• The clinic meets the purpose and scope of regulations in order to meet reimbursement requirements for Medicare and Medicaid

Unless the context indicates otherwise:

Certified nurse-midwife (CNM) means an individual who meets the applicable education, training, and other requirements at 410.77(a) of this chapter.

Clinical psychologist (CP) means an individual who meets the applicable education, training, and other requirements at 410.71(d) of this chapter.

Clinical social worker means an individual who meets the applicable education, training, and other requirements at 410.73(a) of this chapter.

Direct services mean services provided by the clinic's staff.

Marriage and family therapist means an individual who meets the applicable education, training, and other requirements at 410.53 of this chapter.

Mental health counselor means an individual who meets the applicable education, training, and other requirements at 410.54 of this chapter.

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 nurse practitioner by a recognized national certifying body that has established standards for nurse practitioners and possesses a master's or doctoral degree in nursing practice; or
2. Has satisfactorily completed a formal one-academic-year educational program that:
   1. Prepares registered nurses to perform an expanded role in the delivery of primary care.
   2. Includes at least four months (in the aggregate) of classroom instruction and a component of supervised clinical practice.
   3. 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) of this definition 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 means the following:

1. As it pertains to the supervision, collaboration, and oversight requirements, a doctor of medicine or osteopathy legally authorized to practice medicine or surgery in the state in which the function is performed; and
2. Within limitations as to the specific services furnished, a doctor of dental surgery or of dental medicine, a doctor of optometry, a doctor of podiatry or surgical chiropody or a chiropractor.

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 of Physician Assistants to assist primary care physicians; or
2. Has satisfactorily completed a program for preparing physician's assistants that:
   1. Was at least one academic year in length.
   2. Consisted of supervised clinical practice and at least four months (in the aggregate) of classroom instruction directed toward preparing students to deliver healthcare.
   3. 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 under (b) of this definition and assisted primary care physicians for a total of 12 months during the 18-month period that ended on December 31, 1986.

Rural area means an area that is not delineated as an urbanized area by the Bureau of the Census.

Rural Health Clinic (RHC) 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.

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).

• An RHC will be certified for participation in Medicare.
  1. The secretary will notify the state Medicaid agency whenever he or she has certified or denied certification under Medicare for a prospective RHC in that state.
  2. A clinic certified under Medicare will be deemed to meet the standards for certification under Medicaid.

• Physician's services are professional services that are furnished by either of the following:
  1. By a physician at the RHC
  2. b. Outside of the RHC by a physician whose agreement with the RHC provides that he or she will be paid by the RHC for such services and certification and cost reporting requirements are met

Visiting Nurse Services are covered if the services meet the following:

• The RHC is located in an area in which the secretary has determined there is a shortage of home health agencies.
• The services are rendered to a homebound individual.
• The services are furnished by a registered professional nurse or licensed practical nurse that is employed by or receives compensation for the services from the RHC.
• The services are furnished under a written plan of treatment that is both of the following:
  1. Established and reviewed at least every 60 days by a supervising physician of the RHC; OR
  2. Established by a nurse practitioner, physician assistant, or certified nurse midwife; AND
     1. Reviewed at least every 60 days by a supervising physician.
  3. Signed by the supervising physician, nurse practitioner, physician assistant, or certified nurse midwife of the RHC.

• Nursing care that is covered includes the following:
  1. Services that must be performed by a registered professional nurse or licensed practical nurse if the safety of the patient is to be assured and the medically desired results achieved.
  2. Personal care services, to the extent covered under Medicare as home health services. These services include helping the patient to bathe, to get in and out of bed, to exercise, and to take medications.
  3. This benefit does not cover household and housekeeping services or other services that would constitute custodial care.

Homebound means an individual who is permanently or temporarily confined to his or her place of residence because of a medical or health condition. The individual may be considered homebound if he or she leaves the place of residence infrequently. "Place of residence" does not include a hospital or long-term care facility.

Visiting Nurse Services – Determination of shortage of agencies:

• A shortage of home health agencies exists if the secretary determines that the RHC:
  1. Is located in a county, parish, or similar geographic area in which there is no participating home health agency or adequate home health services are not available to patients of the RHC.
  2. Has (or expects to have) patients whose permanent residences are not within the area services by a participating home health agency.
  3. Has (or expects to have) patients whose permanent residences are not within a reasonable traveling distance, based on climate and terrain, of a participating home health agency.

RHCs are permitted to offer Visiting Nurse Services (VNS) in patients' homes if they are located in an area with a shortage of home health agencies.

• To provide VNS, the RHC must apply to the State Agency, which performs an assessment in accordance with regulations. Based on this assessment, the State Agency makes a recommendation to the CMS Regional Office (RO), and the RO makes the determination whether the RHC will be permitted to offer VNS.
• If an RHC provides VNS, the State Agency must confirm that the services are being provided:
  1. By a registered nurse (RN) or a licensed practical nurse (LPN) who is employed by or receives compensation from the RHC for providing such services.
  2. In accordance with a written plan of treatment which is: established and signed by a supervising RHC physician, nurse practitioner, physician assistant, or certified nurse midwife.
  3. Reviewed and signed at least every 60 days by the supervising RHC physician.
  4. Identifies the nursing and personal care services that are to be provided to the individual.
• The VNS must be provided in the patient's home and must be documented in the RHC's clinical records, in accordance with regulatory requirements.

• For survey purposes, the surveyor will:
  1. Review personnel files of staff making VNS visits to ensure that they are currently licensed as either an RN or an LPN.
  2. Review a sample of records of patients receiving VNS to determine:
     1. There is a written treatment plan for each patient, established and signed by an RHC physician or non-physician practitioner.
     2. There is evidence that the plan was reviewed by an RHC physician at least every 60 days.
     3. The clinical record documents the provision of VNS to the patient in accordance with the written plan for that patient.
  3. Observe at least one VNS visit, if any have been scheduled during the survey period, to determine whether care is being provided in accordance with the written treatment plan for that patient.

• The Rural Health Clinic (RHC) and its staff are in compliance with applicable federal, state, and local laws and regulations.

• The clinic is licensed pursuant to applicable state and local law.

• Staff of the clinic are licensed, certified, or registered in accordance with applicable state and local laws.

• The RHC is located in a rural area that is designated as a shortage area and meets definition according to regulation.
  Criteria for designation of rural areas.
  1. Rural areas are areas not delineated as urbanized in the last census conducted by the Census Bureau.
  2. Excluded from the rural area classification are:
     1. Central cities with at least 50,000 inhabitants or more.
     2. Cities with at least 25,000 inhabitants which, together with contiguous areas having stipulated population density, have combined populations of 50,000 and constitute, for general economic and social purposes, single communities.
     3. Closely settled territories surrounding cities and specifically designated by the Census Bureau as urban.
  3. Included in the rural area classification are those portions of extended cities that the Census Bureau has determined to be rural.
  Criteria for designation of shortage areas.
  1. The criteria for determination of shortage of personal health services (under section 1302(7) of the Public Health Services Act), are:
     1. The ratio of primary care physicians practicing within the area to the resident population.
     2. The infant mortality rate.
     3. The percent of the population 65 years of age or older.
     4. The percent of the population with a family income below the poverty level.

• The criteria for determination of shortage of primary medical care manpower (under section 332(a)(1)(A) of the Public Health Services Act) are:
  1. The area served is a rational area for the delivery of primary medical care services.
  2. The ratio of primary care physicians practicing within the area to the resident population.
  3. The primary medical care manpower in contiguous areas is overutilized, excessively distant, or inaccessible to the population in this area.
  Medically underserved population. A medically underserved population includes the following:
  1. A population of an urban or rural area that is designated by Public Health Services (PHS) as having a shortage of personal health services.
  2. A population group that is designated by PHS as having a shortage of personal health services.

• The RHC may be a permanent or mobile unit.
  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.
  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 fixed, scheduled location(s).

• Permanent unit in more than one location. If clinic services are furnished at permanent units in more than one location, each unit is independently considered for approval as an RHC.

• 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.

• Maintenance. 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.

• Drugs and biologicals are appropriately stored.

• The premises are clean and orderly.

• The clinic is under the medical direction of a physician and has a healthcare staff that meets the regulatory requirements.
• The clinic discloses the names and addresses of:
  1. Its owners, in accordance with regulatory requirements.
  2. The person principally responsible for directing the operation of the clinic.
  3. The person responsible for medical direction.

• The organization's policies and its lines of authority and responsibilities are clearly set forth in writing.

• The clinic has a healthcare staff that includes one or more physicians.
• The physician member of the staff may be the owner of the Rural Health Clinic (RHC), an employee of the clinic, or under agreement with the clinic to carry out the responsibilities required under this section.

• RHC staff must also include one or more physician's assistants or nurse practitioners.
• At least one physician assistant or nurse practitioner must be an employee of the clinic.

• The physician assistant, nurse practitioner, certified nurse-midwife, clinical social worker, clinical psychologist, marriage and family therapist, or a mental health counselor member of the staff may be the owner or an employee of the clinic or may furnish services under contract to the clinic.

• The staff may also include ancillary personnel who are supervised by the professional staff.

• The staff is sufficient to provide the services essential to the operation of the clinic.

• A physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, clinical psychologist, marriage and family therapist, or a mental health counselor is available to furnish patient care services at all times the clinic operates.

• In addition, for RHCs, a nurse practitioner, physician assistant, or certified nurse-midwife is available to furnish patient care services at least 50 percent of the time the RHC operates.

• The physician performs the following:
  1. Provides the medical direction for the clinic’s healthcare activities and consultation for, and medical supervision of, the healthcare staff.
  2. In conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing, executing, and periodically reviewing the clinics written policies and the services provided to federal program patients.

• The physician periodically reviews the clinics or centers patient records, provides medical orders, and provides medical care services to the patients of the clinic or center.
• The physician assistant and the nurse practitioner members of the clinic's staff:
  1. Participates in the development, execution, and periodic review of the written policies governing the services the clinic or center furnishes.
  2. Participates with a physician in a periodic review of the patient's health records.
  See Appendix B: Collaborative Chart Audit for a sample form.

• The physician assistant or nurse practitioner performs the following functions, to the extent they are not being performed by the physician:
  1. Provides services in accordance with the clinic’s policies.
  2. Arranges for, or refers patients to, needed services that cannot be provided at the clinic.
  3. Assures that adequate patient health records are maintained and transferred as required when patients are referred.

• All services offered by the clinic are furnished in accordance with applicable federal, state, and local laws.

• The clinic's healthcare services are furnished in accordance with appropriate written policies which are consistent with applicable state law.

• The clinic is primarily engaged in providing outpatient health services and meets all other conditions.
• The clinic must provide primary care services.
• 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 healthcare delivery system. These include:
  1. Medical history
  2. Physical examination
  3. Assessment of health status
  4. Treatment for a variety of medical conditions

• In conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing, executing, and periodically reviewing the clinics written policies and the services provided to federal program patients.

• 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 is not a member of the clinic staff.
• These policies are reviewed at least every two years by the group of professional personnel identified above and reviewed as necessary by the clinic.

• The policies include:
  1. A description of the services the clinic furnishes directly and those furnished through agreement or arrangement.
  2. Guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, the maintenance of healthcare records, and procedures for the periodic review and evaluation of the services furnished by the clinic.
  3. Rules for the storage, handling, and administration of drugs and biologicals.

• The RHC provides basic laboratory services essential to the immediate diagnosis and treatment of the patient, including:
  1. Chemical examinations of urine by stick or tablet method or both (including urine ketones)
  2. Blood glucose
  3. Pregnancy tests
  4. Collection of patient specimens for transmittal to a certified laboratory for culturing.

• 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:
  1. Analgesics
  2. Anesthetics (local)
  3. Antibiotics
  4. Anticonvulsants
  5. Antidotes and emetics
  6. Serums and toxoids

• 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:
  1. Inpatient hospital care.
  2. Physician(s) services (whether furnished in the hospital, the office, the patient's home, a skilled nursing facility, or elsewhere)
  3. Additional and specialized diagnostic and laboratory services that are not available at the clinic.
• If the agreements are not in writing, there is evidence that patients referred by the clinic are being accepted and treated.

• The clinic maintains a clinical record system in accordance with written policies and procedures.

• A designated member of the professional staff is responsible for maintaining the records and for insuring that they are completely and accurately documented, readily accessible, and systematically organized.

• For each patient receiving healthcare services, the clinic maintains a record that includes, as applicable:
  1. Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and healthcare needs of the patient, and a 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 physician or other healthcare professional.
  See Appendix C: Administrative Chart Audit for a sample form.

• The clinic maintains the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use.
• Written policies and procedures govern the use and removal of records from the clinic the conditions for release of information.
• The patient's written consent is required for release of information not authorized to be released without such consent.

• The records are retained for at least six years from date of last entry, and longer if required by state statute.

• The clinic carries out, or arranges for, a biennial evaluation of its total program.
  1. The evaluation includes review of:
     1. The utilization of clinic services, including at least the number of patients served and the volume of services.
     2. A representative sample of both active and closed clinical records.
     3. The clinic's healthcare policies.
  2. The purpose of the evaluation is to determine whether:
     1. The utilization of services was appropriate.
     2. The established policies were followed.
     3. Any changes are needed.

• The clinic staff considers the findings of the evaluation and takes corrective action if necessary.
  See Appendix D: Program Evaluation Agenda for a sample form.

• The Rural Health Clinic (RHC) must establish and maintain an emergency preparedness program that meets the requirements of regulation.

• The RHC must comply with all applicable federal, state, and local emergency preparedness requirements.

• Emergency Plan. The RHC must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every two years.

• Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
• Include strategies for addressing emergency events identified by the risk assessment.

• Address patient population, including, but not limited to, the type of services the RHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.

• Include a process for cooperation and collaboration with local, tribal, regional, state, and federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the RHC/FQHC's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.

• Policies and procedures. The RHC/FQHC must develop and implement emergency preparedness policies and procedures, based on the emergency plan, risk assessment, and the communication plan.
• The policies and procedures must be reviewed and updated at least every two years.

• Safe evacuation from the RHC, which includes appropriate placement of exit signs, staff responsibilities, and needs of the patients.

• A means to shelter in place for patients, staff, and volunteers who remain in the facility.

• A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.

• The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state and federally designated healthcare professionals to address surge needs during an emergency.

• Communication plan. The RHC must develop and maintain an emergency preparedness communication plan that complies with federal, state, and local laws and must be reviewed and updated at least every two years.
• The communication plan must include all of the following:
  1. Names and contact information for the following:
     1. Staff
     2. Entities providing services under arrangement
     3. Patients' physicians
     4. Other RHCs
     5. Volunteers

• Contact information for the following:
  1. Federal, state, tribal, regional, and local emergency preparedness staff
  2. Other sources of assistance

• Primary and alternate means for communicating with the following:
  1. RHC staff
  2. Federal, state, tribal, regional, and local emergency management agencies

• A means of providing information about the general condition and location of patients under the facility's care.

• A means of providing information about the RHC's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.

• Training and testing. The RHC must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan, risk assessment, policies and procedures, and the communication plan.
• The training and testing program must be reviewed and updated at least every two years.

• Training Program. The RHC must do all of the following:
  1. Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles
  2. Provide emergency preparedness training at least every two years
  3. Maintain documentation of the training
  4. Demonstrate staff knowledge of emergency procedures

• Testing. The RHC must conduct exercises to test the emergency plan at least annually.
  1. Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every two years. If the RHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the RHC is exempt from engaging in a community-based or individual, facility-based full-scale exercise for one year following the onset of the actual event.
  2. Conduct an additional exercise that may include, but is not limited to following:
     1. A second full-scale exercise that is community-based or an individual, facility-based functional exercise.
     2. A mock disaster drill.
     3. A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
  3. Analyze the RHC response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the RHC's emergency plan, as needed.
     
  See Appendix E: After Action Report for a sample form.

• Integrated healthcare system. If an RHC is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the RHC may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following:
  1. Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program
  2. Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered
  3. Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program
  4. Include a unified and integrated emergency plan that meets the regulatory requirements. The unified and integrated emergency plan must also be based on and include all of the following:
     1. A documented community-based risk assessment, utilizing an all-hazards approach
     2. A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach
• Include integrated policies and procedures that meet the regulatory requirements, a coordinated communication plan, and training and testing programs that meet the regulatory requirements.