CMS revokes Novocure (NASDAQ: NVCR) billing, putting about $13M monthly revenue at risk

Rhea-AI Filing Summary

Novocure Limited reported that its U.S. subsidiary’s Centers for Medicare & Medicaid Services (CMS) billing privileges were revoked retroactive to December 17, 2025 due to an administrative issue with triannual re-validation, not a substantive qualification failure. The company has filed a Corrective Action Plan and expects billing to be reinstated but cannot predict the timing or final outcome. During the suspension, Novocure continues treating existing and new patients but cannot bill Medicare, Medicare Advantage and other CMS-related programs, and estimates it cannot recognize approximately $13 million per month in revenue from these payors. The company intends to bill for services provided once privileges are restored but cannot estimate how much, if any, will ultimately be recoverable.

Positive

• None.

Negative

• CMS billing privileges revoked with significant revenue disruption: CMS revoked Novocure’s U.S. billing privileges retroactive to December 17, 2025, leading to an estimated loss of about $13 million per month in recognizable revenue from CMS payors, with timing of reinstatement and ultimate financial impact currently undetermined.

Insights

Healthcare policy and reimbursement analyst

CMS billing halt disrupts Novocure’s U.S. reimbursement with material revenue at risk.

Novocure disclosed that CMS revoked its U.S. subsidiary’s billing privileges retroactive to December 17, 2025 over an administrative re-validation issue, not a substantive qualification failure. Even so, the company cannot bill Medicare, Medicare Advantage and related programs while reinstatement is pending.

Novocure estimates it cannot recognize about $13 million per month in revenue from CMS payors during this period. Management has submitted a Corrective Action Plan and expects reinstatement but cannot predict the timing, the ultimate outcome, or how much of the interrupted revenue will be billable later, if any.

The company continues providing services to existing and new patients despite the reimbursement disruption. Subsequent disclosures in company filings will be needed to clarify when CMS billing is restored and how much of the deferred CMS-related revenue, if any, is ultimately collected.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

January 30, 2026

Date of Report (date of earliest event reported)

NovoCure Limited

(Exact name of registrant as specified in its charter)

Jersey			001-37565						98-1057807
(State or other jurisdiction of incorporation or organization)			(Commission File Number)						(I.R.S. Employer Identification No.)
No. 4 The Forum, Grenville Street			St. Helier			Jersey			JE2 4UF
(Address of Principal Executive Offices)									(Zip Code)

+44 (0) 15 3475 6700

Registrant's telephone number, including area code

(Former name or former address, if changed since last report.)

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 (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Ordinary Shares, no par value			NVCR			The Nasdaq Stock Market LLC

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.

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Item 7.01     Regulation FD Disclosure.

On January 30, 2026, the registrant's U.S. subsidiary, Novocure Inc. (the "Company") received a letter dated January 29, 2026 from the Centers for Medicare & Medicaid Services ("CMS") that the Company's billing privileges for its products were revoked retroactive to December 17, 2025. The Company was cited for an administrative process issue relating to the Company's triannual re-validation and not due to a substantive failure on the Company's part to qualify for re-validation.

The Company has filed a Corrective Action Plan with CMS and expects billing privileges to be reinstated; however, the Company is currently unable to predict with reasonable certainty when this will occur. While the reinstatement process is pending, the Company is continuing to provide services to existing patients and accept new patients. Until the Company reestablishes billing privileges, the Company is not permitted to bill Medicare, Medicare Advantage and other CMS-related programs ("CMS Payors") payors for services rendered from the date of revocation.

Based on historical patterns, the Company estimates it will not be able to recognize revenue of approximately $13 million per month from CMS Payors until billing privileges are reinstated. Once reinstated, the Company will attempt to bill CMS Payors for services rendered during the reinstatement process; however, it is unable to predict with reasonable certainty to what extent such amounts will be billable, if any. The ultimate outcome, timing of resolution and financial impact cannot be determined at this time.

The information contained in this Current Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this report may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Item 9.01 Financial Statements and Exhibits

(d)    Exhibits

Exhibit No.			Description
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

NovoCure Limited

(Registrant)

Date: February 5, 2026

By: /s/ Christoph Brackmann

Name: Christoph Brackmann

Title: Chief Financial Officer

FAQ

What did Novocure (NVCR) disclose about its CMS billing status?

Novocure disclosed that CMS revoked its U.S. subsidiary’s billing privileges retroactive to December 17, 2025 due to an administrative triannual re-validation issue. The company has filed a Corrective Action Plan and expects reinstatement but currently cannot predict the timing or final outcome.

How much revenue does Novocure (NVCR) estimate is affected by the CMS action?

Novocure estimates it cannot recognize approximately $13 million per month in revenue from Medicare, Medicare Advantage and other CMS-related payors while billing privileges are suspended. This estimate reflects historical patterns but the ultimate financial impact and recoverability of this revenue remain uncertain.

Is Novocure (NVCR) still treating patients during the CMS billing suspension?

Yes, Novocure continues providing services to existing patients and accepting new patients even though CMS billing is suspended. The company currently cannot bill Medicare, Medicare Advantage and other CMS-related programs for services rendered from the revocation date until billing privileges are reinstated.

Why were Novocure’s (NVCR) CMS billing privileges revoked?

The revocation arose from what Novocure describes as an administrative process issue related to its triannual re-validation, rather than a substantive failure to qualify. CMS’s action applies retroactively to December 17, 2025, affecting the company’s ability to bill CMS-related payors during this interval.

Can Novocure (NVCR) bill CMS for services once privileges are reinstated?

Novocure plans to attempt billing Medicare, Medicare Advantage and other CMS-related programs for services provided during the suspension once privileges are reinstated. However, the company states it cannot predict with reasonable certainty how much of these amounts will be billable, if any.

What uncertainty did Novocure (NVCR) highlight about the CMS issue’s impact?

Novocure emphasized that the ultimate outcome, timing of resolution and overall financial impact of the CMS billing revocation cannot be determined at this time. This uncertainty includes whether and to what extent deferred CMS-related revenue during the suspension period will ultimately be collectible.