Archive

March 3, 2016

New York announced an agreement with Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. (“Endo”), which make and sell the long-acting opioid, Opana ER. The agreement requires Endo to cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on its website. Endo must also create a program that will prevent its sales staff from promoting this powerful narcotic painkiller to health care providers who may be involved in the abuse and illegal diversion of opioids. Endo, an Irish company with U.S. headquarters in Pennsylvania, makes a variety of prescription drugs. Endo’s opioid drug Opana ER has been widely abused in New York State. NY

February 19, 2016

Adventist Health System Sunbelt Healthcare Corporation agreed to pay $2.09 million to resolve allegations that patients were administered portions of single-dose vials of chemotherapy drugs that were left over from administrations to prior patients.  The settlement also resolves allegations that some platinum based drugs were administered inappropriately and that certain infusion services were upcoded.  The allegations originated in a whistleblower lawsuit filed by former Adventist employee Heather Huddleston under the qui tam provisions of the False Claims Act.  She will receive a whistleblower award of $376,452 from the proceeds of the government's recovery.  DOJ (MDFL)

February 11, 2016

Compounding pharmacies WELLHealth and Topical Specialists and four physicians, Manish Bansal, Mehul Parekh, Marisol Arcila, and Syed Asad, agreed to pay approximately $10 million to resolve allegations they violated the False Claims Act by submitting false claims to TRICARE, the military’s healthcare program.  According to the government, the physicians wrote hundreds of prescriptions for pain and scar creams never used by patients and billed to the government at a cost which yielded up to 90% in profits.  Bansal is a cardiologist at Baptist Hospital; Arcila is a pain management physician at Premier Spine & Pain Center; Asad is a neurologist at Universal Neurological Care; Parekh is a general practice physician at Baptist Hospital.  DOJ (M.D.Fla)

January 5, 2016

Nashville Pharmacy Services, LLC, and its majority owner Kevin Hartman, agreed to pay up to $7.8 million to settle charges they violated the False Claims Act by overbilling Medicare and TennCare for pharmacy services.  Specifically, the government claimed the Nashville-based pharmacy that specializes in dispensing HIV and AIDS-related medications automatically refilled medications without a request from the beneficiary or their physician; improperly waived TennCare and Medicare co-payments without an individualized assessment of ability to pay; improperly used pharmaceutical manufacturers’ co-payment cards to pay the co-payments of Medicare beneficiaries; billed for medications dispensed after the deaths of certain beneficiaries; and billed for medications that lacked a valid prescription.  The allegations originated in a whistleblower lawsuit filed by Marsha McCullough, a former Nashville Pharmacy order entry technician, under the qui tamprovisions of the False Claims Act.  She will receive a whistleblower award of 18 percent of the government’s recovery which could amount to $1.4 million.  Whistleblower Insider

December 23, 2015

A $2.5 million settlement with long term care pharmacy Pharmerica, which services hundreds of nursing homes across the nation, completes the final leg of litigation involving the illegal promotion of Aranesp, an anemia drug manufactured by Amgen, Inc.  Including the 2013 settlement with Amgen ($24.9 million) and the 2014 settlement with Omnicare ($4.19 million), this settlement brings the government’s total recovery in this matter to just over $31.5 million.  The allegations were originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act. DOJ (DSC)

December 16, 2015

Qualitest Pharmaceuticals, the company’s corporate shell, Vintage Pharmaceuticals, its parent Endo Pharmaceuticals, and seven of their affiliates, agreed to pay $39 million to 48 states and the federal government to settle charges they violated federal and state False Claims Acts by selling understrength chewable fluoride tablets.  As part of the settlement, Qualitest admitted the drug labeling for its chewable fluoride tablets represented fluoride amounts in line with guidelines of the American Dental Association and the American Academy of Pediatrics when in reality it used less than half of these represented amounts.  The allegations were first raised in a whistleblower lawsuit brought Dr. Stephan Porter under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of roughly $4.71 million from the proceeds of the government’s recovery.  Whistleblower Insider, NY, NH

November 25, 2015

The US settled for more than $30 million allegations against several Florida compound pharmacies and their owners for violating the False Claims Act by fraudulently billing TRICARE, the military’s healthcare program.  The settling defendants and their respective settlements include: MedMatch Pharmacy (agreeing to pay more than $4.7 million to resolve concerns that it paid kickbacks to marketers, that it filled prescriptions it knew or should have known were not legitimate, and that it sent prescriptions to states in which it did not have a valid license); OHM Pharmacy (agreeing to pay $4.1 million to resolve allegations of filling prescriptions from a doctor who was writing them outside the ordinary course of practice); WELL Health Pharmacy and its owner (agreeing to pay more than $3 million, as well as 50% of its net profits for five years, for filling prescriptions written by referral sources that had a financial interest in the prescriptions); Topical Specialists (agreeing to pay more than $2.2 million for submitting prescriptions that were tainted by so-called “research fees,” which was an elaborate guise for paying physicians to write prescriptions); Durbin Pharmacy (agreeing to pay $2.1 million, plus 50% of its net profits for five years, for submitting prescriptions that were tainted by kickbacks); and North Beaches Pharmacy (agreeing to pay $10,000, plus 50% of its net profits for five years, for filling compound prescriptions that the government contends were tainted by illegal kickbacks).  DOJ (MDFL)

November 20, 2015

Novartis Pharmaceuticals Corp. agreed to pay $390 million to resolve charges it gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.  The settlement follows the January 2014 and April 2015 settlements of specialty pharmacies Bioscrip, Inc. and Accredo Health Group under which the pharmacies agreed to pay a total of $75 million to resolve False Claims Act charges based on the same allegations.  That brings to $465 million the total government recovery from this alleged kickback scheme.  The allegations leading to the settlement were first brought to the attention of federal law enforcement by David Kester, who filed a whistleblower lawsuit under the qui tam provisions of the False Claims Act.  He will receive a yet-to-be disclosed whistleblower award from the government’s recovery.  Whistleblower Insider

November 13, 2015

Tamara Esponda, owner of Miami-area pharmacy Biomax Pharmacy Inc., was sentenced to 42 months in prison and to pay roughly $1.6 million in restitution for her role in the submission of more than $1.5 million in fraudulent claims to Medicare Part D.  According to admissions made in connection with Esponda’s guilty plea, Biomax Pharmacy submitted fraudulent claims to Medicare for prescription drugs that were not prescribed by physicians, not medically necessary and not provided to Medicare beneficiaries.  Esponda further admitted that in perpetrating this fraud she and her accomplices used the beneficiaries’ and doctors’ Medicare identification numbers without their consent.  DOJ

November 4, 2015

AstraZeneca LP and Cephalon, Inc. agreed to pay $54 million to settle government charges they violated federal and state False Claims Acts by overcharging state Medicaid programs for their pharmaceutical products.  AstraZeneca will pay $46.5 million and Cephalon, the wholly-owned subsidiary of Teva Pharmaceutical Industries. Ltd., will pay $7.5 million.  According to the government, the two pharmaceutical companies underpaid drug rebates owed the states under the Medicaid Drug Rebate Program, which requires drug makers to periodically return to the government a portion of their Medicaid proceeds.  The allegations first arose in a whistleblower lawsuit filed by Virginia pharmacist and attorney Ronald Streck under the quit tam provisions of the Federal False Claims Act, New York False Claims Act and other state false claims statutes.  Mr. Streck will receive a yet-to-be-disclosed whistleblower award from a portion of the government’s recoveries.  Whistleblower Insider