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 for patient referrals. It also includes inducing another person to furnish any item such as Lupron or Zoladex covered under a federal health program such as Medicare. Therefore, the anti-kickback law may well apply to inducements to use a particular drug, Pretl says.

3. Discounts. The most complicated issues involving Zoladex and Lupron marketing are the discounts manufacturers extend to high-volume prescribers a practice some view as an inducement. Under the law, physicians should be reimbursed at 95 percent of the average wholesale price, but the OIG has eliminated the requirement that providers report discounts. Whether any savings should be passed on is unclear.

Medicares Program Integrity Manual states that there is no need to report the discount, says Sandy Page, CPC,
CCS-P, co-owner of Medical Practice Support Services, a coding and compliance consulting company based in Denver. The manual also states that while you dont have to pass the discount along, you have to provide information on the specific arrangement with the buyer to the Department of Health and Human Services or other state agency, if requested, says Page, adding that this type of discount is unprotected as far as the anti-kickback statute is concerned.

You do not have to report a discount, notes Ray Painter, MD, a urologist who is president of PRS, a coding and compliance consulting company in Denver.

Keep Good Records to Avoid Future Problems

When drugs compete with one another, physicians become targets of aggressive marketing campaigns that also may include coding and billing recommendations. Dont ever take coding or billing advice from a sales rep, says Laura Siniscalchi, RHIA, CCS, CCS-P, CPC, education coordinator for coding at Beth Israel Deaconess Medical Center in Boston. You need to check it out for compliance and correctness first. Siniscalchi also stresses that practices must keep good records on what products have been paid for.

All cost and discount information should be recorded carefully because the physician must provide this upon request to the Department of Health and Human Services. Urologists, like other physicians, who are reimbursed based on fee schedules or charges, have no simple way to record discounts. But they should record any price breaks to steer clear of any problems involving Zoladex and Lupron. The AUA recommends the following:

1. Record all product samples when they are received.

2. Keep all product samples in a separate area.

3. Exclude all product samples from patient billing.

4. Accept no gratuities of value if it would create an
appearance of inducement to use a product.

5. Keep records of all discounts, bonuses or other price
reductions offered by manufacturers or their
intermediaries.

6. Contact an attorney if you have any concerns about
marketing proposals or your own past practices. In
addition, if a federal agency asks for any
documentation related to these activities, contact an
attorney immediately.

7. Consider not accepting any Lupron or Zoladex samples at all.

The AUAs Pretl is available to answer urologists general questions about this matter. He can be e-mailed (the preferred route) at mpretl@auanet.org, or called at (410) 468-1821.