Tuesday, August 13, 2019

Very Brief Blog: Association of Molecular Pathology's Elaborate Position Statements Page

The Association of Molecular Pathology (AMP) has a long record of producing active, detailed policy statements and position letters, some on its own, some in collaboration with other groups (such as College of American Pathologists, CAP). 

It's worth checking out form time to time, and the webpage is in a clear and accessible format.

  • Find the open access AMP policy page here.
Just a few of the recent comments on that webpage include:
  • July 25:  Opposition to Patent Reform Legislation; see also June 3
  • June 20:  Comments on MolDx LCD DL38047 for NGS in myeloid malignancies
  • June 20:  Comments on MolDx LCD DL38045 for NGS in solid tumors
  • June 10:  Position on DTC genetic testing
  • May 29:  Comments on Medicare NCD for NGS Testing in Cancer
  • March 18:  Comments on USPSTF Proposed BRCA Update
  • March 4:  Comments on NCCI Edits for Multiple Tests
The June 20 comments wrestle with MolDx's attempt to craft reasonable policies under some of the poorly written or even ridiculous aspects of the CMS NCD on NGS testing.   After much protest in early 2019 (see trade journal articles and AMP's February 1 letter to CMS), CMS took a comment period May 29-April 29 on how the NCD could be revised.  CMS will issue proposed revisions for another round of public comment by October 29.

In solid tumors, the CMS NCD covers an NGS test only if it has not been used before in the same primary diagnosis of cancer...that sounds like coverage x1.   AMP/CAP note that when tumors are relapsed, recurrent, or simply metastatic, they often show gains and losses in mutations, "rendering them, in effect, new cancers."   MolDx may have been thinking this too, since it seemed to narrow the CMS instruction to apply only to tests performed "on the same tumor specimen." 

On the other hand, the LCD might seem to provide coverage more narrow than the NCD (a scenario which is not allowed), since the NCD covers "any FDA approved NGS test" as long as it has not been performed before.  Seemingly the NCD might be read to allow two different FDA NGS tests to be performed on the same specimen, since, simply, neither has been performed before.  While the LCD says that a CGP (comprehensive genomic profiling) test won't be allowed if another CGP has been performed on the case.  Technical!

AMP Meetings

AMP's annual meeting will be November 7-9, 2019, in Baltimore.  Here.  It looks like registration is $675 member, $850 non-member.  (That's a $175 delta; for $200 you can become a member, so a net cost of $25 if you're going to the meeting anyway).

AMP will also host a "Molecular Pathology Economics Summit" in Washington, Friday, September 20, 2019.  Here.  It look like registration is $975 for for-profit organizations, $375 for non-profit. The preliminary agenda is online here.