the Professional Standards Review Organization program in its State. § 478.105 Duties and functions. Each Advisory Group shall advise and assist its Statewide Council in the performance of the Council's functions, specifically in the following areas and in any other areas considered appropriate by the Statewide Council: (a)(1) In assuring maximum effective involvement of health care practitioners (other than physicians) in the Professional Standards Review Organization activities in its State. (2) In developing effective relationships with organizations representing health care practitioners (other than physicians), hospitals and/or health care facilities within its State. (3) In carrying out the functions of the Statewide Council under section 1160(c) of the Act as they relate to health care practitioners (other than physicians), hospitals and other health care facilities. (4) In carrying out the Statewide Council's functions under section 1162(c) of the Act. (b) An Advisory Group may undertake other activities with the approval of its Statewide Council. § 478.106 Employment nondiscrimination. Attention is called to the requirements of Executive Order 11246 (42 U.S.C. 2000e) which prohibits discrimination against any employee or applicant for employment because of race, color, religion, sex or national origin. Regulations implementing such Executive Order 11246, which are applicable to Advisable Groups under this Subpart, have been issued by the Secretary of Labor (41 CFR Ch. 60). PART 480-ADVISORY GROUPS TO PSRO's Sec. 480. Scope. 480.2 Membership. 480.3 Organizationeal requirements. AUTHORITY: Sec. 1102 and 1162(e), Social Security Act (42 U.S.C. 1302, 1320c-11(e)). SOURCE: 41 FR 28687, July 12, 1976, unless otherwise noted. Redisignated at 42 FR 52826, Sept. 30, 1977. NOTE: Nomenclature changes to Part 480 appear at 42 FR 65122, Dec. 29, 1977. § 480.1 Scope. Section 1162(e) of the Social Security Act (hereinafter termed "the Act") provides that each Professional Standards Review Organization in any State not having a Statewide Professional Standards Review Council shall be advised and assisted in carrying out its functions by an Advisory Group. This part establishes the requirements for Professional Standards Review Organizations to follow in establishing and utilizing such Advisory Groups. § 480.2 Membership. (a) Composition, Terms and Qualifications. (1) Each Advisory Group shall have a minimum of seven and a maximum of eleven members. (2) Advisory Group members shall be appointed for terms of one year. An appointed member shall not be eligible to serve more than three consecutive full terms. To the extent practicable, no more than one-half of the members of an Advisory Group shall be appointed for an initial term in any year subsequent to the first year. (3) The membership of each Advisory Group shall consist of representatives of health care practitioners (other than physicians), of hospitals and of other health care facilities which provide within the Professional Standards Review Organization area health care services for which payment, in whole or in part, may be made under titles V, XVIII, of XIX of the Act and who are knowledgeable about the types of health care services being reviewed in the Professional Standards Review Organization area. In addition, the membership of each Advisory Group shall meet the following requirements: (i) Representatives of health care practitioners (other than physicians). At least one-half of the members of each Advisory Group shall be representatives of health care practitioners (other than physicians). For purposes of this part, health care practitioners (other than physicians) are those health professionals who do not hold a Doctor of Medicine or Doctor of Osteopathy degree, meet all applicable State or Federal requirements for practice of their profession, and are actively involved in the delivery of patient care or services which are directly or indirectly paid for under titles V, XVIII and/or XIX of the Act. Each such representative shall practice his or her profession in the Professional Standards Review Organization area. (ii) Representatives of hospitals. One or more members of each Advisory Group shall be representatives of hospitals. Each such representative shall be actively involved in the administration of or provision of services in a hospital which is located in the Professional Standards Review Organization area, and which has arrangements for reimbursement for services under titles V, XVIII and/or XIX of the Act. (iii) Representatives of other health care facilities. One or more members of each Advisory Group shall be representatives of health care facilities other than hospitals. At least one such member shall be a representative of a skilled nursing facility (as defined in section 1861(j) of the Act) or of an intermediate care facility (as defined in 42 CFR 449.10(b)(15)). Each such representative shall be actively involved in the administration of or provision of services in a health care facility other than hospital which is located in the Professional Standards Review Organization area and which has in effect arrangements for reimbursement for services under titles V, XVIII and/or XIX of the Act. (b) Selection procedures. (1) Each Professional Standards Review Organization in a State not having a Statewide Professional Standards Review Council shall have a standing committee, called the Advisory Group Nominating Committee, which shall solicit recommendations and nominate persons for Advisory Group membership. Each Advisory Group Nominating Committee shall have no fewer than five members and shall include at least three members of the governing body of the Professional Standards Review Organization. (2) Each Professional Standards Review Organization shall develop a written plan for the selection of Advisory Group members. Such plan shall be submitted to the Secretary no later than 90 days after the date of execution of an agreement between the Secretary and the Professional Standards Review Organization under section 1152(a) of the Act, and must be approved by the Secretary prior to the selection of any Advisory Group members. Such plan shall include the following provisions: (i) Specification of the composition of the Advisory Group, including plans to rotate membership among practitioner and health care facility groups. (ii) Specification of the organizations of health care practitioners (other than physicians), of hospitals, of other health care facilities and consumer and other interested groups from which recommendations will be sought by the Advisory Group Nominating Committee. If there are organizations comprised of practitioners or facilities within the Professional Standards Review Organization area, such organizations shall be included in those from which recommendations are sought. (iii) Criteria and procedures for review of recommendations by the Advisory Group Nominating Committee. (iv) Criteria and procedures for selection of Advisory Group members by the governing body of the Professional Standards Review Organization from nominations of the Advisory Group Nominating Committee. § 480.3 Organizational requirements. (a) Each Advisory Group shall establish its own organizational structure, elect its own chairperson, and develop written operating procedures, consistent with this part. (b) Each Advisory Group will report directly to the governing body of the Professional Standards Review Organization. (c) Each Advisory Group shall meet as a whole at least quarterly. (d) Minutes shall be recorded for all Advisory Group meetings and shall be available to the public consistent, as appropriate, with applicable regula (2) The membership of the Advisory Group Nominating Committee. (3) The membership of the Advisory Group. (4) The organization of the Advisory Group. (5) The Advisory Group's activities for the year, including the number of meetings, a description of specific projects, accomplishments, and recommendations made by the Advisory Group to its Professional Standards Review Organization. (b) Each Advisory Group shall prepare an annual report assessing the involvement of health care practitioners (other than physicians), and of hospitals and other health care facilities in the Professional Standards Review Organization program in its Professional Standards Review Organization area. § 480.5 Duties and functions. (a) Each Advisory Group shall advise and assist its Professional Standards Review Organization in the performance of its functions, specifically in the following areas and in any other areas considered appropriate by the Professional Standards Review Organization: (1) In assuring maximum effective involvement of health care practitioners (other than physicians) in the Pro fessional Standards Review Organization activities in its Professional Standards Review Organization area. (2) In developing effective relationships with organizations representing health care practitioners (other than physicians), hospitals and/or health care facilities within the Professional Standards Review Organization area. (3) In carrying out the functions of the Professional Standards Review Organization under section 1160(c) of the Act as they relate to health care practitioners (other than physicians), hospitals, and other health care facilities. (4) In developing any modifications of the formal plan pursuant to section 1154 of the Act. (b) An Advisory Group may undertake other activities with the approval of its Professional Standards Review Organization. Subpart A-Rural Health Clinics: Conditions for Certification § 481.1 Purpose and scope. This subpart sets forth the conditions that rural health clinics must meet in order to qualify for reimbursement under Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Act). § 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 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 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 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) 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 (d)(2) of this section and has been assisting primary care physicians for a total of 12 months during the 18month 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, Education, and Welfare, or any official to whom he has delegated the pertinent authority. (Secs. 1102, 1833 and 1902(a)(13), Social Security Act: 49 Stat. 647, 91 Stat. 1485 (42 U.S.C. 1302, 13951 and 1396(a)(13))) [43 FR 5375, Feb. 8, 1978, as amended at 43 FR 30528, July 14, 1978] § 481.3 Certification procedures. A rural health clinic will be certified for participation in Medicare in accordance with Subpart S of 42 CFR Part 405. The Secretary will notify the State Medicaid agency whenever he has certified or denied certification under Medicare for a prospective rural health clinic in that State. A clinic certified under Medicare will be deemed to meet the standards for certification under Medicaid. § 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. (a) Licensure of clinic. The clinic is licensed pursuant to applicable State and local law. (b) Licensure, certification or registration of personnel. Staff of the clinic are licensed, certified or registered in accordance with applicable State and local laws. § 481.5 Location of clinic. (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. (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). Under this requirement, if clinic services are furnished at permanent units in more than one location, each unit will be independently considered for certification as a rural health clinic. (b) Exceptions. (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. (3) Determinations on these exceptions will be made by the Secretary upon application by the facility. (c) Criteria for designation of rural areas. (1) Rural areas are areas not delineated as urbanized areas in the last census conducted by the Census Bureau. (2) Excluded from the rural area classification are: (i) central cities of 50,000 inhabitants or more; (ii) cities with at least 25,000 inhabitants which, together with contiguous areas having stipulated population density, have combined populations of 50,000 and constitute, for general economic and social purposes, single communities; (iii) closely settled territories surrounding cities and specifically designated by the Census Bureau as urban. (3) Included in the rural area classification are those portions of extended cities that the Census Bureau has determined to be rural. (d) 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: (i) The ratio of primary care physicians practicing within the area to the resident population; (ii) The infant mortality rate; (iii) The percent of the population 65 years of age or older; and (iv) The percent of the population with a family income below the poverty level. (See 42 CFR 110.203(g) and 41 FR 45718, Oct. 15, 1976.) (2) The criteria for determination of shortage of primary medical care manpower (under section 332(a)(1)(A) of the Public Health Services Act) are: |