Imagine you’ve been diagnosed with a serious illness – bad news. But don’t worry, there is a cure – 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. Good news, right? Well, only if you can afford to pay out of pocket.
For many Medicare beneficiaries who could benefit from innovative medical devices and technologies languishing in so-called payment “no man’s land,” that frustrating situation will soon increase.
Often, the Centers for Medicare and Medicaid Services (CMS) must wait to gather enough evidence to determine whether the treatment should be covered. But while they wait for this evidence, patients must also wait to get care. As few patients are able to pay for treatment out of pocket, uptake is often limited, as is evidence collection. This lose-lose situation makes it difficult for innovators to achieve a return on investment and severely limits access to tested and proven treatments for Medicare beneficiaries. Additionally, limiting these innovative technologies to those who can afford them also contradicts government efforts to achieve more equity in health care.
expected in the new Medical Device User Fee Agreement (MDUFA)), an increasing number of new technologies will be submitted to the FDA for premarket review, including through the “breakthrough” pathway and new Product Lifecycle Advisory Program (TAP) pilot.
The current backlog and source of scrutiny for new technologies coming to market should be a clarion call for CMS to pave the way for new and innovative technologies. CMS Announces Preliminary Work on Emerging Technology Transition Coverage as Successor Medicare Coverage for Innovative Technologies (MCIT) program, which was created but later revoked by the government, is good news. But CMS must move quickly to create coverage paths and parameters so that medical technology is accessible to all seniors, not just those who can afford to pay for it out of pocket. The consequences of not having a path are very real.
Focused Ultrasound (FUS) Technology A poster child for how this system fails patients, FUS has the potential to transform the treatment of many medical conditions by using ultrasound energy to target tissue deep in the body without incisions or radiation. When used for uterine fibroids, rapid, non-invasive outpatient surgery has been shown to significantly reduce the risk of complications and preserve fertility. However, for Medicare beneficiaries, the lack of coverage means that many women are deciding whether they are willing to bear the potential complications and potential long-term effects on fertility of an invasive hysterectomy covered by CMS, or pay a Thousands of dollars to pay for FUS procedures not covered.
This is just one example of technology that already exists. AI-enabled imaging software, innovative scanner applications, and new imaging drugs are on the market all the time, and more powerful innovations are on the horizon.
Without reimbursement policies that meet the opportunities of this new era of innovation, patients and their providers will not have access to cutting-edge care. Without a way to address coverage delays, future innovations—perhaps cancer screenings, simple and unambiguous Alzheimer’s diagnoses, or treatments for other diseases—will sit idle.
U.S. medical device manufacturers are ready for tomorrow’s health challenges. We ask CMS to work with us to ensure that these medical breakthroughs are not limited to those who can afford it themselves.
Photo: bob_bosewell, Getty Images
