Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdiction 11 (the Carolinas and Virginias), has just released a very extensive draft local coverage determination (LCD) policy that addresses the overutilization of immunohistochemical (IHC) and special stains by pathologists for breast, gastrointestinal, prostate, lung, gynecologic, genitourinary, skin, soft tissue, central and peripheral nervous systems, bone marrow and tumor chemosensitivity specimens.
It would appear the draft LCD is in direct response to the complaint filed with the Centers for Medicare and Medicaid Services (CMS) by the College of American Pathologists (CAP), which took exception to an educational document Palmetto posted on its website back in May that highlighted ancillary stain overutilization by pathologists on gastric biopsies.
In its complaint, the CAP stated the educational document should “be removed from the Palmetto website or significantly modified immediately”, and that if Palmetto wished to fight ancillary stain overutilization by pathologists, it should go through the LCD process. Soon after the complaint was filed, Palmetto did indeed remove the article from its website.
In the article I wrote about the CAP’s complaint, I stated there was an excellent chance Palmetto would indeed go through the LCD process because of the complaint, and the CAP needed to be careful what it asked for, as an LCD could be far more painful for pathologists than a simple educational document.
Before anyone gets too upset, the reimbursement restrictions Palmetto is proposing will not impact the vast majority of pathologists who already order ancillary stains appropriately. Rather, they will for the most part only impact those pathologists who are ordering ancillary stains inappropriately.
But, the LCD will have an impact on all pathologists in that they will be required to fully explain the medical necessity for each ancillary stain they order in their report if they want to be reimbursed for it.
And it also goes without saying that once the LCD is in place, Palmetto will be able to initiate probes and pre- and post-payment reviews, and refer troubling cases to Recovery Audit Contractors (RAC) and Zone Program Integrity Contractors (ZPIC).
Draft LCD Contents
The draft LCD begins by stating its purpose, which is to address medically unnecessary overutilization of ancillary stains by pathologists via:
- Reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine hematoxylin and eosin (H&E) stain by the pathologist; or
- Use of special stains and/or IHC stains without clinical evidence that the stain is actionable or provides the treating physician with information that changes patient management; or
- Use of stains when the diagnosis is already known based on morphologic evaluation; or
- Hematoxylin and eosin (H&E) staining is included in the billing CPT code and is not a separately billable service.