(a) 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.

(b) 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 improvement program.

(c) 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) Except as provided in paragraph (d) of this section, a PACE organization planning a change in organizational structure must notify CMS and the State administering agency, in writing, at least 14 days before the change takes effect.

(d) Change of ownership. A PACE organization planning a change of ownership must comply with all requirements in 42 CFR part 422, subpart L, and must notify CMS and the State administering agency, in writing, at least 60 days before the anticipated effective date of the change.

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002; 71 FR 71334, Dec. 8, 2006; 84 FR 25673, June 3, 2019]

(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) A quality improvement program as described in § 460.130.

(b) Participant advisory committee. (1) A PACE organization must establish a participant 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.

(2) The participant advisory committee must provide the liaison to the governing body with meeting minutes that include participant issues.

(c) Participant representation on the governing body. (1) A PACE organization must ensure participant representation on issues related to participant care. This shall be achieved by having a participant representative on the governing body.

(2) The participant representative is a liaison of the participant advisory committee to the PACE organization governing body.

(3) Duty of the participant representative. The participant representative must present issues from the participant advisory committee to the governing body.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 84 FR 25673, June 3, 2019]

A PACE organization must adopt and implement effective compliance oversight requirements, which must include measures that prevent, detect, and correct non-compliance with CMS' program requirements, as well as measures that prevent, detect, and correct fraud, waste, and abuse. The compliance oversight program must, at a minimum, include establishment and implementation of procedures and a system for promptly responding to compliance issues as they are raised, investigating potential compliance problems as identified in the course of self-evaluations and audits, correcting such problems promptly and thoroughly to reduce the potential for recurrence, and ensure ongoing compliance with CMS requirements.

(a) If the PACE organization discovers evidence of misconduct related to payment or delivery of items or services, it must conduct a timely, reasonable inquiry into that conduct.

(b) The PACE organization must conduct appropriate corrective actions (for example, repayment of overpayments, disciplinary actions against responsible employees) in response to the potential violation.

(c) The PACE organization should have procedures to voluntarily self-report potential fraud or misconduct related to the PACE program to CMS and the State administering agency.

[84 FR 25673, June 3, 2019]

Link to an amendment published at 89 FR 30844, Apr. 23, 2024.

(a) General qualification requirements. Each member of the PACE organization's staff (employee or contractor) that has direct contact with participants must meet the following conditions:

(1) Be legally authorized (for example, currently licensed, registered or certified if applicable) to practice in the State in which he or she performs the function or action;

(2) Only act within the scope of his or her authority to practice;

(3) Have 1 year of experience working with a frail or elderly population or, if the individual has less than 1 year of experience but meets all other requirements under paragraph (a) of this section, must receive appropriate training from the PACE organization on working with a frail or elderly population upon hiring.

(4) Meet a standardized set of competencies for the specific position description established by the PACE organization before working independently.

(5) Be medically cleared for communicable diseases and have all immunizations up-to-date before engaging in direct participant contact.

(b) Federally-defined qualifications for physician. In addition to the qualification specified in paragraph (a) of this section, a physician must meet the qualifications and conditions in § 410.20 of this chapter.

[71 FR 71334, Dec. 8, 2006, as amended at 84 FR 25673, June 3, 2019]

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.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006; 84 FR 25673, June 3, 2019]

(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;

(3) If the PACE organization determines that an individual's contact with participants would pose a potential risk because the individual has been convicted of one or more criminal offenses related to physical, sexual, drug, or alcohol abuse or use;

(4) Who have been found guilty of abusing, neglecting, or mistreating individuals by a court of law or who have had a finding entered into the State nurse aide registry concerning abuse, neglect, mistreatment of residents, or misappropriation of their property; or

(5) Who have been convicted of specific crimes for any offense described in section 1128(a) of the Social Security Act.

(b) Direct or indirect interest in contracts. The PACE organization shall identify members of its governing body or any immediate family member having a direct or indirect interest in any contract that supplies any administrative or care-related service or materials to the PACE organization.

(1) PACE organizations must develop policies and procedures for handling any direct or indirect conflict of interest by a member of the governing body or by the member's immediate family.

(2) In the event of a direct or indirect conflict of interest by a member of the PACE organization's governing body or his or her immediate family member, the board member must—

(i) Fully disclose the exact nature of the conflict to the board of directors and have the disclosure documented; and

(ii) Recuse himself or herself from discussing, negotiating, or voting on any issue or contract that could result in an inappropriate conflict.

(c) Disclosure and recusal 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; 71 FR 71335, Dec. 8, 2006; 81 FR 80561, Nov. 15, 2016; 83 FR 16756, Apr. 16, 2018; 84 FR 25673, June 3, 2019]

(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, including, at a minimum, the medical specialties identified in paragraph (a)(1) of this section. The PACE organization does not need to have a written contract with entities that provide emergency services as described in § 460.100.

(1) At a minimum, except as noted in paragraph (a)(4) of this section, PACE organizations must have contracts in place for the following medical specialties:

(i) Anesthesiology.

(ii) Audiology.

(iii) Cardiology.

(iv) Dentistry.

(v) Dermatology.

(vi) Gastroenterology.

(vii) Gynecology.

(viii) Internal Medicine.

(ix) Nephrology.

(x) Neurosurgery.

(xi) Oncology.

(xii) Ophthalmology.

(xiii) Oral surgery.

(xiv) Orthopedic surgery.

(xv) Otorhinolaryngology.

(xvi) Palliative Medicine.

(xvii) Plastic surgery.

(xviii) Pharmacy consulting services.

(xix) Podiatry.

(xx) Psychiatry.

(xxi) Pulmonology.

(xxii) Radiology.

(xxiii) Rheumatology.

(xxiv) General Surgery.

(xxv) Thoracic and vascular surgery.

(xxvi) Urology.

(2) Contracts with medical specialists must be executed prior to enrollment of participants and must be maintained on an ongoing basis to ensure participants receive appropriate and timely access to all medically necessary care and services.

(3) A PACE organization is responsible for making all reasonable and timely attempts to contract with medical specialists. If at any time a PACE organization is unable to directly contract or maintain a contract with a specific specialty, the PACE organization must—

(i) Ensure care and services that would otherwise be provided to participants by a contracted specialist are provided and that the participant's needs are met through a different mechanism to include hospitalization; and

(ii) Promptly report the contracting issue to CMS and the State Administering Agency, including the attempts made to contract, the reason why the contract was not effectuated, and the PACE organization's plan to provide access to the necessary services.

(4) A PACE organization is not required to have a contract with a particular medical specialty if the PACE organization directly employs one or more individuals prior to contracting who are legally authorized, and if applicable, board certified in the particular medical specialty.

(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 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) 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.

(6) With respect to an individual who is contracting as a program director or medical director or to be part of the interdisciplinary team as set forth at § 460.60(a) and (b) and § 460.102(b), the contract must specify that the individual agrees to:

(i) Perform all the duties related to its position as specified in this part.

(ii) Participate in interdisciplinary team meetings as required.

(iii) Be accountable to the PACE organization.

(iv) Cooperate with the competency evaluation program and direct participant care requirements specified in § 460.71.

(e) 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(c).

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002; 71 FR 71335, Dec. 8, 2006; 81 FR 80561, Nov. 15, 2016; 83 FR 16756, Apr. 16, 2018; 84 FR 25673, June 3, 2019; 88 FR 22345, Apr. 12, 2023; 88 FR 34780, May 31, 2023]

Link to an amendment published at 89 FR 30844, Apr. 23, 2024.

(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 that includes, 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) Be medically cleared for communicable diseases and have all immunizations up-to-date before engaging in direct participant contact as required under § 460.64(a)(5).

(5) Have been oriented to the PACE program.

(6) Agree to abide by the philosophy, practices, and protocols of the PACE organization.

(c) 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.

(d) Personal care attendants must exhibit competency before performing personal care services independently.

[67 FR 61505, Oct. 1, 2002, as amended at 71 FR 71335, Dec. 8, 2006; 81 FR 80562, Nov. 15, 2016; 83 FR 16756, Apr. 16, 2018; 84 FR 25674, June 3, 2019]

(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. (i) 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.

(ii) A PACE organization must perform the manufacturer's recommended maintenance on all equipment as indicated in the organization's written plan.

(b) Fire safety—(1) General rule. Except as otherwise provided in this section—

(i) A PACE center must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)

(ii) Notwithstanding paragraph (b)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.

(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) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a PACE facility, but only if the waiver will not adversely affect the health and safety of the patients.

(3) A PACE center may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.

(4) When a sprinkler system is shut down for more than 10 hours in a 24-hour period, the PACE must:

(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or

(ii) Establish a fire watch until the system is back in service.

(c) [Reserved]

(d) Standard: Building Safety. Except as otherwise provided in this section, a PACE center must meet the applicable provisions and must proceed in accordance with the Health Care Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6).

(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to a PACE center.

(2) If application of the Health Care Facilities Code required under paragraph (d) of this section would result in unreasonable hardship for the PACE center, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.

(e) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy 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.html. If any changes in this edition of the Code are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes.

(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.

(i) NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.

(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.

(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.

(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.

(v) TIA 12-5 to NFPA 99, issued August 1, 2013.

(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.

(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011;

(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.

(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.

(x) TIA 12-3 to NFPA 101, issued October 22, 2013.

(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.

(2) [Reserved]

[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; 71 FR 55340, Sept. 22, 2006; 71 FR 71335, Dec. 8, 2006; 81 FR 26898, May 4, 2016; 81 FR 64026, Sept. 16, 2016]

(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 Pace 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.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 86 FR 61618, Nov. 5, 2021; 88 FR 36510, June 5, 2023]

(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.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006]

(a) Meal requirements. (1) Except as specified in paragraphs (a)(2) or (a)(3) of this section, the PACE organization must ensure, through the assessment and care planning process, that each participant receives nourishing, palatable, well-balanced meals that meet the participant's daily nutritional and special dietary needs. 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.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006]

(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, as determined by the State in which the PACE organization is located. In the absence of a State standard, a principal language of the community is any language that is spoken in the home by at least 5 percent of the individuals in the PACE organization's service area.

(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 not use the following marketing practices, which are prohibited:

(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, unless the gifts are of nominal value as defined in CMS guidance, are offered to all potential enrollees without regard to whether they enroll in the PACE program, and are not in the form of cash or other monetary rebates.

(4) Marketing by any individual or entity that is directly or indirectly compensated by the PACE organization based on activities or outcomes unless the individual or entity has been appropriately trained on PACE program requirements, including but not limited to, subparts G and I of this part.

(i) PACE organizations are responsible for the activities of contracted individuals or entities who market on their behalf.

(ii) PACE organizations that choose to use contracted individuals or entities for marketing purposes must develop a method to document training has been provided.

(5) Unsolicited door-to-door marketing or other unsolicited means of direct contact, including calling or emailing a potential or current participant without the individual initiating the contact.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25674, June 3, 2019]

The Program for the All-Inclusive Care for the Elderly (PACE) organization must comply with all applicable Federal, State, and local emergency preparedness requirements. The PACE organization must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:

(a) Emergency plan. The PACE organization must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.

(2) Include strategies for addressing emergency events identified by the risk assessment.

(3) Address participant population, including, but not limited to, the type of services the PACE organization has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.

(4) 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.

(b) Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. Policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:

(1) The provision of subsistence needs for staff and participants, whether they evacuate or shelter in place, include, but are not limited to the following:

(i) Food, water, and medical supplies.

(ii) Alternate sources of energy to maintain the following:

(A) Temperatures to protect participant health and safety and for the safe and sanitary storage of provisions.

(B) Emergency lighting.

(C) Fire detection, extinguishing, and alarm systems.

(D) Sewage and waste disposal.

(2) A system to track the location of on-duty staff and sheltered participants under the PACE center(s) care during and after an emergency. If on-duty staff and sheltered participants are relocated during the emergency, the PACE must document the specific name and location of the receiving facility or other location.

(3) Safe evacuation from the PACE center, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.

(4) The procedures to inform State and local emergency preparedness officials about PACE participants in need of evacuation from their residences at any time due to an emergency situation based on the participant's medical and psychiatric conditions and home environment.

(5) A means to shelter in place for participants, staff, and volunteers who remain in the facility.

(6) A system of medical documentation that preserves participant information, protects confidentiality of participant information, and secures and maintains the availability of records.

(7) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.

(8) The development of arrangements with other PACE organizations, PACE centers, or other providers to receive participants in the event of limitations or cessation of operations to maintain the continuity of services to PACE participants.

(9) The role of the PACE organization under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.

(10)(i) Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs.

(ii) Staff who know how to use the equipment must be on the premises of every center at all times and be immediately available.

(iii) A documented plan to obtain emergency medical assistance from outside sources when needed.

(c) Communication plan. The PACE organization 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 2 years. The communication plan must include all of the following:

(1) Names and contact information for staff; entities providing services under arrangement; participants' physicians; other PACE organizations; and volunteers.

(2) Contact information for the following:

(i) Federal, State, tribal, regional, and local emergency preparedness staff.

(ii) Other sources of assistance.

(3) Primary and alternate means for communicating with the following:

(i) PACE organization's staff.

(ii) Federal, State, tribal, regional, and local emergency management agencies.

(4) A method for sharing information and medical documentation for participants under the organization's care, as necessary, with other health care providers to maintain the continuity of care.

(5) A means, in the event of an evacuation, to release participant information as permitted under 45 CFR 164.510(b)(1)(ii).

(6) A means of providing information about the general condition and location of participants under the facility's care as permitted under 45 CFR 164.510(b)(4).

(7) A means of providing information about the PACE organization's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.

(d) Training and testing. The PACE organization must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.

(1) Training program. The PACE organization must do all of the following:

(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.

(ii) Provide emergency preparedness training at least every 2 years.

(iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency.

(iv) Maintain documentation of all training.

(v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures.

(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:

(i) Participate in a full-scale exercise that is community-based or;

(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or

(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.

(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:

(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or

(B) A mock disaster drill; or

(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.

(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.

(e) Integrated healthcare systems. If a PACE 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 PACE may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must—

(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, participant 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 requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:

(i) A documented community-based risk assessment, utilizing an all-hazards approach.

(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.

(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64026, Sept. 16, 2016, as amended at 84 FR 51816, Sept. 30, 2019]

(a) A PACE organization may not pay, directly or indirectly, on any basis, for items or services (other than emergency or urgently needed services as defined in § 460.100) furnished to a Medicare enrollee by any individual or entity that is excluded by the OIG or is included on the preclusion list, defined in § 422.2 of this chapter.

(b) If a PACE organization receives a request for payment by, or on behalf of, an individual or entity that is excluded by the OIG or is included on the preclusion list, defined in § 422.2 of this chapter, the PACE organization must notify the enrollee and the excluded individual or entity or the individual or entity that is included on the preclusion list in writing, as directed by contract or other direction provided by CMS, that payments will not be made. Payment may not be made to, or on behalf of, an individual or entity that is excluded by the OIG or is included on the preclusion list.

[83 FR 16756, Apr. 16, 2018]