Centers for Medicare and Medicaid Services Accepts Myomo’s Application to Classify the MyoPro® as a Brace
03 Juillet 2023 - 2:30PM
Business Wire
MyoPro expected to be reimbursed by CMS in a
lump-sum payment rather than as a rental should the proposal be
finalized following a 60-day public comment period
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, announces that its request to
the Centers for Medicare and Medicaid Services (“CMS”) to classify
the Company’s MyoPro as a brace has been published for public
comment.
Currently the MyoPro is assigned Healthcare Common Procedure
Coding System (“HCPCS”) billing codes L8701 and L8702, with
coverage based on consideration of each patient’s medical necessity
for the powered arm brace. In June 2022, Myomo presented its appeal
to CMS to change the benefit category of the MyoPro from durable
medical equipment, which is reimbursed as a rental, to a brace,
which has historically been reimbursed in a lump-sum payment. On
June 30, 2023, in conjunction with new proposed rules covering home
health services, CMS issued a proposal that clarifies the
definition of a brace to include newer technologies, including the
MyoPro.
The proposed rule states that the L8701 and L8702 HCPCS codes
are to be classified as a brace. Should the proposed rule be
finalized and should there be no change to how braces are
reimbursed, the MyoPro will be reimbursed on a lump-sum basis by
CMS, which is consistent with the payment approach by private
health insurers. A 60-day public comment period is required before
the proposed rule is finalized. In addition, CMS stated that it
intends to publish a fee for the MyoPro HCPCS codes at an upcoming
public meeting. The next public meeting is expected to be held in
late 2023 or early 2024.
The proposed rule as published in the Federal Register is
available here, and the discussion of the changes to the brace
definition begins on page 289.
“This proposed rule represents the culmination of a multi-year
effort to obtain the proper classification for the MyoPro as a
brace,” stated Myomo’s Chief Executive Officer Paul R. Gudonis. “We
are pleased with this outcome and intend to work with CMS and
others in the orthotics and prosthetics industry to support the
proposed rule, which, if enacted, is expected to support health
equity by providing access to the MyoPro for medically-qualified
Medicare Part B beneficiaries.”
Myomo also announces that its initial claims filed with CMS’
billing contractors, referred to as the DME MACs, are currently
under detailed review by the DME MACs as part of the process of
individual consideration. The Company cannot predict whether the
review of these initial claims will be impacted by the publication
of this proposed rule by CMS.
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 regarding
the Company’s future business expectations, including expectations
for finalization of the proposed rule codifying the change in the
benefit category to a brace and timing for the DME MACs to make a
determination on our initial claims, 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 others:
- We have a history of operating losses and our financial
statements for the period ended March 31, 2023 include disclosure
regarding there being substantial doubt about our ability to
continue as a going concern;
- the after-effects of the novel coronavirus (COVID-19) pandemic
on our business and operations, including fabrication and delivery,
sales, patient consultations, supply chain constraints,
manufacturing, insurance reimbursements and employees;
- our ability to continue normal operations and patient
interactions in order to deliver and fit our custom-fabricated
device;
- our marketing and commercialization efforts;
- our ability to achieve reimbursement from third-party payers
for our products, including CMS for Medicare Part B patients;
- 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/20230703662828/en/
For Myomo ir@myomo.com
Investor Relations Kim Sutton Golodetz LHA Investor Relations
212-838-3777 kgolodetz@lhai.com
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