Old News Is, Well Old News!

On December 24th, the Journal Sentinel a Milwaukee, Wisconsin newspaper ran a story "Journal editor gets royalties as articles favor devices" which discussed Tom Zdeblick's consulting relationship with Medtronic Sofamor Danek (MSD) and a potential conflict of interest considering he has been the editor-in-chief of the Journal of Spinal Disorders and Techniques since 2002.

Zdeblick has been an MSD spokesperson and salesman for many years, (I don't remember him ever going through sales training) earning an estimated $20 million dollars in patent royalties.

The reporter, John Fauber, questioned why the readers of JSDT were never informed that Zdeblick, aka Zig Ziglar, was a consultant for the company. Unfortunately, this question should have been asked many years ago. Old news is, well, old news. Mr. Fauber, an industry outsider, must understand that most of us that actually read spine publications have been laughing at Tom for many years, while he has been laughing all the way to the bank.

Six years ago, TSB was sitting in the audience at a spine symposium in Florida when Tom got up to speak about cervical spine disorders. In an instance, a clinical presentation turned into a promo for Medtronic's then new cervical plate. If you closed your eyes you almost felt like it was Dan Aykroyd selling the The Super Bassomatic 76. If Saturday Night Live ever revives this skit, I know just the right guy to play that role. The pathetic side to this story is that most of us, including surgeons, started to snicker about the study let alone Tom's sales pitch. Surely some laughed with envy.

TSB has no problem with Zdeblick getting paid for products that he truly developed. What bothers TSB and others is that as editor-in-chief he is potentially using his clout in publishing studies that commercially benefit Medtronic and financially benefit himself. Would he publish an article that compares the clinical efficacy of a Medtronic plate to a competitors using the same criteria only to find out that both products produce the same results in ACDF's? To paraphrase one of our surgeon readers, "Iz it the Plate or the Playa?" Rarely, if ever, does the surgeon- author(s) ever criticize the product's efficacy or design, why would they, if the study is funded vis-a-vis a grant by the company itself? Isn't that why products are named in studies in order to promote a companies product? Yet, this article raises a bigger question. Is this an assault on the integrity of the medical profession? Today, spine surgeons complain that they do not earn as much money as they had in the past, yet, with the advent of sham consulting agreements, sham royalty agreements, and the proliferation and commoditization of the spine market TSB would argue that there are many more opportunities for greater earnings than ever before.

But what about the publisher? How entertaining is it when Robert Dekker, director of communications for Wolters Kluwer Health/Lippincott Williams & Wilkins is quoted as saying that "all manuscripts go through a rigorous review process using reviewers who have an objective viewpoint." Objectivity is in the eye of the beholder. Is there any surgeon at JSDT that would question the commercial aspect of the white paper? How many of these reviewers have their own consulting agreements? Obviously Dekker declined to provide a list of reviewers. The reader has to laugh at the level of transparency at WKH/LWW. TSB thought the whole purpose of a white paper was to provide the company clinical/commercial visibility? Dekker claims that coverage given to Medtronic products is in no way tied to their relationship with Zdeblick. As Scrooge once said, Bah humbug. Where does Mr. Dekker think his advertising revenue comes from?

If Senators Grassley and Kohler are really serious about enacting the Physicians Payment Sunshine Act of 2009 one of the guidelines should be that spine surgeons be required to wear the logo of the company that they represent on their lab coats in their office and have a promotional billboard in the waiting room for patients and sales people. Considering that surgeons have become personal spokespeople for companies, this really isn't a bad idea. Think of how much more efficient this would make the salespersons life. No more cold calls, no more free lunches, more focus and better time management. Maybe its time that patients have the right to choose the product that they would like the surgeon to implant considering it is their body? In the end, nothing has really changed, and like TSB said old news, is well, old news. You know what Sonny and Cher once sang, "And the beat goes on, And the beat goes on..........drums keep pounding the rhythym to my brain, la de da de de, la de da de da."

The Readers Poll

In closing out 2009 and bringing in the New Year, TSB would like to poll our readers for their feedback on which blogs hit home. This poll can be construed as a referendum by our readers to measure which blogs were topics of interest during the past year. The rationale for the blogspot was to provide the people a platform where your voices can be heard. Your vote counts. Once again thanks for your support and to a successful and prosperous New Year.

Spine The Year in Review: Winners and Losers

February 7th, 2009 was the official launch date of TSB. Our staff felt it appropriate to provide our readers with a snap shot of the year in review. Our objective was to highlight the winners and losers of '09.

During the first quarter of '09 various rumors began circulating within the industry regarding companies that were beginning to exhibit financial and managerial cracks in their organizations. Word on the street was that Vertebron, Inion, Innovative Spine Technologies and Pegasus were taking on water faster than they could bail themselves out. Vertebron was considered the industries first casualty because rumor had been circulating over the past year that they were in trouble. They were offered $10 million by Cardo Med and thumbed their nose at the offer, only to be sold in a bankruptcy auction to Cardo Med for $1.3 million. Cardo Med was the winner by saving themselves $8.7 million, and Vertebron a loser for being so arrogant. Now the question remains, what will Cardo Med do for an encore with this portfolio in 2010? The question must be asked, is there a business model? Innovative Spine Technologies figured out how to burn through $70 plus million, Stephen Hochshuler pointed the finger at Scott Schorer, Schorer refused to comment, not only was IST a loser, so were the investors. Inion couldn't raise capital fast enough to resuscitate itself, and Pegasus went south only to be sold for pennies on the dollar. Chris Lee (Inion) and Michael Will (Pegasus) are the losers. The biggest surprise was Archus which burned through $63 million and eventually failed to raise additional capital via bridge financing only to sell its technology and IP to Facet Solutions. Archus the loser, Facet Solutions....... let's wait and see.

TSB published various blogs about distributors getting stiffed on their commissions by various companies, the art of selling, the future of sales distribution models, ending the year with a blog about surgeon owned distributorships raising the question whether this was a new trend or passing phase? Based on the majority of comments by our readers, it was evident that you questioned the legality, ethics and potential conflict of interest of surgeon owned distributorships, and even wondered whether a new generation of physicians exist, those that are in it purely for the money rather than the art of medicine. Another interesting aspect surfaced, it became evident that physicians and investors believe that sales people make too much money. Could we be on the verge of industry related class warfare?

In February a Boston District Court unsealed a formal whistleblower complaint against Blackstone Medical by two former employees. Much to the readers chagrin, the DOJ has yet to act on the potential criminal charges against former principals and employees of Blackstone. Many of our readers question whether the government will ever bring this to trial, or will the DOJ behave like the paper lion that they are perceived to be, where its bark is bigger than its bite? If anything good has come out of this complaint, it has put many early growth stage and surgeon owned companies on the defensive. Stryker had its own legal issues with former employees convicted or indicted from Stryker Biotech for advocating off-label use of OP-1. Some of the veneer was knocked off of Synthes with the Norian debacle, and as we move into the New Year the industry awaits sentencing of one former and three current Synthes employees for their complicity in this case. In addition, Synthes will have to defend itself in 2010 as the government attempts to prosecute Synthes.

TSB wrote about the value of attending trade shows, these consist of NASS, AAOS, CNS, ISASS (you gotta love that one, couldn't they just left it SAS?) CNS, CSRS, ISSLS, Motion Preservation, Spine Technology Summit, Stem Cell Summit, The Spine Study Group, and various regional meetings. The consensus from our readers was that these meetings were getting stale, can you hear us NASS? The lack of new science and clinical data was knocking the luster off of these meetings. Readers even questioned the integrity and financial interests of some of these platforms. In light of the economy, many of you felt that attending these meetings was becoming an inefficient use of capital.

Speaking of NASS, they had a rough year with some of its respected members in the spotlight. Tim Kuklo, David Polly, and Jeff Wang were in the limelight at various times having to defend their fiduciary responsibilities as employees of the military and educational institutions in relationship to their consulting and employment agreements. The only saving grace for these surgeons was that the spotlight was taken off their conflicts when Mark Kabins was convicted for his conspiratorial role in the Medical Mafia Case that is ongoing in the City of Lost Wages awaiting the trial of Howard Awand and Noel Gage, Esquire. Doctors and Lawyer conspiring, you gotta love it.

TSB published various blogs on Einstein's definition of insanity, "doing the same thing over and over while expecting different results." This was in response to many of our loyal followers e-mails about why does the industry and investors have the propensity to keep hiring the same individuals that have exhibited a track record for mediocrity to run their companies? Could it be that the industry lacks talent, or is this a barometer of what an old boys club this industry has turned into? These individuals have come to be branded as the emperors with no clothes. PT Barnum once said, "there's a sucker born every minute."

As we approached year end the hot topic became NuVasive's XLIF and potential reimbursement issues based on reports that Cigna, AETNA and United Healthcare were questioning the coding on this procedure. Some of our readers expressed their dismay as to why so much ink was dedicated to this story. With a market cap of $1.1 billion, TSB felt that this story warranted attention especially after the stock fell to an all time seven month low. The Analysts felt that NuVasive deserved to be carefully scrutinized. Some of our readers commented that there were no reimbursement issues while others, including Alex Lukianov stated that this was a local not a national issue. Let's wait and see. In all likelihood, NuVa and NASS will work together to find a solution to a potential problem.

In closing, 2010 will probably be a year of challenges for everyone considering that Healthcare Reform is on the horizon, pricing will become the industries main challenge, and though there is investment capital sitting on the sidelines in a holding pattern until investors get a clearer picture as to how this all shakes out.

Merry Christmas, Happy Chanukah to Our Readers!

To my fellow readers, on behalf of those that contribute to what's been heard on the Street, TSB would like to wish you and your loved ones, a Merry Christmas, Happy Chanukah and healthy and happy New Year. As TSB approaches the celebration of its first anniversary in early 2010, we are feverishly working on new ideas.

With over 50,000 hits and 8,200 returning readers in November we continue to be humbled by your interest in our blog site. TSB believes that everyone of our readers is entitled to their opinion with the intent that democracy will rule. As controversial as some topics have been, we hope that our forum has provided an outlet for The People that make a difference in the industry. Many times all we hear are the management talking heads and analysts telling everyone that everything is wonderful, and who wouldn't be if you were attempting to manipulate the market and your financial interests. TSB wouldn't expect it otherwise. In some respects our blog site will keep some of the industry's Usual Suspects honest that probably cast this forum as an agent in provocation.

In closing, please remember that we are fortunate to work in spine. We are afforded an opportunity to earn a great living while being part of an industry that actually provides a social and medical utility (or as Lloyd Blankfein would say, we are doing God's work) hopefully enhancing the patient's quality of life. As you open presents during this Chanukah and Christmas season reflect not only on how much money you have made, but on how we can better the industry, and the world in 2010. Once again, we appreciate the anonymous e-mails regarding industry news and look forward to seeing you down the road in 2010! PEACE!

Surgeon Owned Distributorships: New Trend or Passing Phase?

TSB has learned that a new academic program is being added to the syllabus in medical schools and fellowship programs across the United States. It is called the SOD or Surgeon Owned Distributorship program. It's an attempt to bolster the spine surgeons ability to increase their earning capacity. This program could become part of the standard core curriculum, integrated into a dual M.D./MBA degree program. If approved, many medical schools that are affiliated with universities having law schools intend on offering classes on how to navigate the legalities of this business model so that the surgeon is in compliance with Stark and CMS guidelines. In response to this program, many Deans have reported that they intend on eliminating their course on medical ethics.

Why is this business model picking up momentum at a time when the government is scrutinizing healthcare, let alone the spine industry? The reader can only surmise that the old adage applies; when one door closes, another door opens up. Ten plus years ago as surgeon consulting agreement were picking up momentum, law firms started sending promotional flyers on legal seminars that addressed how to comply with Stark I and II in managing your agreements. These seminars do exist, run by the same profession that surgeons love to complain about, the legal profession. Today consulting agreements have become so rampant that it has become commonplace to broker a surgeon before they have even tried a new product. As sham consulting agreements have become prevalent, ever so more scrutinized by the DOJ's microscope, a different business model is starting to emerge. The surgeon owned distributorship.

Rumors have surfaced that this model has picked up momentum, especially on the West Coast. One of the most important aspects of starting a surgeon run distributorship is to receive legal clearance that what you intend on doing, and how you intend on doing it is within the law. The surgeon investor is looking for a legal opinion to assure that there is no inherent conflict of interest. In all likelihood, the surgeon's role in this business model is usually as a silent partner funding the distributorship, that is run by a non-surgeon. It helps if you have a three to six man group that has a high volume surgical practice because that would produce immediate volume. So the question must be posed, how desperate have some of these surgeons become?

Over the last ten to fifteen years, the medical device industry has used every legal advantage to stretch the rule of law and get an advantage on the competition. This behavior threatens the core of free-market enterprise. Starting around 1991, the evolution of the surgeon has gone through multiple phases, those include; surgeon educator (let's have them teach our sales reps and the residents about surgical technique at company sponsored meetings), surgeon marketeer (let's fund a controlled study to emphasize the efficacy of our product), surgeon consultant (let's hire the surgeon as consultant based on volume), surgeon designer (let's buy their IP), surgeon owner (let's invest in a start-up company and maybe we'll hit the lottery), surgeon owned specialty hospitals (let's profile our patient selection and we'll show the government on how to run healthcare), surgeon investment banker (let's go work for a private equity firm), and last but not least, surgeon owned distributorships. It's a wonder that some surgeons even know how to operate? Could it be that all that is left for spine surgeons is to become salespeople. But doesn't that already exist?

It is debatable as to whether Stark I and II are truly an unwarranted intrusion into the practice of medicine when we deal with the above stated scenarios on a daily basis in our business. Many surgeons including NASS respond to these concerns by stating that while these problems exist, they are not widespread. Of course every parent wants to believe that their children are behaving. If you have invested or own a hospital, company, or distributorship and are a surgeon could this not constitute a potential conflict of interest? Sometimes you have to wonder whether some people would just focus on what they were trained best to do and let others do their job. TSB wants to know what our readers have heard?

The End of a Decade in Spine

In ten days, the industry will close the door on the first decade of the twenty-first century in spine. The industry has come a long way considering our history. When TSB entered spine, there were a few companies in the market. Most of us did not have any idea how quickly the industry would grow in twenty plus years. You know the old Virginia Slims (a now defunct brand of cigarettes) marketing and advertising platform, "You've Come a Long Way Baby!" The industry has come a long way since the Harrington Rod was developed by Dr. Paul Harrington, and the constrained Caspar, Raveh and Morscher plates set off a new wave and craze in anterior cervical discectomy fusions, Orion and CSLP shortly followed, and we were off to the races. We had surgeons like Roy Camille, Magerl and Anderson inventing techniques in posterior cervical plating using lateral mass screws, Jurgen Harms contributed to interbody devices with the invention of the Harms Cage, the TSRH established a new standard in pedicle screw fixation, while a little known product developed by Alan Olsen, aka Danek, came to be known as the cross connector. In 1965 Marshall Urist discovered intramuscular implantation of demineralized bone matrix marking the beginning of the development of what has come to be known as bone morphogenic proteins. These were some of the pioneers and emerging technologies that established a new paradigm in the future modality of treating patients with chronic and debilitating spine disease. These surgeons were the visionaries that provided future generations with a versatile armamentarium in treating their patients.

The last decade has provided the industry with technological and scientific advancements in materials, dynamic stabilization, total disc arthroplasty, minimally invasive surgery and biologics including stem cells. Similar to the automobile industry of yesteryear, the industry has exploded with companies claiming that not only were these products innovative, but that these products would improve upon the patient's quality of life. Nearly ten years ago, the clinical mantra from the podium focused on anterior motion preservation utilizing the first commercially available artificial disc in the U.S. marketplace, whereas today, thought leaders have shifted their focus to the tri-complex of the spine to address pain relief. One has to wonder if the practitioner resects enough of the patients anatomy and replaces it with anterior, posterior and interbody hardware with biologics, will the patient have pain relief? Minimally Invasive Surgery was the marketing buzz word for companies to differentiate themselves from their competition, soft-tissue preservation became important in enhancing the healing process. Today there are more dynamic stabilization systems with variations in design that claim one over the other even though many questions remain as to what constitutes the optimal design. In addition to many of these wonderful technologies, an entire new mind set developed due to economic forces affecting the industry. Questions remain unanswered about the true intent of some of these ventures. Were and are some of these technologies looking for an indication? The commercialization of medicine, and especially spine, has changed the way we once did business. No longer was it honorable to build a foundation and establish a business, entrepreneurial fever became an epidemic in the earlier part of the decade. The acquisition of the ProDisc by Synthes, and Charite by DePuy set off an entrepreneurial frenzy. "If they could do it, why can't we?" Unfortunately, timing and serendipity are important factors in becoming rich in today's economic environment.

So, what does TSB expect as we move into the next decade? Industry consolidation will become key if the we are to survive the many unexpected changes that are in store with the enactment of a new healthcare bill. Research and development along with manufacturing will be exported to countries with a cheaper labor force and product cost as a response to the ever increasing pricing pressures in the US market. The business development model will evolve based on investors need to increase or sustain margins resulting in a more direct-to-consumer (the hospital) by- passing the old sales model. Product development will become more focused. Transparency and accountability will become a tenet of the industry. Money will be always be available, but there will be greater scrutiny in providing capital. This will not be a bad thing, because it will force the industry out of its comfort zone, one that has layered companies with the same executives that still continue to do the same thing over and over expecting different results. TSB wants to know what our readers think?

Bacterin: I Will Survive?

I could hear the old Disco Diva Gloria Gaynor, singing in the deep recesses of my brain, "first I was afraid I was petrified," word on the Street is that potentially Bacterin could be showing some chinks in its armor. There have been many rumors swirling around the current solvency of this organization. TSB has received many e-mail from anonymous readers asking what have we heard?

Having reached out to various sources, and they are not disgruntled employees, TSB has heard that there is a definite cash flow problem at this company. Everything from farming out receivables, bounced checks, to delinquent expense checks, to a confused management team that is causing consternation between independent distributors and direct sales people. Having a plausible distribution strategy usually helps the business model.

When a company starts having these types of issues, "Sirens" have to start going off for the employees. Though the Bacterin Sponge has had a good reception in the market place (n0 this is not an endorsement) there's a difference between having a viable product and having a strong management team in place. TSB wants to know what its readers have heard?

Medical Mafia: Takes a Lickin' but Keeps on Tickin!

If the City of Sin can bring down Tiger Woods, why can't it bring down the Medical Mafia?

The death of a 38 year old U.S. Marine in Las Vegas after having back surgery has once again created a buzz in this sleepy bedroom community. I could hear Elvis in the background singing; "Viva Las Wages!" The reason for the buzz is that the surgeon who performed the case, Mark Kabins, had recently pled guilty to federal charges and is considered to be a central figure in an ongoing investigation that has come to be known as the "Medical Mafia" case by the FBI.

A shroud of secrecy seems to be permeating the death of this patient. Mark Kabins was the attending surgeon, yet, Dr. Annie Cheanvechai a vascular surgeon, who was part of the patient's prep team will sign the death certificate, even though Kabins was listed as the admitting, attending, and the surgeon who performed the procedure. A question that remains to be answered is why Valley Hospital notified the Clark County's Coroner office of the patient's death, but did not mention Kabins as the surgeon of record? Could this be another "Aztec Two-Step?"

Off the record, some of Kabins colleagues are astonished by the ambitious surgery schedule that he has maintained, even though just a few weeks ago he pled guilty to being a willing participant in the medical mafia conspiracy. It was reported that since his plea in late November he has operated on 17 patients. Is this guy a Bassomatic? He slices, he dices? Is he a modern day Paladin? "Have Scalpel will Travel?" The NEVADA MEDICAL BOARD (a complete joke), AND THE JUDGE INVOLVED IN THE SENTENCING SHOULD BE EMBARRASSED, for not immediately revoking his license to practice, and only sentencing him to house arrest and five years probation. Once again, the government had the opportunity to send a STERN MESSAGE to physicians in general, and they have treated him with "kid gloves!" Desperate people that stick up a gas station and rob $50 dollars spend ten years in jail! Where is the justice? Have we lost our moral compass as a society? Isn't it embarrassing when some attorney stands up in court and calls someone like Kabins a pillar of the community? How sociopathic are these people exhibiting a total lack of moral responsibility or social conscience?

TSB understands that this is a highly toxic blog to post, but this is an opportunity to let your voices be heard and send a message to Spine Surgeons and the DOJ, THIS INSANITY HAS TO STOP! It's quite obvious that FEE FOR SERVICE played no role in Kabins behavior. Attorneys and Surgeons conspiring to rip off patients and the healthcare system, it's the American Dream!

Grassley Asks Medical Groups to Reveal Payments from Device Firms

Senator Chuck "aka Chuckie's in Love" Grassley (R-Iowa) is asking medical organizations for info about payments received from medical device companies. Included in the 33 Groups is the North American Spine Society. Grassley's feelings are that these organizations have influence over public policy and people rely on their leadership. NASS is in the process of drafting a response. This is due diligence that is being performed on behalf of the passage of The Physician Payments Sunshine Act that is being sponsored by Grassley and Senator Herb Kohl (D-Wisconsin). This act would require public reporting by the device industry as well as pharma and biologic manufacturers payments made to physicians.

You know what Bill Withers use to sing: " He ought to leave this damn thing alone, ......Ain't no sunshine when you're gone." I guess the party is slowly but surely coming to an end. Who would ever thunk it that a Republican was a socialist?

What's The Buzz Tell Me What's a Happening?

It was announced today that Alpha Tec entered into a definite agreement to acquire Scient'X!

"Is that all there is, Is that all there is, If that's all there is my friend, then let's start dancing, we'll break out the booze and have a paaaaarrrty, if that's all there is! "

As the late, late, late Peggy Lee once sang, is that all there is? The spine industry has to be singing that song after today's announcement. More classic "me too" fusion products, and of course, the public will be told that the company was acquired for its innovative dynamic stabilization system, the Isobar. I guess the sucker that TSB wrote about in September is AlphaTec. Another "me too" cervical plate, more "me too" PEEK, cannibalization of the existing portfolio. Who ever heard of subtraction by addition?

Dirk's Quotations, he sounds a bit like the Dali Lama!

"Increasse scale and global presence in all major geographic markets" - Duh?

"Cross selling opportunities across core spine and Aging Spine products' - How long are you going to sell that propaganda?

"Strengthens and expands the company's product portfolio" - Duh?

"Enhances the company's ability to educate and train spine surgeons?" Haven't you been doing that all along?

"Diversifies potential future U.S. healthcare reform and regulatory risks!" What the hell does that mean Dirk?

Who does this deal really benefit? Did you really acquire Scient'X for its marketshare? What marketshare? Did you acquire Scient'X for its IP? What IP? It smells as though this deal was made to create the illusion that AlphaTec is on the rise. You know what the late Lowell George once sang; "Time Loves a Hero!" Go figure? Isn't this disingenuous considering who owns whom? TSB wants to know what our readers think?

What's Going On at the Wave?

Recently, TSB was speaking to one of our sources on the Street. Word is that Spine Wave is burning through capital faster than you can say $18 million in revenue for fiscal 2009. TSB wants to know what our readers have heard. It's quite obvious that Captain LoGuidice aka Jack Sparrow has surrounded himself with all his former Medtronic/US Surgical henchmen and are paying themselves like they were running a $200 million dollar company. You would think that after seven years in the making we wouldn't start asking: "Is that all there is?" TSB wants to know what our readers have heard?

Is it Ouroborus or Uroborus? A Serpentine Product

Ouroborus or Uroborus is an ancient symbol depicting a serpent swallowing its own tail and forming a circle. It symbolizes the alchemist opus. So fellow readers what is a Ouroborus Spinal System (OSS)?

The OSS can circumferentially organized graft material within the disc space after a total discectomy has been performed that consists of a mesh structure. The OSS comes in different circumferential sizes that once delivered into the space can be expanded until it is opposed to the inner wall of the native annulus.

The device is activated with a removable expander and allows for morselized allograft or autograft to be packed into the core with the mesh using preloaded cartridges. Not a stand alone product but innovative in its own right. A larger endplate footprint? MIS? Will this obsolete PEEK? TSB wants to know what our readers think?

NOVA BONE: Much More Than a Shooting Star!

The definition of the word "Nova" is a star that ejects some material in the form of a cloud and becomes more luminous in the process. Word on the street is that during the last year a synthetic bone graft substitute by the name of "Nova Bone" has been picking up traction in the musculoskeletal marketplace which is made up of much more than just spine. NovaBone is a calcium phosphate silicate composed of naturally occurring elements known as Calcium, Sodium, Phosphorous Silicon and Oxides. The material is also known as Bioactive Glass. Even NovaBone's competitors have acknowledge the benefits of Bioactive Glass witnessed by the addition of this material to Vitoss BA and Actifuse BX.

The biologic material market is highly competitive witnessed by the many players that tout their product as the ultimate panacea for fusion. Some even claim things that they do not need to substantiate. So what makes this product unique? NovaBone differentiates itself from other bone fillers because it is osteostimulative. NB induces bone growth via a cascade of events that culminates in the signaling, proliferation and differentiation of osteoblasts to the defect? Sounds familiar?

Unlike INFUSE, NovaBone only forms new bone at the implantation site. Other spine and musculoskeletal websites have given players like Orthovita, Apatech, INFUSE, and Stryker Biotech publicity about their platforms, unfortunately, TSB believes that they should at least provide NB with some visibility. Charles Caleb Colton once said; "Imitation is the sincerest form of flattery." Word on the street is that this company is led by a team of professionals. TSB believes that this is a company that should be closely watched in 2010 based on their technology and management team. TSB wants to know what our readers think considering NB is another option to offer your surgeons.

New Jersey: What You See, May not be What You Get!

On December 14th, the Gray Sheet reported that the New Jersey Division of Consumer Affairs has advised the State's Attorney General, Annie "get your gun" Milgram, (aka Synthes best friend) that NJ Physicians should be required to report their financial ties with medical device and pharmaceutical firms as a condition of renewing their medical license. In addition to this report which was dated December 4, the NJDCA also recommends that product manufacturers be required to disclose payments and other transfers of value to physicians.

It was recommended that the NJ Board of Medical Examiners should ban doctors from accepting gifts, fees, free food or meals offered by devices makers to prevent potential for conflict in medical decision making. Who would think that a surgeon would have a conflict in making decisions if they were a consultant? Obviously, the State of NJ!

Now that Chris "I love to give my DOJ friends a monitoring job" Christie will be sworn in as Governor of the most corrupt state in the union, there's a new sheriff in town and his name isn't Reggie Hammond! Is this the beginning of the end to a practice that has been abused by many companies in our industry? The report recommends that physicians who enter into consulting or research deals should disclose accepting more than $200 during the preceding two years or risk not having their medical license renewed. TSB does think that the part about not being fed at training conferences is a bit ridiculous. Let's get serious legislators!

Will New Jersey join Massachusetts and Vermont as states that are mandating disclosure? Of course "the Godfather" elect for the Medical Society of NJ, Donald Cinotti commented that "medical decision making is predominantly influenced by health insurance companies through restricted drug formularies and pharmacy benefits managers." In addition he was quoted as saying that the state should go after the companies. Obviously Dr. Cinotti must be an Ophthalmologist because what you see is not necessarily what you get.

Even with an incoming Republican Governor, TSB smells socialism in the air! It's a conspiracy! TSB wants to know what our readers think?

Synthes Execs Sentencing Date Approaches

As the sentencing date approaches for the four Synthes executives convicted in the Norian case, namely Mssrs. Higgins, Huggins, Boehner and Walsh, the question remains what can the government do with the infamous "person of special interest No.7" when Synthes goes to trial in 2010? On December 6, a Philadelphia based website (www.philly.com) reported that Hansjoerg Wyss, was finally outed as special person of interest No. 7. Didn't we all know that from the start? Included in the article was his "rags to riches" story, his love for science and the environment, his love of the outdoors, and his philanthropy to his beloved Harvard. Yet, for all his accomplishments, will Norian and THE DEATH OF THREE PATIENTS be the albatross that tarnishes his legacy based on the 52 felony count indictment against his beloved "Syntes (that's the Wyss lisp)." Regardless of what Synthes legal counsel will tell Wyss, the fact remains that when the government decides to indict, it is positive that it has enough of evidence to get its pound of flesh, witnessed by the recent conviction of Mark Kabins, M.D. in the city of Lost Wages. By the way readers most of you stayed away from that story like it was the H1N1 Flu! A 52 felony count indictment is not a laughing matter, even if there is overlap in the charges. In all likelihood the Feds will get Synthes on a multiple count conviction, with a substantial fine (this time it will not be the size of the puny NJ fine), and potentially mandate that an Ashcroft type monitor provide oversight at the company.

Based on the history and culture of this organization, Synthes is an interesting study in pathology. The Annual Report section on "Integrity" states, "Acting ethically and respectfully is the cornerstone of Synthes business. Synthes is committed to responding to the challenges to our business by operating in accordance with the highest levels of professional and ethical standards in our industry. Simply put, we must always act with integrity. Our commitment is to play by the rules and regulations applies throughout Synthes, to all countries, to all employees, and to all our business partners."

A SLIGHT CONTRADICTION, considering that Synthes has always stretched the rules indicative of their earlier educational grants to teaching institutions, instrument grants to customers to increase the purchase of inventory, and the use of education as a marketing tool. All of you know that this is old news, yet, it is the last few weeks of the year and TSB is starting to anticipate what will be news as we enter 2010. But the question must be asked, "Is Herr Wyss slipping?" This was once a venerable company that many salespeople wanted to work for, unfortunately, over the years, the Synthes management team has exhibited a lack of integrity and respect for its employees and human life. Payback is a ............. At 74 years of age, the possibility exists that Wyss is beginning to show cracks in his armor and his Picasso's. Hopefully, he will be in the spirit of giving to the families of Mssrs. Huggins, Higgins, Boehner, and Walsh considering that they are taking the fall for a decision that was endorsed by the then CEO of the company. Based on what former employees have said, Wyss is a micro-manager and nothing gets by without his approval. Carrying a 40-50 pound backpack is going to be different than carrying the weight of an eighty pound gorilla better known as the Federal Government. TSB is sure that Herr Wyss will not go to jail, but if the government wants to show our industry that this isn't another exercise in futility it will bite louder than its bark.

TSB bets that this doesn't go to trial and that there is a settlement with the government. Money can buy you a lot of things, unfortunately, it can't buy you vision.

Holiday Greetings in Spine!

You're an early growth stage company, you've been around for a few years, you have "me too" products and some IP. Your IP is questionable at best. You're living on a line of credit and exhibit an inability to bring product to the market in a timely manner, sales are flat, yet, being supported by your investing surgeons, you have exhibited an inability to keep continuity in your organization due to your obstinate personality, and you are developing a reputation as being an unstable organization. You've surrounded yourself with the Usual Suspects, aka the zombies of the industry. The question becomes where do you think you're going?

Recently, Mike Matson posted a report which highlighted the addition of many new entrants into the spine industry that were visible at NASS. Unfortunately, what Mr. Matson failed to discuss was how many "me too" companies literally littered the convention floor. You know those companies that built newer and bigger booths, and graphics, to create the illusion that everything was wonderful regardless of the above scenario.

If these newer entrants have any innovation, they are coming to the market at an ideal time. If they are not greedy, and have the capital to launch their products in a professional manner, you know, provide sales samples, training if necessary, and provide marketing collaterals, the opportunity does exist to make an honest living. Why should you believe these comments?

Because their is a major shift in how surgeons are operating and doing business. The enemy lies within, and it is the major corporations in our industry mainly the payors, hospitals and manufacturers, slowly yet surely squeezing the life out of what once was a vibrant and exciting industry. You know where the patient comes first! With the advent of modern technology, "me too" products are all playing on an even playing field, unless you have an inherent poor design. That playing field is price. Can you save the hospital money, and are you willing to discount your product. If a surgeon is an "excellent technician and craftsman," he or she should be able to perform any procedure if the product is comparable, and if your organization is willing to respond to their needs. And therein lies the secret.

No longer is it necessary to work for a major company. These organizations have sliced and diced your territories and continue to build their sales force with younger and inexperienced people allowing these companies to shape the future sales model in spine. Essentially, the Spine Cartel, the Payors, and the Hospitals will control how much money you will be allowed to earn. The onus is on you to figure out how to expand your market share with less territory and customers. Smaller margins means less commissions for the individual sales person because the person making these decisions needs to make more money to feed the beast.

So in the spirit of the holiday season, and the gift of giving, open up your hearts and your minds because opportunities do exist. In many respects the surgeons and the salespeople don't even know that they are the foot soldiers that drive the industry. These are the people along with the O.R. Staffs that ensure that the patient has what is needed to make their quality of life better. Remember, you can design product and create a strategy, but if you don't have the foot soldiers, the people operating and selling, you don't have revenue!

I have seen the enemy, and the enemy is within!

NuVasive Calls an Audible?

It was reported that the quarterback at NuVasive, aka Alex Lukianov, held a team meeting on Tuesday to discuss the current "hoopla" behind reimbursement issues related to the XLIF. So the question is, "How far can you "stretch the rules" so that NuVasive employees can suggest the appropriate way to code and dictate post-op notes?" This is not the TSB's opinion, this was a question raised by an analyst. In addition, we have heard that some big users in the South have expressed their concern about not getting reimbursed and that if this situation continues they will discontinue using the product. TSB wants to know what our readers have heard in the last week?

Is the Distribution Model and Our Way of Doing Business Changing?

Recently, one of readers, aka "Medtronic Man" wanted to know if any of our readers were aware that the company was reducing commissions, or eliminating commissions on certain products? This is a relevant topic of discussion considering the on-going debate in healthcare reform, and how this reform will potentially affect our industry. TSB and our sources have heard of many "early-growth" stage companies reducing commissions, including a "bonus rider" in distribution agreements (are the numbers attainable), terminating the distribution agreements of successful distributors and replacing them with "scrub techs at "cooley wages" in hope of increasing their bottom line so that they could pay themselves larger salaries or use the capital to survive the on-going credit crunch.

The by-product of this has been a shift in the way business is now being done. Smaller companies are now ready to deal, especially when it comes to Dowels, PEEK, Pedicle Screws, Cervical Plates and Biologics. By selling these products to independent distributors at "cost plus" pricing these companies are eliminating the need for middle managers, and are willing to private label the products as needed to attain immediate market penetration! Not a bad idea! Is this a result of larger companies aka the Spine Cartel "slicing and dicing" territories and commissions?

The reality is that as Wall Street sinks more of its influence into our industry, companies are starting to behave as though the "middleman" is no longer needed, or, a necessary evil. Could this be the beginning of Direct-to Consumer (the Surgeon or Facilities) Marketing and Sales? Remember as long as the Surgeon is treated like the king or queen, and the facilities get their discounts, who needs a salesperson. TSB would like to hear some of our readers experiences and ask the question, "Is this the beginning of the end?" How many years will it take to implement this strategy? What will be the end result?

To All Our Readers

Recently, TSB has received a rash of "Anonymous" comments from various readers expressing their dismay of certain individuals at companies that have been in our blog. Even though this site was created as a platform to express "what has been heard on the street," TSB would encourage our readers to express themselves in an intelligent manner.

We are proud that our blog has provided the industry with a forum like no other platform, where your voice can be heard, and does count. Unfortunately, if this continues TSB will have to dis-enable Anonymous! Once again, thanks for your support and keep reading!

TSB

Is NASS Relevant?

Recently, one of our readers posed an interesting question on our blog site; "Is NASS relevant?" Our readers must admit that was an excellent question. Over the last few years NASS has become a venue for the Spine Cartel. Just look at who gets all the exposure. As the Spine Cartel's booths get bigger (did everyone take notice of NuVasive's?) the companies that are truly attempting to bring exciting and potentially cutting edge technologies are being push to the back of the convention center, or the periphery. These smaller companies are being treated like parking lots amongst skyscrapers! Let's be honest, its become a Boys Club where the members aren't even respectful of the companies that subsidize their annual luau! Isn't it funny when we hear NASS prodding its members to make sure they walk the floor as a sign of appreciation? Is there any product at the show that has not, or would not be shown to these surgeons on their own home turf?

How entertaining is their website when it states, "if you are looking to find a captive audience of qualified decision makers to purchase your products or services, NASS WOULD LIKE TO OFFER YOU A SOLUTION that will get you and your products in front of more than 3,500 spine care professionals in one location." Solution, just get me some time in their office or between cases! The last thing these people want to do is hear some rep selling them on something they do not want to use, or have heard a million times before! TSB would like to know how many leads the start-up and early growth stage companies received from this year's meeting? I would bet less than expected, and in some cases non of real interest. This organization has been sucking money out of our industry to feed its members, residents and fellows, then lobby us to subsidize their speakers, offer residents travel scholarships, sponsor Cyber Cafes, luggage and airline check-ins and a massage relaxation station. You would think we were running a professional basketball team! In addition, you can pay to have your name on a conference tote bag and portfolio, sponsor a city map guide (are you kidding, everyone knows where the local strip bars are) and have your company's name on hotel keys. Who knows, you might even get on an elevator and see an advertisement about your company. All for the ridiculous price of a gillion dollars.

How much longer will we pander to an organization that has given us mediocrity in terms of quality and content? The real work is done everyday in the trenches by these surgeons! Today we have NASS, CNS, AAOS, AANS, CSRS, ISSLS, SRS, SAS an alphabet soup array of organizations that in all respect center around the same theme. In addition to these meetings we have the Alex Vaccaro and Todd Albert Meeting in Cabo (is this still in Mexico), Robin Young's Spine Technology and Stem Cell Summit, and last but not least the Dubai Spine Masters (is this a tennis tournament?). These are just venues that are just sucking the life and money out of our industry! It's almost like buying a new marketing report for a thousand dollars every year only to find out that things really haven't changed? It's all in the data, oooooooh!!!!! What will we learn at CSRS that we couldn't have discussed at NASS, only three weeks prior to going skiing in Utah? If I'm skiing, I'm skiing with my friends! Aren't these meetings self-serving? One of my neuro-spine surgeons was laughing at the industry back in May while attending the 2009 AANS meeting when he said, " I thought I was coming to a meeting that would have some new neuro-vascular products when all of a sudden another spine meeting broke out!" So now we meet in March, we meet in April, we meet in May, we meet in June, we meet in October, we meet in November, we meet in December. It's a wonder we get anything done attending these meetings. Is medicine and innovation moving at the speed of light that within a few months there have been so many changes to report about, or, are these organizations designed to feed some people's egos and wallets?

Maybe if we focused on the task at hand we would offer better solutions for patients, and find new and innovative ways to develop products faster at a reasonable cost to the customer. 100% Fused you are 100% right, "Is NASS Relevant?" TSB wants to know what our readers think?

"The definition of insanity is doing the same thing over and over again and expecting different results!"

LDR: The Next Shining Star?

TSB has had many inquiries into a company known as LDR. Based in Austin, Texas, this company was founded by Messeurs Lavigne, Dinville and Richard, hence the acronym LDR. Considering that some of our readers have been critical of French technology, purely from a political perspective , "Les Trois Muskateers" are making an impact in the spine market with a platform called "ROI-A and ROI-C"along with the Mobi Disc.

Recently, TSB spoke to an industry source that stated surgeons are excited about the simplicity and functionality of the ROI-C better known as Vertebridge Plating Technology. This is a stand-alone device that is zer0-profile with a self-locking plate ( I call it blades) that can be inserted with a minimally invasive approach using what TSB calls the 2+2 technique. Two instruments and Two Steps. Yes, readers this company has had an interesting journey, considering that European led companies seem to have a learning curve when it comes to assimilating themselves into the US market.

TSB believes that if this company is starting to pick up traction, and it may be a good time as Wall Street starts to rebound, to take this company public. TSB can see an IPO in the making. So, in the spirit of debate, what do our readers think of these products, and can this company be our next shining star. Besides, TSB is biased because I do like my Chateau Neuf-de-Pape and french fries with vinegar!

LANX, No Thanx!

TSB has spoken to a few sources as to what has transpired at Lanx, a side effect to the Goldman investment. Yes, readers Goldman's Private Equity Group has invested in this venture as per one of TSB's investment banking sources. Whenever there are new investors in a venture, change is imminent, especially if our readers know anyone on the management team.

Supposedly, Lanx is looking to hire 29 direct sales people for the East, and at least a dozen new sales people in the West with a starting salary of $60K per year. The word on the street is that a former "Medtronic Robot" has taken over the helm. Obviously changes are in effect because the once cryptic Lanx Spine website has entered the nebulous world of neverland on the internet. Oh when will we see them Lanx products Mr. Goldman?

Lanx is known for one product and one product only, the ASPEN. Lanx was budgeted for $80 million in revenue for '09. In all likelihood they are going to finish at an estimated $60-65 million, considering that Aspen accounts for roughly 66% of their revenue. The other products are "me too." Obviously, Lanx is recruiting sales people asking the usually questions; "How much business can you bring us in a certain period of time?" "How many surgeons do you know?

"Are any interested in being consultants?" Now that the founders are gone maybe the new management team will start paying back some of the vendors that they have "stiffed" in the past.

TSB wants to know what our readers have heard on the street? Lanx, No Thanx!

Why Are The Analysts So Concerned with NuVasive?

Yes, TSB readers, it's been an arduous week for NuVasive and Wall Street Analysts! Much of the last few days have been focused on NuVasive's XLIF technology and the potential of reimbursement issues. TSB believes that this has been "brewing" for some time considering that we researched articles related to this story, along with analyzing what surgeons were saying at that time. The one thing that TSB has learned during this process is that the Analysts are very meticulous about doing their due diligence when a company that boasts "that in due time, it will be the fourth largest spine company in the industry" starts to exhibit potential reimbursement challenges for its flagship procedural product. Our response to that is, let's wait and see!

During this past summer, NuVasive was a anadromous fish swimming against a tough economic current. Those platforms that spend their days "hyping the industry" with adulations were calling them the shining star! Yet, the majority of NuVa's revenue has been driven vis-a-vis a minimally invasive surgical approach called XLIF. Everyone in the industry knows that up until this point, they have hung their hat on XLIF. Pedicle Screws will never be NuVa's claim to fame based on past cross-threading issues. Osteocel is old technology that cries out the "new new thing" in marketing biologics, stem cells (I still want to know how many viable mesenchymal cells there are in each dose), and they are a few years away from having "the potential" to generate real revenue with a cadre of cervical discs, some old and some new.

But that was then and this is now! During the summer when word started to surface that there could be some changes in reimbursement on XLIF, NuVa's representatives were thumbing their nose. Lukianov is a master marketeer, unfortunately, sooner or later everyone stubs their toe because they begin to believe their own press clippings. In October, news surfaced that CMS was in the midst of considering revisions to codes for spine fusion procedures whose technologies had sprinted ahead of time. Modern medicine has a way of doing that. This potential backlash has nothing to do with a witch hunt, even CMS has an obligation to review and revise current codes to reflect the dynamics of an ever changing medical environment. At that time there were prospective revisions to acronyms like DLIF, XLIF and AxiaLIF that were being proposed for the Code 81.06. CMS staffers felt that these codes presented challenges as both "approach and technique no longer accurately apply in today's environment."

Yes, readers Payors can request changes in CPT Codes. If the insurance company will not cover a procedure, they will reject it based on the device being investigational, experimental or not proven. The potential for reimbursement may be that the payors feel that there is not sufficient evidence that the benefit outweighs the risk. TSB finds that hard to believe considering that there have been thousands upon thousands procedures done with this product. Nor does this issue have anything to do with the FDA's approval of the product. The fact remains that variations in coverage do exist. So why is XLIF being denied coverage?

Payors do audit and analyze surgeons post-op notes and can question whether the coding is accurate to make payment. A payor does have the right to drill down to ask pertinent questions regarding the procedure, considering XLIF comes in around $35-$45,000 per procedure, and payors are always looking to improve the process by reducing cost. The reality is that Spine is always on their radar screen. Surgeons do have a "legal and ethical" obligation to code properly. The onus is now on NuVasive to provide the payors with persuasive literature. Based on what Lukianov said, this is coming.

In closing, my grandfather who was a farmer, taught me that every cow can only produce so much milk, and then it's time to find another cow. Maybe it's time that NuVa start focusing on developing some newer technologies considering their stock has taken a hit, and that they carry an incredible amount of convertible debt. After awhile XLIF will become old hat, as more entrants are appearing in the market witnessed by DLIF, GLIF, Oracle, etc.... I am sure NuVa will weather this storm, but you know eventually everyone wants to know "where's the beef?" TSB wants to know what our readers think?

Abstract, Abstract?

Recently, TSB received a copy of an abstract entitled; "The Impact of Hydrosurgical Instruments and BMP on Minimally Invasive Lumbar Fusion Outcomes." This abstract was submitted for presentation to NASS by Larry Khoo, M.D. A prospective study compared MIS with Conventional Instruments, MIS with Conventional instruments using INFUSE, and MIS TLIF using the SpineJet.

As shown rhBMP improved fusion rates compared to conventional methods, and no statistical difference is seen when rhBMP is compared to the hydrosurgical group.. The rhBMP group exhibited a higher rate of re-operation and post-op radicular pain. The hydrosurgical group had a similar rate of re-op as seen with conventional methods without BMP and significantly fewer incidents of post-op radiculopathy when compared to conventional methods with or without rhBMP. What this all comes down to is that excellent carpentry and disc preparation is tantamount to great results, especially when using rhBMP's. Read Hyun Bae's paper for more information on residual disc material and how it affects BMP's in the disc space.

This is great information from a clinical point of view, but TSB must ask Doug Daniels the proverbial question, "If the product does not have a ICD-9 Code or CPT Code" what good is the product if it adds to the cost of the surgery and you do not get reimbursed? In today's environment, are hospitals in the position to accept an additional $1,400 per case? Once again, arguing that you are reducing OR time is a moot case in point.

Updated XLIF Poll

TSB would like to thank our readers for contributing to an earlier XLIF Poll regarding coding and reimbursement. Yet, one of our prominent readers asked a great question:

Will there be a new ICD-9 and CPT Code assigned to the XLIF?

TSB wants to know what our readers think?

Spine: The Brave New World

TSB had a dystopian nightmare last night! It was Quixotic., farcical, yet serious. It was in black and white, and it was about a futuristic world called spine. A brave new world, intrigued with science and medicine, yet absorbed with survival. No longer were companies, surgeons, patients, distributors and sales people in control of their destiny. They had become slaves to their master. Their vice was greed, and their master was Wall Street, aka the Toecutter. As a result of our greed, there was a divergent path of social, financial, scientific, and medical progress. I saw the future, a future that was a by product of our industry's DNA. I saw the initial cracks in the foundation of what once was a noble and honorable industry. It became an industry that sought to minimize everyone's ability to earn an honest living, and be equitably compensated for their efforts.

I dreamt that surgeons were no longer doctors, they were now working under cover as silent partners in distributorships across the vast tundra know as the U.S. market, frozen in time, seeking to make as much money as they could, because being a surgeon was no longer an honorable profession. There were no morals, no ethics, no soundness of character. No longer were people hired for their talent, the industry became a nepotistic society. Distributors had became the Road Warriors of the industry, no longer working in a civil society, it was an apocalyptic future in the wasteland of spine products. Outlaw gangs defying social order primarily because work had no value.

It's a couple of years into the future, 40% commissions are a thing of the past. You are working for 15% commissions on top of paying your own expenses. There are more deals than Max Rockatansky could handle. The industry is ruled by violent gangs known as the Nightrider (the Spine Cartel) who have turned the industry into a battle ground of survival. Free markets are nothing more than a state of mind, an opiate to dull your senses. Yes readers, you know what I am talking about because we experience it everyday. It's a world where companies no longer play by rules, they make the rules like paint by number dreams, expecting immediate results, sound familiar Wall Street? How quick can you bring me $3 million in revenue? What surgeons can you buy? Whose business can you steal? Sounds familiar? What could we expect when these miscreants have either forgotten what it takes to build a business or have never built a business?

Yes readers we have become slaves to the Street! Unfortunately, the Street doesn't care about anyone prospering but themselves. It's all about short-term prosperity rather than long-term viability. And then I rolled over, woke up in a cold sweat and realized that it was just a bad dream.

Polling Our Readers On XLIF!

In the spirit of a democratic vote TSB asks our readers:

Is the XLIF an anterior surgical approach, or, is this procedure a anterolateral surgical approach?

Let your voice be heard!

XLIF: A Point of Clarification

In retrospect, TSB has had the opportunity to discuss the content of the NuVasive Investors Conference Call. Here are some observations by TSB. If an XLIF is coded as an ALIF, is it the appropriate code to get properly reimbursed? If one adheres to the code established by NASS, the answer is yes. Lukianov was quick to point out the this is not a problem on the national level, but a problem on the local level. So how do surgeons dictate their post-op notes after performing an XLIF? Are they apt to ramble on?

In all likelihood, if the surgeon is dictating that they had performed an XLIF, which would be appropriate, and the payors are scrutinizing the operative notes, don't the codes need to match the procedure? So in the spirit of debate is it an ALIF, or, is it an XLIF? Herein lies the problem! If the surgeon dictates that an ALIF was performed, when in fact an XLIF was performed, would that constitute fraud?

Another point of clarification is that the amount a surgeon is reimbursed for a true ALIF is different than what a surgeon is reimbursed for an XLIF. In an ALIF, there is usually an Access Surgeon whether it be a General or Vascular Surgeon. In all likelihood the primary attending is splitting some percentage of the reimbursement with the access surgeon. Isn't that how NuVasive originally marketed this product? That you would no longer need an Access Surgeon and that the procedure was safer? TSB has the utmost respect for anyone as successful as NuVasive, yet, one has to wonder whether or not some of this commentary was factually correct?

Confusion? Maybe? Could be where the problem lies with the payors. TSB wants to know what our readers think?