Nearly ten million active duty and retired military members and their families now have access to Aesculap Implant Systems, LLC’s lumbar total disc replacement (TDR), the activL Artificial Disc.
On June 4, 2018, three years after FDA approval, the company announced that TRICARE now covers the disc for those individuals in need of lumbar TDR (CPT procedure code 22857).
The company said it met with the U.S. Defense Health Agency in late 2017 to provide decision makers with updated long-term evidence supporting the broader adoption of lumbar TDR for single-level degenerative disc disease (DDD).
“Evidence presented to the Agency included level 1a meta-analytic data demonstrating the superiority of Lumbar TDR to fusion in this patient population and five-year adjacent segment disease data from the activL Artificial Disc Investigational Device Exemption (IDE) study,” stated the company.
After performing its due diligence, the company said the Agency published a policy on May 8, 2018, stating that they found lumbar TDR to be proven and medically necessary.
Kim Norton, the company’s reimbursement and payer relations executive, said along with TRICARE, numerous commercial insurance plans have recently adopted positive coverage policies for lumbar TDR over the last year. “Over 30 million more Americans now have access to this procedure due to the overwhelming evidence and our efforts,” said Norton.
The TRICARE policy is retroactive to November 2017.
TRICARE Leading the Way
The military coverage analysts seem to be ahead of their government and civilian colleagues.
In August 2007, CMS (Centers for Medicare and Medicaid Services) issued a national non-coverage decision for lumbar artificial disc replacement, saying the surgery was not reasonable and necessary for the Medicare population over 60 years of age.
As recently as January 2018, the largest private health insurer in the U.S., UnitedHealthcare, reaffirmed its coverage decision about lumbar artificial discs:
“Lumbar artificial total disc replacement is unproven and not medically necessary for treating single or multiple level degenerative disc disease in skeletally mature patients. The long-term clinical outcome of lumbar disc replacement is unclear.”
In 2015, we wrote that Jack Zigler, M.D., Texas Back Institute’s medical director, said insurance approval for lumbar arthroplasty has failed to gain traction, “despite long term data showing maintenance of dramatically improved outcomes at five years in both fusion and arthroplasty groups (although better in the ADR [artificial disc replacement] patients), and statistically significantly reduced adjacent level radiographic degenerative changes above the ADR’s than above the fusions.”
In this case, TRICARE is marching to its own tune. The military led the way with integration over 60 years ago. Today they’re leading the way with insurance coverage.
As a former CMO for Tricare when it was starting, it is very reassuring to see that Tricare continues to use evidence and clinical outcomes to make decisions regarding coverage. The CMS position on this needs re-evaluation. However, given their history, unlikely it will happen any time soon.
I’ve been told I needed L3-S1 ALIF / PIF to correct for DDD. Hybrid (L3 LADR, M code, A56390/ T code 22857) surgery is recommended to prevent adjacent disc disease. Medicare is my primary and Tricare4Lufe is my secondary. I am over 60yo therefore Medicare NCD states A56390 “Non Covered” ), Tricare 22857 “Covered” Iff: Medicare deems Non-Coverage but not “unnecessary”??? My question/complaint is that neither Medicare nor Tricare will make a “coverage statement/determination” prior to surgery. So, I am presented with the dilemma: go into surgery w/o knowing whether I will be responsible to pay for this very expensive surgery? How can I be assured of coverage before surgery?