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Dr. Robert E. Harbaugh Talks Sunshine Act

Recently, neurosurgery’s very own Dr. Robert E. Harbaugh, participated in the conference, where he was a distinguished panelist during the “Creating Awareness of Sunshine Disclosure Among Physicians and Patients” session.

In his remarks, Dr. Harbaugh said,

“Diseases commonly treated by neurosurgeons – stroke, brain tumors, head and spinal cord injury, epilepsy and Parkinson’s disease and diseases of the spine — contribute very  significantly to the disease burden in the United States.  During my career in neurosurgery there have been great advances in the diagnosis and treatment of patients with these diseases.  In 2013, despite treating a large number of patients who would have been untreatable 30 years ago, the odds of a neurosurgical patient having a favorable outcome are much better than they were when I started my practice in 1985.  

Most of the critical breakthrough advances in neurosurgical diagnosis and treatment have resulted not from hypothesis driven research, but from very practical or applied technology development that occurred only because innovative physicians and surgeons worked closely with industry.

Some examples of this include improved neuroimaging, stereotactic radiosurgery, operative microneurosurgery, endovascular therapy for CV disease, medical therapy, spinal instrumentation, improved anesthetic monitoring, improved shunt valves and endoscopic instruments for treating hydrocephalus, and deep brain stimulation for movement disorders.

Neurosurgery is a much expanded and dramatically improved specialty compared to what it was 30 years ago and nearly all of the advances can be traced to the interaction between physicians and industry.  As we strive to prevent the rare abuses of these interactions we need to be sure to preserve the substantial benefits.”

The session also had a very information Q&A session in which Dr. Harbaugh addressed three questions related to tools available to providers, preliminary insights on the impact of the Sunshine Act, and the effect on Continuing Medical Education (CME).

Moderator: CMS has made a variety of tools available to providers to assist them in understanding the upcoming Sunshine transparency requirements, such as provider outreach calls, a CME course, and mobile applications to track their own data. Which of these tools have been most helpful?  What additional tools and resources would providers like CMS to offer?

Robert Harbaugh (RH): I don’t believe that the CMS efforts have been very helpful for neurosurgeons. Most neurosurgeons are not aware of these efforts and the calls are scheduled at times when they could not participate if they were aware. However, organized neurosurgery is doing quite a bit to educate our surgeons. We have been and will continue to alert our members periodically throughout the year using various communications mechanisms (, monthly electronic newsletter from our Washington Office – ). In addition, we are actively participating in programs such as the campaign, to help educate the patients and physicians about the importance of physician-industry collaboration.
 
Moderator: Can you provide some preliminary insights into what you think the impact of Sunshine will be on research and innovation as well as patient care?

(RH): As noted in my opening remarks, I have concerns that an unintended consequence of the Sunshine law will be to inhibit the valuable interactions between physicians and industry that have led to great advances in patient care in the U.S. The high profile abuses of the relationship between industry and physicians are the exception and not the rule. If the Sunshine law makes physicians feel that all interactions with industry are somehow unethical it will have a profound negative influence on innovation and improvements in patient care. We must work hard to avoid this.
 
Moderator: A third question surrounds the CMS view of Continuing Medical Education (CME) providers. As you know, CMS has determined that payments or transfers of value for CME activities are exempt only if they meet three criteria. The first of these criteria relates to accredited CME providers, and CMS has determined that only the five accredited CME providers listed in their final regulations will be recognized, at least initially. I’d like to ask the panelists if, in their view, this list is too narrow, and if so, what the impact of this interpretation will be on accredited CME and training of physicians generally.

(RH): No disclosure is necessary if the following 3 conditions are met:

  1. Program meets accreditation / certification requirements and standards of one of the following 5 organizations: ACCME, AOA, AMA, AAFP or ADA CERP;
  2. The Manufacturer does not select the speaker and does not provide a distinct, identifiable set of individuals to be considered as speakers; and
  3. The Manufacturer does not directly pay the physician speaker

It is my understanding that neurosurgery’s CME programming meets the requirements of the ACCME and/or AMA, so we don’t have any serious concerns about the first requirement. In addition, the Scientific Program Committees of neurosurgery’s organization, not the manufacturers, select CME speakers so the second requirement does not appear to be problematic. Finally, speakers on our education programs are not paid by manufacturers and this requirement will not prevent us from having a wide variety of educational content in our programs.
 
While time will tell, we do not believe that the CME exemption requirements will negatively impact innovation or clinical education.  We can still educate neurosurgeons and continue innovation within the bounds of the three CME criteria.  The AANS allows presentations by individuals who have ties to industry, provided they disclose any conflict of interest, which allows us to have broad education programming.
 
Finally, neurosurgery will continue to provide non-CME education offerings sponsored by our industry partners.  Neurosurgeons will participate in these programs – even if their names must be reported to the payment transparency website – if they find value from the programming.

One thing is for certain, Dr. Harbaugh clearly makes the case that collaboration between physicians and industry is essential to improve the diagnosis and treatment of neurosurgical patients.  Such collaboration is, in most cases, a very good thing.  Industry support for medical education and research is what has made the United States a world leader in medical innovation.  As we strive to avoid the abuses that may occur because of our collaboration we must also strive to preserve and enhance the benefits.

To accomplish this the AANS has developed programs within two 501(c)(3) organizations — the and its data collection partner the — to allow industry funds to be used in an absolutely transparent and non-conflicted way to support neurosurgical education and clinical research that will benefit industry, neurosurgeons and most important, neurosurgical patients.

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