WASHINGTON, DC – Last week, AAHomecare submitted comments to the proposed rule titled: Medicare Coverage of Innovative Technology and the Definition of “Reasonable and Necessary”.  In this rule, CMS is proposing to establish a new coverage program called “Medicare Coverage of Innovative Technology” (MCIT) and codify the definition of “reasonable and necessary.”

The proposed MCIT is a streamlined pathway for “FDA-designated breakthrough medical devices” to get Medicare coverage. The second portion of the rule proposes to codify the definition of “reasonable and necessary” that will be used under MCIT and other coverage determinations, such as NCDs and LCDs.

Here are key points included in AAH’s letter:

MCIT

• AAH urges CMS to move away from the gap-fill methodology and develop an alternate payment system that would assure appropriate payment and access should a device receive approval under MCIT.
• For a device to be eligible under the proposed MCIT coverage pathway, a product must also fit within a benefit category and not be excluded by statute. We disagree that a product must be within a benefit category, and this restriction seems to be at odds with the intent to open coverage to innovative technology which, often by definition, will not fit in an established benefit category.
• The Agency should strongly consider including digital therapeutics, which do not currently have a benefit category. Under the FDA, digital therapeutics are commonly regulated under the Software-as-a-Medical Device (SaMD) framework. Digital therapeutics and breakthrough-designated SaMD could be covered under the existing benefit category of durable medical equipment.

Reasonable & Necessary

• AAH supports the Agency’s proposal to codify the current Program Integrity Manual definition of “reasonable and necessary,” with some modifications.
• AAH supports the addition of the commercial plan coverage language, as long as the Agency is transparent about the evidence it uses to determine that individuals covered under commercial plans are clinically different from Medicare beneficiaries.

DME Coverage

• AAHomecare requests CMS to take this opportunity to abandon its restrictive interpretation of the “in the home” language in Section 1861(n) of the Social Security Act for coverage of DME to improve beneficiary access for rehab and assistive technology.

You can find AAHomecare’s full comments here. Members interested in submitting comments are welcome to support AAHomecare’s recommendations by sharing a copy of the letter. Comments for this proposed rule are due on Nov. 2, 2020 at regulations.gov.