An LCD is a “local coverage determination” which CMS (Centers for Medicare and Medicaid Services) requires fiscal intermediaries and carriers to issue when they have local guidelines regarding when and how to bill for certain services. These LCD's also place limits on the diagnosis codes that justify medical necessity for some services, establish billing guidelines and include limits on frequency and patient eligibility.
A proposed draft local coverage determination (LCD) policy is in the works by CGS Administrators, Kentucky and Ohio’s Medicare Administrative Contractor regarding the appropriate utilization of immunohistochemistry and special stains by pathologists.
Palmetto GBA (states of NC, SC, VA, WV) and Noridian Healthcare Solutions (states of WA, OR, MT, ID, UT, AZ, AK, ND, SD, NV, CA) have already drafted such policies and the CGS policy seems to be very similar. At this time, Noridian has not been finalized but Palmetto GBA’s was in January 2015.
This policy identifies the medical necessity criteria for the use of special stains and/or IHC stains. Based on claims reviewed, the top scenarios that are found to be medically unnecessary and over-utilized are:
• Reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine H&E stain 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 added stains when the diagnosis is already known based on morphologic evaluation of the primary stain
The most common cases affected specifically will be GI cases. You will no longer order special or IHC stains prior to reviewing the routine stain on specimens such as, esophageal, gastric, duodenum, colon, hyperplastic polyps, or tubular/tublarvillious polyps as it will not be considered reasonable and necessary. If they are deemed to be needed, specific documentation will need to be documented in the report to justify the medical necessity, such as:
• Detection of H pylori in an appropriate milieu when organisms are not seen on routine H and E
• Evaluating atrophic gastritis for evidence of autoimmune etiology and for enterochromaffin-like cell hyperplasia/carcinoid tumor
• Characterizing a carcinoma, lymphoma, melanoma or sarcoma
• Defining a GIST tumor
• Ki-67 by IHC in the differential diagnosis of certain neuroendocrine tumors of the gut
Per the draft policy, routine staining of Ki-67 on breast cases will no longer be covered by Medicare as not reasonable and necessary on breast cases, due to the fact methods of measurement are controversial (scoring low versus high expression) and other factors and it is not currently recommended by the ASCO or NCCN.
IHC stains, whether a single or cocktail, will not be considered reasonable and necessary on prostate specimens if done on negative cores, for IHC testing in a negative or a suspicious core when obvious prostate cancer is present in other core or if you chose to confirm a suspicious focus in one or more cores in a case where the diagnosis of cancer has already been made. It may be considered necessary if done:
• For a suspicious focus and no other cores are positive
• Single core with minimal % tumor
• Single core contralateral to a positive core
• Identify tumor invasion of adjacent structures
• Determine origin of undifferentiated/poorly differentiated neoplasm
This draft also has specific instructions for lung specimens, chemosensitivity and resistant tumor profiling, cervical/gyn/bladder/kidney tumors, skin and sub q tissue and bone marrow cases.
With all of these cases you will be expected to document the designated block(s) on which the IHC/special stain is performed and the reason for the IHC/special stain testing. For IHC, the specific markers and for special stains the name of the stain. For IHC, whether a single antibody or a cocktail of antibodies is used. A statement such as “IHC/special stain confirms the diagnosis” will no longer be covered as reasonable and necessary.
APS will watch for updates on these policies. If and when this would be finalized we will provide additional information at that time.