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Compounding Pharmacies Filing Suit Against Express Scripts

December 22nd, 2014

Compounding pharmacies are specialized drug providers. They carefully follow physicians’ instructions for medications that are not manufactured by large drug companies. For the most part, compounding pharmacies create topical treatments such as creams, powders and ointments made up of highly specific active ingredients. The work is labor intensive and many of the drugs that are created are personalized for each patient’s needs.

Though these pharmacies have been in existence for many years and the drugs that they create have traditionally been covered by prescription insurance, this past summer the nation’s largest pharmacy benefit manager, Express Scripts, announced that they would no longer be providing coverage for about 1,000 of the ingredients that compound pharmacies use. In response, three of the nation’s compounding pharmacies have filed suit against the company, claiming that the company’s action is illegal and is forcing patients to either do without the medicine that they need or to choose more expensive treatment.

According to the lawsuit, Express Scripts actions are motivated by cost interests, and it is true that at the time that the change in coverage was announced, an official from Express Scripts indicated that the average cost of filling compound prescriptions had changed from $90 to $1,100, and that lower cost alternatives were available. However, when asked to comment on the lawsuit, Express Scripts had nothing to say other than referring to a page on their website that indicated the reasoning behind their shift in coverage.

The pharmacies’ suit charges that the change in coverage is a violation of federal law and that the company does not have the authority to make the change. They also claim that Express Scripts is being purposely deceptive. The lawsuit states, ”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.”

There is no doubt that prior to the change in policy, Express Scripts described compounded drugs as “medically necessary, efficacious and properly prescribed by physicians.” The compounding pharmacies specifically reference as evidence an Express Scripts document that cites that the goal of eliminating compound drugs is a spending cut of 95 percent.

Express Scripts reference to FDA approval stems from changes in the laws governing oversight of compounded medications. These changes followed a fatal outbreak of fungal meningitis that originated with a compound pharmacy in Massachusetts. The law, the Drug Quality and Security Act, boosts oversight and has issued warning letters and pursued an increased number of inspections. Compound pharmacies may choose to register with the FDA, and in choosing to do so (or not to do so) place themselves in one of two classes of compounders. The International Academy of Compounding Pharmacists, a trade group, has been lobbying Congress to make adjustments to the law.

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Gavin P. Lentz, Esq.
Bochetto & Lentz

Gavin Lentz (right) was selected as a "Super Lawyer" for 2006-2009 and 2010-2015 in New Jersey by Philadelphia Magazine. He has also been selected as a "Super Lawyer" by Philadelphia Magazine and the Legal Intelligencer in 2004, 2005, 2006, 2007 2008, 2009, 2010, and 2011 - 2015.

On September 16, 2002 Mr. Lentz was selected as one of the top 50 lawyers in Pennsylvania by the Legal Intelligencer.

He has made many television appearances, including on Fox News, The Today Show, Inside Edition, and The Phil Donahue Show.

Mr. Lentz is a member of the American Trial Lawyers Association and the Million Dollar Advocates Forum.

As a former prosecutor, he knows how to aggressively go after large pharmacy chains to prove the facts necessary to protect your loved one's rights.

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