Editorial Note on Part 460
Editorial Note: Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.

§ 460.120 Grievance process. ( a ) *Written procedures.* A PACE organization must have a formal written process to promptly identify, document, investigate, and resolve all medical and nonmedical grievances in accordance with the requirements in this part.
( b ) *Definition of grievance.* For purposes of this part, a grievance is a complaint, either oral or written, expressing dissatisfaction with service delivery or the quality of care furnished, regardless of whether remedial action is requested. 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.
( c ) *Grievance process notification to participants.* Upon enrollment, and at least annually thereafter, the PACE organization must give a participant written information on the grievance process in understandable language, including all of the following: ( 1 ) A participant or other individual specified in paragraph (d) of this section has the right to voice grievances without discrimination or reprisal, and without fear of discrimination or reprisal.
( 2 ) A Medicare participant or other individual specified in paragraph (d) of this section acting on behalf of a Medicare participant has the right to file a written complaint with the quality improvement organization (QIO) with regard to Medicare covered services.
( 3 ) The requirements under paragraphs (b) and (d) through (j) of this section.
( d ) *Who can submit a grievance.* Any of the following individuals can submit a grievance: ( 1 ) The participant.
( 2 ) The participant's family member.
( 3 ) The participant's designated representative.
( 4 ) The participant's caregiver.
( e ) *Methods for submitting a grievance.* ( 1 ) Any individual as permitted under paragraph (d) of this section may file a grievance with the PACE organization either orally or in writing.
( 2 ) The PACE organization may not require a written grievance to be submitted on a specific form.
( 3 ) A grievance may be made to any employee or contractor of the PACE organization that provides care to a participant in the participant's residence, the PACE center, or while transporting participants.
( f ) *Conducting an investigation.* The PACE organization must conduct a thorough investigation of all distinct issues within the grievance when the cause of the issue is not already known.
( g ) *Grievance resolution and notification timeframes.* The PACE organization must do all of the following: ( 1 ) Take action to resolve the grievance based on the results of its investigation as expeditiously as the case requires, but no later than 30 calendar days after the date the PACE organization receives the oral or written grievance.
( 2 ) Notify the individual who submitted the grievance of the grievance resolution as expeditiously as the case requires, but no later than 3 calendar days after the date the PACE organization resolves the grievance in accordance with paragraph (g)(1) of this section.
( h ) *Grievance resolution notification.* The PACE organization must inform the individual who submitted the grievance of the resolution as follows: ( 1 ) Either orally or in writing, based on the individual's preference for notification, except for grievances identified in paragraph (h)(3) of this section.
( 2 ) At a minimum, oral or written notification of grievance resolutions must include the following, if applicable: ( i ) A summary statement of the participant's grievance including all distinct issues.
( ii ) A summary of the pertinent findings or conclusions regarding the concerns for each distinct issue that requires investigation.
( iii ) For a grievance that requires corrective action, the corrective action(s) taken or to be taken by the PACE organization as a result of the grievance, and when the participant may expect corrective action(s) to occur.
( 3 ) All grievances related to quality of care, regardless of how the grievance is filed, must be responded to in writing. ( i ) The response must describe the right of a Medicare participant or other individual specified in paragraph (d) of this section acting on behalf of a Medicare participant to file a written complaint with the QIO with regard to Medicare covered services.
( ii ) For any complaint submitted to a QIO, the PACE organization must cooperate with the QIO in resolving the complaint.
( 4 ) The PACE organization may withhold notification of the grievance resolution if the individual who submitted the grievance specifically requests not to receive the notification, and the PACE organization has documented this request in writing. The PACE organization is still responsible for complying with all other requirements of this section.
( i ) *Continuing care during grievance process.* The PACE organization must continue to furnish all required services to the participant during the grievance process.
( j ) *Maintaining confidentiality of grievances.* The PACE organization must develop and implement procedures to maintain the confidentiality of a grievance, including protecting the identity of all individuals involved in the grievance from other employees and contractors when appropriate.
( k ) *Recordkeeping.* The PACE organization must establish and implement a process to document, track, and maintain records related to all processing requirements for grievances received both orally and in writing. These records, except for information deemed confidential as a part of paragraph (j) of this section, must be available to the interdisciplinary team to ensure that all members remain alert to pertinent participant information.
( l ) *Analyzing grievance information.* The PACE organization must aggregate and analyze the information collected under paragraph (k) of this section for purposes of its internal quality improvement program.
[89 FR 30847, Apr. 23, 2024, as amended at 89 FR 63828, Aug. 6, 2024]