The newly effective HIPAA privacy rule adds another wrinkle to the debate over shadowing.
"It raises not just the issue of conflicts of interest from a financial standpoint," says Janlori Goldman, director of the Health Privacy Project, a Washington-based patient privacy advocacy group. "Unless the drug rep is considered a business associate and has a business-associate agreement with the physician, (shadowing) would become illegal without the patient's authorization."
That's where things get murky. William Sarraille, a healthcare attorney in the Washington office of the law firm of Sidley Austin Brown & Wood, says some practices may take the stance that a pharmaceutical or medical supply sales representative is more than a business associate and is somehow involved in actual patient treatment. The August 2002 modifications to the privacy regulations allow for disclosure of personally identifiable health information for the purposes of treatment, payment and other healthcare operations.
If a business-associate agreement already is in place, does the privacy notice each patient must receive indicate that the practice does business with drug reps?
"It requires consumers to understand what their rights are," Goldman says, noting that the physician is the one ultimately responsible for following the law.
"A critical issue is whether the drug rep is acting for or on behalf of the practice or if the drug rep is acting on behalf of the patient," Sarraille says. If the rep is there to educate patients in making healthcare decisions, "this suggests that this person is involved in treatment, perhaps," he says.
To date, the government has not issued an opinion on whether the practice violates HIPAA.