CMS approves Harrow’s pass-through application for corticosteroid TRIESENCE

Harrow (HROW) announced that the Centers for Medicare & Medicaid Services CMS has approved Harrow’s transitional pass-through application for TRIESENCE or triamcinolone acetonide injectable suspension, 40 mg/mL, a preservative-free synthetic corticosteroid that is approved by the U.S. Food and Drug Administration FDA for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids. Beginning April 1 and for the three years thereafter, TRIESENCE will be eligible for separate reimbursement outside of the surgical bundled payment in both the Ambulatory Surgery Center ASC and Hospital Outpatient Department settings of care. CMS previously approved the issuance of a permanent, product-specific J-Code for TRIESENCE, facilitating reimbursement and access in eyecare professionals’ offices. With this new CMS approval, TRIESENCE becomes the only preservative-free synthetic corticosteroid with separate reimbursement in all traditional settings of care – the eyecare professional’s office, the ASC, and the HOPD. CMS will now separately reimburse TRIESENCE at the Average Sales Price ASP plus 6% in both ASC and HOPD settings. “We sincerely appreciate CMS’s approval of pass-through reimbursement status for TRIESENCE, recognizing its unique value to ophthalmic care,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “Following Harrow’s investment in the restoration of the TRIESENCE supply chain, this decision expands patient access to TRIESENCE, allowing all ophthalmologists, including retina specialists, to return confidently to using an FDA-approved, preservative-free treatment option in lieu of the more dangerous, off-label options they had been forced to use while TRIESENCE was unavailable. This news, which allows for the reimbursement of TRIESENCE in a critical setting of care, increases access to all Medicare beneficiaries and should improve surgical outcomes and patient safety across the country.”