Friday, November 30, 2018

Very Brief Blog: CMS Releases First Transmittal on NCD for Cancer Tumor Testing

In March 2018, CMS released its ground-breaking National Coverage Determination for next generation sequencing tests used in oncology. 

CMS has released its first official "transmittal to contractors" (MACs) on how they should implement the NCD.   This transmittal primarily replicates the effective coverage text of the NCD, and includes a long list of oncology codes that support payment under the NCD.   (The ICD-10 codes must be associated with patient qualifications, such as having advanced/metastatic cancer.)
  • Download the November 30 transmittal here
    • The PDF was very slightly updated after its initial release to clarify that one long set of ICD10 codes in the back (all solid tumor oncology codes) are for FMI CDx, and a one page set of lung codes is for Thermo Oncomine 0022U.
  • Since the NCD does almost nothing except cut/paste/replicate the NCD text, along with the full cut/paste of the ICD-10 oncology code list, it's unclear why it took eight months to be issued.

Workload and task instructions in the transmittal at 10878.4, 10878.5, request MACs to work collaboratively to ensure consistent editing and attend "up to 4 one hour calls" to discuss implementation of the NCD and to provide consensus recommendations on implementation in a "final report to CMS" (10878.5).

What This Is Not

This is not detailed claims processing instructions.  CMS states those will be released in the first as amendments to the CMS "Claims Processing Manual."   CMS says point blank in the introductory paragraph that "A subsequent CR will be released at a later date" with more claims processing instructions.

The NCD has a number of implications that are subject to interpretation, or on which experts disagree.  My best guess is that the Claims Processing Manual rules, when they come out, will generally quote from the existing NCD and may not resolve alot of the remaining fuzzy issues.

What It Says Re LCDs

Regarding coverage by LCDs, the transmittal says that:
Medicare Administrative Contractors may determine coverage of other diagnostic laboratory tests using NGS for patients with cancer only - 
when the test is performed in a CLIA-certified laboratory, ordered by the treating physician and the patient has: 
either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,• either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and,• decided to seek further cancer treatment (e.g. therapeutic chemotherapy).
A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer. 

MACs have covered NGS tests in women with breast cancer & and high family history, and Lynch testing in colorectal cancer, including when the cancer is not metastatic, so MACs will have to decide how to apply the above text in those situations.  (To not cover BRCA panel or Lynch panel in non metastatic patients can't possibly be an intention of the NCD authors, though, since they reviewed only CDx issues in cancer patients and didn't even touch the literature on BRCA panels or Lynch testing, so the effect of the NCD shouldn't pertain to those areas.) 

There are also puzzles such as a new first presentation of advanced leukemia, which isn't literally "recurrent" or "metastatic" or not known to be "refractory" since it hasn't had first-therapy yet, the words found in the bullet-points of the NCD.  But is surely "advanced cancer," the heading of the NCD as a whole.

The NCD covers gene panel testing in some situations that might seem surprising, such as if you have a very small, but recurrent, squamous skin cancer of the trunk (code C44.509).

CMS classifies some high-cost NCDs as payable by Part A/B rather than Medicare Advantage.  I haven't seen a statement that CMS has classified this NCD that way.