Compounding pharmacy enjoined from manufacturing until remedial measures are implemented

Isomeric Pharmacy Solutions LLC (Isomeric) and three executives are permanently enjoined from manufacturing and distributing drugs considered adulterated in violation of the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.). The injunction was entered in the Utah district court following a complaint entered by the Department of Justice (DOJ) after finding that Isomeric, a compounding pharmacy, was producing drugs under insanitary conditions.

Isomeric

Isomeric manufactures, labels, and distributes drugs, particularly injectable hormones and corticosteroids, as well as ophthalmic drops. Most of the drugs are directly distributed to physicians. The company initiated three recalls in 2016 involving three types of injectable drugs. In April 2017, Isomeric recalled all lots of non-expired drug products that should have been sterile and were compounded between October 4, 2016 and February 7, 2017.

Complaint

According to the complaint, the FDA found that Isomeric repeatedly found several types of microorganisms in the air and on surfaces that should have been sterile. Products that were manufactured in these areas were prepared in insanitary conditions. The FDA found that Isomeric deviated from current good manufacturing practice requirements, and failed to thoroughly review discrepancies or failures found in batches of drugs.

The injunction was entered through a consent decree as part of a settlement. Isomeric and its chief executive officer, chief sales officer, and chief operating officer will not resume manufacturing, holding, or distributing drugs until proper remedial measures have been taken.

Sessions creates opioid fraud detection unit, focuses on 12 districts

Twelve federal districts have been selected to participate in an Opioid Fraud and Abuse Detection Unit, created by the Department of Justice (DOJ). The DOJ will fund twelve Assistant United States Attorneys for three year terms to focus solely on investigating and prosecuting fraud related to prescription opioids. Attorney General Jeff Sessions announced the program’s formation at the Columbus Police Academy in Ohio.

Data analytics program

The unit will consist of a data analytics program, which will allow targeted investigation and prosecution. Sessions stated that the team would use such information as physicians who prescribe opioids at a higher rate than peers, the average age of patients receiving the prescriptions, and pharmacies dispensing large amounts of opioids to focus its investigation.

The federal prosecutors, located in districts across the country, will work with various agencies to investigate and prosecute opioid fraud, including pill mills and unlawful diversion of opioids. Most of the districts are located in the east and Midwest, such as Florida, Michigan, Alabama, Kentucky, Ohio, and West Virginia.

Webinar: What Are the Experts Saying on Health Reform?

Since January, both President Trump and Republican leaders in Congress have talked about a three-step process for repealing and replacing the Patient Protection and Affordable Care Act (ACA). While the first six months of the Trump administration has seen mixed results, its efforts to reign in or hold back regulations, combined with its delay in filling lower-level agency roles, has impacted regulatory review and issuance of new regulations. So, despite Congress’ inability to pass legislation to change parts of the ACA, there is still plenty for providers to be concerned about.

Join Associate Managing Editor Kathryn Beard, JD, on Wednesday, August 2, for this half-hour live webinar covering attempts by the Trump Administration and Congress to delay, deregulate, and derail significant parts of federal health policy. She will discuss the two “repeal and replace” bills, FDARA, and significant executive and regulatory actions taken by the Trump administration which directly impact ACA provisions.

Registration Link:

Before the webinar, download the accompanying White Paper.

Houston physician found guilty for role in $1.5M fraud scheme

Following a four-day trial, a Houston-area physician was convicted of conspiracy to commit health care fraud and conspiracy to pay and receive illegal kickbacks in a scheme involving home health services involving Allied Covenant Home Health, Inc. (Allied). Sentencing is scheduled for September 25, 2017.

Scheme

According to the Department of Justice (DOJ), the physician was involved in a scheme to defraud Medicare by submitting $1.5 million in fraudulent claims from 2006 to 2013. Evidence showed that the physician admitted patients for home health services through Allied without regard for qualification for such services. The physician falsified medical records and signed false documentation to show that patients met Medicare criteria for home health service reimbursement when they did not.

The evidence also showed that the physician paid illegal kickbacks to the owner of Harris Health Care Group (Harris). These kickbacks were paid in order to facilitate Medicare billing for facet injections. These injections were not medically necessary or not provided.