United States Drug Enforcement Administration

(CINCINNATI) – Benjamin C. Glassman, United States Attorney for the Southern District of Ohio; Lamont Pugh III, Special Agent in Charge, U.S. Department of Health and Human Services, Office of Inspector General (HHS OIG); Timothy J. Plancon, Special Agent in Charge, Drug Enforcement Administration (DEA), Ohio Attorney General Mike DeWine; Anthony Groeber, Executive Director, State Medical Board of Ohio; Steven Schierholt, Executive Director, State of Ohio Board of Pharmacy, and Sarah D. Morrison, Administrator, Ohio Bureau of Workers Compensation, announced the charges.

Dr. Saad Sakkal

According to a 39-count indictment returned in Cincinnati, Sakkal engaged in the illegal distribution of prescription drugs, including opioids. Sakkal is charged with being responsible for the deaths of at least two patients, who died in 2016, due to complications resulting from drug use.
 
Sakkal, who was arrested by federal agents in Florida today, began practicing at Lindenwald Medical Association, Inc. in Hamilton, Ohio in February 2015. He also owned and operated the medical practice Metabolic Care Center in Mason, Ohio.

It is alleged that Sakkal prescribed medically-dangerous combinations of controlled substances, including:

• “Holy Trinity,” which consisted of an opiate, a benzodiazepine and a stimulant,
• “Prescriptive Speedball” that included an opiate and a stimulant, and,
• “Triple Threat Heaven,” which consisted of methadone, a benzodiazepine and a stimulant.

“According to the indictment, after Sakkal joined Lindenwald Medical Association the type of patients changed, with patients waiting long periods of time in order to see Sakkal, including waiting outside in the parking lot for the practice to open,” U.S. Attorney Glassman said. 
Numerous pharmacies denied to fill Sakkal’s prescriptions, and pharmacists even called Sakkal to warn him of the risks inherent in his prescribing practices.

In response, on December 31, 2016, Sakkal organized and led a small group of his patients on a series of protests at local pharmacies, demanding that they continue to fill his prescriptions.

Dr. Nilesh Jobalia

According to the indictment in this case, Jobalia, 53, of Cincinnati, owned and operated Cincinnati Centers for Pain Relief in Hamilton, Ohio from March 2013 through December 2017. Although the practice was not registered as such, it allegedly operated almost exclusively as a pain clinic.

The 114-count indictment alleges patients were prescribed fentanyl, oxycodone, methadone, morphine and other controlled substances on many occasions without actually being seen by the doctor. According to the indictment, at least one patient died as a result of using the prescribed controlled substances. 

Jobalia’s practice also billed Medicare, Medicaid and the Bureau of Workers’ Compensation for medically unnecessary prescriptions.

“For example, prescriptions to one customer alone caused the Bureau of Workers’ Compensation to pay more than $450,000 for medically unnecessary drugs,” Glassman said. “In total, it is alleged that Jobalia caused more than $2 million in false claims.”

It is also alleged that Jobalia received more than $103,000 from a pharmaceutical company for purported speaking engagements about a product called Fentanyl Spray, a medication intended for breakthrough cancer pain.

The speaking engagements were actually sham programs, though, according to the indictment, in which many attendees were not medical professionals permitted to prescribe Fentanyl Spray.   Usually, Jobalia, some of his staff and the pharmaceutical sales representative were the only people present at the engagements, which were held at fine dining restaurants in the Cincinnati area. It is alleged that Jobalia received $1,600 to $2,200 per “speaking engagement” on 17 separate occasions.

Jobalia is charged with 88 counts of unlawful distribution of a controlled substance, one count of unlawful distribution of a controlled substance with death resulting, eight counts of health care fraud and 17 counts of violating the anti-kickback law.

This case is a result of the Department of Justice’s Opioid Fraud and Abuse Detection Unit’s investigative efforts. United States Attorney General Jeff Sessions announced last summer that the Southern District of Ohio is one of 12 Districts nationwide to receive the pilot program designed to focus specifically on opioid-related health care fraud.

Lindenwald Medical Association, Inc.

Three individuals are charged in the indictment alleging Lindenwald Medical Association, Inc. overcharged Medicare and Medicaid by approximately $400,000 by upcoding billing codes for medical services.

The four-count indictment includes one count of conspiracy to commit health care fraud and three counts of health care fraud.

Dr. Rakesh Sharma, 47, of Alachua, Fla., is the previous owner of Lindenwald Medical Association, Inc. He allegedly directed employees to see as many patients per day as they could, typically between 40 and 60 per provider. He also promised bonuses based on the receivables in the office.

It is alleged that patients were given very cursory exams and then prescribed controlled substances.

“The indictment alleges that urine tests were given to patients but never reviewed,” Glassman said. “In fact, according to the charging document, the results of those urine tests showed that patients were not taking the prescriptions, but likely diverting them.”

The indictment also alleges Sharma and co-conspirators Mike Jones, 51, of Liberty Township, Ohio – a nurse practitioner at the practice and Dr. Paul Yang, 51, of Lebanon, Ohio – one of the practice’s medical doctors, ordered genetic tests regardless of medical necessity and received kickbacks from the labs processing the tests.

The three Southern District of Ohio cases are part of the largest health care fraud enforcement action in Department of Justice history this week, which resulted in at least 76 doctors charged and 84 opioid cases involving more than 13 million illegal dosages of opioids. The national takedown includes charges across 58 federal districts against more than 600 individuals total, who are allegedly responsible for more than $2 billion in fraud losses.

“Health care fraud is a threat to this country, both in terms of the well-being of patients and the integrity of government health care programs,” said Lamont Pugh, Special Agent in Charge for the U.S. Department of Health & Human Services Office of Inspector General. “Our agents will continue to work with our law enforcement partners to ensure these criminals are held accountable for their actions.”

“At the Ohio Attorney General’s Office, we’re committed to protecting Ohio families. Collaborating on the investigation and prosecution of cases like these is one of the ways we fulfill that mission,” Ohio Attorney General Mike DeWine said‎.

U.S. Attorney Glassman commended the investigation of the local cases by the HHS OIG, DEA, Ohio Medical and Pharmacy boards, Bureau of Workers’ Compensation and Ohio Attorney General’s Medicaid Fraud Unit, as well as Assistant United States Attorneys Salvador A. Dominguez, Timothy Oakley and Timothy Mangan and Special Assistant United States Attorney Maritsa Flaherty, who are prosecuting the cases.

An indictment merely contains allegations, and defendants are presumed innocent unless proven guilty in a court of law.