Monday, November 25, 2019

FDA In Brief: FDA explains policy for manufacturers of battery-operated tobacco products and e-liquids who are considering making limited safety-related modifications to their products 

Today, the U.S. Food and Drug Administration issued a guidance, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, which sets out the FDA’s compliance policy for limited safety modifications to tobacco products on the market as of Aug. 8, 2016: (1) battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard; and (2) e-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). This guidance explains that the FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications.

On Aug. 8, 2016, all e-cigarettes and other electronic nicotine delivery systems (ENDS) products became subject to...

Friday, November 22, 2019

10 hours ago - Two doctors and a nurse pleaded guilty in federal court to health care and mail fraud in a scheme to bilk millions through pricey pills and creams.

Two Doctors Plead Guilty to Conspiracy to Commit Health Care Fraud in Compound Fraud Scheme

Department of Justice
U.S. Attorney’s Office
Southern District of Mississippi

FOR IMMEDIATE RELEASE
Thursday, November 21, 2019

Two Doctors Plead Guilty to Conspiracy to Commit Health Care Fraud in Compound Fraud Scheme

Hattiesburg, Miss. – Shahjahan Sultan, M.D., 37 of Madison, Mississippi and Thomas Edward Sturdavant, M.D., 56, of Kingsport, Tennessee, pled guilty today before Senior U.S. District Judge Keith Starrett to conspiring to commit health care fraud, announced U.S. Attorney Mike Hurst and Special Agent in Charge Michelle Sutphin with the Federal Bureau of Investigation in Mississippi. 
“These doctors violated their oaths and harmed our military, our veterans, and every American taxpayer by defrauding TRICARE. I want to commend our law enforcement partners, DOJ trial attorneys, and our federal prosecutors for bringing these criminals to justice.  We will continue to aggressively pursue criminals who pilfer our national treasury and do all that we can to protect victims of these crimes,” said U.S. Attorney Hurst.
In May 2014, Sultan entered into a contract with a pharmacy located in Jackson County, Mississippi.  Pursuant to the contract, Sultan agreed to prescribe expensive compound medications to individuals in exchange for the pharmacy paying Sultan 35% of the reimbursements it received for the prescriptions.  Health care benefit programs, including TRICARE, were billed for the compounded medications. 
Sultan employed others who identified individuals in places like Jones County, Mississippi, who had insurance which covered the expensive compounded medications.  Sultan met with the insured individuals over telemedicine video-chat sessions.  However, during the meetings, he did not perform thorough examinations of the individuals and did not determine the medical necessity of the compounded medications he prescribed. Sultan knew that some of the added ingredients in the compounded medication were not effective and were added solely to increase the reimbursement value.  On occasion, Sultan and Sturdavant even called in compounded medications for individuals they had never previously examined.  
Sultan hired Sturdavant in September 2014 and agreed to pay him $900,000 annually to perform telemedicine services and to prescribe the compounded medications dispensed by the pharmacy.  From May 2014 through October 2014, health care benefit programs, including TRICARE, reimbursed the pharmacy more than $5,000,000 based on claims submitted by the pharmacy in connection with the expensive compounded medications ordered by Sultan and Sturdavant.
Sultan and Sturdavant will be sentenced by Judge Starrett on February 26, 2020 in Hattiesburg.  They each face a maximum penalty of 10 years in prison, 3 years of supervised release, and a $250,000 fine.
The case was investigated by the FBI and DCIS.  Assistant Chief Dustin M. Davis and Trial Attorney Sara E. Porter of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Kathlyn R. Van Buskirk of the Southern District of Mississippi prosecuted the case.