CONFIRMED: The maker of EpiPen overcharged the government

christiefan915

christiefan915

Catalyst
Contributor
The Centers for Medicare & Medicaid Services (CMS) confirmed to lawmakers that Mylan, the drug company that makes EpiPen, has been overcharging the government for the life-saving allergy medication. And naturally, lawmakers are furious about it.

...What the senators wanted to know was whether or not Mylan manipulated the Medicaid Drug Rebate Program (MDRP) by classifying EpiPen as a generic drug when it is in fact not. The short answer from CMS that we have now is: Yes, but they're not sure by how much yet.

...by being classified as a generic Mylan saved itself a bunch of money. Back in 2009, Mylan paid a $124 million fine for misclassifying its drugs and under-paying rebates this way. It is the responsibility of the manufacturer to maintain accurate information of its drug's status. From 2011 to 2015, government spending on EpiPen increased 463%, from $86 million to $487 million, according to CMS. This table was included in their letter.
screen-shot-2016-10-05-at-3.53.56-pm.png

Now it looks like the government may want a chunk of that back.

http://www.aol.com/article/news/201...en-overcharged-the-government-and-l/21575234/
 
Celticguy said:
Gee right about in time for obamacare.
No wonder big pharma jumped on board that gravy train.
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Uh, they've been doing this since 1997.

"A review of our records indicates that, prior to 1997, EpiPen was reported as a single source, or brand drug, for the Medicaid Drug Rebate Program. Since the fourth quarter of 1997, EpiPen has been reported as a non-innovator multiple source, or generic drug. EpiPen is approved under a New Drug Application (NDA) by the Food and Drug Administration (FDA), has patent protection, and has no FDA-approved therapeutic equivalents."
 
christiefan915 said:
Uh, they've been doing this since 1997.

"A review of our records indicates that, prior to 1997, EpiPen was reported as a single source, or brand drug, for the Medicaid Drug Rebate Program. Since the fourth quarter of 1997, EpiPen has been reported as a non-innovator multiple source, or generic drug. EpiPen is approved under a New Drug Application (NDA) by the Food and Drug Administration (FDA), has patent protection, and has no FDA-approved therapeutic equivalents."
Click to expand...

Chart shows 2011.
 
Celticguy said:
Nope. What's surprising is that no one else in the self injectable biz have not offered an alternative.
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The issue is the injector mechanism itself.

Mylan has the patent on that until 2025, and coming up with a better alternative that won't infringe on that patent is the hurdle other manufacturers have yet to jump over.

In addition, anaphylaxis isn't a problem that an overwhelming majority of people face. It's about 2% of the population that's at risk of anaphylactic shock (roughly 1 in 50 people), so until recently there hasn't been a lot of noise about the price of epipen.

The one good thing that may come out of Mylan's obvious cash grab is that it's brought attention to the price.
 
Epipen maker Mylan has agreed to pay $465 million to the government.

The embattled pharmaceutical company said Friday it has agreed to a settlement with the Department of Justice and several other agencies. Mylan was accused of falsely classifying Epipen, a life-saving allergic reaction treatment, in order to overcharge Medicaid for them.

Mylan does not admit to any wrongdoing, the company said in a statement Friday. Drugmakers pay rebates to Medicaid under the Medicaid Drug Rebate program -- and companies pay less money if a drug is classified as generic.

Mylan makes both a generic and name brand version of Epipen, but it was recently discovered that Mylan was paying the lower, generic rate to Medicaid for its name brand Epipen.

The Department of Justice could not immediately be reached for comment.

http://money.cnn.com/2016/10/07/news/companies/epipen-mylan-465-million-fine/
 
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