Myomo Receives Medicare Part B Reimbursement for First MyoPro® Claims
24 Août 2023 - 10:05PM
Business Wire
Appropriate payment amounts received on
two MyoPro claims; Additional claims are under review while CMS
rulemaking to re-classify the MyoPro to the brace benefit category
progresses
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 it has
received payments for two claims submitted for MyoPro® arm braces
provided to Medicare fee-for-service beneficiaries.
Myomo recently delivered the custom-fabricated MyoPro braces to
these two patients. After review of the medical documentation, one
of Medicare’s billing contractors, referred to as a DME MAC, has
covered and paid for these two claims. Because MyoPro currently is
in the durable medical equipment (DME) rental benefit category,
these payments were paid under the capped rental program, which
reimburses for devices over 13 months.
In June of this year, the Centers for Medicare & Medicaid
Services (CMS) issued a proposed rule that codifies the definition
of a brace and includes orthoses/braces such as the MyoPro. Public
comments are due by August 29, 2023. If the proposed rule is
finalized as proposed, MyoPro braces provided to Medicare Part B
beneficiaries will be paid on a lump sum basis, as other braces are
currently reimbursed. The timing to finalize this new rule and the
publication of an allowable fee are dependent on CMS’s internal
process and any future public meetings on this subject.
Paul R. Gudonis, Myomo’s chairman and CEO, stated, “This is a
positive step forward as we have been working collaboratively with
the CMS staff and DME MAC medical directors to enable Medicare Part
B beneficiaries to have access to the MyoPro if it is medically
necessary for them. We are pleased to see appropriate coverage and
payment for these valuable braces that increase the quality of life
and improve health outcomes for those impaired due to stroke and
other neurological conditions.”
Myomo has additional MyoPro claims currently under review by the
DME MACs. The company will continue to work with CMS and the DME
MACs to allow Medicare Part B beneficiary access to the MyoPro and
will keep patients and other interested stakeholders informed on
our progress in the coming months.
About Myomo, Inc.
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 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 Germany, and other
representatives internationally. For more information, please visit
www.myomo.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including those regarding the Company’s expectations related to
reimbursement for its MyoPro product and the outcome and impact of
the proposed rulemaking by CMS, , which is 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 achieve reimbursement from third-party payers
for our products, including CMS for Medicare Part B patients;
- our ability to continue to serve patients with Medicare
Advantage insurance plans if CMS does not cover the MyoPro;
- 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 and
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/20230824757458/en/
For Myomo: ir@myomo.com
Investor Relations: Kim Sutton Golodetz LHA Investor Relations
212-838-3777 kgolodetz@lhai.com
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