Gapfill Pricing Inquiries
Notification of Reconsideration Period –
2013 Gapfill Payment Amounts
Clinical Laboratory Fee Schedule (CLFS)
For Calendar Year (CY) 2013, CMS used the gapfilling methodology to establish payment rates for Molecular Pathology Current Procedural Terminology (CPT) codes being paid using the Clinical Laboratory Fee Schedule (CLFS).
The gapfilling process requires the Medicare Administrative Contractors (MACs) to set payment rates using a broad range of information outlined in CMS’ Code of Federal Regulations (CFR) at 42 CFR 414.508(b).
MACs forwarded their interim contractor-specific payment amounts to CMS earlier in 2013, and CMS posted that information on our web site on May 9, 2013 at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/.
As outlined at 42 CFR 414.509(b)(2), the public had 60 days from the date of this web posting to comment to CMS about this information. CMS appreciates the comments that it received. Each comment was shared with the MACs and carefully considered in regards to the gapfilling decision.
On May 9, 2013, CMS posted contractor submitted gapfill prices and allowed for a 60-day public comment period. CMS shared all comments received with the MACs. On September 30, 2013, CMS posted National Limitation Amounts (NLAs) for 2014 followed by a 30-day reconsideration period. On November 29, 2013, CMS posted the final NLAs.
On September 30, 2013, CMS posted a NLA of $2,795.09 for CPT code 81211 – a test for the BRCA 1&2 gene. On November 29, 2013, CMS posted a NLA of $1,438.14 for CPT codes 81211 and 81214, a test for the BRCA 1 gene only. The NLA for code 81211 was based on the median of MAC submitted prices and is effective for tests performed on or after January 1, 2014.
Prior to a Supreme Court decision earlier this year, only one laboratory was providing tests for the BRCA gene. Following the Supreme Court decision, additional laboratories began providing the test. The MACs received data on the pricing by the laboratories offering the test. Based on the new information, the MACs submitted pricing information for CPT code 81211 that resulted in a NLA of $1,438.14.
As the public had not had an opportunity to provide comment on the new NLA for 81211, we provided an additional public comment period through January 27, 2014. At present, it is our understanding laboratories are offering the CPT code 81211 test for prices that range from approximately $900.00 to $2,900.00. As CPT code 81214 is similar to CPT code 81211, the additional comment period applied to both CPT codes 81211 and 81214.
CPT code 86152 was inadvertently omitted from both the September 2013 and the November 2013 CLFS files and is now reflected in the updated file. CMS also provided an additional public comment period through January 27, 2014 on the pricing of this code.
When we posted the file for the latest comment period, we did not show the MAC’s gapfill price data used to determine the NLA for each of the two test codes that changed between the September 2013 and the November 2013 CLFS files – CPT code 81211 and CPT code 86152. Therefore, we are posting this information and extending the comment period through February 28, 2014 so that the public has an opportunity to provide comment on this background information. Please submit comments to MoPathGapfillInquiries@cms.hhs.gov no later than February 28, 2014. CMS will not consider any comments that are not sent to this e-mail address. Please note that the NLA may change as a result of comments received through this process. Medicare contractor comments may also form the basis for a change in the NLA. If there is any revision to the pricing for either CPT code 81211 or CPT code 86152, the revision will be effective prospectively, from April 1, 2014.
Only the following CPT codes will be subject to public comment through February 28, 2014:
- 81211 (BRCA 1&2)
- 86152 (cell enumeration using immunologic selection and identification in fluid specimen)
- Page last Modified: 01/29/2014 4:16 PM
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