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Feds Go After Mylan For Scamming Medicaid Out of Millions On EpiPen Pricing (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: Over the nine or so years that Mylan, Inc. has been selling -- and hiking the price -- of EpiPens, the drug company has been misclassifying the life-saving device and stiffing Medicaid out of full rebate payments, federal regulators told Ars. Under the Medicaid Drug Rebate Program, drug manufacturers, such as Mylan, can get their products covered by Medicaid if they agree to offer rebates to the government to offset costs. With a brand-name drug such as the EpiPen, which currently has no generic versions and has patent protection, Mylan was supposed to classify the drug as a "single source," or brand name drug. That would mean Mylan is required to offer Medicaid a rebate of 23.1 percent of the costs, plus an "inflation rebate" any time Mylan raises the price of the brand-name drug at a rate higher than inflation. Mylan has opted for such price increases -- a lot. Since Mylan bought the rights to EpiPen in 2007, it has raised the price on 15 separate occasions, bringing the current list price to $608 for a two-pack up from about $50 a pen in 2007. That's an increase of more than 500 percent, which easily beats inflation. But instead of classifying EpiPen as a "single source" drug, Mylan told regulators that it's a "non-innovator multiple source," or generic drug. Under that classification, Mylan is only required to offer a rebate of 13 percent and no inflation rebates. It's unclear how much money Mylan has skipped out on paying in total to state and federal governments. But according to the state health department of Minnesota, as reported by CNBC, the misclassification cost that state $4.3 million this year alone.
It's not an innovative drug. Autoinjectors are nothing new. Epinephrine is a very old, off patent drug. It's not innovative, and there are many sources of epinepherine. In fact, in spite of the lying politicians, we managed to buy a generic for a total of $70; only $11 copay. The kid's doctor just prescribed the generic. This is 100% politicians trying to get Hilary elected, much like the stunt that caused a run on Deutsch Bank.
The pricing structure is a complete scam, and they outright lied to congress on the profit margin.
The company claimed on official government forms for multiple years that the drug is a generic. Make it so. Job done. The government can do that.
Learn to love Alaska
ban drug ad's on tv!
grumpycatgood.jpg. Send the CXX suite to prison for a few years, fine then the millions they made on the scam, and maybe it will slam on the brakes to other companies jacking up the price of generics that were discovered 50 years ago.
Peasant, don't you realize that Mylan is run by a Democratic Senator's daughter? Your lowly kind is not allowed to criticize the royalty of the exulted overclass! Grandees like Manchins or Clintons are not subject to your grubby "laws," nor are their gets.
Know your place!
The Mylan brand Fentanyl patch has jumped to $45 per patch, it doubled in price a few years ago with the BS excuse that there was a shortage. I have to get generic now which only costs $10 per patch because my insurance won't cover it.
"bringing the current list price to $608 for a two-pack up from about $50 a pen in 2007. That's an increase of more than 500 percent," Is my math wrong or should is that increase more like 1200%?
$4.3M in fines... Lets see, increase the price of EpiPens by $200... Report it as a "research investment"...
I'm not sure what all the fuss is about regarding the profit on a medicine and why Mylan would need to lie to congress or anyone else regarding its profit. If they have a patent on a product the company can charge what ever they want and if folks don't want to pay the price they don't have to buy it. In our economy there are many products where the cost of purchase has little relationship to the cost of manufacture. Other examples in the pharmaceutical industry are rampant including those of Martin Shkreli (see https://en.wikipedia.org/wiki/...). There are two examples cited where the price of drugs purchased by companies he was associated with were raised 5,556% (the antiparasitic Daraprim) and 2,000% (Thiola). The price of the second has not been reduced even though Shkreli was removed from the company. Not sure about the first. These prices made a lot of money for the companies, its share holders and the senior executives. Isn't that what capitalism is all about?
In a time of universal deceit, telling the truth is a revolutionary act. George Orwell
As much fun as it is to use Mylan as a punching bag these days, there's a final point in the Ars article that leads me to think this is hardly in the bag for the Feds.
And if that's true - that Medicare was already applying the âoenon-innovator multiple sourceâ rebate schedule to the EpiPen back in 2007 - then that makes this case a lot murkier. The Feds would then have to make a case as to why the drug can and should be reclassified at the higher âoesingle sourceâ tier. It's clear that in practice the EpiPen is a single source device, but the conflict at the heart of this is one of bureaucracy and not medical practices; the Feds would need to justify both the higher rate now, and why they're not culpable for approving the lower rate in the first place.
Given how long that this is going on, I suspect that this isn't an easy case to prove, otherwise the Feds would have done it already. Instead it's probably being brought back up now to either apply additional pressure to Mylan, or to strike while the political iron is hot.
So get Musk to make one and he'll roll it out without FDA approval.
He did just put out an upgrade to the autopilot that can take freeway off ramps.... except it doesn't slow the car down:
http://jalopnik.com/psa-dont-try-to-take-highway-off-ramps-with-teslas-aut-1787206951
No road worthiness law is enforced against Tesla, he's free to just do stuff and nobody dares touch him. Musk would just make the pen, get users to sign an EULA, and be done with it.
All, current government price for 1 box of EpiPen is $212 dollars. This is the VA/DoD contract pricing which is devoid of additional rebates only our wholesaler markup. Therefore, Mylan gets about $200 from each DoD script. So their profit on retail is double that of DoD/VA.
~DoD Pharmacist Manager
The fact that Mylan can charge these prices is government regulations and government-granted monopolies.
And it's hardly surprising why Mylan got this monopoly on a silver platter: they are politically well connected (with Democrats in this case).
Die. Die in several fires. With vigor and fervor. *cockpunch*
In a world of the blind, the one-eyed man is king--and the two-eyed man is a heretic.
And if that's true - that Medicare was already applying the âoenon-innovator multiple sourceâ rebate schedule to the EpiPen back in 2007 - then that makes this case a lot murkier. The Feds would then have to make a case as to why the drug can and should be reclassified at the higher âoesingle sourceâ tier. It's clear that in practice the EpiPen is a single source device
Is it clear? There are other options out there (e.g. Adrenaclick), if you get your doctor to prescribe an "epinephrine autoinjector" instead of specifying "Epipen" by brand name. How different is that from other drugs? If you get a prescription for, say, Lipitor, can you fill that with a generic? Or can you only do that if you get a prescription for atorvastatin rather than the brand-name?
http://www.consumerreports.org...
rage, rage against the dying of the light
When you quintuple the price of an already expensive, widely purchased, life-saving device that is paid for largely by Medicaid and Medicare funds, you should expect that the government that is paying for your device will take notice and comb through the salient documentation to see if there is some possible legal problem with your price increase. Had the government not done so, we'd all be screaming that they were negligent in their financial oversight duties.
Really, these guys are just a different type of patent troll.
these clowns should get crucified for basically holding the public hostage
1 RICO charges should be filed against the company and the execs (i think its called separately and corporately liable??)
2 the IRS should do a full bore forensic audit on the paperwork for the last 7 years
3 the company should be required to pay back every penny plus 25% of the increase
4 their entire patent portfolio should be wiped and they should be required to assist any company currently in the same or semi related market on building a duplicate (in fact those patents should become PD)
if this does cause the company to become bankrupt then the Execs should be bared from any medical business for the next 15 years (or just give them all a nice 10-20 in a not actually nice prison)
next up for the Full Roman Treatment the guys that make Naloxone/Narcan
... a wall a blindfold a fag and ... five minutes will do wonders to the non-productive acquisitive class.
The drug itself is generic. The mechanism in a modern EpiPen is still covered by patents, I say modern because the design gets frequent updates with all new patents.
There are other autoinjectors for Epinephrine. Some of them are not very good, which is a shame because the old 1997 design from Meridian Medical would be to old to still have patents yet it is a satisfactory design.
One problem with these different autoinjectors is that doctors usually teach a patient how to use a particular design, and drug reps usually introduce doctors to the injection method. It's not hard to learn to use one, but every design is a little bit different. And if you're not familiar with a particular design it can result in accidental injection. Some old designs had two doses, but these end up being kind of complicated to use safely, even if they are half the cost of a 2-pack.
that is all. nigger
Drug Dealers steal money, film at 11.
EpiPen comes from Epinephrine. It's called that because it's a pen-like device that injects Epinephrine. Another more commonly known name for Epinephrine is Adrenaline. It's a pen-like device that injects Adrenaline.
Adrenaline/Epinephrine is as "generic" as it gets. You can even extract it from animals. It costs next to nothing. When OP writes "a brand-name drug such as the EpiPen", that is grossly misleading. The "drug" inside is a naturally occuring hormone, and the medical device used to inject it isn't a drug.
Just because they have patented this particular method of drug delivery doesn't mean that others cannot be used. You could inject the drug using a syringe. You could make another type of auto-injector.
Making any kind of judgement about this is hard. From the wording itself, Mylan seems absolutely in the right - Adrenaline is a non-innovator multiple source drug.
It's possible that there are particular rules that extend the term "drug" to a one of several methods of delivering that drug, so that e.g. a syringe could be classified as a drug. But that would be speculation.
This is just more of the mindless agitation, trying to make people angry, and exploiting that anger.
I would suggest an investigation of Health insurance Companies and Big Pharma to see how interlocking the Boards of the companies are. Also source drugs from outside the United States. If you recall they passed laws to make you a criminal for going to Canada for your prescriptions. Call them all in for Congressional hearings and threaten to re-instate anti-trust laws on all involved Bust up the biggest of the bunch. Set down and tell the AMA that there will be more admissions allowed to medical school and there would be government incentives for more medical schools at Public universities. Make it so there are as many Doctors in this country as Subway sandwich shops. To make it more competitive for the consumer. It's sad that free market economies have gotten down to precisely controlled conspiracies to fleece the public. Physician heal thyself. Of course you will have to Jail the members of the house and senate for corruption on failing to investigate the corruption.
With the patent system as it is, where genetic codes and proteins can be patented, and where protection for drug profits is long and deep, there are situations like this that come up that allow unscrupulous companies to hike drug costs ridiculously like these clowns at Mylan.
Yes, many drug research efforts don't pan out. But Epinephrine has been out for a long time. Is anyone seriously going to try to tell me that $50 in 2007 became $304 in 2017? Even given the bogusly low inflation rates that are officially reported, that's insane.
This is profiteering. If the company didn't need to profiteer in 2007, why do they in 2017? No good reason methinks.
How about the definition of sole source is 'no equivalent product available at present'?
And how about you cap the rates at which drug costs can increase unless the providers can show material evidence that their costs have escalated so much?
I don't have $608 to shell out (US) for something I have to replace every 1-2 years. I'm carrying an old epi-pen that's probably not as efficacious now, but it's likely still better than no pen. I just can't afford the money to get a new one (let alone two, since protocol says you hit yourself with the first and about 30 minutes later the second if you haven't reached emergency medical care).
This should be a true generic. There should be equipment whose patents have an earlier mandatory expiry because they exist in the space called 'in the interest of public health'. I'm not suggesting these guys shouldn't have got their money back, but seems to me they are well beyond that point now.
On the other hand, this is exactly why the government or NGOs should be investing in some sorts of medical research in the public interest and making the product patents entirely open and available.
Epinephrine isn't patented. Its the injector. This seems like the kind of thing a Gates Foundation or even the Government could underwrite the development of (and may have already for Atropine and the like in prior days, if we call those syrettes an early version). Make the injector patent available and then it truly is generic because epinephrine is not patented.
The reality is that big Pharma has great lobbyists, political connections, and lawyers and the whole US patent system around biomedical issues defies any sort of common sense or rational thinking.
I hear rumours of alternatives, but I'm not sure they are available beyond the US borders. The Epipen fiasco and the price rise has hit many of us living in other countries too, but I'm not sure any alternatives exist where I live. I am going to look into that now though.
Patents should help protect innovation, but not form monopolies artificially (well, that may be other legislation that does that but that also needs looked at), should not have extensive duration, and should have clauses surrounding medical equipment that if the equipment price rises too quickly or if the provider becomes sole source, that the patent becomes licenseable by other companies for a very modest fee. At some point, the public interest has merit at least as great as profits for corporations.
-- Mal: "Well they tell you: never hit a man with a closed fist. But it is, on occasion, hilarious."
This is why other countries enforce a single buyer system. The US government can't give corporations entitlements (rubber-stamped patent, paperwork advantage), then complain when the corporation maximizes profits. The government can't do anything if other pharma corporations don't want to compete, or the paperwork advantage prevents fair competition.
The government can stop subsidizing the epi-pen and recommend alternative products (hopefully without mentioning brand names), after all, they're not making consumers buy the recommended products. Or, since Obama wants patent reform, the government can contest the epi-pen patent which will allow other pharma corporations to make injector pens without fear of a lawsuit.
And you Americans respond to this, not with "This company is a bunch of unethical shitbags by raising the price of this livesaving medicine from $50 to $600, they should be imprisoned and the entire fucking system replaced with something better" but "Oh hey, it would have been ok if they'd given us a cut of the profit"
Unless Trump wins the election that is. The CEO of Mylan is Heather Bresch, and her father is US Senator Joe Manchin, D-WV. Her prosecution cannot happen under a democratic administration.
Why would Mylan agree to such terms for Medicaid? If Mylan just says "This is the price, buy it, don't buy it, develop an alternative, approve an alternative -- we don't care. If you don't commit to buying some number of units, we may not be able to meet your demands so you will have to buy them at inflated prices on the secondary market. Let us know by next Tuesday.", then Medicaid needs to pay for it or declare that it's not a covered medication for those on Medicaid.
Presumably Medicaid could institute a training program to teach injection without "autoinjectors" to everyone (patients, caregivers, responders in schools etc) who might need to use the "low-tech" solution. However, that would probably be much more expensive than paying list price.
It seems that pharma, if they played their cards right, would discover that the government actually has little negotiating power since Medicare (especially) and Medicaid patients will go to their Congresscritters to complain if a drug isn't covered and their representatives would, for political rather than strictly medical or economic reasons, insist that the drug be available regardless of cost. For an example of how political forces result in bizarre outcomes, consider that Medicare covers late stage renal failure for those under 65 for some reason, but almost no other chronic and expensive conditions are covered for those under 65.
Why is there an "insightful" mod and why isn't it "-1"? If I wanted insight, I wouldn't be reading
The UK NHS net prices for the 3 alternatives approved in the UK are:
Emerald (iMed) £26.94
EpiPen (Meda) £26.45
Jext (ALK-Abelló) £23.99
(aproximately US $30 to $35)
https://www.evidence.nhs.uk/formulary/bnf/current/3-respiratory-system/34-antihistamines-hyposensitisation-and-allergic-emergencies/343-allergic-emergencies/anaphylaxis/adrenalineepinephrine
Meanwhile, in the civilised world, our govenments negotiate huge bulk discounts, and prescrition drugs are subsidised to a fixed maximum.
The best part, we spend less per capita than the US on healthcare. Go figure.
It's a generic.
http://adrenaclick.com/
(And there are others in Europe.)
Mylan marketed EpiPens as if they were a big time non-generic drug, getting many health care providers (including many Medicare offices) to agree that EpiPen was the preferred (or mandated) brand for their patients. This is all marketing and contractual monopolies, not patent protection.
This whole debacle exposes that our health care system cannot properly evaluate competition and cost. When you tell someone "you're the only one I'm going to buy this from, and I'm going to make it really, really hard for anyone else to get even a part of this contract," you're going to get ripped off. It is this severe lack of business sense on the part of our health care administrators (public and private) that allow BS like this to happen. Medicare offices should be working to ensure that they contract with at least two sources for any off-patent drug or device.
Every prescription I've ever gotten has had a thing on it that says that it can be filled with generic equivalents. And responsible, ethical doctors would never write a name brand on a prescription.
> And responsible, ethical doctors would never write a name brand on a prescription.
There can often be subtle differences, including quality, packaging, and filler components, that make one version more effective for a specific patient. So yes, sometimes doctors do name a specific version of a medication for good medical reasons. "Generic" does not mean identical.
Sometimes that may not be the best option for the patient however:
"Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias" http://www.ajconline.org/article/S0002-9149(00)00715-3/abstract
Epinephrine is not a "brand name drug". It's a hormone. Humans produce it. Animals produce it. It's been used medically for scores of years. It's as much of a "brand name" as insulin. Epi-Pen is the INJECTOR, not the drug itself. Now if you're going to tell me that no one else should be allowed to produce an auto-injector - ANY auto injector, because someone has a patent on one DESIGN, then America deserves this. Insulin syringe, 1:1000 epinephrine ampule 1cc, inject .5 cc subcutaneous or im and voila, the $4 "Epi-Pen".
Seven puppies were harmed during the making of this post.
It makes me sad to read all these cries for supposedly needed increases in regulation and how supposedly the Mylan situation shows that "free market" failed. No, it shows entirely the opposite. The whole reason the situation is the way it is is BECAUSE OF vast amounts of regulations. The patent system needs a total reform and there needs to be a very through audit into the practices of the FDA.
" The point is, ladies and gentleman, that greed -- for lack of a better word -- is good.
Greed is right.
Greed works.
Greed clarifies, cuts through, and captures the essence of the evolutionary spirit.
Greed, in all of its forms -- greed for life, for money, for love, knowledge -- has marked the upward surge of mankind." (Gordon Gekko)
The USA doesn't want to be civilized. We want to be great again, not civilized! The USA is going to build a wall, and make the civilized world pay for it! Trump 2016! He'll outlaw belly fat!
Ask your doctor for a generic? Sounds like work to me. It's much easier to pass a bunch of complicated regulations to force things to be cheaper so I don't have to do anything.
My Other Computer Is A Data General Nova III.
This isn't tech, it's not even YRO. It's politics over an off-patent chemical in a fancy plastic case with a stabby bit inside. Why is this on the front page, or even at the site at all?
One problem is that the only word that people know how to use to describe Epipen-like injectors is, er, well "Epipen". Arguably the trademark word "Epipen" has become part of the standard English language like "Escalator", "Aspirin", "Jello" and the like. The trademark puts any competitor (present or future) at a huge disadvantage because they can't use the word Epipen, and the public doesn't know how to ask for anything else.
Another big problem in this space is that the time and money to get FDA and insurance reimbursement approval for generic (off-patent) products huge. This creates a large barrier to entry and helps keep the cost of health products crazy high.
Private company hikes prices by a lot, and scams the Guvmint.
Which somehow becomes an indictment of "socialized" medicine, and showing how the private market is superior and honest and trustworthy.
The shepherds did so well protecting the flock that the sheep no longer believed that wolves existed.
You can cheat the citizens, but you can never cheat Uncle Sam. Doesn't matter if we get screwed, only if the government sees a loss. Then suddenly it becomes a priority.
Weaselmancer
rediculous.
....shake their heads at your whining.
....what's the big fucking deal then? Does the brand name label mean do much to you? Snobbish much?
Every single Mylan employee who needs an Epipen should be found, their allergy triggered and left to die without an Epi.
If they want to go with the "we arent the only ones making this" so they dont have to give so much back to the government, then the government should waive their patent protection and allow other companies to make the stuff. Problem solved, people would then get the things at a reasonable price and the company wouldnt be lying.
They should simply rescind the patent as punishment for stiffing the government.
Don't just stand there, get that other dog!
It may well have been a generic with multiple sources back in 2007. As I understand it, Mylan made some design tweaks, patented them, and then claimed that anyone making a generic version would be infringing on their new patents.
These Drug Companies are only in it for the money. Please shut them down or force them to provide reasonable pricing and provide CURES not a "drug" that makes you feel better that you have to use for your entire life making the drug companies trillions of dollars. I understand the EpiPen is a value and needed product, but come on $608 for a 2 pack that is outrageous!!
There was the generic adrenepak and another whose name escapes me at the moment (it was the subject of an FDA recall), so it is *not* a single-source drug so the higher Medicaid rebate amount is not called for. It seems the real problem isn't the price of the epipen, it's that doctors are writing name-brand epipen prescriptions, locking patients into the higher-priced product. In most states pharmacists can not supply generic equivalents when provided with a name brand-specific prescription.
Nothing will happen because the CEO's Daddy is a big wig Democrat with enough Clinton connections to stop any of this from getting to the criminal stage. It'll be business as usual for the most corrupt political party this side of Stalin's Bolsheviks.