Other Articles

Biologics for Spine: Where We Are Now
Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, discusses the exciting happenings in spine biologics, including growth factors, the use of different genes, and injecting stem cells into the disc. And then there are the challenges, namely the disc environment and the funding environment.

Physician Medicare Payments: Grandma vs. Docs
The fight over Medicare physician payments in Congress has been reduced to a fight over limited public dollars between Grandma and her physician. Is this a prelude to how public health care policy will be decided in the future? Read about the tussle here.

Spine Niche! Opportunity in the Spinal Deformity Market
Given the myriad of start-up companies pursuing the same patients, product differentiation and solutions for specific target markets could be the key in the future. Using the PearlDiver Patient Records Database we estimate procedure volumes for posterior fusion as a treatment for scoliosis—followed by the results of a study identifying complications associated with instrumented posterior thoracic fusion in treating scoliosis.

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.

Just like a spinal fusion, if human beings aren’t mindful, their thoughts can get locked into place. Or, like dynamic stabilization, they can be flexible. Take the case of a certain company that approached the Centers for Medicaid and Medicare Services (CMS) for new codes. In 2004 Applied Spine Technologies, Inc. set out to obtain codes for posterior dynamic stabilization. It would soon become clear that such an effort would be more likely to succeed by working in collaboration with other companies in the spine community.

Tom Wood, President and CEO of Applied Spine Technologies, Inc., chaired this effort, known as the Spine Reimbursement Task Force. He explains, “When we approached CMS in 2004 we invited the esteemed spine surgeon, Dr. Hansen Yuan, as well as Russ Miller, Manager of Health Economics and Reimbursement of Zimmer, to join us. Despite the impressive presentation by these two experts, CMS declined our petition for new posterior dynamic stabilization codes.”

Seeing “no” as a mere speed bump, the leaders of this effort put aside any competitive leanings and reached out to additional spine device manufacturers focused on the motion preservation space. Explains Tom Wood, “We called a number of companies, including major manufacturers, with an invitation to join the task force. To ensure transparency, we asked ADVAMED to participate in our calls and be a part of the initiative, to which they agreed. We worked with a number of consultants who had a lot of knowledge and relationships with CMS. Over a period of two years, we held meetings and conference calls and produced several important documents. We also worked collaboratively with CMS during this process.”

Adds Michele Lucey, Vice President of Regulatory Affairs and Quality Assurance for Applied Spine, “When this effort began in 2004, we at Applied Spine were concerned about being lumped in with other devices, such that the resources necessary for dynamic stabilization would be diluted. Thus, our initial idea was to proceed alone to see if we could get ICD-9 procedure codes to distinguish our product from those of others. Prior to our presentation at CMS, we sent the organization a coding request, after which time they phoned us and stated that they were not clear on the specifics of dynamic stabilization. We saw that as an opportunity to clarify how our technology was different from that of other companies. We started with an informal meeting with CMS to explain the technology, which was followed by a formal presentation by Dr. Yuan at the ICD-9 Coordination and Maintenance Committee Meeting—at that point we also reached out to Russ Miller at Zimmer to provide comment. We were encouraged by the immediate support and interest Zimmer extended.”

Continues Lucey, “After CMS decided not to go forward with assigning new codes, we decided that it made sense to reach out to other companies. We took three months to pull together a range of orthopedic companies developing products in this area. The result was a collection of 14 companies from large corporations to small startups; our first task force meeting was held in January 2005. The task force decided to expand the ICD-9 coding project to encompass other motion preservation technologies, including interspinous process spacers and facet replacement devices. When we went to CMS in 2006 with a cadre of reimbursement and motion preservation experts, our position was, ‘These are all the new technologies, here is where the holes are, these are the codes, and this is the language for the codes.’ It was very much a collaborative process, not just among companies, but also with CMS. They soon realized that if they didn’t work with us as a group, they would have to deal with us company by company and technology by technology.”

Cindy Vandenbosch, President of Strategic Reimbursement Consulting, served as an advisor to the Spine Reimbursement Task Force. She notes, “Without ICD-9 procedure codes to track hospital resource consumption, your ability to successfully commercialize may be limited as payers can make arbitrary hospital payment assignments. As is evident from this experience, it pays to be proactive in seeking out ways to acquire the codes. It was very impressive to witness the collaboration among these companies and see them make the necessary concessions in order to succeed as a group. Had the companies gone in with individual technologies, CMS would have likely denied procedure code assignment as they had done with Applied Spine previously. Companies are often told by the ICD-9 Coordination and Maintenance Committee at CMS that there are a limited number of ICD-9-CM procedure codes available, something that may become a moot point as CMS is considering switching to ICD-10 procedure codes. It’s possible that CMS felt more comfortable because this was a comprehensive effort whereby they could issue codes that would be accurate and all-encompassing in the near future. This is a first in spine. While I have seen some examples of partnering among competitors, these were major companies getting on the same page and working toward a significant common goal.”

Says Vandenbosch, “It is ideal for a company with a novel technology to track a variety of variables during the IDE trial so that when the product comes to market, the technology has clinical and charge data to justify appropriate payment. Therefore, technology assignment of an ICD-9-CM procedure code earlier in the process is extremely helpful. Otherwise the company may experience a delay in obtaining appropriate procedure payment in the hospital setting.”

In this case, it proved helpful that the charge was led by a smaller company. States Michele Lucey, “One of the key things is that Applied Spine is a start-up without a long track record in the industry. The larger players specifically expressed that this was a significant factor in their decision to participate. Had this effort been driven by a major company, I suspect things wouldn’t have gone as smoothly.”

The process wasn’t always easy, says Lucey. “As you might expect, a few individual agendas arose along the way. We had some issues getting people to agree on coding language. And there was one company member of the task force that went and got its own coding and didn’t want anything to interfere with that. We tried to make that company understand that we didn’t want to compromise their efforts, but to no avail. Overall, we just kept hammering away at collaboration until everyone agreed. One of the biggest misconceptions we had to deal with up front is the incorrect assumption that ICD-9 procedure codes are technology- or manufacturer-specific. In fact, ICD-9 codes are neither company- nor technology-specific but rather procedure-specific.”

“The significant point here is that if we did it, it can be replicated by others,” states Lucey. “The model works and proves that companies can compete on technology and collaborate on reimbursement. We are pleased that everyone’s hard work, including that of CMS, has paid off. The codes have just been implemented this month.”

Reaching out resulted in reaching a goal…amazing what can happen when individual interests are put aside.