§ 476.132 - Disclosure of information about patients.

(a) General requirements for disclosure. Except as specified in paragraph (b) of this section, a PRO must—

(1) Disclose patient identified information in its possession to the identified patient or the patient's representative if—

(i) The patient or the patient's representative requests the information in writing;

(ii) The request by a patient's representative includes the designation, by the patient, of the representative; and

(iii) All other patient and practitioner identifiers have been removed.

(2) Seek the advice of the attending practitioner that treated the patient regarding the appropriateness of direct disclosure to the patient 15 days before the PRO provides the requested information. If the attending practitioner states that the released information could harm the patient, the PRO must act in accordance with paragraph (c)(2) of this section. The PRO must make disclosure to the patient or patient's representative within 30 calendar days of receipt of the request.

(b) Exceptions. (1) If the request is in connection with an initial denial determination under section 1154(a)(3) of the Act, the PRO—

(i) Need not seek the advice of the practitioner that treated the patient regarding the appropriateness of direct disclosure to the patient; and

(ii) Must provide only the information used to support that determination in accordance with the procedures for disclosure of information relating to determinations under § 473.24.

(2) A PRO must disclose information regarding PRO deliberations only as specified in § 476.139(a).

(3) A PRO must disclose quality review study information only as specified in § 476.140.

(c) Manner of disclosure. (1) The PRO must disclose the patient information directly to the patient unless knowledge of the information could harm the patient.

(2) If knowledge of the information could harm the patient, the PRO must disclose the information to the patient's designated representative.

(3) If the patient is mentally, physically or legally unable to designate a representative, the PRO must disclose the information to a person whom the PRO determines is responsible for the patient.

The PRO must first attempt to make that determination based on the medical record. If the responsible person is not named in the medical record, then the PRO may rely on the attending practitioner for the information. If the practitioner is unable to provide a name, then the PRO must make a determination based on other reliable information.