Here we go again. Citing a “lack of evidence demonstrating an impact on improved health outcomes, ” Blue Cross Blue Shield of Minnesota (BCBS MN) issued a proposed coverage policy on June 24 that would exclude laparoscopic and axial anterior lumbar interbody fusion (ALIF, AxiaLIF)) and lateral interbody fusion (e.g., XLIF, DLIF) procedures from coverage.
Device makers, Wall Street analysts and medical societies quickly weighed in to assess the potential outcomes of the BCBS MN decision.
Déjà Vu
We’ve seen this story before.
Back in 2006, the North American Spine Society (NASS), led by Chris Bono, M.D. and Bill Mitchell, M.D., put its credibility on the line on this issue. In that year, a SpineLine article outlined NASS’ position that the technical aspects of XLIF and DLIF are not sufficiently distinct from an ALIF to justify another code, and that XLIF and DLIF should be appropriately coded as an ALIF.
In late 2009, as NASS members began to complain about insurance carriers not approving XLIF procedures, those carriers reached out to NASS to solicit the society’s input on whether or not XLIF should be considered investigational/experimental.
In response, NASS decided to make a formal statement to all the payers encouraging them to remove XLIF from their investigational/experimental lists. By 2010, Aetna, Cigna, Humana and United Healthcare had all reversed their previous positions. Apparently BCBS MN didn’t get the memo.
The Blues
In fact, even within the Blues, Blue Cross Blue Shield of Texas, Oklahoma, New Mexico and Illinois proposed making XLIF investigational last year but altered their policy over the span of nine months removing any reference to XLIF as investigational thus ensuring coverage.
BCBS MN told OTW in a written statement on July 13 that the revised policy, which goes into effect September 26, “clarifies that established minimally invasive procedures for anterior, posterior and transforaminal interbody lumbar fusion are covered when deemed medically necessary, while all other minimally invasive procedures are considered investigative at this time.”
“We continue to monitor changes in research and clinical data. Should future studies indicate that additional minimally invasive procedures meet the same efficacy standards as those currently covered; our policy may be revised to reflect such findings.
“Also, coverage and benefits may vary according to different products. Self-insured plans administered by [BCBS MN] may design benefits unique to their organization, so there can be considerable coverage variability among these groups, ” concluded the statement.
It was too early for NASS to issue an official statement on the proposed coverage policy, but NASS Executive Director Eric Muehlbauer told us on July 14, “Rest assured that if it is necessary for NASS to educate the carriers, as we have with other groups, we will do so.”
Industry Reaction
Industry reaction was not as reactionary as one might have expected. The BCBS MN proposal seems at first blush to be a little more nuanced than previous negative coverage proposals.
A NuVasive, Inc. (XLIF) representative confirmed knowledge of the proposed coverage change. He told OTW on July 13, “This proposal is not unlike prior policy proposals which were successfully overturned over the last year or so. NuVasive is well versed in the process of collaborating with the insurance providers to educate them on the clinical merits of XLIF and will continue to fully support the surgical societies in their lead role of working with the insurance providers to ensure access for their patients.”
A Medtronic, Inc. (DLIF) spokesperson told us that the company also was aware of the proposal and was in the process of evaluating the proposed policy.
Ken Reali, president and CEO of Trans1 (AxiaLIF), sent us an email on July 14 that said, “AxiaLIF has been regarded as investigational by BCBS of MN since inception of our category III code in 2009. So this is not new. The AxiaLIF procedure is another interbody fusion with a different access point to the spine (the pre-sacral approach) but once the spine is accessed it is similar to any other interbody fusion procedure.”
Continued Reali, “Our message to payors will continue to be that access to the spine is not as relevant as the fusion itself, as long as that access is proven safe. For AxiaLIF this is further bolstered by recent and upcoming publications in peer reviewed journals that demonstrate the safety of the pre-sacral access route and the efficacy of the fusion.”
Other industry insiders we spoke to are of the opinion that proposed changes like the one from BCBS MN will probably continue to surface from time to time as there is a much larger macro issue at hand. Over the last six-nine months, spine companies have openly acknowledged stricter guidelines for any lumber fusion surgery. This, say the insiders, is just another attempt to slow down the utilization of lumbar fusions in their plans.
Wall Street: “Don’t Hold Your Breath”
Some Wall Street analysts doubt that BCBS MN will be able to make their proposed policy change stick.
On July 12, BMO Capital analyst Joanne Wuensch, who brought the policy to our attention, wrote that BCBS MN is the latest insurance company to propose a policy that would exclude NuVasive’s XLIF and Medtronic’s DLIF from coverage on the basis that they are investigational devices. “As a reminder, ” wrote Wuensch, “Aetna, Cigna, Humana and United Healthcare labeled XLIF as experimental and had non-coverage policies in place in December 2009. NASS responded fiercely in support of the procedure, and NuVasive offered additional clinical studies validating the outcomes of its products, and by January 2011, all of these major providers had reversed their decisions.”
Wuensch says XLIF and DLIF have strong support in the physician community and believes there is substantial clinical evidence showing improved health outcomes, and given past experience, doubts that BCBS MN will be successful in implementing the proposed policy.
“What is more likely, ” wrote Wuensch, “is that BCBS MN implements a more restrictive set of requirements and a more rigorous approval process for the procedures, similar to that implemented by Blue Cross and Blue Shield of North Carolina in January of this year. Such changes have already become common in the U.S.”
A William Blair report on July 13 stated, “We anticipate more of these proposed coverage decisions will appear in the coming quarters (the Blue plans are independent and do not correspond with each other on these policies) but do not expect they will be implemented and will not affect current or future procedural volumes for either NuVasive or Medtronic.
The Blair report stated their analysts spoke with NuVasive’s management, who indicated that there has been no disruption to case volumes as a result of this proposed policy.
“We view all the recent reimbursement pushback surrounding lateral interbody fusion as part of the evolution process for this emerging surgical approach to spinal fusion and believe that eventually all payers will comprehend the clinical and cost benefits associated with this technique, ” concluded the Blair report.
Waiting for NASS
Surgical societies and industry are formulating responses to the BCBS MN proposal. Industry is clearly waiting for NASS to take the lead. Based on past actions, it is likely that NASS will be putting its reputation on the line again to assure coverage and access for patients and payments for their members.
It is also almost certain that NASS, as was the case in 2010, will issue their statement without input from industry representatives, including NuVasive, or any consultant surgeons. In 2010, the authors of the NASS statement had no conflicts with NuVasive or similar companies and devices.
Below is the text of the proposed policy:
Minimally Invasive Lumbar Interbody Fusion
The policy title has been revised from “Axial (Percutaneous) Lumbar Interbody Fusion (ALIF)” to “Minimally Invasive Lumbar Interbody Fusion.”
Minimally invasive interbody fusion of the lumbar spine may be considered medically necessary when one of the following approaches are used AND when the patient has met the criteria for lumbar fusion as defined in Medical Policy #IV-87, Spinal Fusion:Lumbar:
- Anterior lumbar interbody fusion (ALIF);
- Posterior lumbar interbody fusion (PLIF);
- Transforaminal lumbar interbody fusion (TLIF). ·
All other minimally invasive procedures for lumbar interbody fusion are considered investigative, including, but not limited to the following, due to a lack of evidence demonstrating an impact on improved health outcomes:
- Laparoscopic anterior lumbar interbody fusion (ALIF);
- Axial anterior lumbar interbody fusion (AxiaLIF);
- Lateral interbody fusion (e.g., XLIF, DLIF). · Prior authorization: Yes, only for anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF).
Prior authorization: Not applicable for laparoscopic anterior lumbar interbody fusion (ALIF), axial anterior lumbar interbody fusion (AxiaLIF), and lateral interbody fusion (e.g., XLIF, DLIF).
Any procedures (e.g., spinal fusion, allograft, instrumentation) performed in conjunction with the investigative procedures identified above, will not be covered. This includes, but is not limited to, professional, facility and anesthesia services as well as supplies.
To view the policy in it’s entirety – click here.
