(a) Written bill of rights. A PACE organization must have a written participant bill of rights designed to protect and promote the rights of each participant. Those rights include, at a minimum, the ones specified in § 460.112.

(b) Explanation of rights. The organization must inform a participant upon enrollment, in writing, of his or her rights and responsibilities, and all rules and regulations governing participation.

(c) Protection of rights. The organization must protect and provide for the exercise of the participant's rights.

(a) Respect and nondiscrimination. Each participant has the right to considerate, respectful care from all PACE employees and contractors at all times and under all circumstances. Each participant has the right not to be discriminated against in the delivery of required PACE services based on race, ethnicity, national origin, religion, sex, age, sexual orientation, mental or physical disability, or source of payment. Specifically, each participant has the right to the following:

(1) To receive comprehensive health care in a safe and clean environment and in an accessible manner.

(2) To be treated with dignity and respect, be afforded privacy and confidentiality in all aspects of care, and be provided humane care.

(3) Not to be required to perform services for the PACE organization.

(4) To have reasonable access to a telephone.

(5) To be free from harm, including physical or mental abuse, neglect, corporal punishment, involuntary seclusion, excessive medication, and any physical or chemical restraint imposed for purposes of discipline or convenience and not required to treat the participant's medical symptoms.

(6) To be encouraged and assisted to exercise rights as a participant, including the Medicare and Medicaid appeals processes as well as civil and other legal rights.

(7) To be encouraged and assisted to recommend changes in policies and services to PACE staff.

(b) Information disclosure. Each PACE participant has the right to receive accurate, easily understood information and to receive assistance in making informed health care decisions. Specifically, each participant has the following rights:

(1) To be fully informed in writing of the services available from the PACE organization, including identification of all services that are delivered through contracts, rather than furnished directly by the PACE organization at the following times:

(i) Prior to and upon enrollment in the PACE organization.

(ii) At the time a participant's needs necessitate the disclosure and delivery of such information in order to allow the participant to make an informed choice.

(2) To have the enrollment agreement, described in § 460.154, fully explained in a manner understood by the participant.

(3) To examine, or upon reasonable request, to be helped to examine the results of the most recent review of the PACE organization conducted by CMS or the State administering agency and any plan of correction in effect.

(4) To contact 1-800-MEDICARE for information and assistance, including to make a complaint related to the quality of care or the delivery of a service.

(c) Choice of providers. Each participant has the right to a choice of health care providers, within the PACE organization's network, that is sufficient to ensure access to appropriate high-quality health care. Specifically, each participant has the right to the following:

(1) To choose his or her primary care physician and specialists from within the PACE network.

(2) To request that a qualified specialist for women's health services furnish routine or preventive women's health services.

(3) To have reasonable and timely access to specialists as indicated by the participant's health condition and consistent with current clinical practice guidelines.

(4) To receive necessary care in all care settings, up to and including placement in a long-term care facility when the PACE organization can no longer provide the services necessary to maintain the participant safely in the community.

(5) To disenroll from the program at any time and have such disenrollment be effective the first day of the month following the date the PACE organization receives the participant's notice of voluntary disenrollment as set forth in § 460.162(a).

(d) Access to emergency services. Each participant has the right to access emergency health care services when and where the need arises without prior authorization by the PACE interdisciplinary team.

(e) Participation in treatment decisions. Each participant has the right to participate fully in all decisions related to his or her treatment. A participant who is unable to participate fully in treatment decisions has the right to designate a representative. Specifically, each participant has the following rights:

(1) To have all treatment options explained in a culturally competent manner and to make health care decisions, including the right to refuse treatment, and be informed of the consequences of the decisions.

(2) To have the PACE organization explain advance directives and to establish them, if the participant so desires, in accordance with §§ 489.100 and 489.102 of this chapter.

(3) To be fully informed of his or her health and functional status by the interdisciplinary team.

(4) To participate in the development and implementation of the plan of care.

(5) To request a reassessment by the interdisciplinary team.

(6) To be given reasonable advance notice, in writing, of any transfer to another treatment setting and the justification for the transfer (that is, due to medical reasons or for the participant's welfare, or that of other participants). The PACE organization must document the justification in the participant's medical record.

(f) Confidentiality of health information. Each participant has the right to communicate with health care providers in confidence and to have the confidentiality of his or her individually identifiable health care information protected. Each participant also has the right to review and copy his or her own medical records and request amendments to those records. Specifically, each participant has the following rights:

(1) To be assured of confidential treatment of all information contained in the health record, including information contained in an automated data bank.

(2) To be assured that his or her written consent will be obtained for the release of information to persons not otherwise authorized under law to receive it.

(3) To provide written consent that limits the degree of information and the persons to whom information may be given.

(g) Complaints and appeals. Each participant has the right to a fair and efficient process for resolving differences with the PACE organization, including a rigorous system for internal review by the organization and an independent system of external review. Specifically, each participant has the following rights:

(1) To be encouraged and assisted to voice complaints to PACE staff and outside representatives of his or her choice, free of any restraint, interference, coercion, discrimination, or reprisal by the PACE staff.

(2) To appeal any treatment decision of the PACE organization, its employees, or contractors through the process described in § 460.122.

(a) The PACE organization must limit use of restraints to the least restrictive and most effective method available. The term restraint includes either a physical restraint or a chemical restraint.

(1) A physical restraint is any manual method or physical or mechanical device, materials, or equipment attached or adjacent to the participant's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body.

(2) A chemical restraint is a medication used to control behavior or to restrict the participant's freedom of movement and is not a standard treatment for the participant's medical or psychiatric condition.

(b) If the interdisciplinary team determines that a restraint is needed to ensure the participant's physical safety or the safety of others, the use must meet the following conditions:

(1) Be imposed for a defined, limited period of time, based upon the assessed needs of the participant.

(2) Be imposed in accordance with safe and appropriate restraining techniques.

(3) Be imposed only when other less restrictive measures have been found to be ineffective to protect the participant or others from harm.

(4) Be removed or ended at the earliest possible time.

(c) The condition of the restrained participant must be continually assessed, monitored, and reevaluated.

(a) Written policies. A PACE organization must have written policies and implement procedures to ensure that the participant, his or her representative, if any, and staff understand these rights.

(b) Explanation of rights. The PACE organization must fully explain the rights to the participant and his or her representative, if any, at the time of enrollment in a manner understood by the participant.

(c) Display. The PACE organization must meet the following requirements:

(1) Write the participant rights in English, and in any other principal languages of the community, as determined by the State in which the PACE organization is located. In the absence of a State standard, a principal language of the community is any language that is spoken by at least 5 percent of the individuals in the PACE organization's service area.

(2) Display the PACE participant rights in a prominent place in the PACE center.

The PACE organization must have established documented procedures to respond to and rectify a violation of a participant's rights.

For purposes of this part, a grievance is a complaint, either written or oral, expressing dissatisfaction with service delivery or the quality of care furnished.

(a) Process to resolve grievances. A PACE organization must have a formal written process to evaluate and resolve medical and nonmedical grievances by participants, their family members, or representatives.

(b) Notification to participants. Upon enrollment, and at least annually thereafter, the PACE organization must give a participant written information on the grievance process.

(c) Minimum requirements. At a minimum, the PACE organization's grievance process must include written procedures for the following:

(1) How a participant files a grievance.

(2) Documentation of a participant's grievance.

(3) Response to, and resolution of, grievances in a timely manner.

(4) Maintenance of confidentiality of a participant's grievance.

(d) Continuing care during grievance process. The PACE organization must continue to furnish all required services to the participant during the grievance process.

(e) Explaining the grievance process. The PACE organization must discuss with and provide to the participant in writing the specific steps, including timeframes for response, that will be taken to resolve the participant's grievance.

(f) Analyzing grievance information. The PACE organization must maintain, aggregate, and analyze information on grievance proceedings. This information must be used in the PACE organization's internal quality improvement program.

(a) Written procedures. Each PACE organization must have formal written procedures for identifying and processing service determination requests in accordance with the requirements of this Part.

(b) What is a service determination request—(1) Requests that constitute a service determination request. Except as provided in paragraph (b)(2) of this section, the following requests constitute service determination requests:

(i) A request to initiate a service.

(ii) A request to modify an existing service, including to increase, reduce, eliminate, or otherwise change a service.

(iii) A request to continue coverage of a service that the PACE organization is recommending be discontinued or reduced.

(2) Requests that do not constitute a service determination request. 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.

(c) Who can make a service determination request. Any of the following individuals can make a service determination request:

(1) The participant.

(2) The participant's designated representative.

(3) The participant's caregiver.

(d) Method for making a service determination request. An individual may make a service determination request as follows:

(1) Either orally or in writing.

(2) To any employee or contractor of the PACE organization that provides direct care to a participant in the participant's residence, the PACE center, or while transporting participants.

(e) Processing a service determination request. (1) Except as provided in paragraph (e)(2) of this section, the PACE organization must bring a service determination request to the interdisciplinary team as expeditiously as the participant's condition requires, but no later than 3 calendar days from the time the request is made.

(2) If a member of the interdisciplinary team is able to approve the service determination request in full at the time the request is made, the PACE organization—

(i) Must fulfill all of the following:

(A) Notice of the decision to approve a service determination request requirements specified in paragraph (j)(1) of this section.

(B) Effectuation requirements specified in paragraph (k) of this section.

(C) Recordkeeping requirements specified in paragraph (m) of this section.

(ii) Is not required to process the service determination request in accordance with paragraphs (f) through (i), (j)(2), and (l) of this section.

(f) Who must review a service determination request. The full interdisciplinary team must review and discuss each service determination request and decide to approve, deny, or partially deny the request based on that review.

(g) Interdisciplinary team decision making. The interdisciplinary team must consider all relevant information when evaluating a service determination request, including, but not limited to, the findings and results of any reassessments required in paragraph (h) of this section, as well as the criteria specified in § 460.92(b).

(h) Reassessments in response to a service determination request. (1) If the interdisciplinary team expects to deny or partially deny a service determination request, the appropriate members of the interdisciplinary team, as identified by the interdisciplinary team, must conduct an in-person reassessment before the interdisciplinary team makes a final decision. The team members performing the reassessment must evaluate whether the requested service is necessary to meet the participant's medical, physical, emotional, and social needs.

(2) The interdisciplinary team may conduct a reassessment prior to approving a service determination request, either in-person or through the use of remote technology, if the team determines that a reassessment is necessary.

(i) Notification timeframe. Except as provided in paragraph (i)(1) of this section, when the interdisciplinary team receives a service determination request, it must make its decision and notify the participant or their designated representative of its decision as expeditiously as the participant's condition requires, but no later than 3 calendar days after the date the interdisciplinary team receives the request.

(1) Extensions. The interdisciplinary team may extend the timeframe for review and notification by up to 5 calendar days if either of the following occur:

(i) The participant or other requestor listed in paragraph (c)(2) or (3) of this section requests the extension.

(ii) The extension is in the participant's interest because the interdisciplinary team needs additional information from an individual not directly employed by the PACE organization that may change the interdisciplinary team's decision to deny a service. The interdisciplinary team must document the circumstances that led to the extension and demonstrate how the extension is in the participant's best interest.

(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.

(j) Notification requirements—(1) Notice of decisions to approve a service determination request. If the interdisciplinary team makes a determination to approve a service determination request, it must provide the participant or the designated representative either oral or written notice of the determination. Notice of any decision to approve a service determination request must explain the conditions of the approval in understandable language, including when the participant may expect to receive the approved service.

(2) Notice of decisions to deny a service determination request. If the interdisciplinary team decides to deny or partially deny a service, it must provide the participant or the designated representative both oral and written notice of the determination. Notice of any denial must—

(i) State the specific reason(s) for the denial, including why the service is not necessary to maintain or improve the participant's overall health status, taking into account the participant's medical, physical, emotional, and social needs, and the results of the reassessment(s) in understandable language.

(ii) Inform the participant or designated representative of his or her right to appeal the decision under § 460.122.

(iii) Describe the standard and expedited appeals processes, including the right to, and conditions for, obtaining expedited consideration of an appeal of a denial of services as specified in § 460.122.

(iv) For a Medicaid participant, inform the participant of both of the following, as specified in § 460.122(e)(1):

(A) His or her right to continue receiving disputed services during the appeals process until issuance of the final determination.

(B) The conditions for continuing to receive disputed services.

(k) Effectuation requirements. If the interdisciplinary team approves a service determination request, in whole or in part, the PACE organization must provide the approved service as expeditiously as the participant's condition requires, taking into account the participant's medical, physical, emotional, and social needs. The interdisciplinary team must explain when the participant may expect to receive the service in accordance with paragraph (j)(1) of this section.

(l) Effect of failure to meet the processing timeframes. If the interdisciplinary team fails to provide the participant with timely notice of the resolution of the request or does not furnish the services required by the revised plan of care, this failure constitutes an adverse decision, and the participant's request must be automatically processed by the PACE organization as an appeal in accordance with § 460.122.

(m) Recordkeeping. The PACE organization must establish and implement a process to document, track, and maintain records related to all processing requirements for service determination requests received both orally and in writing. These records must be available to the interdisciplinary team to ensure that all members remain alert to pertinent participant information.

For purposes of this section, an appeal is a participant's action taken with respect to the PACE organization's noncoverage of, or nonpayment for, a service including denials, reductions, or termination of services. A request to initiate, modify or continue a service must first be processed as a service determination request under § 460.121 before the PACE organization can process an appeal under this section.

(a) PACE organization's written appeals process. The PACE organization must have a formal written appeals process, with specified timeframes for response, to address noncoverage or nonpayment of a service.

(b) Notification of participants. Upon enrollment, at least annually thereafter, and whenever the interdisciplinary team denies a service determination request or request for payment, the PACE organization must give a participant written information on the appeals process.

(c) Minimum requirements. At a minimum, the PACE organization's appeals process must include written procedures for the following:

(1) Timely preparation and processing of a written denial of coverage or payment as provided in §§ 460.121(i) and (m).

(2) How a participant or their designated representative files an appeal, including procedures for accepting oral and written appeal requests.

(3) Documentation of a participant's appeal.

(4) Review of an appeal by an appropriate third party reviewer or committee. An appropriate third party reviewer or member of a review committee must be an individual who meets all of the following:

(i) Appropriately credentialed in the field(s) or discipline(s) related to the appeal.

(ii) An impartial third party who meets both of the following:

(A) Was not involved in the original action.

(B) Does not have a stake in the outcome of the appeal.

(5) The distribution of written or electronic materials to the third party reviewer or committee that, at a minimum, explain all of the following:

(i) Services must be provided in a manner consistent with the requirements in §§ 460.92 and 460.98.

(ii) The need to make decisions in a manner consistent with how determinations under section 1862(a)(1)(A) of the Act are made.

(iii) The rules in § 460.90(a) that specify that certain limitations and conditions applicable to Medicare or Medicaid or both benefits do not apply.

(6) Responses to, and resolution of, appeals as expeditiously as the participant's health condition requires, but no later than 30 calendar days after the organization receives an appeal.

(7) Maintenance of confidentiality of appeals.

(d) Opportunity to submit evidence. A PACE organization must give all parties involved in the appeal a reasonable opportunity to present evidence related to the dispute, in person, as well as in writing.

(e) Services furnished during appeals process. During the appeals process, the PACE organization must meet the following requirements:

(1) For a Medicaid participant, continue to furnish the disputed services until issuance of the final determination if the following conditions are met:

(i) The PACE organization is proposing to terminate or reduce services currently being furnished to the participant.

(ii) The participant requests continuation with the understanding that he or she may be liable for the costs of the contested services if the determination is not made in his or her favor.

(2) Continue to furnish to the participant all other required services, as specified in subpart F of this part.

(f) Expedited appeals process. (1) A PACE organization must have an expedited appeals process for situations in which the participant believes that his or her life, health, or ability to regain or maintain maximum function could be seriously jeopardized, absent provision of the service in dispute.

(2) Except as provided in paragraph (f)(3) of this section, the PACE organization must respond to the appeal as expeditiously as the participant's health condition requires, but no later than 72 hours after it receives the appeal.

(3) The PACE organization may extend the 72-hour timeframe by up to 14 calendar days for either of the following reasons:

(i) The participant requests the extension.

(ii) The organization justifies to the State administering agency the need for additional information and how the delay is in the interest of the participant.

(g) Notification. A PACE organization must give all parties involved in the appeal appropriate written notification of the decision to approve or deny the appeal.

(1) Notice of a favorable decision. Notice of any favorable decision must explain the conditions of the approval in understandable language.

(2) Notice of partially or fully adverse decisions. (i) Notice of any denial must—

(A) State the specific reason(s) for the denial;

(B) Explain the reason(s) why the service would not improve or maintain the participant's overall health status;

(C) Inform the participant of his or her right to appeal the decision; and

(D) Describe the external appeal rights under § 460.124.

(ii) At the same time the decision is made, the PACE organization must also notify the following:

(A) CMS.

(B) The State administering agency.

(h) Actions following a favorable decision. A PACE organization must furnish the disputed service as expeditiously as the participant's health condition requires if a determination is made in favor of the participant on appeal.

(i) Analyzing appeals information. A PACE organization must maintain, aggregate, and analyze information on appeal proceedings and use this information in the organization's internal quality improvement program.

A PACE organization must inform a participant in writing of his or her appeal rights under Medicare or Medicaid managed care, or both, assist the participant in choosing which to pursue if both are applicable, and forward the appeal to the appropriate external entity.

(a) Appeal rights under Medicare. Medicare participants have the right to a reconsideration by an independent review entity.

(1) A written request for reconsideration must be filed with the independent review entity within 60 calendar days from the date of the decision by the third party reviewer under § 460.122.

(2) The independent outside entity must conduct the review as expeditiously as the participant's health condition requires but must not exceed the deadlines specified in the contract.

(3) If the independent review entity conducts a reconsideration, the parties to the reconsideration are the same parties described in § 460.122(c)(2), with the addition of the PACE organization.

(b) Appeal rights under Medicaid. Medicaid participants have the right to a State Fair Hearing as described in part 431, subpart E, of this chapter.

(c) Appeal rights for dual eligible participants. Participants who are eligible for both Medicare and Medicaid have the right to external review by means of either the Independent Review Entity described in paragraph (a) of this section or the State Fair Hearing process described in paragraph (b) of this section.