One government agency keeps Medicare patients from new treatments
Nearly 40 million Americans live with diabetes, a chronic condition where the body cannot regulate blood sugar. Many of them need to prick their fingers multiple times a day — despite the availability of an easier and more accurate way to check blood sugar, a way that gives physicians a much more complete picture of their patients’ health and enables more personalized and effective care.
That way is a small, noninvasive device called a continuous glucose monitor (CGM), which measures glucose values automatically. It allows people living with diabetes to monitor their blood sugar levels in real time, so they know when those levels veer into dangerous territory. Failure to track blood sugar levels correctly can lead to severe health consequences. Complications from diabetes include heart and kidney disease, nerve damage, vision, and even limb loss.
The Food and Drug Administration (FDA) authorized the first CGMs in 2004. It was a major breakthrough in keeping people with diabetes healthy. The Centers for Medicare and Medicaid Services (CMS) still waited 13 years before covering the cost of its use for patients. Thirteen years. After FDA approval.
The truth is that even after FDA approval, patients on Medicare routinely wait years for CMS to determine whether to provide them with access to a clinically proven, effective new health technology. This prevents patients from accessing the innovative care they need to address serious, often life-threatening conditions. It also slows the research and development of cutting-edge medical devices, because the coverage delay disincentives the massive, risky investments required to make and test these breakthrough health care products.
At the Stanford Byers Center for Biodesign, we surveyed innovators working in a variety of medical specialties — nephrology, cardiovascular disease, skin cancer and hypertension. We asked how long it took for breakthrough technologies to achieve national Medicare coverage, coding and payment.
On average, widespread CMS coverage takes an additional 4.5 years after FDA approval for Medicare patients to gain widespread access to breakthrough technologies. For these patients, the majority of whom are over 65, that’s too long to wait.
Innovation is still the key to solving so many of the health challenges facing patients and our health care system today, but challenges and barriers like these push innovators elsewhere, risking the future of health care. We surveyed the healthtech innovator ecosystem to find out how the delays in coverage affect innovation and investment. More than half the respondents said that the slow and frustrating process to obtain widespread coverage would make them less likely to work on developing another novel therapy or breakthrough device.
Congress is currently considering legislation, dubbed the Cures 2.0 Act, that would establish a transitional coverage program for innovative technology, so that CMS could greatly accelerate Medicare beneficiaries’ access to new therapies while ensuring the ongoing collection of real-world clinical evidence. At the same time, CMS is considering actions it can take under its existing authority to accelerate the coverage process .
Either one of these changes would expand access to novel technologies that have already received FDA approval. Both would send a clear message to both current and future healthtech innovators and patients that U.S. leaders understand the value of innovation in health care.
Universities across the U.S. and in Japan, India and elsewhere are training students to identify an unmet need in health care, invent a new solution, and create a plan to ensure that their breakthrough technology is available for patients everywhere. Many consider health care economics during the innovation process and strive to deliver technologies that meet the triple aim of improving outcomes, lowering costs and increasing access. Yet, as they grasp the challenges ahead of them obtaining reimbursement for their innovations, they are often discouraged.
While the advancements in medicine over the years have been truly amazing, health technology innovators also know that we are just scratching the surface on the next generation of health care. By advancing policies to accelerate coverage for new breakthrough technologies, and ensuring CMS has the resources it needs, we can give more patients the opportunity to live longer, healthier lives and promote more equitable health outcomes for all Americans.