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Drug and DME Pricing

This archive displays posts tagged as relevant to drug and durable medical equipment pricing. You may also be interested in our pages:

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November 15, 2019

Pharmaceutical manufacturer Lupin Limited and related entities, together with company executives Vinita Gupta and Robert Hoffman, will pay $63 million to Texas to resolve claims under the Texas Medicaid Fraud Prevention Action that they reported inflated drug prices to the state's Medicaid program in order to receive excess reimbursements.  The investigation of Lupin was initiated by a whistleblower lawsuit filed by Expess Med Pharmaceuticals, Inc.  TX

November 7, 2019

Compound drug ingredient supplier Fagron Holding USA LLC has agreed to pay over $22 million to resolve two qui tam suits involving three of Fagron’s wholly-owned subsidiaries.  According to whistleblowers, Freedom Pharmaceuticals Inc. grossly inflated the price of active pharmaceutical ingredients used in compound prescriptions, causing pharmacy customers to submit false claims to TRICARE.  Other allegations involved subsidiaries Pharmacy Services Inc. and B&B Pharmaceuticals Inc., which were accused of submitting false claims to federal healthcare programs, manipulating prescription drug pricing, paying kickbacks to physicians, and illegally waiving patient copays.  DOJ

October 28, 2019

The State of Illinois has reached a settlement with more than a dozen drug manufacturers alleged to have published inflated "average wholesale prices" for drugs whose purchase was reimbursed by Illinois's Medicaid program at prices based on those false AWPs.  The settlement for $242 million includes Abbott Laboratories, Inc.; Aventis Pharmaceuticals Inc.; Aventis Behring LLC, n/k/a ZLB Behring; B. Braun Medical Inc.; Forest Laboratories, Inc.; GlaxoSmithKline LLC; Johnson & Johnson, Inc.; Janssen Pharmaceutical Products, LP; McNeil-PPC, Inc.; Ortho Biotech Products, LP; Ortho-McNeil Pharmaceutical, Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Pharmacia Corporation; and TAP Pharmaceutical Products, Inc.  In total, Illinois has settled inflated AWP claims against more than four dozen manufacturers (see, e.g., January 2019 settlement with TEVA Pharmaceuticals), recovering $678 million in total.  IL AG  

May 31, 2019

Generic drug maker Heritage Pharmaceuticals, Inc. has entered into a deferred prosecution agreement for criminal antitrust charges, admitting that it conspired to fix prices, rig bids, and allocate customers for the diabetes drug glyburide.  Heritage will pay a $225,000 criminal penalty and has agreed to cooperate in ongoing antitrust investigations.  In addition, Heritage will pay $7.1 million to resolve allegations under the False Claims Act that the company paid and received unlawful remuneration under the Anti-Kickback Statute through its arrangements with other generic drug makers regarding prices, supply, and allocation of customers for drugs including glyburide, hydralazine, and theophylline.  DOJ; USAO ED Pa

April 30, 2019

Pharma company US WorldMeds LLC has agreed to pay $17.5 million and enter into a corporate integrity agreement to resolve allegations that it improperly induced the use of its drugs Apokyn, used to treat Parkinson's, and Myobloc.  The company was alleged to have improperly used a foundation to pay Apokyn copayments for Medicare beneficiaries, knowing that it was the only donor to the foundation’s Parkinson’s Disease fund and that virtually all of the fund’s donations were spent on Medicare Apokyn patients.  In addition, the company was alleged to have paid kickbacks to physicians, including excessive speaking and consulting fees, to induce them to prescribe Apokyn and Myobloc. The litigation was initiated under the False Claims Act by whistleblowers, who will receive $3.15 million of the settlement.  DOJ; USAO Conn

April 25, 2019

Pharma company Amgen Inc. has agreed to pay $24.75 million and enter into a corporate integrity agreement to resolve allegations that its use of purportedly independent foundations to pay copayments on its drugs Sensipar and Kyprolis for Medicare beneficiaries violated the False Claims Act.  Amgen's "donations" were not bona fide, but were, by design, intended to benefit only patients of its own drugs, thereby constituting an unlawful kickback designed to generate revenue for Amgen.  With respect to Kyprolis, Amgen's donation to the fund was expressly tied to the anticipated amount required to fund Kyprolis copayments.    DOJ; USAO Mass

April 25, 2019

Astellas Pharma US Inc. has agreed to pay $100 million and enter into a corporate integrity agreement to resolve allegations that its use of a purportedly independent foundation to pay copayments on its drug Xtandi for Medicare beneficiaries violated the False Claims Act.  Astellas was alleged to have provided funds to cover copayments for androgen receptor inhibitors (ARIs), although its own drug Xtandi was the only ARI available.  Astellas promoted the existence of the funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. According to the government's allegations, payments to the foundations were not bona fide donations, but instead unlawful kickbacks.   DOJ; USAO Mass

April 9, 2019

A number of telemedicine and durable medical equipment companies, the principals of those companies, and three healthcare providers, were charged with submitting over $1.7 billion in false claims in a scheme to pay unlawful kickbacks and bribes from DME companies in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for medically unnecessary DME including back, shoulder, wrist and knee braces.  DOJ; USAO MD FL; USAO NJ; USAO SC.

April 4, 2019

Alexion Pharmaceuticals Inc. will pay $13 million to resolve allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program for its drug Soliris in a form that created an improper kickback. Soliris, which, at list price and typical dosages, can cost as much as $500,000/year, was unaffordable to many patients.  While Alexion had a free drug program, it referred Medicare patients to a "Complement-Mediated Disease" fund for copayment assistance; Alexion then billed Medicare for the drugs.  Alexion was the sole donor to the fund, and assistance from the fund was contingent on the patient taking Soliris.   DOJ

April 4, 2019

Pharmaceutical company Lundbeck LLC will pay $52.6 million to resolve allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program for its drug Xenazine, approved for Huntington's Disease, in a form that created an improper kickback. Lundbeck was the sole donor to a fund at a foundation that claimed to provide financial support for patients with Huntington’s Disease. However, Lundbeck also referred Xenazine patients with many other conditions to this foundation, which then paid the Xenazine copays for these off-label uses.  When the foundation determined to stop using its Huntington's fund for non-Huntington's patient, Lundbeck redirected its payments to a different general-purpose fund, with the understanding that fund would use the redirected funds to pay Xenazine copays for these same patients.  Lundbeck is alleged to have denied needy Medicare and ChampVA Xenazine patients access to its free drug program, instead referring them to the patient assistance program, permitting Lundbeck to submit claims to federal healthcare programs.   DOJ


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