NCD Released: NGS Testing OK with Medicare
Providers can now be reimbursed for Next Generation Sequencing (NGS) tests for specific cancer situations, a national coverage determination (NCD) by Medicare, the Centers for Medicare & Medicaid Services recently announced.
For medical coders working with advanced cancer patients who may be able to be treated based on the genetic makeup of the cancer, this allows another aspect of patient care and documentation.
What the New NCD Said
Genetic variations in a patient’s cancer can, in concert with clinical factors, predict how each individual responds to specific treatments. CMS said a report of results of a diagnostic laboratory test using NGS can contribute to predicting a patient’s responds to a given drug. The test must be performed before the treatment, and it must fulfill the following criteria:
The patient must suffer from:
- either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and
- either not been previously tested using the sames NGS test fo the same primary diagnosis of cancer or repeat testing using hte same NGS test onlyu when a new primary cancer diagnosis is made by the treatment physician; and
- decided to seek further cancer treatment, such a therapeutic chemotherapy.
The diagnostic laboratory test using NGS must have:
- FDA approval or clearance as a companion in vitro diagnostic; and
- an FDA approved or cleared indication for use in that patient’s cancer; and
- results provided to the treating physician for management of the patient using a report template to specify treatment options.
And, medical coder, before you submit your claim to the patient’s Medicare Administrative Contractor (MAC), know that the MAC can only pay if the test is performed in a CLIA-certified laboratory and the patient has fulfilled the list above.
NCD Outlines Tests
The federal government has determined which tests are acceptable for the NGS testing:
- FoundationFocus CDxBRCA (Foundation Medicine, Inc.) – This test is used to find BRCA1 and BRCA2 alterations in FFPE ovarian tumor tissue. The test is used in patients for whome Rubraca (rucaparib) is being considered.
- F1CDx (Foundation Medicine, Inc.) – This diagnostic device detects substitutions, insertion and deletion alterations, and copy number alterations (CNA) in 324 genes and selet gene rearrangments. It’s also used for to detect microsatellite instability (MSI) and tumor mutational burden (TMB).
- Oncomine Dx Target Test (Thermo Fisher Scientific, Inc.) – This test uses targeted NGS technology to detect single nucleotide variants and deletions in 23 genes in DNA and fusions in ROS1 in RNA isolated tumor tissue samples for patients with small cell lung cancers.
- Praxis Extended RAS Panel (Illumina, Inc.) – This test uses targeted NGS for the detection fo f56 specific mutations in RAS genes [KRAS (exons 2,3, and 4) and NRAS (exons 2,3, and 4) in DNA extracted from colorectal cancer tissues. It aids in identification of patients with colorectal cancer for treatment with Vectibix (panitumumab) based on a no mutation test result.
- MSK-IMPACT (Memorial Sloan Kettering Cancer Center’s Integrated Mutaion Profiling of Actionable Cancer Targets) – This test identifies the presence of mutation in 468 genes and molecular changes in eh genomic makeup of a patient’s tumor. It provides information son somatic mutations and microsatellite instability.
How Do We Code This?
There are some problems with this CMS must sort out. CMS acknowleged the proposed cover and current coding structures don’t agree, as two laboratories may bill under the same genomic sequencing CPT code to measure the same 12 genetic loci, with one lab using NGS technology while another may not.
CMS assures it will “operationalize coverage for these tests through coding and payment. CMS expects to provide operating instructions to MACs to use HCPCS codes only when CPT codes are unavailable or don’t meet the medical coder’s needs. Assignments of any new codes will be made on a quarterly basis.