Local Coverage Article Response to Comments

Response to Comments: Thyroid Nodule Molecular Testing


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Response to Comments: Thyroid Nodule Molecular Testing
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Response to Comments
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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 Thyroid Nodule Molecular Testing LCD. The official notice period for the final LCD begins on October 14, 2021, and the final determination will become effective on December 1, 2021.

Response To Comments


We received six comments from practicing endocrinologists, all focused exclusively on the requirement for repeat FNA biopsy in Bethesda III patients before proceeding to molecular testing. One of the commenters was the author of the 2020 American Association of Endocrine Surgeons (AAES) guidelines (1), cited in the LCD to support the requirement. This commenter stated: “The guidelines discuss options available for patients with Bethesda 3 nodules, which, depending on clinical factors such as nodule size, ultrasonographic appearance, and patient preference include repeat FNA, molecular testing, diagnostic lobectomy, or observation. Although repeat FNA is listed first, it was not the intention of this guideline to indicate that it is a preferable option or that repeat FNA has to occur before other options can be followed.” Another commenter, compensated for speaking by Sonic Healthcare USA (the manufacturer of ThroSeq), expressed doubt on relying on a discordant second biopsy result, due to the limits of light microscopic diagnosis. He cited a study showing that 43% of second biopsies are benign and “are now in this gray zone where it’s unclear whether we should believe or discount the original diagnosis of indeterminate and rely instead on the second diagnosis of benign. I think what this would lead to for this large number of patients is more intensive follow-up, additional ultrasonography, more office visits, additional costs.” All endorsed the idea that while repeat FNA should be an option, depending on clinical and radiologic factors, as well as patient preference, it should not be a requirement.


NGS agrees, given the AAES guideline author clarification, the other comments, and the recent shift in NCCN position from “repeat FNA” to “consider repeat FNA” (2).

  1. Patel KN, Yip L, Lubitz CC, et al. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults. Ann Surg. 2020;271(3):e21-e93.
  2. NCCN Thyroid Carcinoma Version 1.2021. https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed 7/15/21.

Associated Documents

Related Local Coverage Documents
L38968 - Thyroid Nodule Molecular Testing
Related National Coverage Documents
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Updated On Effective Dates Status
10/06/2021 12/01/2021 - N/A Currently in Effect You are here