AHIP Protests Medicare Coverage of Innovative Technology Rule

As CMS reconsiders the Medicare Coverage of Innovative Technology (MCIT) rule which was finalized in mid-January 2021, America’s Health Insurance Plans (AHIP) has expressed its concerns regarding the rule.

The rule was supposed to go into effect in March but has been delayed until May 15, 2021 for reevaluation, as have many other CMS rules that were finalized under the Trump Administration in accordance with an executive order.

AHIP’s comments related to two aspects of the interim final rule.

First, the payer organization expressed concern about the MCIT pathway. The MCIT pathway originally was designed to accelerate breakthrough medical devices for Medicare beneficiaries so that these devices could be developed, manufactured, and offered to beneficiaries more quickly. Once approved, the devices would be covered by Medicare for four years.

The executive order to with this rule complied stated that the devices must be “appropriately reimbursed and widely available, consistent with the principles of patient safety, market-based policies, and value for patients.”

Despite this injunction, AHIP found that the MCIT pathway did not sufficiently address patient safety. Instead, the pathway could be used to bolster fraud, waste, and abuse. False durable medical equipment payments have fueled Medicare improper payment rates in the past, giving rise to CMS fraud prevention strategies that target such scams specifically.

The payer also argued that pathways already exist that could be used to more effectively and safely deliver products to patients, such as the Parallel Review Medicare coverage pathway, the Coverage with Evidence Development, or the existing National Coverage Determination.

AHIP also pointed to operational challenges, which CMS also noted in the rule. The timeline for setting up a website with the list of MCIT-eligible devices, the strategy for making updates to the list, and other potential problems remain unaddressed in the current rule.

Finally, the payer organization objected to the regulatory impact analysis’s projections for the volume of manufacturers that would seek to use this pathway for their devices. If AHIP is correct and CMS has underestimated the number of devices that would utilize this pathway, that could impact projections on the pathway’s ability to ensure that devices are safe.

At present, a device must be considered “reasonable and necessary” in order to receive Medicare coverage. The interim final rule would codify that practice and would also permit CMS to include commercial health plans’ coverage in its evaluation of whether a device meets that standard.

“No later than 12 months after the rule’s effective date, CMS would release for public comment a draft methodology by which commercial insurer policies are determined to be relevant based on the measurement of a majority of covered lives for purposes of making Medicare coverage determinations,” AHIP summarized.

But by including commercial coverage in its assessment for Medicare coverage, CMS might not allow for geographical differences, varying clinical and evidence-based criteria, state regulations, and other factors that differ between payers.

“In some instances, commercial coverage may be dictated by state benefit mandates, which may or may not be evidence-based,” the payer organization noted.

“While this has long been an issue at the individual state level, referencing commercial coverage in the standard for Medicare coverage would exacerbate this challenge on a much broader scale, potentially exposing Medicare beneficiaries to state mandated benefits with little to no supporting evidence.”

Recent studies have highlighted the need for more affordable durable medical equipment in Medicare.

While Medicare Advantage plans tend to perform better than traditional Medicare in cost savings, durable medical equipment can be more costly in Medicare Advantage than in traditional Medicare. However, the results may vary based on the patient population.

In matched populations, Medicare Advantage beneficiaries spent 27 percent more on durable medical equipment than traditional Medicare.