Advanced Medical Technology Association Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, Nov. 23 -- Donald L. May, executive vice president for payment and health care delivery policy at the Advanced Medical Technology Association, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary". The comment was written on Nov. 2, 2020, and posted on Nov. 12, 2020:

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The Advanced Medical Technology Association (AdvaMed) is pleased to offer comments on the Centers for Medicare & Medicaid Services' (CMS) proposed rule on Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary."/1

AdvaMed has long supported a swift and streamlined approach to Medicare coverage of innovative medical devices and diagnostics that improve health outcomes for patients with debilitating or life-threatening illnesses, and we commend CMS for taking this important step.

AdvaMed's member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

In 2016, Congress enacted the 21st Century Cures Act,/2 which among other things advanced medical device innovation by creating a new Food and Drug Administrative (FDA) program to expedite the development of diagnostics and devices that represent breakthrough technologies and to promote their use in health care delivery. At that time, Congress did not include provisions that would have created a streamlined approach to coverage, coding and payment for those innovations.

However, in its fiscal year (FY) 2020 Hospital Inpatient Prospective Payment System (IPPS) final rule, CMS provided for an alternative new technology add-on payment (NTAP) pathway for breakthrough technologies, deeming such technologies to meet criteria for newness and substantial clinical improvement and thus to automatically qualify for NTAP if the cost criterion was also met.

In the calendar year (CY) 2020 Hospital Outpatient Prospective Payment System (OPPS) final rule, CMS provided for an alternative transitional pass-through payment (TPT) for breakthrough technologies, deeming such technologies to meet the substantial clinical improvement and thus to automatically qualify for TPT payment if the newness and cost criteria are also met. Later that year, the October 13, 2019, Executive Order 13890 (E.O. 13890) directed the Secretary to issue proposals that would encourage innovation for patients, including such streamlined approaches.

We applaud these efforts by CMS to recognize the importance of new innovations and the role they play in improving the lives of patients with debilitating illness. The MCIT proposed rule represents CMS's continuing commitment to ensuring Medicare beneficiaries have access to new and innovative technologies that improve health and outcomes.

Overarching Recommendations:

AdvaMed strongly supports the MCIT pathway proposal for FDA-designated breakthrough technologies and urges CMS to finalize the MCIT portion of the proposed rule as quickly as possible. In the final rule, CMS should make clear that the MCIT pathway applies to diagnostic tests. The MCIT provisions are critical for Medicare beneficiary access to breakthrough devices and diagnostics.

Combined with the new breakthrough pathway for inpatient NTAP and outpatient TPT payment, MCIT will help to spur future advancements in patient care because CMS is sending a signal to the entire innovation ecosystem that taking the risk to develop new breakthroughs will be rewarded if those devices receive FDA marketing authorization and improve patient care.

While AdvaMed appreciates CMS's efforts to clarify its definition of "reasonable and necessary" for Medicare beneficiaries, we oppose codification of the proposed definition at this time. Should CMS wish to proceed, it should initiate a more extensive dialogue using an open and transparent process that includes multiple opportunities for stakeholder input and consideration.

Additionally, given key differences between the coverage determination process used by CMS compared to private health plans, AdvaMed opposes and has serious concerns with the proposal to include an analysis of commercial insurance coverage policies as part of the definition of reasonable and necessary when determining Medicare coverage. Commercial insurance coverage decisions lack transparency and processes for stakeholder engagement and are not appropriate for inclusion in Medicare's reasonable and necessary definition.

AdvaMed recommends that CMS move quickly to finalize the MCIT provisions of the rule with the clarifications and refinements below; and we urge CMS to withdraw its proposal to codify the definition of reasonable and necessary.

View full comment at: https://www.regulations.gov/contentStreamer?documentId=CMS-2020-0098-0280&attachmentNumber=1&contentType=pdf

Sincerely,

Donald L. May

Executive Vice President

Payment & Health Care Delivery Policy

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Footnotes:

1/ Federal Register, Vol. 85, No. 170, pp. 54327-39, September 1, 2020.

2/ P.L. 114-255, December 13, 2016.

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0098-0002

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