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.

(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.

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.

(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 shall not discriminate against any participant in the delivery of required PACE services based on race, ethnicity, national origin, religion, sex (including sex characteristics, including intersex traits; pregnancy or related conditions; sexual orientation; gender identity; and sex stereotypes), age, mental or physical disability, or source of payment.

(4) 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) Timeframes for arranging and providing services—(1) Medications. The PACE organization must arrange and schedule the dispensing of medications as expeditiously as the participant's condition requires, but no later than 24 hours after a primary care provider orders the medication.

(2) All other services. The PACE organization must arrange or schedule the delivery of interdisciplinary team approved services, other than medications, as identified in paragraph (c)(2)(i) of this section, as expeditiously as the participant's health condition requires, but no later than 7 calendar days after the date the interdisciplinary team or member of the interdisciplinary team first approves the service, except as identified in paragraph (c)(3) of this section.

(i) Interdisciplinary team approved services include:

(A) Services approved by the full interdisciplinary team.

(B) Services approved by a member of the interdisciplinary team.

(C) Services ordered by a member of the interdisciplinary team.

(D) Care planned services.

(ii) [Reserved]

(3) Routine or preventative services. Routine or preventive services are excluded from the requirement in paragraph (c)(2) of this section when all of the following requirements are met:

(i) The PACE organization documents that they were unable to schedule the appointment due to circumstances beyond the control of the PACE organization.

(ii) The participant does not have a change in status that requires the service to be provided more quickly.

(iii) The PACE organization provides the service as expeditiously as the participant's condition requires.

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

(d) 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.

(e) 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.

(f) 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.

(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.

(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 for each participant:

(i) Assessments and plan of care. The initial assessment, periodic reassessments, and plan of care.

(ii) Coordination of care. Coordination and implementation of 24-hour care delivery that meets participant needs across all care settings, including but not limited to the following:

(A) Ordering, approving, or authorizing all necessary care.

(B) Communicating all necessary care and relevant instructions for care.

(C) Ensuring care is implemented as it was ordered, approved, or authorized by the IDT.

(D) Monitoring and evaluating the participant's condition to ensure that the care provided is effective and meets the participant's needs.

(E) Promptly modifying care when the IDT determines the participant's needs are not met in order to provide safe, appropriate, and effective care to the participant.

(iii) Documenting recommended services. 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).

(iv) Consideration of recommended services. The interdisciplinary team must review, assess, and act on recommendations from emergency or urgent care providers, employees, and contractors, including medical specialists. Specifically, the interdisciplinary team must ensure the following requirements are met:

(A) The appropriate member(s) of the interdisciplinary team must review all recommendations from hospitals, emergency departments, and urgent care providers and determine if the recommended services are necessary to meet the participant's medical, physical, social, or emotional needs as expeditiously as the participant's health condition requires, but no later than 48 hours from the time of the participant's discharge.

(B) The appropriate member(s) of the interdisciplinary team must review all recommendations from other employees and contractors and determine if the recommended services are necessary to meet the participant's medical, physical, social, or emotional needs as expeditiously as the participant's health condition requires, but no later than 7 calendar days from the date the recommendation was made.

(C) If recommendations are authorized or approved by the interdisciplinary team or a member of the interdisciplinary team, the services must be promptly arranged and furnished under § 460.98(c).

(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).

(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. When the interdisciplinary team conducts semiannual or unscheduled reassessments, the interdisciplinary team must reevaluate and, if necessary, revise the plan of care in accordance with § 460.106(c) following the completion of all required assessments.

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

(a) Definition and basic requirements—(1) Definition. For purposes of this section, a “change in participant's status” means a major decline or improvement in a participant's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the participant's health status and requires interdisciplinary team review or revision of the care plan, or both.

(2) Basic requirements. (i) The interdisciplinary team members specified in § 460.102(b) must develop, evaluate, and if necessary, revise a comprehensive person-centered plan of care for each participant.

(ii) Each plan of care must do all of the following:

(A) Take into consideration the most current assessment findings.

(B) Identify the services to be furnished to attain or maintain the participant's highest practicable level of well-being.

(b) Timeframes for developing, evaluating, and revising plan of care. (1) Initial plan of care. The interdisciplinary team must complete the initial plan of care within 30 calendar days of the participant's date of enrollment.

(2) Semi-annual plan of care evaluation. At least once every 180 calendar days from the date the latest plan of care was finalized the interdisciplinary team must complete a reevaluation of, and if necessary, revisions to each participant's plan of care.

(3) Change in participant's status. (i) Except as specified in paragraph (b)(3)(ii) of this section, the interdisciplinary team must complete a re-evaluation of, and if necessary, revisions to a participant's plan of care within 14 calendar days after the PACE organization determines, or should have determined, that there has been a change in the participant's health or psychosocial status, or more expeditiously if the participant's condition requires.

(ii) If a participant is hospitalized within 14 calendar days of the change in participant status, the interdisciplinary team must complete a reevaluation of, and if necessary, revisions to the plan of care as expeditiously as the participant's condition requires but no later than 14 calendar days after the date of discharge from the hospital.

(c) Content of plan of care. At a minimum, each plan of care must meet the following requirements:

(1) Identify all of the participant's current medical, physical, emotional, and social needs, including all needs associated with chronic diseases, behavioral disorders, and psychiatric disorders that require treatment or routine monitoring. At a minimum, the care plan must address the following factors:

(i) Vision.

(ii) Hearing.

(iii) Dentition.

(iv) Skin integrity.

(v) Mobility.

(vi) Physical functioning, including activities of daily living.

(vii) Pain management.

(viii) Nutrition, including access to meals that meet the participant's daily nutritional and special dietary needs.

(ix) The participant's ability to live safely in the community, including the safety of their home environment.

(x) Home care.

(xi) Center attendance.

(xii) Transportation.

(xiii) Communication, including any identified language barriers.

(2)(i) Identify each intervention (the care and services) needed to meet each medical, physical, emotional, and social needs.

(ii) It does not have to identify the medications needed to meet the participant's needs if a comprehensive list of medications is already documented elsewhere in the medical record.

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

(4) Identify how each intervention will be implemented, including a timeframe for implementation.

(5) Identify a measurable goal for each intervention.

(6) Identify how the goal for each intervention will be evaluated to determine whether the intervention should be continued, discontinued, or modified.

(7) The participant's preferences and goals of care.

(d) Implementation of the plan of care. The team must continuously do all of the following:

(1) Implement, coordinate, and monitor the plan of care regardless of whether the services are furnished by PACE employees or contractors, across all care settings.

(2) Evaluate and monitor the participant's medical, physical, emotional, and social needs 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 employees or contractors.

(e) Participant and caregiver involvement in plan of care. (1) The interdisciplinary team must develop, evaluate, and revise each plan of care in collaboration with the participant, the participant's caregiver, or both.

(2) The interdisciplinary team must review and discuss each plan of care with the participant or the participant's caregiver or both before the plan of care is completed to ensure that there is agreement with the plan of care and that the participant's concerns are addressed.

(f) Documentation. The team must do all of the following:

(1) Establish and implement a process to document and maintain records related to all requirements for plans of care, in the participant's medical record.

(2) Ensure that the most recent care plan is available to all employees and contractors within the organization as needed.