Palmetto Issues Coverage Advisories on GI Staining and Breast Cancer Testing

Medicare Administrative Contractor (MAC) Palmetto GBA recently issued revised payment guidelines regarding special stains for gastrointestinal (GI) pathology.   On their website, Palmetto stated “the vast majority of conditions of the stomach on biopsy can be diagnosed by the use of the routine hematoxylin and eosin (H&E) stain alone.  There is potential for either overutilization or under-utilization for these ancillary special stains.  In most cases it is not reasonable or necessary to perform ‘special stains’ such as alcian blue and PAS to determine if clinically meaningful intestinal metaplasia is present.  In addition it is not usually reasonable or necessary to perform special stains or immunostains (IHC) to determine presence of H. pylori.”  The MAC goes on to suggest that special stains should only be conducted on fewer than 20% of all gastric biopsy cases. 

Palmetto also issued an advisory on testing for breast cancer.  According to the MAC, “based on recommendations from the College of American Pathologists, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network, hormone receptor assays, estrogen receptor (ER), progesterone receptor (PR), and Her-2/neu are the only current biomarkers that demonstrate standardized value in breast cancer pathology evaluation.”  With that said, Palmetto will no longer allow payments for Ki-67, PI3K, and gene expression assays. 

Moving forward, it is expected that the 20% threshold will be used for targeted audits of GI cases by Palmetto.  This will likely be adopted by other MACs throughout the country, along with payment policy changes on breast cancer cases.

As a reaction to Palmetto GBA’s recent advisory on medical necessity and utilization of special stains for GI biopsy cases, the College of American Pathologists (CAP) has filed a formal complaint with the Centers for Medicare and Medicaid Services.  The complaint cites three reasons for the objection including:

1. Threatening sanctions is inconsistent with the nature and purpose of an educational document.
2. Palmetto did not go through the local coverage determination (LCD) process to arrive at its policy.
3. The 20% threshold is arbitrary and could result in patient harm.

It is interesting to note the letter made no mention of Palmetto’s advisory on testing for breast cancer.  This complaint was dated in late June.  APS will continue to monitor this and other policy related actions by CMS.  If you have any questions, please contact your Practice Manager.