Medicare Lessons Learned From Spinal Fusion

Martin Gold

Technology Access Partners
And eMedLearn

The much publicized Medicare Coverage Advisory Committee (MCAC) meeting in November had many in the spine industry concerned that the Centers for Medicare and Medicaid Services (CMS) intended to remove spinal fusion from its list of covered services. After a thorough technology assessment and a number of meetings, the agency decided to neither eliminate lumbar spinal fusion from its cadre of covered services nor develop stricter coverage criteria. Why, then, did the CMS decide to undertake this arduous process?

The answer is as much about logical and ethical decision-making as it is about cost-control efforts. As new spinal technologies enter the marketplace, insurers are being pressured by their members to either approve or deny access to these new promising technologies. Many of these spinal technologies are expensive and have limited clinical data to support their efficacy. As a result, insurers are hesitant to offer these procedures to their members (“When FDA Says Yes, But Insurers Say No,” The New York Times. July 6, 2005). This issue is even more acute for the CMS, since its coverage decisions not only affect the 35 million Medicare beneficiaries, but also impact private insurers that often choose to adopt Medicare’s coverage policies as well. In past years, the agency frequently has been criticized for its lack of consistency and responsiveness in its coverage process. Subsequent to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the CMS implemented many new policies and procedures to improve the coverage decision process.

When DePuy Spine launched the Charité artificial disk in 2005, it introduced the first FDA-approved, motion-preserving alternative to spinal fusion. As a result of a formal request by a surgeon, the CMS was required to initiate a coverage analysis of Charité. The coverage analysis forced the agency to look carefully at the spinal fusion procedure and determine if existing clinical data justified offering Charité to its beneficiaries. During this analysis, it became clear to the CMS that not only were the Charité data vague regarding the product’s efficacy in the Medicare population, but that spinal fusion in general suffered from a lack of reliable clinical evidence.

At the same time, the CMS recognized that Charité was just the first of several artificial disk products soon to be released. With the introduction of new artificial disks and other spinal procedures, the agency felt it necessary to determine the availability of comparative data on spinal fusion and to evaluate the efficacy of spinal fusion as the gold standard for the treatment of degenerative disk disease (DDD).

On Nov. 1, 2006, the CMS released the draft results of its technology assessment, titled, “Spinal Fusion for Treatment of Degenerative Disease Affecting the Lumbar Spine.” In its assessment, the agency concluded that “the evidence for lumbar spinal fusion does not conclusively demonstrate short-term or long-term benefits compared with non-surgical treatment, especially when considering patients older than 65 years of age, for degenerative disc disease; for spondylolisthesis, considerable uncertainty exists due to lack of data, particularly for older patients.” The results of the assessment suggest that patients receiving conservative, nonsurgical treatment have similar outcomes to those receiving fusion and that clinical trials need to be structured better to improve the quality of the data resulting from spinal fusion.

The results of this analysis were discussed at the MCAC meeting, and members were asked to respond to a series of questions such as, “How well does available evidence prove that lumbar spinal fusion for lumbar degenerative disc disease improves clinical outcomes as compared to conservative treatment in both the short term (up to two years post fusion surgery) and in the long term (more than two years post fusion surgery)?” In most cases, the committee felt that the evidence was weak and did not adequately prove that the outcomes for fusion to treat DDD were better than the outcomes related to conservative treatment.

Given the results of both the technology assessment and the MCAC review, the CMS is left with many unanswered questions about the clinical relevance of spinal fusion in the Medicare population. To further complicate matters, on Nov. 13, the agency re-opened its national coverage decision for lumbar artificial disc replacement to evaluate clinical evidence for ProDisc, manufactured by Synthes. The CMS expects to release a Proposed Decision Memo in May.
 
While initially it appears that the CMS unjustifiably is scrutinizing the spinal industry, the question of whether spinal fusion and the associated costs are clinically worthwhile is an important issue. As new motion-preservation technologies are developed, it’s imperative for companies to determine whether spinal fusion is the gold standard against which to measure all new technologies. Lacking clear direction from industry, the CMS has taken it upon itself to answer that question.

While such initiative on the part of the CMS might be unexpected, over the last several years the agency has made a number of policy changes that emphasize the need for companies to develop reliable clinical data to support the coverage process. Most recently, the CMS announced the re-chartering of the MCAC to include in its responsibilities activities associated with Coverage with Evidence Development (CED). The CED initiative involves development of national coverage determinations (NCDs) that include, as a condition of payment, requirements for developing additional clinical data on the new technology. This new responsibility is reflected in the committee’s new name, Medicare Evidence Development & Coverage Advisory Committee.

Many of the CED and other data initiatives are still works in progress, but it would be worthwhile for companies that are developing new spinal technologies to have discussions with the CMS early in the process. These types of discussions would provide companies with an opportunity to share important clinical information with CMS representatives and allow the company to gain a better understanding of the clinical standards by which their new products will be measured. 

Martin Gold is a principal at Technology Access Partners and eMedLearn, a Suffern, NY-based consulting firm that specializes in designing and implementing reimbursement and training solutions for medical device companies. He can be reached at (845) 369-9833 or by e-mail at [email protected].