10 Biggest Stories for Spine Surgeons in 2013


This past year brought many changes for the spine field and healthcare in general.


Here are 10 of the biggest stories for spine surgeons in 2013.


YODA releases INFUSE review results. The Yale Open Data Access project funded by Yale University and Medtronic on the outcomes of spinal fusion using the Medtronic bone morphogenic protein product INFUSE findings were released in June. The studies were published in the Annals of Internal Medicine journal and found that pain and cancer were more commonly reported among the patients who received INFUSE as opposed to those who received iliac crest bone grafts.


The studies concluded that while iliac crest bone grafts and INFUSE were effective, INFUSE correlated with adverse outcomes. The North American Spine Society applauded transparency of this data and called for more data-sharing and re-analysis to encourage ongoing critical thought.


"While this transparency is laudable, it is overdue," wrote then-president of NASS Charles Mick, MD. "Neither the original investigators nor industry were exonerated by this repeated data scrutiny, which led to conclusions quite disparate from those in their many published studies on their rhBMP-2 product. Open access post-market analysis may very well help identify mistaken conclusions and foster new creative analysis for existing data. But even the editors of Annals acknowledge that it is not feasible to apply these rigorous, costly and time-intensive methods of analysis to every clinical question."


Medtronic’s BMP-related sales have continued to plummet since reports questioning its safety and effectiveness were published last year. It’s second quarter fiscal year 2014 financial report showed BMP revenue plummeting from $119 million in 2013 to $96 million in 2014.


POD investigations. Physician-owned distributorships have been under investigation for years and in October the Office of the Inspector General released a new report advising against participation in them. According to the report, Medicare reimbursed $3.9 billion to hospitals for spine surgeries in 2012 and PODs were a part of the increasing costs. The report found hospitals that used PODs performed 28 percent more spine surgeries than those not using PODs, and that in general POD devices were not cheaper than devices from other companies.


"This, combined with the volume of spinal surgeries we found at hospitals that purchase from PODs, may increase the cost of spinal surgery to the Medicare program and beneficiaries over time," the OIG concluded.


The report also noted that at hospitals purchasing PODs, the rate of complex spinal fusion grew 16 percent while the rate at all hospitals over the same period grew 5 percent. The lay media has also picked up on this trend, and the Wall Street Journal published another negative editorial on a neurosurgeon’s involvement with PODs. While PODs continue to function, they are under increased scrutiny heading into 2014.


Sunshine Act begins. The Physician Payment Sunshine Act went into effect on Aug. 1, with big changes for spine surgeon relationships with device companies. Starting in September 2014, the CMS will publish the exchange of goods or services more than $10 on their website. Proponents hope this will make the relationships between physicians and device companies more transparent and eliminate conflict of interest.


"We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier database, are current and regularly updated," said AMA President Ardis Hoven, MD, in an organization news release. "We also urge physicians to ask industry representatives with whom they interact to provide an opportunity to review and, if necessary, correct all information they will report before it is submitted to the government."


Physicians have the opportunity to challenge information before its public and can dispute inaccurate report and seek corrections during a two-year period, according to the release. Physicians can register with CMS to receive a consolidated annual report starting on January 1, 2014.


CMS announced it won’t cover PILD. CMS announced in October that it would not cover percutaneous image-guided lumbar decompression for patients with spinal stenosis in a new national coverage determination. The coverage analysis for PILD was opened in April after analyzing several studies and reviewing public comments.


CMS cited lack of consensus on diagnostic criteria; lack of consensus on the treatment of lumbar spinal stenosis; and weak evidence to determine whether it would benefit Medicare patients as the reasons for not covering the procedure. Several private payers also consider PILD “investigational” and don’t cover for it.


On the other hand, the AxiaLIF procedure received a CPT code beginning in January 2013.


Growth in evidence-based medicine efforts. Spine surgeons and researchers are working on increasing the amount evidence-based literature for spinal care. The American Association of Neurological Surgeons now has a registry database and the North American Spine Society plans to have one up and running sometime in 2014.


Since the completion of the Spine Patient Outcomes Research Trial, several studies have been published over the last few years examining the effectiveness of different surgical and non-operative treatments. Efforts to examine the cost-effectiveness of spinal treatment--both short and long term--are now also underway and should produce results over the next five years.


Electronic medical records are now more widely used by hospital and practice-based physicians to gather personal data and benchmark against national numbers. These data gathering efforts will likely continue to grow and have an impact on spine patient treatment pathways and coverage determinations in the future. Several sessions at the NASS Annual Meeting covered evidence-based medicine practice and how spine surgeons can incorporate data analytics into their practice.


Washington Post Article Slams Spinal Fusions. The Washington Post published an article titled “Spinal fusions serve as case study for debate over when certain surgeries are necessary” in October of this year. The article followed patients that underwent spinal fusions and questioned the necessity of these procedures. Reports show spinal fusion grew 137 percent between 1998 and 2008, and some are questioning whether fee-for-service incentivising productivity is the best way to incentivize the right care for patients.


The article also questioned whether spinal fusions are necessary for Medicare patients. Medicare spent $200 billion on spinal fusions in 2011, and the article deemed many of these procedures “unnecessary.” The North American Spine Society responded that while “unnecessary surgery” is an issue, not all spinal fusions should be condemned. The organization sent a letter to the Washington Post to voice concerns with the editorial.


"As in ALL surgical procedures, the key is the surgical indication for the individual patient. Overuse or underuse are both bad medicine and do the patient a disservice. There is universal support for spinal fusion in cases of instability, fracture, tumor, infection and deformity," the letter notes.

The letter also outlined NASS efforts to partner with payers on developing evidence-based guidelines for surgical intervention and mentioned spinal fusion as undergoing rigorous scrutiny.


Medicare to Cut specialist payments, SGR repeal efforts. The Centers for Medicare and Medicaid Services released the final physician payment rule for next year, slashing physician reimbursement 20.1 percent.     The revised final rule would reduce physician payment for Medicare patients based on the sustainable growth rate formula. Every year since 2003, Congress overrode the SGR so physicians would not see sizable cuts; however, unless Congress takes action, physicians will see these cuts in 2014.


Under the current final rule, CMS expects Medicare physician payments to total $87 billion next year. Members of both parties in Congress are working on repealing the sustainable growth rate, and one bill to repeal SGR has been passed by the U.S. House Energy and Commerce Committee.


However, the final rule does expand payments for physicians who use telehealth services and addresses physician quality reporting initiatives associated with Medicare payments. There are now 57 new individual measures and two group measures for the Physician Quality Reporting System. PQRS now includes 287 individual measures and 25 group measures.


Five-year spinal disc replacement data finally comes in. Rick B. Delamarter, MD, of Cedars-Sinai Medical Center in Los Angeles, and Jack Zigler, MD, of Texas Back Institute in Plano, published five-year data on the effectiveness of cervical disc replacement in April. The study included 209 patients who received either total cervical disc replacement with the ProDisc-C or ACDF at 13 different treatment sites, and researchers considered a surgical intervention at any level after the initial procedure a reoperation.


The long-term effectiveness of disc replacement technology has been questioned over the past few years and researchers are just now receiving the first results. Positive results could lead to additional coverage and use of this procedure.


The study published in April found after five years, patients who underwent TDR had a 97.1 percent probability of no secondary procedures, compared with 85.5 percent for ACDF patients. Additional findings include:


•    No reoperations in TDR patients were due to implant breakage or device failure.
•    Pseudarthrosis was the most common reason for reoperation at the index level among ACDF patients.
•    Recurrent neck pain and/or arm pain was the most common reason for reoperation at the adjacent level for both groups.
•    Only 2.9 percent of TDR patients had reoperations within five years of the initial surgery, compared with 14.5 percent of the ACDF patients.


Minimally invasive spine surgery growing. Technological advancements and widespread training on less invasive spine surgical techniques are creating a large opportunity in the minimally invasive spine surgery market. Small and large device companies are competing for market share and developing devices to improve outcomes and cut costs. Patients are interested in undergoing less invasive procedures and surgeons are learning new techniques to remain competitive.


Research and Markets reports the minimally invasive spine implant market in the U.S. will exceed $2.6 billion by 2018, with special emphasis on the growth of MIS interbody fusion and pedicle screws. Additional opportunities include spinous process fixation, facet fixation, interbody devices and spinal endoscopes.


Surgeons continue to debate the pros and cons of adopting minimally invasive techniques, and the many rely only on techniques that allow them to perform the same open procedures through less invasive incision. The move toward less invasive techniques allows surgeons to perform cases on an outpatient basis, with even spinal fusion patients returning home within 24 hours of surgery.


Some surgeons have moved these procedures into ambulatory surgery centers, a growing trend in the spine field today.


Health insurance exchanges begin. Much of the past year's news coverage concerning healthcare reform focused on the state-based insurance exchanges, which opened for enrollment Oct. 1 and allow individuals and small businesses to purchase coverage.


States had the option of running their own exchanges or marketplaces, allowing the federal government to run their exchanges or operating under a federal-state partnership in 2014. Those running their own marketplaces had to submit an exchange blueprint to HHS by December 2012, while those planning to find a middle ground between a state-run and federally facilitated marketplace had until February 2013 to submit their plans, according to the Kaiser Family Foundation. In total, HHS will support or fully run the exchanges in 36 states next year.


The exchanges hit some speed bumps shortly after launching. On the same day enrollment began, the government shut down for about two weeks as Congress struggled to compromise on a spending bill. The federal exchange website also experienced glitches such as crashes due to high traffic and dysfunctional drop down tools, but the Obama administration remained steadfast these problems would not jeopardize the Jan. 1 start of the individual mandate.


More Articles on Spine Surgery:
Outpatient Spine Surgery: 5 Surgeons on Performing Cases in ASCs
8 Hospitals & Health Systems Expanding Spine Programs
Dr. Madhavan Pisharodi Receives Patent for Battery Charger

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