Friday, May 18, 2018

U.S. Department of Justice Intervenes in Five Civil Qui Tam Lawuits in Los Angeles Accusing Insys Therapeutics of Paying Kickbacks in Form of Speaker Fees, Meals, Entertainment, Jobs, Etc. to Encourage Physicians Promote Sybsys, a Sublingual Spray Form of Fentanyl

On May 15, 2018, the United States intervened in five “whistleblower” lawsuits that have been consolidated in United States District Court in Los Angeles and accuse Insys Therapeutics, Inc. of paying illegal kickbacks and defrauding federal health programs in connection with the marketing of Subsys, an opioid painkiller manufactured and sold by the Arizona-based company.   The civil claims asserted against Insys are allegations only, and there has been no determination of liability.

The five cases brought pursuant to the False Claims Act were ordered unsealed late last week, as was the government’s complaint in intervention. The United States has separately pursued a number of criminal cases against Insys employees and Subsys prescribers.

The cases allege illegal marketing tactics related to Subsys, a sublingual spray form of fentanyl, an opioid painkiller. In 2012, Subsys was approved by the Food and Drug Administration for the treatment of persistent breakthrough pain in adult cancer patients who are already receiving, and tolerant to, around-the-clock opioid therapy.

The government’s complaint alleges that Insys paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients. Many of these kickbacks allegedly took the form of sham speaker fees to physicians, jobs for the prescribers’ relatives and friends, and lavish meals and entertainment.

The United States also alleges that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and that Insys employees lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.

Monday, May 14, 2018

Mandatory Use of CURES for California Physicians, Physician Assistants, Nurse Practitioners, Vets, and Other Health Care Providers Prescribing Schedules II, III and IV Starts October 2, 2018

The Controlled Substance Utilization Review and Evaluation System (CURES) was certified for statewide use by the Department of Justice (DOJ) on April 2, 2018. Therefore, the mandate to consult CURES prior to prescribing, ordering, administering, or furnishing a Schedule II–IV controlled substance becomes effective on October 2, 2018. Here is the California Medical Board link to everything you need to know to prepare for October.

Wednesday, May 9, 2018

Suboxone Practice: Family Practice and General Physicians Need to be Vigilant in Treating Patients. Case Study: Five Physicians Charged with Unlawfully Prescribing and Distributing Buprenorphine

With all the emphasis on treatment for those who have opioid dependency or addiction issues, more physicians are becoming prescribers of buprenorphine 
(known as Subutex and Suboxone). This is an area where providers should be careful especially if they are not addiction specialists. 

There are over 230 physicians listed on the Suboxone website who are within 20 miles of my office in downtown Los Angeles and are prescribing Suboxone. Family practice and general practice physicians need to be very careful in treating patients with buprenorphine, a Schedule III drug, and in determining when there is legitimate medical necessity to prescribe.

Thursday, April 12, 2018

Pharmacy Owner And Pharmacist Sentenced To 160 Months In Prison For $4.3 Million Pain And Scar Compounding Creams Where Referral Payments Received When TRICARE Insurance Billed

The compounding cream cases where pharmacies engaged in marketing to obtain patients and where there were billings to TRICARE insurance continue. 

In a recent case, after a five-day trial of one count of conspiracy to pay health care kickbacks and paying and receiving kickbacks, a long sentence was handed out by a federal district court judge to a pharmacy owner and pharmacist.  

On March 30, 2018, the owner of a Florida pharmacy, Larry B. Howard, also a licensed pharmacist, was sentenced by U.S. District Judge Paul G. Byron to serve 160 months in prison and ordered to pay $4.3 million in restitution for his role in this case.

Sunday, April 8, 2018

Two Los Angeles Executives of Provider of Substance Abuse Treatments Billed to Drug Medi-Cal Indicted by Grand Jury

The Drug Medi-Cal program has been under a lot of scrutiny since 2013 when it was the subject of investigative reporting. In 2014, significant changes and audits were made.  Many facilities were closed. However, it seems that there are still criminal filings coming out of those past audits.

On March 29, 2018, two executives at a South Los Angeles company that offered alcohol and drug abuse treatment services were indicted on federal charges that allege they defrauded the Medi-Cal program from 2009 to 2015 by submitting bills seeking more than $2 million for services that did not qualify for reimbursement or simply were never provided. An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty in court. 

Saturday, March 31, 2018

Michigan Home Health Agency Assistant Director of Nursing Sentenced to Three Years for Role in Paying Kickbacks With $1.6 Million in Billings to Medicare

The assistant director of nursing of a Michigan home health agency, Juan Yrorita, age 63, was sentenced to 36 months in prison on March 29, 2018 by U.S. District Judge Drain for his role in a case involving approximately $1.6 million in Medicare claims for home health services that were procured through the payment of kickbacks, and that were also allegedly medically unnecessary and not provided.

Mr. Yrorita plead guilty after four days of trial to one count of conspiracy to commit health care fraud and wire fraud. As part of his guilty plea, Mr. Yrorita admitted that his co-conspirators at Anointed Care Services (Anointed), a Detroit-area home health agency, paid kickbacks to recruit Medicare beneficiaries.  Mr. Yrorita further admitted that as Anointed’s assistant director of nursing, he falsified medical records to support Anointed’s fraudulent claims to Medicare for services that were medically unnecessary and never provided. According to the evidence at trial, Anointed submitted approximately $1.6 million in false and fraudulent claims to Medicare. 


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