MolDX: BDX-XL2 LCD - R1

The following JE Local Coverage Determination (LCD) has been revised under contractor numbers 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), 01312 (NV).

Medicare Coverage Database (MCD) Number: L37504
LCD Title: MolDX: BDX-XL2
Effective Date: January 01, 2019
Summary of Changes: The LCD is revised as follows:

  • Changed the title of the LCD and all Xpresys references to BDX-XL2.
  • Removed "The test is ordered by a physician certified in the XL2 Certification and Training Registry (CTR)."
  • The following information is recorded: all clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors; PET result (if used), physician pre-test risk assessment, physician post-test lung nodule management recommendation, any subsequent procedures (non-invasive or invasive), and clinical diagnosis based on those procedures (i.e., benign or malignant)" from the Coverage Summary section.
  • Added additional data collected by Biodesix to the Analysis of Evidence section. Changed the Level of evidence strength from Limited to Moderate. Added reference #18.
  • Corrected a typographical error in the Analysis of Evidence sentence, "This contractor recognizes that evidence of clinical utility for the (BDX-XL2) assay for =40-year-old patients with an 8 to 30mm lung nodules and a pre-test cancer risk (as assessed by the Mayo Clinic Model for Solitary Pulmonary Nodules) of =50% is promising at the current time." Previous versions indicated "=40-year-old patients" and "of =50%," however in the last revision the "=" and "=" symbols were inadvertently replaced with "=." Removed a reference to Xpresys and replaced it with BDX-XL2 in the Clinical Validation section.
  • Removed 81599 in CPT/HCPCS Group 1 and added 0080U, per the 2019 Q1 CPT/HCPCS Annual Update and is effective 1/1/2019.

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Last Updated May 08, 2019