“If you build it, he will come” is the famous line that inspired Iowa farmer Ray Kinsella in "Field of Dreams" to build a baseball diamond where his cornfields once stood.
It was an iconic leap of faith on the part of Ray that saved ultimately the family farm. It’s lucky for Ray his calling was to build a baseball field and not a medical device. Otherwise, Ray might have heard: “If you build it, it will languish.”
Indeed, languishing is what countless medical devices and other healthcare technologies are forced to do when they are authorized for sale by the Food and Drug Administration (FDA) but not covered by Medicare.
Without coverage, Medicare patients are forced to pay out-of-pocket for such a procedure, an expense that most beneficiaries cannot afford. The cost means these innovative procedures are not utilized as often and the clinical data Medicare demands to consider coverage lags behind.
It’s a no-win scenario that slows needlessly the adoption of new technology or forces it to fade and disappear altogether, depriving patients of alternative treatments that may deliver better outcomes, often with quicker recovery times and fewer side effects.
The wide gap between the timing of FDA authorization and Medicare coverage is emblematic of a disconnect between the two agencies. It also is consistent with the tendency for the Centers for Medicare and Medicaid Services (CMS) to leave pioneered and proven technology in the laboratory and not put it into the clinic for the benefit of patients.
How can this vicious cycle be broken? At a recent forum convened by the Department of Health and Human Services (HHS) to examine the pace of clinical innovation, I argued that CMS should grant a code, payment and provisional coverage for two years to new technology, simultaneously and automatically, when the technology receives FDA authorization.
These two years would allow sufficient time to validate the clinical reasonableness, effectiveness and necessity of the new technology and to obtain sufficient real-world experience to determine an appropriate “final” reimbursement payment level and coverage determination. CMS should also consider alternative data sources to evaluate better a technology's actual value when making such coverage decisions.
For example, imagine a new intervention equivalent to others in terms of disease control and side effect profile that reduces significantly the cost of treatment. These savings certainly should be a part of the CMS coverage calculus.
Focused Ultrasound (FUS) is a case study of the unintended consequences when technology becomes mired between FDA authorization and CMS reimbursement.
FUS works similar to a magnifying glass that focuses the sun’s rays to burn a hole in a leaf. Instead of sunbeams, FUS focuses ultrasound waves to ablate tissue. Just as the focused sunlight will not burn a hand placed in its path on its way to the leaf, FUS waves do not burn the tissue between the device and the focal point tissue. Precise targeting destroys cancer without healthy tissue damage or compromised quality of life.
This technology has been FDA authorized for multiple indications including essential tremors, Parkinson’s tremor, uterine fibroids, painful bone metastases and prostate tissue ablation. It has been in use and paid for around the world for close to two decades. For a man with prostate cancer, a specific class of high-intensity FUS devices, known as High Intensity Focused Ultrasound (HIFU) can be a game-changer. Erectile dysfunction, loss of ejaculation and incontinence are major side effects common to prostatectomy and radiation therapy for prostate cancer. With HIFU, the incidence of side effects is reduced greatly (to practically 0% when it comes to incontinence), postop recovery is essentially free of the need for any pain medication, men can return to work and regular activities in one to two days and the procedure can be repeated if necessary.
However, without Medicare reimbursement, older patients, representing more than 60% of prostate cancer patients, must pay for the procedure out of pocket, sometimes to the tune of $25,000. This lack of coverage affects not only men with prostate cancer but the healthcare system as whole. Our internal assessment of the savings from the use of HIFU in all men with prostate cancer appropriate for HIFU suggests a savings to Medicare approaching $5B over five years when compared to prostatectomy and radiation therapy.
Since the majority of patients can’t afford the cash cost of a procedure, urologists and hospitals are concerned that patient volumes will not be sufficient to support wide adoption of the technology. This means a minimally invasive treatment that has disease control equivalent to existing therapy, but with a vastly superior side effect profile and lower impact on lifestyle may disappear from the marketplace due to lack of corporate viability.
It wasn’t lost on me that a central theme in Field of Dreams was “easing his pain.”
Easing or curing someone’s pain by building an innovative medical device is the dream of many innovators. Once one considers how costly, risky and complicated it is to bring a new medical device to market, it is beyond frustrating to see a life-altering medical device that can receive authorization from the FDA have its adoption by the medical community stymied due to a lack of Medicare coverage.
If HHS wants to spur the continued development of lifesaving clinical innovations, it must help bridge the divide between FDA and CMS so pioneering technologies do not disappear as they venture out into the cornfields of the real world.
Mark Carol is CEO and President of SonaCare Medical which produces the High Intensity Focused Ultrasound (HIFU) technology.