Urology Coding Alert

The federal investigation into incidents of abuse involving the expensive prostate cancer drugs Lupron and Zoladex is expanding beyond its original focus on the marketing practices of manufacturers. The Department of Health and Human Services Office of the Inspector General (OIG) and the Justice Department now are reviewing the handling and use of the drug in urology practices.

According to the American Urological Association (AUA), urologists have been charged by the U.S. Attorneys Office in Boston with:

commingling Lupron or Zoladex samples with purchased drugs;

using Lupron or Zoladex samples in the treatment of patients;

not distinguishing purchased units from nonpurchased units in billing, and

filing a claim for reimbursement of samples.

In their investigation of urology offices, investigators are examining three areas: samples, gifts and discounts.

1. Samples. Samples are the main focus of the investigation. The sale of drug samples is clearly prohibited by the U.S. Food, Drug and Cosmetic Act. The law applies not only to receiving money directly from a patient for a drug sample but also to filing a claim and being reimbursed by Medicare or a commercial insurance company for a sample given to a patient

If a physician files a claim for Lupron administration, for example, but used a sample, that is viewed as tantamount to selling the sample to the patient, warns Michael A. Pretl, general counsel for the American Urological Association (AUA) in Baltimore. The feds have told us that they consider samples to be the clearest avenue for going after doctors, says Pretl. They seem to be focusing, so far at least, on clear-cut cases, he says, but warns that careless record keeping may look like a violation to investigators. If you dont keep really good records, you could fall into a trap, says Pretl.

Claiming a mistake was made because of sloppiness is not a defense, he says.

2. Gifts. The OIGs subpoenas of urologists have mentioned both financial and material incentives educational grants, loans payments, computer software, VCRs and anything of value provided by a pharmaceutical company or an intermediary. Investigators have also requested records of trips, consultant meetings and seminars funded in whole or in part by drug companies. The American Medical Associations ethical guidelines require that a gift be worth less than $100 and have a benefit to patients to be considered of insubstantial value and thus allowable.

When there is an inducement to prescribe a certain drug, however, the picture changes. The federal anti-kickback statute bans the acceptance of any kind of remuneration in exchange for referring patients for items or services covered by Medicare or Medicaid. Many urologists are not aware that the anti-kickback law goes beyond inducements [...]