Thursday, January 17, 2019

Very Brief Blog: MolDx Covers Adaptive Biotechnologies ClonoSEQ Assay


MolDx has released a article providing coverage to the Adaptive Biotechnologies ClonoSEQ test.


On January 16, 2019, Monica Heger of Genomeweb published a long-form trade journal review article on the rapid rise of NGS methods for minimal residual disease testing (here).   FDA has a recent draft guidance document for this class of molecular tests (here).  FDA approved the first NGS based test on September 28, 2018, ClonoSEQ.

Article Released Today

CMS generally releases new articles and LCDs on Thursdays, and there's an important one today.  MolDx article A56270 gives coverage for the ClonoSEQ assay.  The article states:
Effective 03/16/2018, molDX has determined that clonoSEQ Assay testing is reasonable and necessary when performed on bone marrow specimens in patients with B-Cell acute lymphoblastic leukemia (ALL) or multiple myeloma. Medicare will pay for a single episode of testing using clonoSEQ in these patients. For a patient with ALL or multiple myeloma in whom clonoSEQ is being used according to its FDA cleared indications and clinical guidelines, it is anticipated that an episode of testing will typically require a baseline assay and 3 follow-up assays. This service should be billed at the start of the episode of testing.
The Article quotes the overlying NGS NCD text that " Contractors may cover up to one test per beneficiary per cancer diagnosis" and thus defines ClonoSEQ utlization as an episode of care (a baseline assay and 3 follow-up assays) that involves internal assays that are parts of one episode test.

Coverage at Genomeweb here.

Additional Sources

The CMS copy of the article is here and a cloud copy here.   ICD-10 codes listed in the article are in the C90.0X series for multiple myeloma and the C91.00 series for ALL.

See a 2018 press release about ClonoSEQ and the Amgen drug Blincynto (blinatumomab) here.  For an early (2016) but open access article on ClonoSEQ applied in B-cell ALL, here.  See the FDA classification order DEN170080 here.  (ClonoSEQ is a sole-source FDA authorized test.)  FDA Technical Summary here.  ClonoSEQ website here. Adaptive's website here.


Nerd notes.

ClonoSEQ is approved for B-cell ALL; despite the recent upgrade to ICD-10 and its "millions" of codes, there is one code for ALL...not specific to B or T cell.  There were almost no differences in ICD-9 and ICD-10 for cancers.

The CMS NGS NCD would cover ClonoSEQ automatically if it were a combination diagnostic.  Although its use is very similar to a combination diagnostic (it's for treating or not treating with a chemotherapy drug), it is not, technically, approved by FDA as combination diagnostic, so its coverage flows through the MolDx decision, not the NCD.

Super nerd note.

The NCD covers testing in "advanced cancer" (and disallows testing otherwise).  There was some question whether a hyper literal interpretation would be difficult for some cancers like leukemia and glioblastoma.  NCD defines "advanced cancer" as Stage III/IV, metastatic (usually a synonym), or recurrent/relapsed.   A new bad leukemia or glioblastoma is not stage III/VI (they don't metastasize, if GBM, and we don't use Stage in that sense for leukemia), and a new case would not be recurrent or relapsed.   Fortunately, CMS has avoided that rabbit hole and simply views leukemia and lymphoma as advanced cancers, per this article.