LCD Reference Article Response To Comments Article

Response to Comments: Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound

A59542

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Source Article ID
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Article ID
A59542
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound
Article Type
Response to Comments
Original Effective Date
11/12/2023
Revision Effective Date
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Revision Ending Date
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Retirement Date
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Article Text

The proposed policy Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound was presented at the Open Meeting on July 13, 2023. The 45-day comment period began on 6/15/2023 and ended on 7/29/2023. This article is the response to comments received by participating Medicare Administrative Contractors (MACs).

Response To Comments

Number Comment Response
1

Comments were received from MIMEDX Group, Inc.

They commented that the policy addresses skeletal injuries (joints and spine, cartilage damage, osteoarthritis) and tendinopathies (tendon/ligament injuries including of rotator cuff). They state that the term musculoskeletal is confusing and unnecessary.

The term musculoskeletal is used to refer to conditions of the connective tissues including bone, muscle, and their associated tissues such as tendons and ligaments. Therefore, encompasses the structures addressed within the policy. A definition of musculoskeletal has been add to the policy to provide clarification.

2

The next comment addresses the confusion surrounding placental based products and stem cell therapy. They state many Placental-Based Products are devoid of stem cells after processing and do not contain any living cells. Some products do claim to retain and transfer stem cells from the donor placenta to the receipt. They recommend “These two different classes of placental products (no living cells versus living cells) should be recognized and differentiated within the LCD if this emphasis on stem cells is to be maintained.”

They also state the draft LCD does appear to acknowledge this distinction, however they suggest “Placental-Based Products and Stem cells are two very different products and therapies that are often confused among practitioners and policymakers alike. We request that CGS accurately reflect the differences by removing references to Non-Cryopreserved Placental-Based Products as a source of stem cells.”

MACs agree there is an important distinction between Stem cells and Placental-Based Products. While we acknowledge this distinction, we will not remove references which apply to multiple aspects of the LCD and are part of the evidence review used to develop the LCD. This is addressed in the LCD in the Definition section and a clarifying statement has been added to ensure this is clear.

3

The commenter points out that not all products in the Group 1 (non-covered HCPCS) code list are Placental-Based. They suggest “To avoid further confusion with other, unrelated products that are cadeveric, dermal, or xenographic in origin, MIMEDX encourage CGS to ensure that the products listed in Group 1 are truly Placental-Based.”

We agree that products that are not placental derived are not addresses within this policy. Q4113, Q4114 and Q4202 have been removed from the Group 1 codes.

4

MIMEDX comments on the following regulatory language:

Amniotic epithelial layer is not maternal derived but part of amnion which is fetal tissue. The state decellularization is not specific to epithelial cells or amniotic membrane. The pre-marker FDA approval for new drugs requiring IND does not apply to devices and that the FDA section 551 related to dissemination is not regulatory.

Thank you for bringing this to our attention and corrections have been made in the LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Public Versions
Updated On Effective Dates Status
09/22/2023 11/12/2023 - N/A Currently in Effect You are here

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