LCD Reference Article Response To Comments Article

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

A59564

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A59564
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
10/26/2023
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

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 comment 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.

N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
10/16/2023 10/26/2023 - N/A Currently in Effect You are here

Keywords

N/A