Wednesday, September 7, 2016

AMP Comments on Federal Policies - Gapfill

The Association for Molecular Pathology maintains an active webpage posting its federal policy positions - letters to MACs, to CMS, to NYS Department of Health, FDA, and others.  See the full current inventory, here.

In August, AMP posted three letters on molecular test pricing.  These cover, in order, this summer's gapfill/crosswalk process for January 2017 new codes; the current year's MAC gapfill process; and a very detailed molecular testing LCD from the NGS MAC.  Details after the break.

 The first letter, dated August 8, 2016, covers new test pricing proposals, as discussed in the CMS public meeting on July 18, 2016.  CMS is in the midst of pricing tests for its November fee schedule, effective January 1, 2017.   AMP's comment is aligned with its live presentation on July 18, but provides several pages and tables of additional detail.  AMP proposes an exon-based calculation, typical on 81435, hereditary colon cancer panel aka Lynch syndrome.  (81435 is sequencing; there is a separate code 81436 for dup del analysis).   For example, future 2017 code 814X5X is for cardiac channel ionopathies, which AMP calculates involves 254 exons vs. 163 exons for 18435; and they suggest a linear crosswalk multiple of 254/163 or 1.558 x 81435 or 1.558*$796.   Inherited cardiomyopathy panels get a higher multiple (468/163 or 2.871).   Similar math is undertaken for other sequencing codes, and, for other secondary dup-del codes.  Some of their recommendations are less obvious ("cross walk circulating fetal chromosomal microdeletions to 81435 as it has similar resource use.")

The second letter is critical of MAC proposals for pricing active 2016 codes which were put into the MAC gapfill process over the past nine months; letter date August 10, 2016.   "We remain concerned about many of the gapfill values submitted."

Regarding the current gapfill process, AMP writes:
....only NGS [MAC] submitted consistent values that closely resemble values for which gapfill criteria were applied. However, in the remaining cases, the preliminary NLAs are inconsistent with a number of the gapfill criteria and thus AMP cannot support pricing at this level. We encourage the remaining MACs to consider the approach that NGS used....We provide a few examples of such inconsistencies.
AMP was concerned too many pricing decisions were based on a comparison to 81445 (somatic tumor analysis, 5-50 genes) and this is a very different methodology than germline sequencing procedures.    For germline GSP codes, AMP provides tables of multiple-based values that MACs could substitute for their final proposals to CMS, e.g. 81432, hereditary breast cancer related disorders, 81435*1.822 ($796*1.822).

For a letter from another organization also critical of the same 2016 MAC gapfill process, see the letter from Coalition for 21st Century Medicine, here.

The third letter is a very detailed 30 page letter on the NGS MAC's comprehensive molecular testing LCD, covering a wide range of subjects point point by point.  The comment letter is almost the same length as the LCD, which is 29 pages long (here).