Myomo Provides Update on Progress to Obtain Medicare Part B Reimbursement for MyoPro
December 07 2022 - 5:00PM
Business Wire
Company to begin submitting claims after
meeting with DME MAC medical directors in 2023
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 reported progress and
next steps in the process to obtain Medicare Part B reimbursement
for the MyoPro® as a brace from the Centers for Medicare &
Medicaid Services (CMS).
As background, Myomo was issued Healthcare Common Procedure
Coding System (HCPCS) codes L8701 and L8702 by CMS, which became
effective January 1, 2019. At that time, CMS classified the MyoPro
as durable medical equipment, or DME, which is reimbursed on a
13-month capped rental basis. Since 2019, the Company has been in
discussions with CMS to change the benefit category designation
from DME to an orthosis, or brace, which for Medicare Part B
patients would be reimbursed in a single payment. While these
discussions have been taking place, no fee schedule rate has been
set by CMS for the MyoPro.
After a new rule was issued by CMS in early 2022, which defined
the process for requesting benefit category changes, the Company
presented its request to change the benefit category at a CMS
public meeting in June 2022. In September 2022, CMS announced that
more time was required to evaluate this issue, stating that in the
meantime coverage and payment for the MyoPro would be at the
discretion of Medicare’s administrative billing contractors,
referred to as the DME MACs. The information on CMS’ decision is
available here.
While a formal benefit category determination change is pending,
the Company plans to request a meeting with the medical directors
of the DME MACs and to begin submitting claims for Medicare Part B
beneficiaries after these discussions in the first part of
2023.
“MyoPro’s are custom fabricated for long-term, individual
patient use and, as such, do not fit the DME rental classification.
We are committed to bringing the benefits of the MyoPro brace to
clinically qualified Medicare Part B beneficiaries, to supporting
health equity with broader access and to securing appropriate
payment for Myomo,” said Paul R. Gudonis, Myomo’s Chairman and
Chief Executive Officer. “We believe that obtaining designation for
the MyoPro as a brace or orthosis will expand our addressable
market, provide for a faster revenue cycle and allow us to more
efficiently process inquiries from clinicians and patients who have
Medicare Part B coverage.”
Myomo plans to submit for publication in peer-reviewed medical
journals the findings from two research studies that are currently
in process, which are expected to add to existing evidence that the
MyoPro is effective, reasonable, necessary and appropriate for
Medicare beneficiaries. This research is expected to be published
during the first quarter of 2023. Currently, many major payers –
including certain Medicare Advantage and commercial insurers, the
Veterans Health Administration, the Bureau of Workers Compensation
and certain state Medicaid plans – cover the MyoPro and pay for the
brace in a lump-sum payment.
At this time Myomo cannot provide any assurance that CMS will
change the benefit category for the MyoPro to a brace, pay claims
submitted for medically qualified patients or the timing of such
payments.
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 the impact on the Company’s business from a change in the
benefit category to a brace and the timing and impact of the
publication of additional research on the MyoPro 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 September 30, 2022 include
disclosure regarding there being substantial doubt about our
ability to continue as a going concern;
- the direct and indirect impact of the novel coronavirus
(COVID-19) on our business and operations, including fabrication
and delivery, sales, patient consultations, supply chain,
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/20221207005885/en/
For Myomo: ir@myomo.com
Investor Relations: Kim Sutton Golodetz LHA Investor Relations
212-838-3777 kgolodetz@lhai.com
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