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AAHomecare comments on product innovation

AAHomecare comments on product innovation

WASHINGTON - CMS needs to move away from the gap-fill methodology and develop an alternative payment system, AAHomecare urges in comments to a recent proposed rule on innovation and technology.

The association says a new payment system would ensure appropriate payment and access, should a device receive approval under the proposed “Medicare Coverage of Innovative Technology” (MCIT).

CMS has proposed MCIT as a streamlined pathway for “FDA-designated breakthrough medical devices” to get Medicare coverage. The agency's rule also proposes codifying the definition of “reasonable and necessary” that will be used under the MCIT and other coverage determinations, such as NCDs and LCDs.

AAH's other points include:

  • The association disagrees that a product must be within a benefit category to be eligible under MCIT. This restriction seems at odds, it says, with the intent to open coverage to innovative technology which, often by definition, will not fit in an established benefit category.
  • It believes the agency should consider including digital therapeutics, which currently don't have a benefit category, under the existing benefit category of DME.
  • It supports the agency's proposal to codify the current Program Integrity Manual definition of “reasonable and necessary” with some modifications.
  • It supports the addition of 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.
  • It requests CMS to abandon its restrictive interpretation of the “in-the-home” language in Section 1861 of the Social Security Act for coverage of DME to improve beneficiary access for rehab and assistive technology.


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