Rachel Seeger, an OCR spokeswoman, said it “has received a number of requests on this particular issue on both sides of the spectrum. At this time, we haven't made a formal response to any of these requests.”
In 2009, Congress broadly added new restrictions to the use of patient-identifiable health records, such as prescriptions, by hospitals, physicians and other covered entities such as pharmacies, for marketing without a patient's consent. An HHS rule implementing the provisions takes effect Sept. 23.
The Florham Park, N.J.-based Specialty Pharmacy Association of America, which claims 3,500 members including specialty pharmacies, pharmacy manufacturers, payers and others organizations, sent one of the letters July 25, signed by executive director William Sullivan. The SPAARx letter raises issues about what it calls the “compliance and persistency programs developed and implemented by specialty pharmacies to enhance quality of patient care through proactive compliance programs.”
By one estimate, 75 million to 100 million of these mailed messages are sent out each year. Third parties, typically drugmakers, fund many of these refill reminder programs, which are operated by pharmacies for their products using patient information kept by the pharmacies.
One new provision of the 2009 law limits the third-party funding of these refill reminder programs to payments that are “reasonable in amount.” Congress left it to HHS to define what was reasonable. HHS' rule says the payments must be “reasonably related to the covered entity's (e.g., pharmacy's) cost of making the communication.” The preamble to that rule says if a payment “generates a profit or includes payment of other costs, such as financial remuneration, would run afoul of the act's 'reasonable in amount' language.”
In May, CVS Caremark Corp. said it would stop its pharma-funded refill reminder programs, citing limits in the new rule.
The specialty pharmacy group complained that HHS “is limiting remuneration to the specific direct cost” of the communication, such as drafting, printing and mailing, and that “does not fairly recognize the additional expenses of clinicians and staff that deliver therapy management traditionally telephonically.”
SPAARx recommended that HHS consider instead using a standard of fair-market value of the service to determine whether it meets the congressional limit of “reasonable in amount.” It notes that fair-market value is the standard used by the Office of Inspector General in anti-kickback enforcement. The association also asked HHS to review its restrictions with an eye to the use of patient contact lists with mobile devices and social media. Calls for comment were not returned by deadline.
But Pam Dixon, executive director of the World Privacy Forum, wrote a letter to McAndrew dated Aug. 9 that sought to rebut SPAARx. It asked HHS to stand behind the final rule.
“We believe that SPAARx's request is another stalking horse for making marketing communications that the rule properly bans,” Dixon wrote. “We observe that prescription refill reminder programs are often only available for high-priced, patent-protected drugs. Reminders are often sent primarily when the programs are profitable to pharmaceutical manufacturers and to pharmacies. Whether there is any patient benefit is uncertain.”
Besides, Dixon said in an interview, the deadline for changing the rule is past. “We all had our chance to make our comments during the comment period,” she said. “They had theirs and we had ours. It does not seem like a reasonable letter to be sending this late in the game. I don't think HHS can give them what they want without reopening the rule making.”
Dixon said, “I didn't find it (the rule) hazy at all. They just didn't like the outcome. I think Congress was pretty clear about this prescription reminder material. This was hard fought. I recall there was a lot of discussion, and Congress chose not to have additional marketing.”
If drugmakers want to get around the rule lawfully, they can simply ask patients if they want to be alerted when they need a refill or they need to see a physician to get it renewed prescription is about to run out, she noted. “That is completely available to them … to get people to opt in,” Dixon said. “If it's a great service, people are going to opt in.”
Follow Joseph Conn on Twitter: @MHJConn