Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance entitled “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.” In prior posts, we discussed the HITECH final rulehere, here, and here. The guidance, as you guessed it, addresses the refill reminder exception, from the Omnibus Final Rule, and its two prongs: (1) whether the communication is about a “currently prescribed drug or biologic,” and (2) if the communication involves financial
remuneration, whether the remuneration is “reasonably related to the covered entity’s cost of making the communication.”
Addressing the issues in Adheris, Inc. v. Sebelius
HHS’s guidance sheds light on key issues raised in the lawsuit filed by Adheris, Inc. against HHS, which we blogged about here and here.
At issue in Adheris is whether the company, whose main business involves sending refill reminders and medication adherence communications to patients about their prescribed treatment regimens, and is paid for by pharmaceutical companies, can continue to provide its services under the Omnibus Final Rule. In its complaint, Adheris argued that the Omnibus Final Rule violated the First Amendment and misconstrued the HITECH Act.
The HHS guidance clarifies the refill reminder exception and provides an example of permissible communications that is applicable in Adheris: “a pharmacy hires a business associate to assist in administering a medication adherence program that involves mailing adherence communications to patients about their currently prescribed drugs, even though the business associate is paid by the pharmaceutical manufacturers, provided the payment does not exceed the fair market value of the business associate’s services.” HHS’s guidance does not define “fair market value,” but does note that permissible remuneration includes “reasonable direct and indirect costs . . . including labor, materials, and supplies, as well as capital and overhead costs.” We haven’t heard anything yet, but we expect that this will likely take the wind out of the sails of Adheris’s suit.
Additional points addressed in HHS’s guidance
Also, of interest to many of our readers, HHS’s guidance makes clear that communications about specific new formulations of a currently prescribed medicine are not permitted under the Omnibus Final Rule. However, the guidance does permit more general communications about new formulations. So, while a covered entity or business associate can’t say to a patient on an immediate release formulation “Try the new extended release formulation” they can say “speak with your pharmacist about more convenient dosage forms.”
The guidance also addresses:
- Recently-lapsed prescriptions;
- Drug delivery systems;
- REMS and other “government-mandated” communications; and
- Face-to-face discussions with individuals about specific products or services.
quoted from FDALaw Blog found here
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