OPINION:
Every day, doctors diagnose Medicare beneficiaries with life-threatening or debilitating conditions, then confront a harsh reality: Many of the devices on which they rely lack substantial clinical trial data supporting safety and effectiveness.
Physicians must choose between withholding potentially beneficial treatment and risking liability by using an untested device.
Yet Scott Whitaker, president and CEO of AdvaMed, insists the priority is reimbursing devices as quickly as possible. We disagree. The federal government should not pay for many devices until and unless they’re proven safe and effective for their intended uses.
The Food and Drug Administration’s Breakthrough Devices Program undermines this evidence-based policy by allowing reimbursement based on surrogate endpoints, shortened follow-up, limited datasets and heavy reliance on post-market real-world evidence (RWE).
Additionally, the FDA often authorizes breakthrough devices via pathways that do not require rigorous evidence. These accommodations lower the evidentiary bar far below what the FDA and Medicare typically require for experimental and investigational devices: carefully regulated Investigational Device Exemption (IDE) trials.
The Ensuring Patient Access to Critical Breakthrough Products Act exacerbates this problem by using taxpayer dollars to cover authorized devices with no enrollment limits, numerical caps or controlled-study requirements. Although the bill nominally requires some clinical data for 510(k) breakthrough devices, the threshold remains astonishingly low.
And unlike IDE trials — which restrict reimbursement to a closely monitored setting — the Breakthrough Act allows essentially uncapped reimbursement without attendant safeguards. Instead, it relies on RWE, which is often confounded, underreported and slow to detect serious signals.
When these devices are new, unproven and non-standard, their rapid, subsidized entry encourages physicians to breach standards of care. Widespread use of untested devices will reveal problems at scale, leaving the legal system to regulate after harm has occurred.
As lawsuits against physicians and device manufacturers yield jury verdicts and settlements, insurance premiums will rise and carriers may limit or non-renew coverage.
The Breakthrough Act and its proponents represent those who gain financially from this bill: device manufacturers. Our concern is protecting patients, physicians and the public from unnecessary risks to health, livelihoods and resources.
The best way to accomplish this is to use reimbursement as an incentive to demonstrate strong, prospective evidence of safety, effectiveness and comparative benefit before unrestricted taxpayer-funded access.
HOOMAN NOORCHASHM, research professor of law
DAVID SIMON, associate professor of law
Northeastern University School of Law
Boston, Massachusetts
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