Tuesday, May 26, 2015

CMS Releases Draft Gapfill Pricing for 2015 Molecular CPT Codes

Addendum, September 2015: 
May 2015 draft gapfill prices discussed in this blog entry.  
Final September 2015 prices discussed here.
What is going on?
  1. CMS put 29 brand new molecular CPT codes into its contractor-based gapfill process on 1/1/2015.  This included high-profile new codes like "exome sequencing" and "tumor gene panel, >51 genes."
  2. By May, CMS contractors had come up with proposed prices for 10 of the 29 codes.  CMS has published those prices on a state-by-state basis (published May 26, 2015).
  3. CMS is accepting public comment on the proposed test prices until July 20, 2015.
  4. In July and August, Medicare contractors may review incoming public comments.  The contractors may hold, raise, or lower their proposed prices in August.  
  5. In September, CMS will publish the median price for each priced test.  This will become a national fee schedule price on 1/1/2016 and forward.   
What do we know so far?
  1. Contractors only priced 10 of the 29 molecular CPT codes.  19 were left blank.
  2. The more advanced test codes - for genomes, exomes, mitochondrial genomes, and sets of 51+ tumor genes - show no proposed prices at this point.
  3. The Genomic Health Oncotype DX test received a range of prices, between $2000 and $3400, with about half of the MAC regions reporting.

More after the break.

A more detailed explanation:

AMA CPT releases a new code set each fall, for codes that will be effective the coming January 1.   Normally, CMS prepares pricing for the codes between summer and fall.   It uses different methods to price physician services and lab tests.

Many of the molecular codes that became effective this past January 1, 2015, were not priced by CMS during 2014.  CMS national policy staff determined they could not administratively price the codes - such as "exome" and "genome" sequencing and "gene panels" for clinical conditions like cardiac or hearing disorders.   So, currently, from the beginning to the end of 2015, the codes are priced in stages by a "gapfill" process using the expertise of Medicare's regional medical directors.

On May 26, 2015, CMS released a round of draft gapfill prices on 29 CPT codes.  They pricing is open for public comment through July 20.   The CMS website for these prices is here.

Most of the codes received no pricing at all.  CMS released its draft prices on ten codes; the other 19 tests were left blank by the contractor medical directors.

After the public comment period, the harvest of which will be distributed to the contractors, CMS will collect final prices in August and publish them in September.   As a final step, CMS will assign each code the median of the MAC prices.  The assigned prices will become Medicare's national fee schedule prices.   (In 2013, CMS appeared to set median prices only if over half of the contractors submitted a price.)

CMS accepts public comment on the published proposed prices until July 20, 2015.  The full webpage (as found at CMS) is clipped below.

Brief Analysis

Below, note, I list the "average" of the several dozen columns in the CMS spreadsheet - CMS would calculate the median by eleven MAC regions and not by 50 states.  The standard deviation (SD) column gives a rough reference of whether reporting MACs had much difference in pricing, but again, it is an SD of the spreadsheet columns (states), not calculated per MAC region.

There are, by my count, 11 MAC regions, but three pairs are managed by one MAC (Noridian J-E, J-F; NGS J-6, J-K; Novitas J-H, J-L).   Not one of the 29 codes was priced by all MACs.  As many as 10 MACs priced one code, 81287.  As few as 1 MAC priced another code, 81445.   An edited table with all MACs and States, in the cloud, here.  A partial screen shot (illlustrating the table's appearance of randomly filled vs. empty cells) is below:

The text below is copied from the CMS Web site:

Calendar Year 2015 - New Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Gapfill Payment Determinations

This file includes test codes and interim prices, by locality, for clinical diagnostic laboratory tests that CMS determined should be priced by Medicare Administrative Contractors (MACs) for 2015 using the gapfilling methodology.  The criteria and process for gapfilling are specified in 42 CFR 414.508(b).  A reconsideration process for tests that are gapfilled is specified in § 414.509.  The final pricing file will be posted on the CLFS web site around September 2015 and will also include the national limitation amount and midpoint for each test.

If there is no price for a given code by a specific MAC, this may be due to one of several reasons, for example: 

  • There is no benefit category for the test;
  • There is no high quality evidence published in the peer reviewed literature demonstrating clinical utility for the Medicare population;
  • There is a lack of medical necessity: knowing the exact genetic sequencing will not change the treatment or prognosis of a beneficiary;
  • The MAC has not received a technical assessment that qualifies the test for coverage.

For more specific information on why a payment rate is not indicated in this file, please contact the local Medicare Administrative Contractor. 

The public is invited to submit comments on the preliminary pricing decisions.  Please submit any comments to glenn.mcguirk@cms.hhs.gov  by July 20, 2015. 

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