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Medicaid drug selection committees often mismanage COI policies, researchers say
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The current policies to manage conflicts of interest among Medicaid drug selection committees are inconsistent, mismanaged and often are not transparent, according to a report published in JAMA.
“Pharmaceutical companies promote their products by offering gifts, consultation fees, and honoraria to individual practitioners and researchers,” the researchers wrote. “These practices can have an impact on the therapeutic decision making because they skew the body of scientific evidence in favor of newer, more expensive, on-patent drugs.”
Nicole Yvonne Nguyen, PharmD, and Lisa Bero, PhD, of the University of California, San Francisco, performed a content analysis of 27 (56%) conflict of interest (COI) policies of pharmacy and therapeutic committees overseeing drug selection for state Medicaid reimbursement programs. The researchers compared specifics of each policy with the standards of a model policy adapted from the Public Health Service Conflict of Interest Regulations to assess disclosure parameters, management strategies and the committees’ processes of reviewing COI. The model policy was based on 12 factors potentially related to COI, including whether the policy is available on a public website, how frequently committee members are required to submit disclosure statements, and banned relationships with industry.
Lisa Bero
The researchers found high variability in COI policies, lack of public availability and inconsistent COI enforcement and management among states. The most common management strategies represented in the 27 policies included COI disclosure (67%) and self-recusal (52%). Only 15% of the policies ban specific relationships with the pharmaceutical industry.
“Medicaid drug reimbursement decisions should be based on evidence of drug efficacy and harm and free of influence from COI, so stronger COI policies are needed,” Bero told Infectious Disease News.
Federal regulations stated in the CMS prescription drug benefit manual require committee members be free of COI, but the manual does not define COI for disclosure purposes.
Nguyen and Bero suggested that a model policy should:
- Be publically accessible
- Be comprehensive and provide clear guidelines for disclosures
- Be equally applicable to all members of the Medicaid drug selection committee
- Manage strategies beyond disclosures
- Appoint a responsible party to review COI and enforce existing policies
“Managing COI is important in the setting of drug selection for formularies or reimbursement lists to ensure that produces are selected based on evidence and with minimal bias,” the researchers wrote.
In a related commentary, Nirav Shah, MD, MPH, commissioner of the New York State Health Department, said suggesting a standardized approach to managing COI may be easier said than done.
“Because the evidence is sparse, ‘best practices’ are often subjective and may lead to unintended consequences,” Shah wrote. “More frequent disclosure requirements, for example, may be much harder to implement relative to requiring more complete disclosure upfront, and may not add value. And burdensome disclosure requirements may discourage highly qualified candidates from serving on unpaid advisory committees … . Therefore, finding the right balance of disclosure and transparency, relative to other means of managing potential COIs, is paramount.”
For more information:
Nguyen NY. JAMA Intern Med. 2013;doi:10.1001/jamainternmed.2013.2522.
Shah N. JAMA Intern Med. 2013;doi:10.1001/jamainternmed.2013.4184.
Lisa Bero, PhD, can be reached at lisa.bero@ucsf.edu.
Disclosure: Bero reports no relevant financial disclosures.