CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath
CorMedix announced that CMS has granted pass-through status to DefenCath under the Out-Patient Prospective Payment System (OPPS). This status allows for separate Medicare Part B payments for DefenCath for at least two years, and up to three years, in outpatient settings. DefenCath, a combination of taurolidine and heparin, is used to reduce catheter-related bloodstream infections (CRBSI) in chronic hemodialysis patients using central venous catheters. The company estimates around 100,000 HD-CVC placements annually, highlighting the importance of reimbursement for DefenCath to prevent CRBSIs. However, DefenCath is contraindicated in patients with heparin-induced thrombocytopenia or hypersensitivity to any of its components.
- CMS pass-through status allows separate Medicare Part B payments for DefenCath for two to three years.
- DefenCath targets a critical need by reducing CRBSIs in chronic hemodialysis patients using central venous catheters.
- CorMedix estimates around 100,000 HD-CVC placements annually, indicating a significant market opportunity.
- DefenCath is indicated for a population, which could limit market reach.
- The drug is contraindicated in patients with heparin-induced thrombocytopenia or hypersensitivity to its components, potentially limiting its usability.
- No financial figures, revenue projections, or clinical data updates were provided in the PR, leaving financial impacts unclear.
Insights
The granting of pass-through status by the CMS for CorMedix's DefenCath is a significant event for the company's financial outlook. This status means DefenCath will receive separate payments under Medicare Part B for up to three years, directly impacting CorMedix's revenue stream. Given the annual estimate of 100,000 hemodialysis catheter placements, this separate reimbursement can lead to substantial revenue increments, especially in the out-patient ambulatory setting. Moreover, the predictable revenue stream could also positively influence the company's stock price, as investors often react favorably to clear pathways for revenue growth.
From a short-term perspective, the market might respond positively due to the immediate financial benefits and the assurance of reimbursement. Long-term effects include enhanced market penetration and sustained revenue growth, which could improve the company's valuation and attract more institutional investors.
The pass-through status for DefenCath provides a unique advantage in the medical landscape. DefenCath, which reduces catheter-related bloodstream infections (CRBSIs) in dialysis patients, will now be more accessible in the outpatient setting. This not only improves patient care by potentially reducing infection rates but also aligns with the current healthcare trend of minimizing inpatient procedures when possible. The separate reimbursement under Medicare Part B ensures that healthcare providers are compensated adequately, encouraging the adoption of DefenCath in clinical practice.
Furthermore, the medical community will likely perceive this as a validation of DefenCath’s clinical efficacy and safety profile, fostering trust and wider acceptance among practitioners. The implications for stakeholders include better clinical outcomes and a potential reduction in healthcare costs associated with managing CRBSIs.
BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years.
While vascular access for hemodialysis can be initiated in an inpatient setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-based alternative for patients. The company estimates that up to 100,000 HD-CVC placements occur each year, and pass-through status ensures that providers are reimbursed separately for administration of DefenCath in this setting of care. Given that approximately
DefenCath® (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION
These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.
LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.
DefenCath is contraindicated and has warnings and precautions in patients with:
- Known heparin-induced thrombocytopenia (HIT).
- Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.
If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see the full Prescribing Information.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576
FAQ
What is the significance of CMS granting pass-through status to DefenCath?
What patient population is DefenCath intended for?
How many HD-CVC placements occur annually according to CorMedix?
What should healthcare providers be aware of regarding DefenCath's safety?
