Imagine you’re diagnosed with a serious illness – bad news. But don’t worry, there’s a treatment – good news. It is clinically tested, FDA-authorized, and has been shown to have a lower risk of complications or side effects than traditional treatments.  Great news, right? Well, only if you can afford to pay for it out-of-pocket.

This frustrating scenario is soon likely to increase for many Medicare beneficiaries who could benefit from the innovative medical devices and technologies that languish in the so-called payment “no man’s land.”

Typically, the Centers for Medicare & Medicaid Services (CMS) must wait to collect sufficient evidence to determine whether the treatment should be covered. But while they wait for this evidence, patients must also wait for access to care. Because few patients can afford to pay for the treatment out of their own pocket, uptake is often limited and consequently, so is evidence collection. This lose-lose scenario makes it difficult for innovators to capture a return on their investment and severely limits access for Medicare beneficiaries to tested and proven treatments. Furthermore, limiting these innovative technologies to only those who can afford them on their own also contradicts the Administration’s efforts to bring about more equity in healthcare.

It’s expected that under the new Medical Device User Fee Agreement (MDUFA), an increasing number of new technologies will come before FDA for pre-market review, including through the “Breakthrough” pathway and the new Total Product Lifecycle Advisory Program (TAP) pilot.

The current review backlog and wellspring of new technologies coming to market should be a clarion call to CMS to stand up a pathway for new and innovative technologies. CMS’ announcement of initial work on the Transitional Coverage for Emerging Technologies as a successor to Medicare Coverage of Innovative Technology (MCIT) program, which was created but later rescinded by the Administration, is good news. But CMS must move quickly to create coverage pathways and parameters so all seniors can access medical technologies as opposed to only those who can afford to pay out of pocket. And the consequences of not having a pathway are very real.

Focused ultrasound (FUS) technology is the poster child for how the system fails patients FUS has the potential to transform the treatment of many medical disorders by using ultrasound energy to target tissue deep in the body without incisions or radiation. When used for uterine fibroids treatment, the quick non-invasive outpatient procedure has been shown to significantly decrease the risk of complications and preserve fertility. For Medicare beneficiaries, however, the lack of coverage means many women are deciding if they want to risk the potential complications and potentially long-lasting impacts on fertility from an invasive hysterectomy which is covered by CMS or come up with the thousands of dollars to pay for the FUS procedure, which isn’t covered, on their own.

And that’s just one example of a technology that already exists. AI-enabled imaging software, innovative scanner applications, and new imaging drugs are coming to market all the time, with even more powerful innovations on the horizon.

Without reimbursement policies that can meet the opportunity of this new innovative era, patients and their providers will be denied access to the most cutting-edge, care.  Without a solution to coverage delays, future innovations – maybe a cancer screening, a simple and definitive Alzheimer’s diagnostic, or another disease cure will sit idle.

America’s medical device manufacturers are ready to take on the health challenges of tomorrow. We ask CMS to work with us to ensure these medical breakthroughs are not limited to only those who can afford them on their own.

Photo: bob_bosewell, Getty Images