33 physician organizations and 41 state medical societies sent a joint letter on October 28th to Department of Health and Human Services Secretary Kathleen Sibelius requesting that HHS reverse its policy (under Sunshine Act regulations) that states that journal reprints and medical textbooks are considered "transfers of value" and reportable. Certainly, this letter forwards our goal of changing the regulations to include these materials as educational materials that benefit patients.
Letter to Kathleen Sibelius
The letter firmly supports the statutory and congressional intent to exempt educational materials that benefit patients from reporting. Signers for the letter included the American Medical Association publisher of JAMA, the Massachusetts Medical Society Publisher of New England Journal of Medicine plus many others.
The letter states that "We believe the regulations in this regard are contrary to both the statute and Congressional intent and will potentially harm patient care by impeding ongoing efforts to improve the quality of care through timely medical education."
The Coalition for Healthcare Communication has been in the forefront to explain to CMS and the Administration the importance of scientific peer-reviewed publications and textbooks. The groups reminded HHS that the Food and Drug Administration issued guidance in 2009 for the distribution of reprints by manufacturer representatives as long as they were distributed separately from sales materials. The FDA noted "important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications."
The Coalition for Healthcare Communications and the other organizations are hoping that CMS will revise their rule to exempt reprints from reporting.
Session in DC
In addition to the letter, The Coalition for Healthcare Communication recently held a meeting in D.C. where various stakeholders discussed their concerns about compliance with Sunshine regulations. They have 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," the article noted. "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,
- meals have an opt-out provision and
- 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.