2023-07115.pdf

for which CMS may impose sanctions. * * * * * (b) If CMS or the State administering agency 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. 58. Section 460.70 is amended by revising paragraph (a) to read as follows:  460.70 Contracted services. (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, including, at a minimum, the medical specialties identified in paragraph (a)(1) of this section. The PACE organization does not need to have a written contract with entities that provide emergency services as described in  460.100. (1) At a minimum, except as noted in paragraph (a)(4) of this section, PACE organizations must have contracts in place for the following medical specialties: (i) Anesthesiology. (ii) Audiology. (iii) Cardiology. (iv) Dentistry. (v) Dermatology. (vi) Gastroenterology. (vii) Gynecology. (viii) Internal Medicine. (ix) Nephrology. (x) Neurosurgery. (xi) Oncology. (xii) Ophthalmology. (xiii) Oral surgery. (xiv) Orthopedic surgery. (xv) Otorhinolaryngology. (xvi) Palliative Medicine. (xvii) Plastic surgery. (xviii) Pharmacy consulting services. (xviv) Podiatry. (xx) Psychiatry. (xxi) Pulmonology. (xxii) Radiology. (xxiii) Rheumatology. (xxiv) General Surgery. (xxv) Thoracic and vascular surgery. (xxvi) Urology. (2) Contracts with medical specialists must be executed prior to enrollment of participants and must be maintained on an ongoing basis to ensure participants receive appropriate and timely access to all medically necessary care and services. (3) A 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 (i) Ensure care and services that would otherwise be provided to participants by a contracted specialist are provided and that the participants needs are met through a different mechanism to include hospitalization; and (ii) Promptly report the contracting issue to CMS and the SAA, including the attempts made to contract, the reason why the contract was not effectuated, and the PACE organizations plan to provide access to the necessary services. (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. * * * * *  460.121 [Amended] 59. Section 460.121 is amended in paragraph (i)(2) by adding the phrase either orally or after the phrase their designated representative. 60. Section 460.200 is amended by revising paragraph (d)(2) to read as follows:  460.200 Maintenance of records and reporting of data. * * * * * (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 participants care, health, or safety including, but not limited to the following: (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 participants, care, health, or safety. (ii) Communications from an advocacy or governmental agency such as Adult Protective Services. * * * * * 61. Section 460.210 is amended by revising paragraph (b)(6) to read as follows:  460.210 Medical records. * * * * * (b) * * * (6) Original documentation, or an unaltered electronic copy, of any written communication as described in  460.200(d)(2) must be maintained in the participants medical record unless the following requirements are met: (i) The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication, (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  460.200(e), and (iii) Original documentation of the communication is available to CMS and the SAA upon request. * * * * * Dated: March 31, 2023 Xavier Becerra, Secretary, Department of Health and Human. [FR Doc. 202307115 Filed 4523; 4:15 pm] BILLING CODE 412001P VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00227 Fmt 4701 Sfmt 9990 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES2