Programs of All-Inclusive Care for the Elderly (PACE)

Table of Contents

(Rev. 2, Issued: 06-09-11)

Transmittals for Chapter 6

10 - Basic Rule

20 - No Co-payments/Deductibles/Fee-for-Service Limits on Medicare or Medicaid Services

30 - Emergency Care

40 - Urgently Needed and Post Stabilization Care

50 - Service Delivery

50.1 - Primary Care

50.2 - Meal Requirements

50.3 - Sanitary Conditions

50.4 -Transportation Services

50.5 - Safety, Accessibility, and Equipment

50.6 - Maintenance of Vehicles

50.7 - Communication with PACE Center

50.8 - Training

60 - Required Services for Medicare Participant

70 - Excluded Services

10 - Basic Rule

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

The PACE benefit package is required to include for all participants, regardless of source of payment, all Medicare covered services, all Medicaid covered services as specified in the State's approved Medicaid plan, and any other services determined necessary by the IDT to meet the participant's needs and which improve or maintain the participant's overall health status. IDT Assessment is the foundation for provision of participant-specific, appropriate services. See Chapter 8 for composition and description of the scope of IDT responsibilities.

The PACE organization must establish and implement a written plan to provide care that meets the needs of its participants across all care settings on a 24-hour basis each day of the year. The PACE organization must furnish comprehensive medical, health, and social services that integrate acute and long-term care. These services must be furnished at least in the PACE center, the participant's home, and inpatient facilities such as acute and long term care hospitals and nursing/rehabilitation facilities. The PACE organization must not discriminate against any participant in the delivery of required PACE services based on race, ethnicity, national origin, religion, sex, age, sexual orientation, mental or physical disability, or source of payment.

[42 CFR §§ 460.92, 460.98(a) and (b)]

20 - No Co-payments/Deductibles/Fee-for-Service Limits on Medicare or Medicaid Services

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

If a Medicare beneficiary or Medicaid recipient chooses to enroll in a PACE program, Medicare and Medicaid benefit limitations and conditions relating to amount, duration, scope of services, deductibles, copayments, coinsurance, or other cost-sharing do not apply. The amount, duration and scope of services provided to PACE participants are participant-specific and are specified by the IDT in the plan of care. The scope of benefits under PACE includes any other item or service determined necessary by the IDT to improve and maintain the participant's overall health status.

Under Sections 1894(a) and 1934(a) of the Act, PACE participants must receive Medicare and Medicaid benefits solely through the PACE organization. PACE organizations are required to provide enrollees with all medically necessary services, including drugs, without any limitation or condition as to the amount, duration, or scope. The PACE benefit includes all outpatient prescription drugs, as well as over-the-counter medications indicated by the participant's care plan. PACE programs cannot charge deductibles, copayments, coinsurance or other cost-sharing for medications.

The PACE organization may contract with other providers for specialty medical or other services to meet participant needs. The PACE organization must maintain primary responsibility and accountability for participant care in all settings and for all provided

services. Refer to Chapter 9 for a description of PACE organization oversight requirements for all services.

[42 CFR § 460.90; 71 FR 71248 and 71280 (Dec. 8, 2006)]

30 - Emergency Care

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

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. 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 serious jeopardy to health of the participant, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part.

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

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. The written plan also must provide for an on-call provider to be 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.

[42 CFR §§ 460.100(a), (b), (c), (d), and (e)(1)]

40 - Urgently Needed and Post Stabilization Care

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

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 functioning is not in severe jeopardy. 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 of the service area.

The PACE organization must establish and maintain a written plan which provides for coverage of urgently needed out-of-network and post-stabilization care services when either of the following conditions is met:

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

An on-call provider must be 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.

Periodic education of participants is necessary to ensure they and their caretakers can distinguish between urgent and emergent care needs, and to emphasize that PACE authorization is never required before seeking emergency care. The PACE organization needs to educate its participants in the difference between emergency care (where prior authorization is not required), and urgent care (where prior authorization is appropriate). Participants need to understand when to request prior authorization and when to request urgent care.

[42 CFR §§ 460.100(e)(2) and (3); 71 FR 71284 and 71297 (Dec. 8, 2006)]

50 - Service Delivery

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

The PACE organization must operate at least one PACE center either in or contiguous to its designated service area with sufficient capacity for routine attendance by its participants.

The PACE organization must ensure accessible and adequate services to meet the needs of all its participants. When necessary, the organization must increase the number of centers, staff, and other PACE services.

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.

The frequency of a participant's attendance at the center is determined by the IDT based on the needs and preferences of each participant.

At a minimum the following services must be furnished by each PACE center:

1. Primary care services including physician and nursing services;
2. Social work services;
3. Restorative therapies, including physical therapy, occupational therapy;
4. Personal care and supportive services;
5. Nutritional counseling;
6. Recreational therapy;
7. Meals.

These services and others are described in detail below, however, if there is a service a participant needs, that service will be required. For a comprehensive list of possible required services, refer to 42 CFR § 460.92, 66 FR 66286-66287.

[42 CFR §§ 460.98(c), (d), and (e)]

50.1 -Primary Care

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

Primary medical care must be furnished to a participant by a PACE primary care physician. Each primary care physician is responsible for managing a participant's medical situation and for overseeing a participant's use of medical specialists and inpatient care. Other primary care services provided by physicians and/or nurses include:

1. Medical and medication history, assessment, diagnosis, treatment, education and team care planning by a primary care physician;
2. Management of a participant's medical condition;
3. Referral to and oversight of specialists;
4. Oversight of inpatient care;
5. Informing female participants about their right to select a qualified specialist for women's health services;

[42 CFR §§ 460.102(c), 460.104(b)]

50.2 - Meal Requirements

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

Except when a participant has a problem and must receive substitute foods or nutritional supplements or needs nutrition support (as discussed below) 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/medical and special dietary needs. Meals should be procured, prepared and provided by appropriately trained/certified/experienced food service staff (i.e., qualified by training/certification in food safety and sanitation). Each meal must meet the following requirements:

1. Be prepared by methods that conserve nutritive value, flavor, and appearance;
2. Be prepared in a form designed to meet individual needs; and
3. Be prepared and served at the proper temperature.

The PACE organization must provide substitute foods or nutrition supplements that meet the daily nutritional and special dietary needs of any participant who has any of the following problems:

1. Refuses the food served;
2. Cannot tolerate the food served;
3. Does not consume adequate calories and nutrients appropriate in meeting the individual's estimated nutritional needs determined at the initial and interim assessments.

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.

[42 CFR §§ 460.64(a)(1), 460.78(a)]

50.3 - Sanitary Conditions

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

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/safe conditions;

3. Dispose of garbage and refuse properly.

Should Nutrition Services be contracted outside of the PACE organization, the contractor must be able to show appropriate/current state and/or local certification demonstrating adequate food preparation facilities, transportation and have staff with training and experience able to provide safe, nourishing, palatable, well-balanced meals that meet national standards for the population being served.

[42 CFR §§ 460.70, 460.78(b)]

50.4 - Transportation Services

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

Transportation must be provided as indicated in a participant's plan of care. As part of the IDT process, PACE organization staff (employees and contractors) must communicate relevant changes in a participant's care plan to transportation personnel. The IDT must have a process in place to get input from the transportation personnel regarding status and changes noted in participant condition.

[42 CFR §§ 460.76(e), 460.92(i), 460.102(e)]

50.5 - Safety, Accessibility, and Equipment

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

A PACE organization's transportation services must be safe, accessible, and equipped to meet the needs of the participant population.

[42 CFR § 460.76(a)]

50.6 - Maintenance of Vehicles

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

If the PACE organization owns, rents, or leases transportation vehicles, it must maintain these vehicles in accordance with the manufacturer's recommendations.

If a contractor provides transportation services, the PACE organization must ensure that the vehicles are maintained in accordance with the manufacturer's recommendations.

[42 CFR § 460.76(b)]

50.7 - Communication with PACE Center

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

The PACE organization must ensure that transportation vehicles are equipped to communicate with the PACE center.

50.8 - Training

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

The PACE organization must train all transportation personnel (employees and contractors) in the following:

1. Managing the special needs of participants;
2. How to, and types of issues to communicate to the PACE center staff about participants;
3. Handling emergency situations;
4. Transportation workers are considered direct care workers. All health requirements and background checks must be assured by human resources or contractor oversight staff.

[42 CFR §§ 460.64, 460.71(b), 460.76(d), 460.102(e)]

60 - Required Services for Medicare Participants

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

The PACE benefit package for Medicare participants must include, in addition to the service required by 42 CFR § 460.92, the scope of hospital insurance benefits described in 42 CFR Part 409 and the scope of supplemental medical insurance benefits described in 42 CFR Part 410. In addition, some requirements of Title XVIII of the Act are waived and do not apply to services under the PACE program, which include:

1. The provisions of subpart F of Part 409 of 42 CFR that limit coverage of institutional services;
2. The provisions of subparts G and H of 42 CFR Part 409 and Parts 412 through 414 that relate to rules for payment for benefits;
3. The provisions of subparts D and E of 42 CFR Part 409 that limit coverage of extended care services or home health services;
4. The provisions of subpart D of 42 CFR Part 409 that impose a 3-day prior hospitalization requirement for coverage of extended care services; and
5. The provisions of 42 CFR § 411.15(g) and (k) that may prevent payment for PACE program services to individuals enrolled in the PACE program.

[42 CFR § 460.94]

70 - Excluded Services

(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)

The services that are excluded from coverage under the PACE program are as follows:

1. • Any service that is not authorized by the IDT, even if it is listed as a required service, unless it is an emergency service;
2. • Services rendered in a non-emergency setting or for a non-emergency reason without authorization;
3. • Prescription and over-the-counter drugs not prescribed by the PACE provider physician;
4. • For services in inpatient facilities, private room and private duty nursing services, (unless medically necessary) and non-medical items for personal convenience such as telephone charges, radio or television rental, (unless specifically authorized by the IDT as part of a participant's plan of care);
5. • Cosmetic surgery, which does not include surgery required for improved functioning of a malformed part of the body resulting from an accidental injury or for reconstruction following mastectomy;
6. • Experimental medical, surgical or other health procedures.

PACE will not cover services rendered outside the United States, except as may be permitted in accordance with 42 CFR § 424.122 regarding conditions for payment for emergency inpatient hospital services and 42 CFR § 424.124 regarding conditions for payment for physician services and ambulance services or as may be permitted under the State’s approved Medicaid Plan. There are limited exceptions to this rule. For example, a State that borders another country might include some Medicaid coverage across the border, and Medicare covers some emergency hospital, ambulance, and physician services outside the United States. (As defined in 42 CFR § 400.200, the United States includes the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands).

[42 CFR § 460.96; 71 FR 71282 (Dec. 8, 2006)]

Transmittals Issued for this Chapter

Rev #	Issue Date	Subject	Impl Date	CR#
R2PACE	06/09/2011	Initial Publication of Manual	06/03/2011	NA
R1_SO	06/03/2011	Initial Publication of Manual - Rescinded and replaced by Transmittal 2	06/03/2011	NA

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