Speaking of Express Scripts! is being Sued by Co
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http://blogs.wsj.com/pharmalot/2014/11/24/exp...ng-claims/
This past summer, Express Scripts ESRX +0.69% began blocking coverage for approximately 1,000 active ingredients used to make a variety of compounded medicines, mostly ointments, creams and powders that are found in topical treatments.
The move by the nation’s largest pharmacy benefit manager was made in response to the growing cost of some of these medicines. At the time, Express Scripts official said the average cost for each prescription had risen to about $1,100 from $90. Express Scripts officials maintained that less expensive prescription medicines are readily available.
Now, three compounding pharmacies are fighting back. Last week, three compounders filed a lawsuit charging Express Scripts is illegally blocking legitimate prescriptions and unfairly forcing patients to seek more expensive treatments or forgo medical care.
An Express Scripts spokesman declined to comment on the lawsuit and referred us to a page on the company web site in which an explanation for the policy change was made.
The compounders maintain that Express Scripts is violating federal law, because the pharmacy benefits manager allegedly lacks the authority to alter the terms of the affected health plans, according to the lawsuit. As an example, the lawsuit cites a health plan served by Express Scripts in which compounded medicines and ingredients have not been listed as excluded.
“In order to cover up its financially driven scheme, Express Scripts… is issuing intentionally deceptive and misleading letters to patients informing them that there is an unspecified change in their compound medication benefits and that there is a purported lack of FDA approval for compound medications, which is untrue,” the lawsuit states.
The lawsuit goes on to argue that, until now, Express Scripts “routinely paid” for compounded drugs as “medically necessary, efficacious and properly prescribed by patients. The letters are a misleading scare tactic and pretext invented to cover up its true financial goal behind the scheme.” The lawsuit cites a document indicating the move is designed to cut compound spending by 95%.
The safety of some compounded medications became a hot topic two years ago after an outbreak of fungal meningitis was traced to a compound pharmacy in Massachusetts and led to dozens of deaths. This prompting Congress to pass a law called the Drug Quality & Security Act to boost oversight. The FDA, meanwhile, has responded by increasing inspections and issuing warning letters.
Compound pharmacies, however, have been chafing over the law, which creates two classes of compounders – one that voluntarily chooses to register with the FDA and another that may decline to do so. The first group is subject to certain conditions, such as meeting good manufacturing practices, but the FDA hopes the requirements will give hospitals and physicians the confidence needed to purchase needed compounded medicines.
Recently, the International Academy of Compounding Pharmacists, a trade group, began lobbying Congress to alter the law and make “technical corrections.” In response, a group of trade groups for drug makers, along with the Pew Trust, wrote to the FDA to express support for the law in its existing form.