Business
CorMedix Inc. Announces Commercial and Reimbursement Updates
BERKELEY HEIGHTS, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
About this update from Cormedix Inc.
[{"type":"text","content":"BERKELEY HEIGHTS, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced updates related to its business and anticipated launch of DefenCath®. Recent Updates: On January 25, 2024 the Center for Medicare & Medicaid Services (CMS) notified CorMedix that the agency has determined DefenCath will be eligible for reimbursement in accordance with the ESRD PPS. As such, CorMedix is entitled to submit an application for a Transitional Drug Add-On Payment (TDAPA) which currently allows for five years of additional payment reimbursement to outpatient providers. CorMedix submitted its TDAPA application on January 26th after receiving the CMS notification, and CMS has subsequently confirmed receipt.As a result of CMS’ determination that DefenCath is within the scope of the ESRD PPS and eligible for TDAPA, CorMedix has established its list price (WAC) of $249.99 per 3ml vial, to account for the market dynamics and functionality of the TDAPA framework. Should CMS make a future determination that DefenCath is eligible for Medicare Part B reimbursement, CorMedix has committed to CMS to reduce the list price accordingly.CorMedix previously applied for and received a New Technology Add-On Payment (NTAP) from CMS for inpatient reimbursement of DefenCath. Now that the company has established a WAC price for commercialization, CorMedix will notify CMS accordingly to make any necessary adjustment to the NTAP reimbursement payment to inpatient facilities.CorMedix reiterates its previously disclosed launch guidance of April 15, 2024 for inpatient commercialization, and a target of July 1, 2024 for the commencement of outpatient commercialization. The outpatient timing is contingent upon CMS approval and implementation of the DefenCath TDAPA application in accordance with the agency’s publicly stated objective that CMS aims for an effective date for applying the TDAPA for a particular product that is one quarter after the effective date of the HCPCS code for the product. If CMS requires additional time for the implementation of TDAPA, outpatient commercialization could be shifted an additional quarter. CorMedix intends to work closely with CMS on the TDAPA i...