FUTURE LCD Reference Article Response To Comments Article

Response to Comments: Mass Spectrometry (MS) Testing in Monoclonal Gammopathy (MG)

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Article ID
A59900
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Article Title
Response to Comments: Mass Spectrometry (MS) Testing in Monoclonal Gammopathy (MG)
Article Type
Response to Comments
Original Effective Date
12/15/2024
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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 Mass Spectrometry (MS) Testing in Monoclonal Gammopathy (MG). The official notice period for the final LCD begins on October 31, 2024, and the final determination will become effective on December 15, 2024.

Response To Comments

Number Comment Response
1

Mayo Clinic suggested the removal of the following verbiage from the Billing and Coding Article:

  1. “field/types references” regarding electronic claims processing
  2. the wording under “Utilization Guidelines” that is redundant to existing NCCI and MUE editing

NGS agrees and has removed the “field/types references” wording and has deleted the language that is redundant to the NCCI and MUE editing.

2

Mayo Clinic commented: “In addition to monitoring monoclonal gammopathies, this testing is also used to establish diagnosis. Therefore, it would be appropriate to add ICD-10 codes associated with established conditions that lead to the testing and diagnosis of monoclonal gammopathy. Many of the articles referenced in the policy bibliography support the addition of these conditions. Mayo Clinic Clinicians are ordering the M-Protein testing based on these conditions which are represented by the following ICD-10 codes:

Anemia: D63.8, D64.9

Nephrology: N18.1, N18.2, N18.30, N18.31, N18.32, N18.4, N18.5, N18.6, N18.9, N04.0, N04.1, N04.2 N04.20, N04.9, N03.8, N05.5, N05.8, N05.9, R80.9

Cardiac Conditions: D86.85, I11.0, I13.0, I13.10, I13.2, I42.1-I42.9, I50.1, I50.20-I50.23, I50.30-I50.33, I50.40-I50.43, I50.810-I50.814, I50.82, I50.83, I50.84, I50.89, I50.9

Other: C83.00, C91.10, G62.9, M54.50, M79.7, M81.0, R20.2, R53.82, R53.83" 

 

 

NGS agrees and will add the appropriate ICD-10CM diagnosis codes to the “ICD-10-CM That Supports Medical Necessity” section of the Billing and Coding Article.

3

The College of American Pathologists commented: “ We appreciate NGS’ willingness to provide coverage for the initial detection/diagnosis and monitoring of M-proteins by Mass Spectrometry. This new method elucidates valuable information when used to make significant clinical decisions for cancer patients. This is in agreement with the current CAP guideline for Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies1, notes that "laboratorians should confirm an SPEP abnormality suspicious for a presence of a M-protein with additional testing by serum immunofixation electrophoresis (sIFE) or alternative method with similar sensitivity" (i.e., MS in this context). “

“We request that NGS consider concurrent coverage of sIFE and MS when discriminating between therapeutic monoclonal antibodies and endogenous M-proteins and when clinically relevant, such as discriminating between biochemical minimal residual disease and the presence of therapeutic monoclonal antibodies.”

NGS agrees and has revised the verbiage under the Indications and Limitations of Coverage accordingly.

 

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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