Pathologists and coders should be aware of Medicare guidelines that impose a range of medical necessity restrictions on the use of immunohistochemistry (IHC) and special stains in the examination of tissue sections.

In July 2016, a Comparative Billing Report (CBR) was sent to 4,000 pathologists nationwide identified by the Centers for Medicare & Medicaid Services (CMS) as having billing patterns for gastric biopsy services outside the norm for their area. CBR201610 did not identify overpayment, required no response from providers and was sent solely for educational purposes.

The report did, however, compare each pathologist’s calendar 2015 billings for three IHC stains; 88341, 88342, 88344, and three special stain codes; 88305, 88312, 88313, with state and national averages. Accompanying educational material, including a webinar, help desk, and frequently asked questions, provided details about CMS’ new special stain and IHC standards. The CBR was developed by Medicare contractor eGlobalTech in conjunction with Palmetto GBA, the carrier for Medicare Jurisdiction 11.

Organizations or pathologists that received CRBR201610 should familiarize themselves with the stain standards outlined in the CBR and contact their Medicare Administrative Carrier (MAC) to ensure that they’re meeting necessary requirements. They also should examine the 2015 cases identified in the CRB and be prepared to explain the higher stain volumes and ratios.

LCD designed to reduce overutilization

The CBR reflects broad guidance provided in a Local Coverage Determination (LCD) dealing with IHC and special stains that has been adopted by four regional MACs: Palmetto GBA, Noridian Healthcare Solutions, First Coast Service Options and CGS Administrators. A fifth MAC, WPS Health Solutions, has released the LCD in draft form.

Unlike the CBR, which was focused solely on stain use as it relates to gastric biopsy services, the underlying LCD addresses IHC and special stains utilization across every major body system. The new rules are meant to curb overutilization: Medicare spending for lab services increased 29% between 2005 and 2010, versus an increase in Part B enrollment of just 10% over the same period. According to a 2014 Department of Health and Human Services Office of Inspector General (OIG) Report, more than 1,000 labs had unusually high billing for Medicare lab tests in 2010.1

Additional documentation required for IHC and special stain use

The LCD was initially issued by Palmetto GBA in October 2015 and is designed to help ensure medical necessity for both IHC and special stain use. As a result, pathologists will need to provide more detailed documentation to justify stain use in certain circumstances.

For example, when it comes to IHC testing, a statement alone in the pathology report asserting that “IHC confirms the diagnosis” will not by itself be considered reasonable and necessary. Instead, the surgical pathology report is expected to:

  • Designate the specific block or blocks upon which IHC testing is performed
  • The reason for IHC testing
  • Specific markers
  • Whether a single antibody or multiplex stains are utilized

Additionally, three long-standing pathology practices involving special stains identified in the LCD are no longer considered medically necessary. These include:

  • Pre-order of special stains without review of routine hematoxylin and eosin (H&E) stains.
  • Utilization of special stains without clinical evidence that the stain is actionable or changes patient management.
  • Utilization when a diagnosis is already known based on morphologic evaluation of the primary stain.

According to the LCD, a pathologist may perform additional tests, including special stains which have not been specifically requested, under the following circumstances:

  • The services are medically necessary so that a complete and accurate diagnosis can be reported to the treating physician or practitioner;
  • Results of the tests are communicated to, and are used by, the treating physician or practitioner in the treatment of the beneficiary; and
  • The pathologist documents in his or her report why additional testing was done.

The LCD provide specific guidance relating to the use of special and/or IHC stains in a range of diagnostic areas, including chemosensitivity and resistance tumor profiling, breast, gastrointestinal, prostate, lung, cervical, bladder, kidney, skin and cutaneous and bone marrow body systems.

Need more information?

View our recorded webinar “Examining LCDs on IHS and Special Stains,”

Presented by Laura Edgeworth Spaulding, HTL (ASCP), McKesson Business Performance Services for Pathology

Recorded Webinar

1Questionable Billing for Medicare Part B Clinical Laboratory Services,” Department of Health and Human Services, Office of the Inspector General, August 2014

McKesson Helps Meridian Laboratory Physicians Navigate Difficult Waters
Leigh Polk

About the author

Leigh Polk is a Pathology Marketing Specialist with McKesson Business Performance Services