Article ID Number: A57970 Status: A-Approved

Article Title: Billing and Coding: MolDX: HLA Testing for Transplant Histocompatibility

Original Article Effective Date: 04/06/2020

Revision Effective Date: 12/17/2021

Article Text:

Medicare covers the following solid organ transplants: kidney, heart, lung, heart/lung, liver, pancreas, pancreas/kidney, and intestinal/multi-visceral. Medicare also covers stem cell transplants for certain conditions.

Claims for CPT^® codes used to describe Human Leukocyte Antigen (HLA) testing used for transplant histocompatibility testing will be denied. See below for further explanation on correct billing for these services. This does not refer to HLA testing for non-transplant services.

HLA testing for histocompatibility testing as part of transplantation are part of solid organ acquisition services.

Services for organ transplants must be billed as described in the Centers for Medicare and Medicaid Services (CMS) Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Inpatient Hospital Billing, Chapter 3 Section 90 and as described in the Electronic Code of Federal Regulations, Title 42, Public Health, Part 412 Prospective Payment Systems for Inpatient Hospital Services. The acquisition costs of hearts, kidneys, livers, lungs, pancreas, and intestines (or multivisceral organs) incurred by approved transplantation centers are paid on a reasonable cost basis by approved transplant centers; they are not billed as stand-alone laboratory services.

HLA typing is a component of the acquisition services for an allogeneic stem cell transplant as well. Payment for these acquisition services is included in the MS-DRG payment for the allogeneic stem cell transplant when the transplant occurs in the inpatient setting and in the OPPS APC payment for the allogeneic stem cell transplant when the transplant occurs in the outpatient setting. The Medicare contractor does not make separate payment for these acquisition services, because hospitals may bill and receive payment only for services provided to the Medicare beneficiary who is the recipient of the stem cell transplant and whose illness is being treated with the stem cell transplant. Unlike the acquisition costs of solid organs for transplant (e.g., hearts and kidneys), which are paid on a reasonable cost basis, acquisition costs for allogeneic stem cells are included in prospective payment.

Acquisition charges do not apply to autologous transplants.

HLA CPT^® codes unrelated to transplant testing have coverage as outlined in the following Local Coverage Determinations (LCDs):

• CPT^® 81381-The MolDX: Pharmacogenomics Testing L38335 LCD addresses limited coverage for gene-drug interactions.

• CPT^® 81383 - The MolDX: HLA-DQB1*06:02 Testing for Narcolepsy L36551 LCD addresses non-coverage of HLA-DQB1*06:02 typing for the diagnosis or management of narcolepsy.