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Procedures for Handling Complaints Regarding AMA PRA Credit

Purpose
The following procedures have been established by the American Medical Association for the handling of complaints that a CME provider has failed to comply with the requirements of the Physician's Recognition Award (PRA) credit system established by the AMA. Such PRA credit system requirements include, but are not limited to: compliance with all PRA standards; proper representation of PRA credit; proper preparation, content and evaluation of CME activities; proper recording and maintenance of CME attendance records; and compliance with relevant AMA Council on Ethical and Judicial Affairs (CEJA) opinions. Relevant CEJA opinions include E-8.061 (“Gifts to Physicians from Industry”) and E-9.011 (“Ethical Issues in CME”).

Handling of Complaints
•  All complaints that a CME provider has failed to comply with the PRA credit system requirements established by the AMA must be submitted in writing to the Department of AMA PRA Standards and Policy, AMA Division of Continuing Physician Professional Development (CPPD). If requested by the complainant, the identity of the complainant shall be kept confidential to the fullest extent possible.

•  CPPD will review all complaints together with any other available materials. CPPD shall have discretion to disregard complaints which, in its judgment, are frivolous, without merit or are lacking in sufficient information to be able to be properly evaluated.

•  If the complaint is determined to be covered by this procedure, the CME provider will be (i) advised of the nature of the complaint, (ii) requested to furnish in writing all relevant documentation together with its explanation of how it is in compliance with the AMA's PRA credit system requirements, (iii) furnished a copy of these Procedures and (iv) given thirty (30) calendar days to respond to the complaint.

•  Upon review of all available relevant information, CPPD may take one of the following actions:

•  If CPPD determines that there is no violation, the complainant and the CME provider will each be notified of that finding.

•  If CPPD determines that remedial action is needed, the CME provider will be requested to take the remedial action and confirm to CPPD that the remedial action will be instituted. Confirmation by the CME provider that the requested remedial action has been taken must be provided to CPPD within thirty (30) calendar days. CPPD will continue to monitor the CME provider for a period of no less than one year.

•  If CPPD determines that an egregious violation has occurred, CPPD will recommend to the CME Subcommittee that the CME provider's privilege to designate AMA PRA Category 1 Credit ™ be revoked. This will automatically trigger the offering of a hearing as outlined below.

(5) If (i) the CME provider fails to confirm within thirty (30) calendar days of CPPD's request that the CPPD specified remedial action has been taken, or (ii) CPPD recommends the immediate revocation of the provider's privilege to continue to designate AMA PRA Category 1 Credit™ , the CME provider will be offered a hearing before the CME Subcommittee of the AMA Council on Medical Education (“Council”).

(6) The offer of a hearing shall state that the CME provider (i) must affirmatively request a hearing in the manner to be specified in the offer within thirty (30) calendar days and (ii) may explain its compliance with the AMA PRA credit system requirements through oral testimony at the hearing. If the CME provider timely requests a hearing, the CME Subcommittee shall notify the CME provider of the date and time of the hearing and the manner in which the CME Subcommittee will proceed.

(7) Where CPPD has recommended a revocation of the privilege to designate AMA PRA Category 1 Credit ™, failure of the CME provider to timely request a hearing shall waive the right to a hearing, and result in the recommended action immediately becoming effective without further action from the AMA. The CME provider will be immediately notified by first class mail in such event.

Hearing Procedure
•  The CME Subcommittee shall not be bound by technical rules of evidence or procedures usually employed in legal proceedings. The CME Subcommittee shall consider any written information previously submitted to or developed by CPPD. The CME provider shall be given access to such written information at least twenty (20) calendar days in advance of the hearing date. The CME provider may copy any and all such information at its own expense. Only oral testimony shall be provided during the hearing.

•  The hearing may be held in person or by teleconference and both parties (CPPD and the CME provider) may be accompanied by legal counsel.

•  The CME Subcommittee may determine such additional procedures for the hearing as it determines to be appropriate and shall announce such procedures in advance to the extent feasible.

(4) The deliberations of the CME Subcommittee shall be confidential.

(5) The CME Subcommittee may, by a majority vote, recommend endorsement, rejection or modification, in any manner, of the revocation of the privilege to designate AMA PRA Category 1 Credit™ recommended by CPPD.

(6) As promptly as reasonably possible after the hearing, the Council and the CME provider will be notified of the recommended decision of the CME Subcommittee.

(7) The CME provider may, within fifteen (15) calendar days from receipt of notice of the recommended decision of the CME Subcommittee, submit a written statement of no longer than ten (10) pages in length to the Council, with a copy to CPPD. Submission of a written statement is at the option of the CME provider.

(8) CPPD may, within fifteen (15) calendar days following receipt of any written statement of the CME provider, submit its own written statement of no longer than ten (10) pages in length to the Council, with a copy to the CME provider, in response to the CME provider's written statement. Submission of a written statement is at the option of CPPD.

Review by Council on Medical Education
(1) The members of the CME Subcommittee shall recuse themselves from the deliberations and decision making of the Council.

(2) The disinterested members of the Council will review the recommended decision of the CME Subcommittee, together with the written statements of the CME provider and CPPD, and all other documentation submitted to the CME Subcommittee, and shall render a final binding decision, either (a) affirming the recommended decision of the CME Subcommittee by a simple majority vote of the disinterested Council Members or (b) rejecting or modifying the recommended decision of the CME Subcommittee by a simple majority vote of the disinterested Council members.

•  The CME provider will be immediately notified by first class mail of the final binding decision of the Council.

Notification of Accrediting Body
If a CME provider's privilege to designate AMA PRA Category 1 Credit™ has been revoked, effective pursuant to (a) section 7 of “Handling of Complaints” or (b) section 2 of “Review by Council on Medical Education,” the CME provider's accrediting body shall be promptly notified.

Reinstatement of AMA PRA Category 1 Credit™
A CME provider may reapply to CPPD to designate AMA PRA Category 1 Credit™, upon demonstrating that it meets the requirements for awarding credit.