Wednesday, September 17, 2008

Medicaid programs should put antipsychotic drugs higher on the radar

Pharmalot: Florida is an example where there’s controversy over antipsychotics given kids with ADHD.
Stallard: I think they shouldn’t be experimenting when it’s never been tested on children. It’s a big mistake. Sometimes, legislators say they need to be liberal with vulnerable segments of society to give them medicines that may have some benefit. I turn it around and say we shouldn’t be experimenting with the most vulnerable segments of our society.

Antipsychotics & State Lawsuits: Stallard Explains
By Ed Silverman
David Stallard, Assistant AG Utah

More states are filing lawsuits against drugmakers over allegations they failed to disclose side effects caused by their antipsychotics and improperly marketed the pills, therefore, causing state Medicaid programs to overpay for the medications. Meanwhile, many of these same state programs have been paying for antipsychotic prescriptions for unapproved uses in children, such as ADHD. We spoke with David Stallard, a special assistant attorney general in Utah, which sued Eli Lilly last year, about a state’s view of the problem…

Pharmalot: How’d you get involved in this litigation?
Stallard: I was working as an assistant attorney general for about five years and, most of that time, I was working in the Medicaid fraud control unit, spending a large part of my time, almost exclusively the last two years, on civil medicaid fraud, specifically, pharmaceutical fraud with respect to Medicaid.

Pharmalot: There’s that much fraud?
Stallard: There’s a lot of fraud. These are pretty intensive cases and take a lot of time. My opinion it’s because Medicaid drugs are such a huge part of the business for pharmaceutical companies and it’s very attractive market - feeding at the taxpayer trough. I’m kind of a skeptic having worked in the trenches, but pharmaceutical companies try to get as much reimbursement as they can from Medicaid, because it’s a big payer. And not just on price, but utilization. As many pills as they can, and the highest price they can engineer.

Pharmalot: Why did Utah sue Lilly?
Utah has chosen to sue on behalf of its state Medicaid program only two companies for what I call failure to warn - risks we allege were known early on by the company but concealed - Merck’s vioxx and Lilly’s zyprexa. In my opinion, there was a common theme. If they got what was going to be a blockbuster, they focus on the positives, but not give the FDA the negatives. And they would also train reps to dodge questions from docs. Separately, there was pricing fraud - overcharging medicaid - they falsely inflated list prices to First Databank and other compendia relied on by Medicaid and other third-party payors for medicaid reimbursement prices.

But with Lilly specifically, there was a lot of off-label use that was promoted by Lilly improperly. It’s actually illegal under Federal Food Drug & Cosmetic Act. But under state law, we’re claiming Lilly improperly marketed the drug and caused us to pay more than we should have.

Pharmalot: But there was another issue raised, right?
Stallard: Yes, and in fact, I wrote a memo that has to do with a second component - medically accepted indications for proper use. My legal analysis of federal Medicaid law is that, in order to be eligible for Medicaid reimbursement, the drug must be covered outpatient drugs. It’s basically a threshold requirement. There is a limitation on the definition of covered outpatient drugs that is tied to use of drug and it does not include ‘a drug or biological used for a medical indication which is not a medically accepted indication.’

Pharmalot: So you’re saying, under that definition, a state Medicaid program shouldn’t be paying.
Stallard: To me, it means that to be eligible for reimbursement for Medicaid - to be a covered outpatient drug - it has to be used for a medically accepted indication. Under that provision, it’s not a covered outpatient drug unless its used for a medically accepted indication. It’s not just a term of art. It’s specifically defined in the federal statute. It has to be FDA approved for use supported by specific compendia.


1 comment:

Anonymous said...

There is a recent New York Times article that actively promotes use of antipsychotic drugs by small children and basically details how these drugs are enforced on the parents and the kids. And the parents feel guilty about the risk they are exposing their children to. The article really doesn't go into how it is illegal to promote the prescription of off-label drugs not tested on children or the numerous lawsuits by states against the drug companies by states Attorney General based on drug companies' failure to warn. Or that one drug company has had to set aside over $1 billion to cover the costs of these lawsuits. Here is the link.

The author naively asks if the small children will be bipolar as adults. She rather naively supposes that they will actually reach adulthood without sustaining major mental and physical damage from having taken these drugs.