Payment Denied for Coflex Titanium implants to treat lumbar spinal stenosis?



…for more information about what’s been mentioned in this article​ or something else you’d like to learn more about

and... Thank You!

… for being part of my professional community. Thank you for reading, watching, commenting, sharing, and spreading all of my information around the web so other healthcare industry professionals can thrive and succeed as well.

Blue Shield treats Coflex as an "investigational" procedure, but Paradigm Spine won FDA approval for Coflex in 2012.

About the Author

About the Author

Maria Todd is frequently hired as a consulting expert and trusted authority on orthopedic surgery claims denials and appeals. She uses her training and experience in managed care and as a health law paralegal and former health plan provider relations director to help medical groups, individual physicians, hospitals and ambulatory surgery facilities and other healthcare providers collect what's owed to them.

Maria believes that when payers breach contracts and breach implied covenants of good faith that their misdeeds should be taken to task.

Follow Maria on LinkedIn

FOLLOW MARIA  Join the more than 30,000 healthcare industry colleagues who already read  and download Maria Todd’s content on social media channels to stay up to date and informed.


Who pays?

Should insurers pay for Coflex as a treatment for lumbar spinal stenosis as a stand alone procedure or following decompression surgery?

Should they have the right to intentionally avoid or delay updating medical and reimbursement policies to the extent that they continue to deny coverage in the “absence” of updated medical policies to reflect current standards of care?

That’s what’s being argued in California this month. The law firm of Gianelli & Morris is suing Blue Shield of California, alleging bad faith and statutory violations based on the insurer’s blanket denials of coverage for the use of the Coflex medical device to treat lumbar spinal stenosis.

I’ve dealt with similar payer denials on a number of fronts in all different specialties. Usually, I win the appeals. But sometimes, I have to fight harder than others.

Simply arguing that the FDA cleared something or that Medicare pays for it is often irrelevant. There’s far more to policy review in order to argue that a service, supply or drug should be paid for by the payer. But after two or more years, underwriters and actuaries that continue to evade policy and risk for the cost of claims, and new risk assessments and plan budgets filed with State regulators, the grace period is over and the gloves removed.

Many health plans “borrow” or adopt the Aetna Coverage and Blue Cross medical policies, so there’s a viral effect when these two plans delay or avoid appropriate standard of care updates. At some point the action (or inaction) switches from tardy to intentional bad faith allegations. 

According to the complaint, Blue Shield still treats Coflex as an “investigational” procedure and, therefore, not eligible for coverage. Blue Shield’s “Medical Policies” on investigational procedures, cited in the complaint, deem a procedure or treatment investigational in the following situations:

  • The treatment is not recognized under generally accepted professional medical standards as being safe and effective for use in the treatment of the condition at issue

  • Services have not been granted approval when required by state or federal government agency

  • Services are not approved or recognized according to accepted professional medical standards, even though authorized for use in testing, trials, or human studies

Coflex does not fit into any of these categories and shouldn’t still be stuck in the investigational or experimental “bucket”. Doctors who are credentialed and privileged by health plans should be allowed independent medical judgement to choose what’s best for their patient from any FDA-approved device like Coflex for a covered surgery for a covered condition.  No health plan should be allowed to unilaterally dictate or influence a surgeon’s independent medical judgment or be limited to what a health plan deems ‘investigational,’ after 8 years past market approval by the FDA. This is even more egregious when decisions are influenced by factors that include economic strategies beyond the medicine. 

Providers who face delays should fight for payment and damages that include lost opportunity, payment delay, loss of brand equity as the patients whose claims remain unpaid take a dim view of the hospital and surgeon or ASC that must then balance bill the patient for a “non-covered service” after they went through the pre-approval motions and efforts to protect all concerned.

If you have a similar problem with Coflex or any other device, supply,  medication or surgical approach, call me and let’s discuss your preliminary appeal options before taking the matter to court. If I see an easier way, I’ll help you in any way possible. But if the matter really is best served in court, I’ll direct you to a number of experts I work with regularly who can help. 

Get practical advice and expertise you need
from Maria Todd
on this topic and related subjects

Maria is a bestselling author and a top healthcare industry influencer and thought leader. She has excellent references and a huge project portfolio spanning 40+ years in healthcare business development and management.

She holds 25 copyrights, several trademark registrations, and shares several patent applications for software inventions.

She’s been recognized with numerous industry lifetime achievement awards for her work in contracted reimbursement, managed care, physician integration and alignment, and health tourism in the USA and 116 countries. 

Books by Maria Todd on this and related subjects

Master Classes with Maria Todd on this and related subjects

View scheduled classes and learn which courses are available as a private Master Class just for your team at your location!


If you found this unrestricted content valuable to you, the greatest compliments you can pay me is to "Like" it, "Share" it, print it, or repost it on your social networks or quote me in an article or invite me to present on this topic at an event. It is my pleasure to exchange authoritative mentions and links with appropriate sources and other respected experts. Please feel free to send me a question and I will personally answer.​

Do you have questions about international accreditation or medical tourism marketing or branding strategies?

Would you like unbiased answers from experts who aren't in the business of selling any accreditation?

Schedule an appointment to discuss your concerns. Request a time for a courtesy chat with this form.


…for more information about what’s been mentioned in this article​ or something else you’d like to learn more about

Skip to content