LCD Reference Article Response To Comments Article

Response to Comments: Molecular Pathology Procedures

A59767

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Source Article ID
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Article ID
A59767
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Molecular Pathology Procedures
Article Type
Response to Comments
Original Effective Date
08/01/2024
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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 Molecular Pathology Procedures. The official notice period for the final LCD begins on June 13, 2024, and the final determination will become effective on August 1, 2024.

Response To Comments

Number Comment Response
1

Mayo Clinic commented: “The information presented demonstrates the value of the risk score in the therapeutic management of patients. Other cardiac markers do not fall under NGS or CMS coverage decisions and Ceramides should have the same coverage approach.”

Although the ceramide risk score may have promise as an indicator of potential cardiovascular events, additional research is required to fully understand the value of the risk score in therapeutic medical management of the patient's condition. Ceramide testing is therefore not considered medically necessary at this time.

NGS believes as ceramide risk score testing evolves in the therapeutic management of the patient that the testing may be considered for coverage on a local or national basis.

2

Mayo Clinic also stated: “The request for coverage was only submitted because it uses a PLA code, and NGS denies all PLA codes until a coverage policy is established.”

As NGS clarified in response at the February 29, 2024 Open Meeting, based on the 21st Century Cures Act, Contractors are prohibited from developing blanket policies to indicate coverage or non-coverage for Category III, and PLA codes. Category III and PLA codes, not present in an existing LCD, are individually reviewed for medical necessity.

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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
Related National Coverage Documents
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SAD Process URL 2
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Updated On Effective Dates Status
06/03/2024 08/01/2024 - N/A Currently in Effect You are here

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