Is Your LDT Headed Down a Dangerous Path?
Does your go-to-market (GTM) plan include using existing test component codes in a code stack to obtain reimbursement?
Billing multiple codes (one for each step of the testing process) does not provide any indication of the analyte being tested, which can be problematic, as it leaves health plans in the dark about what they’re paying for. For this reason, CMS moved away from methodology-based code stacking and embraced AMA’s analyte-specific MoPath codes in 2013. Code stacking creates a risk around fraud and non-payment.
Are Your Studies Positioning Your LDT Properly?
Medicare has been adamant over the past several years that if a test isn’t represented by a singular code, the answer would be to bill a miscellaneous code. This is an area that has gotten several labs in hot water with clawbacks, audits, and in some cases even worse – criminal charges.
Miscellaneous codes can create unnecessary churn, documentation, delay, and often face no set payment rate.
Screening tests are those that are performed in the absence of signs, symptoms, complaints, personal history of disease, or injury and are not covered except when there is a statutory provision that explicitly covers specific tests.
Don’t let a complex and confusing landscape take you down the wrong path, costing you millions of dollars, and perhaps your company. Have your GTM plan and market access roadmap evaluated by the right experts who have decades of experience successfully commercializing hundreds of medical technologies in the US.