Obtaining reimbursement for new spine surgery technology isn't a walk in the park. There are instances where a new technology receives FDA clearance, support from spine societies, a Category 1 CPT code and coverage by Medicare and Medicaid, and a number of articles detailing clinical evidence supporting use of the technology is published, yet commercial insurance companies still question the procedure.
"The coverage bar in the US has been set pretty high for reimbursement from commercial payers," says Jeffrey Dunn, president and CEO of SI-BONE. "It appears that it's not enough to have positive clinical evidence. In our particular case, there are over 30 peer-reviewed clinical publications specific to the iFuse Implant System® demonstrating safety and effectiveness. Among these publications are 12-month results from a Level I randomized controlled trial and 12-month results from a prospective multicenter single-arm study. Combined, these studies involve over 300 patients treated with iFuse and so far have demonstrated improved pain, patient function, and quality of life at 12 months post-implantation. All of our iFuse studies have been summarized in a systematic review or meta-analysis that was published in the International Journal of Spine Surgery in July 2015. There are also several U.S. retrospective publications, European publications, studies comparing iFuse to open SI joint fusion, all of which show positive improvements after the iFuse procedure. In addition, there are long-term outcome publications showing that positive results achieved at one year are sustained to 4 ½ and five years. Beyond what’s currently published, additional publications are expected in the coming months, including six-year single-center results, three-year multicenter results and 24-month results from two ongoing prospective multicenter trials, one of which is INSITE, the randomized controlled trial. You would think with this substantial body of clinical evidence showing consistent positive outcomes, along with positive coverage recommendations from NASS and ISASS that include well-defined inclusion and exclusion criteria saying minimally invasive SI joint fusion should be covered, that insurance companies would cover this procedure. But there are still many that aren't."
There are more than 1,100 surgeons that have performed minimally invasive sacroiliac joint fusions with the iFuse Implant System, which allows the surgeon to fuse the joint with triangular titanium implants. But expanding the procedure to include additional covered lives across the United States has become a chicken-and-egg situation; insurance companies won't cover the procedure until surgeons adopt it regularly with positive results, and surgeons don't want to perform the procedure unless they get paid.
In Europe, insurance coverage is more available but in the United States, adoption is much slower with these minimally invasive procedures, which are largely invented here.
"You need lots of people pushing for the procedures — surgeons, patients and societies — to show insurance companies that patients need this treatment and it can and should be done," says Mr. Dunn. "Patients and surgeons need to be persistent and willing to appeal any denials. Over time, these appeals will help demonstrate an increase in utilization of minimally invasive sacroiliac joint fusion and patient need, an increase in physician awareness of the importance of including the diagnosis and treatment of the sacroiliac joint in patients with low back pain; and increasing physician support for the procedure. But the challenge is that it also costs surgeons and their offices a great deal of time and money to process these appeals and interface with these insurance companies. It's a big dilemma that poses a significant challenge to healthcare providers and device companies. All the while patients are debilitated and suffering."
Practicing medicine requires providers to practice safe and effective care with good quality outcomes and consider the financial implications of their decisions.
"So moving forward, in addition to having positive clinical evidence, you will also need favorable economic evidence to show that a new technology provides a cost-savings for commercial insurance companies and Medicare," said Mr. Dunn.
SI-BONE commissioned a study comparing the economics of minimally invasive SI joint fusion to continued nonoperative care. The three-year and five-year differentials in commercial insurance payments — cost of nonoperative care minus cost of minimally invasive SI joint fusion — was $14,545 and $6,137 per patient respectively. The minimally invasive surgery costs accrued largely in the first year whereas the nonoperative care costs accrued overtime with 92 percent of the upfront minimally invasive procedure costs offset by year five.1
In addition, two recent publications reported on the cost-effectiveness and cost-savings of minimally invasive SI joint fusion with iFuse. The first of these two studies reported an incremental cost-effectiveness ratio of $13,313 per quality of life year gained which is highly favorable compared to the $50,000 and $100,000 per QALY benchmarks commonly cited.2
A second recent publication analyzed a cost model describing care for patients with severe chronic lower back pain who are candidates for lumbar fusion. The model compared the cost of treating these patients without considering the SI joint as a pain source versus the cost of treatment when the SI joint is considered as a pain source.
The result, when taking into account the additional costs of SI joint diagnosis and treatment, is a direct two-year healthcare cost savings of approximately $3,100 per patient when the SI joint is considered in the overall diagnostic workup of these patients.3
"We all know there is enormous economic pressure among healthcare providers and payers," says Mr. Dunn. "Patients might get pain relief from these procedures, but you have to prove the economics. We are working on showing the cost-savings data because we believe in the clinical and economic evidence that is published. Our company has invested a great deal of effort to make sure we have all these pieces in place so insurance companies will cover the procedure to provide access to patients with net cost-savings."
In the case of minimally invasive sacroiliac joint fusion, some insurance companies are looking for safety and durability information before moving forward with coverage. They also know new procedures are initially more expensive and are reluctant to cover until they are sure. However, the patient benefits have been positive.
"I was with one of the almost 20,000 patients who had our procedure who was in her early 30s. She had been debilitated after having three children. In fact, she had been in a wheelchair for three years because her pain was so severe. After she had the surgery, both she and her husband said she had her life back and she was her old self again," said Mr. Dunn.
"It has not only been work to produce the evidence but we have been crisscrossing the United States educating payers about diagnosis, clinical outcomes and potential cost savings," says Mr. Dunn. "Medicare covers almost 50 million lives in the United States and we visited all 8 Medicare contractors numerous times. By April all states will cover except Florida, and I hope Florida will soon. I'm a believer that the more communication and data we can present, the better understanding the insurers will have about the condition and the coverage will move forward. We hope the commercial payers are listening and they now are realizing this is about 15 to 30 percent of lower back pain. We believe that educating surgeons and other healthcare providers on the diagnosis of lower back pain to include the sacroiliac joint will benefit patients and reduce healthcare costs."
The economic benefits become more pronounced when the procedure is performed in the outpatient setting. While SI-BONE doesn't recommend site of service to surgeons, minimally invasive sacroiliac joint fusions have been successfully performed on an outpatient basis in the health care provider’s sole discretion. Some might be able to be done in ambulatory surgery centers. ASCs are typically lower-cost settings for care.
"In our case, if the physician decides the right site of service is outpatient, the facility might lose money or break-even on the procedure," says Mr. Dunn. "Hopefully in the future, Medicare will consider paying a higher amount for safe outpatient spine procedures and I think it will save Medicare money."
Mr. Dunn is optimistic about the coverage for minimally invasive SI joint fusion. More than 19,000 iFuse Implant System procedures have been performed worldwide. Healthcare trends, such as value-based care and data transparency, are expected to spread the procedure among more providers and provide access to more patients in the future. Commercial insurance covers over 200 million lives in the United States and very few of the payers are covering.
"I observed half a dozen private payers a few weeks ago discussing minimally invasive SI joint fusion, and they said that they think minimally invasive SI joint fusion is finally coming of age and the results from the two-year randomized study might push them to cover. Twenty-four month follow-up from our randomized controlled trial is expected this summer along with three other longer term peer-reviewed papers. Let's hope that the data carries the day," said Mr. Dunn.
But the big question is how consolidation will affect the field going forward.
"If the potential private payer mergers are completed, such as Aetna and Anthem merging with Humana and Cigna, the top three insurance companies will cover more than 100 million lives," says Mr. Dunn. "If you have the top three insurance companies and Medicare covering 150 million lives, there will be fewer payers to change policy. One-third of the country will be covered by a handful of payers and it could be an issue if one has inadequate coverage. That said, I am hopeful that they will all cover the iFuse procedure from SI-BONE at some point. We believe that the data is compelling."
1. Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States commercial payer population: potential economic implications of a new minimally invasive technology. Ackerman SJ, Polly DW, Knight T, Schneider K, Holt T, Cummings J Jr. Clinicoecon Outcomes Res. 2014;6:283–96. Published online 2014 May 24.
2. Cost-effectiveness of minimally invasive sacroiliac joint fusion. Cher DJ, Frasco MA, Arnold RJG, Polly DW. Clinicoecon Outcomes Res. 2016;8:1-14.
3. Ignoring the sacroiliac joint in chronic low back pain is costly. Polly DW, Cher DJ. Clinicoecon Outcomes Res. 2016;8:23-31. Published online 2016 Jan 21.