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Major Health Insurer Refuses Patient Access to Lumbar Total Disc Replacement

Published March 6, 2019
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A Note from the BackerNation CEO

Having had artificial disc replacement surgery, I am constantly fielding questions about my story, the procedure, health insurance coverage and various related topics. Always willing to help however I can. What pains me though is when I hear someone  share their back pain story and it ends with getting denied for disc replacement by their insurance company.

While the majority of insurers now offer positive coverage, the third largest, Aetna, does not.  I had a burning desire to know why.  So my team and I investigated.  We found out that Aetna did offer positive coverage at one point... it was actually the first provider to do so... claiming disc replacement was medically necessary, but has since changed its policy. 

Our investigation uncovered a very interesting series of events.  Read below to learn more about the history of Aetna's disc replacement policy.  

And when you're done, join us in taking action to convince Aetna's Review Board that it's about time they reverse their current policy and provide positive coverage for lumbar disc replacement surgery for their 22+ million members.

Click here to see all the ways you can get involved.

Sign our Change.org petition right now.

I appreciate your help and support.  Thanks.
Jay

Jay Resio
CEO
BackerNation


A History of Why Aetna Went from Positive Coverage to Non-Coverage

“Aetna considers the Charité artificial disc medically necessary for spinal arthroplasty for patients with degenerative disc disease at one level from L4 to S1 who have failed at least six months of conservative management.”*

When Aetna became the first health care insurance provider to offer its network positive coverage for Johnson & Johnson’s Charité artificial disc, the first disc to be approved by the U.S. Food & Drug Administration (FDA), the provider positioned itself as an advanced medicine trendsetter. 

Europeans had reaped the benefits of lumbar artificial disc replacement in treating degenerative disc disease for nearly 15 years, and Aetna stepped forward to lead the way in ensuring its enrollees would have better quality lives using this innovation. 

That was Aetna’s public face. 

Hindsight now paints a different picture of America’s third largest health insurance company’s position on lumbar artificial disc replacement—and leading the way in health care wasn’t its motivation.

The Charité Innovation

The Charité artificial disc.Photo Credit - The CHARITE´ Artificial Disc: Design History, FDA IDE Study Results, and Surgical TechniqueDeveloped in the 1984 by East German orthopedic surgeon Karin Büttner-Janz and Kurt Schellnack, the Charité artificial disc was created to treat severe chronic lower back pain by replacing a damaged disc with an artificial disc. The replacement disc duplicated the natural motion and dynamics of a human lumbar disc, restoring flexibility, preventing further degeneration of adjacent segments, and eliminating patients back pain while allowing them to enjoy everyday activities.

Early versions of the Charité artificial disc were designed using stainless steel endplates. It underwent two design changes in 1984 and 1985 before its final iteration in 1987 by Waldemar Link, a German medical equipment company. This version featured a movable high-density plastic core surrounded by a pair of cobalt chromium alloy endplates. When inserted between the vertebrae, six triangular teeth on the inferior and superior endplates fixed the artificial disc into place within the spine to achieve long-term fixation and stability.

From the time of its redesign until it was removed from the global market in 2012, the Charité artificial disc was implanted in thousands of patients.

In France during the 1990s, Dr. Thierry Marnay developed early versions of what would become the ProDisc-L lumbar artificial disc. Later that decade, both the Charité and ProDisc-L were being evaluated for possible study by the U.S. Food & Drug Administration.

As the technology became successful in Europe, it drew the interest of medical device and pharmaceutical companies.


The Johnson & Johnson Acquisitions

In a 1998 $3.5 billion stock deal, U.S.-based medical device manufacturer and pharmaceutical giant Johnson & Johnson acquired orthopedic device maker DePuy Inc., one the world's largest reconstructive medical device companies. This acquisition later positioned DePuy, now a subsidiary of Johnson & Johnson under the name DePuy Synthes, to purchase Link Spine Group, owner of the Charité, in May 2003. The merger included exclusive worldwide rights to the product.

Following a two-year trial, the Charité artificial disc was approved by the FDA on October 26, 2004, making Johnson & Johnson the first company in the United States to produce and market an artificial disc. Aetna, health care insurance provider for Johnson & Johnson, followed suit providing positive coverage for artificial disc replacement for its network.

In August 2006, the FDA approved its second artificial disc, Synthes’ ProDisc-L device, which had over 15 years of clinical follow-up in Europe and was in use in 39 countries worldwide.

For the next six years, the Charité Artificial Disc and the ProDisc-L were the only two lumbar artificial discs available in the U.S, both covered under Aetna. The next FDA-approved artificial disc wouldn’t come until 2015—the activL® Artificial Disc from Aesculap Implant Systems.

Johnson & Johnson purchased Synthes for $19.7 billion in cash and stock in 2011. This allowed Johnson & Johnson to integrate two of the largest device companies in the world in DePuy and Synthes—and gave the company control of the U.S. artificial disc market with Charité and ProDisc-L.

The 2011 Synthes purchase became Johnson & Johnson’s largest acquisition to date and gave Johnson & Johnson a 28% share in the orthopedic-devices market. Meanwhile, Charité delivered weaker sales than the ProDisc-L, so DePuy Synthes made the business decision to remove it from the global market in 2012 in order to focus on ProDisc-L.

An Experimental Procedure

In May 2013, Aetna acquired Maryland-based Coventry Healthcare. In a statement on Aetna’s website, Mark T. Bertolini, Aetna’s chairman, CEO and president stated, “The successful completion of our acquisition of Coventry presents new opportunities for Aetna and supports our strategy for growth in the changing health care marketplace. Together, we are well positioned – competitively, strategically and financially – to meet the evolving needs of the people we serve.”

For patients in the newly merged insurance platform, Aetna’s commitment to “meet the evolving needs of the people we serve” meant no longer offering access to lumbar artificial disc replacement technology. Since it was no longer Johnson & Johnson’s health insurance provider, Aetna could distance itself from positive coverage for lumbar artificial disc replacement. In a statement on its website dating back to September 13, 2013 (and most recently reviewed on June 5, 2018), Aetna reversed its policy of positive coverage, stating:

“Aetna considers lumbar prosthetic intervertebral discs (e.g., the activL Artificial Disc, the Charité Artificial Disc, and the ProDisc-L Total Disc Replacement) experimental and investigational for lumbosacral degenerative disc disease and for all other indications.”

The reversal caught the surgical community by surprise since Aetna, the first of the major indemnity insurers to approve both the Charité and ProDisc-L lumbar artificial disc, previously deemed them medically necessary in the treatment of degenerative disc disease.

“With no warning or explanation (such as new scientific data or claims history not shared with the medical community), Aetna released a new Clinical Policy Bulletin on Intervertebral Disc Prostheses in mid-September 2013, abruptly reversing its eight-year-old coverage policy,” wrote spine surgeon Dr. Jack Zigler in an Orthopedics This Week article published October 16, 2013.

Was the end of Aetna’s relationship with Johnson & Johnson cause for change in positive coverage or was it the Coventry acquisition? Until 2013, Aetna was the lone major insurer to cover artificial disc replacement surgery until Cigna approved lumbar arthroplasty that same year. The access to care gave Aetna the appearance of being trendsetters in medical technology advancement. However, once merged with Coventry, Aetna’s stunning reversal came with no explanation and was an adoption of Coventry’s negative coverage perspective on artificial disc replacement despite data, studies and years of successful implantations proving otherwise.

“With no warning or explanation (such as new scientific data or claims history not shared with the medical community), Aetna released a new Clinical Policy Bulletin on Intervertebral Disc Prostheses in mid-September 2013, abruptly reversing its eight-year-old coverage policy,”

In June, Aetna’s clinical policy will be up for review. Insurance companies use annual policy reviews to determine whether procedures, services or supplies are "medically necessary, experimental and investigational, or cosmetic" in determining which position they will take. 

When asked about its clinical review protocol, a representative at Aetna stated, “As with all of our policies, we will go through an annual review about mid-year. As part of that review, we will perform a thorough clinical evidence review and evaluate any information that we receive on the topic.” Should Aetna's upcoming review yield the same outcome as its previous decisions, policy holders can expect a continuation of negative coverage for lumbar artificial disc replacement procedures.

As Positive Coverage Increases, Aetna Remains Negative

In September 2018, UnitedHealthcare became the latest major insurer to issue positive coverage for lumbar artificial disc replacement. The decision to provide coverage to patients followed the U.S. Military's TRICARE health plan opening the door for ten million active duty and retired military members and their families to receive coverage. Many BlueCross BlueShield plans have also moved to positive coverage. With 65 percent of commercial insurance coverage in the United States, the remaining providers not yet providing positive coverage are a few small, local plans, about half of the BlueCross BlueShield plans in the country, and Aetna.

This graph shows the percentage of health care insurers that cover ADR.

While the UnitedHealthcare reversal is inspiring, the health insurer changed its stance after class action litigation. Prior to this legal battle leading to a change in policy, UnitedHealthcare customer Carrie Guthrie of Washington state navigated a three-month external appeal process to fight UnitedHealthcare's denial of her case. With help from the activL Patient Assistance Line, she gained approval for her lumbar disc replacement surgery, performed by Dr. Tapan Daftari of Resurgens Orthopaedics in Atlanta, Georgia.

Through the Affordable Care Act, she could exercise her right to an external review process. Knowing her rights forced UnitedHealthcare to put her case in the hands of an independent third party to assess the medical necessity of her case. Not only was her appeal successful, but her case helped bring UnitedHealthcare into the positive coverage column.

"I like to think my case was part of the change," said Guthrie "Living with severe daily pain year after year had changed my perception of life; it had dulled my ability to enjoy anything."

For healthcare giants like Aetna, it may take patients fighting for their rights through the court systems to cause them to issue a statement of positive coverage. The outcome data—surgical success rates, longevity of the device, advances in the technology and quality of life—speaks for itself.

When compared to spinal fusion, the lumbar surgery approved by Aetna, studies show artificial disc replacement surgery as clinically advantageous to spinal fusion for patients with degenerative disc disease. Researchers called the treatment “beneficial,” while referring to it as “a desirable treatment option to spinal fusion.” 

The study concluded, “Overall, our study demonstrates that TDR achieves clinical results at 5 years that are at least as good as or better than fusion in patients who suffer from single-level lumbar DDD and have failed conservative care. There is clearly a role for surgery in this patient population. Furthermore, TDR may reduce the need for future adjacent-level surgery after primary surgery by reducing the occurrence of radiographic adjacent-level disease at 5 years, a generally accepted precursor of the future need for additional adjacent-level surgery. With more than 119,000 TDR implants worldwide over the past 30 years, major universal issues of wear, breakage, breakdown, and other complications would certainly be common knowledge at this point, yet they are only rarely reported.”

Conclusion

As Aetna continues to refuse to provide positive coverage of lumbar artificial disc replacement for its 22 million medical customers, it’s not because the data are inconclusive. Lumbar artificial disc replacement surgery has become a common treatment improving the quality of long-suffering patients’ lives. And as more and more of the surgical community gets behind the technology, will Aetna fall behind the surgeons, or just the times?

Learn how you can make a difference.

Help convince Aetna to cover lumbar artificial disc replacement.  Check out all the ways that you can learn, act and mobilize.

Updated: May 2, 2019

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