Monday, August 3, 2020

MolDx Article Covers BRACAnalysis Germline CDx in Prostate Cancer; And the Little Puzzles

On July 31, 2020, Genomeweb ran an article that the MolDx program had agreed to cover Myriad Genetics' BRACAnalysis Germline CDx test for prostate cancer patients.  Early indications had been in ovarian cancer.

The Genomeweb article is here.  It points to MolDx article Palmetto A54338 here, updated July 17.  (Cloud copy of A54388 here.)

Some quiz questions of varying complexity.

  1. Why isn't this genomic CDx under the NCD for genomic companion diagnostics, NCD 90.2?
    1. BRACAnalysis CDx, as the article explains, is a Sanger test with PCR for large dup-dels. 
    2. The NCD 90.2 for cancer genomic testing applies only to "next generation sequencing" based tests.  See FDA P140020 here...BRACAnalysis CDx is a Sanger test.
      1. See NCD 90.2 here, look for Appendix B for full effective text.
    3. The Genomeweb article notes the FDA gave approval for this this drug, based on both germline Myriad BRACAnalysis CDx and for somatic mutation Foundation Medicine F1CDx.  
    4. Coverage for F1 CDx, an NGS test, falls under the CMS NCD.
    5. I think CMS may cover both tests (CDx BRCA germline and CDx BRCA FMI) if both are ordered.
  2. Why isn't this test coded by PLA code 0172U, which has CMS "ADLT" status?
    1. Myriad has another test, Myriad MyChoice CDx, which is a somatic mutation test of BRCA1, BRCA2, and other homologous repair deficiency genes.   0172U is a somatic test and this BRCAnalysis is a germline test.  
    2. CMS has granted the other test, 0172U, ADLT status (going back to December 2019), with CMS payments from January to September 2020 at the 0172U ADLT rate of $4040. 
      1. See PMA P190014 here.  
    3. Somatic MyChoice CDx (0172U) was approved for ovarian cancer for niraparib (Zejula).  
    4. At least as of today, I didn't easily find Medicare articles either for code 0172U or via keyword MyChoice CDx.  
  3. How is BRACAnlaysis CDx coded?
    1. The MolDx article from Palmetto says that BRCAnalaysis is coded as 81162, which is the standard everyday CPT code for combined BRCA 1-2 sequencing plus dup del analysis.  The 2020 fee schedule price is $1824.
    2. This suggests MolDx is not paying any premium for FDA approval status in this case.  There have been a few PLA codes that have been paid some premium over regular CPT codes due to having FDA approval status, but this has always been an uncertain and contentious process.  
      1. E.g. Qiagen is asking CMS to up-price code 0177U for PIK3CA this summer, due to its FDA status.  Here.
  4. How does MolDx usually code BRCA testing?
    1. MolDx frequently uses unlisted code 81479.  For example, in a Fall 2019 copy of the MolDx master edit file (via FOIA), 4,937 of 13,000 Z codes, or 38% of Z codes, were walked to the 81479 code for billing, of which 66% were "non covered."
    2. In the article revision history (see above), this BRACAnalaysis CDx testing was to be coded as 81479 before January 2019, but as 81162 after January 2019.
      1. This appears to reflect shifting MolDx usage of 81479.
    3. But: At least as of Fall 2019, there were quite a few Z codes for BRCA testing that the Master Edit File was crossing to code 81479 for $2395, much higher than the Fall 2019 fee schedule price for BRCA testing under regular code 81162.
      1. See screenshot below.
MolDx, BRCA tests under 81479 for extra pay at $2395, Fall 2019 (click to enlarge)

Myriad and PLA Codes

Myriad has at least PLA codes - 0172U for MyChoice CDx somatic BRCA, 0090U for MyPath Melanoma - both as ADLT codes.   As of the July (Q3) PLA cycle, the agenda for which AMA posted publicly on July 20, I haven't seen any sign that Myriad is applying for a PLA code for BRACAnalysis CDx.

Why didn't Myriad apply for ADLT for BRACAnalysis?

Short answer: I don't know.  Long answer: If BRACAnalysis was covered by Medicare before 1/1/2018, the current ADLT rules wouldn't fully apply (or at least, the intersecting ADLT regulations, policy, and definitions for what happens get really cryptic).  The test's approval seems to go back to 2014.

Future FDA Labeling Embedded in Article

The article A54388 promises that MolDx will cover future on label indications for BRACAnalysis CDx on a rolling basis.  


Myriad's BRACAnalysis has no PLA code and is a Sanger test.  MyChoice CDX in contrast IS an NGS code and DOES have a PLA code - 0172U.

In a transmittal dated July 31, 2020, CMS NCD instructions update to ensure that the NGS Cancer NCD, NCD 90.2, provides automatic coverage for 0172U.

See the NCD transmittal here.