This was a rather busy week for me surgically, which means I spent a significant amount of time with the representatives from various surgical companies. In addition to my surgical caseload this week, I also spent a few hours over the weekend working through new surgical techniques at the lab of one of these surgical companies. My interactions this week had me thinking about the importance of physicians’ relationships with representatives from drug and surgical device companies.

Most of us are well informed about the Sunshine Act. However, as a quick review, let’s go over some of the details of this act, all of which are easily available online. Recall that this is actually called the Physician Payments Sunshine Act, which is a provision in the 2010 Affordable Care Act (section 6002) requiring medical products manufacturers to report to the Centers for Medicare and Medicaid Services (CMS) payments to physicians or teaching hospitals.

Here’s a list of what must be reported:

	General payments such as cash, in-kind services, consulting and speaker fees, gifts, honoraria, travel and entertainment expenses, charitable contributions, and grants.
	Ownership or investment in the company by physicians or their families.
	Research payments for clinical investigations.

Here’s a shorter list of what does not need to be reported:

	Any payment of less than $10 unless the payments total more than $100 over one year.
	Product samples, discounts and rebates, educational materials intended for patients, devices loaned for clinical trials, warranty services, and shares in publicly traded mutual funds.

The consequences for failure to report are significant. Manufacturers may be fined anywhere from $1000-$10,000 per unreported payment, with a maximum of $150,000 per year. If it was deemed the manufacturer deliberately failed to report, they may be fined up to $1 million per year.

Let me state here my bias. I am no fan of the Sunshine Act. I completely understand the need and importance of regulating medical products manufacturers as well as protecting patients from both predatory physicians and corporations. However, I have a few personal issues as a physician and surgeon who works with these companies.

Cost

Let’s talk first about cost. Many of the surgical products we all use are incredibly expensive to develop. Surgical instruments require many stages in their development and utilization. Think about your favorite fixation device. That device has undergone years of development, testing, and revision before being used in your hands. Remember, that, in addition to working well in the patient, these devices must also be relatively simple for us to use quickly in an operating room. That alone makes the surgical instrument development process much more complicated. Remember also that medical supplies must also be sterile and safe to use in patients. This is a very expensive undertaking. This requires a company to invest significant amounts of money, and this is not something individual physicians or, in many cases, academic institutions are able to afford. Can you imagine one of our podiatry schools spending millions of dollars to develop a surgical implant or drug? Me neither.

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“Can you imagine one of our podiatry schools spending millions of dollars to develop a surgical implant or drug? Me neither.”

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Patient Care

This leads to the next issue, which is patient care. It seems brutally obvious that without these companies, the developing art and science of surgery and medicine would proceed at a much slower pace. For example, the AO/ASIF Foundation created a surgical instrument company in order to further develop internal fixation. Similarly, the incredibly important drug insulin was also developed by a private company, as are all drugs today. I sometimes wonder where we would be if something like the Sunshine Act was around in the 1920s. For me, I like to try out new techniques and technologies on bone models and cadavers rather than patients. How much more difficult would this be without a surgical company willing to spend the money on this type of thing? I do not like experimenting on my patients, and this relationship allows me the opportunity to improve my own skills while keeping my patients safe.

Physician Education

Consider also physician education. These companies invest heavily in our educational process for students, residents, and physicians. How many journal clubs around the country are sponsored by these companies? What would our national conferences look like without the sponsorship of medical companies?

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“What would our national conferences look like without the sponsorship of medical companies?”

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Now, I am not so naïve as to believe these companies just want to educate us. Any fool will realize this is part of their marketing strategy. Can you blame them? In order for any business to continue to exist, they must make money. For them, making money means selling their products. This is the real world. These companies live or die based on the market. If their product is not good enough, then in a very Darwinian fashion, they will lose the completion against better products and the company then must either change or disappear.

I have never been put in the position of using a poor product simply to improve a company’s bottom line. None of the companies I work with have ever asked this, and if they did, I would stop working with them. Laws like the Sunshine Act have arisen as a result of the government’s and perhaps the public’s perception that individual physicians and companies have acted unethically. However, most of us do not function this way, and this law seems excessive and unnecessary. We do need to protect our patients, and we do need some regulation. But that regulation must be well-balanced. Currently, that is not the case and this balance needs to be reestablished.

For me, I will continue to work with the representatives from the surgical supply companies with full knowledge of their importance to patient care and the medical profession. To those companies who continue to support us despite the difficulties of increasing regulation, I send my thanks and hope you will continue to do so.

*Approved for 16 CME/CECH Credit Hours

PODIATRISTS: This activity has been planned and implemented in accordance with the standards and requirements for approval of providers of continuing education in podiatric medicine through a joint provider agreement between the New York College of Podiatric Medicine and PRESENT e-Learning Systems.

The New York College of Podiatric Medicine (NYCPM) is approved by the Council on Podiatric Medical Education as a provider of continuing education in podiatric medicine. The NYCPM has approved this activity for a maximum of 16 continuing education contact hours.

PHYSICIANS: Professional Education Services Group (PESG) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Professional Education Services Group (PESG) designates this live educational activity for AMA PRA Category 1 Credits^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. A maximum of 16 AMA PRA Category 1 Credits^TM will be awarded.

NURSES: Professional Education Services Group (PESG) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. PESG is awarding a maximum of 16 contact hours for this activity.