Earlier in March 2022, MOLDX posted an elaborate LCD for molecular infectious disease panels. The elaborate LCD included an elaborate "billing and coding" article. Entry point here. L38988. See also the TA document here.
Now, on March 17, they've also posted one of the longest public comment responses, I've ever seen. Medicare article A59005. 25,000 words. From the CMS website, the article prints out at 72 PDF pages for me.
(For original comments in their original letter form, I found one online at AMP, the June 2021 AMP / AGA / CAP comment here.)
Find the MolDx response to comments online here:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59005&ver=8
Given the length of the Q&A, what's in it? In the left column, they quote comment letters in full. In many cases, in the right column, they state briefly "Comment has been answered, see above." or "Thanks for comment."
Most head-spinning moments for me were when stakeholders comment, and I read and re-read this stuff, "This looks like an inpatient policy" and MolDx responds, "This is not an inpatient policy, as we state, "This is not an inpatient policy" quote unquote. And yet the policy and Q&A comments exchanges repeatedly state for many situations patients must be admitted as critical care facility inpatients or ER patients." In which circumstances, the tests are bundled to the ER APC visit or the facility DRG visit.
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See an article sponsored by Biofire on its use in identification in blood culture analysis. Note, that patients getting blood culture will usually be inpatients (or ER patients) where tests are bundled (except if they are human DNA-RNA).