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Masimo Issues Public Comment on Centers for Medicare & Medicaid Services Rule

Targeted News Service - 6/12/2021

WASHINGTON, June 12 -- Paul M. Ordal, vice president for government relations and public policy at Masimo, Irvine, California, has issued a public comment on the Centers for Medicare and Medicaid Services rule entitled "Medicare Program: Coverage of Innovative Technology and Definition of Reasonable and Necessary; Delay of Effective Date; Public Comment Period". The comment was written on April 16, 2021, and posted on June 7, 2021:

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Masimo appreciates the opportunity to provide additional comments on the Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" proposed rule. We applaud the Centers for Medicare & Medicaid Services (CMS) for moving expeditiously to establish the MCIT pathway to provide beneficiaries nationwide access to new and innovative medical devices more rapidly. We strongly urge CMS to continue this progress by implementing the final MCIT rule without delay to provide timely access to life-saving treatments for the Medicare population.

BACKGROUND

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative sensors, patient monitors, and automation and connectivity solutions. Masimo's mission is to increase patient safety, improve patient outcomes and reduce the cost of care. Masimo was one of eight companies selected by the Food and Drug Administration (FDA) for its Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder,/1 because of our innovative remote physiologic monitoring and intervention technology aimed at preventing harm from opioid overdoses.

The impact of opioid overdoses has been tragic. Opioid Induced Respiratory Depression is responsible for more than 200,000 deaths nationwide since 2015. During the first 8 months of 2020, a total of 31,651 Medicare Part D beneficiaries had an opioid overdose. As the Medicare population is at higher risk, this breakthrough technology that will help reduce harm from opioid overdoses is a perfect example of why MCIT is such an important initiative, and why implementing it as soon as possible is essential to save lives./2

DISCUSSION

CMS Question: The MCIT pathway would address uncertainty in Medicare coverage for newly FDA market-authorized breakthrough devices. While the rule would eliminate coverage uncertainty early after FDA market authorization and automates coverage "so that innovative products are brought to market faster," the rule did not directly address operational issues, such as how the agency would establish coding and payment levels for particular devices, which are both central to prompt market access. How should CMS resolve the operational issues, such as benefit category determinations, coding, and payment levels?

Masimo Response: Given the stated purpose of the rulemaking of ensuring Medicare beneficiaries have access to new and improved breakthrough technologies more rapidly, CMS should implement the rule expeditiously. It is imperative for the MCIT program to go into effect as soon as possible. Any operational issues can be swiftly addressed after implementation of the rule.

CMS Questions: Would commenters have raised additional concerns if there had been an opportunity to comment on the DMEPOS payment and MCIT rules at the same time? Does the proposal for benefit category determinations for DMEPOS provide a model that would be workable for breakthrough devices eligible for MCIT coverage?

Masimo Response: We believe the comment period was sufficient and that the MCIT pathway, its possible impact, advantages and disadvantages were appropriately discussed and considered in this rulemaking such that the program should go into effect on May 15, 2021. We do not believe any of the DMEPOS issues noted warrant a delay in the start of the MCIT pathway.

CMS Question: Was the assumption about the potential volume of FDA breakthrough devices flawed such that the public did not have a meaningful opportunity to comment on the proposed rule?

Masimo Response: We note that some of the devices that received breakthrough status may not receive FDA clearance; others may not apply for MCIT as they already have clear coverage pathways, and others may not fit within the current benefit categories, excluding them from the MCIT pathway.

We believe the comment period was sufficient and that the final rule represents the intent behind this initiative; therefore, immediate implementation of the file rule is appropriate. The MCIT Program followed Executive Order 13890, "Protecting and Improving Medicare for Our Nation's Seniors," which directed the Secretary to "propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients" including by "streamlining the approval, coverage, and coding process." The intent of the program was to ensure that our seniors have access to lifesaving innovative technologies.

CMS Question: Do the revisions in the MCIT final rule adequately address the public's concern of clinical benefit to the Medicare population?

Masimo Response: We believe the final rule adequately addresses the need for the Medicare population to have access to innovative technologies and applaud CMS for all of the diligent work to advance this rule. Any delay in the implementation of the final rule will prevent seniors from receiving the life-saving benefits of these innovative technologies.

To illustrate this point, please note that the opioid crisis has been classified an epidemic. While progress has been made to address a rising death toll caused by opioids, major gaps in protection against opioid risks for older adults remain. 31,651 Medicare beneficiaries suffered an opioid overdose in the first 8 months of 2020./3

Medicare currently pays for one-third of [all?] opioid related hospital stays./4

The Department of Health and Human Services Office of Inspector General (HHS OIG) recommended that steps be taken to mitigate the risk of misuse and overdose in Medicare beneficiaries.

Multiple federal agencies have contributed to plans and possible solutions to support better patient outcomes and prevent further harm and deaths from opioid overdoses. As part of this effort, the FDA established the Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder (OUD). Eight companies were selected out of 250 and Masimo's monitoring device received breakthrough device designation from the FDA in early 2019. These types of lifesaving devices are eagerly awaiting the implementation of MCIT and are in alignment with Executive Order 13890, "Protecting and Improving Medicare for Our Nation's Seniors."

We understand that medical technology must be a part of any strategy to prevent opioid overdose and death. The MCIT pathway will benefit Medicare beneficiaries by providing much-needed access to innovative care, as well as generating real-world clinical data that will help improve care for this vulnerable patient population.

CMS Question: Did the public have adequate opportunity to comment on the proposed rule? In the final rule, did CMS adequately respond to objections to the proposed rule, including whether interested parties had fair opportunities to present contrary facts and arguments that may help to improve the final rule?

Masimo Response: We believe that the comment period was sufficient, and that immediate implementation of the final rule is appropriate. This program was specifically set up to ensure that these breakthrough devices are available to the Medicare population.

In the final rule, CMS provided a thoughtful examination of the safeguards in the four-year period of coverage that will provide ongoing analysis and transparency. For example, the four-year period will enable continued data collection and evidence development for improved health outcomes for Medicare patients. This will help support coverage through other mechanisms after MCIT and provide critical information to physicians and patients about the most appropriate treatment for specific conditions. Further, to provide increased transparency about the program, the public will be able to review all devices that are covered through the MCIT pathway on the CMS website.

CONCLUSION

Masimo applauds CMS for taking such a meaningful step to ensuring access to innovative technologies for Medicare beneficiaries and urges swift implementation of the final rule.

Sincerely,

Paul M. Ordal

Vice President, Government Relations and Public Policy

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Footnotes:

1/ See FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, FDA.gov, https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm (last visited Oct. 6, 2020).

2/ https://oig.hhs.gov/oei/reports/OEI-02-20-00400.pdf

3/ https://oig.hhs.gov/oei/reports/OEI-02-20-00400.pdf

4/ https://innovation.cms.gov/innovation-models/value-in-treatment- demonstration#:~:text=Medicare%20has%20experienced%20the%20largest,of%20opioid%2Drelated%20hospital%20stay s

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The rule can be viewed at: https://www.regulations.gov/document/CMS-2020-0098-0347

TARGETED NEWS SERVICE (founded 2004) features non-partisan 'edited journalism' news briefs and information for news organizations, public policy groups and individuals; as well as 'gathered' public policy information, including news releases, reports, speeches. For more information contact MYRON STRUCK, editor, editor@targetednews.com, Springfield, Virginia; 703/304-1897; https://targetednews.com