UPDATE: EpiPen Rip Offs Continue

An update to our previous blog post: Mylan will pay $465 million in fines to settle claims brought by the U.S. Justice Department. In a rare instance of a corporation being the whistleblower, the drug company Sanofi first brought the matter to the U.S. Attorney's office in 2014 because it was selling a competing drug. Sanofi will receive $38.7 million as its share of the recovery.

EpiPen Rip Offs Continue

EpiPen pricing has been in the headlines often lately. The manufacturer, Mylan, keeps raising the price and ripping off patients. EpiPens went from costing $57 in 2007 to around $600 in 2016. With no generic option available, the company has no price ceiling. Now, it seems they have also been ripping off the government.

It appears that Mylan has been taking advantage of reimbursement rates with Medicare and Medicaid by miscategorizing its product. By law, pharmaceutical companies have to reimburse Medicare/Medicaid for 13% of the total cost of a generic drug that’s paid for by the programs. But for name brand drugs, pharmaceutical companies have to reimburse 23.1%. Mylan classified the EpiPen as generic and now Uncle Sam is calling.

Back in October, Mylan agreed to pay the US government $465 million without admitting any wrongdoing. It was the end of a long saga with Mylan and the company was quickly rewarded with a bounce in its stock price. As more information comes to light as to the extent of the fraud, however, Mylan is at serious risk of the settlement being voided.

CMS Overpays Millions in Meaningful Use Incentives

With the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, CMS offered significant incentives to health care providers to encourage the use of EHR systems that satisfied “meaningful use” requirements. To be eligible for EHR incentive payments, providers were required to self-attest that they satisfied federal program requirements and retain all documentation supporting their attestation for a period of six years following the attestation submission.

CMS recently conducted an audit of the program to ensure program integrity. Out of the sampling of 100 eligible healthcare providers who received incentives, 14 did not meet the program requirements. Extrapolating based on this sample, the OIG estimates that CMS inappropriately paid $729,424,395 in incentive payments to providers who did not satisfy the meaningful use requirements. OIG is now tasking CMS with the responsibility of recovering improper incentive payments of more than $729 million and educating healthcare providers on proper documentation requirements.

This new emphasis on recovering EHR incentive payments may present an opportunity for whistleblowers to come forward and correct a blatant fraud. The attorneys at Bracker & Marcus have represented whistleblowers in EHR false attestation cases, and are familiar with the incentive program requirements. If you are aware of a medical practice that has fraudulently obtained EHR incentive payments, give us a call.

The Largest Health Care Fraud Enforcement Action in DOJ History

Attorney General Jeff Sessions and HHS Secretary Tom Price announced today the largest ever health care fraud enforcement action by the U.S. Medicare Fraud Strike Force. The action involved 412 defendants including 115 doctors, nurses, and other medical professionals for their alleged involvement with $1.3 billion in false billings.

Over 120 of those defendants were charged for their roles in prescribing opioids and other dangerous narcotics. Last year approximately 59,000 Americans died of drug overdoses, with many of those from the misuse of prescription drugs.

“This week, thanks to the work of dedicated investigators and analysts, we arrested once-trusted doctors, pharmacists and other medical professionals who were corrupted by greed,” said Acting Director of the FBI, Andrew McCabe. “The FBI is committed to working with our partners on the front lines of the fight against heath care fraud to stop those who steal from the government and deceive the American public.”

Three defendants in Georgia were charged in two health care fraud schemes involving nearly $1.5 million in fraudulent billing. Two of the defendants were brought to the Government's attention by the attorneys at Bracker & Marcus.

For additional details, please see the Department of Justice press release, found here.