This document is a letter submitted in response to a proposed rule from the Centers for Medicare & Medicaid Services regarding Medicare coverage of innovative medical devices designated as breakthrough by the FDA. The letter applauds the proposed rule, which would provide national Medicare coverage starting on the date of FDA market authorization for 4 years. This would help start-up medical device companies commercialize their products after FDA approval and avoid the "Valley of Death" period between approval and reimbursement when patients may go untreated and companies may fail financially. The letter urges CMS to finalize and implement the proposed rule, arguing it would benefit both patients and the medical device industry. It is signed by current and former executives, investors, and advisors in start-up medical

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AVOIDING THE “VALLEY OF DEATH”
October 16, 2020
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention:CMS-3372-P
P.O. Box 8013
Baltimore, MD 21244-8013
RE: Comment on ProposedRule: Medicare Coverage of Innovative Technology
and Definitionof “Reasonable and Necessary”
We are a group of currentand former executives of, investors in or advisors
to start-up and smaller life science and medical device companies with an interest
in new and innovativemedical devices. Individuals areindicated at the end of this
letter.
We are responding to the entry in the Federal Register requesting
comments on the Centers for Medicare & Medicaid Services Proposed Ruleon
Medicare Coverage of InnovativeTechnology (MCIT) and Definition of
“Reasonable and Necessary”.
This proposed rulewould establish a Medicare coveragepathway to
provideMedicare beneficiaries nationwide with faster access to new, innovative
medical devices designated as breakthrough by the Food and Drug Administration
(FDA). After the final rule is effective, the Medicare Coverageof Innovative
Technology (MCIT) pathway would begin national Medicare coverageon the date
of FDA market authorization and would continue for 4 years. Regulatory
standards arealso being proposed to be used in making reasonableand necessary
determinations for use of such devices.
We applaud the leadership on this matter and urge CMS to move
expeditiously to finalize and implement this important proposal. Technologies
that receive a Breakthrough Designation fromthe FDA are thosethat producea
meaningful improvementin quality of care and public health. Accordingly, this
proposed rule is important for patients, particularly, senior citizens, and start-up
and smaller medical device companies because:

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 Start-up and smaller medical device companies have often spent
years and millions of dollars developing their productand having it
approved by the Food & Drug Administration (FDA). The companies
have relied on personalinvestments and financial supportfrom
friends and family and angel investors, often with substantial
personalsacrifice, because they believed in the productand the
positive impact it could haveon patients.
 Getting to the point of FDA approval, after investing years of effort
and millions of dollars, sometimes results in the company’s financial
position requiring quick approvalfor reimbursementof the medical
device to bring the productto market, to benefit patients and to
stabilize the company.
 Unless Medicare or other reimbursementis in place, medical
providers willnot purchaseand use the new medical device. As a
result, patients in need of the device may miss the opportunity to be
adequately medically treated and the medical device company’s
financial position weakens, risking the futurecommercialization and
advancement of the innovative, potentially life-saving technology.
 If a patient does need the medical device and reimbursementdoes
not exist, the patient mustpay for the device, which may be
unaffordable. The patient may need to choosebetween lack of
adequate medical treatment or severe financial consequences,
creating a needless double jeopardy.
The current lag Between FDA approvaland Medicare reimbursementis
often referred to as the “Valley of Death”. During this “Valley of Death”period a
patient may go untreated and potentially die and the medical device company
may not be able to financially survive.
We understand that historically decisions to use medical devices have been
made by the patient and/or doctors, under the guidance of their medical
institution, professionalassociations, and the American Medical Association. We
recommend continuing leaving the decision making on reasonableand necessary
use to the patient’s doctor and the patient since they are familiar with the
specifics of the patient’s condition and the risk of using or not using a medical

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device. The doctor at the patient’s bedside is best able to determine what is
“reasonableand necessary”.
This proposed rulewould accelerate providing new, breakthrough medical
device technology to patients in need and would avoid the “Valley of Death”.
Accordingly, webelieve that this proposed rule is a win/win for patients and the
medical device industry, and we supportthe approvaland adoption of the
proposed rule.
Sincerely yours,
Robert Dickson
Retired CFO
CardiacAssist, Inc. (dba TandemLife)
Partner McCracken Alliance Partners
Peter Stephans
Chairman and CEO
Trigon Holding Inc.
Pete DeComo
Chairman and CEO
ALung Technologies, Inc.
Louis H. Miller Jr.
Managing Director, Life Sciences
Innovation Works
James Jordan
President& CEO
Pittsburgh Life Sciences Greenhouse
Ernest K. Manders, MD
Chief Executive Officer
Promethean LifeSciences, Inc.
Names Submitting Continued on Next Page

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Christian Manders
Chief Operating Officer
Promethean LifeSciences, Inc.
J. Howison Schroeder
Chief Executive Officer
RZ Acquisition, Inc.
Jim Browne
Chairman of the Board
PECA Labs, Inc.
Ned Laubacher
Chair and CEO
PhotoPhageSystems, LLC
and Director Intelomed, Inc.
John Friel
Retired CEO
Medrad, Inc.
Robert Svitek, PhD
VP of R&D, CTO TandemLife
CardiacAssist, Inc. dba TandemLife
Doug Bernstein
CEO
PECA Labs, Inc.
Jamie Quinterno
COO
PECA Labs, Inc.
Matt Burlando
Principal & CFO
Matthew Burlando Advisors MBA LLC