Ocular Therapeutix™ Announces Update from the Centers for Medicare and Medicaid Services (CMS) for the Reimbursement of DEXTENZA®

Rhea-AI Summary

Ocular Therapeutix announced that the Centers for Medicare and Medicaid Services (CMS) confirmed separate payment for DEXTENZA in 2022 and beyond, enhancing accessibility for patients. The recent OPPS final rule supports DEXTENZA's eligibility as a non-opioid surgical supply. Additionally, the new Category I CPT Code 68841 for DEXTENZA's insertion establishes standard payments of $37.29 in physician offices and $31.58 in outpatient settings, broadening reimbursement coverage. These developments signify important financial and operational milestones for the company.

Positive

• Continued separate payment for DEXTENZA by Medicare enhances patient access and revenue stability.
• Category I CPT Code 68841 ensures standardized payment, resulting in broader reimbursement coverage.
• The FDA's recent approval for DEXTENZA as a treatment for ocular itching may expand its market.

Negative

• None.

DEXTENZA® to Maintain Separate Payment via Pass-Through Payment Status Through 2022

CMS Indicates DEXTENZA Meets Criteria for Separate Payment after Pass-Through Period Ends

BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced that the Centers for Medicare and Medicaid Services (CMS) released its final rules for the Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) for 2022.

The OPPS final rule confirms that DEXTENZA will continue to be separately paid by Medicare in the hospital outpatient department (HOPD) and ambulatory surgical center (ASC) settings for 2022. CMS further indicated that DEXTENZA is eligible to receive separate payment in the ASC setting because it meets the criteria set forth in the non-opioid as a surgical supply provision, which is favorable for 2023 and beyond.

“We believe both the continued separate payment for 2022 and the provision facilitating continued separate payment after that are enormously exciting developments as patients will continue to have access to DEXTENZA and its clinical benefits for the foreseeable future,” said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. “This decision effectively extends the reimbursement horizon for DEXTENZA in the surgical setting while we open a new dawn in the physician office setting with the FDA’s recent approval of DEXTENZA as a treatment for ocular itching associated with allergic conjunctivitis.”

The MPFS final rule establishes payment for Category I Current Procedural Terminology (CPT) Code 68841 which replaces Category III CPT Code 0356T, effective January 1, 2022. The physician payment for the insertion of DEXTENZA in the physician office is $37.29 and in the ASC or the HOPD is $31.58. The Company believes achieving Category I status for the new CPT Code represents an important milestone because Category I codes standardize payment and are more widely accepted by the payer community, resulting in broader coverage.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease in Phase 2 clinical trials. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company’s product candidates; the commercial launch of, and the effectiveness of and amounts applicable to reimbursement codes for, DEXTENZA; the conduct of post-approval studies of and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI for the treatment of retinal diseases including wet AMD; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company’s product candidates; the potential benefits and future operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; potential market sizes for indications targeted by the Company’s product candidates, if approved; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to successfully develop and commercialize products for the ophthalmology office setting, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the Company’s ability to generate its projected net product revenue and in-market sales on the timeline expected, if at all, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, any additional financing needs and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211105005537/en/

Investors

Ocular Therapeutix

Donald Notman

Chief Financial Officer

dnotman@ocutx.com

or

ICR Westwicke

Chris Brinzey, 339-970-2843

Managing Director

chris.brinzey@westwicke.com

Media

Ocular Therapeutix

Scott Corning

Senior Vice President, Commercial

scorning@ocutx.com

Source: Ocular Therapeutix, Inc.

FAQ

What did the CMS decision mean for Ocular Therapeutix's DEXTENZA?

The CMS confirmed that DEXTENZA will continue to receive separate payment in 2022 and beyond, enhancing patient access and potential revenue.

What is the new payment rate for DEXTENZA as per the 2022 MPFS?

The payment rate for DEXTENZA insertion is $37.29 in physician offices and $31.58 in ambulatory surgical centers.

How does the new Category I CPT Code benefit DEXTENZA?

The new Category I CPT Code 68841 standardizes payment, leading to broader reimbursement coverage by payers and facilitating easier access.

What are the implications of the CMS ruling for 2023 and beyond?

The CMS ruling indicates that DEXTENZA will continue to be eligible for separate payment in future years, ensuring ongoing access for patients.

What recent approval was announced for DEXTENZA?

The FDA recently approved DEXTENZA as a treatment for ocular itching associated with allergic conjunctivitis, potentially increasing its market reach.