Changes to Medicare Reimbursement

What do the changes entail?

Decrease in Number of Applications per Episode of Care (EoC)

• Four applications per 12-Week Episode are allowed, compared to the previous 10 applications per 12-Week Episode.
• Coverage for repeated applications is not deemed medically necessary and reasonable when:
  • “…a previous application was unsuccessful.”
  • “Unsuccessful treatment is defined as increase in size or depth of an ulcer, or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing)”

Guidelines to Remain in Effect

12-Week Episode of Care

• Cellular and/or Tissue-Based Product (CTP) applications take place over a 12 week episode
• Products may be changed during this 12-week span BUT changes in product selection do not increase allotted time, nor allowed number of applications.
• Applications of CTPs beyond the 12-week episode will be denied

JW and new JZ Modifier

• Use of modifiers like JW and JZ are still required
• JW: denotes the number of product units wasted
• JZ: denotes that no units of product were wasted, and that the entirety of the packaged CTP was utilized

Kerecis Coverage

Kerecis CTP products remain covered by these MACs, including:

• Kerecis MariGen, Q4158
• Kerecis Shield Adhesive, A2019

Kerecis was cited on two accounts as part of the rationale behind the CMS guideline changes.

“A fortieth commenter asserts that while they agree that not all wounds require the current allotted amount of 10 grafts in a 12-week episode, most wounds require more than two applications. In Kerecis clinical studies, the average number of applications until complete wound closure is 4.5 grafts.” The study referenced is by Dr. Michael et al. on diabetic foot ulcers, which saw an average of 4.5 applications used to achieve healing. (PMID: 31730505)

“A third commenter indicates that many wounds do not heal within 12 weeks. Kerecis has numerous case studies demonstrating wound closure, over the course of 6-12 months, utilizing grafts as needed rather than squeezing as many in as possible in the short time frame allowed. Most of these case studies utilized only five or less grafts over a longer period of time.”

More information can be found on the following sites

• Medicare Enrollment Numbers:
  https://medicareadvocacy.org/medicare-enrollment-numbers/#:~:text=The%20Centers%20for%20Medicare%20%26%20Medicaid,are%20enrolled%20in%20Original%20Medicare
• Codes affected:
  https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54117&ver=104
• Policy guidelines:
  https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=35041&ver=120&bc=0
• Kerecis references: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59517&ver=4
• Michael, Acellular Fish Skin Graft Use for Diabetic Lower Extremity Wound Healing:
  https://pubmed.ncbi.nlm.nih.gov/31730505/ PMID: 31730505

Contact

Feel free to reach out to reimbursement@kerecis.com or your local Kerecis representative with any questions.

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