CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare
November 14, 2024
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Kerecis MariGen is intact fish skin for the management of chronic wounds such as diabetic wounds, pressure ulcers, vascular ulcers, and draining wounds commonly treated in hospital-based outpatient departments.
The Kerecis fish-skin grafts contain fat, protein, elastin, glycans, and other natural skin elements and are supplied in multiple shapes, variants, and sizes.
The product is classified as a medical device and consists of a full-thickness fish skin that has been processed using Kerecis’ proprietary EnviroIntact™ method. It is not subject to the May 31, 2021, FDA 351 regulation.
| Product Code | MariGen Product Description – Size | Total Size cm2 | Billable Units | HCPCS Code | UPC | |
|---|---|---|---|---|---|---|
|
50200S16B0D |
MariGen – 16 mm, Circular, Diameter |
2.01 |
2 |
Q4158 |
5694310960151 |
|
|
50200S00B0D |
MariGen – 1.75 x 1.75 cm |
3.06 |
4 |
Q4158 |
5694310960052 |
|
|
50200S01B0D |
MariGen – 3 x 3.5 cm |
10.50 |
11 |
Q4158 |
5694310962391 |
|
|
50200S02B0D |
MariGen – 3 x 7 cm |
21.00 |
21 |
Q4158 |
5694310962414 |
|
|
50200S05B0D |
MariGen – 5 x 7 cm |
35.00 |
35 |
Q4158 |
5694310960892 |
|
|
50200S04B0D |
MariGen – 7 x 7 cm |
49.00 |
49 |
Q4158 |
5694310960236 |
|
|
50200S03B0D |
MariGen – 7 x 10 cm |
70.00 |
70 |
Q4158 |
5694310962438 |
|
|
50200P00B0D |
MariGen Micro – 4 sq cm |
4.00 |
4 |
Q4158 |
5694310961578 |
|
|
50200P01B0D |
MariGen Micro – 8 sq cm |
8.00 |
8 |
Q4158 |
5694310961592 |
|
|
50200P02D0D |
MariGen Mirco – 19 sq cm |
19.00 |
19 |
Q4158 |
5694310961615 |
|
|
50200P04D0D |
MariGen Micro – 38 sq cm |
38.00 |
38 |
Q4158 |
5694310961653 |
|
|
50200F01B0D |
MariGen Fenestrated – 3 x 3.5 cm |
10.50 |
11 |
Q4158 |
5694310960175 |
|
|
50200F02B0D |
MariGen Fenestrated – 3 x 7 cm |
21.00 |
21 |
Q4158 |
5694310960199 |
|
|
50200F03B0D |
MariGen Fenestrated – 7 x 10 cm |
70.00 |
70 |
Q4158 |
5694310960212 |
|
|
50200N11B0D |
MariGen Expanse – 7 x 8 cm |
56.00 |
56 |
Q4158 |
5694310962216 |
|
|
50200N13B0D |
MariGen Expanse – 8 x 10 cm |
80.00 |
80 |
Q4158 |
5694310962230 |
|
|
50200N42B0D |
MariGen Expanse – 2 x 2 cm |
4.0 |
4 |
Q4158 |
5694310964463 |
|
|
50200N43B0D |
MariGen Expanse – 3 x 3 cm |
9.0 |
9 |
Q4158 |
5694310964487 |
|
|
50200N44B0D |
MariGen Expanse – 4 x 4 cm |
16.0 |
16 |
Q4158 |
5694310964500 |
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• FDA Approval Link
• Instructions for USE
• Contact Information
The product is derived from a fish source and should not be used in patients with a known allergy or sensitivity to fish.
Note that fish allergy is not the same as shellfish allergy.
The product and its variations are not available in all countries and may be known under different trade names. Products, product names, indications, and claims vary between jurisdictions. Contact your Kerecis representative if you have questions about the availability of Kerecis products in your area.
Always check with your local healthcare professional and read the printed package information before use. The information on this website may not be current and may not accurately reflect current product labeling.
This website is not intended to provide diagnosis, treatment, or medical advice. Products, services, information, and other content provided on this website, including information that may be provided directly or by linking to third-party websites, are provided for informational purposes only.
Information on this website should not be considered a substitute for a healthcare professional’s advice. Consult with a physician or other healthcare professional regarding any medical or health-related diagnosis or treatment options.
A Surgeon must always rely on their professional clinical judgment when deciding whether to use a particular product when treating a patient. Kerecis does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
The information presented on this website is intended to demonstrate the Kerecis product offerings. Before using any Kerecis product, a surgeon must always refer to the package insert, product label, and/or instructions for use.
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