Update: Special Histochemical and IHC Stain LCDs

Upon the implementation of ICD10 in October, 2015, CMS updated many LCDs, which no longer listed allowed diagnoses but provided coverage indications, limitations and medical necessity policy for Special and IHC Stains.  This was discussed in APS’ White Paper acknowledging that Cigna Adopted LCD L35986 (updated 6/27/16).

As a recap, the LCD applicable, after implementation of ICD10 for these stains first indicates that it is not meant to designate specific stains to be used in differential diagnosis of tissue or neoplasms because this information is readily available in text books and various scientific publications.  The policy instead identifies medically necessary criteria for the use of these stains based on claims reviews and overutilization or incorrect billing for the services which includes:

• Reflex templates or pre-orders for Special Stains and/or IHC stains prior to review of the routine 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 added stains when the diagnosis is already known based on morphologic evaluation of the primary stain

Since our last newsletter, LCD L35986 has been superseded and republished on the CMS website.  There were no changes to the entire LCD, but only to the section pertaining to prostate cases.  The changes are meant to further outline where ordering IHC stains on prostate cases are medically reasonable and necessary.  The LCD states that “prostate cases that may require reasonable and necessary IHC staining include, but are not limited to, the following” (changes in this section are highlighted in red below):

• Indeterminate/suspicious focus and no other cores are positive for cancer;
• Single worrisome core with minimal % tumor (roughly <5%);
• Worrisome core contralateral to a positive core(s):
  • In a multi-part biopsy with Gleason 3+3=6 cancer in 1 part, and atypical small acinar proliferation (ASAP) suspicious for Gleason 3+3=6 cancer in other part(s); the number of positive biopsy sites and % core involvement of these sites can affect therapeutic choices for active surveillance (AS), focal therapy or surgery;
  • In a multi-part biopsy with 4+3=7 or 4+4=8 cancer in 1 part, and ASAP suspicious for the same grade cancer in other part(s); workup is justified since the extent of high grade cancer affects treatments
• Identify tumor invasion of adjacent structures;
• Determine origin of undifferentiated/poorly differentiated neoplasm, such as bladder vs prostate;
• Other unexpected results when specific cell stains would be necessary

 Additionally, CMS added verbiage to this section of the LCD to highlight when IHC should not be used.  CMS states, “Prostate cases when IHC workup is not reasonable and necessary include the following”:

• In a multi-part biopsy with =3+4=7 cancer in 1 part, and ASAP suspicious for 3+3=6 cancer in other part(s), because stains are unlikely to change treatment; or
• In a multi-part biopsy with =4+3=7 cancer in 1 part, and "atypical cribriform lesson" (ACL) suspicious for intra-ductal carcinoma versus invasive, Gleason pattern 4 cancer in other part(s), because intra-ductal carcinoma is almost always closely associated with invasive high-grade cancer.

There were no other changes to this LCD in its current version.  The full LCD can be found at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35986&ContrId=228&ver=7&ContrVer=2&CntrctrSelected=228*2&Cntrctr=228&name=CGS+Administrators%2c+LLC+(15102%2c+MAC+-+Part+B)&DocType=Active%7cFuture%7cAllProposed&LCntrctr=228*2&bc=AgACAAQAAAAAAA%3d%3d&

APS’ coding team continues to work hard to ensure our client’s compliance and revenue are not at risk through routine coding and documentation audits.  As the first year of ICD10 comes to an end, we will continue to monitor this and other LCDs implemented by all MACs and provide necessary feedback to ensure your billing integrity.