Monday, December 1, 2014

Express Scripts May Have the Most to Gain and Compounding Pharmacies May have the Most to Lose from the Pending Lawsuits

Sue Tuck Richmond
December 1, 2014

Earlier this year Express Scripts said the average cost for compounded prescription had risen from about $90 to $1,100 and that in a number of cases less expensive alternatives than compounded prescriptions existed.  Express Scripts then took a bold move.  It then announced it would deny coverage for approximately 1,000 active ingredients  (API) used to make a variety of compounded medicines.  Three compounding pharmacies filed a federal lawsuit, claiming Express Scripts is violating federal law.

As I have mentioned before on the blog, I think there is a potential issue of whether these compounding pharmacies have standing to bring this lawsuit.  At this point, I will leave that issue to the lawyers in the case and the court to determine.

Assuming this case moves forward on the merits with no one being dismissed for lack of standing, the final results will be ground breaking to say the least.  What is also going to be very interesting is the discovery phrase.  The underlying documents that these compounding pharmacies may have to produce in discovery could end up being very telling about the industry.  In some ways, one might hope that standing isn't an issue just so documents can be produced, interrogatories can be asked and answered, and depositions can be taken.  A wealth of information about the compounding industry could be invaluable.  There has been some chatting on the internet about this becoming a class action. Wow. Wouldn't that be a "discovery" dream for some to learn all the in's and out's of the compounding industry.

If Express Scripts loses the lawsuit filed against them by three compounding pharmacies, what have they lost?  Sure compounding pharmacies will claim victory and tout how they fought for patient's rights. Sure Express Scripts will have lost legal fees involved in the litigation, but the bottom line is they will just go back to covering API that is used to make compounded medications as they did prior to their announcement to exclude coverage.

The bigger issue is what will the compounding industry lose if they three compounding pharmacies lose this case.  There will be binding precedent on that books that allows PBMs to exclude coverage for API used to make compounded medications.  Other PBMs and insurance companies could then follow Express Scripts lead to not just restrict coverage but also to eliminate coverage causing compounding pharmacies to lose a bigger piece of the pie than they have already lost.   In my opinion the stakes are very high for compounding pharmacies in this lawsuit.  In my opinion, it is essential that they win the cases they have filed; otherwise, their decision to sue may have a much larger impact than compounding pharmacies, pharmacists and consumers of compounded drugs have bargained for.

This is definitely a case to keep a close watch on.  It will most likely have a huge impact no matter who wins the case.

ASADA seeks subpoenas to compel Shane Charter and Nima Alavi to give evidence in Essendon case

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    www.foxsports.com.au/.../story-e6frf3e3-1227140988775
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    13 hours ago - ... the banned peptide Thymosin beta-4 to former Bombers sports scientist Stephen Dank in 2012 and Alavi the pharmacist who allegedly compoundedthe drug.

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Between state crackdowns, drug formularies, and stricter inspections compounding pharmacies are feeling the pressure....read Ben Miller's article at Worker's Comp central

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    www.theaustralian.com.au/.../story-fnca0u4y-12271411051...
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Question of the Day December 1, 2014 Just as the ASADA is having trouble producing witnesses, isn' this a problem in the United States regarding illegal compounding pharmacies and pharmacist who make illegal compounds? No one in the industry (especially the good compounders) wants to do what is right and report or give evidence against the bad compounders, and this in turn tarnishes the good compounders because they stand by silently as if aiding and abetting the bad, illegal compounders to stay in business, allowing all compounders not just the ones who deserve the negative, bad image to receive it. What long-term effect will this have on the good compounders? Will they eventually be the ones forced out of business by the corruption and illegal compounding?


ASADA reportedly struggling to produce key witnesses in case against 34 past and present Essendon players : Alavi told the anti-doping agency a batch of Thymosin from China was delivered to his pharmacy and he compounded the peptide and gave it to controversial sports scientist Stephen Dank.

ASADA reportedly struggling to produce key witnesses in ...

www.abc.net.au/.../5931420?...
Australian Broadcasting Corporation
6 hours ago - Alavi told the anti-doping agency a batch of Thymosin from China was delivered to his pharmacy and he compounded the peptide and gave it to controversial

Prime Therapeutics Pharmacy Audit Recovery Guidelines

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www.primetherapeutics.com/.../RecoveryGuidelinesE...
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20 hours ago - original documentation supporting drug was compounded. CNE. Incorrect. NDC(s) billed on compound claim. Incorrect NDC submitted for XYZ drug- Pharmacy.