This is the second in our series on provisions of the HHS proposed rule implementing the HITECH Act that, if included in the final rule, are likely to have the greatest impact on the business operations of pharmaceutical and other life sciences companies. We previously covered HHS’s proposed treatment of refill reminders and other communications about currently prescribed drugs. HHS has indicated that the final rule will be issued in March.
Today, we will look at the new requirements contained in the HHS proposed rule issued last July for what HHS is calling “remunerated treatment communications.”
Remunerated Treatment Communications
The HIPAA Privacy Rule generally requires that a covered entity obtain prior written authorization from an individual before using that individual’s protected health information for marketing purposes. Prior to the HITECH Act, certain communications, including those related to treatment and care coordination, were excluded from the definition of marketing. But under the HITECH Act, if a covered entity or business associate is compensated by a third party for making certain communications (including those related to treatment and care coordination), the covered entity generally must obtain prior authorization. As we previously reported, the HITECH Act contains one limited exception for communications about currently-prescribed drugs.