needed to complete the cost report correctly.
Q: How are flu and pneumoccal shots billed in RHCs
A: A log or roster of Medicare patients is maintained and submitted with the cost report at yearend.
Medicare pays the cost of the shots. No bill is submitted to Medicare.
Q: What does Medicare require regarding documentation in the flu and pneumoccal logs
A: Patient Name, HIC Number (Medicare Number), and Date of service (shot).
Q: Can RHC bill for both a Rural Health Clinic visit and an inpatient admission on the same
day
A: No. Medicare would consider this double dipping.
Q: If you perform a surgery in the hospital using a global fee and the patient has a pre-op and a
post-op visit in the RHC, can I bill Medicare Part A for the RHC visits
A: No. Medicare would consider this double dipping.
Sources: Rural Resource Center, Rural Health Clinics, http://www.raconline.org/info_guides/clinics/rhc.php#faq;
J.E. Estes, Healthcare Horizon; Rural Resource Center, Federally Qualified Health Centers, http://www.raconline.
org/info_guides/clinics/fqhc.php.; National Association of Rural Health Clinics, RHC Technical Assistance, RHC
The Basics: Part II; Centers for Medicare and Medicaid Services, Announcement of Medicare Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs) Payment Rate Increase, http://www.cms.hhs.gov/Transmittals/Downloads/R796CP.PDF;
AHCCCS, Arizona state plan amendment (SPA) 03-007, http://www.ahcccs.state.
az.us/Publications/PlansWaivers/Amendments/MedicaidSPAs/2003/03_007ApprovalCMS1_5_04.pdf; Oregon Office
of Rural Health, Rural Health Clinics, http://www.ohsu.edu/ohsuedu/outreach/oregonruralhealth/clinics/aboutclinics.cfm.
13

E. Steps to Becoming a Certified Rural Health Clinic
Step 1: Determine Eligibility for Certification. The interpretive guidelines for Rural Health
Clinics are listed in section II. B. Interpretive Guidelines for Rural Health Clinics of this manual.
Step 2: Financial Feasibility Assessment. A financial study should assess the actual (for existing
clinics) or estimated (for new clinics) data on payor mix (Medicare, Medicaid, and other). Experts
say that a good rule of thumb to follow is if at least thirty-five to forty percent of your patients are
combined Medicare and Medicaid patients, then becoming a certified RHC could be financially
beneficial. Additionally, if an existing practice does not currently employ an NP, PA, or CNM, the
practice must decide whether the cost of hiring one would be offset by increased revenue.
Step 3: File an RHC Application.
If the site is already licensed as an Outpatient Treatment Center by the state of Arizona, the site
must send a letter to the Arizona Department of Health Services, Division of Licensing Services,
Office of Medical Facilities Licensing (http://www.azdhs.gov/als/medical) stating that the site
would like to be certified as a Rural Health Clinic. The letter should also include a request for an
RHC application packet. It is important that the site contact their Medicare fiscal intermediary
before completing the CMS 855A provider/supplier enrollment application form. If the site does
not know who their fiscal intermediary is, they may check the Centers for Medicare and Medicaid
Service’s Intermediary Carrier Directory website (http://www.cms.hhs.gov/ContractingGeneralInformation/Downloads/02_ICdirectory.pdf)
or they may contact the Arizona Department of Health
Services, Division of Licensing Services, Office of Medical Facilities Licensing.
If the site is not already licensed as an Outpatient Treatment Center by the state of Arizona, the site
must send a letter to the Arizona Department of Health Services, Division of Licensing Services,
Office of Medical Facilities Licensing (http://www.azdhs.gov/als/medical) stating that the site
would like to be licensed as an Outpatient Treatment Center and certified as a Rural Health Clinic.
In the letter, the site should request both a licensing packet and an RHC application packet. It is
important that the site contact their Medicare fiscal intermediary before completing the CMS 855A
provider/supplier enrollment application form (this form can be obtained from the following website:
http://www.cms.hhs.gov/CMSForms). If the site does not know who their fiscal intermediary
is, they may check the Centers for Medicare and Medicaid Service’s Intermediary Carrier Directory
website (http://www.cms.hhs.gov/ContractingGeneralInformation/Downloads/02_ICdirectory.
pdf).
Please note: Facilities located on an Indian Reservation do NOT have to be licensed as an Outpatient Treatment Center
in order to apply for Rural Health Clinic certification. In addition, private practice clinics not providing urgent care
services may not be required to be licensed as an Outpatient Treatment Center in order to apply for Rural Health Clinic
certification. Contact the Arizona Department of Health Services, Division of Licensing Services, Office of Medical
Facilities Licensing for more information.
Step 4: RHC Certification Inspection. The site should contact the Arizona Department of
Health Services, Division of Licensing Services, Office of Medical Facilities Licensing, in writing,
and indicate when the site would be ready for an inspection. To be ready for the inspection, the site
needs to be in compliance with RHC requirements and have seen patients at the site. The
14

E. Steps to Becoming a Certified Rural Health Clinic (con’t)
Arizona Department of Health Services, Division of Licensing Services, Office of Medical Facilities
Licensing will then conduct a survey.
Step 5: Rural Health Clinic Cost Report. Once a clinic has received its Medicare Provider Letter
from the Centers for Medicare and Medicaid Services, the clinic then files a projected cost
report in order to have its Medicare Rate determined. Independent Rural Health Clinics complete
the CMS-222-92 Form and Provider-based Rural Health Clinics complete Worksheet M of the
CMS-2552-96 Form. These forms are available from the CMS Web site (http://www.cms.hhs.
gov/CMSForms/).
Adapted from: Rural Assistance Center, Rural Health Clinics, http://www.raconline.org/info_guides/clinics/rhc.php.
15

A. State Licensing
II. Licensing and Certification Requirements
A site must be licensed by the Arizona Department of Health Services, Division of Licensing Services,
Office of Medical Facilities Licensing as an Outpatient Treatment Center in order to become
a certified Rural Health Clinic in Arizona. If a site is interested in becoming both licensed and a
certified Rural Health Clinic, then the site may request both a licensing application packet and an
RHC application packet from the Arizona Department of Health Services, Division of Licensing
Services, Office of Medical Facilities Licensing (see Appendix A. Important Contact Information).
The requirements for licensing medical facilities are according to Title 9, Chapter 10 of the
Arizona Administrative Code. To see the sections of the code pertaining to the licensing of health
institutions in its entirety, please visit the following website http://www.azsos.gov/public_services/Title_09/9-10.htm
The forms required for licensing (see Appendix E. Licensing Forms) can be printed from the internet
from the Arizona Department of Health Services, Division of Licensing Services, Office of
Medical Facilities Licensing’s website (http://www.azdhs.gov/als/medical). If the site is applying
for an initial license, the site must complete the “Initial Application for a Health Care Institution
License.” The initial application is for a new facility just being licensed for the first time or for
an already licensed facility that has had a change in location or ownership. If the site is applying
for a renewal of their license, the site must complete the “Renewal Application for a Health Care
Institution License.” In addition, an Outpatient Facility Information sheet must accompany the
initial or renewal application.
An important aspect of licensing is that the facility’s floor plan must be contiguous. For example, if
a patient must pass through a hallway in order to get to another area of the clinic, and that hallway
is not licensed, then the patient of the clinic cannot pass through that hallway. Therefore, once the
patient comes into the licensed area, the patient must be able to stay in the licensed area for the
duration of the visit. It is important to note that the Arizona Department of Health Services, Division
of Licensing Services, Office of Medical Facilities Licensing must be notified, in writing, if
any changes are made to the site’s building, administration, or to the services offered by the site.
Please note: Facilities located on an Indian Reservation do NOT have to be licensed as an Outpatient
Treatment Center in order to apply for Rural Health Clinic certification. In addition, private
practice clinics not providing urgent care services may not be required to be licensed as an Outpatient
Treatment Center in order to apply for Rural Health Clinic certification. Contact the Arizona
Department of Health Services, Division of Licensing Services, Office of Medical Facilities
Licensing for more information.
Source: Arizona Department of Health Services, Division of Licensing Services, Office of Medical Facilities Licensing,
http://www.azdhs.gov/als/medical.
16

B. Interpretive Guidelines for Rural Health Clinics
A site must comply with the following guidelines in order to become a certified Rural Health
Clinic. These interpretive guidelines are available online from the National Association of Rural
Health Clinics at: http://www.narhc.org/uploads/pdf/RHCmanual1.pdf The forms required for certification
as a Rural Health Clinic are listed in Appendix F. Certification Forms.
INTERPRETIVE GUIDELINES - RURAL HEALTH CLINICS
Conditions for Certification
I. COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAWS (42 CFR 491.4)
The RHC and its staff are in compliance with applicable Federal, State, and local laws and regulations.
A. Federal Laws and Regulations.--The Federal regulations governing the certifi cation of RHCs were
published in the Federal Register on July 14, 1978, 43 FR 136. Conditions for certifi cation under those
regulations are the subject of these guidelines.
B. State Laws and Regulations. All States have practice acts that govern the activities of health professionals.
While there is considerable variation in the States’ practice acts concerning physician assistants, nurse
practitioners and certifi ed nurse-midwives, there is a broad mandate in the medical practice acts of all States
giving physicians authority to diagnose and treat medical conditions. The extent to which the physician may
delegate these responsibilities and to whom, and under what conditions, varies in the states. Some States
have updated their practice acts since the advent of the physician assistant, nurse practitioner and certifi ed
nurse-midwife health care professionals. In some instances, these updated practice acts have included
defi nitions and specifi c references to permitted/prohibited activities, supervision/guidance required by a
physician, and location/situations in which nurse practitioners, certifi ed nurse-midwives and physician
assistants may function. In some States where nurse practice acts have not been signifi cantly updated,
some functions of the nurse practitioner are viewed as an extension of the traditional nursing role as being
covered by the existing nurse practice act.
Rural health clinics can be certifi ed only if the State permits--that is, does not explicitly prohibit--the delivery
of primary health care by a nurse practitioner, certifi ed nurse-midwife or a physician assistant. The surveyor
will encounter wide variations in the wording, interpretation, and application of States’ practice acts as they
affect the physician assistant, nurse practitioner and certifi ed nurse-midwife in the RHC setting.
In situations where the State law is silent, or where the state law does not specifi cally prohibit the functioning
of a physician assistant, nurse practitioner or certifi ed nurse-midwife with medical direction by a physician
and with the degree of supervision, guidance, and consultation required by the RHC regulations, the
surveyor may consider this condition as being met. Interpretations needed on specifi c aspects of the State’s
practice act should be sought through the State regulatory agency or board(s) dealing with the practice and
profession.
II. LOCATION OF CLINIC (42 CFR 491.5)
Consult with the Regional Offi ce (R.O.) to preliminarily ascertain that a clinic meets the basic requirement
of location prior to scheduling a survey. The clinic must be located in a rural area that is designated as
a shortage area. Applicants determined not qualifi ed under this requirement should be sent a letter (see
Exhibit.27) with the appropriate notation.
A. Rural Area Location. The law requires the clinic to be located in an area “that is not an urbanized area as
defi ned by the Bureau of the Census.” The Bureau has published both a narrative defi nition of an urbanized
17

B. Interpretive Guidelines for Rural Health Clinics (con’t)
area and maps displaying the land area of urbanized areas. Lists and maps of the urbanized areas are
contained in the “number of inhabitants” census volume for that State (census of population series PC-
80-1-A). Note that this definition is different from that of a metropolitan statistical area (MSA). Contact the
Census Bureau for a determination on whether the clinic is located in a non-urbanized area.
B. Shortage Area Designation. After it has been ascertained that the clinic is located in a non-urbanized
area, the CMS RO will certify whether or not the clinic is located in a “currently” designated shortage
area. The CMS RO, after consulting with PHS RO staff, promptly responds in writing to the request for a
determination. This information may be given by telephone as long as it is followed by a written response.
This consultation explores designation:
-- As an area with a shortage of personal health services under 5330(b)(3) or 1302(7) of the PHS
Act;
-- As a health professional shortage area described in 5332(a)(1)(A) of the PHS Act;
-- As an area which includes a population group which the Secretary determines has a health
professional shortage under 5332(a)(1)(B) of the PHS Act;
-- As a high migrant impact area described in 5329(a)(5) of the PHS Act; or
-- As an area designated by the chief executive offi cer of the State and certifi ed by the Secretary
as an area with a shortage of personal health services.
These designations are published periodically in the Federal Register by the PHS Bureau of Health
Care Delivery and Assistance. Designation under any section qualifi es a RHC location. The designation
process is a continuing process, with additions of newly designated areas and deletions of previously
designated areas occurring daily. Designation information can also be obtained on-line by going to: http://
datawarehouse.hrsa.gov/
For HPSA information, click on Health Professional Shortage Areas (HPSAs) under the Health Professions
header and for MUA information click on Medically Underserved Areas/Medically Underserved Populations
which is under the Primary Health Care header.
C. Mobile Units. The Conditions for Certifi cation must be met by a mobile unit for it to qualify as a RHC. In
addition, it should be ascertained that the mobile unit has fi xed scheduled locations, each of which meet the
rural and shortage area requirements.
Since the mobile unit is a clinic, it is expected that the RHC services are provided in the unit and not in
a permanent structure, with the unit serving only as a mobile repository for the equipment, supplies, and
records. The only exception would be if the RHC services are furnished off the clinic’s premises (away from
the unit) to homebound patients.
Where a facility offers RHC services at a permanent structure as well as in a mobile unit, each facility must
be certifi ed separately as a RHC. This is differentiated from the situation where a permanent structure
provides RHC services off the premises, e.g., to homebound patients, with the use of a vehicle to transport
supplies, equipment, records, and staff.
D. Exceptions to the Location Requirement. There are two grandfather provisions applicable to the
certifi cation process.
1. Loss of Location Eligibility. This grandfather provision applies to the annual recertifi cation process. It
should be used as a “yea” response to item J11 and on the CMS-30 when a facility which was previously
certifi ed as being located in a nonurbanized and designated shortage area subsequently loses either or both
of these characteristics. When this occurs, the facility does not lose its eligibility for continued participation
in the program because it does not meet the location requirement. If J11 is marked yes, mark J17 and J18
N/A.
18

B. Interpretive Guidelines for Rural Health Clinics (con’t)
2. Clinics Operating on July 1, 1977. Potential applicants under this grandfather provision still have to
meet the rural location requirement. The other requirement under this provision is that the Secretary has
determined that the area served has an insuffi cient supply of primary care physicians. Facilities providing
services on July 1, 1977, in a nonurbanized area which is determined to have unmet needs for primary
health care but which is not a designated shortage area are potential applicants. Therefore, the facility may
be primarily serving a designated area but not located in a designated shortage area. It must be determined
whether the location of the clinic is an appropriate part of a service area which includes areas or populations
which have been designated either as having a health manpower shortage, or as being medically
underserved. Aiding this determination will be previous PHS decisions made on behalf of the Secretary.
The answer to question V on CMS-29 is an important indicator. Several PHS programs provide or have
provided grant support to enable the facility to provide health care to designated areas. These programs do
not require that the facility be located in a designated shortage area. Many of these facilities were operating
with PHS grant support prior to enactment of the Rural Health Clinic Services Act of 1977 (P.L.95-210) and
may constitute certifi able RHC applicants.
Some examples of these PHS programs are National Health Service Corps (KHSC), Migrant Health, Health
Underserved Rural Areas (HURA), and Rural Health Initiative (RHI). Prior to P.L.95-210 a number of states
had programs to assist their rural areas with greater access to primary care. The location of the facilities
developed by these programs was determined by valid criteria established by the State, although location
in a designated shortage area may not have been one of them. These facilities are also potential applicants
under this grandfather provision.
When it is determined that an applicant clinic not located in a designated shortage area may be a potential
applicant under this grandfather provision, develop the following information and submit it to the CMS RO
for a determination as to whether the facility meets the requirements of this ‘grandfather provision:
-- A description of the geographic boundaries of the facility’s service area;
-- Information developed through consultation with the PHS RO, staff about whether the area,
or any portion of the area, had ever been reviewed for designation under any of the applicable
sections of the PHS Act;
-- Identification of any designated population group or institution in the facility’s service area;
-- Information secured from the appropriate Health Systems Agency and the State Health
Planning and Development Agency and about the primary care resources available
in the facility’s service area;
-- Information about any planning, developmental, or operating funds awarded to the facility by
the county, State, or Federal Government to assist in providing, greater access- to health care
in the area;
-- Information about the factors considered in determining where the facility was to be located;
and
-- Any additional information the SA or RO feels is relevant.
III. PHYSICAL PLANT AND ENVIRONMENT (42 CFR 491.6)
A. Physical Plant Safety. To insure the safety of patients, personnel, and the public, the physical plant
should be maintained consistent with appropriate State and local building, fi re, and safety codes. Reports
prepared by State and local personnel responsible for insuring that the appropriate codes are met should
be available for review. Determine whether the clinic has safe access and is free from hazards that may
affect the safety of patients, personnel, and the public.
B. Preventive Maintenance. A program of preventive maintenance should be followed by the clinic. This
includes inspection of all clinic equipment at least yearly, or as the type, use, and condition of equipment
dictates; the safe storage of drugs and biologicals (see 42 CFR 491.6(b)(2)) and inspection of the facility to
assure that services are rendered in a clean and orderly environment. Inspection schedules and reports
19

B. Interpretive Guidelines for Rural Health Clinics (con’t)
should be available for review by the surveyor.
C. Non-medical Emergencies. Review written documentation and interview clinic personnel to determine
what instructions for non-medical emergency procedures have been provided and whether clinic personnel
are familiar with appropriate procedures. Non-medical emergency procedures may not necessarily be the
same for each clinic.
IV. ORGANIZATIONAL STRUCTURE (42 CFR 491.7)
A. Basic Requirements. Ascertain that the clinic is under the medical direction of a physician(s), has a staff
that meets the requirements of 5491.8,and has adequate written material covering organization policies,
including lines of authority and responsibilities.
B. Written Policies. Written policies should consist of both administrative and patient care policies.
Patient care policies are discussed under 42 CFR 491.9(b). In addition to including lines of authority
and responsibilities, administrative policies may cover topics such as personnel, fi scal, purchasing, and
maintenance of building and equipment. Topics covered by, written policies may have been infl uenced
by requirements of the founders of the clinic, as well as agencies that have participated in supporting the
clinic’s operation.
C. Disclosure of Names and Addresses. The clinic discloses names and addresses of the owner, person
responsible for directing the clinic’s operation, and physician(s) responsible for medical direction. Any entity
may organize itself as an owner of a RHC. The types of organizations being referred to are described in
answers to question IV on the Request to Establish Eligibility. These range from:
-- A physician in a private general practice located in a shortage area who employs either a nurse
practitioner, certifi ed nurse-midwife or a physician assistant;
-- A nurse practitioner, certified nurse-midwife or a physician assistant in solo practice in a
shortage area who develops the required relationship with a physician for medical direction; to
-- Organizations either for profi t or not for profi t who own primary care clinics located in shortage
areas.
Any change in ownership or physician(s) responsible for the clinic’s medical direction requires prompt notice
to the RO. Neither of these changes requires resurvey or recertifi cation if the change can otherwise be
adequately verifi ed. Notice of any change in the physician(s) responsible for providing the clinic’s direction
should include evidence that the physician(s) is licensed to practice in the state.
V. STAFFING AND STAFF RESPONSIBILITIES (42 CFR 491.8)
A. Suffi cient Staffing. The staffi ng described in 42 CFR 491.8(a) is the minimum staffi ng requirement.
However, you also determine whether the clinic is suffi ciently staffed to provide services essential to its
operation. Because clinics are located in areas that have been designated as having shortages of health
manpower or personnel health services, they frequently are not able to employ what would be considered
suffi cient health care staffs. When item J42 on the SRF is marked no, explain, with reasonable detail,
the circumstances (and efforts to overcome them) that make employment of additional needed staff not
possible.
Should the loss of a physician, physician assistant, certifi ed nurse-midwife or nurse practitioner member
of the staff reduce the clinic’s staff below the required minimum, the clinic should be afforded a reasonable
time to comply with the staffi ng requirement. The clinic must provide some type of documentation showing
the its good faith effort to obtain staff. The clinic should inform the State of all actions taken to recruit a
replacement and expected outcome. The loss of a physician assistant or nurse practitioner staff member
may require a temporary adjustment of the clinic’s operating hours or services and an adjustment in the
scheduled visits by the physician(s) providing medical direction. The loss of the physician member will
20

B. Interpretive Guidelines for Rural Health Clinics (con’t)
require the clinic to make temporary arrangements for medical direction with another physician(s), and this
might alter the scheduled times the physician is present in the clinic. Follow these situations closely, and
make recommendations about approvals pending correction of defi ciencies, compliance, or decertifi cation.
It in the responsibility of the clinic to promptly advise you of any changes in staffi ng which would affect its
certifi cation status.
B. Staffi ng Availability. A physician, nurse practitioner, certifi ed nurse-midwife (meeting the defi nition in
42 CFR 405.2401(b)(10)) or physician assistant must be available to furnish patient care services at all
times the clinic operates. Only the scheduled operating hours the clinic is offerring RHC services are to be
considered (as distinguished from other ambulatory services or related health activities).
A nurse practitioner, certifi ed nurse-midwife or physician assistant must be available to furnish patient care
services at least 50 percent of the scheduled operating hours during which RHC services are offered, even
though a physician is present in the clinic on a full-time basis during the time RHC services are offered. The
phrase “available to furnish patient care services” means (1) providing RHC services in the clinic; (2) being
physically present in the clinic even though not providing RHC services; or (3) providing RHC services to
clinic patients outside the clinic. These services must be RHC services. Items (1) and (2) indicate that a
physician, physician assistant, certifi ed nurse-midwife or nurse practitioner is present on the premises, not
on call, during the scheduled operating hours when RHC services are offered at the facility. Item (3) refers
to that part of the clinic’s operating schedule utilized in providing RHC services outside the clinic.
A RHC’s total operating schedule, therefore, consists of offering RHC services at the clinic, as well as
providing RHC services to patients outside the clinic. Determinants of how a clinic schedules its operating
time include the size of the required staff, patient population, and where the services need to be provided.
Some clinics, within their scheduled hours, may be able to concurrently offer RHC services both on and off
the clinic’s premises, whereas other clinics may have to schedule separate hours for offering the services
on and off the clinic’s premises (e.g., a clinic’s total operating schedule may be from 9 a.m. to 5 p.m. daily,
with on-premises services offered from 9 a.m. to 3 p.m., and off-premises services offered from 3 p.m. to
5 P.M.).
Section 1861(aa)(2)(J) of the Act requires that a physician assistant, certifi ed nurse-midwife or nurse
practitioner must be available to provide patient care services during at least 50 percent of the RHC’s
total operating schedule. Therefore, a physician must provide needed services at other times during the
clinic’s scheduled operating hours. A RHC which does not have a physician, physician assistant, certifi ed
nurse-midwife or nurse practitioner on the premises to render services during the scheduled operating
hours of the clinic does not meet the requirements of S1861(aa)(2) of-the Act, even though the 50 percent
requirement may be met.
The following are examples of how determinations regarding these requirements may be made. A clinic has
a total operating schedule of from 9 to 5 Monday through Friday, and from 9 to 1 on Saturday (44 hours a
week). RHC services are offered from 10 to 5 Tuesday through Friday (28 hours a week, which satisfi es the
51 percent requirement). A physician, nurse practitioner, certifi ed nurse-midwife, or a physician assistant
must be available to furnish patient care services from 10 to 5 Tuesday through Friday (28 hours a week).
Of these 28 hours, a nurse practitioner, certifi ed nurse-midwife or physician assistant must be available at
least 14 hours (5.0 percent of 28 hours) to furnish patient care services.
In some cases, the clinic’s weekly schedule may not be a logical period of time on which to base these
determinations, and consideration of the biweekly or even a monthly schedule may be more appropriate.
Such a situation may occur when a clinic has a very limited total operating schedule and the schedule
offering RHC services is concentrated in a specifi ed period of the biweekly or monthly total, schedule.
An example would be a clinic that is open only every other Tuesday and Friday from 10 to 4 (24 hours a
month), and RHC services are offered every other Tuesday from 10 to 4, and one Friday a month from 10
21

B. Interpretive Guidelines for Rural Health Clinics (con’t)
to 4 (18 hours a month). In this situation, it is appropriate to consider the clinic’s total monthly operating
schedule for determining whether RHC services are offered during at least 51 percent of the schedule. A
physician, a nurse practitioner, certifi ed nurse-midwife, or a physician assistant must be available to furnish
patient care services every other Tuesday from 10 to 4, and one Friday from 10 to 4 (18 hours a month).
Of these 18 hours, a nurse practitioner, certifi ed nurse-midwife or physician assistant must be available at
least 9.18 hours to furnish patient care services.
C. Staff Responsibilities. The requirement that a physician, physician assistant, certifi ed nurse-midwife,
and/or nurse practitioner participate jointly in the development of the clinic’s written policies does not require
the development of new policies in the event of changes in these staff members. Nevertheless, each staff
member must review, agree with, and adhere to, or propose amendments to the clinic’s policies. Compliance
with this requirement has a special relationship to the clinic’s written patient care guidelines. There should
be suffi cient written documentation that this requirement is appropriately carried out. There should be some
mechanism to ensure that new clinic personnel are completely familiar with these policies.
1. Physician Responsibilities. Ascertain through written documentation, such as dates and signatures, that
the physician staff member satisfactorily meets the requirement of periodically reviewing the clinic’s patient
records, provides medical orders, and provides medical care services to the patients.
A physician member is required to be present in the clinic for suffi cient periods of time to perform the duties
and responsibilities described in 42 CFR 491.8(b)(i), (ii), and (iii). The term “suffi cient periods of time”
requires relative evaluations. There are a number of elements to consider in weighing what would constitute
a reasonable time suffi cient to discharge the physician member’s responsibilities. These elements include:
patient case load and mix (type), number of patient care records which must be reviewed in order to
establish a good overview for adherence to policies and principles of quality patient care, number of patient
care records which require review and discussion of specifi c health problems and regimens of therapy;
need for consultative time with other members of the clinic’s staff; need for revision to the clinic’s patient
care guidelines; and need for time to provide medical care to patients.
Time required to accomplish these activities will fl uctuate. Thus, the “sufficient time” the physician must
spend in the clinic will vary. The survey should verify the time spent in the clinic by the physician for
consulting records, etc. Extraordinary circumstances which constitute exceptions to the requirement that
the physician Member be present in the clinic at least once every 2 weeks for “suffi cient time to discharge
the physician’s responsibilities are primarily nonrecurring circumstances beyond the control of the physician
and which postpone (not cancel) the visit. These circumstances include illness, extreme weather or driving
conditions of short duration, or those emergencies which occur in the physician’s practice and require his
presence elsewhere. When nonrecurring circumstances cause postponement of the physician’s visit, they
should be documented in the clinic’s records.
In some instances, recurring extraordinary circumstances may constitute reasonable exception to the
physician’s presence requirement. This type of exception requires specifi c approval from the CMS RO for
certifi cation purposes, and must be documented by the surveyor. The essential areas for consideration of
this exception would include:
-- The remoteness of the clinic (due to extraordinary distance and inaccessibility of the terrain)
make frequent travel impossible or unreasonable;
-- The remoteness of the physician members location has already placed the physician in an
extraordinary extended practice and/or designated shortage area and required visits at
least once in every 2 week period to a clinic located at a great distance would severely detract
from the physician’s practice; or
-- It is clearly established in advance that continuing conditions are known to be expected (snow,
fl ood, bridge repair, etc.) which will make reasonable access to the clinic not possible
for extended periods of time.
22

B. Interpretive Guidelines for Rural Health Clinics (con’t)
2. Physician Assistant, Nurse Practitioner and Certifi ed Nurse Midwife Responsibilities. The surveyor
verifi es through appropriate written documentation that the physician assistant, certifi ed nurse-midwife
and/or nurse practitioner is periodically performing the necessary responsibilities listed under J51, CMS
30.
VI. PROVISION OF SERVICES (42 CFR 491.9)
A. Basic Requirements
1. State and Local Laws. Know the State’s position, generally, with respect to implementing the Federal
RHC requirements vis-a-vis the State’s Medical Practice Act, Nurse Practice Act, the Pharmacy Act and
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (P.L. .91513) and the general scope of
practice permitted for nurse practitioners, certifi ed nurse-midwives and physician assistants.
Some States may have legal impediments because applicable practice acts prohibit nurse practitioners,
certifi ed nurse-midwives and/or physician assistants from independent acts of medical diagnosis and
treatment precluding the fullest implementation of the Federal RHC requirements.
This does not necessarily preclude participation by a RHC that provides RHC services (physician-type
services) furnished by nurse practitioners, certifi ed nurse-midwives and/or physician assistants under the
direct supervision (as distinguished from indirect supervision) of a physician.
Therefore, inquiries to State authorities about compliance with the Federal RHC requirements, as well as
decisions concerning applicant RHCs, must be weighed against several determinations, including:
-- The medical direction and supervision described in the regulations is the minimum requirement;
many participating RHCs operate with greater medical direction and supervision than
these minimums.
-- The word “supervision” does not automatically equate with direct, over the shoulder
supervision. Many States requiring physician supervision of medical acts performed by a nurse
practitioner or a physician assistant have held that performances of such medical acts under
written patient care guidelines developed and/or approved by a licensed physician satisfy the
requirement of supervision.
2. Providing Rural Health Clinic Services. The law describes a RHC as a facility primarily engaged in
providing RHC services as defi ned in this subpart. Under this defi nition, a facility may provide services in
addition to RHC services; usually, related health care services such as the “other ambulatory services”
covered by Medicaid State plans. Certifi cation as a RHC applies to the facility as a whole and the total
operating schedule of the facility (the hours it is open) is considered when determining if the facility is
primarily engaged in providing RHC services. If onsite observation of services provided and discussion with
the staff indicate that the majority of the services provided by the clinic are primary medical care (treatment
of acute or chronic medical problems which usually bring a patient to a physician’s offi ce), then the clinic
may satisfy the “primarily engaged” requirement providing that RHC services are offered at least 51 percent
of the total operating schedule. The time RHC services are offered may differ from the total operating
schedule of the facility, but may not be less than 51 percent of this total operating schedule.
If there is a question about this condition, review a sample of patient health records covering a reasonable
period of time to determine the majority of specifi c services actually furnished.
An example of a clinic schedule that combines RHC services and “other ambulatory services” would be a
clinic in which primary medical care is offered from 9 to 4 Monday through Thursday, and dental services
are offered from 9 to 4 on Friday.
23

B. Interpretive Guidelines for Rural Health Clinics (con’t)
B. Patient Care Policies Requirements. Review the clinic’s policies and ascertain who developed them.
Where changes in clinic personnel and/or clinic administration make it impossible or not relevant to ascertain
who developed the policies, it is necessary to ascertain that the current physician member(s) and
the nurse practitioner, certifi ed nurse-midwife, and/or physician assistant member(s) of the staff have an
indepth knowledge of the policies and have had the opportunity to discuss them, adopt them as is, or make
any agreed-to written changes in them. If a clinic’s organizational structure includes a governing body,
ascertain whether the governing body has ultimate authority in approving the patient care policies and, if
so, when such approval was last given., While clinics frequently seek the participation of other health care
professionals in developing patient care policies (particularly the written guidelines for the medical management
of health problems) the term “a group of professional personnel” is not restricted to health care
professionals. In some cases, the clinic will have involved health care professionals representatives to a
hospital with which the clinic has an agreement for patient referral. In any event, one member of the group
of three or more may not be a member of the clinic’s staff, and professions which are not directly related to
health care delivery (attorneys, community planners, etc.) are potentially useful.
C. Description of Services. A description of the services the clinic furnishes directly and those furnished
through agreement or arrangement. The services furnished by the clinic should be described in a manner
that informs potential patients of the types of health care available at the clinic, as well as setting the
parameters of the scope of what services are furnished through referral. Such statements as the
following suffi ciently-describe services: Taking complete medical histories, performing complete physical
examinations, assessments of health status, routine lab tests, diagnosis and treatment for common acute
and chronic health problems and medical conditions, immunization programs, family planning, complete
dental care, emergency medical care. Statements such as “complete management of common acute and
chronic health problems” standing alone, do not suffi ciently describe services.
Additional services, furnished through referral, are suffi ciently described in such statements as: Arrangements
have been made with X hospital for clinic patients to receive the following services if required: specialized
diagnostic and laboratory testing, specialized therapy, inpatient hospital care, physician services, outpatient
and emergency care when clinic is not operating, referral for medical cause when clinic is operating.
2. Guidelines for Medical Management. The clinic’s written guidelines for the medical management of health
problems include a description of the scope of medical acts which may be undertaken by the physician
assistant, certifi ed nurse-midwife, and/or nurse practitioner. They represent an agreement between the
physician providing the clinic’s medical direction and the clinic’s physician assistant, certifi ed nurse-midwife,
and/or nurse practitioner on the privileges and limits of those acts of medical diagnosis and treatment which
maybe undertaken without direct, over the shoulder physician supervision. They describe the regimens to
be followed and stipulate the conditions in the illness or health care management at which consultation or
referral is required.
Acceptable guidelines may follow various formats. Some guidelines are collections of general protocols,
arranged by presenting symptoms; some are statements of medical directives arranged by the various
systems of the body (such as disorders of the gastrointestinal system); some are standing orders covering
major categories such as health maintenance, chronic health problems, common acute self-limiting health
problems, and medical emergencies.
The manner in which these guidelines describe the criteria for diagnosing and treating health conditions
may also vary. Some guidelines will incorporate clinical assessment systems that include branching logic.
Others may be in a more narrative format with major sections covering specifi c medical conditions in which
such topics as the following are discussed: The defi nition of the condition, its etiology, its clinical features,
recommended laboratory studies, differential diagnosis, treatment procedures, complications, consultationreferral
required, and follow-up.
24

B. Interpretive Guidelines for Rural Health Clinics (con’t)
Even though approaches to describing guidelines may vary, acceptable guidelines for the medical
management of health problems must include the following essential elements. They:
-- Are comprehensive enough to cover most health problems that patients usually see a physician
about;
-- Describe the medical procedures available to the nurse practitioner, certifi ed nurse-midwife,
and/or physician assistant;
-- Describe the medical conditions, signs, or developments that require consultation or referral;
and
-- Are compatible with applicable State laws.
A number of patient care guidelines have been published by members of the medical profession. Should a
clinic choose to adopt such guidelines (or adopt them essentially with noted modifi cations), this would be
acceptable if the guidelines include the essential elements described above.
3. Drugs and Biologicals. Written policies cover at least the following elements:
-- Requirements dealing with the storage of drugs and biologicals in original manufacturer’s containers to
assure that they maintain their proper labeling and packaging;
-- Requirements dealing with outdated, deteriorated, or adulterated drugs and biologicals being stored q
separately so that they are not mistakenly used in patient care prior to their disposal in
compliance with applicable laws;
-- Requirements dealing with storage in a space that provides proper humidity, temperature, and light to
maintain the quality of drugs and biologicals;
-- Requirements for a securely constructed locked compartment for storing drugs classifi ed under
Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1970;
-- Requirements dealing with the maintenance of adequate records of receipt-and distribution of
controlled drugs that account for all drugs in Schedules 11, 111, IV, and V; with Schedule II drugs
being accounted for separately;
-- Requirements that containers used to dispense drugs and biologicals to patients conform to the Poison
Prevention Packaging Act of 1970;
-- Requirements dealing with the complete and legible labeling of containers used to dispense drugs and
biologicals to patients;
-- Requirements concerning the availability of current drug references and antidote information; and
-- Requirements dealing with prescribing and dispensing drugs in compliance with applicable State laws.
4. Review of Policies. The group of professional personnel, which can be the governing body acting as the
group, is responsible for an annual review of patient care policies.
C. Direct services. The purpose of the Rural Health Clinic Services Act is primarily to make available
outpatient or ambulatory care of the nature typically provided in a physician’s offi ce or outpatient clinic and
the like. The regulations specify the services which must be made available by the clinic, including specifi ed
types of diagnostic examination, laboratory services, and emergency treatments.
The clinic’s laboratory is to be treated as a physician’s offi ce for the purpose of licensure and meeting health
and safety standards. The listed laboratory services are considered essential for the immediate diagnosis
and treatment of the patient. To the extent they can be provided under State and local law, the six services
listed in J61, CMS-30, are considered the minimum the clinic should make available through use of its own
resources.
If any of these laboratory services cannot be provided at the clinic under State or local law, that laboratory
service is not required for certifi cation. Some clinics are not able to furnish the six services, even though they
may be allowed to do so under State and local law, without involving an arrangement with a Medicare
25

B. Interpretive Guidelines for Rural Health Clinics (con’t)
approved laboratory.
Those clinics unable to furnish all six services directly when allowed to by State and local law should be
given defi ciencies. Such defi ciencies should not be considered suffi ciently signifi cant to warrant termination
if the clinic has an agreement or arrangement with an approved laboratory to furnish the basic laboratory
service it does not furnish directly, especially if the clinic is making an effort to meet this requirement.
VII.PATIENT HEALTH RECORDS (42 CFR 491.10)
A. Records System. The clinic is to maintain patient health records in accordance with its written policies
and procedures. These records are the responsibility of a designated member of the clinic’s professional
staff and should be maintained for each person receiving health care services. All records should be kept at
the clinic site so that they are available when patients may need unscheduled medical care.
Examine a randomly selected sample of health records to determine if appropriate information, as related
in J70 of the SRF and 42 CFR 491.10(a)(3), is included. This listing is the minimum requirement for record
maintenance. If defi ciencies are found while reviewing the records, review additional records to determine
the prevalence of these defi ciencies. Record on the SRF the number of records reviewed and defi ciencies
found, if any, and as questions arise concerning the records, discuss them with the person responsible for
record maintenance.
B. Protection of Record Information.--The clinic must ensure the confi dentiality of the patient’s health records
and provide safeguards against loss, destruction or unauthorized use of record information. Ascertain that
information regarding the use and removal of records from the clinic and the conditions for release of record
information is in the clinic’s written policies and procedures. The patient’s written consent is necessary
before any information not authorized by law may be released.
C. Retention of Records. Review the clinic policy pertaining to the retention of patient health records. This
policy refl ects the necessity of retaining records at least 6 years from the last entry date or longer if required
by State statute.
VIII. PROGRAM EVALUATION (42 CFR 491.11)
An evaluation of a clinic’s total operation including the overall organization, administration, policies and
procedures covering personnel, fi scal and patient care areas must be done at least annually. This evaluation
may be done by the clinic, the group of professional personnel required under 42 CFR 491.9(b)(2), or
through arrangement with other appropriate professionals. The surveyor clarifi es for the clinic that the State
survey does not constitute any part of this program evaluation.
The total evaluation does not have to be done all at once or by the same individuals. It is acceptable to
do parts of it throughout the year, and it is not necessary to have all parts of the evaluation done by the
same personnel. However, if the evaluation is not done all at once, no more than a year should elapse
between evaluating the same parts. For example, a clinic may have its organization, administration, and
personnel and fi scal policies evaluated by a health care administrator(s) at the end of each fi scal year; and
its utilization of clinic services, clinic records, and health care policies evaluated 6 months later by a group
of health care professionals.
If the facility has been in operation for at least a year at the time of the initial survey and has not had an
evaluation of its total program, report this as a defi ciency. It is incorrect to consider this requirement as not
applicable (N/A) in this case.
A facility operating less than a year or in the start-up phase may not have done a program evaluation.
However, the clinic should have a written plan that specifi es who is to do the evaluation, when and how it is
to be done, and what will be covered in the evaluation. What will be covered should be consistent with the
26

B. Interpretive Guidelines for Rural Health Clinics (con’t)
requirements of 42 CFR 491.11. Record this information under the explanatory statements on the SRF.
Review dated reports of recent program evaluations to verify that such items are included in these
evaluations. When corrective action has been recommended to the clinic, verify that such action has been
taken or that there is sufficient evidence indicating the clinic has initiated corrective action.
27

C. See Addendum: Regulatory Guide:
RHC/FQHC Proposed Rule
28

D. Preparing for the Certification Inspection
This section will help your clinic prepare for the certification inspection. In Arizona, the Arizona
Department of Health Services, Division of Licensing Services, Office of Medical Facilities Licensing
is the state agency that conducts the inspection. The four key elements to preparing for the
RHC Certification inspection are: 1) Policy and Procedure Manual Review, 2) Medical Records
Review, 3) Facility Inspection, and 4) Program Evaluation.
The following is an excerpt from Starting a Rural Health Clinic - A How-To Manual, published by
the U.S. Department of Health and Human Services, Health Resources and Services Administration,
Office of Rural Health Policy. The complete manual is available online at: http://ruralhealth.
hrsa.gov/RHC/RHCmanual.htm. The form used by the surveyor during the inspection can be
referenced in Appendix G. Rural Health Clinic Survey Report.
The RHC Policy and Procedure Manual
The policy and procedure manual should cover key human resource policies, administrative policies,
clinical procedures and protocols, and medical guidelines per RHC Code of Federal Regulations (CFR)
§491.7(a)(2) [available online at: http://www.access.gpo.gov/nara/cfr/waisidx_02/42cfr491_02.html]. Each
clinic’s policy and procedures manual should be drafted with that clinic in mind. This document should be
an accurate refl ection of how the clinic truly intends to operate.
The Policy and Procedures Manual section of the RHC Interpretive Guidelines states, “Written policies
should consist of both administrative and patient care policies. Patient care policies are discussed under
42 CFR 491.9(b). In addition to including lines of authority and responsibilities, administrative policies may
cover topics such as personnel, fi scal, purchasing, and maintenance of building and equipment. Topics
covered by written policies may have been infl uenced by requirements of the founders of the clinic, as well
as agencies that have participated in supporting the clinic’s operation.”
When looking at developing human resource policies there are several laws, administrative rules, acts, and
regulations that must be considered: RHC Code of Federal Regulations [available online at: http://www.
access.gpo.gov/nara/cfr/waisidx_02/42cfr491_02.html], RHC Interpretative Guidelines [see section II.B.
Interpretive Guidelines for Rural Health Clinics], State and Federal Laws, State Public Health Code, and
Professional Practice Standards.
The Human Resource policies should include:
• job descriptions
• benefits, compensation and pay practice
• employment criteria and conditions of employment
• smoking, drug use/possession and distribution
• appointment of providers/credentialing
• confidentiality
• personnel fi les (organization, management, and access)
• harassment, and employee privacy
The Code of Federal Regulations for the RHC program and the RHC Interpretive Guidelines [see the following
website for the Code of Federal Regulations: http://www.access.gpo.gov/nara/cfr/waisidx_02/42cfr491_
02.html; see section II.B. Interpretive Guidelines for Rural Health Clinics) are often the best place to start
when developing RHC policies. CFR Section 491.8 Staffi ng and staff responsibilities, outlines some of the
program requirements for physician assistants, nurse practitioners and certifi ed nurse midwives. The
29

D. Preparing for the Certification Inspection (con’t)
regulations state that, “A nurse practitioner or a physician assistant is available to furnish patient care
services at least 50 percent of the time the clinic operates.” When developing the job description of the
PA/NP/CNM, part of their responsibilities should include the following: “The PA/NP/CNM will be scheduled
in the clinic and available to provide patient care services for at least 50 percent of the time the clinic
operates.”
As you develop your Administrative section, you will want to consider the following resources: RHC Code
of Federal Regulations and Interpretative Guidelines, State and Federal Laws, State Court Rules, Federal
and State OSHA Standards, Medicare and Medicaid reimbursement policy, State Public Health Code, Administrative
rules, and the Freedom of Information Act.
Administrative policies should include:
• Life safety
• Confidentiality
• Exposure control plan
• Hazardous materials
• Health services
• Informed consent
• Medical records (storage, release of information, documentation standards)
• Reporting of suspected child neglect/abuse and abandonment
• TB screening for health care workers
• Medical waste management
• Organizational structure
• Personal accident/incident
• Physical plant and environment
• Patient compliant-grievance procedure
• Performance improvement plan
• Preventative maintenance
• Patient rights and responsibilities
• Quality assurance
• Medicare bad debt
• Cleaning
When developing your Administrative section, the best place to start is with the Code of Federal Regulations
(CFR). An example of an Administrative policy would be Preventive Maintenance. CFR Section 491.6(b)
States, “The clinic has a preventive maintenance program to ensure that: (1) All essential mechanical, electrical
and patient care equipment is maintained in safe operating condition.” The RHC Interpretive Guideline
for this regulation defi nes the requirement further, “A program of preventive maintenance should be followed
by the clinic. This includes inspection of all clinic equipment at least yearly, or as the type, use, and
condition of equipment dictates.” By using these two resources the preventive maintenance policy could
contain the following statements:
1. All Clinic equipment will be inspected at least yearly, or as the type, use, and condition of equipment
dictates. Each time an inspection or repair occurs, an entry will be made in the Inspection and Maintenance
Log and signed by the service person to verify the event.
2. The medical/clinical assistant prior to each use must inspect all equipment.
3. An electrician or bio-medical engineer will inspect each piece of bio-medical equipment. The inspection
will ensure that the equipment is in proper operating condition, is safe to use, and is calibrated properly.
30

D. Preparing for the Certification Inspection (con’t)
When developing clinical procedures/protocols, it is helpful to keep in mind that this section refers to those
procedures that are performed by support personnel, e.g., nurse, certifi ed medical assistant, registered radiologic
technologist, clinical assistant, etc. Resources that you would want to consider as you develop this
section are: RHC Regulations and Interpretive Guidelines, manufacturer recommendations, professional
practice standards, pharmacy regulations and administrative rules, American Heart Association, Federal
and State OSHA standards, CLIA [Clinical Laboratory Improvement Amendments] regulations, CDC [Centers
for Disease Control and Prevention], State Public Health Code, American Academy of Pediatrics, and
PHS Standards for Pediatric Immunization Practices.
Clinical policies should include:
• Administration of Sub-Q, IM, or IV Medications
• Policies for all invasive procedures performed
• Vaccine administration, handling and storage
• Procedures for the operation of all medical equipment
• Medications (stock and sample)
• Laboratory services
• Communicable disease care
• HIV testing
• Universal Precautions
• Diagnostic tracking
• Adverse drug reactions
• Policies that address the testing and quality control of all lab/diagnostic test(s) performed
• Storage of sterile supplies, sterilization of sterile supplies and instruments
As with the Human Resources and Administrative sections, the fi rst resources to consider are the Code of
Federal Regulations and the Interpretive Guidelines. Using the Code you can easily start to put together
your clinical procedures/protocol section. For example, CFR Section 491.6(b)(2) states, “The clinic has a
preventive maintenance program to ensure that drugs and biologicals are appropriately stored.” Based on
this regulation, the medication policy could contain the following Statements (among others):
1. Medications will be refrigerated as necessary and will be kept separate from any food substances. Refrigerator
and freezer temperatures will be obtained and recorded on a daily basis.
2. On a monthly basis, medications will be checked for expiration dates and those which are outdated will
be discarded in the following manner: Given back to drug representative or discarded via the biohazard
container. A log will be maintained to indicate when monthly checks are done and by whom.
3. All medications stored on the Clinic premises will be kept in cabinets, shelves, drawers, and/or refrigerators
and locked during non-patient care hours.
Finally, the RHC program requires that the clinic have guidelines for the medical management of health
problems which include the conditions requiring medical consultation and/or patient referral, the maintenance
of health care records, and procedures for the periodic review and evaluation of the services furnished
by the clinic. Acceptable guidelines may follow various formats.
Some guidelines are collections of general protocols, arranged by presenting symptoms; some are Statements
of medical directives arranged by the various systems of the body (such as disorders of the gastrointestinal
system); some are standing orders covering major categories such as health maintenance, chronic
health problems, common acute self-limiting health problems, and medical emergencies.
31

D. Preparing for the Certification Inspection (con’t)
Even though approaches to describing guidelines may vary, acceptable guidelines for the medical management
of health problems must include the following essential elements:
• They are comprehensive enough to cover most health problems that patients usually see a physician
about;
• They describe the medical procedures available to the nurse practitioner, certifi ed nurse-midwife,
and/or physician assistant; and
• They are compatible with applicable State laws.
The professional organizations of the health professionals typically found in an RHC (physician, PA, NP and
CNM) have published a number of patient care guidelines. Should a clinic choose to adopt such guidelines
(or adopt them essentially with noted modifi cations), this would be acceptable if the guidelines include the
aforementioned essential elements.
Often the regulations will over lap and you need to be aware of the areas where this occurs. Policy and
procedure development is one area. The physician and PA, NP or CNM responsibilities include participation
in developing, executing, and periodic reviewing of the clinic’s written policies. Additionally, the policies are
developed with the advice of a group of professional personnel that includes one or more physicians and
one or more physician assistants or nurse practitioners. At least one member of the advisory group must
not be a member of the clinic staff.
Medical Records
The RHC program has been recognized for its emphasis on documented patient care. This is the direct result
of the requirements and expectations clearly stated in the Code of Federal Regulations. The clinic has
written policies and procedures of how it will maintain confi dentiality of patient health records and provide
a safeguard against: loss, destruction, or unauthorized use of patients’ health record. CFR Section 491.10
Patient health records of the Code, outlines expectations for medical record confi dentiality, maintenance,
organization, content, protection, release and retention. As part of the Certifi cation Survey process, a representative
sample of the clinic’s medical records will be reviewed. The focus should be on Medicare and
Medicaid records only. The clinic may have the opportunity to select the records for review. If not, it will be
the surveyor who determines the records to be reviewed.
Documentation must include but is not limited to:
• Identification and social data, evidence of consent forms, pertinent medical history, assessment
of the health status and health care needs of the patient, and a brief summary of the episode,
disposition and instructions to the patient;
• Reports of physical examinations, diagnostic and laboratory test results and consultative fi ndings;
• All provider orders, reports of treatments and medications and other pertinent information necessary
to monitor the patient’s progress; and
• Signatures of the provider and other health care professionals.
In addition to these program expectations, the clinic must also comply with reimbursement policy, legal expectations,
and standard of practice guidelines. Remember, if it wasn’t documented, it wasn’t done.
Facility
Preparing the facility is not only a requirement of the RHC program but may also be a requirement for compliance
with local, State and Federal laws. An inspection of the physical plant is one of the key elements of
the survey process. Some of the regulations, laws, rules, and standards that impact the facility are: RHC
32

D. Preparing for the Certification Inspection (con’t)
Code of Federal Regulations, Clean Indoor Air Act, OSHA Hazardous Communication Standard, local
building, zoning and, fi re ordinances, and State laws for storage and disposal of medical waste.
To insure the safety of patients, personnel, and the public, the physical plant should be maintained consistent
with appropriate State and local building, fi re, and safety codes. Reports prepared by State and local
personnel responsible for insuring that the appropriate codes are met should be available for review. The
facility must have safe access and be free from hazards that may affect the safety of patients, personnel,
and the public. The clinic must also be constructed, arranged, and maintained to insure access to and
safety of patients, and provide adequate space for the provision of direct services. The clinic must provide
laboratory services directly to its patients. Each clinic must have, at a minimum, its own CLIA certifi cate of
waiver. Provider-based RHCs may not use the CLIA certifi cate of the parent hospital. The clinic must have a
preventive maintenance program to ensure that all essential mechanical, electrical, and patient-care equipment
is maintained in safe operating condition. The clinic must make provisions for the appropriate storage
of drugs and biologicals and the premises must be clean and orderly. The clinic is responsible for assuring
the safety of patients in case of non-medical emergencies that include, placing exit signs in appropriate
locations and taking other appropriate measures that are consistent with the particular conditions of the
area in which the clinic is located.
Program Evaluation
An evaluation of the clinic’s total operation including the overall organization, administration, policies and
procedures covering personnel, fi scal and patient care areas must be done at least annually. This evaluation
may be done by the clinic; an outside group of professional personnel that includes one or more physicians
and one or more physician assistants or nurse practitioners and at least one individual who is not part
of the clinic staff; or through arrangement with other appropriate professionals. The State survey does not
constitute any part of this program evaluation.
The total evaluation does not have to be done all at once or by the same individuals. It is acceptable to
do parts of it throughout the year, and it is not necessary to have all parts of the evaluation done by the
same staff person. However, if the evaluation is not done all at once, no more than one year should elapse
between evaluating the same parts. For example, a clinic may have its organization, administration, and
personnel and fi scal policies evaluated by a health care administrator(s) at the end of the fi scal year; and
its utilization of clinic services, clinic records, and health care policies evaluated six months later by a group
of health care professionals.
If the facility has been operational for at least a year at the time of the survey and has not completed an
evaluation of its total program, the surveyor must report this as a defi ciency. If the facility has been operational
for less than one year or is in the start-up phase, it is not required to complete a program evaluation.
However, the clinic should have a written plan that specifi es who is to do the evaluation, when it is to be
done, how it is to be done, and what will be covered in the evaluation.
The evaluation must include a review of the following:
• Utilization of clinic services (including at least the number of patients served and the volume of
services)
• A representative sample of both active and closed clinical records, and
• The clinic’s health care policies
The purpose of the evaluation is to determine whether: the utilization of services was appropriate; the established
policies were followed; and whether any changes are needed.
33

D. Preparing for the Certification Inspection (con’t)
The clinic staff or a group of professional personnel must consider the fi ndings of the evaluation and take
corrective action if necessary. The Balanced Budget Act of 1997 requires RHCs to have a clinical quality
assurance plan. However as of the writing of this manual, CMS had not published the rules outlining how
RHCs can meet this requirement. Many State surveyors expect to see such a plan in the policy and procedures
manual.
Once the clinic submits its Letter of Readiness to the State agency, the State agency has 90 days in which
to schedule the RHC Certifi cation Survey. Some clinics may experience a delay in the process depending
on national initiatives and budget constraints.
The State agency does have the option, under certain conditions, of giving clinics a 48-hour notice of the
scheduled survey. Some States, however, will not exercise this option and the survey will be unannounced.
To ensure a successful survey, have a plan and prepare ahead. [In Arizona, the Arizona Department
of Health Services, Division of Licensing Services, Offi ce of Medical Facilities Licensing conducts unannounced
survey visits for the Medicare Rural Health Clinic certifi cation inspection].
The following documents should be prepared and available to the surveyor.
Policy and Procedure Manual:
• All Professional Group, Staff, and Provider mtg. minutes
• Fire and Evacuation Training logs CLIA Certifi cate
• Exposure Control and Blood borne Pathogen Training
• Personnel Files
• X-ray Certifi cate (if applicable)
• Sample Drug Log
MSDS Manual:
• Minimum of 10 medical records (Medicare/Medicaid only) – mix of all life cycles and providers
• CLIA Certifi cate
• Quality Assurance and Performance Improvement Activity
• Preventative Maintenance Reports
• Laboratory Control Logs
• Diagnostic Results Tracking System
When the Certifi cation Survey results in no defi ciencies, the State agency has ten (10) calendar days to
prepare the Survey Packet for the CMS Regional Offi ce (RO) with a recommendation of approval. The RO
has 60 days to review and approve the survey packet and issue the Medicare Provider Letter to the clinic.
For those clinics that fi le their application as a Provider-based entity, the provider-based request must be
submitted to the RO with the survey packet. The RO will make the Provider-based determination and will
notify the appropriate Fiscal Intermediary via the Medicare Tie-In Notice.
Should the survey result in defi ciencies or citations, a Statement of Defi ciencies will be sent to the clinic by
the State agency within ten (10) days of the survey. The clinic will have 10 days to develop a Plan of Correction
(POC) and submit the POC back to the State agency. An initial applicant to the Medicare program
cannot be certifi ed or approved unless they are in compliance with the Conditions for Coverage. If in the
judgement of the surveyor, the defi ciencies evince non-compliance at the Condition level, then the applicant
cannot be approved until those defi ciencies have been corrected and the corrections have been verifi ed
through a follow-up survey. If there are defi ciencies but they do not constitute non-compliance at the condition
level, then the facility can be approved for participation with an approved plan of correction in place. A
sample “Plan of Correction with Defi ciencies” appears at the end of this chapter. The State agency will then
review the POC for completeness.
34

D. Preparing for the Certification Inspection (con’t)
Key elements to a POC include: it must be doable or realistic, it must have completion dates, it must specifi
cally address the citation, and if appropriate, the clinic must be able to document proof of compliance.
There are no time constraints placed on the State agency when reviewing a POC. Once the State agency
has found the POC to be acceptable, they will submit the survey packet with recommendations to the RO.
The RO has 60 days to review and approve the survey packet and issue the Medicare Provider Letter to
the clinic. For those clinics that fi le their application as a Provider-based entity, the provider-based request
must be submitted to the RO with the survey packet. The RO will make the Provider-based determination
and will notify the Fiscal Intermediary via the Medicare Tie-In Notice.
Once the Medicare Provider Letter has been received by the clinic, the clinic is eligible to fi le a projected
cost report and have their Medicare Rate determined.
Source: U.S. Department of Health and Human Services, Health Resources and Services Administration, Office of
Rural Health Policy, Starting a Rural Health Clinic: A How-To Manual, http://ruralhealth.hrsa.gov/RHC/RHCmanual.htm.
35

30 Most Common RHC Survey/Certification Deficiencies
Surveyor Code CFR Section Summary of Requirement
J20
491.6(a)
The clinic is constructed, arranged, and maintained to ensure
access to and safety of patients, and provides adequate space
for the provision of direct services.
J22
491.6(b)(1)
The clinic has a preventive maintenance program to ensure
that all essential mechanical, electrical and patient-care
equipment is maintained in safe operating condition.
J23
491.6(b)(2)
The clinic has a preventive maintenance program to ensure
that drugs and biologicals are appropriately stored.
J24
491.6(b)(3)
The clinic has a preventive maintenance program to ensure
that the premises are clean and orderly.
J26
491.6(c)(1)
The clinic assures the safety of patients in case of non-medical
emergencies by training staff in handling emergencies.
J28
491.6(c)(3)
The clinic assures the safety of patients in case of non-medical
emergencies by taking other appropriate measures that are
consistent with the particular conditions of the area in which
the clinic is located.
J32
491.7(a)(2)
The organization's policies and it's lines of authority and
responsibilities are clearly set forth in writing.
J41
491.8(a)(6)
A physician, nurse practitioner, or physician's assistant is
available to furnish patient care services at all times during the
clinic's regular hours of operation. A nurse practitioner or a
physician's assistant is available to furnish patient care
services during at least 50 percent of the clinic's regular hours
of operation.
J47
491.8(b)(2)
Physician responsibilities: In conjunction with the physician
assistant and/or nurse practitioner member(s), the physician
participates in developing, executing and periodically
reviewing the clinic's written policies and the services provided
to Federal program patients.
J48
491.8(b)(3)
Physician responsibilities: The physician periodically reviews
the clinic's patient records, provides medical orders, and
provides medical care services to the patients of the clinic.
Physician assistant and the nurse practitioner responsibilities.
The physician assistant and the nurse practitioner members of
the clinic's staff:
J51
491.8(c)
I. Participate in the development, execution and periodic
review of the written policies governing the services
the clinic furnishes;
II. Provide services in accordance with those policies;
III. Arrange for, or refer patients to, needed services that
cannot be provided at the clinic;
IV. Assure that adequate patient health records are
maintained and transferred as required when patients
are referred; and
V. Participate with a physician in a periodic review of the
patient's health records.
36

30 Most Common RHC Survey/Certification Deficiencies (Con’t)
J55
J56
J57
J58
491.9(b)(1)
491.9(b)(2)
491.9(b)(3)(iii)
491.9(b)(4)
The clinic's health care services are furnished in accordance
with appropriate written policies, which are consistent with
applicable State law.
The patient care policies are developed with the advice of a
group of professional personnel that includes one or more
physicians and one or more physician's assistants or nurse
practitioners. At least one member of the group is not a
member of the clinic's staff.
The policies include guidelines for the medical management
of health problems, which include the conditions requiring
medical consultation and/or patient referral, the maintenance
of health care records, and procedures for the periodic review
and evaluation of the services furnished by the clinic.
These policies are reviewed at least annually by the group of
professional personnel as required under 491.9(b)(2), and
reviewed as necessary by the clinic.
The clinic provides basic laboratory services essential to the
immediate diagnosis and treatment of the patient, including:
J61
491.9(c)(2)
1. Chemical examinations of urine by stick or tablet
methods or both (including urine ketones);
2. Hemoglobin or hematocrit;
3. Blood sugar;
4. Examination of stool specimens for occult blood;
5. Pregnancy tests; and
6. Primary culturing for transmittal to a certified
laboratory.
J62 491.9(3)
The clinic provides medical emergency procedures as a first
response to common life-threatening injuries and acute
illness, and has available the drugs and biologicals commonly
used in life saving procedures, such as analgesics,
anesthetics (local), antibiotics, anticonvulsants, antidotes and
emetics, serums and toxoids.
37

30 Most Common RHC Survey/Certification Deficiencies (Con’t)
For each patient receiving health care services, the clinic
maintains a record that includes, as applicable:
J70
491.10(a)(3)
1. Identification and social data, evidence of consent
forms, pertinent medical history, assessment of the
health status and health care needs of the patient,
and brief summary of the episode, disposition, and
instructions to the patient;
2. Reports of physical examinations, diagnostic and
laboratory test results, and consultative findings;
3. All physician's orders, reports of treatments and
medications and other pertinent information
necessary to monitor the patient's progress;
4. Signatures of the provider or other health care
professional.
J72
491.10(b)(1)
The clinic maintains the confidentiality of record information
and provides safeguards against loss, destruction, or
unauthorized use.
J76 491.11 Program evaluation
J77
491.11(a)
The clinic carries out, or arranges for, an annual evaluation of
its total program.
J78 491.11(b) Reviews included in evaluation
J79
491.11(b)(1)
The evaluation includes review of the utilization of clinic
services, including at least the number of patients served and
the volume of services.
J80
491.11(b)(2)
The evaluation includes review of a representative sample of
both active and closed clinical records.
J81
491.11(b)(3)
The evaluation includes review of the clinic's health care
policies.
J82 491.11(c) Purpose of the evaluation
J83
491.11(c)(1)
The purpose of the evaluation is to determine whether the
utilization of services was appropriate.
J84
491.11(c)(2)
The purpose of the evaluation is to determine whether the
established policies were followed.
J85
491.11(c)(3)
The purpose of the evaluation is to determine whether any
changes are needed.
J86
491.11(d)
The clinic staff considers the findings of the evaluation and
takes corrective action if necessary.
38

F. RHC Cost Report
The Medicare cost report is a required form that is completed annually by all Rural Health Clinics.
Independent RHCs must complete the CMS 222-92 form and provider-based RHCs are required
to complete Worksheet M of form CMS 2552-96.
The following is an excerpt from the U.S. Department of Health and Human Services, Health Resources
and Services Administration, Office of Rural Health Policy’s Starting a Rural Health Clinic
- A How-To Manual (Available online at: http://ruralhealth.hrsa.gov/RHC/RHCmanual.htm):
This chapter will discuss the rural health clinic cost report, the process for fi ling the cost report, and an example
of a completed cost report. It is intended to provide you with an overall summary of the cost reporting
process. By also providing you with defi nitions of terms and a sample of a cost report, we hope to give you
a better understanding of how the process works.
We cannot emphasize enough the importance of getting expert advice. Expert advice should be from individuals
with experience with cost reports and specifi cally with the CMS-222 (or Schedule M) Cost Report,
as it relates to issues such as calculation of FTE, reassignment of costs, and the completion of an independent
or provider-based RHC Cost Report.
While it is possible for individual practices without signifi cant experience to complete the cost report, in
many instances there are multiple errors that occur and this is often to the fi nancial detriment of the clinic.
In addition, it is important to acknowledge that the accuracy of the data provided can have a signifi cant
fi nancial impact on the year-end cost report. We, therefore, recommend getting appropriate expert advice
when attempting to complete a Medicare Cost Report.
Form 222, the Medicare RHC cost report, (schedule M of the hospital, nursing home or home health cost
report), is a required form that is completed on an annual basis by all rural health clinics.
The cost report is a statement of costs and provider utilization that occurred during the time period covered
by the cost report. The cost report is the means by which Medicare determines how much money is due to
the provider, or due back from the provider, for RHC services rendered to Medicare benefi ciaries during the
cost reporting period. The cost report typically covers a twelve (12) month period of time and is due fi ve (5)
months from the date of the end of the fiscal year of the RHC.
There are exceptions to the twelve (12) month period covered by a cost report. The exceptions would be
due to the sale of the RHC or a change in ownership of the RHC during the twelve (12) month period; leaving
a shorter time period than twelve (12) months that would be covered by the cost report. If a clinic experiences
a change of ownership or decides to discontinue operation as an RHC, a cost report is due 150 days
from the date of ownership change or RHC termination.
On July 26, 2002, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that,
if adopted, would have required electronic submission of all RHC cost reports for cost reporting periods
ending after December 31, 2002. As of the publication of this book, that rule has not be fi nalized. The proposed
rule indicated that exceptions would be available for providers who can demonstrate that electronic
submission would represent a hardship. However, no details of the exception process were provided. The
authors anticipate the proposed rule will be fi nalized and electronic submission of RHC costs reports will
be mandatory at some point.
The maximum time period that can be covered by a fi led cost report is thirteen (13) months. There are no
extensions to file cost reports except under special circumstances, such as a natural disaster (i.e. fl ood,
earthquake, fi re, etc.). The Fiscal Intermediary generally will grant this type of extension. [A listing of the F.
39

F. RHC Cost Report (con’t)
Fiscal Intermediaries for the independent RHCs is available online at: http://www.cms.hhs.gov/apps/contacts/incardir.asp].
As has been previously noted, there are two types of RHC’s - Independent and Provider-based. Each must
fi le a cost report, but the cost report is different for each of the two types of RHC’s.
All Rural Health Clinics are presumed to be independent unless the clinic requests designation as a provider-based
facility. Whereas, an independent RHC can be owned by any type of entity authorized under
State law to own a medical practice: physicians; physician assistants; nurse practitioners; certifi ed nurse
midwives; hospitals; skilled nursing facilities; home health agencies; for-profi t corporations; not-for-profi t
corporations; or government entities; only those entities recognized by Medicare as a “provider” can own
a provider-based RHC. Entities designated by Medicare as providers are: hospitals, skilled nursing facilities,
and home health agencies. Although this chapter will focus on the fi ling of an independent RHC cost
report, the provider-based RHC cost report is very similar. A provider-based cost report is fi led as a part of
the sponsoring provider’s cost report. It is prepared on Schedule M.
The following list includes the title and explanation of each worksheet contained in the RHC cost report:
•Worksheet S
This is the statistical data and certifi cation statement (requires original signature when submitted). The
statistical data includes information such as: whether the cost report is based on actual or projected cost,
time period covered, provider name, Medicare number, location, provider numbers of physicians/PAs/NPs/
CNMs, operational control, hours of operation, etc.
•Worksheet A, Columns 1 & 2
Worksheet A is used to record the trial balance of expense accounts from the provider books and records
for the cost reporting period stated. The total dollar amount of Column 1 and 2 should tie to the records of
the provider for total expenses. (Column 1 is for compensation amounts, while column 2 reports amounts
other than compensation). Column 3 is the total of Column 1 & 2. This worksheet also provides for the necessary
reclassifi cations (Column 4) and adjustments (Column 6) to certain accounts.
•Worksheet A-1, Column 4
This worksheet provides for reclassifi cation of any amounts in order to refl ect the proper cost allocation in
a given cost center. This worksheet “moves” certain amounts from one cost center to another cost center.
Supporting documentation is needed for each reclassifi cation made on this worksheet.
•Worksheet A-2, Column 6
This worksheet provides for adjustments, which are necessary under the Medicare principles of reimbursement.
Types of items to be entered on this Worksheet are 1) those needed to adjust expenses incurred {accrual
accounting} 2) those that represent recovery of expenses through refunds, sales, etc. 3) those needed
to adjust expenses that are non-allowable for Medicare purposes 4) those needed to adjust expenses in
accordance with offsets from “other/miscellaneous” income received. Supporting documentation is needed
for each adjustment made on this worksheet.
•Worksheet A-2-1, Column 6, Flows thru Worksheet A-1
This worksheet fl ows into the above worksheet A-2 at the net amount of the total adjustment. It provides
for information and amounts on related parties of the organization including costs applicable to services,
facilities, and supplies furnished to providers by a related organization or by common ownership. This worksheet
allows for any adjustments that are needed to reduce related party transactions amounts to allowable
Medicare amounts.
40

F. RHC Cost Report (con’t)
•Worksheet B
This worksheet is used to summarize the number of facility visits to be used in the rate determination. The
visits include the visits furnished by the provider’s health care staff and any physicians under agreement.
This worksheet also calculates the overhead cost incurred which applies to the services.
•Worksheet B-1
The cost and administration of Pneumococcal and Infl uenza vaccines to Medicare benefi ciaries are 100
percent reimbursable by Medicare. This worksheet calculates the cost per injection of each of these vaccines
and determines the total amount of reimbursement for the vaccines administered to Medicare benefi
ciaries.
•Worksheet C
This worksheet provides for the determination of the provider’s cost per visit and calculates the total amount
due the provider or due the intermediary. Part I calculates the cost per visit and Part II determines the total
Medicare payment due the provider for services furnished to Medicare benefi ciaries. This worksheet also
allows the provider to claim reimbursement for bad debts related to uncollectible Medicare deductible and
coinsurance amounts.
The following is information that needs to be gathered in order to complete a rural health clinic cost report:
1) Financial statements for the cost reporting period; to include the trial balance.
2) Total number of visits for the cost reporting period for each of the following health care providers (individual
by name):
A. Physicians
B. PAs/NPs/CNMs
C.Any Other Health Care Providers (list on worksheet by name and title)
Total visits broken down by the following, per health care provider listed above.
I. Medicare Visits
II. Regular Medicaid Fee-For-Service Visits
III. Crossover Visits (Medicare Primary and Regular Medicaid Secondary)
IV. Medicaid HMO (Qualifi ed Health Plan) Visits per each HMO Crossover Visit (Medicare Primary
and Medicaid HMO Secondary per each HMO)
V. Private Visits (workers’ comp., commercial, self pay, sliding fee, etc.)
3) The clinic’s hours of operation per week.
4) Individual average hours worked per week for the following health care providers:
1. Physicians
2. PA/NP’s
3. Any Other Health Care Providers
5) Total average hours worked per week for each of the above health care providers broken down by the
following:
1. Administrative hours
2. Patient Care hours
3. Inpatient hours
Job titles and wages should be broken down for all employees of the RHC for the cost reporting period. Be
specifi c for those employees related to a lab technician job description for actual hours worked as “lab tech”
and other hours worked.
41

F. RHC Cost Report (con’t)
Fringe Benefi ts and Employer related payroll taxes of each employee.
6) Total number of vaccines given for the following vaccinations for all insurances totaled together:
A. Pneumovax
B. Infl uenza
Total number of above vaccines given - broken down by the following:
I. Medicare vaccines given for Pneumo and Infl uenza listed separately.
II. Medicaid vaccines given for Pneumo and Infl uenza listed separately.
III. Vaccine logs for Medicare Pneumovax and Infl uenza vaccines to include Patients name, HIC
Number, and Date of Injection to support the above Medicare vaccinations.
IV. Cost per dose of each vaccine.
7) Payments Received for the following:
A. Medicare Payments
B. Medicaid Straight or Regular FFS Payments
C. Medicaid HMO Payments per each HMO
D. Medicare Crossover Payments made by Medicare
E. Medicaid Crossover Payments made by Medicare
F. Medicaid Other Third Party Payments (i.e. primary insurance’s, besides Medicare, that have
paid when Medicaid is the secondary insurance)
G. Medicare Benefi ciary Deductible Received (Payments made by the Medicare Patient)
8) Any new assets purchased If so, submit the following:
A. Date Asset Purchased
B. Description of Asset
C. Cost of Asset
D. Depreciation Schedule to match depreciated expenses in Financial Statement
9) Listing of Medicare Bad Debts with Medicare Patients, to include the following information:
A. Beneficiary Name
B. Beneficiary HIC Number
C. Date(s) of Service
D. Date of First Bill
E. Medicare Paid Date
F. Date of Write-Off
G. Amount of Debt
H. Medicare Deductible and Coinsurance amount
I. Medicaid Payment Amount
In order to be considered “allowable bad debt”, debt must be written off during cost reporting period.
NOTE: Reasonable collection efforts may be waived for Medicare indigent patients. A Medicare benefi ciary
who also qualifi es for Medicaid may be considered indigent automatically. For other Medicare benefi ciaries,
the provider should apply its customary practices for determining indigency. Please refer to PRM Section
312 for the factors, which should be incorporated into the provider’s indigency guidelines. The bad debt for
an indigent patient may be written off and claimed upon discharge or upon the determination of indigency,
whichever is later. If indigency is determined, please indicate Medicaid number of recipient, if applicable,
to claim as bad debt to Medicare.
10) Copy of PSR from Medicare Fiscal Intermediary to compare clinic visit and payment information for the
cost reporting period.
42

F. RHC Cost Report (con’t)
11) Listing of each Medicaid HMO (QHP) [Qualifi ed Health Plan] contracted with to include the following
information:
A. Name of Medicaid HMO (QHP)
B. Address of Medicaid HMO (QHP)
C. Contact and phone number of HMO (QHP)
D. Provider Number of HMO (QHP)
E. Total the number of members assigned per each HMO (QHP) for each month of the cost reporting
period - these numbers are then added up to make one complete total for the entire
year.
F. Visits and Payments broken down per Medicaid HMO (QHP) by capitation payments and FFS
payments.
12) Please Note: Information is needed for any “Lab Tech” personnel employed/contracted by the clinic
not solely considered a lab tech and who provides services outside of lab tech services; please break
hours down for the year based on description of job performed by lab tech duties vs. all other RHC duties
(2 categories needed): Other duties include, but are not limited to; billing, administrative, nursing, medical
assistant, etc. This is only needed for lab tech’s that perform other job functions other than lab technician
services, as any cost beginning January 1, 2001 related to lab tech services is a non-allowable RHC cost.
43

G. Important Resources
1) Starting a Rural Health Clinic- A How-to Manual, U.S. Department of Health and Human
Services, Health Resources and Services Administration, Office of Rural Health Policy, 2004
Available online at: http://ruralhealth.hrsa.gov/RHC/RHCmanual.htm
This manual includes the following information:
-Overview of the RHC Program
-Getting Started - Does Your Site Qualify
-Feasibility Analysis - Is The RHC Program For You
-How to File the RHC Application
-Preparing for the RHC Certification Inspection
-Completing the Cost Report
-RHC Coding and Billing Issues
-State Survey and Certification Agencies
-State Offices of Rural Health
-Criteria for Designation as a HPSA or MUA
-Sample Policy and Procedures Manual
-Other Resources
2) Medicare Benefit Policy Manual: Chapter 13 - Rural Health Clinic (RHC) and Federally Qualified
Health Center (FQHC) Services
Available online at: http://www.cms.hhs.gov/manuals/Downloads/bp102c13.pdf
This manual includes the following information:
-Rural Health Clinics (RHCs) Defined
-Rural Health Clinic and Federally Qualified Health Center Service Defined
-Physician Services
-Services and Supplies Furnished Incident to Physician’s Services
-Nurse Practitioner, Certified Nurse Midwife, and Physician Assistant Services
-Services and Supplies Incident to Nurse Practitioner’s, Certified Nurse Midwives’s
-Conditions for Coverage of Visiting Nurse Services
-Clinical Psychologist Services Away and at the RHC/FQHC Clinic or Center
-Clinical Social Worker (CSW) Services Away and at the RHC/FQHC Clinic or Center
3) Medicare Claims Processing Manual: Chapter 9 - Rural Health Clinics/Federally Qualified
Health Centers
Available online at: http://www.cms.hhs.gov/manuals/downloads/clm104c09.pdf
This manual includes the following information:
-General Differences Between RHCs and FQHCs
-Method of Medicare Payment for RHC and FQHC Services
44

G. Important Resources (con’t)
-Annual Reconciliation With Cost Report
-Allowable Costs
-Deductible and Coinsurance
-Mental Health Services Limit
-Determining How Much to Charge Patient Before Billing Is Submitted for Part B Pay
ment
-General Billing Requirements for Preventive Services
-Laboratory Services
-FI/Carrier Coordination
-Agreements Between CMS and RHC/FQHC
-Content and Terms of Agreements
-Termination of Agreement
45

IV. Appendices
Appendix A. Important Contact Information
Arizona Department of Health Services
Division of Licensing Services
Office of Medical Facilities Licensing
150 North 18th Avenue
4th Floor
Phoenix, AZ 85007
(602) 364-3030
(602) 364-4806 Fax
http://www.azdhs.gov/als/medical/index.htm
For information regarding RHC Certification,
contact: Helena Hoover at the above phone
number.
For information regarding Licensing, contact
the Office of Medical Facilities Licensing at the
phone number listed above.
Rural Health Office
Mel and Enid Zuckerman College of Public
Health
The University of Arizona
P.O. Box 245177
Tucson, AZ 85724
(520) 626-5823
(520) 626-3101 Fax
http://www.rho.arizona.edu/
The mission of the Rural Health Office is to
promote the health of rural and medically underserved
individuals, families, and communities
through service, education, and research.
They can provide technical assistance to groups
wishing to apply for RHC certification. Contact
Alison Hughes at (520) 626-6253.
Healthcare Horizon
J.E. Estes, Owner
Route 5 Box 226
Bartlesville, OK 74003
(800) 399-0874
(918) 336-6269 Fax
http://www.healthcarehorizon.com
Healthcare Horizon has offered consultation
services to Rural Health providers across the
nation since 1989. With health experience dating
back to 1976, this firm is well rooted and established
in the Rural Health field. Healthcare
Horizon provides clients with a powerful
combination of knowledge, experience, and integrity.
The Centers for Medicare and Medicaid
Services (CMS)
7500 Security Boulevard
Baltimore, Maryland 21244-1850
1-877-267-2323
http://www.cms.hhs.gov
The Centers for Medicare & Medicaid Services
(CMS) is a Federal agency within the U.S. Department
of Health and Human Services. Programs
for which CMS is responsible include
Medicare, Medicaid, State Children’s Health Insurance
Program (SCHIP), HIPAA, and CLIA.
1735 Babcock Road
San Antonio, Texas 78229
(800) 782-5621
(210) 349-0015
(210) 349-0225 Fax
46

Appendix A. Important Contact Information (con’t)
M& M Computer Services
Contact Name: John Linn
http://mnm-medical.com
M & M Computer Services is the originator and
sole owner of the Medical Accounts Receivable
System (M.A.R.S.), the leading Medicare certified
Rural Health Clinic billing and information
system software in the country.
National Association of Rural Health Clinics
2 East Main Street
Fremont, MI 49412
info@narhc.org
(866) 306-1961
info@narhc.org
http://www.narhc.org
The National Association of Rural Health Clinics
(NARHC) is the only national organization
dedicated exclusively to improving the delivery
of quality, cost-effective health care in rural under
served areas through the Rural Health Clinics
(RHC) Program. NARHC works with Congress,
federal agencies, and rural health allies
to promote, expand, and protect the RHC Program.
Through the association, NARHC members
become actively engaged in the legislative
and regulatory process.
National Rural Health Association
Headquarters
521 East 63rd Street
Kansas City, MO 64110
(816) 756-3140
(816) 765-3144
Government Affairs Office
1108 K Street NW
Washington DC, 20005
(202) 639-0550
(202) 639-0559 Fax
National Rural Health Association (con’t)
http://www.nrharural.org
The National Rural Health Association is a
national nonprofit membership organization,
whose mission is to improve the health and
health care of rural Americans and to provide
leadership on rural issues through advocacy,
communications, education, and research.
Office of Rural Health Policy
Health Resources and Services Administration
5600 Fishers Lane, 9A-55
Rockville, MD 20857
(301) 443-0835
(301) 443-2803 Fax
http://ruralhealth.hrsa.gov
The Office of Rural Health Policy (ORHP)
promotes better health care service in rural
America. Established in August 1987 by the
Administration, the Office was subsequently
authorized by Congress in December 1987 and
located in the Health Resources and Services
Administration. Congress charged the Office
with informing and advising the Department of
Health and Human Services on matters affecting
rural hospitals and health care, coordinating
activities within the department that relate
to rural health care, and maintaining a national
information clearinghouse.
Rural Information Center
National Agricultural Library
10301 Baltimore Avenue, Room 132
Beltsville, MD 20705
ric@nal.usda.gov
1-800-633-7701
(301) 504-5181 Fax
http://ric.nal.usda.gov
47

Appendix A. Important Contact Information (con’t)
Rural Information Center (con’t)
The Rural Information Center (RIC) of the National
Agricultural Library provides information
and referral services to local, tribal, state,
and federal government officials; community
organizations; rural electric and telephone cooperatives;
libraries; businesses; and, citizens
working to maintain the vitality of America’s
rural areas.
Rural Assistance Center
School of Medicine and Health Sciences,
Room 4520
501 North Columbia Road Stop 9037
Grand Forks, ND 58202
1-800-270-1898
1-800-270-1913 Fax
info@raconline.org
http://www.raconline.org
A product of the U.S. Department of Health
and Human Services’ Rural Initiative, the Rural
Assistance Center (RAC) was established
in December 2002 as a rural health and human
services “information portal.” RAC helps rural
communities and other rural stakeholders access
the full range of available programs, funding,
and research that can enable them to provide
quality health and human services to rural
residents.
48

Appendix B. Definitions for Rural Health Clinic Designation
Rural:
The U.S. Census Bureau defines rural as “all territory, population, or housing unit located outside
of UAs [urbanized areas] and UCs [urbanized clusters].”
Source: United States Census Bureau, Census 2000 Urban and Rural Classification, http://www.census.gov/geo/www/
ua/ua_2k.html.
Urban:
“For Census 2000, the Census Bureau classifies as ‘urban’ all territory, population, and housing
units located within an urbanized area (UA) or an urban cluster (UC). It delineates UA and UC
boundaries to encompass densely settled territory, which consists of core census block groups or
blocks that have a population density of at least 1,000 people per square mile and surrounding
census blocks that have an overall density of at least 500 people per square mile.”
Source: United States Census Bureau, Census 2000 Urban and Rural Classification, http://www.census.gov/geo/www/
ua/ua_2k.html.
Urbanized Area:
According to the U.S. Census Bureau, an urbanized area “consists of contiguous, densely settled
census block groups (BGs) and census blocks that meet minimum population density requirements,
along with adjacent densely settled census blocks that together encompass a population of at least
50,000 people.”
Source: United States Bureau of the Census, Urban Area Criteria for Census 2000, http://www.census.gov/geo/www/
ua/uafedreg031502.txt.
Urban Cluster:
According to the U.S. Census Bureau, an urban cluster “consists of contiguous, densely settled
census [block groups] and census blocks that meet minimum population density requirements,
along with adjacent densely settled census blocks that together encompass a population of at least
2,500 people, but fewer than 50,000 people.”
Source: United States Bureau of the Census, Urban Area Criteria for Census 2000, http://www.census.gov/geo/www/
ua/uafedreg031502.txt.
Health Professional Shortage Area (HPSA):
The purpose of the HPSA designation is to identify an area or population that has a shortage of
dental, mental, and primary health care providers. The HPSA designation is based on the following
three criteria: the geographic area involved must be rational for delivery of health services; a
49

Appendix B. Definitions for Rural Health Clinic Designation (con’t)
specified population-to-provider ratio representing shortage must be exceeded within the area;
resources in contiguous areas must be shown to be overutilized, excessively distant, or otherwise
inaccessible. A HPSA designation may be for a geographic area, a certain population (i.e., lowincome),
or a facility. HPSA designation criteria are developed by the Shortage Designation Branch
in the HRSA Bureau of Health Professions, National Center for Health Workforce Analysis. For
information on how to apply for a HPSA designation, visit: http://bhpr.hrsa.gov/shortage/hpsapply.
htm.
In addition, automatic facility HPSA status is available for all Federally Qualified Health Centers
(FQHCs) and those Rural Health Clinics (RHCs) that meet the requirement of providing access to
care regardless of ability to
pay. For more information, visit: http://bhpr.hrsa.gov/shortage/autoscore.htm.
Sources: Arizona Department of Health Services, Office of Health Systems Development, Health Professional Shortage
Areas, http://www.azdhs.gov/hsd/hpsa.htm; HRSA Bureau of Health Professions, Shortage Designation, http://bhpr.
hrsa.gov/shortage/; HRSA Bureau of Health Professions, Shortage Designation: Automatic Facility HPSA Scoring,
http://bhpr.hrsa.gov/shortage/autoscore.htm.
Medically Underserved Area (MUA):
The purpose of the MUA designation is to identify areas that are in need of medical services on the
basis of demographic data. The designation is dependent on the area having an Index of Medical
Underservice (IMU) score of 62.0 points or less. The IMU is a weighted score and is based on
the following four criteria: ratio of primary medical care physicians per 1,000 population, infant
mortality rate, percentage of population below the federal poverty level, and percentage of the
population 65 years and older.
Source: Arizona Department of Health Services, Office of Health Systems Development, Federal Medically
Underserved Areas and Populations, http://www.azdhs.gov/hsd/mua_mup.htm.
50

Appendix C. Federal Primary Care HPSAs in Arizona (as of 3/2007)
APACHE
• Chinle
Designation Type: Geographic
• Ganado
Designation Type: Geographic
• Kayenta
Designation Type: Geographic
• Sanders
Designation Type: Geographic
• St. Johns/Springerville
Designation Type: Geographic
COCHISE
• Benson
Destination Type: Population Low
Income
• Bisbee
Designation Type: Geographic
• Douglas
Designation Type: Geographic
• Arizona State Prison Complex-Douglas
Designation Type: Facility
• Elfrida
Designation Type: Geographic
• Sierra Vista/ Tombstone
Designation Type: Geographic
COCONINO
• Fredonia
Designation Type: Geographic
• Grand Canyon Village
Designation Type: Population Low
Income
• Hopi
Designation Type: Geographic
• Page/Tuba City
Designation Type: Geographic
GILA
• Globe
Designation Type: Population Low
Income
GILA (con’t)
• Hayden
Designation Type: Geographic
• Northern Young
Designation Type: Geographic
• Young
Designation Type: Geographic
GRAHAM
• Arizona State Prison Complex- Safford
Designation Type: Facility
• Federal Correctional Institution-
Safford
Designation Type: Facility
• Graham County
Designation Type: Geographic
GREENLEE
• Entire County
Designation Type: Geographic
LA PAZ
• Entire County
Designation Type: Geographic
MARICOPA
• Adobe Mountain School
Designation Type: Facility
• Arizona State Prison Complex- Lewis
Designation Type: Facility
• Avondale/Tolleson
Designation Type: Population Low
Income
• Buckeye
Designation Type: Geographic
• Chandler
Designation Type: Geographic
• El Mirage
Designation Type: Population Low
Income
• Federal Correctional Institution-
Phoenix
51

Appendix C. Federal Primary Care HPSAs in Arizona (con’t)
MARICOPA (con’t)
Designation Type: Facility
• Gila Bend
Designation Type: Geographic
• Glendale
Designation Type: Geographic
• Maricopa County Jails
Designation Type: Facility
• Rio Salado
Designation Type: Geographic
• South Central Phoenix
Designation Type: Population Low
Income
• South Mountain
Designation Type: Population Low
Income
• Southwest Phoenix
Designation Type: Population Low
Income
• West Phoenix
Designation Type: Population Low
Income
• Wickenburg
Designation Type: Geographic
MOHAVE
• Bullhead City
Designation Type: Population Low
Income
• Dolan Springs
Designation Type: Geographic
• Fort Mohave
Designation Type: Population Low
Income
• Kingman
Designation Type: Population Low
Income
• Mohave North
Designation Type: Geographic
NAVAJO
• Arizona State Prison Complex-
Winslow
Designation Type: Facility
• Chinle
Designation Type: Geographic
• Dilkon
Designation Type: Geographic
• Heber/Overgaard
Designation Type: Geographic
• Hopi
Designation Type: Geographic
• Kayenta
Designation Type: Geographic
• Showlow
Designation Type: Population Low
Income
• Snowflake
Designation Type: Geographic
• Winslow
Designation Type: Population Low
Income
PIMA
• Ajo
Designation Type: Geographic
• Arivaca
Designation Type: Geographic
• Arizona State Prison Complex- Tucson
Designation Type: Facility
• Children’s Rehabilitative Services of
Tucson
Designation Type: Facility
• Continental
Designation Type: Geographic
• Federal Correctional Institution-
Tucson
Designation Type: Facility
• Marana
Designation Type: Geographic
• Tucson Central
Designation Type: Geographic
52

Appendix • C. Federal Primary Care HPSAs in Arizona (con’t)
PIMA (con’t)
Tucson Southeast
Designation Type: Geographic
• Tucson Southwest
Designation Type: Geographic
PINAL
• Apache Junction
Designation Type: Geographic
• Arizona State Prison Complex- Eyman
Designation Type: Facility
• Central/West Pinal
Designation Type: Population Low
Income/Migrant Farm Worker
• Florence Prison, INS
Designation Type: Facility
• San Pedro Valley
Designation Type: Geographic
• Superior/Kearny
Designation Type: Population Low
Income
SANTA CRUZ
• Entire County
Designation Type: Geographic
YAVAPAI
• Ash Fork
Designation Type: Geographic
• Cordes Junction
Designation Type: Geographic
• Yavapai South
Designation Type: Geographic
YUMA
• Arizona State Prison Complex- Yuma
Designation Type: Facility
• Yuma County
Designation Type: Geographic
Source: Arizona Department of Health Services, Office
of Health Systems Development, Primary Care HPSAs
(by County), http://www.azdhs.gov/hsd/pc_hpsa.htm.
53

Appendix D. Federal MUAs/MUP in Arizona (as of 6/2007)
APACHE
• Entire County
Designation Type: MUA
COCHISE
• Benson Division
Designation Type: MUA
• Bisbee
Designation Type: MUP - Low Income
• Bowie/Willcox
Designation Type: MUA
• Douglas
Designation Type: MUA
• Elfrida Division
Designation Type: MUA
• Sierra Vista Division
Designation Type: MUA
COCONINO
• Flagstaff- Medically Indigent
Population
Designation Type: Governor’s Request
• Kaibab Division
Designation Type: MUA
• Tuba City
Designation Type: MUA
GILA
• Entire County
Designation Type: MUP - Low Income
GREENLEE
• Duncan Division
Designation Type: MUA
LA PAZ
• Parker
Designation Type: MUP - Low Income
• Quartzsite
Designation Type: MUA
• Salome
Designation Type: MUA
MARICOPA
• Avendale/Tollesm
Designation Type: MUP
• Chandler
Designation Type: MUA
• El Mirage
Designation Type: MUA
• Gila Bend Division
Designation Type: MUA
• Glendale
Designation Type: MUA
• Guadalupe
Designation Type: MUA
• North Tempe
Designation Type: MUA
• Rio Salado
Designation Type: MUA
• South Central Phoenix
Designation Type: MUP - Low Income
• South Mountain
Designation Type: MUA
• West Phoenix
Designation Type: MUA
• Wickenburg
Designation Type: MUA
MOHAVE
• Bullhead City
Designation Type: MUP
• Dolan Springs
Designation Type: MUA
• FT Mojave
Designation Type: MUP
• Kingman
Designation Type: MUA
• Mohave North Division
Designation Type: MUA
• Peach Springs
Designation Type: MUA
54

Appendix D. Federal MUAs in Arizona (con’t)
NAVAJO
• Entire County
Designation Type: MUA
PIMA
• Arivaca
Designation Type: MUA
• Marana
Designation Type: MUA
• South Tucson
Designation Type: MUA
PINAL
• Apache Junction
Designation Type: MUA
• Central-West Pinal
Designation Type: MUP - Low Income
• Gila River Division
Designation Type: MUA
• Superior
Designation Type: MUA
SANTA CRUZ
• Entire County
Designation Type: MUA
YAVAPI
• Entire County
Designation Type: MUP - Low Income
YUMA
• Yuma North
Designation Type: MUA
• Yuma West
Designation Type: MUA
Source: Arizona Department of Health Services, Office
of Health Systems Development, Federal Medically
Underserved Areas and Populations, http://www.azdhs.
gov/hsd/mua_mup.htm.
55

Appendix E. Licensing Forms
1. INSTRUCTIONS FOR COMPLETING THE APPLICATION FOR A HEALTH
INSTITUTION LICENSE- Page 57
2. INITIAL APPLICATION FOR A HEALTH CARE INSTITUTION LICENSE-
Pages 58-60
3. INITIAL APPLICATION CHECKLIST- Page 63
4. RENEWAL APPLICATION FOR A HEALTH CARE INSTITUTION
LICENSE- Pages 63-64
5. RENEWAL APPLICATION CHECKLIST- Pages 66
6. OUTPATIENT FACILITY INFORMATION- Pages 67-68
56

Instructions for completing HCI Application
PLEASE TYPE OR PRINT IN BLACK INK.
Please submit the application, with all required attachments and the required fee. This
application will not be complete until all required attachments and fees have been submitted to
the Department. If any corrections are made to the application using correction fluid or
correction tape, the application will be returned. If you make a mistake filling out the application,
put a line through the mistake and your initials.
I. HEALTH CARE INSTITUTION INFORMATION
Provide all required information.
“Tax ID number” means a numeric identifier that a person uses to report financial information to the
United States Internal Revenue Services. (If you are using an individual’s Social Security Number, it will
be treated as confidential information and redacted from the copy of the application in the facility’s public
file.)
According to Arizona Revised Statutes, Title 36, Chapter 4, or Arizona Administrative Code, Title 9,
Chapter 10, a person may apply for a license as a health care institution class or subclass, which are
listed below. Select one of the following classifications and write it on the application.
Abortion clinic
Adult day health care facility
Adult foster care
Assisted living center
Assisted living home
Home health agency
Hospice inpatient facility
Hospice
Hospital
Nursing care institution
Outpatient surgical center
Outpatient treatment center
Recovery care center
Unclassified Health Care Institution.
II. OWNER INFORMATION
“Owner” means a person who appoints, elects, or otherwise designates a health care institution’s
governing authority. “Proprietary” means an owner or owners. “Non-Proprietary means a leased
business, franchise, or in certain instances, a Governmental Agency.
III. GOVERNING AUTHORITY
“Governing authority” means the individual, agency, group or corporation, appointed, elected or
otherwise designated, in which the ultimate responsibility and authority for the conduct of the health care
institution are vested.
IV. CHIEF ADMINISTRATIVE OFFICER
“Chief administrative officer” means the individual implementing a governing authority’s direction in a
health care institution. This is the on-site administrator, or the certified manager.
V. SIGNATURES
According to A.R.S, § 36-422(B) the application must be signed, as follows:
(1) If an individual, by the owner of the institution;
(2) If a partnership or corporation, by two of the partners or corporate officers; or
(3) If a governmental unit, the head of the governmental department having jurisdiction.
G:/Instructions for completing HCI ApplicationMEDICAL.doc 06/05/08
57

ARIZONA DEPARTMENT OF HEALTH SERVICES
DIVISION OF LICENSING SERVICES
150 N. 18 th Avenue, Suite 450, Phoenix, Arizona 85007 *** 400 W. Congress, #116, Tucson, Arizona 85701
INITIAL APPLICATION FOR A HEALTH CARE INSTITUTION LICENSE
A.R.S. Title 36, Chapter 4 and A.A.C. Title 9
I. HEALTH CARE INSTITUTION INFORMATION
Name of health care institution
Street address
City Zip code Phone number
Tax I.D. number Fax number E-mail address
Mailing address
City State Zip code
Requested health care institution class or subclass:(listed in R9-10-102)
Requested Licensed Capacity:
A. Is the proposed health care institution (except for a home health agency or a hospice service agency) located within
1/4 mile of agricultural land
Yes No If yes:
1. Include on a separate sheet of paper the names and addresses of owners or lessees of any agricultural land
within 1/4 mile of the proposed health care institution, and
2. Attach a copy of the written agreement between the health care institution owner and the owner or lessee of
agricultural land prescribed in A.R.S. ' 36-421(D).
B. Is the proposed health care institution located in a leased facility
Yes No If yes, attach a copy of the lease showing rights and responsibilities of the parties.
C. If a proposed health care institution is not exempt from submitting architectural plans and specifications pursuant to
A.R.S. ' 36-422(E) attach one of the following:
1. A copy of DHS approval of the proposed health care institution=s architectural plans and specifications, or
2. The architectural plans and specifications for the proposed health care institution required in A.A.C. R9-10-
105(A)(5)(a).
D. Is the proposed health care institution ready for an inspection by Department representatives
Yes No If no, date the proposed health care institution will be ready
II. OWNER INFORMATION (Name of Corporation, LLC, etc.)
Owner’s name
Address
City
Telephone number
Zip code
Fax number
The owner is a: (check one) Proprietary (for profit) Non-proprietary (non-profit)
The owner is a: (check one) _____Sole proprietorship _____Partnership
_____Limited liability company _____Corporation _____Governmental Agency
58

A. PLEASE LIST IN THE SPACE PROVIDED BELOW:
If the owner is a partnership, the name of each partner;
If the owner is a limited liability company, the name of the designated manager, or if no manager is designated, the
names of any 2 members of the limited liability company;
If the owner is a corporation, the name and title of each corporate officer; or
If the owner is a governmental agency, the name and title of the individual in charge of the governmental agency or
the individual designated in writing by the individual in charge of the governmental agency.
Name
Name
Name
Title
Title
Title
Name
Title
B. If applicable, attach a copy of the articles of incorporation, the partnership documents, or the limited liability
company documents.
C. Has the person applying for a license or a person with 10% or more business interest in the health care institution had
a health care professional license or certificate denied, revoked or suspended
____Yes ____ No
D. Has the person applying for a license or a person with 10% or more business interest in the health care institution had
a license to operate a health care institution denied, revoked or suspended
____Yes ____ No
E. If either of the above questions is answered yes, include on a separate sheet of paper for each yes answer:
1. The reason for the denial, suspension, or revocation;
2. The date of the denial, suspension, or revocation;
3. The name and address of the licensing agency that denied, suspended, or revoked the license.
Statutory agent (or individual designated to accept service of process and subpoenas)
Name
Address
Title
Telephone number
III. GOVERNING AUTHORITY
Name
IV. CHIEF ADMINISTRATIVE OFFICER (Facility Administrator)
Name
Title
Education (list the highest educational degree obtained and any instruction related to the health care institution class or subclass
for which licensure is requested)
Experience (list work experience related to the health care institution class or subclass for which licensure is requested)
59

V. SIGNATURES
According to A.R.S. ' 36-422(B) an application must be signed, as follows:
(1) If an individual, by the owner of the institution;
(2) If a partnership or corporation, by two of the partners or corporate officers; or
(3) If a governmental unit, the head of the governmental department having jurisdiction.
_____________________________________________
Signature
Date
_____________________________________________
Title
_____________________________________________
Signature
Date
_____________________________________________
Title
VI. TIME FRAME
Pursuant to A.R.S. § 41-1075 The applicant agrees to extend the substantive review time frame if necessary. This will not exceed 25% of the
overall time frame.
Provider Signature:_______________________________________ Representative of DHS:______________________________________
Attach:
1. Documentation from the local jurisdiction of compliance with all applicable local building codes and ordinances.
2. If accredited by a nationally recognized health care accreditation agency, a copy of the current accreditation.
For DHS use only: Correct application fee enclosed: Yes No Check #:
60

MEDICAL FACILITIES LICENSING
150 N. 18 th Avenue, Suite 450-Phoenix, Arizona 85007
400 W. Congress, Suite 116-Tucson, Arizona 85701
HEALTH CARE INSTITUTION INITIAL APPLICATION
AND LICENSE FEE REMITTANCE FORM
PLEASE RETURN THIS FORM WITH THE PAYMENT TO THE ADDRESS ABOVE
FACILITY I.D. #: LICENSE #: LEVEL OF CARE
OR SERVICES
APPLICANT/ENTITY NAME:
FACILITY NAME:
STREET ADDRESS: SUITE #:
CITY: STATE: ZIP:
PHYSICAL ADDRESS:
CITY: STATE: ZIP:
FEES
Application Fee
(Please do not submit the application fee if the fee has already been paid.)
AMOUNT DUE
$ 50.00
LICENSED CAPACITY
Check One: Licensed Capacity: Base Fee: Number of Beds x
$10.00 each:
Total base fee plus number
of beds fee:
None $ 100.00 $
1 to 59 beds 100.00
60 to 99 beds 200.00
100 to 149 beds 300.00
150 or more beds 500.00
TOTAL AMOUNT DUE $
Payment should be by cashier=s check, money order or business check made payable to:
ARIZONA DEPARTMENT OF HEALTH SERVICES
Write the Facility I.D. # on the check.
Cash and personal checks are not accepted.
AMOUNT ENCLOSED $
ALL FEES ARE NON-REFUNDABLE pursuant to A.R.S. ' 36-405(c), 36-882(f) and 36-897.01(c), except as provided in
A.R.S. ' 41-1077.
61

CHECKLIST FOR
HEALTH CARE INSTITUTION
LICENSE APPLICATION
AND
REQUIRED ATTACHMENTS
INITIAL
Your license application packet must include the following:
License Application For Health Care Institution
$50.00 Application Fee (Please include name of facility/agency)
Services Provided and Staffing Form (Forms provided in package)
Medical Specialties (if applicable)
Current Fire Inspection Report from local municipality
Resume for Administrator
Lease Agreement (if applicable)
Board of Directors list or list of Officers of the Corporation
Licensed Capacity (if applicable)
Full Accreditation Report and Cover Letter (if applicable)
Certificate of Occupancy
Zoning Authority Clearance (original with signatures)
Floor Plan indicating entrance/exits and rooms being used
Food Service Report (if applicable)
Home Health Agency - Roster for T.B./Fingerprinting of staff & Area Map
NOTE:
1. Applications are legal documents. DO NOT use correction fluid or correction tape on the
license application. Applications must have original signatures. Photocopies of
signatures will not be accepted.
2. The Fees must be made payable to the Arizona Department of Health Services. Please
include the name of the facility/agency on check.
3. Full Accreditation Report must be from a Nationally Recognized Organization; such as:
i.e.; JCAHO, AAAHC, AOA, CARF and CHAP. The report must include all surveyed
locations.
62

ARIZONA DEPARTMENT OF HEALTH SERVICES
DIVISION OF LICENSING SERVICES
150 N. 18 th Avenue, Suite 450, Phoenix, Arizona 85007 *** 400 W. Congress, #116, Tucson, Arizona 85701
RENEWAL APPLICATION FOR A HEALTH CARE INSTITUTION LICENSE
A.R.S. Title 36, Chapter 4 and A.A.C. Title 9
I. HEALTH CARE INSTITUTION INFORMATION
Name of Health Care Institution
Physical Address (optional) City State Zip Code
Mailing Address City State Zip Code
Telephone number Fax number E-mail address (optional)
Health care institution class or subclass: License Number Expiration Date
II. OWNER INFORMATION (Name of Corporation or LLC, etc.)
Owner’s name
Address
City
Telephone number
Zip code
Fax number
The owner is a: (check one) Proprietary (For Profit) Non-proprietary (Non-Profit)
The owner is a: (check one) _____Sole proprietorship _____Partnership
_____Limited liability company _____Corporation _____Governmental Agency
A. PLEASE LIST IN THE SPACE PROVIDED BELOW:
If the owner is a partnership, the name of each partner;
If the owner is a limited liability company, the name of the designated manager, or if no manager is designated, the names
of any 2 members of the limited liability company;
If the owner is a corporation, the name and title of each corporate officer; or
If the owner is a governmental agency, the name and title of the individual in charge of the governmental agency or the
individual designated in writing by the individual in charge of the governmental agency.
Name
Name
Name
Title
Title
Title
Name
Title
B. Has the person applying for a license or a person with 10% or more business interest in the health care institution had a
license to operate a health care institution denied, revoked or suspended since the last application was submitted
____Yes ____ No.
C. Has the person applying for a license or a person with 10% or more business interest in the health care institution had a
health care professional license or certificate denied, revoked or suspended since the last application was submitted
____Yes ____ No.
63

D. If either of the previous questions is answered yes, include on a separate sheet of paper for each yes answer:
1. The reason for the denial, suspension, or revocation;
2. The date of the denial, suspension, or revocation;
3. The name and address of the licensing agency that denied, suspended, or revoked the license.
Statutory agent (or individual designated to accept service of process and subpoenas)
Name
Title
Address
III. GOVERNING AUTHORITY
Telephone number
Name
IV. CHIEF ADMINISTRATIVE OFFICER (Facility Administrator)
Name
Title
Education (list the highest educational degree obtained and any instruction related to the health care institution class or subclass
for which licensure is requested)
Experience (list work experience related to the health care institution class or subclass for which licensure is requested)
V. SIGNATURES
According to A.R.S. § 36-422(B) the application must be signed, as follows:
(1) If an individual, by the owner of the institution;
(2) If a partnership or corporation, by two of the partners or corporate officers; or
(3) If a governmental unit, the head of the governmental department having jurisdiction.
_____________________________________________
Signature
Date
_____________________________________________
Title
_____________________________________________
Signature
Date
_____________________________________________
Title
VI. TIME FRAME
Pursuant to A.R.S. § 41-1075 The applicant agrees to extend the substantive review time frame if necessary. This will not exceed 25% of the
overall time frame.
Provider Signature:______________________________________ Representative of DHS:_______________________________________
For DHS use only: Correct application fee enclosed: Yes No Check #:
64

MEDICAL FACILITIES LICENSING
150 N. 18 th Avenue, Suite 450
Phoenix, Arizona 85007
HEALTH CARE INSTITUTION RENEWAL APPLICATION
AND LICENSE FEE REMITTANCE FORM
PLEASE RETURN THIS FORM WITH THE PAYMENT TO THE ADDRESS ABOVE
FACILITY I.D. #: LICENSE #: LEVEL OF CARE
OR SERVICES
APPLICANT/ENTITY NAME:
FACILITY NAME:
STREET ADDRESS: SUITE #:
CITY: STATE: ZIP:
PHYSICAL ADDRESS:
CITY: STATE: ZIP:
FEES
Application Fee
(Please do not submit the application fee if the fee has already been paid.)
AMOUNT DUE
$ 50.00
LICENSED CAPACITY
Check One: Licensed Capacity: Base Fee: Number of Beds x
$10.00 each:
Total base fee plus number
of beds fee:
None $ 100.00 $
1 to 59 beds 100.00
60 to 99 beds 200.00
100 to 149 beds 300.00
150 or more beds 500.00
TOTAL AMOUNT DUE $
Payment should be by cashier=s check, money order or business check made payable to:
ARIZONA DEPARTMENT OF HEALTH SERVICES
Write the Facility I.D. # on the check.
Cash and personal checks are not accepted.
AMOUNT ENCLOSED $
ALL FEES ARE NON-REFUNDABLE pursuant to A.R.S. ' 36-405(c), 36-882(f) and 36-897.01(c), except as provided in
A.R.S. ' 41-1077.
65

LICENSE APPLICATION FOR HEALTH
CARE INSTITUTION AND REQUIRED
ATTACHMENTS CHECKLIST
RENEWAL
Your license application packet must include the following:
9 License Application For Health Care Institution
9 $50.00 Application Fee (Please include license number of
facility/agency).
9 License Fee (See Remittance Form for License Fees)
9 Services and Staffing Provided Form
9 Current Fire Inspection Report
9 Resume for Administrator
9 Lease Agreement (if applicable)
9 Board of Directors or list of Officers of the Corporation
9 Bed Count (if applicable)
9 Accreditation Report and Cover Letter (if applicable)
9 Current Food Service Report (if applicable)
9 Roster for T.B. and Fingerprinting for the current 12 months of Home
Health Agency staff.
9 FOR SURGERY CENTERS: Please contact the Architectural Review
Unit at (602) 364-3055 for Architect Certification For Health Care
Institutions application.
NOTE:
1. DO NOT use correction fluid or correction tape on the license application.
Applications must have original signatures. Photocopies of signatures will
not be accepted.
2. The Application Fee must be made payable to the Arizona Department of
Health Services. Please include the license number of the facility/agency.
3. Accreditation Report must be from a Nationally Recognized Organization;
such as: ie; JCAHO, AAAHC, AOA, CARF, AAASF, AABB, ASHI,
COLA, CAP and CHAP. The report must include all surveyed locations.
66

http://www.azdhs.gov/als/forms/otcstaff.htm
Page 1 of 2
8/14/2008
OUTPATIENT FACILITY INFORMATION
Name
Date
Address
Phone
1. Hours of operation: (indicate hours clinic is open, i.e., 8-4; 12-6)
Sun Mon Tue Wed Thur Fri Sat
2. A. Medical Director _______________________________________________
(if applicable)
(name)
B. Director of Nursing _______________________________________________
(if applicable)
(name)
C. Number of Staff Physicians (excluding Medical Director) F/T _____ P/T _____
3. Administrative Staff:
Person in charge of Medical Records ___________________________________
4.
Other Employees Staffing F/T P/T Other Employees Staffing F/T P/T
Nurse Practitioners Housekeeping
Physician Assistants Maintenance
R.N.'s X-ray Techs
L.P.N.'s Social Workers
Nurse's Aides Respiratory Therapists
Pharmacists Nutritionists
Laboratory Techs Others
5. SERVICES OFFERED:
Dental
Emergency Care
E.K.G.
Family Planning
Home Health Care
Immunizations
Inhalation Therapy
Laboratory
Maternity
Outpatient Surgery
Pharmacy
Podiatric Services
Social Services
Substance Abuse Services
T.B. Screening
Well-baby Clinic
W.I.C. Program
67

http://www.azdhs.gov/als/forms/otcstaff.htm
Page 2 of 2
8/14/2008
X-ray
V.D. Detection/Treatment
Opth. Testing
Other
68

Appendix F. Certification Forms
1. CMS-29 REQUEST TO ESTABLISH ELIGIBILITY TO PARTICIPATE IN HEALTH
INSURANCE I FOR AGED/DISABLED TO PROVIDE RURAL HEALTH CLINIC SER
VICES- Pages 71-73
2. CMS-1561A HEALTH INSURANCE BENEFIT AGREEMENT- RURAL HEALTH CLINIC-
Page 74
**Please note: THREE ORIGINAL COPIES of this form are required to be submitted with the
application packet.
3. CMS-1513 DISCLOSURE OF OWNERSHIP & CONTROL INTEREST STATEMENT-
Pages 75-78
4. HHS-690 CIVIL RIGHTS ASSURANCE OF COMPLIANCE- Page 79
**Please note: THREE ORIGINAL COPIES of this form are required to be submitted with the
application packet.
5. CMS-855A MEDICARE ENROLLMENT APPLICATION- INSTITUTIONAL PROVID-
ERS- Page 80
**Please note: This form must be submitted directly to the FISCAL INTERMEDIARY.
Only the cover page of the 42-page CMS-855A Form has been included in this manual.
To obtain a complete copy of the CMS - 855A Application please go to
http://www.cms.hhs.gov/cmsforms/downloads/cms855a.pdf
6. CMS-222-92 INDEPENDENT RURAL HEALTH CLINIC WORKSHEET (Cost Report)-
Pages 81-82
All CMS forms are available online at: http://www.cms.hhs.gov/CMSForms/CMSForms/list.
asp#TopOfPage
69

INSTRUCTIONS FOR COMPLETING REQUEST TO ESTABLISH ELIGIBILITY TO PARTICIPATE IN THE
HEALTH INSURANCE FOR THE AGED AND DISABLED PROGRAM
TO PROVIDE RURAL HEALTH CLINIC SERVICES
The filing of this request for eligibility will initiate the process of obtaining a decision as to whether the conditions for certification are met.
Please do not delay returning the form. Assistance in filling out the form is available from the State agency.
Please answer all questions as of the current date.
GENERAL INSTRUCTIONS
Return the form to the State agency in the envelope provided; retain a copy for your files. If a return envelope is not provided, the name and
address of the State agency may be obtained from the nearest Social Security Administration district office.
Detailed Instructions for Specific Questions
These instructions are designed to clarify certain questions on the form. Instructions are listed in question order for easy reference. No
instructions have been given for questions considered self-explanatory.
The Following to be Completed by the Applicant
Question I — Identifying Information
Insert the full name under which the clinic operates. A rural health clinic site is the location at which health services are furnished. If a
central organization operates more than one clinic site, a seperate Request to Establish Eligibility Application for each rural health clinic
site must be submitted. In these instances, the location of the health clinic site, rather than the central organization, will determine eligibility
to participate and the applicant site must be situated in a rural area which is designated as either an area with a shortage of personal health
services or as a health manpower shortage area because of its shortage of primary medical care manpower. If the name of the rural health
clinic site does not identify the owner(s), the name and address of the owner(s) is to be inserted in the space provided, otherwise, that space
is to be left blank.
Question II — Medical Direction
Insert the name and address of the physician(s) responsible for providing medical direction for the health clinic site.
Question III — Clinic Personnel
(A), (B), and (C) – Personnel are to be described in terms of full-time equivalents. To arrive at full-time equivalents, add the total number of
hours worked by personnel in each category in the week ending prior to the week of filing the request and divide by the number of hours in
the standard work week (as determined by clinic policies). If the result is not a whole number, express it as a quarter fraction only (e.g., .00,
.25, .50, or .75).
Exclude all trainees and volunteers.
A nurse practitioner and/or physician assistant in addition to the physician, is required for clinic eligibility and must be shown in B and/or C
respectively.
(D) – Where other types of personnel are utilized (e.g., technicians, aides, etc.), the discipline, by name, is to be indicated in addition to the
full-time equivalents.
Under (A), (B) and (C), include in the count only those defined as follows:
Physician — A doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which such function
or action is performed. (A physician listed in II. above, should be included in this category for purposes of determining full-time
equivalents.)
Nurse Practitioner — A registered professional nurse who is currently licensed to practice in the State, who meets the State's requirements
governing the qualifications of nurse practitioners and who meets one of the following conditions:
1. Is currently certified as a primary care Nurse Practitioner by the American Nurses Association or by the National Board of Pediatric
Nurse Practitioners and Associates; or
2. Has satisfactorily completed a formal one academic year educational program that:
(i) prepares registered nurses to perform an expanded role in the delivery of primary care;
(ii) includes at least four months (in the aggregate) of classroom instruction and a component of supervised clinic practice; and
(iii) awards a degree, diploma, or certificate to persons who successfully complete the program; or
Form CMS-29 (05/78) INSTRUCTIONS 70

3. Has successfully completed a formal educational program for preparing registered nurses to perform an expanded role in the delivery
of primary care that does not meet the requirements of paragraph (2) of this section, and has been performing an expanded role in
the delivery of primary care for a total of 12 months during the 18-month period immediately preceding the effective date of this
subpart.
Physician Assistant — A person who meets the applicable State requirements governing the qualifications for assistants to primary care
physicians and who meets at least one of the following conditions:
1. Is currently certified by the National Commission on Certification of Physician Assistants to assist primary care physicians: or
2. Has satisfactorily completed a program for preparing physician's assistants that:
(i) was at least one academic year in length;
(ii) consisted of supervised clinical practice and at least four months (in the aggregate) of classroom instruction directed toward
preparing students to deliver health care; and
(iii) was accredited by the American Medical Association's Committee on Allied Health Education and Accreditation; or
3. Has satisfactorily completed a formal educational program for preparing physician assistants that does not meet the requirements of
paragraph (2) of this section and has been assisting primary care physicians for a total of 12 months during the 18-month period
immediately preceding the effective date of this subpart.
Question IV – Type of Control
Identify the rural health clinic in terms of its control by checking the appropriate part of A, B, C or D. Nonprofit status is based on
Internal Revenue Service tax exemption interpretation; i.e., section 501 of the Internal Revenue Code of 1954.
The following, where applicable, is to be completed in addition to the above. Those rural health clinic sites which are associated with any
existing Medicare provider; i.e., both are licensed as a single health entity; the rural health clinic site and the provider are subject to the
bylaws and operating decisions of the same governing body; and the medical personnel of the rural health clinic site are considered by
the governing body to be subject to the rules of the provider's medical staff, are to indicate this alliance by showing the Medicare provider
number of the facility in the appropriate space.
State Agency Responsibility
The State agency, when reviewing IV. Type of Control, should refer to 2208 of the State Operations Manual.
A function of the resurvey process is to obtain updated statistical information on organizations providing rural health clinic services. At
the time of resurvey, the surveyor will bring this form with him and request that a representative of the organization complete, sign, and
date it and return it to him at the completion of the onsite visit. The surveyor will review the form for completeness and accuracy and
place his initials after the signature of the organization's representative. On all resurveys insert the clinic's assigned six-digit provider
number. Do not complete the categories identified as State/County or State Region at anytime; the regional office will complete these
items.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
0MB control number. The valid 0MB control number for this information collection is 0938-0074. The time required to complete this information
collection is estimated to average 15 minutes per response, including the time to review instructions, search existing data resources, gather
the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time
estimate(s) or suggestions for improving this form, please write to CMS, Attn: PRA Reports Clearance Officer, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
71

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
REQUEST TO ESTABLISH ELIGIBILITY TO PARTICIPATE IN THE
HEALTH INSURANCE FOR THE AGED AND
DISABLED PROGRAM TO PROVIDE RURAL HEALTH CLINIC SERVICES
PROVIDER NO.
FORM APPROVED
OMB N0. 0938-0074
Each rural health clinic site providing rural health clinic services and desiring
STATE/COUNTY (RH2)
to establish eligibility in the health insurance program should complete this
form and return it to the State agency that is handling the certification process.
If a return envelope is not provided, the name and address of the State
STATE REGION (RH3)
agency may be obtained from the nearest Social Security Administration
district office.
I.
NAME OF CLINIC
STREET ADDRESS
IDENTIFYING
INFORMATION
(TO BE COMPLETED
FOR EACH CLINIC SITE) CITY, COUNTY AND STATE
ZIP CODE
TELEPHONE NO. (Including Area Code)
(RH1)
(RH2)
(RH3)
(RH4)
NAME AND
ADDRESS
OF
CLINIC OWNER(S)
II.
(RH5)
MEDICAL
DIRECTION
III.
IV.
CLINIC
PERSONNEL
(FULL TIME
EQUIVALENTS)
(A) PHYSICIAN
(B) NURSE
PRACTITIONER
(C) PHYSICIAN
ASSISTANT
(D) OTHER
(RH6) (RH7) (RH8) (RH9)
A. INDIVIDUAL B. CORPORATION C. PARTNERSHIP D. GOVERNMENT
TYPE OF
CONTROL
(check one)
1. PROFIT
2. NON-
PROFIT
STATE
3.
LOCAL
4.
FEDERAL
5.
V.
FEDERAL
SUPPORT
(RH10)
If the rural health clinic site is part of an existing
Medicare provider, indicate the provider number___________________
Is this clinic site receiving support from a Federal Program
to provide health services in a medically underserved area
or in an area with a shortage of primary care health manpower YES NO
TITLE OF FEDERAL PROGRAM: ____________________________________________
Is this clinic participating in the Physician Extender Experiment
Program (Section 222)
YES NO
(RH11)
(RH12)
(RH13)
(RH14)
I certify that this application is true, correct, and complete. I agree, if approval is granted, that all services rendered by the
clinic shall be in conformity with Federal, State, and local laws. I further understand that a violation of such laws will
constitute grounds for withdrawal of approval under the regulations. This information will not be released to any persons or
organizations outside the official administrative channels unless the undersigned individual specifically requests in writing
that such disclosures be made. (Privacy Act of 1974 Public Law 93–579.)
SIGNATURE OF AUTHORIZED OFFICIAL TITLE DATE
Form CMS-29 (05/78) 72
(RH15)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0832
HEALTH INSURANCE BENEFITS AGREEMENT
(Agreement with Rural Health Clinic Pursuant to
Section 1861(aa)(2)(K)(ii) of the Social Security Act)
For the purpose of establishing eligibility for payment under Title XVIII of the Social Security Act,
hereafter referred to as the Rural Health Clinic, hereby agrees:
(Insert name of clinic)
(A) to maintain compliance with the conditions for certification set forth in part 491 of chapter IV, title 42 of the Code of Federal
Regulations, and to report promptly to the Centers for Medicare & Medicaid Services any failure to do so;
(B) not to charge the beneficiary or any other person for items and services for which the beneficiary is entitled to have payment
made under the provisions of part 405 of chapter IV, title 42 of the Code of Federal Regulations (or for which the beneficiary
would have been entitled if the Rural Health Clinic had filed a request for payment in accordance with §410.165 of chapter IV),
except for any deductible or coinsurance amounts for which the beneficiary is liable under §405.2410;
(C) to refund as promptly as possible any money incorrectly collected from a beneficiary or from someone on his or her behalf;
(D) to accept beneficiaries for care and treatment without limitations, except as it may impose on all other persons;
(E) to accept any additional provisions that the Secretary finds necessary or desirable for the efficient and effective administration
of the Medicare program.
This agreement, upon submission by the Rural Health Clinic and upon acceptance for filing by the Secretary of Health and Human
Services, shall be binding on the Rural Health Clinic and the Secretary. The agreement may be terminated by either party in
accordance with regulations. In the event of termination, payment will not be available for Rural Health Clinic services furnished on
or after the effective date of termination.
This agreement shall become effective on the date specified below by the Secretary or the Secretary’s delegate, and shall remain in
effect unless terminated.
In the event of a transfer of ownership, the agreement is automatically assigned to the new owner subject to the conditions specified
in this agreement and 42 CFR 489, to include existing plans of correction and the duration of this agreement, if the agreement is
time limited.
ATTENTION: Read the following provision of Federal law carefully before signing.
Whoever, in any matter within the jurisdiction of any department or agency of the United States knowingly and willfully falsifies,
conceals or covers up by any trick, scheme or device a material fact, or make any false, fictitious or fraudulent statement or
representation, or makes or uses any false writing or document knowing the same to contain any false, fictitious or fraudulent
statement, or entry, shall be fined not more than $10,000 or imprisoned not more than 5 years or both (18 U.S.C. section 1001).
Accepted for Rural Health Clinic by:
NAME (SIGNATURE)
TITLE
DATE
Accepted for the Secretary of Health and Human Services by:
NAME (SIGNATURE)
TITLE
DATE
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-0832. The time required to complete this information
collection is estimated to average 5 minutes per response, including the time to review instructions, search existing data resources, gather the data
needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or
suggestions for improving this form, please write to CMS, 7500 Security Boulevard, N2-14-26, Baltimore, Maryland 21244-1850.
Form CMS-1561A (4-02) Previous version obsolete 73

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
INSTRUCTIONS FOR COMPLETING DISCLOSURE OF
OWNERSHIP AND CONTROL INTEREST STATEMENT (CMS-1513)
Completion and submission of this form is a condition of participation, certification, or recertification under any of the programs established by titles V,
XVIII, XIX, and XX, or as a condition of approval or renewal of a contractor agreement between the disclosing entity and the Secretary of appropriate
State agency under any of the above-titled programs, a full and accurate disclosure of ownership and financial interest is required. Failure to submit
requested information may result in a refusal by the Secretary or appropriate State agency to enter into an agreement or contract with any such
institution or in termination of existing agreements.
SPECIAL INSTRUCTIONS FOR TITLE XX PROVIDERS
Form Approved
OMB No. 0938-0086
All title XX providers must complete part II (a) and (b) of this form. Only those title XX providers rendering medical, remedial, or health related homemaker
services must complete parts II and III. Title V providers must complete parts II and Ill.
General Instructions
For definitions, procedures and requirements, refer to the appropriate
Regulations:
Title V – 42CFR 51a.144
Title XVIII – 42CFR 420.200 – 206
Title XIX – 42CFR 455.100 – 106
Title XX – 45CFR 228.72 – 73
Please answer all questions as of the current date. If the yes block for
any item is checked, list requested additional information under the
Remarks section on page 2, referencing the item number to be
continued. If additional space is needed use an attached sheet.
Return the original and second and third copies to the State
agency; retain the first copy for your files.
This form is to be completed annually. Any substantial delay in
completing the form should be reported to the State survey agency.
DETAILED INSTRUCTIONS
These instructions are designed to clarify certain questions on the
form. Instructions are listed in question order for easy reference. No
instructions have been given for questions considered self-explanatory.
IT IS ESSENTIAL THAT ALL APPLICABLE QUESTIONS BE
ANSWERED ACCURATELY AND THAT ALL INFORMATION BE
CURRENT.
Item I (a) Under identifying information specify in what capacity the
entity is doing business as (DBA), example, name of
trade or corporation.
(b) For Regional Office Use Only. If the yes box is checked for
item VII, the Regional Office will enter the 5-digit
number assigned by CMS to chain organizations.
Item II - Self-explanatory.
Item III - List the names of all individuals and organizations having
direct or indirect ownership interests, or controlling interest separately
or in combination amounting to an ownership interest of 5 percent or
more in the disclosing entity.
Direct ownership interest is defined as the possession of stock, equity
in capital or any interest in the profits of the disclosing entity. A
disclosing entity is defined as a Medicare provider or supplier, or other
entity that furnishes services or arranges for furnishing services under
Medicaid or the Maternal and Child Health program, or health related
services under the social services program.
Indirect ownership interest is defined as ownership interest in an entity
that has direct or indirect ownership interest in the disclosing entity.
The amount of indirect ownership in the disclosing entity that is held by
any other entity is determined by multiplying the percentage of
ownership interest at each level. An indirect ownership interest must be
reported if it equates to an ownership interest of 5 percent or more in
the disclosing entity. Example: if A owns 10 percent of the stock in a
corporation that owns 80 percent of the stock of the disclosing entity,
A's interest equates to an 8 percent indirect ownership and must be
reported.
Controlling interest is defined as the operational direction or
management of a disclosing entity which may be maintained by any or
all of the following devices: the ability or authority, expressed or
reserved, to amend or change the corporate identity (i.e., joint venture
agreement, unincorporated business status) of the disclosing entity; the
ability or authority to nominate or name members of the Board of
Directors or Trustees of the disclosing entity; the ability or authority,
expressed or reserved, to amend or change the by-laws, constitution,
or other operating or management direction of the disclosing entity; the
right to control any or all of the assets or other property of the
disclosing entity upon the sale or dissolution of that entity; the ability or
authority, expressed or reserved, to control the sale of any or all of the
assets, to encumber such assets by way of mortage or other
indebtedness, to dissolve the entity, or to arrange for the sale or
transfer of the disclosing entity to new ownership or control.
Items IV – VII - Changes in Provider Status
Change in provider status is defined as any change in management
control. Examples of such changes would include: a change in Medical
or Nursing Director, a new Administrator, contracting the operation of
the facility to a management corporation, a change in the composition
of the owning partnership which under applicable State law is not
considered a change in ownership, or the hiring or dismissing of any
employees with 5 percent or more financial interest in the facility or in
an owning corporation, or any change of ownership.
For Items IV – VII, if the yes box is checked, list additional information
requested under Remarks. Clearly identify which item is being continued.
Item IV - (a & b) If there has been a change in ownership within the
last year or if you anticipate a change, indicate the date in the
appropriate space.
Item V - If the answer is yes, list name of the management firm and
employer identification number (EIN), or the name of the leasing
organization. A management company is defined as any organization
that operates and manages a business on behalf of the owner of that
business, with the owner retaining ultimate legal responsibility for
operation of the facility.
Item VI - If the answer is yes, identify which has changed
(Administrator, Medical Director, or Director of Nursing) and the date
the change was made. Be sure to include name of the new
Administrator, Director of Nursing or Medical Director, as appropriate.
Item VII - A chain affiliate is any free-standing health care facility that is
either owned, controlled, or operated under lease or contract by an
organization consisting of two or more free-standing health care
facilities organized within or across State lines which is under the
ownership or through any other device, control and direction of a
common party. Chain affiliates include such facilities whether public,
private, charitable or proprietary. They also include subsidiary
organizations and holding corporations. Provider-based facilities, such
as hospital-based home health agencies, are not considered to be
chain affiliates.
Item VIII - If yes, list the actual number of beds in the facility now and
74 the previous number.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Form Approved
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0086
DISCLOSURE OF OWNERSHIP AND CONTROL INTEREST STATEMENT
I. Identifying Information
(a) Name of Entity
D/B/A
Provider No.
Vendor No.
Telephone No.
Street Address
City, County, State
Zip Code
(b) (To be completed by CMS Regional Office) Chain Affiliate No. ■ ■ ■ ■ ■ LB1
II. Answer the following questions by checking "Yes" or "No." If any of the questions are answered "Yes," list names and addresses of individuals or corporations
under Remarks on page 2. Identify each item number to be continued.
(a) Are there any individuals or organizations having a direct or indirect ownership or control interest of 5 percent or more in the institution, organizations,
or agency that have been convicted of a criminal offense related to the involvement of such persons, or organizations in any of the programs established
by titles XVIII, XIX, or XX
■ Yes ■ No LB2
(b) Are there any directors, officers, agents, or managing employees of the institution, agency or organization who have ever been convicted of a criminal
offense related to their involvement in such programs established by titles XVIII, XIX, or XX
■ Yes ■ No LB3
(c) Are there any individuals currently employed by the institution, agency, or organization in a managerial, accounting, auditing, or similar capacity who
were employed by the institution's, organization's, or agency's fiscal intermediary or carrier within the previous 12 months (Title XVIII providers only)
■ Yes ■ No LB4
Ill. (a) List names, addresses for individuals, or the EIN for organizations having direct or indirect ownership or a controlling interest in the entity. (See instructions for
definition of ownership and controlling interest.) List any additional names and addresses under "Remarks" on page 2. If more than one individual is
reported and any of these persons are related to each other, this must be reported under Remarks.
Name Address EIN
LB5
(b) Type of Entity:
■ Sole Proprietorship ■ Partnership ■ Corporation LB6
■ Unincorporated Associations
■ Other (Specify)
(c) If the disclosing entity is a corporation, list names, addresses of the Directors, and EINs for corporations under Remarks.
Check appropriate box for each of the following questions:
(d) Are any owners of the disclosing entity also owners of other Medicare/Medicaid facilities (Example: sole proprietor, partnership or members of Board
of Directors.) If yes, list names, addresses of individuals and provider numbers.
■ Yes ■ No LB7
Name Address Provider Number
75
CMS-1513 (5/86) Page 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Form Approved
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0086
IV. (a) Has there been a change in ownership or control within the last year
If yes, give date _____________ ■ Yes ■ No LB8
(b) Do you anticipate any change of ownership or control within the year
If yes, when _______________ ■ Yes ■ No LB9
(c) Do you anticipate filing for bankruptcy within the year
If yes, when _______________ ■ Yes ■ No LB10
V. Is this facility operated by a management company, or leased in whole or part by another organization
If yes, give date of change in operations ____________ ■ Yes ■ No LB11
VI. Has there been a change in Administrator, Director of Nursing, or Medical Director within the last year
■ Yes ■ No LB12
VII. (a) Is this facility chain affiliated (If yes, list name, address of Corporation, and EIN)
Name EIN # ■ Yes ■ No LB13
Address
LB14
VII. (b) If the answer to Question VII.a. is No, was the facility ever affiliated with a chain
(If yes, list Name, Address of Corporation, and EIN)
Name EIN # ■ Yes ■ No LB18
Address
LB19
VIII. Have you increased your bed capacity by 10 percent or more or by 10 beds, whichever is greater, within the last 2 years
■ Yes ■ No LB15
If yes, give year of change ____________
Current beds _____________ LB16 Prior beds _____________ LB17
WHOEVER KNOWINGLY AND WILLFULLY MAKES OR CAUSES TO BE MADE A FALSE STATEMENT OR REPRESENTATION OF THIS STATEMENT, MAY
BE PROSECUTED UNDER APPLICABLE FEDERAL OR STATE LAWS. IN ADDITION, KNOWINGLY AND WILLFULLY FAILING TO FULLY AND ACCURATELY
DISCLOSE THE INFORMATION REQUESTED MAY RESULT IN DENIAL OF A REQUEST TO PARTICIPATE OR WHERE THE ENTITY ALREADY PARTICIPATES,
A TERMINATION OF ITS AGREEMENT OR CONTRACT WITH THE STATE AGENCY OR THE SECRETARY, AS APPROPRIATE.
Name of Authorized Representative (Typed)
Title
Signature
Date
Remarks
CMS-1513 (5/86) 76
Page 2

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 0MB control
number. The valid 0MB control number for this information collection is 0938-0086. The time required to complete this information collection is estimated to
average 30 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the
information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to CMS,
7500 Security Boulevard, N2-14-26, Baltimore, Maryland 21244-1850.
77

ASSURANCE OF COMPLIANCE
ASSURANCE OF COMPLIANCE WITH TITLE VI OF THE CIVIL RIGHTS ACT OF 1964, SECTION 504 OF THE REHABILITATION ACT OF
1973, TITLE IX OF THE EDUCATION AMENDMENTS OF 1972, AND THE AGE DISCRIMINATION ACT OF 1975
The Applicant provides this assurance in consideration of and for the purpose of obtaining Federal grants, loans, contracts, property, discounts
or other Federal financial assistance from the Department of Health and Human Services.
THE APPLICANT HEREBY AGREES THAT IT WILL COMPLY WITH:
1. Title VI of the Civil Rights Act of 1964 (Pub. L. 88-352), as amended, and all requirements imposed by or pursuant to the Regulation
of the Department of Health and Human Services (45 C.F.R. Part 80), to the end that, in accordance with Title VI of that Act and the
Regulation, no person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be
denied the benefits of, or be otherwise subjected to discrimination under any program or activity for which the Applicant receives
Federal financial assistance from the Department.
2. Section 504 of the Rehabilitation Act of 1973 (Pub. L. 93-112), as amended, and all requirements imposed by or pursuant to the
Regulation of the Department of Health and Human Services (45 C.F.R. Part 84), to the end that, in accordance with Section 504 of
that Act and the Regulation, no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap,
be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity
for which the Applicant receives Federal financial assistance from the Department.
3. Title IX of the Educational Amendments of 1972 (Pub. L. 92-318), as amended, and all requirements imposed by or pursuant to the
Regulation of the Department of Health and Human Services (45 C.F.R. Part 86), to the end that, in accordance with Title IX and the
Regulation, no person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or
be otherwise subjected to discrimination under any education program or activity for which the Applicant receives Federal financial
assistance from the Department.
4. The Age Discrimination Act of 1975 (Pub. L. 94-135), as amended, and all requirements imposed by or pursuant to the Regulation of
the Department of Health and Human Services (45 C.F.R. Part 91), to the end that, in accordance with the Act and the Regulation, no
person in the United States shall, on the basis of age, be denied the benefits of, be excluded from participation in, or be subjected to
discrimination under any program or activity for which the Applicant receives Federal financial assistance from the Department.
The Applicant agrees that compliance with this assurance constitutes a condition of continued receipt of Federal financial assistance, and that it
is binding upon the Applicant, its successors, transferees and assignees for the period during which such assistance is provided. If any real
property or structure thereon is provided or improved with the aid of Federal financial assistance extended to the Applicant by the Department,
this assurance shall obligate the Applicant, or in the case of any transfer of such property, any transferee, for the period during which the real
property or structure is used for a purpose for which the Federal financial assistance is extended or for another purpose involving the provision
of similar services or benefits. If any personal property is so provided, this assurance shall obligate the Applicant for the period during which it
retains ownership or possession of the property. The Applicant further recognizes and agrees that the United States shall have the right to seek
judicial enforcement of this assurance.
The person or persons whose signature(s) appear(s) below is/are authorized to sign this assurance, and commit the Applicant to the above
provisions.
Date
Signature and Title of Authorized Official
Name of Applicant or Recipient
Street
Mail Form to:
DHHS/Office for Civil Rights
Office of Program Operations
Humphrey Building, Room 509F
200 Independence Ave., S.W.
Washington, D.C. 20201
Form HHS-690
5/97
City, State, Zip Code
78

MEDICARE ENROLLMENT APPLICATION
INSTITUTIONAL PROVIDERS
CMS-855A
SEE PAGE 1 TO DETERMINE IF YOU ARE COMPLETING THE CORRECT APPLICATION
SEE PAGE 2 FOR INFORMATION ON WHERE TO MAIL THIS APPLICATION.
SEE PAGE 41 TO FIND A LIST OF THE SUPPORTING DOCUMENTATION THAT MUST BE
SUBMITTED WITH THIS APPLICATION.
79

03-02 Form CMS 222-92
2990 (Cont.)
FORM APPROVED
OMB NO: 0938-0107
WORKSHEET S - PART I
INDEPENDENT RURAL HEALTH CLINIC/FREESTANDING For Intermediary Use
FEDERALLY QUALIFIED HEALTH CENTER WORKSHEET Date Received
STATISTICAL DATA AND CERTIFICATION STATEMENT
This report is required by law (42 USC. 1395g: CFR 413.20(b)). Failure to report can
Intermediary Number
result in all payments made during the reporting period being deemed overpayments (42 USC 1395g).
PART I - STATISTICAL DATA [ ] Projected Cost Report [ ] Actual/Final Cost Report
1. Facility Name and Address 1a. County
2. Facility Number 3. Designation 4. Reporting Period
From
To
5. Type of Control (Check One)
A. Voluntary Non Profit B. Proprietary C. Government
[ ] Corporation [ ] Individual [ ] Partnership [ ] Federal [ ] County
[ ] Other (Specify) [ ] Corporation [ ] Other (Specify) [ ] State [ ] Other
(Specify)
[ ] City
6. Source of Federal Funds GRANT AWARD DATE
NUMBER
A. Community Health Center (Section 330(d),
Public Health Service Act)
B. Migrant Health Center
(Section 329 (d), PHS Act)
C. Health Services for the Homeless
(Section 340(d), PHS Act)
D. Appalachian Regional Commission
E . Look-Alikes
F. Other (Specify)
7. Names of Physicians Furnishing Services At The Health Facility or Under Agreement
(As Described In Instructions) And Medicare Billing Numbers (Include All Part B Billing Numbers)
Name
Billing Number
8. Supervisory Physicians
Name Hours of Supervision
For Reporting Period
FORM CMS-222-92 (10/96) (INSTRUCTIONS FOR THIS WORKSHEET ARE PUBLISHED IN CMS PUB. 15-II,
SECTIONS 2903 and 2903.1)
Rev. 5 29-303
80

2990 (Cont.) Form CMS 222-92
03-02
INDEPENDENT RURAL HEALTH CLINIC/
WORKSHEET S
FEDERALLY QUALIFIED HEALTH CENTER WORKSHEET
PART I (Cont.) &
STATISTICAL DATA AND CERTIFICATION STATEMENT
PART II
PART I (CONTINUED)-STATISTICAL DATA
9. If the facility operates as other than an RHC or FQHC (i.e., as a physicians office, independent
laboratory, etc.) check yes and specify what type of operation and what days and hours RHC/FQHC
services and other than RHC or FQHC services are provided at the facility as instructed below.
YES [ ] NO [ ]
Type of Operation ______________________________________________________________________
Identify days and hours by listing the time the facility operates as an RHC or FQHC next to the applicable da
Sunday _____________________
Monday ____________________
Tuesday ____________________
Wednesday _________________
Thursday ____________________
Friday ______________________
Saturday ____________________
Identify days and hours by listing the time the facility operates as other than an RHC or FQHC next to
the applicable day(s)
Sunday _______________________
Monday ______________________
Tuesday ______________________
Wednesday ___________________
Thursday _______________________
Friday __________________________
Saturday ________________________
PART II - CERTIFICATION BY OFFICER OR ADMINISTRATOR
MISREPRESENTATION OR FALSIFICATION OF ANY INFORMATION CONTAINED IN THIS COAT REPORT M
BE PUNISHABLE BY CRIMINAL, CIVIL AND ADMINISTRATIVE ACTION, FINE AND/OR IMPRISONMENT UND
FEDERAL LAW. FURTHERMORE, IF SERVICES IDENTIFIED IN THIS REPORT WERE PROVIDED OR PROC
THROUGH THE PAYMENT DIRECTLY OR INDIRECTLY OF A KICKBACK OR WHERE OTHERWISE ILLEGAL
CRIMINAL, CIVIL AND ADMINISTRATIVE ACTION, FINES AND/OR IMPRISONMENT MAY RESULT.
CERTIFICATION BY OFFICER OR ADMINISTRATOR
I HEREBY CERTIFY that I have read the above statement and that I have examined the accompanying cost
report prepared by
(Provider Name and Number) for the
cost report period beginning and ending and that to the best of my knowle
and belief, it is a true, correct and complete statement prepared from the books and records of the
Provider in accordance with the laws and regulations regarding the Provider in accordance with the laws and
regulations regarding the provision of health care services and that the services identified in this cost report w
provided in compliance with such laws and regulations.
(Signed)
Officer or Administrator of Facility Title Date
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0107. The time required to complete this
information collection is estimated to average 50 hours per response, including the time to review instructions, search existing data
resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to: Centers for Medicare & Medicaid Services, 7500
Security Boulevard, N2-14-26, Baltimore, Maryland 21244-1850.
FORM CMS-222-92 (10/96) (INSTRUCTIONS FOR THIS WORKSHEET ARE PUBLISHED IN CMS PUB. 15-II,
SECTIONS 2903 and 2903.2)
29-304 Rev. 5
81

APPENDEX G.
RURAL HEALTH CLINIC
SURVEY REPORT
82

RURAL HEALTH CLINIC SURVEY REPORT
Form Approved
OMB No. 0938-0074
§ 481.2 Definitions.
As used in this subpart, unless the context indicates otherwise:
(a)“Direct services” means services provided by the clinic's staff.
(b)“Nurse practitioner” means a registered professional nurse who is
currently licensed to practice in the State, who meets the State's
requirements governing the qualifications of nurse practitioners, and who
meets one of the following conditions:
(1) Is currently certified as a primary care Nurse Practitioner by the
American Nurses' Association or by the National Board of Pediatric
Nurse Practitioners and Associates; or
(2) Has satisfactorily completed a formal 1 academic year educational
program that:
(i) prepares registered nurses to perform an expanded role in the
delivery of primary care;
(ii) includes at least 4 months (in the aggregate) of classroom
instruction and a component of supervised clinical practice; and
(iii) awards a degree, diploma, or certificate to persons who successfully
complete the program; or
(3) Has successfully completed a formal educational program for preparing
registered nurses to perform an expanded role in the delivery of primary
care that does not meet the requirements of paragraph (b)(2) of this
section, and
(i) has been performing an expanded role in the delivery of primary
care for a total of 12 months during the 18-month period
immediately preceding the effective date of this subpart.
(c)“Physician” means a doctor of medicine or osteopathy legally authorized
to practice medicine or surgery in the State.
(d) “Physician assistant” means a person who meets the applicable State
requirements governing the qualifications for assistants to primary care
physicians, and who meets at least one of the following conditions:
(1) Is currently certified by the National Commission on Certification on
Physician Assistants to assist primary care physicians; or
(2) Has satisfactorily completed a program for preparing physician’s assistants
that:
(i) was at least 1 academic year in length;
(ii) consisted of supervised clinical practice and at least 4 months in the
aggregate of classroom instruction directed toward preparing students
to deliver health care; and
(iii) is accredited by the American Medical Association’s Committee on
Allied Health Education and Accreditation; or
(3) Has satisfactorily completed a formal educational program for preparing
physician assistants that does not meet the requirements of paragraph (d)(2)
of this section, and
(i) has been assisting primary care physicians for a 12-month period
in the 18 month period immediately preceding the effective date of
this subpart.
(e) “Rural area” means an area that is not delineated as an urbanized area by the
Bureau of the Census.
(f) “Rural health clinic” or “clinic” means a clinic that is located in a rural area
designated as a shortage area, is not a rehabilitation agency or a facility
primarily for the care and treatment of mental diseases, and meets all other
requirements of this subpart.
(g)“Shortage area” means a defined geographic area designated by the
Department as having either a shortage of personal health services (under
section 1302(7) of the Public Health Service Act) or a shortage
of primary medical care manpower (under section 332 of that Act).
(h) “Secretary” means the Secretary of Health and Human Services, or
any official to whom he has delegated the pertinent authority.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information
collection is 0938-0074. The time required to complete this information collection is estimated to average 1.5 hours per response, including the time to review instructions, search existing data resources, gather the data
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Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Form CMS-30 (05/78) EF 10/2004 83

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Form Approved
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0074
PROVIDER NUMBER
RURAL HEALTH CLINIC SURVEY REPORT
(J1)
NAME OF CLINIC STREET NUMBER CITY COUNTY STATE ZIP CODE
SURVEYED BY
SURVEYOR’S PROFESSIONAL TITLE
■ INITIAL SURVEY
■ RESURVEY (J2)
LIST ADDITIONAL SURVEYOR’S NAMES TITLE PARTICIPATION UNDER TITLES 18 AND 19
DATE SURVEYED
A clinic certified under Medicare will be deemed to meet
the standards for certification under Medicaid.
CODE YES NO N/A
J3
■ MET
■ NOT MET
EXPLANATORY STATEMENTS
CLINIC LICENSE NUMBER (IF APPLICABLE)
II. §481.4 Compliance with Federal, State and local laws.
The rural health clinic and its staff are in compliance with
applicable Federal, State and local laws and regulations.
PHYSICIAN(S) NAME LIC. NO. CERT. NO. REG. NO.
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(a) Licensure of clinic.
The clinic is licensed pursuant to applicable State and local law.
NURSE PRACTITIONER(S) NAME LIC. NO. CERT. NO. REG. NO.
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PHYSICIAN ASSISTANT(S) NAME LIC. NO. CERT. NO. REG. NO.
(b) Licensure, certification or registration of personnel.
Staff of the clinic are licensed, certified or registered in
accordance with applicable State and local laws.
OTHER LICENSED PERSONNEL – IDENTIFY
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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II. §481.5 Location of Clinic.
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(a) Basic requirement.
The clinic is located in a rural area that is designated as a
shortage area, and may be a permanent or a mobile unit.
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(1) Permanent unit.
The objects, equipment and supplies necessary
for the provision of the services furnished
directly by the clinic are housed in a permanent
structure. If clinic services are regularly furnished at
permanent units in more than one location, each unit
will be independently considered for certification as a
rural health clinic.
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(2) Mobile unit.
The objects, equipment and supplies necessary
for the provision of the services furnished
directly by the clinic are housed in a mobile structure
which has a fixed, scheduled location(s).
List schedule of operation — day, time and location
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(b) Does the facility meet location eligibility in a rural
health shortage area through either of the following
exceptions.
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(1) A facility certified under this subpart will not be
disqualified if the area in which it is located subsequently
fails to meet the definition of rural, shortage area.
(2) A private, nonprofit facility that meets all other
conditions of this subpart except for location in a
shortage area will be certified if, on July 1, 1977, it was
operating in a rural area that is determined by the
Secretary (on the basis of the ratio of primary care
physicians to the general population) to have an
insufficient supply of physicians to meet the needs of
the area served. Determinations on these exceptions will
be made by the Secretary upon application by the facility.
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(c) The facility meets rural area requirements under one
of the following criteria.
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(1) Rural areas are areas not delineated as urbanized areas
in the last census conducted by the Census Bureau.
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(2) Included in the rural area classification are those
portions of extended cities that the Census Bureau has
determined to be rural.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(d) The facility meets the shortage area requirements
under one of the following criteria.
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(1) Determination of shortage of personal health services
(under section 1302(7) of the Public Health Service Act).
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(2) Determination of shortage of primary medical care
manpower (under section 332(a) (1) (A) of the Public
Health Service Act).
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87

NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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III. §481.6 Physical plant and environment.
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(a) Construction.
The clinic is constructed, arranged, and maintained to ensure
access to and safety of patients, and provides adequate space
for the provision of direct services.
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(b) Maintenance.
The clinic has a preventive maintenance program to ensure
that:
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(1) All essential mechanical, electrical and patient-care
equipment is maintained in safe operating condition;
(2) Drugs and biologicals are appropriately stored; and
(3) The premises are clean and orderly.
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(c) Emergency procedures.
The clinic assures the safety of patients in case of non-medical
emergencies by:
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(1) Training staff in handling emergencies;
(2) Placing exit signs in appropriate locations; and
(3) Taking other appropriate measures that are consistent
with the particular conditions of the area in which the
clinic is located.
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88

NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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IV. §481.7 Organizational structure.
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(a) Basic requirements.
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(1) The clinic is under the medical direction of a physician,
and has a health care staff that meets the requirements
of §481.8.
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(2) The organization’s policies and its lines of authority and
responsibilities are clearly set forth in writing.
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(b) Disclosure.
List names and addresses of owners:
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The clinic discloses the names and addresses of:
(1) Its owners, in accordance with section 1124 of the Social
Security Act (42 USC 132 A-3);
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(2) The person principally responsible for directing the operation
of the clinic; and
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(3) The person responsible for medical direction.
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89

NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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IV. §481.8 Staffing and Staff Responsibilities.
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(a) Staffing.
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For each qualified nurse practitioner, indicate the number
qualifying under the respective parts of §481.2(b):
(1)
(2)
(3)
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(1) The clinic has a health care staff that includes one or more
physicians and one or more physician’s assistants or nurse
practitioners.
For each qualified physician’s assistant, indicate the number
qualifying under the respective parts of §481.2(d):
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(2) The staff, i.e., the nurse practitioner(s), physician(s), or
physician’s assistant(s) meets qualification requirements in
section 481.2(b), (c), (d).
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(1)
(2)
(3)
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(3) A physician, nurse practitioner, or physician’s assistant is
available to furnish patient care services at all times during
the clinic’s regular hours of operation. A nurse practitioner
or a physician’s assistant is available to furnish patient care
services during at least 60% of the clinic’s regular hours of
operation.
Clinic’s regular weekly operating schedule:
Nurse practitioner or physician’s assistant regular weekly on
duty schedule:
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(4) The staff is sufficient to provide the services essential to
the operation of the clinic.
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90

NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(b) Physician responsibilities:
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(1) The physician provides medical direction for the clinic’s
health care activities and consultation for, and medical
supervision of the health care staff.
(2) In conjunction with the physician’s assistant and/or nurse
practitioner member(s), the physician participates in
developing, executing and periodically reviewing the clinic’s
written policies and the services provided to Federal
program patients; and
(3) The physician periodically reviews the clinic’s patient
records, provides medical orders, and provides medical
care services to the patients of the clinic.
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(4) A physician is present for sufficient periods of time, at least
once in every 2 week period (except in extraordinary
circumstances), to provide the medical direction, medical
care services, consultation and supervision described in
paragraph(b)(1) of this section, and, is available through
direct telecommunication for consultation, assistance with
medical emergencies, or patient referral. The extraordinary
circumstances are documented in the records of the clinic.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(c) Physician’s assistant and nurse practitioner
responsibilities.
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(1) The physician’s assistant and the nurse practitioner
members of the clinic’s staff:
(i) participate in the development, execution and periodic
review of the written policies governing the services
the clinic furnishes;
(ii) provide services in accordance with those policies;
(iii) arrange for, or refer patients to, needed services
that cannot be provided at the clinic;
(iv) assure that adequate patient health records are
maintained and transferred as required when
patients are referred; and
(v) participate with a physician in a periodic review of
the patients’ health records.
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VI. §481.9 Provision of services.
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(a) Basic requirements
The clinic is primarily engaged in providing outpatient health
services as described in §481.9 (c).
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(b) Patient care policies.
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(1) The clinic’s health care services are furnished in
accordance with appropriate written policies which are
consistent with applicable State law.
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(2) The policies are developed with the advice of a group of
professional personnel that includes one or more physicians
and one or more physician’s assistants or nurse practitioners.
At least one member of the group is not a member of the
clinic’s staff.
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(3) The policies include:
(i) a description of the services the clinic furnishes directly
and those furnished through agreement or arrangement;
(ii) guidelines for the medical management of health
problems which include the conditions requiring medical
consultation and/or patient referral, the maintenance of
health care records,and procedures for the periodic
review and evaluation of the services furnished by the
clinic;
(iii) rules for the storage, handling, and administration
of drugs and biologicals.
(4) These policies are reviewed at least annually by the group
of professional personnel required under (b)(2) above in this
section, and reviewed as necessary by the clinic.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(c) Direct services.
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(1) General.
The clinic staff furnishes those diagnostic and therapeutic
services and supplies that are commonly furnished in a
physician’s office or at the entry point into the health care
delivery system. These include medical history, physical
examination, assessment of health status, and treatment
for a variety of medical conditions.
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(2) Laboratory.
The clinic provides basic laboratory services essential to
the immediate diagnosis and treatment of the patient,
including:
(i) chemical examinations of urine by stick or tablet
methods or both (including urine ketones);
(ii) microscopic examination of urine sediment;
(iii) hemoglobin or hematacrit;
(iv) blood sugar;
(v) gram stain;
(vi) examination of stool specimens for occult blood;
(vii) pregnancy tests;
(viii) primary culturing for transmittal to a certified
laboratory; and
(ix) test for pinworms.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(3) Emergency.
The clinic provides medical emergency procedures as a
first response to common life-threatening injuries and acute
illness, and has available the drugs and biologicals
commonly used in life saving procedures, such as
analgesics, anesthetics (local), antibiotics, anticonvulsants,
antidotes and emetics, serums and toxoids.
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(d) Services provided through agreements or
arrangements.
J64
(1) The clinic has agreements or arrangements with one or
more providers or suppliers participating under Medicare or
Medicaid to furnish other services to its patients, including:
(i) inpatient hospital care;
(ii) physician(s) services (whether furnished in the hospital, the
office, the patient’s home, a skilled nursing facility, or
elsewhere); and
(iii) additional and specialized diagnostic and laboratory
services that are not available at the clinic.
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(2) If the agreements are not in writing, there is evidence that
patients referred by the clinic are being accepted and treated.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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VII. §481.10 Patient health records.
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(a) Records system.
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(1) The clinic maintains a clinical record system in accordance
with written policies and procedures.
(2) A designated member of the professional staff is responsible
for maintaining the records and for ensuring that they are
completely and accurately documented, readily accessible,
and systematically organized.
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(3) For each patient receiving health care services, the clinic
maintains a record that includes, as applicable:
(i) identification and social data, evidence of consent forms,
pertinent medical history, assessment of the health status
and health care needs of the patient, and a brief summary
of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and
laboratory test results, and consultative findings;
(iii) all physician’s orders, reports of treatments and
medications and other pertinent information necessary
to monitor the patient’s progress;
(iv) signatures of the physician or other health care
professional.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(b) Protection of record information.
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(1) The clinic maintains the confidentiality of record information
and provides safeguards against loss, destruction or
unauthorized use.
(2) Written policies and procedures govern the use and removal
or records from the clinic and the conditions for release of
information.
(3) The patient’s written consent is required for release of
information not authorized by law.
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(c) Retention of records.
The records are retained for at least 6 years from date of
last entry, and longer if required by State statute.
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VIII. §481.11 Program evaluation.
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(a) The clinic carries out, or arranges for, an annual evaluation
of its total program.
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NAME
CODE YES NO N/A EXPLANATORY STATEMENTS
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(b) The evaluation includes review of:
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(1) the utilization of clinic services, including at least the
number of patients served and the volume of services;
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(2) a representative sample of both active and closed clinical
records; and
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(3) the clinic’s health care policies.
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(c) The purpose of the evaluation is to determine whether:
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(1) the utilization of services was appropriate;
(2) the established policies were followed; and
(3) any changes are needed.
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(d) The clinic staff considers the findings of the evaluation and
takes corrective action if necessary.
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98