• AAMC Task Force Releases Guidelines for Clinical Conflicts of Interest
  • July 26, 2010
  • Law Firm: SNR Denton - Chicago Office
  • On June 30, 2010, the Association of Academic Medical Centers ("AAMC") released the "Report of the Task Force on Financial Conflicts of Interest in Clinical Care" ("Report") encouraging academic medical centers to establish and implement policies to address conflicts of interest in clinical practice.  The Report is the work of a 20-member panel convened by the AAMC, comprised of senior leadership from medical schools and teaching hospitals nationwide.  The current Report is the third and final installment of the AAMC's conflict of interest policy initiatives.  The Report details how the existence of individual and/or institutional financial interests in clinical settings may adversely impact the provision of patient care and, more generally, distort the values of medical professionalism.  The Report also offers academic medical centers concrete guidelines to assess and manage conflicts of interest.

    The Report explores the challenges attendant to the medical community's financial ties to the pharmaceutical industry and stresses the need to adopt policies and procedures to mediate these complexities.  Through its endorsement and adoption of the Institute of Medicine ("IOM") definition of conflicts of interest, the AAMC posits that clinical conflicts of interest occur when a secondary financial interest creates the risk that the primary duty to the patient and delivery of optimal care will be unduly influenced by personal financial interests of the care provider or care provider institution.

    While focused on academic medical centers, the substance of the Report—as its authors acknowledge—is more widely applicable to the practice of medicine in general.  Highlighted below are several of the Task Force's key recommendations:

    1. Compensation mechanisms of academic medical centers should align with the best interests of patients.
    2. Medical or professional societies should set standards to address their financial relationships with industry.
    3. Academic medical centers should address their physician's financial relationships with industry in the context of the clinical care they deliver.
    4. Academic medical centers should address institutional financial relationships with industry in the context of the clinical care they deliver.
    5. Academic medical centers should disclose industry ties of their physicians to their patient communities as one method, though not the exclusive method, of managing actual and perceived conflicts of interest in clinical care.
    6. Academic medical centers should involve patient communities in determining the manner in which financial relationships of their physicians and the institutions themselves are made available to patients.

      The issuance of the Report coincides with legislative trends suggestive of heightened scrutiny and regulation in the arena of research conflicts of interest and public disclosure of the financial ties to industry physicians and teaching hospitals may have.  On May 20, 2010, the NIH published a Notice of Proposed Rulemaking (NPRM) that would significantly revise and expand the scope of current conflict of interest regulations for all Public Health Service (PHS) grant applicants, amending the regulations found at 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 90.

    Another notable development is that provisions of the Physician Payments Sunshine Act have now been enacted as part of the Patient Protection and Affordable Care Act of 2010 ("Affordable Care Act").  Applicable to pharmaceutical companies, biotech firms and medical device manufacturers that have products which are eligible for payment by Medicare, Medicaid or the Children's Health Insurance Program (CHIP), this law requires reporting of payments to physicians and teaching hospitals to HHS beginning March 31, 2013 for the preceding year.  It also mandates that manufacturers post submitted information on a publicly available internet Web site that is searchable with downloading functionality on September 30, 2013.