The North American Spine Society (NASS) has joined the International Society for the Advancement of Spine Surgery (ISASS) in endorsing 2-level cervical arthroplasty for appropriate conditions.
The two Associations of Spine Surgeons agree. Will payers listen? Will it make a difference to patients? Is there a market for artificial discs? The answers are maybe, yes and yes.
Coverage Policy Statements
More than a year ago, according to Jack Zigler, M.D. of the Texas Back Institute, Dom Coric, M.D. wrote the following Policy Statement for ISASS:
“Anterior cervical discectomy and fusion has an established record of clinical and radiographic efficacy. The safety and efficacy of cervical arthroplasty has been established with a growing body of Level 1 evidence that is compelling enough to no longer consider cTDR (cervical total disc replacement) investigational. This evidence is bolstered by experience with multiple devices, at multiple sites, in and out of the investigational setting and with short-, intermediate- and long-term follow-up. cTDR is a viable alternative to ACDF (anterior cervical disc fusion) in select patients with symptomatic 1- and 2-level cervical radiculopathy or myelopathy.
Cervical arthroplasty is indicated in patients meeting the following criteria:
- Skeletally mature
- Clinically symptomatic cervical radiculopathy and/or myelopathy due to neural compression C3-C7 at one-level or two contiguous levels
- Failed at least 6 weeks of nonsurgical treatment or shows signs of progressively clinical deterioration”
And just this month, NASS revised its policy recommendation and stated the following:
“Cervical artificial disc replacement (CADR, also known as cervical total disc replacement and cervical arthroplasty) may be indicated for the following diagnoses with qualifying criteria, when appropriate:
- Radiculopathy related to nerve root compression from one or two-level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain that has been refractory to medical or non-operative management.
- Myelopathy or myeloradiculopathy related to central spinal stenosis from one or two level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain.”
Pressure on Payers
Now that the two major spine societies with thousands of spine professional members having taken a position to recommend 2-level cervical arthroplasty as a surgical alternative to fusion for patients with 2-level cervical disc disease, payers should take note, said Zigler.
“The members of the societies have discussed and debated presentations on cervical arthroplasty for over a decade, and have carefully evaluated the results of Level I scientific investigation. Their resultant endorsement of the use of two level cervical disc replacement for the treatment of two level cervical disc disease should carry significant weight in the determination of coverage by indemnity insurance companies and governmental decision makers.
Who best to evaluate this information than medical professionals who have devoted their entire careers to studying the effectiveness of different treatments on spinal disease processes?”
Who indeed?
Zigler: “Best Clinical Investigation”
According to Zigler, the arthroplasty IDE (investigational device exemptions) studies represent the best clinical investigation that has ever been done in the field of spinal surgery.
“Carefully selected patient populations were externally randomized to treatment and followed closely, with excellent follow-up, for 5-7 years. This has generated a huge database from which we have better learned the outcomes of both arthroplasty and fusion interventions. Defined inclusion and exclusion criteria have clearly demonstrated a patient population for whom surgical intervention works better, by many parameters, than continued failed conservative care, and for whom one and two level arthroplasty works at least as well as fusion, with the decided advantage of lower reoperation rates.
As spine surgeons we should be justifiably proud of these studies, and should fight hard, through our professional organizations, against external forces that denigrate the value of this information. We need to support organizations that will use our hard-won comparative effectiveness data to show governmental and insurance industry decision-makers that they cannot be allowed to dictate treatment options by arbitrarily labeling them ‘investigational and experimental.’”
Surgeons should demand that insurance companies be honest and transparent with patients if their written medical policies deny access to specific scientifically proven treatment options such as arthroplasty, “so that patients can then use the marketplace to choose their providers more wisely. As physicians, we must be advocates for our patients, and our organizations need to stand behind us, particularly when backed by such incredibly strong scientific evidence, ” concluded Zigler.
The Market
What is the demand for cervical discs?
In a November 18, 2015 investor note, RBC Capital Market Analyst Glenn Novarro gave NASS faint praise for “Finally” recommending coverage for 2-level cervical discs.
He says his recent checks at the NASS annual meeting and the recent results of his firm’s 2015 U.S. spine surgeon survey, keep him a believer in the multi-year growth opportunity that exists in the U.S. cervical artificial disc market.
With both NASS and ISASS now supporting two-level cervical artificial discs, Novarro said it is only a matter of time before commercial insurers follow suit. He estimates that there are approximately 20–25 million lives currently covered for 2-level disc replacement versus about 160 million lives covered for 1-level disc replacement.
“We continue to believe this will change over the next 12 months, as a final NASS recommendation supporting two-level coverage should put increased pressure on commercial payers to cover these cases, ” stated Novarro.
Coverage policy changes won’t occur overnight though, says Novarro, as most commercial insurers review medical coverage policies on an annual basis. The next major insurer to review its cervical artificial cervical disc coverage policy is Cigna in mid-December 2015.
While NASS’s support of 2-level CADR may increase the likelihood that Cigna will changes its 2-level coverage policy in December, it does not ensure it.
The First Device Approved
LDR Holding Corp’s Mobi-C is the first cervical disc to be approved in the U.S. for a 2-level indication.
Christophe Lavigne, president and CEO of LDR, was understandably thrilled about the coverage recommendation. He said, “NASS is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, value- and evidence-based spine care for patients, so its recommendation for both one- and two-level cervical disc replacement as a treatment option for those patients who satisfy the clinical indications is a major milestone in the treatment of cervical disc degeneration.
“The revised NASS policy recommendation further validates the emergence of CADR as an alternative to ACDF in appropriate patients and should help to further expand coverage for the Mobi-C Cervical Disc for both one and two-level procedures in the United States.”
Novarro reminded us that LDR’s five-year Mobi-C 2-level data has yet to be published, and seeing five-year data in a peer-reviewed journal is a prerequisite for some insurers. “We expect a subset of the five-year Mobi-C two-level data to be published in a peer-reviewed journal over the next 3–6 months and the full dataset to be published in a separate journal sometime in 2016.
Growth Expected
The surface of the market for cervical discs is just being scratched. And that is happening in an overall U.S. spine market that Novarro says is continuing to show signs of improvement.
He believes the underlying health of the worldwide spinal market improved in the first half of 2015, with better-than-expected U.S. and international growth. “This better-than-expected U.S. growth was in line with our takeaways post 2015 NASS and our recent U.S. spine surgeon survey.”
The U.S. cervical disc market is doing even better, growing around 20%, according to Novarro. He pegs the U.S. cervical disc market at over $150 million.
But that U.S. market growth has been slow to develop, “owing to reimbursement constraints; however, we believe that the market is on the cusp of quickly expanding. Most recently, major payers in the U.S. such as UnitedHealthcare have established reimbursement for two-level disc procedures. We also note that the CPT Editorial Panel recently decided to create a new Category 1 CPT code for two-level artificial cervical discs, which went into effect on January 1, 2015.
NASS Coverage Policy Development
Pointing out Novarro’s comment about NASS finally issuing a revised recommendation, the Society’s Executive Director Eric Muehlbauer told us that, “we were simply being responsive to comments from members regarding the need to update the literature referenced and clarify some of the statements. Once we prepared the revision, we had many comments from members during a 30 day open comment period.”
NASS began developing coverage policy recommendations a couple of years ago, under the leadership of now, NASS president, Chris Bono, M.D. The current co-chairs of the NASS Coverage Committee are John Glaser, M.D. and Scott Kreiner, M.D.
Bono said spine specialists spend a great deal of time—“time they could be spending caring for their patients—doing labor-intensive research, filling out onerous paperwork and participating in peer-to-peer reviews to justify even common treatments to payers.” NASS has published an eBook of evidence-based recommendations help members get their patients the care they need, added Bono.
According to NASS, to develop each published recommendation, the Coverage Committee conducts an extensive review of available scientific literature. They develop credible and reasonable coverage recommendations based on that data, using an evidence-based approach when possible. In the absence of high-level data, recommendations reflect the multi-disciplinary experience and expertise of the committee members to present reasonable standard practice indications in the U.S.
“Maintaining patient access to high-quality, evidence-based and ethical spine care is the single most important part of NASS’ mission, ” said Bono.
So the evidence has spoken for itself, a growing marketplace is hungry for devices and spine societies are in agreement. Soon we’ll learn if the payers will pay.
