Myomo Announces that CMS has Classified the MyoPro Orthosis Under the Brace Benefit Category
02 Novembre 2023 - 3:08PM
Business Wire
Standard Medicare Part B Patients now have
access to the MyoPro, which will be reimbursed on a lump sum
basis
Myomo, Inc. (NYSE American: MYO) (“Myomo” or the
“Company”), a wearable medical robotics company that offers
increased functionality for those suffering from neurological
disorders and upper-limb paralysis, today announced that the
Centers for Medicare & Medicaid Services (CMS) published a
final rule classifying the MyoPro under the brace benefit category.
Braces are paid on a lump sum basis under the Social Security Act.
The finalization of MyoPro’s classification as a brace paid on a
lump sum basis, rather than on a capped rental basis, brings
Medicare payment methodology in line with how all other insurance
plans currently pay for the MyoPro. This rule is expected to be
published in the Federal Register on November 13, 2023 and is
effective on January 1, 2024.
The MyoPro has already been covered and paid on a rental basis
for five Medicare beneficiaries covering all of Medicare’s billing
regions after review of their medical documentation. Future claims
for devices delivered to patients are expected to continue to be
reviewed on a claim-by-claim basis.
Paul R. Gudonis, Myomo’s chairman and CEO, stated, “On behalf of
the many stroke survivors and others with long term muscular
weakness or partial paralysis with Medicare Part B insurance, we
are pleased that CMS has moved forward to facilitate access to the
MyoPro brace. The MyoPro has been shown to be effective for
Medicare beneficiaries with the requisite medical necessity, and
this reclassification is very supportive of CMS’ goal of health
equity for this population.”
A national fee for the MyoPro has not yet been established, so
claims will continue to be paid by the DME MACs at regional rates
until a national fee is determined. In the final rule, CMS states
that it intends to issue a payment determination in conjunction
with its second bi-annual non-drug public meeting to be held later
this year, or at the subsequent bi-annual public meeting in
2024.
About Myomo
Myomo, Inc. is a wearable medical robotics company that offers
improved arm and hand function for those suffering from
neurological disorders and upper-limb paralysis. Myomo develops and
markets the MyoPro product line. MyoPro is a powered upper-limb
orthosis designed to support the arm and restore function to the
weakened or paralyzed arms of certain patients suffering from CVA
stroke, brachial plexus injury, traumatic brain or spinal cord
injury, ALS or other neuromuscular disease or injury. It is
currently the only marketed device that, sensing a patient’s own
EMG signals through non-invasive sensors on the arm, can restore an
individual’s ability to perform activities of daily living,
including feeding themselves, carrying objects and doing household
tasks. Many are able to return to work, live independently and
reduce their cost of care. Myomo is headquartered in Boston,
Massachusetts, with sales and clinical professionals across the
U.S. and representatives internationally. For more information,
please visit www.myomo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
the Company’s future business expectations, including expectations
for the effective date of the final rule, the expectation that
future claims will be evaluated under individual consideration and
the timing for a payment determination by CMS, which are subject to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are only
predictions and may differ materially from actual results due to a
variety of factors.
These factors include, among other things:
- We have a history of operating losses and our financial
statements for the period ended June 30, 2023 include disclosures
regarding there being substantial doubt about our ability to
continue as a going concern;
- our ability to obtain sufficient reimbursement from third-party
payers for our products, including CMS for Medicare Part B
patients;
- our revenue concentration with a particular insurance payer as
a result of focusing our efforts on patients with insurers who have
previously reimbursed for the MyoPro;
- our ability to continue normal operations and patient
interactions without supply chain disruption in order to deliver
and fit our custom-fabricated device;
- our marketing and commercialization efforts;
- our dependence upon external sources for the financing of our
operations, to the extent that we do not achieve or maintain cash
flow breakeven;
- our ability to effectively execute our business plan and scale
up our operations;
- our expectations as to our product development programs,
and;
- general market, economic, environmental and social factors that
may affect the evaluation, fitting, delivery and sale of our
products to patients.
More information about these and other factors that potentially
could affect our financial results is included in Myomo’s filings
with the Securities and Exchange Commission, including those
contained in the risk factors section of the Company’s annual
report on Form 10-K, quarterly reports on Form 10-Q and other
filings with the Commission. The Company cautions readers not to
place undue reliance on any such forward-looking statements, which
speak only as of the date made. Although the forward-looking
statements in this release of financial information are based on
our beliefs, assumptions and expectations, taking into account all
information currently available to us, we cannot guarantee future
transactions, results, performance, achievements or outcomes. No
assurance can be made to any investor by anyone that the
expectations reflected in our forward-looking statements will be
attained, or that deviations from them will not be material or
adverse. The Company disclaims any obligation subsequently to
revise any forward-looking statements to reflect events or
circumstances after the date of such statements or to reflect the
occurrence of anticipated or unanticipated events.
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version on businesswire.com: https://www.businesswire.com/news/home/20231102206028/en/
For Myomo: ir@myomo.com
Investor Relations: Kim Sutton Golodetz LHA Investor Relations
kgolodetz@lhai.com 212-838-3777
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