“Serve a paper and sue me ….” Is this really the only way to get HHS to agree to promulgate long-promised guidance for medication adherence contractors and others that face “restrictions on remunerated refill reminders and other communications.” under the HIPAA Omnibus Rule?
Apparently it is.
The final rule was promulgated eight months in advance of the compliance date coming up on September 23, yet Adheris (great name, eh?) found it necessary to seek an injunction earlier this month barring HHS/OCR from enforcing the Omnibus Rule insofar as it would infringe on the company’s constitutionally-protected right of free (commercial) speech.
The joint motion filed yesterday by the plaintiff and the government basically said that instead of agreeing to a rapid briefing and argument schedule so as allow the court to render a decision before September 23, “HHS expects to issue [the] guidance by September 23” and “the Secretary has decided, as an exercise of her discretion, not to enforce the restrictions on remunerated refill reminders and other communications about drugs and biologics (as set forth in 45 C.F.R. § 164.501) for a period of 45 days following the announced compliance date, or until November 7, 2013.” That will give the parties some time to peruse the guidance.
“Remunerated refill reminders,” after all, are probably a good idea (medication adherence generally improves health and reduces overall health care expenses for an individual or a population — cf. experience of Iora Health, as one example), and consonant with other Federal health reform initiatives, such as promoting Accountable Care Organizations and reducing preventable readmissions, to name a couple.
For those Covered Entities and Business Associates who aren’t yet ready for the compliance date but who aren’t interested in suing the federales, it’s never too late to undertake a concerted effort to come in to full compliance.
You know where to find me.
David Harlow
The Harlow Group LLC
Health Care Law and Consulting
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The refill reminder guidance is out:
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/marketingrefillreminder.html
And here is another post on the subject, including a letter I received from HHS in connection with exploring the range of options available to a client under the rule and the guidance: https://healthblawg.com/2014/04/hipaa-marketing-rule-guidance-better-than-nothing.html