CorMedix Inc. Supports CMS Policy Updates Regarding Access to Innovative Drug Products

Rhea-AI Summary

CorMedix welcomes significant CMS policy updates that will enhance hemodialysis patients' access to innovative therapies. Starting January 2025, CMMI's Kidney Care Choices model will exclude TDAPA payments from financial calculations, facilitating access to new drugs including DefenCath®. This change affects over 30% of ESRD patients in the US currently enrolled in KCC programs, removing financial barriers to innovative drug utilization and ensuring patient care choices aren't by cost considerations.

Positive

• Policy change removes financial barriers for DefenCath adoption in dialysis centers
• Access to over 30% of ESRD patient market through KCC programs
• Potential for broader system-wide implementation of DefenCath across clinics

Negative

• Implementation delayed until January 2025

News Market Reaction

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-1.71% News Effect

On the day this news was published, CRMD declined 1.71%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

BERKELEY HEIGHTS, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today highlights key policy changes from CMS that benefit hemodialysis patients. Yesterday, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) released important policy updates that will broaden the access of Medicare patients managing End Stage Renal Disease (ESRD) and on dialysis to innovative new therapies.

Beginning in January 2025, CMMI’s Kidney Care Choices (KCC) value-based care model will carve out Transitional Drug Add-on Payment Adjustments (TDAPA payments) from financial calculations such as benchmarks, performance year expenditures and USPCC trend rates, allowing ESRD patients participating in a KCC to have increased access to certain innovative new drugs, including CorMedix drug product DefenCath® (taurolidine and heparin). Given that more than 30% of ESRD patients in the US are currently enrolled in a KCC, this change removes a significant barrier to the utilization of innovative therapies by patients in need, and will ensure that financial considerations do not diminish ESRD patients’ care choices and access to innovative new drugs.

Joe Todisco, CorMedix CEO, commented, “CorMedix applauds CMS for making a patient-centered policy change that will align provider incentives with patient care and broaden access to innovation. I am appreciative of the industry stakeholders, patient advocacy organizations, and CorMedix team members that worked closely with CMS to enact this change for the benefit of patient access. This important change will better allow providers to more easily protocolize a product like DefenCath across clinics and patient payor segments system-wide.”

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^® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and 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
daniel@lifesciadvisors.com
(617) 430-7576

FAQ

When will CMS policy changes for TDAPA payments take effect for CRMD's DefenCath?

The CMS policy changes regarding TDAPA payments will take effect in January 2025.

What percentage of ESRD patients will be affected by the new CMS policy change for CRMD?

More than 30% of ESRD patients in the US, who are currently enrolled in Kidney Care Choices programs, will be affected by this policy change.

How will the new CMS policy affect DefenCath accessibility for CRMD?

The policy will remove financial barriers to DefenCath utilization by excluding TDAPA payments from financial calculations, making it easier for providers to implement the drug across their systems.