FUTURE LCD Reference Article Response To Comments Article

Response to Comments: Molecular Pathology Procedures

A60451

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Source Article ID
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Article ID
A60451
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Molecular Pathology Procedures
Article Type
Response to Comments
Original Effective Date
07/15/2026
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Molecular Pathology Procedures LCD. The official notice period for the final LCD begins on May 28, 2026, and the final determination will become effective on July 15, 2026.

Response To Comments

Number Comment Response
1

One commentor stated support for the proposed policy and agrees that removing APOE from the Tier 2 non-covered list recognizes its clinical relevance in light of FDA-approved anti-amyloid monoclonal antibody therapies and boxed warnings related to patient safety. The commentor also states that the proposed LCD provides needed clarity and consistency, reduces administrative uncertainty, supports consistent claims adjudication, and helps ensure timely access to medically necessary diagnostic services for Medicare beneficiaries with Alzheimer’s disease.

Wellpoint Federal agrees and is grateful and appreciative for your support.

 

2

One commentor expressed support for removing APOE from the Tier 2 non-covered codes/gene combinations list. The commentor stated that APOE genotyping is medically necessary before FDA-approved anti-amyloid monoclonal antibody therapy, such as lecanemab or donanemab, because it helps assess ARIA safety risk, particularly for APOE ε4 carriers. The commentor emphasized that testing should be used for pretreatment safety stratification and shared decision-making, not population screening, and requested that CPT 81401/APOE be added to Group 1 Covered Codes to clarify coverage and reduce administrative burden.

 

As the commentor pointed out, testing of APOE may not always be reasonable or necessary. Given the lack of granularity found in both CPT code descriptors for APOE testing and ICD-10 coding for Alzheimer’s disease (and other dementias), no further changes will be made to the draft billing and coding article.

 

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L35000 - Molecular Pathology Procedures (Future)
Related National Coverage Documents
NCDs
90.2 - Next Generation Sequencing (NGS)
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Updated On Effective Dates Status
05/21/2026 07/15/2026 - N/A Future Effective You are here

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