(a) Scope of the QIO review. In completing its review, the QIO shall consider any information and materials submitted by the Medicare beneficiary or his or her representative and any information submitted by the provider and/or practitioner. All information obtained by the QIO that fits within the definition of “confidential information” under § 480.101, will be held by the QIO as confidential.

(1) The QIO's review will focus on the episode of care from which the complaint arose and address the specific concerns identified by the beneficiary and any additional concerns identified by the QIO. The QIO may separate concerns into different complaints if the QIO determine that the concerns relate to different episodes of care.

(2) The QIO will use evidence-based standards of care to the maximum extent practicable. If no standard of care exists, the QIO will use available norms, best practices and established guidelines to establish the standard that will be used in completing the review. The QIO's determination regarding the standard used is not subject to appeal.

(b) Medical information requests. (1) Upon request by the QIO, a provider or practitioner must deliver all medical information requested in response to a Medicare beneficiary complaint within 14 calendar days of the request. A QIO is authorized to require the receipt of the medical information sooner if the QIO make a preliminary determination that the complaint involves a potential gross and flagrant or substantial quality of care concern as specified in part 1004 of this title and circumstances warrant earlier receipt of the medical information. A practitioner's or provider's failure to comply with the request for medical information within the established timeframe may result in the QIO taking action in accordance with § 476.90.

(2) In requesting medical information in response to a Medicare beneficiary complaint, the QIO must notify the practitioner and/or provider that the medical record is being requested in response to a beneficiary complaint, explain the practitioner's and/or provider's right to discuss the QIO's interim initial determination, and request the name of a contact person in order to ensure timely completion of the discussion.

(c) Interim initial determination. The QIO peer reviewer will complete the review and the practitioner and/or provider will be notified of the interim initial determination within 10 calendar days of the receipt of all medical information.

(1) A practitioner and provider will be notified by telephone of the opportunity to discuss the QIO's interim initial determination with the QIO in those situations where the peer reviewer determines that the quality of services does not meet professionally recognized standards of care for any concern in the complaint. The discussion must be held no later than 7 calendar days from the date of the initial offer.

(2) The interim initial determination becomes the final initial determination if the discussion is not completed timely as a result of the practitioner's and/or provider's failure to respond.

(3) Written statements in lieu of a discussion must be received no later than 7 calendar days from the date of the initial offer.

(4) In rare circumstances, the QIO may grant additional time to complete the discussion or submission of a written statement in lieu of a discussion.

(d) Final initial determination. The QIO must issue written notification of its final initial determination in those cases in which the QIO has determined that care met professionally recognized standards, as well as in those cases in which the QIO determined that standards were not met and the opportunity for discussion has been completed.

(1) No later than 3 business days after completion of its review, or for cases in which the standard was not met, no later than 3 business days after the discussion or receipt of the provider's and/or practitioner's written statement, the QIO will notify (by telephone) the beneficiary and the provider/practitioner of its final initial determination and of the right to request a reconsideration of the QIO's final initial determination.

(2) Written notice of the QIO's final initial determination will be forwarded to all parties within 5 calendar days after completion of its review, and must include:

(i) A statement for each concern that care did or did not meet the standard of care;

(ii) The standard identified by the QIO for each of the concerns; and

(iii) A summary of the specific facts that the QIO determines are pertinent to its findings, including references to medical information and, if held, the discussion with the involved practitioner and/or provider.