McDonald Hopkins' clinical laboratory and pathology policy watchers suggest that certain pathology or laboratory providers begin reviewing two Medicare administrative contractor (MAC) local coverage determinations (LCDs) affecting medical necessity for special stains used in pathology and lab services, sooner rather than later.
For a legal update published June 3, McDonald Hopkins attorney Jane Pine Wood advised providers in MAC jurisdictions covered by Palmetto GBA or WPS to review two recently finalized LCDs (L36805 and L35922). While L36805 and L35922, both targeting medical necessity and documentation for special histochemical stains and immunohistochemical (IHC) stains, are not ideal, they are less restrictive than the proposed LCDs, according to Pine Wood.
The two LCDs are significant because they identify the medically necessary criteria for the use of special stains and/or IHC stains; they go into effect July 14. Pathology or laboratory providers will need to ensure that the ordering of the stains and the documentation of the medical necessity for the stains comply with the updated LCDs in connection with pathology services for Medicare and Medicare Advantage patients.
"This does not mean, however, that the guidance in these two LCDs is limited only to Medicare and Medicare Advantage service within the Palmetto and WPS jurisdictions," added Pine Wood, who said that other MACs could adopt the guidelines that are identical or similar. "In addition, private payers increasingly look to restrictive LCDs in making their own coverage and medical necessity determinations," Pine Wood wrote.
Among many points of interest in the new policy, the LCDs stipulate medical necessity criteria for special stain and IHC studies and what must be documented in the surgical pathology report. The LCDs limit coverage and call attention to special stains and IHC stains for various pathology services, such as breast pathology, prostate pathology, lung cancer, predictive marker tumor profiling, bone marrow samples, and cervical, gynecological, bladder, and kidney tumors, among others.
Read the full McDonald Hopkins' legal update here.
For coverage comparisons, check the LCD version currently in effect until July 13.
