A federal task force comprised of Department of Justice, FBI and OIG officials is expanding a probe of Central Florida physicians involved in sales of the prostate cancer drug Lupron (Leuprolide). The investigators are targeting physicians who received excess supplies of Lupron and resold the drug to others or sought reimbursement from Medicare, Medicaid or insurance companies for free samples. Two Central Florida physicians have pleaded guilty to misdemeanor conspiracy charges and agreed to pay $1.13 million in fines and penalties. At least three other physicians in other parts of the country also have pleaded guilty to criminal charges.
The manufacturer of Lupron, TAP Pharmaceutical Products Inc., recently confirmed that its marketing and pricing practices are being investigated under the Federal False Claims Act, the anti-kickback statute, the Prescription Drug Marketing Act and other Medicare and Medicaid fraud statutes. Government investigators have obtained from TAP and certain of its distributors records of Lupron sales and deliveries of free samples to Central Florida physicians. Physicians who resold Lupron or other drugs, or billed for free samples of Lupron or other drugs, should immediately contact competent legal counsel for advice.
Pharmaceutical companies aggressively market prescription drugs to physicians using a variety of techniques. Some techniques implicate the anti-kickback statute. It is a crime for pharmaceutical companies to pay kickbacks, bribes, rebates or any remuneration to physicians to induce the prescription of drugs reimbursed by Medicare and Medicaid. The criminal statute prohibits both the giving and receipt of the remuneration, thus subjecting both pharmaceutical company personnel and physicians to criminal exposure. In one such scheme, a pharmaceutical company agreed to supply a physician with free samples of Lupron in exchange for switching patients from a competing drug, Zoladex. The physician then administered free samples of Lupron to patients and billed Medicare, the patients and their insurers for the samples.
The Council on Ethical and Judicial Affairs of the American Medical Association recently clarified its guidelines on gifts to physicians from industry. These guidelines apply to gifts from pharmaceutical companies, device and equipment manufacturers and any other health care entity that might present a conflict of interest. The guidelines are located at www.ama-assn.org/ama/pub/category/4263.html
Free drug samples are legitimate when given to the patient at no cost in small quantities to test the medication’s efficacy. The use of drug samples for personal or family use is permissible as long as the use does not interfere with patient access to drug samples. Drug samples must be explicitly labeled as "Physicians’ Sample," "Complimentary Sample," "Patient Starter Package," or similar language. It is a violation of federal and Florida law to resell or trade drug samples.
In light of stepped-up government enforcement, physicians should take careful precautions to segregate drug samples in storage areas apart from billable drugs. Additionally, drug samples— like all drugs—should be regularly inventoried. Expired samples should be destroyed with appropriate backup documentation or returned to the pharmaceutical manufacturer or distributor.
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