CMS’s National Coverage Determination for Next Generation Sequencing (NGS) – What Does This Mean for the Future of NGS Testing for Molecular Oncology?

I thought I’d take a break from the next generation sequencing (NGS) wet bench description this month to review news occurring in the world of reimbursement of testing of cancer specimens with next generation sequencing. As a tech, I don’t deal with the nitty gritty of insurance reimbursement of our tests on a day to day basis, but this one caught my eye as it would have had a real impact on the NGS testing in our lab. On November 30^th, 2017, a proposal was released by the Centers for Medicare & Medicaid Services (CMS) to review the national coverage analysis tracking sheet for NGS for Medicare beneficiaries with advanced cancer. In the original wording of the proposal, one thing it stated was that CMS should only reimburse NGS testing for advanced cancers when the testing was done with an FDA approved assay. This caught me, as well as many others in the molecular community, by surprise. The reason? Currently, there are only a few FDA approved assays on the market; much of the testing occurring right now for oncology assays by NGS are lab-developed tests (LDTs), including the ones that we run in our lab. Under the proposal’s language, these types of assays would not be reimbursed for Medicare patients (and where CMS reimburses, the major insurance companies follow), making it very difficult for us to continue the testing that we perform.

The process for a proposal such as this one includes posting the proposal, then allowing a period for public comments about the proposal. Six weeks were given for people to post their comments online, during which, 315 comments were left. These comments included praise to CMS for recognizing that NGS testing is increasingly useful for precision medicine, but also stressed the limitations of only allowing FDS approved assays to be used. Some comments pointed out how clinicians and pathologists work together in the institutions performing the NGS assays in a way that would be impossible if forced to use an assay from an outside institution. They also indicated how difficult it would be for all NGS testing to be performed by the very small number of FDA approved assays and how it is almost impossible for small academic institution labs to get FDA approval for assays due to the amount of money and time the approval process takes.

On March 16, 2018, the final decision memo was released with altered wording compared to the original and can be found here https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290 and is also shown below:

“A. Coverage

The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:

Patient has:
1. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and
2. 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
3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
The diagnostic laboratory test using NGS must have:
1. FDA approval or clearance as a companion in vitro diagnostic; and
2. an FDA approved or cleared indication for use in that patient’s cancer; and
3. results provided to the treating physician for management of the patient using a report template to specify treatment options.
The diagnostic laboratory test using NGS must have:
1. FDA approval or clearance as a companion in vitro diagnostic; and
2. an FDA approved or cleared indication for use in that patient’s cancer; and
3. results provided to the treating physician for management of the patient using a report template to specify treatment options.
4. Other

Medicare Administrative Contractors (MACs) may determine coverage of other Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by a 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).

See Appendix D for the NCD manual language.”

In part B, it addresses those assays that are not FDA approved, but are run in a CLIA-certified laboratory. This part was added in the final decision and makes it possible for non-FDA approved assays run in CLIA-certified laboratories to be reimbursed, dependent upon the local MACs. While this is a huge improvement over the previous, there are still questions regarding some of the wording and we will have to see how this affects testing for our patients. For example, in 1b, where it mentions repeat testing – some patients have multiple mutations that are followed over time for hematological malignancies – will this be considered repeat testing? It will remain to be seen. Needless to say, I am happy to be able to continue doing my job.

rapp_small