September 22, 2021
“The best laid plans of mice and men often go awry.” The original quote from poet Robert Burns is a bit different with its Gaelic inflections, but this approximate version of the maxim has become the standard rendering for modern ears. However the statement is styled, its sentiment cannot be misunderstood. Sometimes our perfectly designed proposals end up crashing and burning. In 1975, Betamax introduced their revolutionary video recording format for the average consumer. A year later, VHS introduced their version. In time, Beta went the way of the dodo bird—even though some would argue it was the superior product. “The best laid plans.”

As we well know, this same dynamic is also found in the bureaucratic bastions of Washington. Federal regulators often draw up highly complicated proposals designed to solve a particular problem, but new administrations tend to upend those perfectly drawn-out plans. Evidence of this can be found in a recent decision by government healthcare officials.

A Change in Tack

On September 15, the Centers for Medicare and Medicaid Services (CMS) announced its plan to rescind the breakthrough payment rule that was originally meant to advance the introduction of new medical device technologies. The Medicare Coverage of Innovative Technology (MCIT) rule was designed to allow medical technology companies to obtain quick coverage for a period of four years with the imprimatur of the U.S. Food and Drug Administration (FDA). Now, however, CMS has published a proposed rule (PR) in which it indicates its “significant concerns” about the clinical evidence for breakthrough devices that would be used within the Medicare population.

As you may recall, MCIT came about near the end of the Trump administration. The rule was put on hold by the succeeding administration to allow them time to review the rule and determine whether or not it was in keeping with the new administration’s goals, priorities and standards. According to one news outlet, CMS was lobbied by certain insurance and physician organizations to kill the MCIT rule. The concerns raised by these groups are reported to have had a cumulative effect on CMS, ultimately leading to this PR.

For example, America’s Health Insurance Plans (AHIP)—a lobbying organization on behalf of the health insurance industry—submitted comments to CMS back in April, in which they expressed concerns that the MCIT rule could “potentially result in premature coverage of unproven devices for the Medicare population, exposing seniors and people with disabilities to increased health risks.” They went on to state that “once a device is on the market and covered, removing it from the market can be exceedingly difficult, even if additional data indicate safety concerns.” Comments such as these led CMS to conclude that the MCIT rule may end up providing coverage for devices prior to there being sufficient evidence of their efficacy. In other words, there would be a potential that these breakthrough technologies may not meet the “reasonable and necessary” standard in terms of their usage within the Medicare population. Accordingly, CMS, in its September PR, declared that the MCIT rule “is not in the best interest of Medicare beneficiaries.”

A Disappointed Lot

While there were groups pointing out the perils of providing coverage for unproven technologies, there were others who were just as outspoken about the importance of keeping the MCIT rule in place. As one would imagine, those in the medical technology (medtech) industry were ecstatic at the prospect of getting fast-track approval for their new devices as it concerns Medicare coverage. The position of these MCIT proponents echoes that of the previous administration: use MCIT to incentivize innovation that will lead to breakthrough technologies.

The CEO for one such medtech company, AdvaMed, said the proposed repeal of the MCIT rule is the “wrong decision.” As to the charge that MCIT could have the effect of spending federal money on ineffective technologies or devices, AdvaMed’s CEO stated that “doctors and patients should be trusted to make the right medical decision.” In other words, the argument is that a doctor is unlikely to deploy new breakthrough technologies unless he or she (a) has sufficient evidence of its effectiveness, and (b) believes the breakthrough technology is the best solution available at the time for that particular patient. In addition, the patient’s choice to move forward with new technologies or devices should be respected as part of the informed consent process.

Further Light

Despite these arguments, CMS is proposing to shelve the previous administration’s MCIT program. This does not mean, however, that the full tenets of MCIT are dead. There are two ways in which this program—in full or in part—can survive. First, the current administration’s proposal to quash MCIT must be finalized. That is not a certainty. CMS is allowing comments in response to its PR to be sent for 30 days past the publishing of the PR—so, until October 15. Second, elements of the MCIT may be included in future rulemaking.

For those who want to know more about this topic, you can download the proposed rule at the following link: 2021-20016.pdf (federalregister.gov). As always, if you have a question about our hospital-specific services, please contact us at info@miramedgs.com.