Other Articles

AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.

Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?

Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.

Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.

What the Knees Need: Baby Boomers and Their Options
Knee patients often show up at the doctor’s office with recurrent mechanical symptoms. It is up to the orthopedist, says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, to thoroughly assess the patient and then determine if nonoperative treatment will do, or if the person needs a unicompartmental or total knee procedure.

Physician: Report Thyself
The government says its healthcare anti-fraud efforts are working and it wants to encourage physicians to self-report possible fraud. How well did the government do in 2007 and what about those deferred-prosecution deals with undisclosed evidence? Read about it here.

Revising the Statistics
The word that orthopedic patients least want to hear is “revision.” Who, in the universe of large joint patients, do we expect to see on the receiving end of this news? If you guessed “the elderly” you would have been wrong. The reality of who is hearing “revision” may come as a surprise. Read what we found when probing PearlDiver’s database.

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

Arthroscopic Treatment for Tennis Elbow: Coming on Strong
“Tennis elbow” or lateral epicondylitis is, according to our PearlDiver database, one of the most reported diagnosis for problems with the elbow. Lately clinical evidence has shown that arthroscopic treatment for tennis elbow can provide long-term stability and, in most cases, return of the elbow to its optimal function. Check out the data from PearlDiver.

Do Republicans Make Better Orthopedic Surgeons?
A recent Nature Neuroscience journal study of the decision making differences between liberals and conservatives appears to argue in favor of Republican surgeons! Which, frankly, explains a lot—to BOTH sides and, to stretch an analogy almost to its breaking point, it may also explain why McCain’s health care plan is different from Obama’s. Read OUR take here.

"Sound of Music" Turns to Greek Tragedy for Smith & Nephew
Smith & Nephew’s Swiss (mis)adventure with Plus Orthopaedics is turning into a Greek Tragedy. The company’s whole acquisition strategy is being called into question. Read how CEO Illingworth explained it to the brutal British press.

“Dear John Letter” for Hip Resurfacing?
“Dear John H. Resurfacing: I hope this little note finds you well. We certainly have had some great times and, gosh, I’ll never forget those wonderful moments when the FDA approved your PMA. We’ve just celebrated our second anniversary together and, well, I’m just not feeling the magic anymore….” Two years after FDA approval, how happy are orthopedists with hip resurfacing? Read our analysis here.

In the Beginning, There Was the End: Manuscripts 101
Dr. Paul Manske, Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis and Editor-in-Chief of The Journal of Hand Surgery, shares his thoughts and experience on the details of shepherding a manuscript through publication.

Did ConMed Get Re-Wired?
Ever hear about the neurosurgeon who used an $80 Bosch power drill to do brain surgery? It really happened. Surgeons like their power tools. Increasingly they also like a particular line of sterilizeable power tools from ConMed’s Linvatec unit. Did ConMed get re-wired? We have the details here.

It’s enough to make a CEO reach for an antacid. Getting a spine device to market, that is. Contending with the alphanumeric soup of CMS, AMA, and 510(k) can get even the most seasoned executives tied up in knots. Knowing the rules, written and unwritten, says Cindy Vandenbosch, President of Strategic Reimbursement Consulting, makes all the difference.

“In the late 1990s the concept of payer coverage and its impact on surgical spine procedures was fairly new,” states Vandenbosch. “I think it caught many manufacturers and providers by surprise and left them looking for concrete answers. This all began with the advent of novel spine treatment options like intradiscal electrothermal therapy and kyphoplasty. Many investors involved didn’t realize reimbursement could affect market adoption. Many in the industry were blindsided because their mindset was, ‘We can develop something that works well, addresses an unmet need, is something the doctors can do, and something the FDA will clear.’ They didn’t imagine that the market wouldn’t pay for it. Then we started to see payers focusing on new technology and reviewing them based on the merits of the published clinical data.”

Delineating the view from the payer’s chair, Vandenbosch says, “Even if the novel technology is accurately described by existing procedure codes, payers won’t cover the procedure unless it has been peer reviewed in the literature. Many devices introduced to the market receive 510(k) approval so their safety is based on predicate devices. Manufacturers may think because the FDA has cleared the technology it will be reimbursed, but payers don’t see it that way. It’s a situation where you think you have a defined pathway to procedure reimbursement, you hit the payer radar, and the technology is assessed and denied coverage.”

Continues Vandenbosch, “Payers identify new technologies in many ways and quickly develop restrictive coverage guidelines. With spine being such an innovative area, it is the focus of many non-coverage policies. As many in the industry know, CMS (the Centers for Medicare and Medicaid Services) initiated a review of the clinical data supporting fusion for the treatment of degenerative disc disease. Some payers in the private sector have performed similar reviews of seemingly standard of care treatment modalities. In general, the previous clinical threshold for evidence-based medicine wasn’t as high as it is now. The study design mandated by the FDA for PMA approval is often not sufficient to secure payer coverage. This has been painfully experienced by the manufacturers of disc arthroplasty devices.”

For new procedures without existing codes to describe them, there is the additional burden of obtaining procedure codes. Enter the societies. Says Vandenbosch, “Because there are so many evolving spine technologies, particularly in the motion preservation space, the spine societies are becoming more proactive regarding CPT coding assignment. In recent years, a number of Category III CPT codes have been assigned by the AMA for novel spine procedures, including disc arthroplasty, interspinous process procedures and the presacral approach for lumbar fusion. This type of CPT code assignment indicates that a procedure is promising and emerging but not the standard of care. Unlike Category I CPT codes, these codes are not assigned relative value units (RVUs). Payment is therefore left to the payer’s discretion. Although the AMA’s intent in creating these codes was to facilitate procedure tracking and payment, many payers use these codes to identify new technology and deny physician payment for the associated procedures. Device manufacturers do not have an explicit role in the AMA’s process of CPT coding assignment. However, a manufacturer might consider partnering with physicians and their relevant societies to provide procedure-related information and clinical data to support a strong coding application.”

As a manufacturer, one’s strategy should involve working a bit backwards. Advises Vandenbosch, “A client of mine in the motion preservation space knew they had a novel technology, and they were aware the FDA would require a randomized multicenter trial. Our approach was, ‘OK, how should we design the study to incorporate the variables payers require? Also, how does this procedure compare to the alternatives in cost, patient candidacy and outcomes?’ Once the trial design was complete, we negotiated a reasonable budget with the clinical sites for compensation of clinically related costs if insurance declined payment for the investigational treatment. We then pursued Medicare coverage for the trial-related clinical costs and received hospital procedure code assignment from CMS. Medicare payment mediated the trial cost and the coding assignment allowed tracking of procedure costs during the trial. As you can imagine, the time and expense in funding and managing this type of trial can be large. For a start-up company, this requires pre-planning and sufficient funding. The goal is to manage as much of the process as you can.”

In some cases, riding on some corporate coattails might smooth the way forward. “There are a number of companies in development who hope to ride the kyphoplasty bandwagon,” states Vandenbosch. “One of my clients has an innovative kyphoplasty alternative. In working together, we wanted to ensure that the technology was appropriately described by existing procedure codes. This gets to an important point, especially for a small company: If another company has created a solid reimbursement foundation for a technology space, take advantage of that.”

But if you have to go the traditional route, says Vandenbosch, mind your Ps and Qs. “The standard way to find out whether a procedure is appropriately described by an existing CPT code is through the AMA. You submit a clinical vignette or operative note and request their opinion on appropriate coding. However, it is important to confirm that the inquiry was reviewed by the relevant AMA specialty society coding advisor(s), as these individuals will likely render opinions at some point if the technology is widely adopted. I worked with an orthopedic manufacturer that received conflicting coding recommendations from the AMA. The company established revenue projections based upon the initial coding recommendation. When a different recommendation was issued, physician adoption slowed as procedure payment was affected.”

Final insight from a reimbursement sharpshooter? “With a crowded field of manufacturers and investors asking more questions about reimbursement, reimbursement is only going to get more challenging. For small companies with one technology, there is often a limited short-term reimbursement pathway to generate revenue. In this situation, the company may need to identify an acquirer, find another revenue-generating technology, or pursue additional funding.”