Unedited Summary of Webinar by AI - 20230629

 Unedited AI summary (GPT3.5) from typed bullet notes.  Not proofed or corrected.

20230629 - MolDx program and Z codes; hosted by Dark Daily; sponsored by Xifin.

https://www.discoveriesinhealthpolicy.com/2023/06/moldx-90-minute-webinar-on-z-codes-via.html

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Report on MolDx Medical Policy Webinar

The webinar, organized by DARK DAILY, provided valuable insights into the changing landscape of medical policies and reimbursement strategies. The speakers included industry experts from XIFIN, ARUP, MolDx, and executive Kyle Fetter. The meeting consisted of three informative segments followed by a panel discussion.

Segment 1: Overview of Payment Controls and Policies by Dr. GBW

Dr. GBW provided a comprehensive overview of the payment controls and policies implemented to address challenges faced by laboratories. The existing coding system often poses difficulties for payors to understand the services provided due to vague codes and lack of standardization. To tackle this, policies and payment controls were introduced to provide clarity. Dr. GBW emphasized the importance of explaining the services performed and their significance to payors, highlighting the need for clear codes and documentation. The MolDx program, initiated in 2011/2012, focuses on addressing these issues for Medicare while also benefiting other payors. The program aims to automate processes, including identifying relevant molecular tests, determining coverage policies, and establishing reimbursement rates. Dr. GBW stressed the increasing importance of automated solutions in the industry, especially with the growing number of tests.

Segment 2: Lessons Learned and Processes of MolDx by Valerie Collier, ARUP

Valerie Collier, with her extensive experience in MolDx, shared valuable insights and lessons learned. The process involves Technical Assessments (TAs), which require significant effort in areas such as background information, reporting, quality control, analytical validation, and clinical validation. TAs also involve evaluating clinical validity and utility by referring to clinical literature and guidelines. Collier discussed the challenges associated with obtaining representative clinical samples and stressed the importance of effective communication with medical directors to determine the required data. She emphasized the need to meet policy requirements, provide comprehensive information, and address any insufficiencies identified during the review process.

Segment 3: Insights on Z Codes and Reimbursement by Kyle Fetter, XIFIN

Kyle Fetter provided insights into the significance of Z Codes and their impact on reimbursement. Z Codes, used alongside CPT codes, provide valuable information to payors, enabling them to understand the specific tests performed. Fetter explained that while Z Codes contribute to reducing paperwork and requests for additional documentation related to the performed tests, they do not guarantee payment. He emphasized the importance of understanding that commercial plans may base their reimbursement rates on Medicare rates but are not bound by them. Fetter also highlighted the improvements observed in the prior authorization process and the reduction in denials after the implementation of Z Codes.

Panel Discussion and Q&A

The panel discussion covered various topics related to Z Codes, Technical Assessments, FDA-approved tests, and utilization management. The experts clarified that Z Codes are primarily required for Medicare jurisdictions, but compliance becomes necessary if specific commercial plans, such as UHC, demand their use. They also discussed the ongoing collaboration between laboratories and MolDx, the process for updating TAs when making changes to lab procedures, and the differences in review criteria between FDA-approved tests and Laboratory-Developed Tests (LDTs).

Additionally, the panel addressed questions regarding Z Code rates, the proprietary nature of Z Codes, the usage of Z Codes for in-house molecular tests, and the possibility of multiple registrations for labs. They emphasized the importance of test-specific Z Codes and the need for each lab to register its unique tests. The experts highlighted the ongoing efforts to streamline coverage and reduce administrative burdens while acknowledging the challenges associated with transparency, increased prior authorization requests, and potential inconsistencies in private payer rates.

User

Please summarize each of the questions individually.

ChatGPT

Certainly! Here's a summary of each question addressed during the webinar:

Question 1: Can Technical Assessments (TAs) be appealed if a lab fails the assessment?

Summary: TAs are tailored to specific services, and if a lab fails the assessment, collaboration and communication continue. The lab receives an insufficiency list to work on, and resubmission is always possible. Appeals can be made if the lab believes the assessment process was flawed.

Question 2: How long does a TA require, and who typically works on it?

Summary: The duration of a TA varies depending on the focus and any potential issues. On average, it takes about a week if the lab is focused and no major problems arise. The lab develops internal protocols for assembling TAs, involving medical directors, R&D scientists, and coordinated efforts. The process can be time-consuming but is essential for thorough assessment.

Question 3: What are the differences between Z codes, CPT codes, and ICD-9/ICD-10 codes?

Summary: CPT codes are the primary codes used for adjudication, while Z codes provide additional information about the specific tests performed. They are not replacements for CPT codes. ICD-9 and ICD-10 codes are used for diagnosis purposes and are separate from Z and CPT codes.

Question 4: Are there differences in the review process between FDA-approved tests and Laboratory-Developed Tests (LDTs)?

Summary: While FDA approval is important for assessing Analytical Validity (AV), MolDx reviews both AV and Clinical Validity and Utility (CU) to the same standards. The review process may involve disagreements with the FDA regarding AV, but that has rarely occurred.

Question 5: If a lab is located in a non-MolDx state, are Z codes still required?

Summary: MolDx is a Medicare program, so if a lab is not in a Medicare jurisdiction, Z codes are not required. However, if the lab works with UnitedHealthcare (UHC) and UHC demands Z code registry, compliance with Z codes is necessary.

Question 6: Will UHC start rejecting claims without Z codes and Technical Assessments (TAs)?

Summary: It is expected that UHC will reject claims without Z codes and TAs, although there might be some initial leeway during the transition period. Rejections are likely to occur shortly after the implementation date, August 1. The existence of subplans or exceptions was not clarified.

Question 7: When will the second wave of CPT codes be rolled out?

Summary: The speakers focused on the current wave of implementation and suggested focusing on that rather than speculating about future waves. No specific timeline was provided for the second wave of CPT codes.

Question 8: A lab in the 28 states relies on a reference lab located outside these states. The reference lab refuses to obtain a Z code. What should be done in this case?

Summary: If the reference lab is providing the service, it needs to register the test and obtain a Z code. The lab submitting the claim is responsible for ensuring compliance with the rules and requirements, including having a Z code. The reference lab must obtain a Z code for the specific test performed.

Question 9: Can Code 87999 be used for FDA-approved panels even if they have proprietary codes?

Summary: Code 87999 is typically not used if a proprietary code is available for FDA-approved panels. However, in certain cases where the proprietary code lacks clarity, Code 87999 might be considered. The general rule is to use the specific PLA code if available.

Question 10: Are the processes the same for small panels as for larger panels?

Summary: For small panels, referred to as subpanels, the same process is followed as for larger panels. The master validation platform is used, and the subpanels are submitted as individual Z codes under the master panel Technical Assessment. Each subpanel is accompanied by an executive summary to describe its indication and significance.

Question 11: If ARUP is the reference lab, can Z codes be obtained from them if needed?

Summary: ARUP can provide Z codes to another laboratory if they need them. Sharing Z codes is possible within the DEX registry, and the payer can also verify the authorized usage of Z codes by a lab.

Question 12: Why are Z codes considered proprietary and not viewable?

Summary: Z codes are considered proprietary due to the potential risks associated with unauthorized access. Only authorized users should have access to Z codes to prevent any misuse or disruption in the claims processing system.

Question 13: If the molecular test is conducted in-house, is a Z code still necessary?

Summary: Yes, if the molecular test is conducted in-house, a Z code is required. The location of the lab, whether it is within a hospital or not, does not affect the necessity of obtaining a Z code.

Question 14: Is there a limit to the number of individuals from a lab who can register for the DEX account?

Summary: ARUP currently allows two seats per lab for DEX account registration. It is unclear if this is their preferred number or if there is a cap on the number of registrations.

Question 15: Can a Z code be used for different tests?

Summary: Z codes are test-specific, and each unique test requires its own Z code. A lab may have multiple Z codes for different tests. If two labs perform the same test, it usually indicates an FDA-approved test that can share the same Z code.

Question 16: How many Technical Assessments (TAs) are received, how many are approved, and what is the current timeline for TAs?

Summary: On average, 100-300 TAs are received per week, but the success rate depends on the complexity of the service and the lab's performance. A global success rate is not provided, as it varies significantly. The current timeline for TAs is approximately two months, ensuring that labs receive a timely response.