UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01 Other Events.
On September 26, 2022, the Centers for Medicare and Medicaid Services ("CMS") issued final benefit category and payment determinations for its first semi-annual coding cycle for Level II Healthcare Common Procedure Coding System ("HCPCS") codes, which were requested by applying companies and presented at the HCPCS public meeting in June 2022. Myomo (the "Company") presented its request for a benefit category change for its MyoPro products at that public meeting. The Company requested that CMS reclassify the MyoPro as a brace, which is reimbursable on a lump sum basis, rather than its existing classification as durable medical equipment, which is reimbursable on a rental basis. In its determinations, CMS stated that it needs more time to evaluate the scope of the benefit for arm and leg braces generally and elected not to make a determination at this time on the Company's benefit category change application. The full text of CMS' final determinations has been published and is available from CMS.
In rulemaking, CMS has indicated that benefit category determinations under complex circumstances can take several months until a subsequent coding cycle, which in this case began in July 2022. Final determinations from the current coding cycle are expected to be published by CMS during the first quarter of 2023.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MYOMO, INC. |
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Date: |
September 27, 2022 |
By: |
/s/ David A. Henry |
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Name: Title: |
David A. Henry |