Conflicts of Interest and Medicaid Drug Selection Committees

To ensure that products selected for formularies and reimbursement lists are selected based on evidence without bias, it is important to manage potential conflicts of interest (COI). In the past, according to researchers, physicians who had interactions with pharmaceutical companies may have been more likely to request that drugs be added to their hospital formularies compared with physicians with no such interactions. Industry relationships may have also played a role in decisions related to drugs and drug approvals by the federal government.

To protect against COI, government agencies and medical institutions may implement policies aimed at limiting financial and other relationships with the pharmaceutical industry. Researchers recently conducted a study that focused on COI that could affect reimbursement decisions made by public programs. The primary area of interest was pharmacy and therapeutic committees that make drug selection decisions for state Medicaid reimbursement programs.

The study was designed to (1) describe the content of Medicaid drug selection committees’ COI policies for the United States and District of Columbia; (2) categorize the policies by strength; and (3) identify characteristics of a storing policy. Study results were reported in JAMA Internal Medicine [2013;173(5):338-343].

In addition to the District of Columbia, 47 states have Medicaid Preferred Drugs Lists; the researchers conducted a systematic search of official Medicaid websites and contacted Medicaid staff via e-mail and/or telephone to identify drug selection committee COI policies.

The researchers obtained policy documents from 27 of the 48 (56%) Medicaid programs identified—14 documents were available on websites and 13 were obtained by contacting committees. Of the 27 documents, 20 (74%) specifically address COI. The states whose policies did not address COI were Alabama, Alaska, New York, North Carolina, North Dakota, Ohio, and Vermont.

The researchers identified 12 policy components for the 27 policies: (1) disclosure requirement, (2) self-recusal requirement, (3) disclosure frequency, (4) public availability, (5) defined monetary cut-offs, (6) disclosure form available, (7) enforcement, (8) assigned reviewer, (9) immediate family relationships, (10) reporting window specified, (11) additional management strategies, and (12) banned relationships. The requirements for disclosure of COI at a stated frequency occurred most often (18 of the 27 policies; 67%), along with a requirement for self-recusal (14/27; 52%). Banned relationships (4/27; 15%) and other management strategies were described less often.

The policies that called for committee members to recuse themselves from matters that pose a COI required the members to recuse themselves from both voting and discussion. Connecticut policy, for example, informs recused members to “not participate in deliberations or debates and to not make recommendations, give advice or in any way assume responsibility for, or participate in any aspect of, decision-making relating to the matter where there are potential COI…[members are] not required to leave the room, although the member may voluntarily choose to do so.”

The researchers noted that processes for reviewing disclosed COI were unclear, although 8 of 27 policies (30%) assigned an entity to review disclosed COI, typically the committee chair. Most policies did not mention any enforcement procedures, although 8 of 27 policies (30%) stated that the consequence for not disclosing COI was immediate dismissal from the committee.

In summary, the researchers stated, “Current policies are not transparent and not standardized and no state policy included all model components. Wide variations suggest that some policies may not adequately protect drug selection decisions against COI and industry influence. With expected growth of Medicaid due to healthcare reform, the selection of drugs for Medicaid patients should be protected from the influence of COI.”