WASHINGTON, DC – As shared in the Sept. 9 edition of AAH Insider, CMS published a 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.
AAH is currently developing comments and will notify membership after they have been submitted. In the meantime, to help membership with the comment writing process, we are sharing key points included in AAH’s letter:
- 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.
- 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.
Comments for this proposed rule are due on Nov. 2, 2020 at regulations.gov. Members interested in submitting comments are welcomed to support AAHomecare’s recommendations.
CMS Provides Updates on Audits
WASHINGTON, DC – Earlier this week, CMS’ Provider Integrity Group hosted the Provider Compliance Focus Group meeting. This is usually a quarterly in-person meeting that is available to all provider types, but due to the pandemic, this was held for the first time this year virtually.
During the meeting, CMS provided information on the status of the Prior Authorization program, audits, and answered attendee questions. Regarding audits, CMS shared that it recommended MACs to exempt suppliers that passed a TPE Round from post-pay reviews that are active today for one year. In addition, CMS indicated that post-pay reviews are limited to 20 claims per HCPCS code per NPI per six-months.
CMS also shared that between October 2019-March 2020, approximately 1,365 DMEPOS suppliers completed Round 1 of TPE, 127 DMEPOS suppliers completed Round 3 of TPE, and 694 DMEPOS suppliers were released from reviews due to errors being corrected by education. CMS revealed that A4253 (blood glucose strips) is in the top five topics most referred to CMS due to failure to pass Round 3. Of the 335 total referrals to CMS, A4253 accounts for 43 referrals.
Members should be aware that TPEs are not currently active due to the Public Health Emergency. DME MACs are directed to only conduct post-pay reviews during this time.