In April 2015, Noridian finalized its cardiac biomarker LCD with relatively few changes - but there are a few. Details after the break.
The public Q&A response document is here. Noridian (and/or MolDX) provided lengthy comment summaries and equally lengthy responses. (Note: Yellow highlighting is my own, to highlight a few points).
I've provided a redline that compares the draft and final versions of the LCD, here. Read closely, the LCD, its redlined revisions, and the Q&A document provide insights into CMS MAC medical director thinking and reasoning.
The full final LCD is here. It was posted on April 14 and has a go-live date of May 31, 2016.
The LCD explains that Medicare is highly adverse to ordering of panels under nearly any circumstances, except the small lipid screening panel covered every 5 years under Medicare law. If esoteric cardiac biomarkers are ordered, each one must be ordered for a specific rationale "documented in the medical record." A successful biomarker should:
- Adds clinical knowledge that improves patient outcomes (criteria for Medicare “reasonable and necessary”);
- Provides risk information that is independent of established predictors;
- Is easy to measure and interpret in the clinical setting;
- Is accurate, reproducible and standardized.
It appears that Lp(a) testing is shifted from not covered to covered "particularly for intermediate risk patients" in certain circumstances.
Apo B is covered under narrow, defined circumstances, with quotation of ACCE guideline criteria.
B-type natriuretic peptide / BNP is noted, but coverage criteria are referred to a separate LCD (L35526).
In the Q&A document, Noridian notes it received 70 letters, presumably form letters, complaining the LCD would be to strict, that it views these together as "one comment" and that this type of comment did not provide new data or literature.