Tag Archives: medicare

Blog, Business Law, Drug Companies, Legal News

Trump administration plans to require drug companies to include prices in ads

BY JESSIE HELLMANN AND NATHANIEL WEIXEL – 10/15/18 04:33 PM EDT

Drug companies would be required to list prices in advertisements under a Trump administration proposal released Monday.

Under the new proposal, which was announced by Health and Human Services Secretary Alex Azar, drug manufacturers would need to state the list price of a 30-day supply of any drug that is covered through Medicare and Medicaid and costs at least $35 a month.

The plan is the boldest step the administration has taken to date as part of its efforts to bring down drug prices, and puts the administration squarely at odds with the powerful prescription drug lobby.

“Patients deserve to know what a given drug will cost when they’re being told about the benefits and risks it may have,” Azar said during a speech Monday in Washington, D.C.

“And they deserve to know when a drug company has pushed its prices to abusive levels, and they deserve to know this every time they see a drug advertised to them on TV.”

The proposal will be officially published Wednesday, and will be open for public comment for 60 days.

According to HHS, the 10 most commonly advertised drugs have list prices ranging from $535 to $11,000 per month for a usual course of therapy. Under the proposal, companies would be required to post that information in clear, legible text onscreen at the end of the ad.

HHS officials said the agency will publish a list of companies that don’t comply with the policy. Those companies would also be subject to potential litigation, officials said during a press call.

The pharmaceutical industry opposes the proposal, arguing it would confuse consumers because a drug’s list price is often lower than what the patient will actually pay.

PhRMA, the deep-pocketed trade group representing pharmaceutical companies in the U.S., tried getting ahead of Azar’s announcement, telling reporters Monday morning that its members would begin directing patients to more information about drug costs in television ads.

Every ad mentioning a prescription drug by name will include a voiceover or text telling patients to go to a company-sponsored website where they can find information about the list price, as well as a range of potential out-of-pocket costs and potential patient assistance. 

“We want patients to have more cost information and support using direct-to-consumer advertising,” said PhRMA President Steven Ubl, but “just including list prices is not sufficient and would be misleading.”

Azar acknowledged PhRMA’s plan in his speech Monday afternoon, but said it doesn’t go far enough. 

Full Read – https://thehill.com/policy/healthcare/411505-trump-administration-to-require-drug-companies-include-prices-in-ads

Blog, Business Law, Drug Companies, Legal News, Personal Injury

Has Charitable Giving Become A Profitable Form Of Investing For Pharmaceutical Companies?

Martin Shkreli, the notorious ex-CEO of Turing Pharmaceuticals, made waves last summer when he purchased the rights to Daraprim and raised its price more than 5,000 percent. Physicians use the drug to treat toxoplasmosis, a life-threatening condition that affects those with weakened immune systems (due to HIV/AIDS, etc.).

Days after Shkreli’s purchase, he contacted Patient Services Inc., a charity committed to making medical care more affordable. Shkreli wanted to create a fund for – you guessed it – patients who suffer from toxoplasmosis.

Patient Services Inc., or PSI, jumped at the opportunity, suggesting an initial donation of $22 million, including $1.6 million of its operational costs. Shkreli countered with an offer of $1 million and $80,000 of the company’s costs. This was a paltry offer, considering that Daraprim now costs $60,000 to $90,000 for six-week treatment in light of Shkreli’s price hike.

And that isn’t the worst of it.

Finding A Loophole

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PSI is a copay charity, one of seven large ones in the U.S. health care system. It exists to offer payment assistance to the 40 million Americans who qualify for Medicare, helping them to a smaller copay and smaller up-front costs. Even with the help of copay charities, Medicare recipients were still paying around $3,000 for their Daraprim prescriptions.

American taxpayers shoulder the difference. This is where the controversy of “charitable giving” comes into play. By donating a paltry $1 million to a copay charity, Shkreli was able to collect millions more from Medicare, thanks to his own drug price hike. “Big pharma” benefits, while taxpayers and patients suffer.

The Great Charitable Giving Illusion

Many pharmaceutical companies give the illusion that they participate in charity copay for altruistic reasons. Congress recently released an internal case study of Turing Pharmaceuticals, suggesting that its patient payment programs should be “repeatedly referenced” to promote public relations. Experts explain that giving millions to these copay charities makes pharmaceutical companies look altruistic, when the opposite is actually true.

The real intent of these donations is often to deflect criticism when they hike drug prices, leaving the health care system to pick up the broken pieces.

A History Of Deceit

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Daraprim may be the most high-profile example of this charitable funding phenomenon, but it’s certainly not the first. Retrophin, another drug company run by the now-infamous Shkreli, hiked the price on Thiola, a drug intended to treat recurring kidney stones, nearly 2,000 percent. At the same time, his company gave a donation to PSI for kidney stone patient copays.

Read Full Article – https://www.summitbehavioralhealth.com/blog/charitable-giving-profitable-investing-pharmaceutical-companies/

Blog, Business Law, Drug Companies, Legal News

Drug Companies Subpoenaed Over Questionable Charity Connections

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Whenever there is a report of a drug company jacking up the price of a prescription medication, the pharma industry is often quick to point out that there are non-profit charities ready and willing to help patients get these drugs at a more affordable rate. However, those charities may have very close ties to the drug maker that could not only help the company turn a profit, but avoid some tax obligations. In recent months, several large pharmaceutical companies have been subpoenaed as part of an ongoing federal investigation into these connections.

It works like this: Bob’s Drug Company acquires the rights to prescription drug Gleemonex and decides to jack up the price 500%, knowing that some people will not be able to afford the co-pay. However, it’s in the interest of Bob to keep as many patients using Gleemonex as possible, so it looks for ways to make the drug more affordable to those most in need: low-income patients on Medicare.

Now, Bob’s Drug Co. can’t directly fund the co-pay of a Medicare patient. That would effectively be Bob paying Bob, which is an illegal kickback under federal law. What Bob can do is call Sally’s Drug Charity, which will cover the Medicare co-pay on certain drugs.

So Bob makes a sizable donation, which Sally can then use to make Medicare co-pays, meaning patients continue using Gleemonex.

Thing is, while the Medicare patient isn’t having to go broke paying for Gleemonex, taxpayers might be. After all, the co-pay is usually only a fraction of the full amount that Medicare pays to the drug maker. Thus, Bob continues to get the full Medicare payment and enjoy the tax write-off from his donation to Sally’s charity.

Bloomberg BusinessWeek recently published an entire cover story on how the pharma industry uses these charities for their own financial, tax, and public-relations benefit. You should definitely check it out.

Today, Bloomberg published a story on the string of subpoenas issued to four high-profile pharma companies — Valeant, Gilead Sciencse, Biogen, and Jazz Pharmaceuticals — since last fall, mostly by federal prosecutors out of Massachusetts.

The nature of the subpoenas is vague, though they do reference investigations into the companies’ relationships with co-pay charties.

With Medicare on the hook for the balance of these prescription payments, the federal government is taking a particular interest in the possibility that drug makers have exerted too much influence over these charities as donations have grown.

Since 2010, donations to the seven biggest co-pay charities have more than doubled, reaching $1.1 billion in 2014.

Going back to the above fictional example: Under the law, Sally is not supposed to be swayed by Bob or other donors when it comes to which drugs it chooses to cover, which patients to accept, or how much of each drugs co-pay it will subsidize. So if Sally is covers co-pays for a competitor to Gleemonex, she can’t be swayed by Bob’s big bucks to give preferential treatment to his drug.

Recent reports indicate that some charities’ practices may have been motivated by donor money. For example, former employees at one charity told Bloomberg that when patients needed Jazz narcolepsy medication Xyrem, they were processed in a time manner, while patients seeking co-pay help for competing narcolepsy drugs were sometimes steered away or wait-listed if that other company wasn’t also donating to the charity.

The charities have denied allegations of favoritism of bad practices.

Sourced From –  https://consumerist.com/2016/05/27/drug-companies-subpoenaed-over-questionable-charity-connections/

Blog, Criminal, Drug Companies, International, Legal News, Supreme Court

Drug company leaders should face prosecution, Oregon official says

William Theobald, USA Today 12:12 p.m. PST February 23, 2016

WASHINGTON – Drug company executives should be prosecuted for improper actions that contribute to the growth of opioid addiction, an Oregon assistant attorney general told a Senate committee Tuesday.

“We have to have more personal accountability of the executives who make these decisions,” David Hart testified at a hearing of the Senate Finance Committee on the opioid addiction epidemic. “They can’t walk away with their stock options and their salaries.”

Hart, head of the Oregon attorney general’s health fraud unit, has led several investigations into improper marketing and promotion practices by pharmaceutical companies that make the highly addictive painkillers.

In response to questions from Sen. Ron Wyden, the ranking Democrat on the committee, Hart also said the companies should be required to forfeit the profit they earn from their improper actions.

“We need to have these companies help clean up the messes they make,” Hart said.

He cited the state’s investigation of Insys, the maker of a painkiller called Subsys. Investigators alleged the company provided “improper financial incentives” to doctors to increase prescriptions, promoted the drug to doctors not qualified to prescribe it, and deceptively promoted its use for mild pain.

The company agreed to a voluntary settlement last August that included a $1.1 million payment, which Hart said amounted to two times its sales of the drug in the state of Oregon. The money is being used to fight opioid addiction.

Hart also was involved in a 2007 settlement among Oregon and 26 other state attorneys general and Purdue Pharma, after the company was accused of misrepresenting OxyContin’s risk of addiction.

Wyden said one common theme he heard during public meetings in Oregon last week on opioid abuse was a phenomenon he dubbed the “prescription pendulum.”

In past years, he said, doctors were criticized for not being aggressive enough in prescribing medication to manage severe pain. Now, the issue has swung the other way and doctors are being criticized for overprescribing pain killers.

Oregon ranked fourth among states in the rate of abuse of prescription painkillers, according to a 2013-2014 survey by the federal Substance Abuse and Mental Health Services Administration. That’s down from first among the states in the same 2010-2011 survey.

Between 2000 and 2013, there were 2,226 deaths in Oregon due to opioid overdoses. While the overdose death rate has dropped in recent years, in 2013 it was still nearly three times the rate in 2000.

“This epidemic is carving a path of destruction through communities all across the country,” Wyden said.

He said he worries policymakers are splitting into opposing camps: one focused on increasing enforcement and the other favoring more resources for treatment.

“What’s needed is a better approach that includes three things: more prevention, better treatment, and tougher enforcement,” Wyden said. “True success will require all three to work in tandem.”

The committee is expected to take up legislation soon that would allow for people in the Medicare program who are identified as at-risk for opioid addiction to be placed in a special program under which all of their prescriptions would be handled by one doctor and/or one pharmacy. Opioid abusers often will obtain multiple prescriptions for the painkillers.

In 2013, 3.6 million prescriptions for opioid painkillers were dispensed in Oregon, enough for nearly one prescription for every resident.