Thursday, November 5, 2015

Medicare Releases CY2014 Utilization of Part B Genomic Tests

Data on CMS payments for CY2014 genetic CPT codes have been released.  Total payments were about $650M in Part B; about 10% flowed through "Tier 2" codes.  The top five codes by total dollar volume including the winner - 81401Tier 2, Level 2; followed by two CYP genes and the clotting factor genes Factors 2 and 5.  Just 3 codes captured 55% of the $650M spend.

Every fall, Medicare releases a "National Summary Data File" for Part B data for the previous year, listing the payments for every AMA CPT code.   (In the last two years, Medicare also releases vast datasets which show CPT code pyaments by physician).

To see Part B CY2014 payments broken out by CPT code, line by line, see the CMS website: here.

That's the full data set for all CPT codes.  I culled genomic test codes, in the cloud, here.

Some highlights are shown in the screen shots below.  The top table is sorted based on the number of services.   The lower table is sorted by dollar volume per genetic CPT code.

For top number of services paid by Medicare, Tier 2 Level 2 is the winner, at 422,649 services.  Payments per service are only about $110.

Just behind 91401 are several CYP genes and then hematology genes (F5, F2).  The unlisted codes 81479 and 83999 come in at about $70-80M each and circa an average payment of $1000 each.  Given the size of the payments, this are likely often molecular tests and not other uses of the clin chem unlisted code.  In CY2014 much of the unlisted codes were likely MAAA tests.

Code use is highly concentrated.  3 codes account for over half of dollars spent, and 20 codes account for about 95%.   Total spending for genetic test codes (including a couple unlisted codes, as mentioned) was about $650M.

Use of Tier 2 codes was as follows.  About 10% of all payments flowed through Tier 2 codes.

Appying the number of services, in 2014, to the number of genes in each Tier 2 level (using 2014 names of genes data), we can calculate a blunt average of the number of times a gene name listed in a Tier 2 level was paid by CMS.  Of course, the actually usage is surely skewed to the most popular genes in each tier, but no data at the level of gene name is available.

I have heard that the AMA CPT committee uses a rough rule of thumb of 3,000-5,000 uses per year as a line between Tier 2 status and Tier 1 (regular CPT code) status.  If this were so, and if usage were distributed evenly, all of the 76 genes listed under level 81401 would be eligible for Tier 1 (an average use of 5,561).   In contrast, all of the 128 gene names listed in 81405 are used a blunt average of once for CMS patients.

Despite the large volume of payments shown above for CYP and other pharmacogenetics tests, CMS coverage policies are generally written narrowly (as are policies of most private payers).

  • For the MOLDX policy on CYP testing as of November 2015, see here.   For an interesting article discussing the LCD rationale, written by MOLDX, see here.   
  • For a JAMA Internal Medicine article on "clinical utility" of FDA pharmacogenetic labeling, here.
  • A MAAA code for "comprehensive pharmacogenetic testing" appears on the February 2016 AMA CPT agenda, my note on this, here.
  • For two (subscription) articles on CYP testing and pharmacogenetics coverage battles, see Genomeweb on Genelex (November, 215, here) and GnomeDx (November 2015, here.)

Prices per test are a bit lower than full CMS fee schedule prices due to deductibles.