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HIPAA's privacy regulations are making pharmacists leery of reporting drug diversion information
It's still legal to communicate information about drug diversion to appropriate law enforcement agencies, says the key advisory committee for the Health Insurance Portability & Accountability Act (HIPAA). It calls for more education of pharmacists and physicians on that fact.
The National Committee on Vital and Health Statistics (NCVHS), a panel of 18 external experts that is a major developer of federal HIPAA policy, received testimony on the issue from the Drug Enforcement Administration earlier this year. DEA said some providers have been reluctant to report potential drug abuse to the agency or to state prescription-monitoring programs since the rule's implementation last year.
In June, NCVHS wrote to Department of Health & Human Services secretary Tommy Thompson calling on HHS to cooperate with DEA in reassuring providers that such reporting is permissible. So far, there's been no specific response from HHS, which has several issues to sift through on the new privacy rules.
Richard K. Harding, M.D., a member of the NCVHS privacy subcommittee that heard the testimony, said some attorneys have used "extraordinarily wide" interpretations of the privacy rules in telling providers not to allow DEA or state monitoring programs to see records. In general, he said, disclosures to these agencies that were proper prior to the release of the privacy regulations, are still proper.
John Burke, VP of the National Association of Drug Diversion Investigators, said this kind of overly conservative HIPAA interpretation has eased over the past few months, at least in NADDI members' experience, as more attorneys and providers become better educated on the new rules.
However, Susan Bishop, senior manager of regulatory affairs and political action, American Pharmacists Association, said R.Ph.s may need more specific guidance on other aspects of cooperating with law enforcement on drug diversion. On the one hand, she noted, the rules are pretty clear that disclosure to DEA and state Rx-monitoring programs is permitted. On the other hand, she said, some requests can get sticky because they are "situation specific."
Bishop pointed to, for example, parts of the HIPAA regulation that indicate that providers may disclose records in response to an administrative subpoena or summons, a civil or authorized investigation, or similar legal process if the information is relevant to the inquiry and the request is specific and limited according to the request's purpose. The R.Ph. is left to decide if those conditions are met.
APhA offers some general guidance for pharmacists, but it also advises them to consult with legal counsel when they draft procedures for handling these requests. The association's information is posted at www.pharmacist.com/hipaa.cfm.
Beyond just education of providers, Kevin Nicholson, R.Ph., J.D., director of pharmacy regulatory affairs at the National Association of Chain Drug Stores, called for language in the regulation that would protect R.Ph.s and physicians from being sued if they disclose information in good faith. He noted that, at the same hearing at which DEA testified, the American Civil Liberties Union (ACLU) expressed concerns that HIPAA allows providers to disclose information to law enforcement without a judicial review, in the cases of subpoenas, summons, or civil investigative demand.
ACLU called for a requirement that government agents get judicial approval under a "probable cause" standard. That testimony illustrates the clash between law enforcement and civil liberties philosophies, Nicholson observed, that may lead to legal actions catching providers in the middle.
Kathryn Foxhall. HIPAA rules spur questions on drug diversion reports.
Aug. 9, 2004;148:37.