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Question of the Week — Should Pharmacy Benefit Managers (PBMs) be allowed to deny patients access to essential life-saving drugs prescribed by their doctor?

Posted  08/19/19
pharmacy pills
As described in a recent article in The Fresno Bee, thousands of patients nation-wide have been denied access to essential life-saving medications by pharmacy benefit managers (PBMs) under the guise of ensuring that patients receive the most appropriate and cost-effective treatment. PBMs are the quintessential “middlemen” in the healthcare system, standing between patients and their physicians on one side, and...

Question of the Week — Will Healthcare Settlements Continue to Dominate False Claims Act Recoveries?

Posted  07/24/19
Recent blockbuster settlements continue past trends: healthcare fraud has so far this year dominated FCA recoveries. During the first half of 2019, the Department of Justice (“DOJ”) secured over $750 million in settlements from False Claims Act (“FCA”) cases. And just past the mid-year point, total recoveries have nearly doubled due to a $700 million civil settlement ($1.4 billion total) entered on July 11th...

Question of the Week — Is DOJ’s Blockbuster $1.4 Billion Opioid Settlement Just the Tip of the Iceberg?

Posted  07/12/19
Pill container spilled over with pills fallen out.
On July 11, DOJ announced a record-breaking $1.4 billion settlement with Reckitt Benckiser Group plc (RB Group) over allegations that its former subsidiary Indivior Inc. inflated prescriptions of its opioid-withdrawal drug Suboxone through numerous unestablished representations about the drug’s safety and addictiveness. The settlement resolves RB Group’s potential civil and criminal liability, but Indivior still...

New York Introduces Bills to Expand Whistleblower Protections

Posted  06/21/19
statute of liberty New York symbol
Under current law, whistleblowers who reported fraudulent activity in the government or other settings in the State of New York are typically barred from bringing other legal actions. Maybe not anymore. Last week, both the New York State Senate and Assembly signed off on a series of amendments aimed at providing greater protection for employees who notice and report illegal activity, and expanding the definition of a...

Catch of the Week — Wound Care Device Manufacturer ACell Inc.

Posted  06/14/19
Nurse Wrapping a Wound on Mans Wrist
Our Catch of the Week goes to ACell Inc., a Maryland-based medical device manufacturer that pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to report that it had partially removed its wound-care product, MicroMatrix, from the market because it was contaminated with endotoxins, placing treated patients in danger of serious infection, even death, without informing the FDA that it...

Question of the Week — Should institutions return past donations from Big Pharma executives and their family members implicated in the opioid crisis?

Posted  05/23/19
Money with Pills Spilled Over
The New York Times recently reported that the Metropolitan Museum of Art has decided to stop accepting gifts from members of the Sackler family linked to Purdue Pharma, the maker of OxyContin, one of the drugs at the center of the opioid epidemic that has killed more than 200,000 Americans in the past two decades. The Met’s decision follows that of other museums and universities, including the Tate Modern, the...

Question of the Week — Should the CEO Be Held Accountable?: Lessons from the Insys verdict.

Posted  05/10/19
Handcuffed business-leader walking through jail.
In a shocking first, a federal jury has convicted an opioid-company CEO and other top executives of a criminal racketeering conspiracy. Insys founder and chairman John Kapoor and four other executives bribed doctors to overprescribe a highly addictive fentanyl painkiller, and ran a phony call-center to defraud insurance companies into paying for the expensive drug. Although the company itself had already paid over...

Ohio Seeks to Recover Overcharges from OptumRx

Posted  02/21/19
Office building with logo for Optum
After a 2018 investigation by the Ohio Bureau of Workers Compensation (BWC) of its prescription drug spending, the BWC pharmacy program manager, John Hanna, concluded that "we were being hosed."  The BWC had contracted with OptumRx to act as a pharmacy benefits manager (PBM).  PBMs act as middlemen between drugmakers, pharmacies, and payors such as worker's compensation programs, Medicaid, Medicare, and other...

Catch of the Week – Justice Department Sues Tennessee Pharmacies and Pharmacists Illegally Dispensing Opioids

Posted  02/11/19
Stethoscope with computer tablet saying "Opiod epidemic"
On Friday, the Justice Department announced that it has sued several pharmacies and pharmacists in Tennessee to stop them from illegally dispensing opioids. According to the complaint, both defendants have “fueled and profited from” the opioid epidemic by “repeatedly dispensing opioids and other controlled substances prone to abuse without a legitimate medical purpose and outside the usual course of professional...

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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