Medicare has a National Coverage Decision on Human Tumor Stem Cell Sensitivity Assays (NCD 190.7) which addresses two distinct types of assays:

• Human Tumor stem cell drug sensitivity assays, and
• Fluorescent Cytoprint Assays

The NCD specifically notes noncoverage of these two specific assays.

In October 2003, CMS notified all contractors that “[The NCD] was very specific to those tests and does not include tumor cell sensitivity or resistance testing on any other class of cells other than tumor stem cells.  Contractors have the discretion to determine whether drug response assays on any tumor cell line other than tumor stem cells are reasonable and necessary.”  In 2006, Medicare officially recognized cancer chemosensitivity tests as a special test category in Federal Regulations (42 CFR 414.510(b)(3), 71 FR 69705, 12/01/2006).

Highmark Medicare Services has been providing coverage for in vitro chemosensitivity and chemoresistance assays performed in its Part B contractor jurisdiction (Pennsylvania Part B) since mid-2004, per Individual Consideration for those indications supported by peer-reviewed clinical literature and “generally accepted” in the medical community.

Specifically, the laboratory Precision Therapeutics, Inc., located in Pittsburgh, Pennsylvania, provides In Vitro Chemoresponse Cultures, In Vitro Chemoresistance Assays, and In Vitro Chemosensitivity Assays via their ChemoFx^® process.  As the services are provided in Pennsylvania, all assays performed by Precision Therapeutics are billed to the Pennsylvania Medicare Part B contractor, Highmark Medicare Services.

Precision Therapeutics, Inc. (PTI), has provided peer-reviewed literature on their chemoresponse assays, as well as hundreds of letters of support for their assay’s clinical utility, from Oncology and Surgical Oncology physicians and practices from across the country.

In addition to the current peer-reviewed literature [e.g., Gallion H. et al (2006) Progression-free interval in ovarian cancer and predictive value of an ex vivo chemoresponse assay. Int J GYN Cancer 16:194], PTI has numerous clinical studies in the pipeline.

As no specific CPT/HCPCS codes exist to adequately and fully describe the Chemoresponse Assays, those services have been billed to Medicare utilizing the “Not Otherwise Classified” (NOC) CPT code 89240, with the proper description of the service noted in box 19 or its electronic equivalent.

Highmark Medicare Services has not limited coverage of the number of assays per tumor culture, but rather has worked with PTI to establish “reasonable and necessary” numbers of assays per individual tumor and patient treatment options.