The Insurance Industry Strikes Again!

As of September 13, 2013, Aetna reverses an eight year policy and now “…considers lumbar prosthetic intervertebral discs…to be experimental and investigational…”

REALLY????!!!!!!!!!!

When the Charité lumbar artificial disc was approved by the FDA in 2005, and labeled for use in appropriate patients with single-level degenerative lumbar disc disease, Aetna was the first of the major indemnity insurers to approve its use for on-label indications. How much of this was due to foresight on Aetna’s part, or the fact that Johnson & Johnson (manufacturer of the Charité disc) contracted with Aetna for health insurance for its >100, 000 global employees is open to conjecture.

In fact, Aetna remained the only major insurer to do so until Cigna began approvals a few years later, and Blue Cross finally approved lumbar arthroplasty in 2013. Amazingly, UnitedHealthcare still considers lumbar disc replacement “experimental and investigational” some eight years following FDA approval, and publication of two- and five-year clinical follow-ups, publications reporting lower reoperation rates than fusion, and lower adjacent level degeneration than above fusion. This is obviously an internal and proprietary definition of the term.

When ProDisc-L was approved by the FDA in 2006, Aetna extended its lumbar coverage to ProDisc, adding L3-4 as a covered level for that device, per FDA labeling. This remained status quo through September 2013. Charité was pulled from the worldwide market in 2012. Long-term five year data was published on the ProDisc IDE (investigational device exemption) patients in late 2012, as well as information showing statistically significantly less adjacent level lumbar degenerative disease in patients who had been randomized to arthroplasty rather than fusion (by a factor of 3), along with a very low reoperation rate following arthroplasty.

With no warning or explanation (such as new scientific data or claims history not shared with the medical community), Aetna released a new Clinical Policy Bulletin on Intervertebral Disc Prostheses in mid-September 2013, abruptly reversing its eight-year-old coverage policy, now stating that:

“Aetna considers lumbar prosthetic intervertebral discs (e.g. the Charité Artificial Disc and the ProDisc-L Total Disc Replacement) experimental and investigational for lumbosacral degenerative disc disease and for all other indications”

Really?? And for substantiation, it recycles a superficial and biased literature review of articles that are negative or lukewarm-at-best towards the technology.

1. Specifically, this “documentation” spends a lot of time reviewing the early Charité literature, which is pretty moot since the device is no longer available for implantation anywhere in the world. Didn’t Aetna get the memo that Charité was pulled off the market over a year ago? One would think that a major global health care company so obviously interested in making key decisions regarding approval of devices for its insured population, would at least know that the device they devote several pages to “disrespecting” is now part of history, but no longer germane to the present discussion.
2. The cited literature is a fairly weak collection of early interim single-site analyses. These are not the strong Level I studies that have been published, using multicenter, multi-surgeon prospectively collected data on externally randomized patients, with high long-term follow-up. Instead, most of the literature cited is at least five years old, and is certainly not considered the strongest evidence by the spine surgeon community. Ignoring the published two-year data (included in the reference list but not mentioned in the review), the published five-year data, the published adjacent level degeneration data, the reoperation rate data, the published economic data from 2010 through 2013, etc. does a disservice to everyone.
3. Aetna certainly has the resources to update their analyses, to disregard lengthy discussion of an extinct device, and to properly ascribe weight to very strong Level I studies (or at least to mention them!) rather than to insult the scientific community with its obviously biased and self-serving literature review of weaker articles. Aetna should be embarrassed by this document.
4. What was the rationale for the complete reversal of their position? Health care providers are certainly going to have to inform Aetna’s policy holders that they may no longer receive a lumbar disc replacement. Patients will then angrily ask their surgeons to explain why, and Aetna has not supplied that information. Has there been an uptick in negative claims experience (reoperations, increased need for subsequent medical expense) or some real data analysis that Aetna has chosen not to share with the scientific and medical provider community? If so, why aren’t they letting us know, so we can understand their decision and explain it to our patients?

Where is the oversight to the insurance industry? We had previously questioned Anthem Blue Cross’ decision to require spondylolisthesis as a pre-condition for arthroplasty, which changed the FDA labeling, and asked the FDA, in an open letter, to intercede.

We now see a complete 180º reversal of policy by a major insurance carrier with no good explanation. Lumbar arthroplasty is a proven technology with 40, 000 to 50, 000 patients implanted worldwide, post-market surveillance of U.S. IDE patients out to five years by the FDA, and publication of high quality data analysis. How can boardroom decisions be allowed to alter patient care based on a business model, rather than by careful scientific analysis of comparative effectiveness modeling?

New technologies that have shown effectiveness, cost savings, and better outcomes, like lumbar arthroplasty, should be supported and made available to patients. Patients are doing their homework, researching on the Internet, reading and understanding the literature, and are frustrated by draconian decision-making by their insurance companies. Medical decisions should be made by educated health care providers, and not by insurance company executives, whether they have M.D. degrees or not.

Who besides health care providers (spine surgeons, in this case) is watching out for patient’s rights?  We need the FDA or Congressional committees to turn their searchlight onto the insurance industry. Physicians cannot do this alone.

Our role is to point out the problems, but we need help.