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Background:
On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”. This proposed rule has a two fold agenda: (1) fast tracking Medicare coverage of devices designated as “Breakthrough Devices” (BD) by the Food and Drug Administration (FDA), and (2) proposing regulatory standards to be used in making reasonable and necessary determinations under section 54328 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B. The proposed rule is in alignment with the Trump Administration’s efforts to fast track Medicare beneficiary access to innovative medical devices presented in the “Protecting and Improving Medicare for our Nation’s Seniors” October 3, 2019 Executive Order 13890 (E.O. 13890). This MCIT pathway also has been proposed because of stakeholders’ request to fast track the coverage of BD and because the CMS National Coverage Determination (NCD) process is long and would not provide immediate coverage of BD.
Proposal Highlights:
If finalized, a new coverage pathway called Medicare Coverage of Innovative Technology (MCIT) would provide nationwide coverage for technologies designated as “breakthrough”. It also would include coverage determinations by commercial insurers as a factor in making Medicare coverage determinations in addition to the current definition of “reasonable and necessary” items and services based used by Medicare Administrative Contractors (MACs).
Under the proposed rule, Medicare will provide national coverage for the labeled use of a breakthrough device for four years after FDA approval. If the device does not fit into a Medicare benefit category or if it is not covered by Medicare statute, then the medical device would not have the MCIT pathway option.
MCIT coverage is voluntary and the device manufacturer would need to inform CMS by email of the decision to participate in this initiative. Meetings, and other forms of communication will ensue between CMS and the manufacturers during the MCIT coverage process. CMS will post the names of devices that qualify for MCIT pathway on their website to inform stakeholders of technologies that will be covered through the MCIT pathway. Manufacturers are encouraged to conduct clinical studies during the four-year period to ensure continued Medicare and commercial payer coverage after the four-year period is over. At the end of the four-year period, coverage may vary as follows: 1) positive or negative coverage by an NCD; 2) coverage by MAC decisions.
Comment Details:
CMS is seeking comments on the following key issues:
- the opening of a national coverage analysis if a MAC has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT period.
- the proposed MCIT pathway and the considerations described in the Proposed Rule;
- should any of the existing coverage options be modified to achieve the goals set out by the E.O.,
- alternatives to these proposals?
- should the MCIT pathway also include diagnostics, drugs and/or biologics that utilize breakthrough or expedited approaches at the FDA?
- manufacturer input on whether an opt-in or opt-out approach if the MCIT pathway is found to be burdensome;
- when a manufacturer has opted-out of coverage, they can subsequently opt-in to MCIT.
Public comment can be made to CMS regarding the proposed rule no later than 5 p.m. on November 2, 2020.
For more information, email us at info@girsinc.com or call us at 901-834-9119.
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About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.