Medical device malpractice at CMS

Looming midnight rule could unleash a flood of untested products

The Trump administration will likely pass a midnight rule making Medicare pay for many new medical devices before anyone knows how well they work in elderly patients.

The proposed rule will grant automatic payment coverage to any medical device given “breakthrough” status prior to their approval by the Food and Drug Administration. That will likely include minor variations on some of the artificial knees and hips and cardiovascular implants used by millions of beneficiaries.

The agency has handed out hundreds of breakthrough designations in recent years. They’ve included devices designated as “follow-on” devices, which means they aren’t much different than older devices and needn’t bother conducting clinical trials to gain FDA approval.

Such devices also wouldn’t have to go before Medicare’s Evidence Development and Coverage Advisory Committee (MedCAC), which is charged with determining if new medical products are “reasonable and necessary” for America’s elderly. MedCAC, as part of its coverage-with-evidence-development process, has the power to demand manufacturers collect and submit data from registries or clinical trials after the agency has agreed to pay for a new technology.

FDA calls a device a ‘breakthrough’ when it is expected — though not yet proved — to be helpful to patients with serious conditions,” Dr. Peter Bach, the chairman of MedCAC wrote last week in a New York Times commentary. “The designation has nothing to do with how the device works in older patients, or even if it was studied in that population at all.”

The impact of the proposed rule will go far beyond Medicare. Most insurers’ reimbursement policies take their cues from what to agency decides to cover.

One FDA-approved device that will get covered by Medicare under the proposed rule is already generating controversy. Boston-based Pear Therapeutics reSET-O is a digital app that helps patients stay in opioid use disorder treatment programs. The FDA gave the app “breakthrough” status despite its use of the 510(k) approval process, which is reserved for devices similar to those already on the market.

A draft review of three such apps was released last month by the non-profit Institute for Clinical and Economic Review, which looks at new technologies to see if their effectiveness justifies their price, in this case, a $1,200 app for smart phones. Its reviewers concluded “the available evidence on the benefits of reSET-O, Connections and DynamiCare has substantial limitations and can provide no firm estimate of net health benefit for patients with opioid use disorder versus usual care for any of these interventions.”

Several public comments on the review called for rigorous clinical trials to determine whether opioid adicts in treatment found the apps actually helped them stay off drugs. “To what extent have the products been subjected to rigorous independent (arms-length) scientific evaluations?” asked Joe Glass, an investigator with Kaiser Permanente’s Washington Health Research Institute. “By rigor, the level of evidence would include an adequately powered randomized controlled trial beyond the pilot stage.”

The trials should “compare a digital therapeutic to a ‘treatment as usual’ condition and/or an additional active intervention control condition,” wrote Lisa Marsch, PhD, a professor of psychiatry at Dartmouth and head of its Center for Technology and Behavioral Health. She further cautioned ICER to treat even those trials with some skepticism since “‘treatment as usual’ conditions often do not reflect the standard of treatment offered in real-world treatment settings but rather often exceed that level of care.”

In a scathing commentary last week on the Health Affairs website, Peter Neumann and James Chambers of the Center for Evaluation of Value and Risk and Health at Tufts Medical Center said the proposed rule “risks eroding decades of progress made to bolster the scientific evidence underlying coverage decisions for medical technology.” The proposal’s “vision of an unfettered path to coverage is a recipe for future problems.”

President-elect Joe Biden, who on Sunday made his first choices for new leaders at the Health and Human Services department, left out the secondmost important nominee at the agency — the head of CMS. The first year on the job for whomever that person is will be undoing the damage done by the outgoing administration, which likely will include finalization of this dangerous rule.