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 The charity, Patient Services Inc, filed the lawsuit in federal
court in Richmond, Virginia. It came amid a U.S. Justice Department
investigation into drugmakers' financial support of patient
assistance charities.
Drugmakers are prohibited from subsidizing co-payments for patients
enrolled in Medicare, the government healthcare program for the
elderly. But they may donate to non-profits providing co-pay
assistance as long as the charities are independent.
Amid increased attention to rising drug prices, concern has arisen
that drugmakers' donations to such charities may be contributing to
price inflation.
In its lawsuit, Midlothian, Virginia-based PSI said it had long
operated under an advisory opinion issued by the U.S. Department of
Health and Human Services Office of Inspector General that
essentially gave it approval to help Medicare patients.
But PSI said the Office of Inspector General in 2017 imposed new
guidance requiring it to refrain from engaging in conversations with
drugmakers that are donors to obtain information about issues like
patient populations and drug costs used to create programs.
"The OIG's restrictions on PSI's communications with donors are
unreasonable, unfair and unconstitutional," PSI's general counsel,
Neil Millhiser, said in a statement.
The agency declined to comment.
The Justice Department has been investigating drugmakers' support of
charities like PSI. The investigation led United Therapeutics Corp
in December to pay $210 million to claims related to its support of
one charity.
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That charity, Caring Voice Coalition, last week said it will not
provide financial aid in 2018 after the inspector general revoked
its advisory opinion.
In September, the Justice Department alleged a PSI donor, Aegerion
Pharmaceuticals Inc, violated an anti-kickback law by using PSI to
defray co-payments for patients prescribed an expensive cholesterol
drug, Juxtapid.
The government alleged PSI promoted its ability to create a
"reimbursement vehicle" for Aegerion, which was able to eliminate
price sensitivity for Juxtapid via an Aegerion-supported fund that
PSI created.
Aegerion, a Novelion Therapeutics Inc unit, agreed to pay $40.1
million to resolve probes into its promotion of Juxtapid. PSI was
not charged and denies funneling funds for manufacturers.
PSI has said it helps hundreds of thousands of patients, but expects
to help 2,000 fewer people in 2018 due to a 17 percent drop in its
operating budget caused by reduced donations.
(Reporting by Nate Raymond in Boston; Editing by Leslie Adler)
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