This article was corrected to noted that CPT code 86152 describes circulating tumor cell testing, not full sequencing of the BRCA 2 gene.
The Centers for Medicare & Medicaid Services has decided to revise the reimbursement for the CPT code describing BRCA testing from $1,438 to $2,184.
In public comments, industry stakeholders had criticized CMS for failing to follow gapfill procedures for establishing payment levels for molecular pathology codes when it finalized pricing in December for CPT code 81211 and 81214 at $1,438. Code 81211 describes a test for the full sequencing of the BRCA1/ 2 genes and code 81214 is for full sequencing of only the BRCA1 gene.
The price was taken by many, including BRCA testing market leader Myriad Genetics, to be an error in the price submitted by Medicare contractors to CMS. However, in a statement, CMS said this was not the case. "To our knowledge, there were no errors in the amounts posted for the molecular pathology codes on September 30, 2013," CMS said, further noting that contractors submitted prices for code 81211 between $995 and $2,800. Noridian, the contractor serving the jurisdiction Myriad is in, submitted $1,449 for the code and "informed CMS that the … price was appropriate" during the reconsideration period.
However, due to mounting industry concerns, CMS extended the public comment period regarding its gapfill payment amounts for BRCA1/2 testing until Feb. 28. During this time, the American Clinical Laboratory Association, The Coalition for 21st Century Medicine, the California Clinical Laboratory Association, and AdvaMed submitted comments to CMS asking the agency to reconsider its pricing for BRCA testing.
"Based on the information submitted during the two comment periods, we are revising the median price for CPT code 81211 to $2,200.00," CMS said.
Additionally, CMS reimburses more than $500 for Code 81213 describing BRCA1/2 large rearrangement testing. In a filing with the US Securities & Exchange Commission, Myriad noted that based on the CMS revision, the total reimbursement for integrated BRACAnalysis – including BRCA1/2 sequencing and large rearrangement testing – will be around $2,800.
Less than 10 percent of Myriad's total revenues for BRACanalysis come from the Medicare population. The company had submitted comments to CMS to try to sway the agency to revise its reimbursement of CPT codes that describe BRCA testing.
However, given the passage of HR4302 (see related story, in this issue), which included provisions that would base Medicare pricing for clinical lab tests on a weighted median of private payor pricing, Myriad officials feel assured that there will be no changes in Clinical Lab Fee Schedule pricing of these BRCA codes until the new scheme is slated to take effect in 2017. "We believe this is an important consideration because it gives us pricing stability and visibility on our current Medicare reimbursement rates for a three year timeframe," the company said in a statement.
The bill also includes a provision for newly introduced "advanced tests," where such complex, algorithm based tests or diagnostics approved by the FDA would be paid at the list price for three quarters before transitioning to market-based pricing. "We view this provision favorably as well as it will aid in predictability around value-based pricing for Myriad’s new tests," Myriad said.
In an unrelated note, in the final pricing released last year, CMS didn't list CPT code 86152, a new code for circulating tumor cell testing. This was an error, the agency admitted.
"While the [Medicare Administrative Contractors] 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 said, adding that the median price of the code is now $337 based on industry comments. There are a number of lab-developed tests that may be described by this code, including an FDA-approved test, called CellSearch.