DOJ official spells out possible targets

Physician freebies to get scrutiny

Assistant U.S. Attorney James Sheehan recently told a gathering of the American Health Lawyers Association that his office is looking to prosecute cases involving such physician-pharmaceutical company arrangements as:

  • drug "education" programs that are really nice lunches and dinners that drug representatives sponsor for physicians (and sometimes even for their staffs);
  • free "gas and go" service station privileges for physicians;
  • "educational" honoraria or "study" grants that place few or no requirements on the physician to get and/or keep them;
  • gifts of professional sports tickets, golf rounds, and trips to vacation resorts;
  • free drug samples that physicians then resell;
  • "independent" speeches that a drug company writes and then pays the physician to present.

Sheehan also noted that under a 1994 special fraud alert from the Office of the Inspector General covering prescription drug schemes (59 Fed Reg 65,372), items such as frequent flyer programs, conversion payments, and "research grants" to physicians may violate federal anti-kickback laws.

"The federal government is also studying how to go after drug companies when Medicare does not pay" for the prescription, says Michael D. Geldart, an attorney in the St. Petersburg, FL, law office of Holland and Knight. According to Geldart, some prosecutions might occur in instances where a prescription is paid for by private insurance. Investigators may use laws relating to the payment of anything of value to a physician if it constitutes interstate commercial bribery, a federal crime punishable under the Travel Act. Also, investigators could use the fact that paying anything of value to a doctor is an improper inducement "in furtherance of a health care fraud conspiracy," he notes.

The federal government is also focusing on drug manufacturer marketing programs, warns Geldart. One specific area to watch is any approach by drug representatives to use or recommend any of their products for reasons other than those specified on the label. In 1999, Genentech, a biotech firm in San Francisco, paid $30 million in criminal fines and $20 million in civil penalties for improperly promoting and marketing the off-label use of its products to doctors, hospitals, and other health care facilities.