42 C.F.R. Subpart E—PACE Administrative Requirements
Title 42 - Public Health
(a) A PACE organization must be, or be a distinct part of, one of the following: (1) An entity of city, county, State, or Tribal government. (2) A private not-for-profit entity organized for charitable purposes under section 501(c)(3) of the Internal Revenue Code of 1986. The entity may be a corporation, a subsidiary of a larger corporation, or a department of a corporation. (b) Program director. The organization must employ, or contract with in accordance with §460.70, a program director who is responsible for oversight and administration of the entity. (c) Medical director. The organization must employ, or contract with in accordance with §460.70, a medical director who is responsible for the delivery of participant care, for clinical outcomes, and for the implementation, as well as oversight, of the quality assessment and performance improvement program. (d) Organizational chart. (1) The PACE organization must have a current organizational chart showing officials in the PACE organization and relationships to any other organizational entities. (2) The chart for a corporate entity must indicate the PACE organization's relationship to the corporate board and to any parent, affiliate, or subsidiary corporate entities. (3) A PACE organization planning a change in organizational structure must notify CMS and the State administering agency, in writing, at least 60 days before the change takes effect. (4) Changes in organizational structure must be approved in advance by CMS and the State administering agency. (5) Changes in organizational structure approved by CMS and the State administering agency must be forwarded to the consumer advisory committee described in §460.62(c) of this part for dissemination to participants as appropriate. [64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002] (a) Governing body. A PACE organization must be operating under the control of an identifiable governing body (for example, a board of directors) or a designated person functioning as a governing body with full legal authority and responsibility for the following: (1) Governance and operation of the organization. (2) Development of policies consistent with the mission. (3) Management and provision of all services, including the management of contractors. (4) Establishment of personnel policies that address adequate notice of termination by employees or contractors with direct patient care responsibilities. (5) Fiscal operations. (6) Development of policies on participant health and safety, including a comprehensive, systemic operational plan to ensure the health and safety of participants. (7) Quality assessment and performance improvement program. (b) Community representation. A PACE organization must ensure community representation on issues related to participant care. This may be achieved by having a community representative on the governing body. (c) Consumer advisory committee. A PACE organization must establish a consumer advisory committee to provide advice to the governing body on matters of concern to participants. Participants and representatives of participants must constitute a majority of the membership of this committee. (a) General qualification requirements. Except as specified in paragraphs (b) and (c) of this section, each member of the staff (employee or contractor) of the PACE organization must meet the following conditions: (1) Be legally authorized (currently licensed or, if applicable, certified or registered) to practice in the State in which he or she performs the function or actions. (2) Only act within the scope of his or her authority to practice. (b) Federally-defined qualifications for physician. (1) A physician must meet the qualifications and conditions in §410.20 of this chapter. (2) A primary care physician must have a minimum of 1 year's experience working with a frail or elderly population. (c) Qualifications when no State licensing laws, State certification, or registration requirements exist. If there are no State licensing laws, State certification, or registration applicable to the profession, the following requirements must be met: (1) Registered nurse. A registered nurse must meet the following requirements: (i) Be a graduate of a school of professional nursing. (ii) Have a minimum of 1 year's experience working with a frail or elderly population. (2) Social worker. A social worker must meet the following requirements: (i) Have a master's degree in social work from an accredited school of social work. (ii) Have a minimum of 1 year's experience working with a frail or elderly population. (3) Physical therapist. A physical therapist must meet the following requirements: (i) Be a graduate of a physical therapy curriculum approved by one of the following: (A) The American Physical Therapy Association. (B) The Committee on Allied Health Education and Accreditation of the American Medical Association. (C) The Council on Medical Education of the American Medical Association and the American Physical Therapy Association. (D) Other equivalent organizations approved by the Secretary. (ii) Have a minimum of 1 year's experience working with a frail or elderly population. (4) Occupational therapist. An occupational therapist must meet the following requirements: (i) Be a graduate of an occupational therapy curriculum accredited jointly by the Committee on Allied Health Education and Accreditation of the American Medical Association and the American Occupational Therapy Association or other equivalent organizations approved by the Secretary. (ii) Be eligible for the National Registration Examination of the American Occupational Therapy Association. (iii) Have 2 years of appropriate experience as an occupational therapist and have achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service, except that the determination of proficiency does not apply with respect to persons initially licensed by a State or seeking initial qualification as an occupational therapist after December 31, 1977. (iv) Have a minimum of 1 year's experience working with a frail or elderly population. (5) Recreation therapist or activities coordinator. A recreation therapist or activities coordinator must have 2 years experience in a social or recreational program providing and coordinating services for a frail or elderly population within the last 5 years, one of which was full-time in a patient activities program in a health care setting. (6) Dietitian. A dietitian must meet the following requirements: (i) Have a baccalaureate or advanced degree from an accredited college with major studies in food and nutrition or dietetics. (ii) Have a minimum of 1 year's experience working with a frail or elderly population. (7) Drivers. A PACE center driver must meet the following requirements: (i) Have a valid driver's license to operate a van or bus in the State of operation. (ii) Be capable of, and experienced in, transporting individuals with special mobility needs. (a) The PACE organization must provide training to maintain and improve the skills and knowledge of each staff member with respect to the individual's specific duties that results in his or her continued ability to demonstrate the skills necessary for the performance of the position. (b) The PACE organization must develop a training program for each personal care attendant to establish the individual's competency in furnishing personal care services and specialized skills associated with specific care needs of individual participants. (a) Persons with criminal convictions. A PACE organization must not employ individuals or contract with organizations or individuals— (1) Who have been excluded from participation in the Medicare or Medicaid programs; (2) Who have been convicted of criminal offenses related to their involvement in Medicaid, Medicare, other health insurance or health care programs, or social service programs under title XX of the Act; or (3) In any capacity where an individual's contact with participants would pose a potential risk because the individual has been convicted of physical, sexual, drug, or alcohol abuse. (b) Direct or indirect interest in contracts. No member of the PACE organization's governing body or any immediate family member may have a direct or indirect interest in any contract that supplies any administrative or care-related service or materials to the PACE organization. (c) [Reserved] (d) Disclosure requirements. A PACE organization must have a formal process in place to gather information related to paragraphs (a) and (b) of this section and must be able to respond in writing to a request for information from CMS within a reasonable amount of time. [64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002] (a) General rule. The PACE organization must have a written contract with each outside organization, agency, or individual that furnishes administrative or care-related services not furnished directly by the PACE organization except for emergency services as described in §460.100. (b) Contract requirements. A contract between a PACE organization and a contractor must meet the following requirements: (1) The PACE organization must contract only with an entity that meets all applicable Federal and State requirements, including, but not limited to, the following: (i) An institutional contractor, such as a hospital or skilled nursing facility, must meet Medicare or Medicaid participation requirements. (ii) A practitioner or supplier must meet Medicare or Medicaid requirements applicable to the services it furnishes. (iii) A contractor must comply with the requirements of this part with respect to service delivery, participant rights, and quality assessment and performance improvement activities. (2) A contractor must be accessible to participants, located either within or near the PACE organization's service area. (3) A PACE organization must designate an official liaison to coordinate activities between contractors and the organization. (c) List of contractors. A current list of contractors must be on file at the PACE center and a copy must be provided to anyone upon request. (d) Copies of signed contracts. The PACE organization must furnish a copy of each signed contract for inpatient care to CMS and the State administering agency. (e) Content of contract. Each contract must be in writing and include the following information: (1) Name of contractor. (2) Services furnished (including work schedule if appropriate). (3) Payment rate and method. (4) Terms of the contract, including beginning and ending dates, methods of extension, renegotiation, and termination. (5) Contractor agreement to do the following: (i) Furnish only those services authorized by the PACE interdisciplinary team. (ii) Accept payment from the PACE organization as payment in full, and not bill participants, CMS, the State administering agency, or private insurers. (iii) Hold harmless CMS, the State, and PACE participants if the PACE organization does not pay for services performed by the contractor in accordance with the contract. (iv) Not assign the contract or delegate duties under the contract unless it obtains prior written approval from the PACE organization. (v) Submit reports required by the PACE organization. (vi) Agree to perform all the duties related to its position as specified in this part. (vii) Participate in interdisciplinary team meeting as required. (viii) Agree to be accountable to the PACE organization. (ix) Cooperate with the competency evaluation program and direct participant care requirements specified in §460.71. (f) Contracting with another entity to furnish PACE Center services. (1) A PACE organization may only contract for PACE Center services if it is fiscally sound as defined in §460.80(a) of this part and has demonstrated competence with the PACE model as evidenced by successful monitoring by CMS and the State administering agency. (2) The PACE organization retains responsibility for all participants and may only contract for the PACE Center services identified in §460.98(d). [64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002] (a) The PACE organization must ensure that all employees and contracted staff furnishing care directly to participants demonstrate the skills necessary for performance of their position. (1) The PACE organization must provide each employee and all contracted staff with an orientation. The orientation must include at a minimum the organization's mission, philosophy, policies on participant rights, emergency plan, ethics, the PACE benefit, and any policies related to the job duties of specific staff. (2) The PACE organization must develop a competency evaluation program that identifies those skills, knowledge, and abilities that must be demonstrated by direct participant care staff (employees and contractors). (3) The competency program must be evidenced as completed before performing participant care and on an ongoing basis by qualified professionals. (4) The PACE organization must designate a staff member to oversee these activities for employees and work with the PACE contractor liaison to ensure compliance by contracted staff. (b) The PACE organization must develop a program to ensure that all staff furnishing direct participant care services meet the following requirements: (1) Comply with any State or Federal requirements for direct patient care staff in their respective settings. (2) Comply with the requirements of §460.68(a) regarding persons with criminal convictions. (3) Have verified current certifications or licenses for their respective positions. (4) Are free of communicable diseases. (5) Have been oriented to the PACE program. (6) Agree to abide by the philosophy, practices, and protocols of the PACE organiztion. [67 FR 61505, Oct. 1, 2002] (a) Space and equipment—(1) Safe design. A PACE center must meet the following requirements: (i) Be designed, constructed, equipped, and maintained to provide for the physical safety of participants, personnel, and visitors. (ii) Ensure a safe, sanitary, functional, accessible, and comfortable environment for the delivery of services that protects the dignity and privacy of the participant. (2) Primary care clinic. The PACE center must include sufficient suitable space and equipment to provide primary medical care and suitable space for team meetings, treatment, therapeutic recreation, restorative therapies, socialization, personal care, and dining. (3) Equipment maintenance. A PACE organization must establish, implement, and maintain a written plan to ensure that all equipment is maintained in accordance with the manufacturer's recommendations. (b) Fire safety—(1) General rule. Except as otherwise provided in this section— (i) A PACE center must meet the applicable provisions of the 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association that apply to the type of setting in which the center is located. The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to PACE centers. (2) Exceptions. (i) The Life Safety Code provisions do not apply in a State in which CMS determines that a fire and safety code imposed by State law adequately protects participants and staff. (ii) CMS may waive specific provisions of the Life Safety Code that, if rigidly applied, would result in unreasonable hardship on the center, but only if the waiver does not adversely affect the health and safety of the participants and staff. (3) Beginning March 13, 2006, a PACE center must be in compliance with Chapter 9.2.9, Emergency Lighting. (4) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to PACE centers. (5) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a PACE center may install alcohol-based hand rub dispensers in its facility if— (i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities; (ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls; (iii) The dispensers are installed in a manner that adequately protects against access by vulnerable populations; and (iv) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00–1(101), issued by the Standards Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00–1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any additional changes are made to this amendment, CMS will publish notice in the (c) Emergency and disaster preparedness—(1) Procedures. The PACE organization must establish, implement, and maintain documented procedures to manage medical and nonmedical emergencies and disasters that are likely to threaten the health or safety of the participants, staff, or the public. (2) Emergencies defined. Emergencies include, but are not limited, to the following: (i) Fire. (ii) Equipment, water, or power failure. (iii) Care-related emergencies. (iv) Natural disasters likely to occur in the organization's geographic area. (An organization is not required to develop emergency plans for natural disasters that typically do not affect its geographic location.) (3) Emergency training. A PACE organization must provide appropriate training and periodic orientation to all staff (employees and contractors) and participants to ensure that staff demonstrate a knowledge of emergency procedures, including informing participants what to do, where to go, and whom to contact in case of an emergency. (4) Availability of emergency equipment. Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs, along with staff who know how to use the equipment, must be on the premises of every center at all times and be immediately available. The organization must have a documented plan to obtain emergency medical assistance from sources outside the center when needed. (5) Annual test of emergency and disaster plan. At least annually, a PACE organization must actually test, evaluate, and document the effectiveness of its emergency and disaster plans. [64 FR 66279, Nov. 24, 1999, as amended at 68 FR 1386, Jan. 10, 2003; 69 FR 49266, Aug. 11, 2004; 70 FR 15238, Mar. 25, 2005] (a) Standard procedures. The PACE organization must follow accepted policies and standard procedures with respect to infection control, including at least the standard precautions developed by the Centers for Disease Control and Prevention. (b) Infection control plan. The PACE organization must establish, implement, and maintain a documented infection control plan that meets the following requirements: (1) Ensures a safe and sanitary environment. (2) Prevents and controls the transmission of disease and infection. (c) Contents of infection control plan. The infection control plan must include, but is not limited to, the following: (1) Procedures to identify, investigate, control, and prevent infections in every center and in each participant's place of residence. (2) Procedures to record any incidents of infection. (3) Procedures to analyze the incidents of infection to identify trends and develop corrective actions related to the reduction of future incidents. (a) Safety, accessibility, and equipment. A PACE organization's transportation services must be safe, accessible, and equipped to meet the needs of the participant population. (b) Maintenance of vehicles. (1) If the PACE organization owns, rents, or leases transportation vehicles, it must maintain these vehicles in accordance with the manufacturer's recommendations. (2) If a contractor provides transportation services, the PACE organization must ensure that the vehicles are maintained in accordance with the manufacturer's recommendations. (c) Communication with PACE center. The PACE organization must ensure that transportation vehicles are equipped to communicate with the PACE center. (d) Training. The PACE organization must train all transportation personnel (employees and contractors) in the following: (1) Managing the special needs of participants. (2) Handling emergency situations. (e) Changes in care plan. As part of the interdisciplinary team process, PACE organization staff (employees and contractors) must communicate relevant changes in a participant's care plan to transportation personnel. (a) Meal requirements. (1) Except as specified in paragraphs (a)(2) or (a)(3) of this section, the PACE organization must provide each participant with a nourishing, palatable, well-balanced meal that meets the daily nutritional and special dietary needs of each participant. Each meal must meet the following requirements: (i) Be prepared by methods that conserve nutritive value, flavor, and appearance. (ii) Be prepared in a form designed to meet individual needs. (iii) Be prepared and served at the proper temperature. (2) The PACE organization must provide substitute foods or nutritional supplements that meet the daily nutritional and special dietary needs of any participant who has any of the following problems: (i) Refuses the food served. (ii) Cannot tolerate the food served. (iii) Does not eat adequately. (3) The PACE organization must provide nutrition support to meet the daily nutritional needs of a participant, if indicated by his or her medical condition or diagnosis. Nutrition support consists of tube feedings, total parenteral nutrition, or peripheral parenteral nutrition. (b) Sanitary conditions. The PACE organization must do the following: (1) Procure foods (including nutritional supplements and nutrition support items) from sources approved, or considered satisfactory, by Federal, State, Tribal, or local authorities with jurisdiction over the service area of the organization. (2) Store, prepare, distribute, and serve foods (including nutritional supplements and nutrition support items) under sanitary conditions. (3) Dispose of garbage and refuse properly. (a) Fiscally sound operation. A PACE organization must have a fiscally sound operation, as demonstrated by the following: (1) Total assets greater than total unsubordinated liabilities. (2) Sufficient cash flow and adequate liquidity to meet obligations as they become due. (3) A net operating surplus or a financial plan for maintaining solvency that is satisfactory to CMS and the State administering agency. (b) Insolvency plan. The organization must have a documented plan in the event of insolvency, approved by CMS and the State administering agency, which provides for the following: (1) Continuation of benefits for the duration of the period for which capitation payment has been made. (2) Continuation of benefits to participants who are confined in a hospital on the date of insolvency until their discharge. (3) Protection of participants from liability for payment of fees that are the legal obligation of the PACE organization. (c) Arrangements to cover expenses. (1) A PACE organization must demonstrate that it has arrangements to cover expenses in the amount of at least the sum of the following in the event it becomes insolvent: (i) One month's total capitation revenue to cover expenses the month before insolvency. (ii) One month's average payment to all contractors, based on the prior quarter's average payment, to cover expenses the month after the date it declares insolvency or ceases operations. (2) Arrangements to cover expenses may include, but are not limited to, the following: (i) Insolvency insurance or reinsurance. (ii) Hold harmless arrangement. (iii) Letters of credit, guarantees, net worth, restricted State reserves, or State law provisions. (a) Information that a PACE organization must include in its marketing materials. (1) A PACE organization must inform the public about its program and give prospective participants the following written information: (i) An adequate description of the PACE organization's enrollment and disenrollment policies and requirements. (ii) PACE enrollment procedures. (iii) Description of benefits and services. (iv) Premiums. (v) Other information necessary for prospective participants to make an informed decision about enrollment. (2) Marketing information must be free of material inaccuracies, misleading information, or misrepresentations. (b) Approval of marketing information. (1) CMS must approve all marketing information before distribution by the PACE organization, including any revised or updated material. (2) CMS reviews initial marketing information as part of an entity's application for approval as a PACE organization, and approval of the application includes approval of marketing information. (3) Once a PACE organization is under a PACE program agreement, any revisions to existing marketing information and new information are subject to the following: (i) Time period for approval. CMS approves or disapproves marketing information within 45 days after CMS receives the information from the organization. (ii) Deemed approval. Marketing information is deemed approved, and the organization can distribute it, if CMS and the State administering agency do not disapprove the marketing material within the 45-day review period. (c) Special language requirements. A PACE organization must furnish printed marketing materials to prospective and current participants as specified below: (1) In English and in any other principal languages of the community. (2) In Braille, if necessary. (d) Information on restriction of services. (1) Marketing materials must inform a potential participant that he or she must receive all needed health care, including primary care and specialist physician services (other than emergency services), from the PACE organization or from an entity authorized by the PACE organization. (2) All marketing materials must state clearly that PACE participants may be fully and personally liable for the costs of unauthorized or out-of-PACE program agreement services. (e) Prohibited marketing practices. A PACE organization must ensure that its employees or its agents do not use prohibited marketing practices which includes the following: (1) Discrimination of any kind, except that marketing may be directed to individuals eligible for PACE by reason of their age. (2) Activities that could mislead or confuse potential participants, or misrepresent the PACE organization, CMS, or the State administering agency. (3) Gifts or payments to induce enrollment. (4) Contracting outreach efforts to individuals or organizations whose sole responsibility involves direct contact with the elderly to solicit enrollment. (5) Unsolicited door-to-door marketing. (f) Marketing Plan. A PACE organization must establish, implement, and maintain a documented marketing plan with measurable enrollment objectives and a system for tracking its effectiveness.
Title 42: Public Health
PART 460—PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
Subpart E—PACE Administrative Requirements
§ 460.60 PACE organizational structure.
§ 460.62 Governing body.
§ 460.64 Personnel qualifications.
§ 460.66 Training.
§ 460.68 Program integrity.
§ 460.70 Contracted services.
§ 460.71 Oversight of direct participant care.
§ 460.72 Physical environment.
§ 460.74 Infection control.
§ 460.76 Transportation services.
§ 460.78 Dietary services.
§ 460.80 Fiscal soundness.
§ 460.82 Marketing.
