LCD Reference Article Response To Comments Article

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

A59893

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Article ID
A59893
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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
10/17/2024
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The following are the comment summaries and contractor responses for First Coast Proposed Local Coverage Determination (LCD) DL39877 Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound which was posted for comment 06/06/2024 through July 20, 2024 and presented at the June 2024 Open Meeting. First Coast appreciates the comments received from stakeholders during the open comment period. All comments were reviewed in their entirety. Submitted comments that cite published, peer-reviewed literature provide a suitable source of data that may inform draft policy revision(s). However, while anecdotal or unpublished information not subject to peer-review offer important perspectives, its influence on policy determinations is limited, reflecting the established evidence hierarchy which prioritizes more rigorously vetted sources.

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13: In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Accordingly, the final policy and our response to comments are grounded in the best currently available published clinical evidence. This approach ensures that our decisions are informed by the best available research, ultimately supporting optimal health outcomes in Medicare beneficiaries.

NOTE: First Coast reviews all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact, or withhold certain submissions (or portions thereof) such as those containing unrelated proprietary subject matter, or inappropriate language. This may result in discrepancies between the number of comments in the article and the actual number of comments received.

Response To Comments

Number Comment Response
1

A comment was received that these products are absolutely indicated, beneficial, and within the standard of care and that they should be approved.

Thank you for your comment. No literature was submitted with this comment. Medicare Administrative Contractors (MACs) are required to base their coverage determinations on scientific evidence. The proposed Local Coverage Determination (LCD) provides a summary of evidence and analysis of evidence to support our coverage decisions. Providers may submit peer-reviewed full-text articles to support coverage of amniotic and placental-derived product injections for musculoskeletal conditions via the reconsideration process outlined on our website once the LCD is finalized.

2

A comment was received indicating that the FDA reviewed and approved biologics, for the management of musculoskeletal conditions. The commenter feels that the use of these products is supported by high-quality randomized controlled trials (RCTs) published in peer-reviewed publications and demonstrate safety, efficacy, and ability to improve health outcomes. Therefore, they feel the products should be covered in this policy. The commentator discussed the 2019 publication by Farr et al in the Journal of Knee Surgery in which a biologic, ReNu, was trialed for the treatment of knee osteoarthritis and stated that 2 additional RCTs for ReNu are completed or ongoing, neither of which were cited in the draft LCD. Topline data is available for one, Phase 3 RCT, and publication in a peer-reviewed journal will be pursued. The other, a second Phase 3 RCT, is estimated to have Topline results by the end of the first quarter in 2025. They suggest that the LCD should set forth requirements for amniotic and placental-derived product injections and/or applications for musculoskeletal indications and specify that any product subsequently found to meet the final LCDs’ criteria could then be designated as “covered” through updates to the local coverage article (LCA) rather than submission of the LCD reconsideration process.

Thank you for your comments. FDA approval or clearance is not dispositive of the reasonable and necessary threshold for Medicare coverage. The publication by Farr et al in 2019 was reviewed and included in the summary of evidence and analysis of evidence and its source is located in the bibliography. No literature was submitted with these comments. Medicare Administrative Contractors (MACs) are required to base their coverage determinations on scientific evidence. Unpublished proprietary topline data or any data that has not been published in peer-reviewed publicly available journals cannot be used to support coverage determinations. Providers may submit peer-reviewed full-text articles to support coverage of amniotic and placental-derived product injections for musculoskeletal conditions via the reconsideration process outlined on our website once the LCD is finalized. This process is governed by IOM 100-08, Medicare Program Integrity Manual, Chapter 13. Coverage cannot be modified to any product without going through the reconsideration process since Medicare requirements mandate that a coverage change must go through the entire LCD development process, including open meetings, to effectuate revisions to coverage.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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