On June 30, 2010, the Association of American Medical Colleges (AAMC) issued a report entitled In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making (the 2010 AAMC Report, or the Report).1 The Report, which reinforces and complements the recommendations made in the AAMC’s three prior reports that concentrated on individual and institutional conflicts of interest in human subjects research and conflicts of interest relating to medical education, 2 outlines the Association’s recommendations for the identification and management of conflicts of interest that can create bias in judgments and decisions made in the clinical care setting. As such, it provides the third and final leg of the conflicts of interest stool the AAMC began to construct almost a decade ago. The Report reflects the predominant attitudes towards, and concerns about, conflicts of interest that have emerged during this same time frame.
The 2010 AAMC Report embodies the analysis, findings and recommendations of the Task Force on Financial Conflicts of Interest in Clinical Care formed by the AAMC in 2009. The Task Force was charged with two tasks: (1) examining the existing policies and practices relating to conflicts of interest in clinical care in the academic medical center (AMC) context, and (2) making recommendations to guide the AMC community in addressing conflicts of interest in the clinical care setting that go beyond the guidance and recommendations provided in the three prior AAMC reports on conflicts of interest in research and medical education, while extending to the clinical care setting the principles articulated in those reports.
This Report comes in the midst of, and will likely provide further fuel for, the virtually relentless scrutiny of financial ties between providers and the pharmaceutical and medical device industry by federal and state governments, courts, the public, professional associations and journals, pundits, watchdogs and the media. Among the most recent federal government efforts to more closely regulate these relationships are (1) the new federal “Sunshine Law,” which was enacted as part of the recent health reform legislation and, like its various state-law counterparts,3 requires drug companies and device manufacturers to report and publicly disclose certain financial relationships with physicians and “teaching hospitals,”4 and (2) the newly proposed Public Health Service (PHS) regulations governing conflicts of interest in PHS-funded research, which would both expand conflict of interest reporting and would establish a new public disclosure requirement.5 The proposed PHS regulations and the 2010 AAMC Report focus primarily on the risk of harm to research subjects and individual patients, respectively, that can arise from researchers’ and clinicians’ financial ties with industry. The primary objective of the federal Sunshine Law, however, is to promote self-compliance under laws such as the federal False Claims Act and the federal Anti-Kickback Statute that have been used aggressively as a basis for investigating and sanctioning financial relationships that increase the costs to government healthcare reimbursement programs by incentivizing unnecessary or excessive use of industry products. The federal Sunshine Law nonetheless reinforces the interplay between financial conflicts of interest and other compliance concerns and priorities.
Highlights of the 2010 AAMC Report
The Report uses and endorses the following definition of a “clinical practice conflict of interest” from the Institute of Medicine (IOM) Report:
A clinical practice conflict of interest … occurs when a secondary financial interest creates the risk that the primary duty to the patient and the delivery of optimal care will be unduly influenced by personal financial interest of the care provider or care provider institution.6
The Report provides the following seven recommendations relating to clinical care conflicts of interest [emphasis added throughout]:
- The principles articulated in the 2010 AAMC Report are applicable to the medical profession generally, not just to AMCs.
- Compensation mechanisms of AMCs should be aligned with the best interests of patients.
- Medical societies should set standards of addressing their own relationships with industry.
- Institutional providers should address their physicians’ financial relationships with industry in the context of the clinical care they deliver.
- Institutional providers should address institutional financial relationships with industry in the context of the clinical care they and their affiliated health care professionals provide.
- Institutional providers should disclose the industry ties of their physicians to their patient communities as one way, though not the exclusive method, of managing actual and perceived conflicts of interest in clinical care.
- Institutional providers should involve their patient communities in determining the manner in which financial relationships of its physicians and of the institution itself should be made available to patients.
Much of the 2010 AAMC Report is devoted to a discussion of the policy goals and principles underlying these seven recommendations. Particularly noteworthy among them are the following:
- The presence of individual or institutional financial interests in the patient care setting may create real or perceived bias in clinical decision making and may distort the values of medical professionalism among physicians, medical students and other trainees.
- It is imperative that the possibility or perception of conflict between financial interests in industry entities, held by clinicians or the institution, and the primacy of the interests of patients be deliberately examined and appropriately evaluated through a well-defined and publicized institutional process to ensure that medicine is fundamentally dedicated to the welfare of patients and the improvement of public health.
- Because the transmission of both professional expertise and professional values formally begins in the context of academic medicine, AMCs and their physicians have a special responsibility to implement programs that meet the highest professional standards.
- It is critically necessary that institutional providers’ clinical care conflicts programs address their own “myriad [institutional] relationships” with industry (e.g., royalties and charitable donations) and those of “institutional officials” serving in direct leadership roles (e.g., division chiefs and department chairs).
- The nature and extent of a physician’s relationships with industry are among the many pieces of information that one might consider in making appropriate health care decisions. An understanding of these relationships begins with an awareness of them, and awareness depends on the relationships being transparent. Physicians, their medical centers and the industry companies all have the information necessary to take the initial step towards transparency by revealing these relationships to the public.
- Disclosure to the patient and public transparency is not always sufficient to manage the risk of a conflict.
The balance of the Report discusses key considerations to address in designing the core elements of a conflicts of interest program, such as (1) what interests should be addressed (e.g., payments for services, royalties and ownership interests); (2) the more challenging prospect of “transactional” as opposed to annual reporting of interests; (3) the use and amount of thresholds for reporting, assessment and disclosure of financial interests; (4) the approach to and adequacy of disclosure to the patient; (5) the development of conflict management steps, and associated sanctions for non-compliance, and the challenge of tailoring them to the unique “exigencies” of the clinical care setting; and (6) the need for, and the limitations and risks of, public transparency.
Observations and Analysis
In many respects, the 2010 AAMC Report reinforces the principles and guidelines established in its predecessor AAMC reports on conflicts of interest in research and medical education. In particular, this Report similarly stresses the need to address both individual and institutional conflicts, and that actual and perceived conflicts present risks that must be addressed. In other respects, however, the Report’s recommendations are more closely aligned with those made by the IOM in its comprehensive 2009 report entitled Conflict of Interest in Medical Research, Education, and Practice,7 which provided an in-depth analysis and detailed recommendations to “inform the design and implementation of policies to identify and manage conflicts of interest in the context of medical research, education, clinical practice and clinical guideline development without damaging constructive collaborations with industry.”8
What all the AAMC conflict of interest reports and the IOM Report have in common is an implicit concern for patient safety in the context of real and perceived conflicts of interest resulting from personal and institutional financial ties with industry and an explicit recognition of the need for policies and practices that “strike the right balance between addressing egregious cases and creating burdens that stifle relationships that advance the goals of professionalism and generate knowledge to benefit society.”9
The 2010 AAMC Report differs from prior AAMC conflict of interest reports in the following notable respects:
- The Report affirmatively states that the principles it enunciates extend outside of the AMC setting to the entire medical profession — a recognition, perhaps, that delivery of clinical care, as opposed to involvement in research and education, is the common thread that runs through all care delivery settings and that management of clinical conflicts is equally important in all of them.
- Previously, the AMMC, other trade associations, the government, the media and others have focused solely on relationships between industry and either healthcare professionals or institutions as the source of real or perceived conflicts. The 2010 AAMC Report identifies yet another source: current models of physician compensation used by institutions and third-party payors, such as fee-for-service, managed care incentives, salaried arrangements and pay-for performance.10 This is a particularly noteworthy departure and introduces a novel and challenging dimension, both in the ethical and the regulatory compliance realms.
- Following the IOM Report’s lead, the 2010 AAMC Report addresses the need for the institution (not just the manufacturers) to inform and educate the public about healthcare professionals’ financial ties to industry. It discusses at length, and provides a model template for, an institution’s creation of websites for this purpose.11 The Report’s transparency standard would require disclosure both of the physician’s financial interest and its value and of the steps taken to mitigate and manage the potential conflict. In contrast to the new federal Sunshine Law, it does not suggest that the disclosure address the institution’s financial ties.
- The Report addresses only financial relationships and not associational relationships (e.g., family relationships, friendships, fiduciary positions or obligations). Further, among the myriad of financial relationships that have been identified as sources of potential conflicts, the Report focuses primarily on three types of physician financial interests: (1) payments for services; (2) royalties; and (3) ownership interests. On the other hand, it singles out royalties as worthy of close conflict scrutiny — a notable departure from a long-standing practice of giving royalties a lighter touch in the conflicts milieu.12
- The 2010 AAMC Report includes minimal discussion of suggested conflict management approaches and offers no hypotheticals to illustrate possible clinical conflict scenarios and corresponding management approaches.13 It also draws no clear lines concerning the use of thresholds for reporting and assessment of interests.14 In both these respects, the Report reflects the reality that identifying and managing clinical care conflicts of interest is more difficult than in the research or continuing medical education contexts and will require somewhat different policies and procedures.
With regard to public transparency, the Report recognizes the challenges institutions will face in determining the type of information to disclose and the time periods the disclosure should cover, and in achieving at least some consistency or uniformity in reporting approaches across institutions that will be necessary to avoid exacerbating patient uncertainty as to how to interpret the information and what effect, if any, the financial relationships will have on their care.15 The Report encourages institutions to collaborate with patients concerning disclosure methods.16 As suggested by the IOM Report, collaboration with other key stakeholders, such as the federal government and industry, would also be productive.
The 2010 AAMC Report comes at a time when many AMCs and other institutional providers are continuing to struggle to implement the recommendations of prior AAMC reports, especially as they relate to institutional conflicts of interest. The nature and exigencies of the clinical care setting alone make the design, implementation and enforcement of a conflict of interest program in that setting meaningfully more challenging than in the research and education setting. AAMC has promised, and institutions will clearly need, further guidance and tools, particularly with regard to the use of financial thresholds for reporting; assessment and disclosure of financial interests; adapting traditional conflict reporting and assessment policies and procedures to the exigencies of decision-making in the clinical care setting; and developing an approach to meeting the public and patient transparency requirements that will be useful, rather than alarming and confusing, to patients and the public. As the clinical conflicts of interest concern of the government, patients, the public at large, the media and other watchdogs has been real and, with the issuance of this Report, is likely to grow, it should generate a sense of urgency on the part of all institutions about tackling these challenges, not only on their own but in collaboration with one another, industry, the AAMC and other stakeholders.