Nonsensical Processes Prevent Patient Access to New and Safe Treatments

Insurance companies label new products as investigational to justify the denial of care.

Health technological innovations only have value if doctors and patients have access to them. Insurance companies label new products as investigational to justify the denial of care. Nonsensical processes prevent patient access to new, safe, and effective treatments.

The pandemic proved new therapeutics and vaccines are able to navigate through the bureaucratic quagmire when there is the public will to make it happen. New antivirals therapies, monoclonal antibodies, and mRNA vaccines are now saving lives. 

These success stories are outliers. In reality, pharmaceutical and medical device innovations move through the system at a snail’s pace. 

A product must pass through a lengthy FDA approval process to verify safety and efficacy. Despite FDA approval, a new medical device still can not get into the hands of surgeons. New technologies run into a brick wall as they fight for acceptance as an approved product by third-party payers. 

Insurance companies hide behind the word “investigational” to justify the denial of care. An FDA-approved medical device has little value to doctors and patients if none of the third-party payers pay for its use. 

Every insurance company must accept and authorize a new medication or medical device into their approved formulary before it is considered a covered benefit. Even after CMS approval, each managed care Medicare and Medicaid plan also submit new products to this lengthy process.

Medical practices spend countless hours jumping through pre-authorization hoops and appealing denied claims. 

We invest this time and energy to get our patients the most effective options, but patient care does not have to be so hard. Patients want doctors to spend time in the exam room, not writing insurance appeal letters. 

Finn Partners manager of global health, Gil Bashe, summarizes the barriers stifling medical device innovation in his article “Investigational” Is Payer Code for “Coverage Denied”

It is time for insurance companies to tear down the walls, stop playing games and help doctors provide the best care to their patients. 


Medika Life has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by Medika Life

Dr Jeff Livingston
Dr Jeff Livingston
Jeff is Co-Founder of Medika Life. He is a Board Certified Obgyn and CEO of MacArthur Medical Center in Irving, Texas. He is a nationally recognized thought leader, speaker, writer, blogger, and practicing physician who is considered an expert in the use of social media to educate patients, using new and innovative technology to improve care outcomes and the patient experience.
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