U.S. Reimbursement

Kerecis® MariGen is reimbursed by Medicare and has wide coverage through private insurers.

Hospital Outpatient Department

Kerecis® MariGen is reimbursed by Medicare and has wide coverage through private insurers. Kerecis® MariGen is available in Veterans Administration hospitals and is on the Federal Supply Schedule in all Veterans Integrated Service Networks (VISNs).®

Kerecis® MariGen is reimbursed by Medicare in the high cost group for applications of skin substitutes in the HOPD setting using CPT codes 15271-15278.

Medicare payment for Q4158 – Kerecis® MariGen is included in the payment for the application.
The Medicare National Payment rate for high cost group in 2025 is $1,829.23 in a Hospital Outpatient setting for wounds less than 100 sq cm (site of service 22).

Kerecis MariGen Expanse expands to over 100 sq cm to economically treat large wounds in the HOPD Setting.
Kerecis Expanse utilizes Q4158.  The Medicare National Payment rate in 2025 for CPT 15273: Wounds over 100 sq cm is $3,660.97

Medicare Local Coverage Determinations (LCDs)
The following LCD summaries provide the clinical coverage context for the use of Kerecis® MariGen in the outpatient setting.

NOVITAS LCD – L35041 / CGS L36690
APPLICATIONS: 10 applications over 12 weeks.
CRITERIA Require 4 weeks of documented failed healing.
WOUND TYPES: DFU, VLU, Other chronic full thickness wounds.
PRODUCTS: “All products with U.S. Food and Drug Administration (FDA) clearance/approval or designated 361 HCT/P exemption used in accordance with that product’s individualized application guidelines will be equally considered.”

FCSO: LCD – L36377
APPLICATIONS: 12 week treatment episode.
CRITERIA SUMMARY: Require 4 weeks of documented failed healing.
WOUND TYPES: DFU, VLU.
PRODUCTS: “This LCD does not endorse particular products for separate payment so the physician’s documentation must support the need for skin replacement surgery and the product used.”

Other Part B MACs
LCD Status: Do not currently have active LCDs specific to skin substitutes
Coverage Basis: Falls under “Reasonable and Necessary” provisions

Q4158–CPT Crosswalk and Medicare Payment
The table below links HCPCS code Q4158 (Kerecis® MariGen) with the applicable CPT codes for skin substitute application procedures and the 2025 Medicare national payment rates.

HCPCS CodeCPT CodeWound SizeSite of Service2025 Payment Rate
Q415815271< 100 sq cmASC (24)$981.09
Q415815271< 100 sq cmHOPD (22)$1,829.23
Q415815273> 100 sq cmASC (24)$1,957.33
Q415815273> 100 sq cmHOPD (22)$3,660.97

References and Guidance

  • CMS OPPS Final Rule CY2025
  • MLN Matters SE20006 – Skin Substitutes Policy
  • LCD L35041: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35041
  • LCD L36690: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36690
  • LCD L36377: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36377

Ambulatory Surgical Center

Kerecis® MariGen is reimbursed in the high cost group for applications of skin substitutes in the ASC setting using CPT codes 15271-15278.

Medicare payment for Q4158 – Kerecis® MariGen is included in the payment for the application. The Medicare National Payment rate for high cost group in 2025 is $981.09 in a Freestanding Ambulatory Surgical Center (site of service 24).

Physician’s Office Setting

Kerecis has separate reimbursement for MariGen, Q4158, and Shield Adhesive, A2019, if applied in a physician’s office (site of service 11).

Contact the Reimbursement Hotline at 844-KERECIS (844-537-3247) for Benefit Investigation and fee schedule information.

Reimbursement Hotline and Benefit Verification

Once you decide to use Kerecis® MariGen, our Reimbursement Hotline team will work closely with you throughout your benefit verification and prior authorization and update you on the policy status of Kerecis in your area.

If you have any questions about reimbursement for Kerecis® MariGen, contact us:

Email: reimbursement@kerecis.com
Reimbursement Hotline: 844-KERECIS (844-537-3247)
Fax: 844-529-3247

Need more information?

From the town of Isafjordur in northwest Iceland, Kerecis develops, manufactures, and sells patented fish skin soft tissue regeneration products that have regulatory approval in the United States, Europe and several other jurisdictions.
Kerecis is pioneering the use of fish skin and fatty acids in the globally expanding field of cellular therapy.
Kerecis is part of Coloplast, the leading global supplier of intimate healthcare products.
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