And now, we bring you the latest concern over conflicts of interest. Many of the state Medicaid drug selection committees lack sufficient conflicts policies for adequately protecting the decisions for choosing medicines, according to a study in JAMA Internal Medicine. The problem: policies vary widely among states, many policies are not publicly available and there is inconsistent enforcement and management of conflicts.
Specifically, the most common strategy for addressing conflicts of interest is disclosure, which is done by 67 percent of the programs. Self-recusal is next at 52 percent, and only 15 percent of the policies ban certain relationships with drugmakers. The study examined 27 policies from state programs, as well as the District of Columbia, by visiting web site or contacting Medicaid officials.
"The absence of publicly available policies illustrates a lack of transparency about how conflicts of interest are managed," the study authors write. "Identification of policies was further complicated by the fact that not all states have designated committees that make their drug selection decisions. Improving public access to policies can increase transparency and public trust in the drug selection process."
And at a time of mounting concern over rising healthcare costs, they add that more uniform policies and increased transparency could lower prescription drug costs, in particular, and improve patient care. "As health care reform is implemented and the number of Medicaid patients is expected to grow, drug selection for this population should be guided by the best available evidence and free from the influence of (conflict of interest)," they wrote.
Of the 27 policy documents analyzed, 20, or 74 percent address conflicts of interest. States with policies that did not do so included Alabama, Alaska, New York, North Carolina, North Dakota, Ohio and Vermont. There were 21 states that either did not furnish their policies - including California, Massachusetts, Mississippi, Florida, Utah, and Virginia - or acknowledged that none exists. Tennessee, New Jersey and New Mexico were excluded because their entire Medicaid population is served by managed care organizations (here is the abstract).
However, a bureau chief for Medicaid Pharmacy Services from one state responded this way to the researchers: "I get to know the P & T (Pharmacy & Therapeutic) members pretty well, and to date, have not had any problems with conflict of interest. Our committee positions are voluntary, and the agency does not pay an honorarium for members to attend..." the official wrote.
"The lack of honorarium creates a disincentive for participation by physicians and pharmacists who act as paid speakers or consultants for the pharmaceutical industry. They want to get paid, and I don't believe that the pharmaceutical industry would pay a committee member an honorarium to be on the committee and attend meetings. That would really be 'over the top.' ” Presumably, this serves as a policy.
In any event, the approach taken by states varies a great deal. In Nevada, committee members “may not have a current affiliation" with a drugmaker. But in Colorado and Kansas, the policies explicitly state that the existence of such relationships will not “automatically preclude an individual from participating" on the drug selection committee.
Then, there is Idaho. In the Gem State, committee members are prohibited from employment, contractual relationships and participating as a director or committee member for drugmakers or pharmacy benefits managers, and from holding greater than 1 percent stock in drugmakers, the researchers wrote, adding that beyond these relationships, Idaho required disclosure.
Similarly, recusal takes various forms. Indiana disallowed voting for committee members who recuse themselves, but still permit them to participate in discussions. Maryland allows recused members to submit written comments to the voting committee. And Maine requires members to recuse themselves, but also disallowed members to resume voting on the conflicted matters no sooner than one year after the declaration date of a conflict, the study states.
"Our findings show the need for a model COI policy for drug selection committees that can be adapted for individual states. A model policy should (1) be publically accessible, (2) be comprehensive and provide explicit parameters for disclosure, (3) be equally applicable to all committee members, (4) include management strategies beyond disclosure, and (5) indicate a responsible party for review of COI and enforcement of policies."
Indeed, the findings are sobering and suggest the state agencies could and should do more to manage conflicts. There is no reason, in fact, not to look more closely at updating policies. After all, no one wants to be known as an easy mark.