By Andrew M. Seaman
NEW YORK (Reuters Health) - No standard policy covers whether the state-level Medicaid committee members choosing which drugs and treatments the program pays for should disclose their ties to drug and medical device companies, according to a new report.
Health policy researchers at the University of California, San Francisco, who set out to examine conflict of interest policies for the 47 U.S. states plus the District of Columbia with Medicaid Preferred Drug List committees, found that many have no policy, and in the states that do, rules vary widely.
"The take home message is that there is no such thing as typical. There is no such thing as a uniformed process," said Lisa Bero, the study's lead author.
For Medicaid, the federal- and state-funded insurance program for poor Americans, decisions to pay for drugs are left up to a state committee that's made up of doctors, pharmacists and other healthcare professionals.
The U.S. Centers for Medicare and Medicaid Services, which oversees the federal part of the insurance program, requires that two members of those committees be free of conflicts of interest, but the agency does not define what constitutes a conflict.
That raises concerns over whether committee members with ties to companies may consciously or unconsciously support drugs and products that benefit those relationships, instead of making decisions based on scientific evidence.
Bero and a colleague, who published their findings in JAMA Internal Medicine, searched the states' Medicaid websites to find their policies.
If a state's committee membership policy was not listed on its website, the researchers called or emailed the state Medicaid office.
They were only able to get 27 of the policies. Some state Medicaid offices didn't answer the inquiry, two that did answer said the state had no policy and one state office said the policy is "not in the public domain."
With the 27 state policies they obtained, the researchers compared each against a list of 12 possible disclosure requirements - looking to see whether the policy included, for example, a requirement to disclose any conflicts of interest, or to update disclosure documents on a regular schedule or a ban on ties between members and companies.
Seven of the state policies did not even mention conflicts of interest. Of the remaining 20 policies, five met between two and four of the requirements, 13 met between five and eight requirements and two met nine of them.
Only four of the states - Idaho, Washington, Nevada and Texas - banned committee members from having relationships with companies.
"So if I am a committee member and I have a financial tie with a drug company, I wouldn't be allowed to participate in that discussion. Very few had that type of policy," Bero said.
One state's bureau chief for Medicaid Pharmacy Services quoted in the report told the researchers he didn't worry about conflicts since committee members were not paid to serve on the panel, 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.'"
Bero said it's hard to have a "cookie-cutter approach" to the state policies, but that she hoped the federal government would provide some advice on the matter.
"Basically, the medicine people have available to them should be available because they are the safest and most effective medicine for their condition, and not just because it's driven by people's profits motives," Bero said.
Dr. Nirav Shah, commissioner of the New York State Department of Health in Albany, told Reuters Health it's important to note that this does not mean conflicts of interest are happening, but that there is the potential for conflicts of interest.
"We need to do a better job of explaining ourselves, but the public should not be afraid and the public should not be worried," said Shah, who wrote a commentary accompanying the study.
He added that he believes it's hard to make a blanket statement about what type of system states should have, but he agrees that the federal government should issue some guidance.
"We can all do better and work toward greater transparency, and it would be very helpful if we had federal guidance of what we should adhere to because that's a level playing field for everyone," Shah said.
SOURCE: http://bit.ly/YrGQ23 and http://bit.ly/12MaHsU JAMA Internal Medicine, online February 11, 2013.