Jurisdiction J Starts MolDX Program

on Tuesday, 12 June 2018.

Get Ready for Some Z Codes

If you scan through the coverage updates from the Medicare Administrative Contractors (MACs) found at the end of this article, you will notice several new draft Local Coverage Determinations (LCDs) for molecular diagnostic tests. The descriptions of these LCDs begin with “MolDX.” This is not surprising as molecular diagnostic testing (MDT) is one area of laboratory advancements that is having a tremendous impact on the practice of medicine overall. New molecular diagnostic tests are being developed and approved for coverage on a regular basis.  Human genomics is reshaping the medical approach to therapy and diagnosis in areas such as inherited genetic diseases, infectious disease, oncology, coagulation, predicting immune function, and predicting the efficacy of certain drugs.  As this testing has become more common, healthcare payers have struggled with determining the appropriate coverage and payment for these tests.

Medicare’s solution was the Molecular Diagnostic Services (MolDX) Program, which was developed by Palmetto GBA in 2011. The MolDX program performs the following functions, which solve the challenges of appropriate coverage and payment for molecular diagnostic tests:

  • Facilitates detailed and unique identification through registration of molecular diagnostics tests to facilitate claims processing and to track utilization.
  • Establishes clinical utility expectations
  • Completes technical assessments of published test data to determine clinical utility and coverage
  • Establishes reimbursement

Palmetto GBA currently administers the MolDX Program and all its information.  Several MACs participate in the program, including Palmetto JM, Noridian JE and JF, CGS J15, and WPS J5 and J8.  Each participating MAC has coverage policies and websites dedicated to the MolDX program. 

Since Jurisdiction J transitioned to Palmetto as their MAC earlier this year, providers in JJ will begin participation in the MolDX program effective July 1, 2018. Specifically, claims received on or after July 1, 2018 with dates of service on or after February 26, 2018 will require a Z-code on the claim line if the service is covered under the MolDX Molecular Diagnostic Testing (MDT) LCD L35025.

The program applies to all private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare Part A or Part B.  The following molecular diagnostic assays/tests are included in MolDX.

Code Category/Description2018 MolDX CPT Code Range
Tier 1 81105-81112, 81120-81121, 81161-81383
Tier 2 81400-81408
Genomic Sequencing Procedures 81410-81471
Molecular Multianalyte Assays (MAAA) 81490-81595
MAAA Admin Codes All codes
Immunology 86152-86153
PLA All Codes
Cytology 88120-88121
NOC 81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, 89398

Affected providers start by registering in the DEX Diagnostics Exchange if they plan to submit claims for the MolDX codes to MACs participating in the MolDX program. Then they must apply for and obtain a unique test identifier for each MDT or LDT (lab developed test) they perform. Hospital providers billing for molecular services performed by their hospital-based laboratory must register and obtain a unique DEX Z-CodeTM for each molecular test in the MolDX code ranges designated above. See MolDX Registration and Claims Submission webpage for more information.

Hospital laboratories are NOT expected to submit tests to obtain Z-Codes for tests sent to another laboratory to perform. They can obtain the DEX Z-CodeTM for the molecular test(s) from the performing laboratory, either directly or through the DEX system. Providers billing Part A for molecular tests performed by a proprietary or reference laboratory will “Request Sharing” in DEX, from the reference lab, to get access to the Z-Code for billing purposes. However, as stated in the MolDX FAQs, it is the responsibility of the billing provider to obtain a DEX Z-Code™ identifier, such as in cases where the performing lab is not in a jurisdiction under the MolDX program. Since reference labs performing genetic testing generally offer services across the nation, most will have already obtained the necessary Z-codes.

Once a Z-code is assigned, coverage is determined through a technical assessment (TA). Established FDA-approved tests with proven utility that are performed within labeling indications may not require a technical assessment. A TA is required for molecular assays that are laboratory developed tests (LDT), employ new or novel technology, or have undefined or unproven clinical utility. For these tests, labs/developers must submit a detailed dossier of clinical data to substantiate the test meets Medicare’s requirements for coverage. The Technical Assessment Submission Instructions provide the steps to submit a dossier. It is unlikely tests performed in a hospital-based laboratory would require a technical assessment since they generally already have proven utility.

Through the MolDX program assessment of clinical utility, the MACs will determine appropriate coverage. An LCD or Coverage Article will be developed conveying the reasonable and necessary limitations of coverage.  MDTs and LDTs not identified as covered in an NCD, LCD, or coverage article are not covered.  Palmetto GBA will continue to accept and consider requests on excluded genetic tests.  You can find a link to Palmetto’s LCDs, as well as list of covered and excluded tests, on Palmetto’s MolDX website.

Once approved and assigned, the unique test identifier (DEX Z-Code™) must be reported in conjunction with the appropriate CPT/HCPCS code on the claim. This allows Medicare to determine the exact test that has been performed, facilitating the process of making pricing and/or coverage determinations. Refer again to the  MolDX Registration and Claims Submission webpage for claim submission information. Part A providers will need to specify which lines are billed for MolDX and the appropriate DEX Z-Code per line within the remarks section of the claim.  

If you are a laboratory in Jurisdiction J, you need to be ready to start submitting Z codes by the first of next month. For all providers currently or soon to be affected by the MolDX program, we encourage you to check your MAC’s coverage policies and instructions on the MolDX program.

LCD updates since last month for all MACs are listed below.

Palmetto JJ and JM Coverage Updates

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A55945  Accreditation and Credentialing Requirements for Polysomnography LCD L36593  10/1/2018 N/A 10/2/2018 3/29/2018 New
A56008  MolDX: FDA Approved CLL Companion Diagnostic Test Coding and Billing Guidelines  6/7/2018 N/A N/A 5/31/2018 New
A55944  Billing and Coding for the Rezum® System for Benign Prostatic Hyperplasia (BPH)  5/7/2018 N/A N/A 3/27/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37779  Intraoperative Radiation Therapy  6/4/2018 7/19/2018 No  Draft
DL37761  Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor  6/4/2018 7/19/2018 No  Draft
DL37794  MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test  6/4/2018 7/19/2018 No  Draft
DL37785  MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease  6/4/2018 7/19/2018 No  Draft

 

CGS J15

IDTitleComment Start DateComment End DateFinal Status
DL37790  Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor  6/20/2018 8/6/2018 No  Draft
DL37787  MolDX: Corus® CAD Assay  6/20/2018 8/6/2018 No  Draft
DL37366  MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC)  6/20/2018 8/6/2018 No  Draft

 

First Coast JN

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L33279  Circulating Tumor Cell Testing  10/1/2015 5/12/2017 5/25/2018 5/25/2018 Retired 
IDTitleComment Start DateComment End DateFinal Status
DL37798  Noncovered Service - 4Kscore Test  5/17/2018 7/5/2018 No  Draft
DL37804  Noncovered Service – Dopamine Transporter Single-Photon Emission Computed Tomography (DAT-SPECT) with Iodine I-123 Ioflupane  5/17/2018 7/5/2018 No  Draft

 

National Government Services J6 and JK

IDTitleComment Start DateComment End DateFinal Status
DL37733  Biomarker Testing for Prostate Cancer Diagnosis  6/25/2018 8/8/2018 No  Draft
DL37808  Water Vapor Energy Ablation (WAVE) for LUTS/BPH  6/25/2018 8/8/2018 No  Draft

   

Noridian JE

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37086  Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder  5/14/2018 N/A  N/A  3/14/2018 New
A55970  MolDX: CDH1 Genetic Testing Billing and Coding Guidelines  7/15/2018 N/A N/A 5/24/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37729  Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor  6/7/2018 8/14/2018 No  Draft
DL37750  MolDX: DecisionDx-Melanoma  6/7/2018 8/14/2018 No  Draft
DL37746  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  6/7/2018 8/14/2018 No  Draft
DL37742  MolDX: Pigmented Lesion Assay (PLA)  6/7/2018 8/14/2018 No  Draft

   

Noridian JF

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37088  Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder  5/14/2018 N/A  N/A  3/14/2018 New
A55971  MolDX: CDH1 Genetic Testing Billing and Coding Guidelines  7/15/2018 N/A N/A 5/24/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37738  Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor  6/7/2018 8/14/2018 No  Draft
DL37748  MolDX: DecisionDx-Melanoma  6/7/2018 8/14/2018 No  Draft
DL37744  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  6/7/2018 8/14/2018 No  Draft
DL37740  MolDX: Pigmented Lesion Assay (PLA)  6/7/2018 8/14/2018 No  Draft

   

Novitas JH and JL

IDTitleComment Start DateComment End DateFinal Status
DL37792  4Kscore Test  5/17/2018 7/5/2018 No  Draft
DL37796  Sclerotherapy and Endovenous Non-Thermal Treatment of Varicose Veins  5/17/2018 7/5/2018 No  Draft

 

WPS J5 and J8

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A55703  Coding for Hemodialysis Sessions  9/15/2018 N/A N/A 3/16/2018 New
55951  Endometrial Hyperplasia Treatment with Intrauterine Device (Hormone-Eluting)  6/1/2018 N/A N/A 5/21/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37770  MolDX: CORUS® CAD ASSAY  6/7/2018 7/22/2018 No  Draft
DL37768  MolDX: CYSTATIN C Measurement  6/7/2018 7/22/2018 No  Draft
DL37766  MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs)  6/7/2018 7/22/2018 No  Draft
DL37772  MolDX: MDS FISH  6/7/2018 7/22/2018 No  Draft
DL37764  MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels  6/7/2018 7/22/2018 No  Draft

Article by Debbie Rubio

Debbie Rubio, BS, MT (ASCP), is the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc.  Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system.  In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers.  You may contact Debbie at This email address is being protected from spambots. You need JavaScript enabled to view it..

This material was compiled to share information.  MMP, Inc. is not offering legal advice.  Every reasonable effort has been taken to ensure the information is accurate and useful.

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