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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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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

April 4, 2019

Jazz Pharmaceuticals will pay $57 million to settle allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program in a form that created an improper kickback.  The funds provided by Jazz were used to cover the copayments for patients to purchase Jazz's drugs Xyrem, a narcolepsy medication, and Prialt, an injectable pain medication.  Jazz referred Medicare patients to the fund, and denied them access to Jazz's free drug program, enabling Jazz to bill Medicare for their purchases. DOJ  

March 11, 2019

Pfizer will pay $975,000 to the State of Oregon to resolve allegations that the pharmaceutical company distributed misleading advertising materials and coupons to state residents.  The materials advertised Pfizer's drugs the Flector Patch, Estring, Quillivant, and Quillichew, claiming that consumers would "pay no more than" specified amounts -- $15, $20, or $25.  In fact, consumers ended up paying more than advertised for the Pfizer drugs, despite the availability of cheaper generic alternatives.  A large portion of the settlement, $620,000, will go to Oregon nonprofits that provide medical care to low-income uninsured and underinsured, including migrant and seasonal farmworkers.  In addition, consumers who used the coupons will receive refunds.  OR AG

Catch of the Week – Walgreens Pays Record $273 Million To Settle Three FCA Suits

Posted  01/25/19
Storefront of brick-faced Walgreens location
Three separate qui tam actions brought by whistleblowers against Walgreens Boots Alliance, Inc. (Walgreens) have resolved in what amounts to the largest settlement payouts for a retail pharmacy. In the first action, two former Walgreens pharmacists alleged that the company sought reimbursement for insulin pens it dispensed to Medicare and Medicaid beneficiaries who did not need them. Walgreens did so in two ways....
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