Clinical Lab LCD L40140: Allograft Rejection Molecular Testing — Bill by August 30
CGS LCD L40140 finalizes Medicare coverage criteria for molecular allograft rejection testing in KY and OH, effective August 30, 2026.
Action required by
August 30, 2026
Review the Action Required section below and ensure your team has completed all compliance steps before this date.
CGS Administrators has finalized LCD L40140, "MolDX: Molecular Testing for Solid Organ Allograft Rejection," establishing Medicare coverage criteria for molecular diagnostic testing used in transplant rejection workups for beneficiaries in Kentucky and Ohio. This is a final Local Coverage Determination — not a proposed rule — with a compliance effective date of August 30, 2026. Laboratories and revenue cycle teams billing Part A or Part B claims for these services in the CGS jurisdiction must align documentation and billing practices to L40140's specific criteria before that date or face denial.
Regulatory Background
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Quick answers
Does LCD L40140 apply to both independent laboratory Part B claims and hospital outpatient Part A claims in Kentucky and Ohio?
Yes. L40140 governs CGS coverage determinations for both Part A and Part B claims, meaning hospital-based laboratories billing on the 837I and independent laboratories billing on the 837P in the CGS Kentucky and Ohio jurisdiction are both subject to the LCD's coverage criteria and documentation requirements effective August 30, 2026.
Where do I find the specific HCPCS codes covered under L40140 for dd-cfDNA and gene expression profiling?
MolDX LCDs enumerate covered codes in a companion Billing and Coding Article rather than in the LCD body itself. Access the CMS Medicare Coverage Database record for L40140 at the source URL and navigate to the linked Billing and Coding Article for the authoritative HCPCS code list. Do not rely on codes from prior-jurisdiction MolDX articles, as CGS may implement a jurisdiction-specific article.
What clinical documentation must be in the record at the time of service to support a L40140-compliant claim?
Per L40140's coverage criteria, the medical record must document the solid organ transplant history, the organ type, and a clinical indication for a rejection workup at the time the molecular test is ordered. This documentation must be present in the ordering physician's record and retrievable on ADR — it cannot be reconstructed post-service. Review the full coverage criteria in the source document for any additional indication-specific requirements.
Content summarized from publicly available federal publications including CMS, MAC contractors, and the Federal Register. CLV Intelligence is not affiliated with or endorsed by any government agency. This is not legal or medical advice.