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

Final Rule Summary

The Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS), recently issued a Final Rule regarding the Programs of All-Inclusive Care of the Elderly (PACE). These regulations are effective on June 5, 2023 and are applicable to coverage beginning January 1, 2024. A summary follows, however, the full text of the final rule can be found in the Federal Register, Vol. 88, No. 70, April 12, 2023 (https://www.federalregister.gov/documents/2023/04/12/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program).

42 CFR 460.6 Definitions

Amended by revising the definition of contract year.

Current:

Contract year means the term of a PACE program agreement, which is a calendar year, except that a PACE organization’s initial contract year may be from 12 to 23 months, as determined by CMS.

Revised:

Contract year means the term of a PACE program agreement, which is a calendar year, except that a PACE organization’s initial contract year may be 19 to 30 months, as determined by CMS, but in any event will end on December 31.

42 CFR 460.40(b) 

Amended to clarify imposition of sanctions and penalties.

Current:

(b) If CMS or the State administering agency (SAA) makes a determination that could lead to termination of a PACE program agreement under § 460.50, CMS may impose any of the sanctions specified at §§ 460.42 and 460.46.

Revised:

(b) If CMS or the SAA makes a determination under § 460.50 that could lead to termination of a PACE program agreement, CMS may impose any of the sanctions specified at §§ 460.42 and 460.46. If CMS or the State administering agency determines that the circumstances in § 460.50(b)(1) exist, neither CMS nor the State administrating agency has to determine that the circumstances in 460.50(b)(2) exist prior to imposing a CMP or enrollment and/or payment suspension.

42 CFR 460.70 Contracted Services

Amended to minimally specify 26 medical specialties with which the PACE organization must execute and maintain contracts. Adds requirements for making attempts to contract with the medical specialists specified, ensuring that care and services are provided irrespective of contract execution/maintenance status, and reporting contract execution/maintenance issues to CMS and the SAA.

Current:

(a) General rule. 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 as described in § 460.100.

Revised:

(a) General rule. 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 must include, at a minimum, the medical specialties listed in § 460.70(a)(1).

(a)(1) PACE organizations must have contracts in place, at minimum, for the following medical specialties, except as provided for in § 460.70(a)(4): Anesthesiology, Audiology, Cardiology, Dentistry, Dermatology, Gastroenterology, Gynecology, Internal Medicine, Nephrology, Neurosurgery, Oncology, Ophthalmology, Oral surgery, Orthopedic surgery, Otorhinolaryngology, Palliative Medicine, Plastic surgery, Pharmacy consulting services, Podiatry, Psychiatry, Pulmonology, Radiology, Rheumatology, General Surgery, Thoracic and vascular surgery, and Urology.

(a)(2) Contracts with medical specialists must be executed prior to enrollment of participants and must be maintained on an ongoing basis.

(a)(3) The PACE organization is responsible for making all reasonable and timely attempts to contract with medical specialists. If at any time a PACE organization is unable to directly contract or maintain a contract with a specific specialty, the PACE organization must –

(a)(3)(i) Ensure care and services that would otherwise be provided to participants by a contracted specialist are provided and that the participant’s needs are met through a different mechanism which may include hospitalization; and

(a)(3)(ii) Promptly report the contracting issue to CMS and the SAA, including the attempts made to contract, the reason why a contract was not effectuated, and the PACE organization’s plan to provide access to the necessary services.

(a)(4) A PACE organization is not required to have a contract with a particular medical specialty if the PACE organization directly employs one or more individuals prior to contracting who are legally authorized, and if applicable, board certified in the participant medical specialty.

42 CFR 460.121 Service Determination Process

 Amended to allow extension notices to be provided either orally or in writing.

Current:

(i)(2) Notice of extension. When the interdisciplinary team extends the timeframe, it must notify the participant or their designated representative in writing. The notice must explain the reason(s) for the delay and must be issued as expeditiously as the participant’s condition requires, but no later than 24 hours after the IDT decides to extend the timeframe.

Revised:

(i)(2) Notice of extension. When the interdisciplinary team extends the timeframe, it must notify the participant or their designated representative either orally or in writing. The notice must explain the reason(s) for the delay and must be issued as expeditiously as the participant’s condition requires, but no later than 24 hours after the IDT decides to extend the timeframe.

42 CFR 460.200 Maintenance of Records and Reporting of Data

Amended to allow for more administrative flexibility in how PACE organizations maintain written communications relating to the care, health, or safety of participants.

Current:

(d)***

(2) Maintain all written communications received from participants or other parties in their original form when the communications relate to a participant‘s care, health, or safety in accordance with  460.210(b)(6), Content of medical records.

Revised:

(d)***

(2) Maintain all written communications received in any format (for example, emails, faxes, letters, etc.) from participants or other parties in their original form when the communications relate to a participant’s care, health, or safety, including, but not limited to, the following:

(d)(2)(i) Communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participant’s care, health or safety.

(d)(2)(ii) Communications from an advocacy or governmental agency, such as Adult Protective Services.

42 CFR 460.210 Medical Records

Amended to remove the requirement that written communications received from participants and other parties be stored in the participant’s medical record.

Current:

(b)***

(6) Original documentation, or an unaltered electronic copy, of any written communication the PACE organization receives relating to the care, health or safety of a participant, in any format (for example, emails, faxes, letters, etc.) and including, but not limited to the following:

(6)(i) Communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participant‘s health or safety or both.

(6)(ii) Communications from an advocacy or governmental agency such as Adult Protective Services.

Revised:

(b)***

(6) Original documentation, or an unaltered electronic copy, of any written communication as described in § 42 CFR 460.200(d)(2) must be maintained in the participant’s medical record unless the following requirements are met:  

 (6)(i) The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication.

(6)(ii) Original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors of the PACE organization when necessary, and in accordance with § 42 CFR 460.200(e), and

(6)(iii) Original documentation of the communication is available to CMS and the SAA upon request.