At a recent meeting in Washington, D.C., Rep. Michael Burgess, M.D. (R-TX) spoke to the importance of H.R. 5539, bipartisan legislation he co-sponsored that would exempt peer-reviewed medical journal reprints and independent continuing medical education from Sunshine Act reporting. Burgess serves as Vice Chairman of the Subcommittee on Health in the Energy and Commerce Committee, and practiced medicine for nearly 30 years prior serving in the House.
The session, led by Sylvia Trujillo, Legislative Counsel at the American Medical Association, also included valuable input from Christina Taylor, M.D. from the Iowa Clinic and Jeffrey Drazen, M.D., Editor-in-Chief of the New England Journal of Medicine. Dr. Taylor discussed the role and value of textbook reprints to busy practicing doctors. Dr. Drazen brought his perspective as an editor of an independent peer-reviewed journal, as well as an educator.
Background on the Educational Exemption of the Sunshine Act
One of the most troublesome aspects of the Physician Payments Sunshine Act is its potential chilling effect on physician access to independent education on cutting edge medical issues. Peer-reviewed medical journal reprints and accredited or certified continuing medical education remain two of the most important ways for doctors to stay up-to-date on the best ways to treat patients with particular diseases.
In the Affordable Care Act, Congress outlined 12 specific exclusions from Sunshine Act reporting, including “[e]ducational materials that directly benefit patients or are intended for patient use.” The Centers for Medicare and Medicaid Services (CMS), tasked with implementing the Sunshine Act, took the view that medical textbooks and reprints of peer-reviewed scientific clinical journal articles were not "directly beneficial to patients," nor are they "intended for patient use." Thus, these education materials have to be reported under the Sunshine Act.
The AMA has noted that CMS's conclusion is "inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge.”
Furthermore, CMS has also gone back-and-forth on whether to exempt accredited or certified continuing medical education.
Rep. Burgess's goal in introducing the bill was to "try to minimize the negative impacts that…the interpretation of this provision of the ACA is having on medical education and patient care." Thus, H.R. 5539 seeks to highlight Congress' intent in passing the Sunshine Act and would exempt medical textbooks, peer-reviewed journals and reprints, and transfers of value related to continuing medical education.
“It is important that doctors and caregivers continue to have access to the latest medical education materials as well as continuing medical education,” states Burgess. He notes that patient care has suffered due to a definite chilling effect on the transfer of information: “Doctors and companies are afraid that in the reporting there is going to be the veiled implication that something bad has been going on.”
Burgess notes that in all likelihood the bill will be re-introduced in the next Congress. "I'm not sure we'll get this across the finish line this time," he states, but he is confident about the bill's success. Unlike many aspects of the Affordable Care Act, Burgess notes, "this bill has bipartisan support." Both sides have recognized that it is important for doctors to "stay as up to date as possible" in a rapidly changing medical environment.
Sylvia Trujillo of the AMA states that the Association supports the Sunshine Act's transparency goal. However, H.R. 5539 would ensure that the policy does not undermine efforts to provide physicians with the most current independent medical knowledge in a timely manner. "Telemedicine and personalized medicine," for example, are "areas of medicine that are rapidly emerging and changing," for which evidence-based education really matters.
Dr. Taylor, an internist from the Iowa Clinic, provided her experience to illustrate how CMS's interpretation of the Sunshine Act is affecting practicing physicians and patients. The intent of the Act, she notes, was to shine a light on financial relationships between physicians and pharmaceutical and device industries. "Everyone would agree that is a reasonable thing," Taylor states. Where Taylor disagrees, however, is in CMS's interpretation of what constitutes "educational materials," which would rightfully be excluded from reporting requirements. Specifically, that peer-reviewed medical journal articles are not considered to be a "benefit to patients."
Most obviously, she states, patients benefit from their doctor learning about the proper treatments or guidelines to help the patient. The other aspect is that often doctors show patients the actual guidelines as part of the treatment during the office visit.
Despite the fact that when Dr. Taylor receives an article there is "no financial transfer of any kind," the mere Sunshine reporting suggests that she is receiving direct funds from industry.
"If I received a New England journal...that is now a reportable item, just like cash."
"What doctors really want to see are independent, peer reviewed evidence," states Taylor. "Peer-reviewed journals and Immediate access to those is absolutely crucial to practicing medicine appropriately." However, with this information now reportable just as a cash payment, Taylor notes that she is less likely to accept these reprints from reps during her two-minutes in between patients. "Frankly, I don't want my name anywhere near that list saying that I received some sort of financial payment...or having the appearance of receiving something."
Taylor states that even today, it can take 10-20 years for completed research to reach the practicing private physician in their office. Thus, if physicians have a way to get the latest treatment guidelines quickly in front of them, this process should not be discouraged.
“There is an ever increasing challenge to see every patient and keep them healthy, take care of patients with chronic diseases, and to stay on top of documentation requirements that are vastly increasing," Taylor states. Unless physicians are in an academic insitutiton where they either have time or staff to sift through research and present their finding, most simply do not have time each week to go through peer reviewed articles. Many doctors, especially those in private practice do not have the resources to allocate to exploring articles as they are published. "Not having access to peer-reviewed journal articles, unfortunately, is one of the unattended consequences of the Sunshine Act as interpreted by CMS."
Trujillo added that physicians are not reading medical textbooks for fun--they reference these texts for a specific patient. "Clearly, this is a specific benefit to the patient."
Dr. Drazen, the Editor-in-Chief of the New England Journal of Medicine (NEJM) echoed many of these sentiments, making the point that a NEJM reprint article could have prevented the Ebola scare in Texas.
Drazen also went into detail about what separates a peer-reviewed journal from potential "advertising." He states: "We just don't take stuff that people send us and publish it. We have knowledgeable people that spend their time making sure that every single point in the article is defensible with data."
The "paradox," he states for patients, is that these articles are both "the most valuable things your doctor can have" and on the other hand "have absolutely no value--they are available for free on the web." Indeed, despite being classified as "transfers of value" to physicians, independent journal reprints are actually free or of very low value for almost all physicians. The problem is, doctors have to search online on their own off-hours time to seek them out.
Dr. Taylor gave a multi-faceted endorsement for H.R. 5539 in conclusion: "Passing this resolution is not only in better standing with the original intent of the [Sunshine Act], but it's also better for the advancement of evidence-based medicine, the distribution of medical knowledge, and ultimately will help us improve the care we provide to our patients every day."
Trujillo spoke to the important impact H.R. 5539 would have on medical education as well. CMS has provided mixed guidance over the years on the reportabilty of CME payments. While the agency has landed on the side of exempting accredited CME payments right now, H.R. 5539 would prevent them from changing their minds yet again down the line.