LCD Reference Article Response To Comments Article

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

A59078

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A59078
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Response to Comments: Mass Spectrometry (MS) Testing in Monoclonal Gammopathy (MG)
Article Type
Response to Comments
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08/01/2022
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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) LCD. The official notice period for the final LCD begins on June 16, 2022 and the final determination will become effective on August 1, 2022.

Response To Comments

Number Comment Response
1

We received a comment from Mayo Clinic, the developer of MASS-FIX (a matrix-assisted laser desorption/ionization (MALDI) mass spectrometry-based assay). Their primary request was to cover urine mass spectrometry (uMS) interchangeably with urine immunofixation electrophoresis (uIFE), similar to that of their serum counterparts in the draft LCD. In support, they cite guidelines that endorse use of uIFE in diagnosis and treatment response in myeloma and amyloidosis, published studies showing similar sensitivity between uMS, serum MS (sMS) and uIFE, and finally, that they are “in final validation stages of urine IFE replacement using mass spectrometry.” They also request that both urine and serum MS can be billed concurrently (i.e., the code shared by both can be “billed twice per date of service”).

NGS disagrees. While the very recent College of American Pathologists (CAP), American Association for Clinical Chemistry (AACC), and American Society for Clinical Pathology (ASCP) collaborative guidelines do recommend uIFE for certain indications, they only endorse an “alternate method with similar sensitivity” (which published validation studies have yet to establish), in the context of sIFE (1). Also notable is the absence of this request in CAP’s own comment below.

1. Keren DF, Bocsi G, Billman BL, et al. Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies: Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology. Arch Pathol Lab Med. 2021.

2

Another request from Mayo Clinic was that serum and urine MS testing “is not limited to only Myeloma indications,” citing desired symptom specific coding (e.g., 150.32 chronic systolic heart failure, D64.9 anemia).

This comment was confusing, in that the draft billing and coding article already includes diagnoses beyond myeloma, even the general diagnosis of monoclonal gammopathy (D47.2). We also believe symptom-based coding too nonspecific, especially in the context of the draft LCD coverage indications, where a MG diagnosis is being confirmed or known.

3

A comment from CAP requested 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.” They argue that concurrent (rather than reflex or sequential) testing using the same specimen, besides preventing blood redraw and reporting delay, also makes cross-interpretation between the two tests more reliable.

NGS disagrees. Studies and guidelines promote sMS as an alternative, not an addition to, sIFE (1). This option should be exercised in the setting were conflation of endogenous M-protein and therapeutic monoclonal antibodies is a possibility. Even in the context of appropriate reflex testing, the problem of different specimens would seem soluble by holding some original sample in reserve.

1. Keren DF, Bocsi G, Billman BL, et al. Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies: Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology. Arch Pathol Lab Med. 2021.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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