February 2012 Newsletter
The Evolving MolDx Program
Palmetto GBA’s launch of the Molecular Diagnostic (MolDx) Services Program triggered strong opposition from leading medical organizations, including the American Medical Association (AMA), American Clinical Laboratory Association (ACLA), and the College of American Pathologists (CAP). Under the program, McKesson Z-Codes™ would be required on claims for Jurisdiction 1 A/B MAC (covering California, Hawaii, Nevada, Pacific Islands) to identify molecular diagnostic tests and determine coverage and reimbursement. As molecular testing is the fastest-growing segment of the clinical laboratory industry, Palmetto GBA and other payers have an increasing interest in the sizable outlay for these tests. Laboratories now typically bill for these tests through “stacked” CPT codes that describe each step in the analysis process without naming what is being tested. Palmetto asserts that Z-Codes will help payers identify the specific analyte tested and reduce inefficiencies since coverage and reimbursement are predetermined.
Opponents voiced several objections. The AMA charged that MolDx violates HIPAA because it establishes a new code set—Z-Codes—in addition to the standard code sets. In 2012, the AMA introduced over 100 new molecular pathology procedure (MPP) codes, designed to replace stacked CPT coding with test-specific codes, that they contend are sufficient for identification and are in compliance. Other concerns focused on the short implementation timeline (effective date was March 1, 2012) and the Z-Code application process. Supporting evidence for a coverage and reimbursement determination must be submitted with the Z-Code application, and a panel of experts reviews the evidence and approves or denies the Z-Code request. Critics wanted assurances about the confidentiality of the data submitted to McKesson, especially for proprietary tests, and about the impartiality of the review panel.
In response to these and other concerns, Palmetto GBA recently extended the deadline and made other modifications to the MolDx program.
Alternate identifier. Although Z-Codes are preferred, the Palmetto Test Indicator (PTI), which is a J1 specific identifier, will be accepted on claims instead of a Z-Code. Laboratories who bill services for CPT codes 83890-83914, 88384-88386, and the pathology/laboratory not otherwise classified (NOC) codes should apply for one of these identifiers if one has not already been assigned. Application forms are available on the MolDx Registration page on the Palmetto Web site. The Z-Code or PTI should be included in the comment/narrative field (Item 19) of paper claims and with every line of stacked CPT codes for electronic claims. See the MolDx Claim Submission Guidelines for details.
New deadlines. The effective date of MolDx has been extended to May 1, 2012. Claims for molecular diagnostic tests for dates of service on or after this date processed through the J1 A/B MAC will be rejected for insufficient documentation unless a MolDx identifier is on the claim or the required information is faxed. Check the MolDx Timelines page on the Palmetto Web site for updates to the timeline. The McKesson Diagnostics Exchange™ Test Assessment Module, which allows laboratory providers to submit online coverage determination requests, is also expected to be released in May.
Faxing MolDx information with claims. Recognizing the short deadline, Palmetto will accept the required information by fax.
- If a laboratory is unable to implement the necessary changes to their systems to pass the identifier on claims by May 1, 2012, the MolDx test identifier can be sent by fax. The Palmetto fax cover sheets have been updated with a new field for the identifier code.
- If a PTI or Z-Code has not been issued yet, a MolDx Test Information Form may be faxed with claims to identify the service provided. The forms may be used until August 31, 2012.
MolDx exempt tests. Palmetto listed the molecular diagnostics tests that require Z-Codes, including the ones that do not require a tech assessment. See MolDx Exempt Tests for the list.
Confidentiality of proprietary information. The licensing agreement for Z-Codes was updated to better clarify the protections of registrants’ confidential and proprietary information. The information that will be exposed to public view will be clearly specified, and the confidential information will not be released. In addition, the subject matter experts who review the technical assessment must sign confidentiality agreements and will only access data assigned to them by Palmetto GBA. Electronic access to the test registry and proprietary intellectual property will be strictly controlled.
Since the program is still evolving, check the MolDx page on the Palmetto site for further changes.
Quadax has begun the process of modifying our HARP A/R management software and PAS reimbursement support software to accommodate the MolDx identifiers. The functionality to add the identifiers to charge lines on the Charge and Charge Repository screens and pass the codes on claims will be implemented in a software release before the MolDx implementation deadline. Be assured that we will monitor changes to MolDx so your claims meet the new requirements.
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