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Stark and Anti-Kickback

The Anti-Kickback Law makes it illegal for health care providers to accept bribes, money, or gifts “knowingly and willfully” in return for Medicare, Medicaid, or other federal health care program business.

The Stark Law also prohibits physicians from referring patients for certain health services – paid for by Medicare – to anyone with whom they have a financial relationship.

Both the Anti-Kickback and Stark Laws are intended to ensure that medical decision-making is not compromised by improper financial incentives.

These laws ensure health care providers and organizations base medical decisions on the best interest of the patient – not the best interest of their own wallet.

The False Claims Act is a valuable tool to ensure that health care organizations and providers comply with the Anti-Kickback and Stark Laws and especially so with the changes that the U.S. Department of Health and Human Services made in November 2020 to these laws.

If you share knowledge and proof that a hospital, drug company, or health care provider may be getting kickbacks, you may be entitled to a financial reward under the False Claims Act.

If you are aware of old, new, or evolving fraud schemes involving the Stark or Anti-Kickback Laws, the Department of Justice may be very interested in learning more about the information you have.  You may also be entitled to a financial reward.  Tell us about the information you have.  We will provide you a free consultation.

Off-label Marketing

Pharmaceuticals and certain medical devices must be approved by the FDA before they can be marketed or sold to the public. Medicare and Medicaid require that reimbursement for pharmaceuticals and medical devices is only available when those pharmaceuticals or devices are used in the manner approved by the FDA. Companies that market and sell pharmaceuticals or devices, however, often unlawfully promote the use of their products for uses not approved by the FDA (called “off-label” uses) to increase profits. This off-label marketing leads to the submission of improper claims to Medicare and Medicaid.

The Department of Justice has been particularly aggressive about investigating these fraud schemes and some of the largest qui tam cases ever – including some cases that have settled for more than $1 billion – arose out of such off-label marketing schemes.

If you are aware of old, new, or evolving fraud schemes involving off-label marketing, the Department of Justice may be very interested in learning more about the information you have.  You may also be entitled to a financial reward. Tell us about the information you have.  We will provide you a free consultation.

Pharma Speaker Programs

All too often, pharma and medical device companies are providing some kind of unlawful financial incentives to health care providers while they are also unlawfully marketing their drugs or devices “off-label.”  These fraud schemes seem to go hand-in-hand.

A common kickback scheme is where a pharma or device company unlawfully pays physicians thousands of dollars to participate in a sham speaker program whereby the physician is provided expensive meals and alcohol with the expectation that the physicians will write more prescriptions for the company’s drugs than the physicians normally would in the absence of such incentives.

This has been one of the most aggressive areas of False Claims Act enforcement for the Department of Justice.  In almost every case, DOJ was “put onto the fraud” by individuals who worked inside the company, often sales representatives who marketed the drugs to health care providers.

One pharma company paid over $95 MILLION for violating the False Claims Act by marketing one of its drugs off-label and by paying physicians in the form of money, speaker program fees, travel, and food to induce them to write prescriptions for the drugs.

The three former employees of the pharmaceutical company who reported the fraud scheme to the Department of Justice received more than $17 MILLION.

In another case, a pharma company paid bribes and kickbacks to physicians to write prescriptions for a powerful opioid.  The pharma company admitted that it set up a sham speaker program to funnel the payments to physicians.  It paid $225 MILLION dollars.

Several individuals reported this sham speaker program to the Department of Justice and were entitled to a share of the $225 MILLION recovery.

Another pharmaceutical company paid $350 MILLION for allegedly inducing clinics and physicians with lavish dinners, drinks, entertainment and travel, medical equipment and supplies; unwarranted payments for purported speaking engagements and bogus case studies; and cash, credits, and rebates.

Numerous individuals reported this unlawful kickback scheme to the Department of Justice and were entitled to a reward.

If you are aware of old, new, or evolving fraud schemes involving sham speaker programs or other kickback schemes, the Department of Justice may be very interested in learning more about the information you have.  You may also be entitled to a financial reward. Tell us about the information you have and provide you a free consultation.

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