If a Medicare beneficiary or Medicaid beneficiary chooses to enroll in a PACE program, the following conditions apply:

(a) Medicare and Medicaid benefit limitations and conditions relating to amount, duration, scope of services, deductibles, copayments, coinsurance, or other cost-sharing do not apply.

(b) The participant, while enrolled in a PACE program, must receive Medicare and Medicaid benefits solely through the PACE organization.

(a) The PACE benefit package for all participants, regardless of the source of payment, must include the following:

(1) All Medicare-covered services.

(2) All Medicaid-covered services, as specified in the State's approved Medicaid plan.

(3) Other services determined necessary by the interdisciplinary team to improve and maintain the participant's overall health status.

(b) Decisions by the interdisciplinary team to provide or deny services under paragraph (a) of this section must be based on an evaluation of the participant that takes into account:

(1) The participant's current medical, physical, emotional, and social needs; and

(2) Current clinical practice guidelines and professional standards of care applicable to the particular service.

[86 FR 6132, Jan. 19, 2021]

(a) Except for Medicare requirements that are waived for the PACE program, as specified in paragraph (b) of this section, the PACE benefit package for Medicare participants must include the following services:

(1) The scope of hospital insurance benefits described in part 409 of this chapter.

(2) The scope of supplemental medical insurance benefits described in part 410 of this chapter.

(b) Waivers of Medicare coverage requirements. The following Medicare requirements are waived for purposes of the PACE program and do not apply:

(1) The provisions of subpart F of part 409 of this chapter that limit coverage of institutional services.

(2) The provisions of subparts G and H of part 409 of this chapter, and parts 412 through 414 of this chapter that relate to payment for benefits.

(3) The provisions of subparts D and E of part 409 of this chapter that limit coverage of extended care services or home health services.

(4) The provisions of subpart D of part 409 of this chapter that impose a 3-day prior hospitalization requirement for coverage of extended care services.

(5) Section 411.15(g) and § 411.15(k) of this chapter that may prevent payment for PACE program services that are provided to PACE participants.

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

The following services are excluded from coverage under PACE:

(a) Cosmetic surgery, which does not include surgery that is required for improved functioning of a malformed part of the body resulting from an accidental injury or for reconstruction following mastectomy.

(b) Experimental medical, surgical, or other health procedures.

(c) Services furnished outside of the United States, except as follows:

(1) In accordance with § 424.122 and § 424.124 of this chapter.

(2) As permitted under the State's approved Medicaid plan.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006; 86 FR 6132, Jan. 19, 2021]

Link to an amendment published at 89 FR 30845, Apr. 23, 2024.

(a) Access to services. A PACE organization is responsible for providing care that meets the needs of each participant across all care settings, 24 hours a day, every day of the year, and must establish and implement a written plan to ensure that care is appropriately furnished.

(b) Provision of services. (1) The PACE organization must furnish comprehensive medical, health, and social services that integrate acute and long-term care. These services must be furnished in accordance with § 460.70(a).

(2) These services must be furnished in at least the PACE center, the home, and inpatient facilities.

(3) The PACE organization may not discriminate against any participant in the delivery of required PACE services based on race, ethnicity, national origin, religion, sex, age, mental or physical disability, or source of payment.

(4) Services must be provided as expeditiously as the participant's health condition requires, taking into account the participant's medical, physical, emotional, and social needs.

(5) The PACE organization must document, track and monitor the provision of services across all care settings in order to ensure the interdisciplinary team remains alert to the participant's medical, physical, emotional, and social needs regardless of whether services are formally incorporated into the participant's plan of care.

(c) Minimum services furnished at each PACE center. At a minimum, the following services must be furnished at each PACE center:

(1) Primary care, including services furnished by a primary care provider as defined in § 460.102(c) and nursing services.

(2) Social services.

(3) Restorative therapies, including physical therapy and occupational therapy.

(4) Personal care and supportive services.

(5) Nutritional counseling.

(6) Recreational therapy.

(7) Meals.

(d) PACE center operation. (1) A PACE organization must operate at least one PACE center either in, or contiguous to, its defined service area with sufficient capacity to allow routine attendance by participants.

(2) A PACE organization must ensure accessible and adequate services to meet the needs of its participants. If necessary, a PACE organization must increase the number of PACE centers, staff, or other PACE services.

(3) If a PACE organization operates more than one center, each PACE center must offer the full range of services and have sufficient staff to meet the needs of participants.

(e) Center attendance. The frequency of a participant's attendance at a center is determined by the interdisciplinary team, based on the needs and preferences of each participant.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, 71335, Dec. 8, 2006; 84 FR 25674, June 3, 2019; 85 FR 37243, June 19, 2020; 86 FR 6132, Jan. 19, 2021]

(a) Written plan. A PACE organization must establish and maintain a written plan to handle emergency care. The plan must ensure that CMS, the State, and PACE participants are held harmless if the PACE organization does not pay for emergency services.

(b) Emergency care. Emergency care is appropriate when services are needed immediately because of an injury or sudden illness and the time required to reach the PACE organization or one of its contract providers, would cause risk of permanent damage to the participant's health. Emergency services include inpatient and outpatient services that meet the following requirements:

(1) Are furnished by a qualified emergency services provider, other than the PACE organization or one of its contract providers, either in or out of the PACE organization's service area.

(2) Are needed to evaluate or stabilize an emergency medical condition.

(c) An emergency medical condition means a condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in the following:

(1) Serious jeopardy to the health of the participant.

(2) Serious impairment to bodily functions.

(3) Serious dysfunction of any bodily organ or part.

(d) Explanation to participant. The organization must ensure that the participant or caregiver, or both, understand when and how to get access to emergency services and that no prior authorization is needed.

(e) On-call providers. The plan must provide for the following:

(1) An on-call provider, available 24-hours per day to address participant questions about emergency services and respond to requests for authorization of urgently needed out-of-network services and post stabilization care services following emergency services.

(2) Coverage of urgently needed out-of-network and post-stabilization care services when either of the following conditions are met:

(i) The services are preapproved by the PACE organization.

(ii) The services are not preapproved by the PACE organization because the PACE organization did not respond to a request for approval within 1 hour after being contacted or cannot be contacted for approval.

(3) Definitions. As used in this section, the following definitions apply:

(i) Post stabilization care means services provided subsequent to an emergency that a treating physician views as medically necessary after an emergency medical condition has been stabilized. They are not emergency services, which PACE organizations are obligated to cover. Rather, they are non-emergency services that the PACE organization should approve before they are provided outside the service area.

(ii) Urgent care means the care provided to a PACE participant who is out of the PACE service area, and who believes their illness or injury is too severe to postpone treatment until they return to the service area, but their life or function is not in severe jeopardy.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006; 84 FR 25674, June 3, 2019]

Link to an amendment published at 89 FR 30845, Apr. 23, 2024.

(a) Basic requirement. A PACE organization must meet the following requirements:

(1) Establish an interdisciplinary team, composed of members that fill the roles described in paragraph (b) of this section, at each PACE center to comprehensively assess and meet the individual needs of each participant.

(2) Assign each participant to an interdisciplinary team functioning at the PACE center that the participant attends.

(b) Composition of interdisciplinary team. The interdisciplinary team must be composed of members qualified to fill, at minimum, the following roles, in accordance with CMS guidelines. One individual may fill two separate roles on the interdisciplinary team where the individual meets applicable state licensure requirements and is qualified to fill the two roles and able to provide appropriate care to meet the needs of participants.

(1) Primary care provider.

(2) Registered nurse.

(3) Master's-level social worker.

(4) Physical therapist.

(5) Occupational therapist.

(6) Recreational therapist or activity coordinator.

(7) Dietitian.

(8) PACE center manager.

(9) Home care coordinator.

(10) Personal care attendant or his or her representative.

(11) Driver or his or her representative.

(c) Primary care provider. (1) Primary medical care must be furnished to a participant by any of the following:

(i) A primary care physician.

(ii) A community-based physician.

(iii) A physician assistant who is licensed in the State and practices within his or her scope of practice as defined by State laws with regard to oversight, practice authority and prescriptive authority.

(iv) A nurse practitioner who is licensed in the State and practices within his or her scope of practice as defined by State laws with regard to oversight, practice authority and prescriptive authority.

(2) Each primary care provider is responsible for the following:

(i) Managing a participant's medical situations.

(ii) Overseeing a participant's use of medical specialists and inpatient care.

(d) Responsibilities of interdisciplinary team. (1) The interdisciplinary team is responsible for the following:

(i) The initial assessment, periodic reassessments, plan of care, and coordination of 24-hour care delivery.

(ii) Documenting all recommendations for care or services and the reason(s) for not approving or providing recommended care or services, if applicable, in accordance with § 460.210(b).

(2) Each team member is responsible for the following:

(i) Regularly informing the interdisciplinary team of the medical, functional, and psychosocial condition of each participant.

(ii) Remaining alert to pertinent input from any individual with direct knowledge of or contact with the participant, including the following:

(A) Other team members.

(B) Participants.

(C) Caregivers.

(D) Employees.

(E) Contractors.

(F) Specialists.

(G) Designated representatives.

(iii) Documenting changes of a participant's condition in the participant's medical record consistent with documentation polices established by the medical director.

(e) Team member qualifications. The PACE organization must ensure that all members of the interdisciplinary team have appropriate licenses or certifications under State law, act within the scope of practice as defined by State laws, and meet the requirements set forth in § 460.71.

(f) Exchange of information between team members. The PACE organization must establish, implement, and maintain documented internal procedures governing the exchange of information between team members, contractors, and participants and their caregivers consistent with the requirements for confidentiality in § 460.200(e).

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61506, Oct. 1, 2002; 71 FR 71334, 71336, Dec. 8, 2006; 84 FR 25674, June 3, 2019; 86 FR 6132, Jan. 21, 2021]

Link to an amendment published at 89 FR 30845, Apr. 23, 2024.

(a) Initial comprehensive assessment—(1) Basic requirement. The interdisciplinary team must conduct an initial in-person comprehensive assessment on each participant. The assessment must be completed in a timely manner in order to meet the requirements in paragraph (b) of this section.

(2) Members present. As part of the initial comprehensive assessment, each of the following members of the interdisciplinary team must evaluate the participant in person and develop a discipline-specific assessment of the participant's health and social status:

(i) Primary care provider

(ii) Registered nurse.

(iii) Master's-level social worker.

(iv) Physical therapist.

(v) Occupational therapist.

(vi) Recreational therapist or activity coordinator.

(vii) Dietitian.

(viii) Home care coordinator.

(3) Additional professional disciplines. At the recommendation of the interdisciplinary team, other professional disciplines (for example, speech-language pathology, dentistry, or audiology) may be included in the initial comprehensive assessment process.

(4) Initial comprehensive assessment criteria. The initial in-person comprehensive assessment must at a minimum include the evaluation of:

(i) Physical and cognitive function and ability.

(ii) Medication use.

(iii) Participant and caregiver preferences for care.

(iv) Socialization and availability of family support.

(v) Current health status and treatment needs.

(vi) Nutritional status.

(vii) Home environment, including home access and egress.

(viii) Participant behavior.

(ix) Psychosocial status.

(x) Medical and dental status.

(xi) Participant language.

(b) Development of plan of care. Within 30 days of the date of enrollment, the interdisciplinary team must consolidate discipline-specific assessments into a single plan of care for each participant through team discussions and consensus of the entire interdisciplinary team. In developing the plan of care:

(1) If the interdisciplinary team determines that certain services are not necessary to the care of a participant, the reasoning behind this determination must be documented in the plan of care.

(2) Female participants must be informed that they are entitled to choose a qualified specialist for women's health services from the PACE organization's network to furnish routine or preventive women's health services.

(c) Semi-annual reassessment. On at least a semi-annual basis, or more often if a participant's condition dictates, the following members of the interdisciplinary team must conduct an in-person reassessment:

(1) Primary care provider.

(2) Registered nurse.

(3) Master's-level social worker.

(4) Other team members that the primary care provider, registered nurse and Master's-level social worker determine are actively involved in the development or implementation of the participant's plan of care.

(d) Unscheduled reassessments. In addition to semi-annual reassessments, unscheduled reassessments may be required based on the following:

(1) A change in participant status. If the health or psychosocial status of a participant changes, the members of the interdisciplinary team listed in paragraph (c) of this section must conduct an in-person reassessment.

(2) In response to a service determination request. In accordance with § 460.121(h), the PACE organization must conduct an in-person reassessment if it expects to deny or partially deny a service determination request, and may conduct reassessments as determined necessary for approved services.

(e) Changes to plan of care. Team members who conduct a reassessment must meet the following requirements:

(1) Reevaluate the participant's plan of care.

(2) Discuss any changes in the plan with the interdisciplinary team.

(3) Obtain approval of the revised plan from the interdisciplinary team and the participant (or designated representative).

(4) Furnish any services included in the revised plan of care as a result of a reassessment to the participant as expeditiously as the participant's health condition requires.

(f) Documentation. Interdisciplinary team members must document all assessment and reassessment information in the participant's medical record.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71336, Dec. 8, 2006; 84 FR 25674, June 3, 2019; 86 FR 6132, Jan. 19, 2021]

Link to an amendment published at 89 FR 30845, Apr. 23, 2024.

(a) Basic requirement. Within 30 days of the date of enrollment, the interdisciplinary team members specified in § 460.104(a)(2) must develop a comprehensive plan of care for each participant based on the initial comprehensive assessment findings.

(b) Content of plan of care. The plan of care must meet the following requirements:

(1) Specify the care needed to meet the participant's medical, physical, emotional, and social needs, as identified in the initial comprehensive assessment.

(2) Identify measurable outcomes to be achieved.

(3) Utilize the most appropriate interventions for each care need that advances the participant toward a measurable goal and outcome.

(4) Identify each intervention and how it will be implemented.

(5) Identify how each intervention will be evaluated to determine progress in reaching specified goals and desired outcomes.

(c) Implementation of the plan of care. (1) The team must implement, coordinate, and monitor the plan of care whether the services are furnished by PACE employees or contractors.

(2) The team must continuously monitor the participant's health and psychosocial status, as well as the effectiveness of the plan of care, through the provision of services, informal observation, input from participants or caregivers, and communications among members of the interdisciplinary team and other providers.

(d) Evaluation of plan of care. On at least a semi-annual basis, the interdisciplinary team must reevaluate the plan of care, including defined outcomes, and make changes as necessary.

(e) Participant and caregiver involvement in plan of care. The team must develop, review, and reevaluate the plan of care in collaboration with the participant or caregiver, or both, to ensure that there is agreement with the plan of care and that the participant's concerns are addressed.

(f) Documentation. The team must document the plan of care, and any changes made to it, in the participant's medical record.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25675, June 3, 2019]