APPLICATION REQUIREMENTS (§ 460.12)

• This amendment adds time-frames for submission to current provisions requiring applicants to submit a complete application in the form and manner specified by CMS. Additionally, the rule now requires that applicants submit an application to qualify as a Part D sponsor in the form and manner required by CMS.

Myers and Stauffer insight(s): States should consider establishment and implementation of processes to evaluate the quality and timeliness of application-required submissions, including compliance with application instructions for Attestations and Document Uploads (e.g., Readme files detailing which files to group and which to individually upload, document upload naming conventions).

CMS EVALUATION OF APPLICATIONS (§ 460.18)

• This provision permits the use of information from a current or prior PACE program agreement. It describes conditions under which CMS may deny an application, including, but not limited to, failure to comply with the requirements of the PACE program and termination or non-renewal of a PACE program agreement. It also provides that CMS may also deny an application if the applicant’s parent organization or another subsidiary of the parent organization meets the criteria for denial.

Myers and Stauffer insight(s): States should consider incorporating past performance, as described in the new regulation, into its procurement process to safeguard against quality issues and potential compliance concerns. Additionally, using past performance will facilitate CMS application approval. Ultimately, both CMS and states want to establish an environment for a PACE organization to provide high-quality, comprehensive medical, health, and social services that meet the needs of its participants. In doing so, all information from the applicant’s parent organization or another subsidiary of the parent organization should be considered.

ISSUANCE OF COMPLIANCE ACTIONS FOR FAILURE TO COMPLY WITH THE TERMS OF
THE PACE PROGRAM AGREEMENT (§ 460.19)

• This new rule reflects that CMS may take compliance actions if it determines that the PACE organization has not complied with the terms of a current or prior PACE program agreement with CMS and a state administering (SAA) agency, describes compliance actions, and CMS’ decision making process for those actions. Among the circumstances considered is the history of prior offenses by the PACE organization or its related entities.

Myers and Stauffer insight(s): States should consider establishment and implementation of processes to monitor PACE organization and related entities’ compliance with the terms of the PACE program agreement; this should not only serve to facilitate quality care, but also may avoid system failures that could lead to access issues, or media events that presents a potential or actual harmful characterization of a PACE organization, the PACE model of care, or the state.

NOTICE OF CMS DETERMINATION (§ 460.20)

• This amendment reflects that an application is incomplete if it does not include the state assurances documentation. If, upon submission, the application is determined to be incomplete, CMS will withdraw it and notify the applicant accordingly; the applicant is not entitled to a fair hearing when CMS withdraws an incomplete application on this basis.

Myers and Stauffer insight(s): States should consider establishment and implementation of processes to conduct quality review of the state assurances document with focus on areas frequently the subject of Requests for Additional Information and monitor applicant submission time-frames to avoid application withdrawal and resubmission.

PERSONNEL MEDICAL CLEARANCE (§§ 460.64 & 460.71)

Personnel qualifications for staff with direct participant contact (§ 460.64)

• Amended to require that staff (employee and contractors) must be cleared for communicable diseases based on a physical examination performed by a licensed physician, nurse practitioner, or physician assistant acting within the scope of their authority to practice.
• As an alternative, the PACE organization must conduct an individual risk assessment that meets specified conditions, the results of which indicate that the individual does not require a physical examination for medical clearance.
• Added the requirement that staff must have all immunizations up to date before engaging in direct participant contact [this provision currently resides in § 460.64(a)(5) with medical clearance].

Myers and Stauffer insight(s): States should consider exercising compliance with these requirements during periodic oversight activities.

OVERSIGHT OF DIRECT PARTICIPANT CARE (§ 460.71)

• Amended to be consistent with § 460.64.

Myers and Stauffer insight(s): States should consider exercising compliance with these requirements during periodic oversight activities.

SERVICE DELIVERY (§ 460.98)

• Amendments include the establishment of time-frames for the PACE organization to arrange and schedule approved, ordered, or authorized services, including medications. Medications must be scheduled within 24 hours of the order/authorization of the medication. Other services (non-medications) must be arranged/scheduled within seven calendar days of the order/authorization. Excludes routine or preventative services from the seven-day time-frame requirement under specified circumstances.

INTERDISCIPLINARY TEAM (§ 460.102)

• Amended to clarify the responsibilities of the interdisciplinary team (IDT), including assessments, plan of care, and coordination, implementation of 24-hour care delivery, consideration and documentation of recommended services.
• The coordination of care provisions articulate that the IDT is responsible to ensure that care is implemented as it was ordered, approved, or authorized by the IDT across all care settings (e.g., participants residing in Skilled Nursing Facilities).
• The documentation of recommend services provisions require documentation of all recommendations for care or services and the reason(s) for not approving or providing recommended care or services, if applicable.
• The consideration of recommended services provisions require that the appropriate member(s) of the IDT review all recommendations from hospitals, emergency departments, and urgent care providers and determine whether 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. All recommendations from other employees and contractors must be considered no later than seven calendar days from the date the recommendation was made.

Myers and Stauffer insight(s): States should consider exercising compliance with of these requirements during periodic oversight activities.

PARTICIPANT ASSESSMENTS (§ 460.104)

• Amended to reflect that, when the IDT conducts semiannual or unscheduled reassessments, it must reevaluate and, if necessary, revise the plan of care following the completion of all required assessments.

Myers and Stauffer insight(s): States should consider exercising compliance with of these requirements during periodic oversight activities.

PLAN OF CARE (§ 460.106)

• Amended to define change in participant status, significantly expands the basic and care plan content requirements, add time-frames for developing, evaluating, and revising plan of care following semi-annual and change of status assessments. Thirteen criteria were added as the minimum content a care plan must address, including the participant’s ability to live safely in the community and the safety of their home environment.

Myers and Stauffer insight(s): States should consider exercising compliance with of these requirements during periodic oversight activities.

SPECIFIC RIGHTS TO WHICH A PARTICIPANT IS ENTITLED (§ 460.112)

• Amended to add participant rights, including the right to appropriate and timely treatment – specifically, to receive all care and services needed to improve or maintain the participant’s health condition and attain the highest practicable physical, emotional, and social well-being and to access emergency health care services when and where the need arises without prior authorization by the PACE interdisciplinary team.
• Information disclosure requirements were significantly amended to reflect that each PACE participant and her/his designated representative has the right to be fully informed, in writing, before the PACE organization implements palliative care, comfort care, or end-of-life care services.
• Additional information disclosure-related amendments include participants’ right to:
  – A description of the PACE organization’s palliative care, comfort care, and end-of-life care services (as applicable) and how they differ from the care the participant is currently receiving.
  – Be advised of whether palliative care, comfort care, or end-of-life care services (as applicable) is provided in addition to or in lieu of the care the participant is currently receiving.
  – Identification of all services that are impacted and provide a detailed explanation of how the services will be impacted if the participant or designated representative elects to initiate palliative care, comfort care, or end-of-life care.

Myers and Stauffer insight(s): States should consider exercising compliance with of these requirements during periodic oversight activities.

RESOLUTION OF COMPLAINTS IN THE COMPLAINTS TRACKING MODULE (§ 460.119)

• This new section requires PACE organizations to comply with requirements related to responding to complaints in the CMS complaints tracking module.

Myers and Stauffer insight(s): States should consider exercising compliance with these requirements during periodic oversight activities.

GRIEVANCE PROCESS (§ 460.120)

• Revised to add grievance procedures including prompt identification, documentation, investigation, grievance resolution, and notification time-frames; expands the definition to reflect that a grievance is a grievance, regardless of whether remedial action is requested; clarifies that grievances may be between participants and the PACE organization or any other entity or individual through which the PACE organization provides services to the participant.
• Amended by adding caregivers to the current list of individuals (participants, their family members, or representatives) that can submit a grievance.
• Clarifies that a grievance can be submitted either verbally or in writing and prohibits the PACE organization from requiring a written grievance to be submitted on a specific form. Includes ensuring Medicare participants have access to the quality improvement organization.

Myers and Stauffer insight(s): States should consider establishment and implementation of processes to assess the quality and timeliness of grievance processing.

SERVICE DETERMINATION PROCESS (§ 460.121)

• Clarifies that requests to initiate, modify, or continue a service do not constitute a service determination request if the request is made prior to completing the development of the initial plan of care; while not processed as service determinations requests, the IDT must document the request, discuss the request during the care planning meeting, and either approve the requested service and incorporate it into the participant’s initial plan of care or document the rationale for not approving the service in the initial plan of care.

Myers and Stauffer insight(s):States should consider exercising compliance with these requirements during periodic oversight activities.

CORRECTIVE ACTION (§ 460.194)

• This provision is amended to specify that, at their discretion, CMS or the SAA may monitor the effectiveness of corrective actions.

Myers and Stauffer insight(s):States should consider exercising compliance with these requirements during periodic oversight activities.

DISCLOSURE OF COMPLIANCE DEFICIENCIES (§ 460.198)

Amended to add that CMS may require a PACE organization to disclose to its PACE participants or potential PACE participants the PACE organization’s performance and contract compliance deficiencies in a manner specified by CMS.

Myers and Stauffer insight(s): States should develop policies and procedures that address the state’s requirements for disclosure of compliance deficiencies to the state and participants consistent with those required for managed care organizations within the state.

PARTICIPANT HEALTH OUTCOMES DATA (§ 460.202)

Amended to eliminate reference to the program agreement for participant health outcomes data. The health outcomes data (quality data) is updated through the Paperwork Reduction Act.