Too many of our seniors are afflicted by conditions for which no treatment options exist. From heart failure to cancer, from Alzheimer’s to diabetes, too many are suffering with ailments that actually could be treated with next-generation care. Last week, the Center for Medicare and Medicaid Services announced an important update to Medicare policy that will change that. It’s a change that has bipartisan support in Congress, and we urge the incoming administration to implement it fully, as well as to strengthen and improve it. Here’s why.
By definition, “breakthrough” technologies treat life-threatening or irreversibly debilitating conditions – conditions for which there are no treatments or for which existing treatments are lacking. In other words, breakthrough technologies are a beacon of hope for seniors suffering with terrible, often untreatable, diseases or conditions.
But pause for a moment. Think about your own family before you continue reading. Medicare beneficiaries are all around you. Perhaps one is your grandfather, or your grandmother – or your older brother or sister. Perhaps you are on Medicare.
Imagine a brain implant that cures your father’s blindness and allows him to see your children for the first time. Or a “wearable,” portable artificial kidney that keeps the often-fatal end-stage renal disease at bay for your grandmother. Or a nanoknife that treats your aging brother’s stage 3 pancreatic cancer. Or a groundbreaking diagnostic test that can detect your own ovarian or pancreatic cancer.
Many such breakthrough medical technologies have earned approval after rigorous review by the Food and Drug Administration – the global gold standard for medical device safety and effectiveness – but the above-mentioned Medicare patients, until CMS acted, didn’t have access to them because of an unfortunate and unnecessary disconnect between a device’s FDA approval and CMS’ ability to cover that device through their Medicare policy.
It’s a pattern we saw play out many times: FDA expedited a promising breakthrough technology’s development, assessment, and review for market approval, but there was no equivalent expedited process at CMS, so our seniors had to wait to access them – sometimes years, if that coverage was ever granted at all.
Most of these patients don’t have years to wait. A day can mean the difference between life and death.
Under the new rule, called Medicare Coverage of Innovative Technology, as soon as the FDA approves a new breakthrough technology, Medicare can cover that breakthrough technology. It’s that simple and it should be that simple. When a device or diagnostic test that is designated as a breakthrough and determined by the FDA to be safe and effective, Medicare patients can be the first in line to get it.
The MCIT rule will ensure automatic national coverage of innovative, FDA-approved devices like those mentioned above for Medicare beneficiaries at the time of their FDA approval, allowing these medical technologies to improve the quality of life – and even extend the lives – of so many seniors. This crucial change to federal law will leave the decision about whether a breakthrough medical technology is right for your grandfather precisely where it belongs: between your grandfather and his doctor. If it is the right choice, Medicare will pay for it; if it is not, then at least that medical technology is available through Medicare to other seniors who could benefit from it.
Further, the MCIT program will allow for ongoing collection of real-world data to better understand the true impact of these life-altering technologies on Medicare patients.
This issue is personal. We all want our loved ones to have access to the very best medical technologies to help save and improve their lives. Especially right now, in the midst of COVID-19, when we’re doing everything we can to make sure our families are taken care of. We owe it to our seniors – our most vulnerable family members – to ensure this policy lives on. Because lives depend on it.
Opponents of this rule are essentially saying that one set of government clinical experts at FDA – the global gold standard for device safety and effectiveness – determining that an innovative medical technology is safe and effective isn’t enough, and we need a second set of government clinical experts at another federal agency to make this decision for our seniors.
But what we’re saying is simple, and it’s good government, and it’s good common sense: For truly breakthrough technologies, FDA approval should be enough. CMS recognized that it’s time to let you and your doctor decide what’s best for you and your health. We look forward to working with the Biden administration’s leaders at CMS to ensure that this bipartisan policy is here to stay. Too many seniors’ lives depend on it.
Scott Whitaker is the president and CEO of AdvaMed, the world’s largest trade association with more than 400 members who produce and manufacture medical devices and technologies.
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