Insurance for ADR: Shifting from Proof to Coverage
Part 3 in a three-part series on insurance and lumbar artificial disc replacement surgery
- Danica Dubaich sued CIGNA after the health insurance carrier denied her coverage to a two-level artificial disc replacement surgery.
- Judge Dolly M. Gee said the insurance provider failed to show that the surgery was ineffective and therefore had to grant Dubaich coverage.
- Despite having FDA-approved discs available, many insurance carriers ignore the data and require patients and surgeons to "convince them" of the effectiveness of the procedure.
- Following the landmark ruling, other major insurance carriers changed from negative to positive coverage for lumbar artificial disc replacement surgery.
In a landmark ruling in 2013, Judge Dolly M. Gee of the U.S. District Court ruled that Danica Dubaich was entitled to coverage for a multi-level ADR and that her health insurance provider, CIGNA, had to pay.
In her ruling, Gee said, “The Court concludes that CIGNA has failed to prove that two-level ADR is an experimental procedure excluded from the Plan’s coverage.”
Dubaich, who had “bilateral foot pain, low back pain, left arm and hand weakness, right thigh numbness, right hip pain, and headaches,” was diagnosed with degenerative disc disease at L5-S1 by her physician, Brian Rudin, M.D.
CIGNA rejected Dr. Rudin’s request for a pre-authorization deeming artificial disc replacement surgery “not medically necessary.” According to the health insurance giant’s medical coverage policy document, it states that spinal fusion is the reimbursable course of treatment for patients. But Dubaich, who was in agony, did not want fusion, nor did Rudin.
So she fought back and, after hiring a law firm to take her case, over the course of a year, Gee ruled in her favor.
Dubaich’s case isn’t an isolated incident. Three of the major objections of health care providers is that artificial disc replacement is not safe, it’s not effective, and it's extremely expensive. It’s going to take a collective effort between the industry and the surgeon community to open the eyes—and eventually wallets—of health care companies.
In 2016, Anthem BlueCross and BlueShield, which covers more than 31 million Americans in 26 states, updated its coverage policy for cervical total disc replacement. Aetna also announced that it was covering two-level total disc replacement procedures. There are presently over 80 health care providers who have some level of coverage available for artificial disc replacement. There is still a lot of ground to cover. Much of that will be on the shoulders of the industry and the surgical community to work in tandem to show health insurance companies that the surgery isn’t just safe, but effective and not cost prohibitive. According to an Aesculap press release, “In five-year studies, total disc replacement has shown a threefold reduction from fusion in the rate of further degenerative disease at other motion segments in the spine.” Despite the data, insurance plans require convincing, meaning that both industry providers and surgeons will have to collect and publish long-term, randomized, controlled, superiority data that shows the medical necessity and favorable outcomes for patients with artificial discs. They will also have to advocate for the patient particularly during appeals while also helping to guide patients to the appropriate legal resources.
At the 31st Annual North American Spine Society (NASS) meeting in Boston, Massachusetts, in 2016, a 19-surgeon panel shared observations on insurance hesitation on artificial disc replacement. The panel, which featured Faheem Sandhu, MD, Faheem Sandhu, MD, PhD, director of spine surgery at MedStar Georgetown University Hospital and professor of neurological surgery at Georgetown University Medical Center.; Scott Blumenthal, MD, orthopaedic spine surgeon with the Texas Back Institute; Betsy Grunch, MD, neurosurgeon at The Longstreet Clinic; Brent Kimball, MD, medical director of CarePoint Neurosurgery and the director of Neuro-Oncology at Sky Ridge Medical Center; Nicole Ferko, senior director at Cornerstone Research Group; and Sarah M. Hollmann, associate director at Cornerstone Research Group, concluded that the demand for artificial disc replacement surgery would grow if insurance companies covered the procedure. They stated that by offering the procedure it "would result in minimal or no budget impact for commercial insurance plans."
The panelists noted that a growing number of artificial discs are FDA-approved and backed by five-year safety and efficacy trials. Despite significant evidence, some insurance carriers continue to show reluctance to cover the procedure. "There is a general lack of understanding by the payers of how well lumbar TDR has been studied and how positive the outcomes have been," said Lynn Miller, MD, a neurosurgeon whose practice is focused on motion preservation in the Twin Cities.
Even though artificial disc replacement surgery isn’t covered by all carriers, the list is growing, which is encouraging and is tipping in favor of more carriers covering than not. The outlook for getting other insurance plans on board with artificial disc replacement seems optimistic, says a reimbursement executive at a spine company that manufactures an artificial disc, “I think we'll have it closer to fully covered for the current FDA indication within the next 18 months or so.”
In the Dubaich case, CIGNA was ordered to pay for her surgery. In three of the seven-points from Gee’s ruling, the judge said that the insurer failed to show that multi-level ADR is of questionable medical effectiveness, made no showing that multi-level ADR is experimental, and failed to show that multi-level ADR lacks therapeutic benefit. Dubaich is now living well with her two artificial discs.