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Durable Medical Equipment Company’s Pricing Structure Violates Anti-Kickback Statute

DMEDurable Medical Equipment (DME) manufacturers can face serious fines for violating the Anti‑Kickback Statute (“AKS”). In a recent settlement, Respironics, a manufacturer of sleep therapy products, agreed to settle allegations that its bundled pricing structure for sleep apnea masks violated the AKS. Since violations of the AKS give rise to fines under the False Claims Act, DME manufacturers can face trebled damages and fines up to $10,000 per violation.

According to Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, “The payment of illegal remuneration in any form to induce patient referrals threatens public confidence in the health care system. Americans deserve to know that when they are prescribed a device to treat a serious health care problem, the supplier’s judgment has not been compromised by illegal payments from equipment manufacturers.”

Respironics, Inc. provided call center services to DME companies at no cost so long as the patients ordered Respironics masks. DME companies had to pay a monthly fee based on the number of patients who used masks manufactured by Respironics’ competitors. According to the U.S. Department of Justice, this made suppliers more likely to use Respironics masks. Respironics has since changed the pricing structure of its call center services.

A South Carolina pharmacists recognized that the arrangement likely violated the AKS and filed a qui tam (whistle-blower) lawsuit. The U.S. Justice Department intervened along with 29 other states and the District of Columbia.

Respironics agreed to pay $34.8 million in order to settle the lawsuit even without admitting wrongdoing, and the company continues to maintain that its pricing structure fit within the discount Safe Harbor. However, this settlement serves as a powerful reminder that companies must be aware of potential AKS violations. Respironics’ “good-faith belief” that the arrangement met a Safe Harbor did not save it from AKS scrutiny or a multimillion dollar settlement.

If you have any questions or need assistance with healthcare regulatory issues, Jeyaram & Associates attorneys can help. Contact DJ Jeyaram at DJ@Jeylaw.com or 678.325.3872.

Work In Healthcare? You Could Face Steep Fines Or Jail Time For Healthcare Fraud

Healthcare FraudNewly Released Health Care Fraud Report shows that HHS/DOJ Enforcement Efforts Remain Strong

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released their annual joint report outlining the results of their healthcare fraud enforcement efforts throughout FY 2015.

The Report shows that during that period the DOJ opened 983 new criminal health care fraud investigations and over 800 new civil health care fraud investigations. Additionally, HHS investigations resulted in 800 criminal actions against individuals or entities that engaged in crimes related to Medicare and Medicaid, and 667 civil actions, CMP settlements, and administrative recoveries related to provider self-disclosure matters.

Over the course of the year, the government won or negotiated over $1.9 billion in health care fraud judgment and settlements.

High Number Of Fraud Convictions

The Report also highlights the activity of the Medicare Fraud Strike Force whose efforts resulted in over 300 guilty pleas and 48 defendant convictions throughout the year, and over 260 defendants going to jail. The Report summarizes several successful enforcement actions by the Strike Force including:

  • 2 physicians owners of a mental health clinic were each sentenced to 10+ years in prison for certifying that certain Medicare patients qualified for partial hospitalization services when they did not and paying kickbacks to group home operators and patient recruiters in exchange for referring Medicare patients;
  • An owner of a DME company was sentenced to 84 months in prison for paying kickbacks to medical clinics for fraudulent prescriptions for DME which the patients did not need; and
  • 2 home health directors were sentenced to over 10 years in prison and ordered to pay $18.6 million in restitution after pleading guilty to conspiracy to commit fraud and payment of kickbacks in exchange for Medicare referrals and home health service prescriptions.

You Could Personally Be Fined Or Go To Jail

The government is clearly cracking down and the healthcare industry should heed the warning. The Report indicates that any individual in the healthcare realm, whether physician or hospital CFO, could incur steep fines, penalties and even serve jail time for violating the Federal Anti-Kickback Statute, Stark Law and False Claims Act.

Jeyaram & Associates can help you assess and minimize your risk under these healthcare fraud and abuse laws. If you have any questions please contact Danielle Hildebrand at Dhildebrand@jeylaw.com or 678.325.3872.

To review the Report it is available here.