The U.S. Justice Department has the manufacturer of Copaxone (glatiramer acetate injection) in its crosshairs, and the outcome could have a much greater reach. It appears the case could directly affect the copay help many of us receive for our medications and the patient services some drug companies provide.
The legal case targets the interaction between pharmaceutical companies and nonprofit organizations that provide grants to people who need help paying for their treatments. For example, when I couldn’t afford the monthly copay for Aubagio (teriflunomide) several years ago, I qualified for a $6,000 foundation grant that covered my copay for a year.
Now, the Justice Department is eyeing two Teva Pharmaceutical subsidiaries that donate funds to two foundations that in turn provide grants like the one I received. So, you might ask, what’s the problem?
Is this a kickback?
It’s complicated. If you have commercial drug insurance, a pharmaceutical company is allowed to help you pay either part or all of your insurance copay. But that’s prohibited for people receiving Medicare. For Medicare patients, drug companies must provide their medication free of charge or they can’t provide any financial help. In those cases, people may be forced to turn to a foundation for copay help.
In a complaint filed a few days ago, the Justice Department accused two Teva subsidiaries of skirting this copay restriction by donating to foundations and using them as “conduits.” The foundations allegedly paid the part of the copay that the pharmaceutical company couldn’t directly pay.
According to the complaint, Teva’s intent allegedly was to ensure that Copaxone users never had to pay very much, if anything, for the medication. That induced patients, including those on Medicare, to use Copaxone. And that, government prosecutors allege, violates a federal anti-kickback statute that bars nonprofits that assist with drug copayments from helping Medicare patients this way.
In a statement to news organizations including The Wall Street Journal, Teva vowed to fight the lawsuit. “This case brought by the Department of Justice regarding these charitable contributions only seeks to further restrict patients’ access to important medicines and health care,” the statement said.
Are patient assistance programs in danger?
The federal government has been probing the legality of the patient assistance programs of several pharmaceutical companies since at least 2018. The Wall Street Journal has reported that this includes direct copay assistance, donations to foundations, and even programs that make nurses available around the clock to answer patients’ questions by phone.
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