Friday, December 13, 2013

Marketing, HIPAA, Rules & Exceptions

---Terri Bernacchi, PharmD, MBA,  President, Cambria Health Advisory Professionals

Health Care Reform (the ACA, PPACA, “Obamacare” or whatever you want to call this hot mess) was basically an outline or framework.  Along with ACA, there have been  myriad other bills and regulatory or administrative rules which have come out piecemeal since 2009 that---combined---make it very difficult to assimilate, plan, or manage changes in business operations for many businesses directly or indirectly involved in the US Health Care Sector. 
One of these—HITECH---contains some rules that impact what is considered prohibited in terms of “marketing” drugs directly to patients, citing HIPAA and other related privacy rules. 
In 2009, the HITECH Act was signed into law as part of the American Recovery and Reinvestment Act. (ARRA) One effect of HITECH was to reduce the range of permitted communications with patients.  It declared that a communication “about a product or service . . . that encourages recipients of the communication to purchase or use the product or service shall not be considered a health care operation” if the covered entity receives direct or indirect payment in exchange for making the communication.
As is common with federal regulations or laws, there were various limited exceptions to the rules, but the net result of this specific provision is that payments to covered entities (such as pharmacies) to provide particular types of communications to patients on behalf of a pharmaceutical company would be considered marketing and thus excluded under HIPAA permitted “TPO” (treatment, payment or operations activities.)  The HITECH Act did not, however, state whether some communications (done for compensation) might be considered “treatment,” and thus, excluded from the “marketing” label.
Health and Human Services undertook rulemaking (recently released) in the Final Rule.  Permissible communications that are not considered marketing (e.g., refill reminders) should have been clarified by the Final Rule. 
If covered entities receive any financial (direct or indirect payment) remuneration in exchange for making the treatment-related or health care operations-related communication, the communication is now thus considered marketing. If the same activity goes on without remuneration, it is okay. 
Importantly, this represents a striking departure from past law and guidance and common practice.  The rule also dropped the opt-out requirement under which a patient may choose to “opt out”.  
There are more details in the Final Rule, including the exception for “face-to-face” versus electronic, telephone or written messaging.  HHS announced that it would not enforce the restriction on financially remunerated prescription refill reminders until November 7, 2013.  That means that these rules are currently in place, and enforceable.
 
Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers, clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA.