The company has better options. If it coordinated its sampling policies with the patient-assistance program, for example, it could avoid trouble with OIG and save some money as well. If Pharma ABC shared patient-assistance data with the sales representative—which few, if any, pharmaceutical companies do—the rep might discover that Dr. Ryan has never accessed the program. And why should he? Sales reps are giving him so many samples that he doesn't need a program designed for indigent people.

In this case, the company needs the patient-assistance program to keep OIG at bay. Instead of loading up Dr. Ryan with samples, his sales rep could help him enroll in the patient-assistance program, get him stock bottles of medication for free (which cost the company about 50 percent of what samples cost) and take a tax deduction on the donation. The doctor receives fewer samples and probably writes more prescriptions.

Why don't companies do this? Usually because they don't know that they can. The biggest challenge facing most companies that want to change is their own internal organizations. Data silos prevent global data integration, a critical success factor to achieving OIG compliance.

These good intentions went so far that they now handicap companies' efforts to respond to OIG regulation. Companies maintain separate data silos that prevent marketers and sales reps from making good decisions about how to sample doctors. The silos may have served a purpose once, but they are liabilities now.

No HIPAA violations result from telling a rep whether a physician has accessed the program, or how many times. Reps who help physicians enroll are not offering a quid pro quo. Nor are they asking for specific patient information. They need information to serve the doctors' needs, and to help the company meet this new wave of regulation. Often representatives get into the bad habit of distributing samples more or less evenly to all practices. They need to tailor the number of samples to account for practice size, demographics, and prescribing behavior.

To be ready to respond to an OIG investigation, the data silos must be broken down, so the data can be integrated into a whole-systems approach to sampling physicians. Data on demographics and prescribing, for instance, which are almost always held in separate departments, need to be combined. In fact, companies will save millions of dollars if they do this.

Ironically, by embedding OIG compliance into marketing initiatives, pharma companies will help derive more accurate ROI per practitioner and better control of overall selling expenses. Five years ago the industry had about 45,000 reps. Today, the number exceeds 100,000. The population of physicians, however, has grown by just three percent. When I sold in the field in 1974, I got eight to 10 minutes with each physician. Today, the average call is 60 to 90 seconds. Samples, which were once a crucial, tactile part of the sales detail, have become expensive door openers.

Samples remain the most valued commodity offered by sales reps. But offering help to patients may be equally productive. Pitching it is worth a try: "Look, I've been calling on you for two years. I've given you thousands of samples. I've noticed you've never accessed our patient-assistance program. Are you aware we have one? How many indigent patients do you treat?"

What are the likely benefits?

• The rep now is going to get more than a 90-second call, because he or she is asking about something important to that doctor's practice.
• The rep will engender good will.
• Those stock bottles for indigent patients are significantly less expensive than an equal number of samples, because of the packaging involved.
• The federal government has established tax incentives for companies that supply products to this underserved population.
• The company reduces the sample budget for that office and avoids OIG concerns about overutilization, inducement, or enticement.
• Samples delivered to the office are reserved for fee-for-service patients.

That's just one pitch for one case study. Other sampling scenarios will also attract the attention of OIG. In many cases, responding to the challenge with integrated data and a whole-systems approach will enhance the promotional efforts of a company while achieving compliance under OIG.

Steve Tarnoff is executive vice president and managing director at The Franklin Group. He can be reached at starnoff@franklinpharmaservices.com