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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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Gordon Schnell and Max Voldman Published in Newsweek on How Whistleblowers are Key to Reining in Prescription Drug Costs

Posted  04/21/22
Newsweek published an OpEd by Constantine Cannon whistleblower lawyers Gordon Schnell and Max Voldman on the need to expand the Medicaid Drug Rebate Program to Medicare.  The piece was prompted by DOJ's recent $235 million settlement with U.K. and St. Louis-based pharma company Mallinckrodt for allegedly violating the Medicaid rebate rule. On the books since 1990, the rule requires drug companies to rebate state...

March 7, 2022

Pharmaceutical company Mallinckrodt ARD LLC will pay $260 million to resolve allegations that it violated the False Claims Act in the sale and marketing of its drug H.P. Acthar Gel.  The government intervened in whistleblower actions alleging that Mallinckrodt and its predecessor Questcor Pharmaceuticals Inc. knowingly underpaid state Medicaid programs by improperly calculating amounts it owed under the Medicaid Drug Rebate Program, and unlawfully used a foundation as a conduit to subsidize co-payments.  With respect to the Medicaid rebate claims, which represent $234.7 million of the settlement, defendants were alleged to have calculated rebate amounts as if Acthar was a “new drug” first marketed in 2013, rather than a drug that had been approved since 1952.  By using 2013 for Acthar’s Base Date Average Manufacturer Price (AMP), the company ignored price increases prior to 2013 and fraudulently reduced Acthar drug rebates.  With respect to the copayment fraud claims, which represent $26.3 million of the settlement, defendants were alleged to have violated the Anti-Kickback Statute by subsidizing copayments through payments to three funds that Mallinckrodt had a foundation set up to induce Medicare-reimbursed purchases of Acthar, using the subsidies to counteract doctor and patient concerns about the drug’s high cost.  The whistleblower in the Medicaid rebate case, James Landolt will receive an award of $24.7 million, representing 20% of the $123.6 million federal share of that settlement; the relator’s share for the state share of the settlement was not announced.  The whistleblowers in the copayment case, Charles Strunck and Lisa Pratta, will receive an award of $4.9 million, representing 19% of that settlement.  The settlement includes a five-year corporate integrity agreement (CIA) with monitoring provisions.  DOJ; USAO MA; USAO EDPA

December 8, 2021

Pharmacist Riad “Ray” Zahr and two pharmacies he owned and operated, Plymouth Towne Care Pharmacy Inc. and Shaska Pharmacy LLC will pay $1 million to resolve a lawsuit initiated by a whistleblower alleging that the pharmacies submitted false claims for Evzio, a naloxone hydrochloride product used for the rapid reversal of an opioid overdose.  The government alleged that the claims included false and misleading prior authorization requests, including forged physician authorizations.  In addition, defendants dispensed Evzio without collecting or attempting to collect co-payments. DOJ; USAO MA

December 7, 2021

Vyera Pharmaceuticals, LLC and its parent company Phoenixus AG will pay up to $40 million and have agreed to make its drug Daraprim available to any potential generic competitor at list price to resolve claims of anticompetitive conduct.  The federal government and state governments alleged that Vyera principals Martin Shkreli and Kevin Mulleady enacted a plan to acquire life-saving toxoplasmosis drug, Daraprim, and dramatically raise its list price by 400% while engaging in conduct to prevent generic competition and protect their monopolistic pricing.  The resolution also bars Mulleady from working in the pharmaceutical industry for seven years; claims against Shkreli are continuing.  FTC; CA; NY; NC; VA

December 6, 2021

Pharmacy benefit manager Centene Corp. will pay $27.6 million to the State of Kansas to resolve allegations that it failed to satisfy its obligation to represent the state’s best interests in negotiations with companies that supply drugs to the state Medicaid program, failed to accurately report discounts it received from CVS-Caremark on certain retail pharmacy claims, and artificially inflated dispensing-fee amounts reported to state regulators.  The state alleged that Centene used an opaque reporting system that made it difficult for the state to determine the nature and appropriateness of certain pharmacy transactions.  As part of the settlement, Centene also agreed to change certain business practices to ensure greater transparency.  KS

October 1, 2021

Pharmaceutical manufacturers Taro Pharmaceuticals USA, Inc., Sandoz Inc. and Apotex Corporation have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act and Anti-Kickback Statute arising from unlawful compensation received through arrangements on price, supply and allocation of customers with other pharmaceutical manufacturers of various generic drugs.  In connection with the FCA settlements, Taro will pay $213.2 million, Sandoz will pay $185 million, and Apotex will pay $49 million.  The civil settlements are in addition to previous deferred prosecution agreements resolving related criminal charges, pursuant to which Taro paid a criminal penalty of $205.6 million, Sandoz paid a criminal penalty of $195 million, and Apotex paid a criminal penalty of $24.1 million.  DOJ

Court says that fraudsters who violate rules they later claim are unclear may not violate the False Claims Act

Posted  08/19/21
Red and yellow pills scattered on hundred dollar bills
Last week, the Seventh Circuit Court of Appeals, the federal appellate court for Illinois, Indiana, and Wisconsin decided U.S. ex rel. Yarberry v. Supervalu, an important decision that may lead more unscrupulous government contractors to help themselves to public funds to which they are not entitled.  Unless the Supreme Court or Congress steps in to correct the Seventh Circuit’s errors, the government may have...

June 14, 2021

Centene Corp. will pay a total of $143.8 million to resolve claims by Ohio and Mississippi that it overbilled the states' Medicaid programs in its role as a pharmacy benefit manager.  The states alleged that Centene engaged in practices including "spread pricing," charging more than allowed price caps based on industry standards, inflation of dispensing fees, failure to disclose discounts received, and claiming reimbursement for prescriptions already paid for by third parties.  Ohio will receive $88.3 million, and Mississippi will receive $55.5 million.  OH; MS

Bristol-Myers Squibb Settlement Highlights a Common-Sense Law: The Medicaid Drug Rebate Program

Posted  04/2/21
Drug prices are out of control.  They now account for roughly 10% of our healthcare spending and America’s per capita outlay has nearly doubled over the past two decades.  For the least fortunate among us, many of these medications have become out of reach altogether. While new proposals are regularly made, one approach that often gets overlooked is simply enforcing the laws already on the books. That is just...
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