Greetings from Dallas. Our research team reports on the 27th annual conference of the North American Spine Society (NASS).
The Pipeline will be here the remainder of the week, reporting live on the latest issues facing the spine care community. Our experts will give updates on new releases of clinical research and current innovation projects at both the organizational and program level.
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A recent study done by a team at the Rothman Institute at Jefferson found that patients being treated for lumbar stenosis and spondylolisthesis with epidural steroid injections (ESI) had worse physical health and greater bodily pain than those who did not receive ESI. These patients also had a higher rate of crossover into surgery.
These findings came as a surprise, as the researchers had hypothesized that ESI patients would have better physical outcomes and lower surgery rates due to the provision of early conservative therapy.
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While at the North American Spine Society (NASS) annual sessions in Chicago, reactions to the Patient Protection and Affordable Care Act (PPACA) are still vigorous. The keynote address by outgoing president Dr. Przybylski, along with presidential guest speaker Karl Rove, were noticeably different in tone from last year’s presentation on the same topic. It’s clear from these conversations and others that the spine community feels especially sensitive about the implications of PPACA and how it will affect the care they deliver. Payment cuts and increased regulation are major sources of the community’s wariness, but underlying everything is the question of how to value spine care.
A perennial topic, value in spine care was discussed last year as well, but in 2011, the mechanics of actually measuring quality took a more prominent role. To that end, several sessions were focused on defining and delivering value in spine care.
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Here in Chicago, the North American Spine Society (NASS) is holding its annual scientific sessions. The Pipeline will be here the remainder of the week, reporting live on the latest issues facing the spine care community.
Things are just getting started, but it's already clear that several issues will become front and center throughout the week: Health care reform, quality, controversies in spine, and the latest in minimally invasive spine surgery will show up during keynote sessions, instructional courses, paper presentations, vendor displays, and countless conversations among the attendees. Throughout the week we will aim to investigate each of these important areas to provide the latest findings and major takeaways.
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A Danish medical device company, FBC Device ApS, recently received a U.S. patent for an interbody fusion device that allows patient-customized alignment. The device allows for spine surgeons to work with the patient’s anatomy and insert the two-piece implant, which provides natural spine alignment to individual patients. Founder and CEO of FBC Device ApS, Finn Christensen, has dubbed the device “Natural Balance,” as it allows for relative movement between the two pieces of the implant and enables the patient’s body to naturally align itself to the optimal fusion position.
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Last week, a group of spine specialists reported that the clinical research that has supported the widespread adoption of Medtronic's bone morphogenic protein product, InFuse, is misleading and biased. The main analysis, which was led by editors of the The Spine Journal, found a systematic failure to report serious complications with Infuse in 13 industry-sponsored studies. The researchers found complication rates that were 10 to 50 times greater than the estimated complication rates revealed in the peer-reviewed medical literature. Reported side effects include male sterility, infection, bone loss and unwanted bone growth.
The editors of The Spine Journal also charged that researchers with financial ties to Medtronic overstated the product's benefits with inadequate reporting of associated risks. Additionally, the authors claimed that conflicts of interest were either not reported or were unclear in the various studies. The 13 papers reviewed in The Spine Journal were co-authored by doctors who received a median of at least $12 million to $16 million per study from Medtronic, the journal reported.
In response to these findings, Medtronic chairman and CEO Omar Ishrak stated that he strongly continues to back the safety profile of Infuse. He states that while The Spine Journal questions the findings in peer-reviewed literature, the journal does not find faults in the data submitted to the FDA in 2002 for the approval of this product. To that end, Ishrak maintains that InFuse remains safe for use in the identified indications on the product's label.
The analyses in the current issue of The Spine Journal followed another investigation in late May which linked Infuse to retrograde ejaculation, a cause of infertility. According to FDA records, it was found that in the primary clinical trial which led to the approval of product in 2002, five of the 78 men treated with InFuse developed the retrograde ejaculation compared to 1 of 68 men who received the standard hip bone graft. The physicians involved in the study contended the sterility complication was caused by the surgical technique as opposed to InFuse, which is why the sterility data was not included in the published papers. However, other physicians accuse these researchers of "cherry-picking" the results and maintain that all serious complications should be listed in published papers, regardless of what is believed to be the cause.
Medtronic's InFuse remains the primary product in the BMP/biologics market to date and is estimated to be used in approximately one quarter of all spinal fusions performed in this country every year.
The latest news from The Spine Journal follows a slew of negative press Medtronic has received this year for its class of bone growth products. Despite receiving recommendations for approval last year, the FDA refused to approve Medtronic's Amplify rhBMP-2 Matrix, a bone graft product for use in posterolateral spinal fusions, earlier this year due to possible cancer risks associated with the product. With recent Department of Justice investigations on BMP, insurance pushback on overuse, and this recent data on InFuse, the impact on Medtronic and the market for bone growth products remains to be seen.
On April 19, the Centers for Medicaid and Medicare Services released their proposed Inpatient Prospective Payment System (IPPS) for fiscal year 2012. In total, overall payments to hospitals will see a 0.5% decrease starting October 1, 2011. Amidst the overall cuts, spine surgery cases will see a notable rate increase, while the orthopedic service line will see cuts, including one of the most common procedures, major joint replacement.
Last year's payment updates also saw increases for spine cases, and this year the trend continues with an overall 0.4% rate increase for all spine DRGs. 360 fusions, in which both a posterior and anterior fusion is performed, would see some of the highest rate increases, rising nearly 3% across MS-DRGs 453-455. The high device cost of these procedures, however, will continue to make it difficult to maintain strong margins despite the higher payments. In all, fusion reimbursement will be relatively flat, with other surgical spine cases seeing a 0.8% positive growth.
The situation is not as positive for orthopedics. While overall payments will remain relatively flat, major joint replacement procedure payments will decrease by 0.7%. Accounting for just over 5% of inpatient hospital stays that Medicare paid for in 2010, the payment cuts alone could save Medicare over $100 million dollars next fiscal year. At the same time, this will make the need to control device costs on the provider side even more pressing.
The final rule won't be released until later this summer, at which point we will do more careful analyses to measure the potential impact on hospital payments.
Once touted as the future of spine surgery, artificial disc replacement has not gained much traction since it's introduction several years ago. Higher revision rates, poor outcomes, and the fact that the implant procedures were complicated all limited adoption. The initial markets, however, were largely dominated by lumbar discs. Now, with a shift in focus to the cervical market, the future of disc replacement is looking brighter. One recent study highlights the clinical advantages of disc replacement over fusion in the cervical spine.
Published in the official journal of the Spine Arthroplasty Society, this recent study demonstrated the advantages of Synthes' ProDisc-C over anterior cervical discectomy and fusion (ACDF). The randomized trial compared 103 artificial disc patients to 106 ACDF patients. An additional 136 artficial disc patients were also followed, though outside of the initial trial design. In several standard quality metrics--neurologic success, visual analogue scale (VAS) for neck and arm pain, SF-36 score, and patient satisfaction--artificial disc replacement scored better than ACDF.
More interesting, perhaps, was the rate of secondary surgery procedures. These procedures (any re-operation, revision, supplemental fixation, or removal of implant) were tracked at 24 and 48 months. The results show that fusion patients were four times as likely to require an additional surgery; half of those additional surgeries were attributed to adjacent level disease, suggesting that disc replacement may slow the rate of adjacent level disease.
Adjacent level disease remains a major sticking point for traditional spinal fusion. With clinical evidence mounting that cervical disc replacement performs equally or better in quality metrics, and that they may arrest the spread of adjacent level disease, we expect disc replacement to see stronger growth in years to come. This will likely bring new cost concerns to hospitals as they will need to venture into new product categories, as those come up, look to Technology Insights for guidance and support.