Oct. 15, 2013 – Now that Sunshine Act implementation is underway, pharmaceutical companies need to tighten up their reporting policies and procedures and help to educate and inform healthcare professionals (HCPs) before the federal database goes live in September 2014, according to speakers presenting at the recent Coalition for Healthcare Communication D.C. meeting.
The Coalition has been working to prevent important educational tools such as reprints and textbooks from being considered “transfers of value” (TOV), which are reportable under the final rule.
“The Sunshine Act has proven to be a big, bureaucratic snowball, and I don’t think any of us expected how far it would go,” said Jack Angel, Executive Director, Coalition Education Foundation, at the Sept. 24 Coalition meeting. He explained that Coalition representatives have met with the Centers for Medicare & Medicaid Services (CMS) and the Office of Management and Budget (OMB) in an attempt to roll back these provisions, but to date, they remain covered by the final rule. “We continue to work at correcting the situation,” Angel said.
Adam Huftalen, Senior Manager of Federal Government Affairs for Reed Elsevier, explained that efforts to rectify the reprint and textbook issue will hinge on making clear the value both types of these materials have to both physicians and patients. For example, he said that journal reprints help to keep clinicians informed and up to date, which allows them to provide better patient care, and that the journal peer-review process and existing FDA regulations ensure that these materials are of high quality.
Huftalen also remarked that textbooks are not consulted for routine care, but are accessed at the point of care as needed. “The sole purpose of disseminating a textbook is to convey the ideas contained therein,” he said. “Though CMS is not banning speech, it is substantially burdening speech, and such burdens are subject to First Amendment constraints.” Legislative language may be the only way to resolve these issues if current letter-writing efforts are not successful, he added. “There are a lot of politics involved with this issue. But we are optimistic about producing results.”
One way industry can work toward positive implementation is to increase physician awareness of the rule’s provisions. Charlie Hunt, publisher of BulletinHealthcare, told the Coalition meeting attendees that recent surveys of physicians show that awareness is rising. However, there is still room for improvement. He explained that targeted awareness-raising programs increased physician awareness of the financial reporting requirements from 47 percent to 58 percent in fewer than six months.
At a Sept. 23 session of the Coalition meeting, Mike McCaughan, Senior Editor, The RPM Report, asserted that drug companies should utilize Sunshine Act transparency to strengthen relationships with physicians. “Companies should have their own Web sites to crow about their dealings and relationships,” he suggested. “I would brag about everything I do to improve healthcare around the world. I would count them all and report them all,” he said.
But strengthening those relationships may be difficult due to growing tension between companies and physicians. To improve that situation, companies should implement some best practices for data collection, accountability, reports, and financial systems, according to Kathy Bronshtein, Chief Compliance Officer, Sudler and Hennessey.
For example, on the data collection front, she suggested that attendee sign-up sheets be used at events, that meals have an opt-out provision and that the value of the event to the HCP be made known to event recipients. This way, she explained, it should be clear to HCPs that they are participating and that a certain value will be reported in their name. She noted that a lack of standardization within and among companies is bound to be confusing to physicians, and that the dispute resolution process is “when all hell is going to break loose. Make sure you have the info to back up your position.”
Bronshtein also encouraged industry to raise HCP awareness by ensuring that they inform HCPs about what they are signing up for, which process the company will use to report, and that they should register on the CMS Web site to view the TOV reported against their names.
“We need to work together to ensure that we engage physicians and highlight the importance of our collaboration with them,” Angel noted.