Noridian's August 4, 2015 article is here.
For the full article, as available on August 12, 2015, copied here:
Noridian Healthcare Solutions Announces MolDX Expansion to JF and JE A
All laboratory service providers in Jurisdictions E and F both Part A and Part B providing Molecular Diagnostic Testing (MDT) must register those MDT procedures/services with Palmetto GBA dba the CMS MolDX Contractor and McKesson Health Solutions and submit coverage requests to Palmetto GBA prior to consideration for reimbursement.
As a CMS contractor, Noridian must determine reasonable and necessary services and apply fair reimbursement to services that are provided to Medicare beneficiaries. Noridian will work together with the CMS MolDX Contractor to determine coverage. Such decision making includes a technical assessment of the test as well as its clinical utility in the care of a patient in accordance with the Medicare statutes and rules.
For a wide range of laboratory and molecular diagnostic services, correct coding is complicated because the available CPT® code descriptions do not identify the specific test/service performed.
The vast numbers of new diagnostic and molecular assays entering the market magnify these issues. To address these vulnerabilities, the MolDX program, a laboratory and molecular diagnostic services program, has been developed to meet the following objectives:
- Identify the specific services performed and billed to Medicare
- Collect and analyze claim submission data
- Develop correct coding/billing guidelines to report services
- Determine coverage for services
- Determine a fair reimbursement for services within current CMS guidelines
This program is currently in effect for Jurisdiction E Part B and will be effective in Jurisdiction E Part A, October 1, 2015.
For Jurisdiction F, both Parts A and B, the program effective date will also be October 1, 2015. Please note that at this time the program also includes the following four LCDs that became effective for Jurisdictions E and F, Part A and B on June 22, 2015:
- CYP2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing
- MolDx: Breast Cancer Index Genetic Assay
- MolDx: ConfirmMDx Epigenetic Molecular Assay
- MolDx: Genesight Assay for Refractory Depression
The MolDX program defines a clear, evidence-based process to ensure clinical quality and to manage molecular diagnostic services and the associated impact that they have on cost.
The program requires a registration process to:
- Create/maintain a master catalog/test registry
Identification and cataloging of all known molecular diagnostic tests, assessment status, and the final CMS coverage determination and code assignments will be maintained in an electronic, readily accessible, Internet-based registry with secure information access levels for CMS, administrators, and the provider community. Click here,https://www.ncbi.nlm.nih.gov/gtr/genes/ 
, to find out more about the master catalog/test registry or to register a test.
- Provide objective, evidence-based assessments for each test
In addition to evaluating analytical and clinical validity data, this project will provide a comprehensive assessment of clinical utility. Subject-matter experts will evaluate tests and develop coverage recommendations to CMS. For more information, please refer to the MolDX Contractor's website (link at the bottom of this article).
- Provide test specific description recommendation
Subject-matter experts will review new test literature and design unique descriptions or designate current appropriate descriptions to facilitate the CMS development of unique codes for appropriate utilization tracking and potential payment.
- Provide reimbursement recommendation
The CMS MolDX Contractor will review the overall test elements and make a value based recommendation for each test.
MolDX will be supported by the Molecular Diagnostics Tests (MDT) LCD, effective October 1, 2015. The program establishes a clear, evidence-based process to ensure clinical quality and to manage molecular diagnostic services and the associated healthcare cost impact. The CMS MolDX Contractor has contracted with McKesson Health Solutions to configure and maintain a Master Test Code Registry that will increase the efficiency and transparency of the evaluation and valuation of the affected procedures/assays.
- A/B MAC affected by this Project: Jurisdictions E and F
- Diagnostic services affected: Molecular Diagnostic Testing (MDT) refers to any laboratory assay that quantifies a measurable characteristic of the patient care process at the molecular level. This includes gene tests (e.g. DNA or RNA, reported with appropriate codes), infectious disease probes, tumor markers (any type), pharmacogenomic assays, selected predictive and/or risk assessment interpretative scores, and any other molecular test, with or without an existing CPT or HCPCS code that does not specify ONE test per ONE code. Multi-variant Molecular testing (MVMT) is considered a subset of Molecular Diagnostic Testing (MDT).
- Provider Requirements: Obtain a unique test identifier for your test from McKesson and register MDT procedures/services with the CMS MolDX Contractor and submit coverage requests.
- Timelines: Claims for MDT will NOT be considered for adjudication unless the test in question has been submitted to the test registry for review and a McKesson Z-Code Identifier has been assigned to the test. Following this process the MolDX contractor in coordination with Noridian will determine coverage for that particular test/assay. Please refer to the links below for further information in how to properly register your test(s)/assays with the CMS MolDX Contractor and McKesson.
For more information, please refer to MolDx Frequently Asked Questions .
Last Updated Aug 04, 2015
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As of August 12, 2015, and per the CMS Coverage Database for LCDs, Jurisdiction E had 15 LCDs for which the final period had closed between December 2013 and August 2015 that had not yet been "released to final." But half of these had been part of the June-August comment cycle.
Of these 15 LCDs, 11 were laboratory test LCDs, of which all but 1 (drugs of abuse) is branded as a MolDX LCD. Of the 11 laboratory test LCDs, 7 were in the recent June-to-August comment cycle. One insight is that while lab tests may be "2% of healthcare by costs" they occupy a far disproportionate share of current policymaking. Nearly all new LCDs in Jurisdiction E in 2015 have been for laboratory tests.
____________________________________
As of August 12, 2015, and per the CMS Coverage Database for LCDs, Jurisdiction E had 15 LCDs for which the final period had closed between December 2013 and August 2015 that had not yet been "released to final." But half of these had been part of the June-August comment cycle.
Of these 15 LCDs, 11 were laboratory test LCDs, of which all but 1 (drugs of abuse) is branded as a MolDX LCD. Of the 11 laboratory test LCDs, 7 were in the recent June-to-August comment cycle. One insight is that while lab tests may be "2% of healthcare by costs" they occupy a far disproportionate share of current policymaking. Nearly all new LCDs in Jurisdiction E in 2015 have been for laboratory tests.
