CMS Pub. 100-11, ch. 9
(Rev. 2, Issued: 06-09-11)
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Each member of the PACE organization's staff who has direct participant contact (employee or contractor) must:
The PACE organization must ensure that these requirements are met and, as discussed in section 10.2, have policies and procedures regarding these requirements.
In order to maintain compliance with program integrity the PACE organization must:
[42 CFR §§ 460.64(a); 460.68(a)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In order to comply with PACE requirements, it is required that the PACE organizations have a policy and procedure in place for assuring that staff and contractors:
The policy and procedures would also demonstrate that the PACE organization has a system for updating staff competency information, and discloses, upon request, information regarding:
PACE organizations may wish to refer to credentialing guidance in the Medicare Managed Care Manual for a description of one option on which to build the policy and procedure:
(http://www.cms.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=1&sortOrder=ascending&itemID=CMS019326&intNumPerPage=10).
[42 CFR § 460.64]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must develop a competency evaluation program to ensure all employees and contracted staff providing direct care to participants can demonstrate the skills, knowledge and abilities necessary for performance of their position. 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. The competency evaluation program must be completed by each employee prior to providing direct participant care. An employee demonstrating competence for their position is essential to ensure the delivery of safe care.
All personnel, including personal care attendants, need to meet the credentialing criteria and a standardized set of competencies for their specific position prior to their engaging in direct participant care. The PACE organization's competency evaluation program must:
The PACE organization must conduct an annual competency review with their employees, including personal care attendants. The PACE organization's annual competency review program will:
[460 CFR § 460.66(a) and (c); 460.71(a)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization is required to provide training to maintain and improve the skills and knowledge of each staff member with respect to the individual's specific duties that result in his or her continued ability to demonstrate the skills necessary for the performance of the position.
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. The PACE organization must provide each employee and all contracted staff with an orientation. The orientation must include, at a minimum, the organization's mission, philosophy, policies on participant rights, emergency plan, ethics, the PACE benefit and any policies related to the job duties of specific staff.
The PACE organization must develop a training program that will:
[42 CFR §§ 460.66(a), 460.71(a)(1)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must provide a comprehensive orientation program to each employee and all contracted staff. Documentation of completion date(s) for each and every component of the orientation must be maintained in staff records. This orientation must be provided prior to personnel engaging in direct participant care. The orientation must include, at a minimum, the organization's mission, philosophy, policies on participant rights, emergency plan, ethics, the PACE benefit, and any policies related to the job duties of specific staff. Additionally, the orientation may include, but isn't limited to:
Training on medical equipment used in the PACE organization;
Medical documentation requirements.
[42 CFR § 460.71(a)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In addition to the general training program, the PACE organization must develop a training program for each directly employed and contracted PCA in order to establish the individual’s baseline competency in furnishing personal care services and specialized skills associated with the specific care needs of individual participants. The training plan must indicate how each skill is tested to determine the PCA’s initial and ongoing competency. The PACE organization must evaluate the skills of each newly hired PCA and develop a training program specific to the competencies or deficiencies that they demonstrate. PCAs must exhibit competency before performing personal care services independently. A process must be in place for monitoring ongoing competency assessments and identify the individual responsible for supervising PCAs. This training must be performed by qualified professionals. The personnel file must contain the results of any testing, both written and oral.
[42 CFR § 460.66(b) and (c)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must provide ongoing training to maintain and improve the skills and knowledge of each employee and contracted staff member with respect to their specific duties in order to ensure that PACE participants receive the highest quality care possible. A PACE organization has the ultimate responsibility for all care provided to their participants and, therefore, it is in the best interest of PACE participants and the PACE organization that they provide training specific to their participant population. Ongoing in-service training for all staff will ensure that skills remain current and any detrimental practices are caught and rectified as early as possible.
Annual training must be related to specific positions which include relevant topics. Training needs to be staggered throughout the year to enable all staff to participate. The training program needs to describe plans for in-service training, the methods of teaching including handouts, pre and post test, if applicable, and the person/position conducting the training. Some PACE organizations may have the ability to use the health care facility to which they are related or they may use an outside agency for training purposes.
OSHA training must be provided on hire and is required annually, [29 CFR 1910.1030(g)(2)] by a qualified trainer. The employee cannot be given just a manual, pamphlet or policy to read. This training must be given in an interactive session with a trainer present.
[42 CFR §§ 460.66(a); 460.71]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE regulation stipulates that the PACE organization must develop and implement an infection control plan having specific procedures to prevent, identify, investigate, and control infections. Specifically, this regulation mandates compliance with the standard precautions developed by the Center for Disease Control and Prevention (CDC). A primary standard precaution in caring for the frail elderly population is immunization of healthcare workers. The CDC strongly recommends that healthcare workers be immunized against hepatitis B virus, influenza, measles, mumps, rubella, and varicella to protect them from acquiring or transmitting these vaccine-preventable infections.
The PACE organization must also include procedures in its infection control plan to prevent healthcare workers from acquiring or transmitting tuberculosis and bloodborne pathogens. In the exposure control section of the infection control plan, the PACE organization must identify the specific job classifications that perform duties in which exposure to active tuberculosis disease or bloodborne pathogens occurs. In a typical PACE organization, most, if not all, healthcare workers deliver direct care services to participants and should be classified as at-risk for exposure to these pathogens.
Pursuant to CDC recommendations, CMS issued regulation 42 CFR § 460.64(a)(5) which states that staff having direct participant contact must be “medically cleared for communicable diseases and have all immunizations up to date before engaging in direct participant contact.” To meet this regulatory requirement, CMS expects the PACE organization to minimally take the following actions:
resistant Staphylococcus aureus (MRSA), varicella zoster (shingles), pediculosis (lice infestation), etc.) which are transmittable through close contact;
Develop and implement policies and procedures to assure appropriate healthcare worker immunization.
Additional information on CDC recommendations for immunizations of staff can be found at the following links:
Centers for Disease Control and Prevention, Immunization of Health-Care Workers: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR 1997;46(No. RR-18): http://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf.
Centers for Disease Control and Prevention, Protecting Health Care Workers: http://www.cdc.gov/ncidod/dhqp/worker.html.
Centers for Disease Control and Prevention, Influenza Vaccination of Health-Care Personnel: recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) and the Advisory Committee on Immunization Practices (ACIP): http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5502a1.htm.
Centers for Disease Control and Prevention, Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR 2005;54(No. RR-17): http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must develop a policy and procedure that provides for formal oversight activities such as periodic observation of service delivery, review of service
documentation, assurance of participation in refresher training, and review of applicable credentials.
[42 CFR § 460.71]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must have a written contract with each outside organization, agency, or individual that furnishes administrative or care-related services not furnished directly by the PACE organization except for emergency services. A current list of contractors must be on file at the PACE center and a copy must be provided to anyone upon request.
Each contract needs to be in writing and contain the following information:
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:
(2) A contractor must be accessible to participants, located either within or near the PACE organization's service area; and
(3) A PACE organization must designate an official liaison to coordinate activities between contractors and the organization.
[42 CFR §§ 460.70(a), (b), (c), and (d)(1) through (4)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In addition to the contract requirements in section 30.1 above, a contractor agreement must include the following written requirements for the contractor to adhere to:
[42 CFR § 460.70(d)(5)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Institutional providers include, but are not limited to:
Rehabilitation hospitals and distinct part rehabilitation units of acute care hospitals;
Psychiatric hospitals and distinct part psychiatric units of acute care hospitals; and
The PACE organization must contract only with institutional entities that meet all applicable Federal and State requirements as well as meet the Medicare and Medicaid participation requirements. There is provider specific Conditions of Participation for institutions that participate in the Medicare program. Therefore, all institutional contractors must be in compliance with their respective Conditions of Participation.
A practitioner or supplier must meet Medicare or Medicaid requirements applicable to the services it furnishes.
[42 CFR § 460.70]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Authorization is required for services a participant may need while temporarily absent from the PACE organization's service area that are not emergency services but cannot be delayed until the participant returns.
A PACE organization must establish a written plan for handling emergency health care needs. The plan must include that the participants and their caregiver know:
Listed below are the types of services that fall under this special rule category:
out of the PACE organization's service area and that are needed to evaluate or stabilize an emergency medical condition. Emergency services that fall within this description do not require authorization by the PACE organization. Determination of the need for emergency care is dependent on the prudent layperson standard with average knowledge of health and medicine;
[42 CFR § 460.100(b), (c), (d) and (e); 71 FR 71284 (Dec. 8, 2006)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must meet certain criteria to contract out PACE center services. The following criteria must be included:
The PACE organization retains responsibility for all participants and may only contract for the PACE center services identified in 42 CFR § 460.98(d) as described in detail in Chapter 6, which include: primary care, social services, restorative therapies, personal care and supportive services, nutritional counseling, recreational therapy, and meals.
[42 CFR § 460.70(e)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The burden of documenting contractors’ compliance with applicable standards ultimately rests with the PACE organization.
It is especially important to identify specific responsibilities of a contractor. The PACE organization must develop its own procedures to ensure that the entity complies with the standards of competency and quality of care.
The PACE organization must not contract with organizations or individuals who have been excluded from the Medicare or Medicaid programs; who have been convicted of criminal offenses related to their involvement in Medicaid, Medicare, other health insurance or health care programs, or social service programs under Title XX of the Act; or for those having participant contact, who would pose a potential risk because of prior physical, sexual, drug, or alcohol abuse conviction.
The PACE organization must contract with only those entities that meet all applicable Federal and State requirements.
All employees and contractors must meet the personnel qualifications for the physician, registered nurse, social worker, physical therapist, occupational therapist, recreational therapist, dietitian and driver.
Although the PACE organization is not performing the actual compliance checks (in the case of a hospital, physician, medical equipment, or supplies), the organization must ensure that the contractor is in compliance with the written contract. The written contract must state that the contractor will meet all applicable Federal and State requirements allowing the PACE organization some flexibility in determining the organizational process that will occur to ensure their contractors meet all program requirements.
In the case of an independent contractor or provider-based organization who provides direct participant care and has not been credentialed through a Medicare or Medicaid contracting organization, the PACE organization will have to receive the same documents from the contractor as they would for an employee. If the contractor is working for the contracted organization and not independently, then the contracted organization must forward all of their staff credentials prior to performing participant care.
The PACE organization is responsible for not only ensuring the contract staff meet requirements at the onset of the contract, but on an ongoing basis. The contract organization has to have a process in place to ensure this compliance and the PACE organization has to have a process to review contract compliance. The contract organization must have a process in place to notify the PACE organization when one of their staff is out of compliance so that the PACE organization does not utilize that staff
member for participant care (in the case of a license expiring, other sanctions, or illegal activity).
[42 CFR §§ 460.64; 460.68(a); 460.70(b)(1)]
| 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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