Medical Device Manufacturers Association Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, Nov. 28 -- Mark Leahey, president and CEO of the Medical Device Manufacturers 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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On behalf of the Medical Device Manufacturers Association (MDMA), a national trade association representing the innovative sector of the medical device market, we appreciate the opportunity to provide the following comments to the proposed rule on coverage for breakthrough medical devices and the definition of "reasonable and necessary" for purposes of determining coverage./1

As stated in the preamble to the proposed rule, the Administration and Centers for Medicare & Medicaid Services (CMS) are "committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes."/2

Furthermore, CMS is issuing the proposed rule as part of its effort to implement the Administration's policy set forth in Section 6 of the President's Executive Order (E.O.) on Protecting and Improving Medicare for Our Nation's Seniors (E.O. 13890)./3

We enthusiastically support the Administration's objectives as laid out in Section 6. Minimizing the time between the receipt of marketing authorization from the Food and Drug Administration (FDA) and the completion of the coverage, coding and payment changes needed to effectuate patient access will improve the health of Medicare beneficiaries and encourage investment in more technologies that will drive continued improvements in patient outcomes.

We appreciate the careful work that has gone into developing this proposed rule, as well as the opportunity to provide these comments on behalf of the hundreds of medical technology innovators who are members of MDMA.

General Comments

We believe it is important to note up front that the proposed rule includes two separate and distinct proposals--the establishment of a four-year period of automatic coverage for medical devices upon receipt of market authorization from the FDA for any device designated by the FDA as a "breakthrough device"; and, separately, the codification in regulation of a definition of "reasonable and necessary" for purposes of determining Medicare coverage of an item or service. Furthermore, the latter proposal can be further divided into two distinct parts--the codification of the longstanding definition of reasonable and necessary, and the proposed use of coverage policies from insurers in the commercial market as determinative in evaluating whether a particular item or service meets certain requirements set forth in the definition. In developing the final rule, MDMA urges CMS to evaluate each of these distinct proposals independently, and to move forward expeditiously with adopting those parts with broad stakeholder support, while rejecting or allowing for additional consideration of parts for which there is substantial stakeholder opposition or unresolved questions.

In addition, the final rule should be consistent with the intent of E.O. 13890, which is to expand access to innovative medical therapies for Medicare beneficiaries. As will be described below in our detailed comments, we are concerned that certain proposals could actually adversely impact access for Medicare beneficiaries in ways that are both direct (e.g., by imposing coverage limits from the commercial market that otherwise would not have been adopted by CMS for Medicare beneficiaries) and indirect (e.g., by overburdening the coverage determination process in a way that delays the development of local and national coverage policies.)

We appreciate the clarity with which CMS set forth specific requests for comment in the proposed rule, especially with regard to the proposed MCIT coverage pathway. While there is some overlap between some of the requests, to the extent possible we have organized our comments to address each specific question regarding the MCIT pathway in the order they are raised in the proposed rule. With regard to the definition of reasonable and necessary, we have organized our comments around the two general questions that are presented by the proposed rule: the codification of the definition and the use of commercial coverage policies by CMS and Medicare Administrative Contractors (MACs) in making coverage determinations.

Conclusion

Thank you for your leadership on this important issue as well as for the opportunity to provide comments on this important proposal.

We appreciate the efforts of the Administration and CMS to enhance access to new medical technologies, providing more therapeutic options for Medicare beneficiaries and providers and improving outcomes.

MDMA looks forward to working with CMS as it develops the final rule. If we can be of any further assistance, please contact me at mleahey@medicaldevices.org or (202) 354-7171.

View full comment at: https://www.regulations.gov/contentStreamer?documentId=CMS-2020-0098-0242&attachmentNumber=1&contentType=pdf

Sincerely,

Mark Leahey

President and CEO

Medical Device Manufacturers Association

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Footnotes:

1/ 85 Fed. Reg. 54327-54339 (Sep. 1, 2020).

2/ Id. at 54328.

3/ E.O. 13890 (Oct. 3, 2019) (https://www.whitehouse.gov/presidential-actions/executive-order-protectingimproving-medicare-nations-seniors/) Section 6 of EO provides that "Within 1 year of the date of this order, the Secretary shall propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients by:

"(a) streamlining the approval, coverage, and coding process so that innovative products are brought to market faster, and so that such products, including breakthrough medical devices and advances in telehealth services and similar technologies, are appropriately reimbursed and widely available, consistent with the principles of patient safety, market-based policies, and value for patients. This process shall include:

"(i) adopting regulations and guidance that minimize and eliminate, as appropriate, the time and steps between approval by the Food and Drug Administration (FDA) and coverage decisions by the Centers for Medicare and Medicaid Services (CMS);

"(ii) clarifying the application of coverage standards, including the evidence standards CMS uses in applying its reasonable-and-necessary standard, the standards for deciding appeals of coverage decisions, and the prioritization and timeline for each National Coverage Determination process in light of changes made to local coverage determination processes; and "(iii) identifying challenges to the use of parallel FDA and CMS review and proposing changes to address those challenges[.]"

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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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