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Gapfill Pricing Inquiries

2014 Clinical Laboratory Fee Schedule Pricing Reconsiderations for Test Codes 81211 and 86152

Responses to Comments During the Additional Comment Periods April 1, 2014

Revised prices for CPT codes 81211 and 86152 for FY 14 are now posted at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/clinlab.html.  Below is a summary of comments received during the two additional comment periods and CMS responses.  

COMMENT: The NLA established for Current Procedural Terminology (CPT) code 81211 for 2014 will force providers to use lower-quality, lower-priced tests, rather than high-quality tests. 

RESPONSE:  CMS establishes one price for each code under the Clinical Laboratory Fee Schedule (CLFS) and does not establish separate prices for the test codes based upon the quality of the test results.  Providers are free to select the test that they believe is most appropriate for the patient. 

COMMENT:  Noridian’s listed price for CPT code 81211 in the September file was an error.

RESPONSE:  Noridian’s price for CPT code 81211 in the September 30, 2013 file was $1,449.09, which properly reflected the price that Noridian reported.  The $1,449.09 was based on data sources as outlined in 42 CFR § 414.508(b)(1).  Under the regulations at section 414.509(b)(2), CMS considers comments and other information during the reconsideration time period and may revise the national limitation amount (NLA) for the new test code.  During the reconsideration period, Noridian informed CMS that the $1,449.09 price was appropriate and CMS used that information along with other information in establishing the NLA.

COMMENT:  CMS did not have complete data that represented current market pricing when establishing the NLA for CPT code 81211 in November.

RESPONSE:  The gapfill process relies on prices reported by the contractors as described in the regulations at 42 C.F.R. part 414, subpart G.  The prices in the November 2013 file were based on information current at that time.  We have numerous data from our contractors that test prices at that time ranged from $995 to $2,800.  We based the median price on the information reported by the contractors.  During the two subsequent comment periods in 2014, three Medicare contractors provided additional information that they had received data indicating that the prices for CPT code 81211 ranged from $2,000 to $2,500.  Based on the available information, including the information submitted by contractors during the comment periods, we are revising the median price for CPT code 81211 to $2,200.00 (applying the -.75 update factor will result in the new NLA, effective April 1, 2014).

COMMENT:  The payment amount for CPT code 81211 cannot equal that of CPT code 81214. The commenter cited differences in the sizes of genes tested by CPT codes 81211 and 81214, and stated that since they are different sizes, it cannot cost the same to test one gene (BRCA1 and 2 vs. BRCA 1 alone). 

RESPONSE:  None of the prices of the molecular pathology tests on the CLFS are related to gene size.  As stated previously, CMS used the data it received from the contractors to set the payment rate contained in the November 2013 files.  The contractors understood the differences between the two tests but, based on information they received, believed that the prices they reported to CMS were appropriate.    

COMMENT:  CMS did not follow the correct procedure for gapfilling the molecular pathology tests.  Specifically, commenters were concerned that there were errors in the amounts posted on September 30, 2013, and that CMS accepted additional information from the Medicare contractors during this time period.

RESPONSE:  The regulatory guidance for the gapfilling process is set forth at 42 C.F.R. part 414, subpart G.  Our actions were consistent with these regulations.  We posted the interim contractor specific prices and accepted public comment, and, on September 30, 2013, posted the updated contractor specific prices (subject to the reconsideration process).  On November 30, 2013, we released the final NLAs to the Medicare contractors for payment beginning January 1, 2014.  Medicare contractors provided us with additional information during the reconsideration period.  To our knowledge, there were no errors in the amounts posted for the molecular pathology codes on September 30, 2013.  Given the concerns about the change in price during the reconsideration period, CMS provided two additional time periods for public comment. 

Based on the information submitted during the two comment periods, we are revising the median price for CPT code 81211 to $2,200.00 (applying the -.75 update factor will result in the new NLA, effective April 1, 2014).

COMMENT:  The payment rates posted in January 2014, established by the Medicare Administrative Contractors (MACs) as part of the gapfill process, are insufficient to cover the direct cost of CPT code 86152.  Also, CMS did not include the payment amount for CPT code 86152 on its September 30, 2013 file, so we were precluded from the ability to provide comments during the reconsideration period.

RESPONSE:  While the MACs had gapfill priced CPT code 86152, the pricing and code inadvertently were omitted from the September 30, 2013 file and were not posted on the November 2013 file.  CMS became aware of this omission and subsequently posted the NLA for CPT code 86152 in January 2014 and provided the additional comment periods to allow interested parties the opportunity to comment on the pricing.  During the two comment periods, CMS received additional detailed cost information regarding CPT code 86152.  Based on CMS’s review of the information, we are revising the median price for CPT code 86152 to $337.74 (applying the -.75 update factor will result in the new NLA, effective April 1, 2014).