MolDX Q&A Version 11 (November 11, 2016)

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V11  (November 11, 2016)

2016 MOLDX 1111 Q and A V 11

MolDX General Questions (M00086, V11)

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Select the category of questions you would like to view:

• MolDX General Questions
• MolDX Registration
• Technical Assessment (TA)
• Billing and Coding
• Reimbursement
• Coverage Issues

MolDX General Questions

1. What is the purpose of the MolDX program?
To identify tests, determine coverage, and determine reimbursement.

2. How does this program help claim adjudication?
Once the required information is received and a unique identifier is assigned, Palmetto MolDX can determine coverage and payment without documentation review. This process removes the need for the provider to submit large amounts of additional information with every claim and expedites claim payment.

3. What laboratories will be affected?
All private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare in JE, JF, JM, J15, J5, or J8 on forms CMS 1500 (Part B), UB04 (Part A) or electronic claims on a 5010-837P (Part B) or 837I (Part A) are affected by this program. (Please reference the specific jurisdiction MDT policy for effective dates.)

4. What molecular diagnostic assays/tests are included in MolDX?
Tests that meet the description for CPT codes 81161-81383, Tier 2 CPT codes, 81400-81408, Genomic Sequencing Providers and Other Molecular Multianalyte Assays (MAA), 81410-81471, *MAA with Algorithmic Analyses, 81490-81595 microdissection codes, 88380-88381, HCPCS professional interpretation code, G0452, Proprietary MAA, 0001M-00010M , and not otherwise classified CPT codes (NOC), 81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, and 89398.  For more information review MolDX article Test Registration (M00019). Submit questions about specific tests/assays not described in this chart, to MolDX@PalmettoGBA.com.

5. Is the MolDX Program national in scope?
The MolDX Program currently covers JE (American Samoa, CA, Guam, HI, NV, North Mariana Islands), JF (AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY), JM (NC, SC, VA, WV), J15 (KY, OH), J5 (IA, MO, KS, NE), and J8 (MI, IN). Labs that perform services for patients in those states, must register in order to submit a Medicare claim.

6. Will this project align with the AMA effort to publish CPT codes for MDT?
The AMA efforts and the MolDX program are not related or interdependent.

7. How does a lab register a test?
Review MolDX Test Registration (M00019) for instructions and the registration link.

8. What is McKesson’s involvement in the MolDX program?
McKesson is the contracted technology provider for the MolDX program. Palmetto will leverage the McKesson Diagnostics Exchange™ (DEX) the online test registry and technical assessment components of the MolDX program. DEX is a web-based service designed to identify tests and help establish transparency in the evidence-based coverage of them. This tool enables labs to confidentially share test information with MolDX online

9. What information will be made available to the public?
MolDX information collected for the registry will only be available to those labs electing to submit a Z-Code Identifier application and is consistent with the public/private indications therein.

10. Will the MolDX Program expand to other jurisdictions?
At this time CMS has not determined how MolDX will be expanded. Palmetto GBA will continue to administer active LCDs and articles published in JM, Noridian will administer the MolDX in JE and JF, CGS will administer MolDX in J15, and WPS will administer MolDX in J5 and J8.

MolDX Registration (Z-Code applications)

1. Should the manufacturer or the performing lab register an FDA-approved, in vitro diagnostic test that utilizes a kit?
The manufacturer and the performing labs should submit an application. The MolDX team will review each submission for accuracy and assign each performing lab that reports the test without modifications the same code. The lab must submit an application in order to obtain an identifier for submission. Without the application information, MolDX cannot determine the kit is unmodified and the labs that intend to use the kit.

2. Should the manufacturer also register for Alternative Summary Reporting (ASR's) that have not been FDA approved?
No.

3. If multiple tests may be performed and billed within one assay, is the lab required to register each test within the assay?
A unique identifier application is required for a single assay that may involve multiple tests in order to produce a single result.

4. Is a unique identifier application required for each specimen source, i.e. blood and bone marrow, for the same test?
No.

5. In addition to the unique identifier application, should labs send peer-reviewed articles to ensure MolDX has enough information to make a positive coverage determination?
No. Peer-reviewed literature used in coverage determination is  required only during the Technical Assessment (TA) process.

6. Is a unique identifier application required for an FDA-approved test?
The FDA approval process ensures only the clinical and analytical validity of the test. The FDA does not include clinical utility in their review, which is required to establish Medicare coverage.

7. Is a new unique identifier required for updated tests or a test expansion?
If the updated or expanded test is substantively different, you will need to submit an application and a new identifier will be assigned.

8. After a test is granted a unique identifier, can a hospital bill their respective MAC directly for the test using the assigned code?
Yes. Although MolDX has NOT expanded to Part A, hospitals may add the Z-Code Identifier as additional information to help reviewers determine coverage.

9. If a pathologist plans to submit a claim for the professional component of a MolDX test, should the pathologist register the test?
No. In the rare instance when an additional and separate professional interpretation is needed, the pathologist must obtain the ID for the interpreted test from the performing lab. A G0452 claim service may ONLY be submitted when the clinician interprets the raw data for a test. The clinician must use the Z-Code Identifier assigned to the test interpreted.

Sample Claim:

Service	CPT Code	Z-Code Identifier
BCR-ABL, major breakpoint	81260	Z1234
Interpretation	G0452 (HCPCS)	Z1234

10. Is a unique identifier required for tests billed with a NOC code?
Yes. Review MolDX Test Registration (M00019)

11. Are labs expected to register tests sent to another lab to perform?
You are only required to register tests if you plan to submit claims to jurisdictions that implement MolDX.  Please indicate the referenced lab in the application.

12. If a lab performs the same exact test from two different locations, operating under two different CLIA numbers, will the lab be required to submit both tests for unique identifiers?
If the test process is standardized and the same method is used to acquire the results in both locations, labs will only have to submit one application for the test. However, if there is a difference in the method, an application will be required from both locations.

13. Should labs that provide lab products alert their lab customers about MolDX registration requirements?
Yes.

14. If the kit used in an LDT is not FDA-approved, should the lab apply for a unique identifier for that kit?
Yes.

15. How do labs identify test reagents in the MolDX unique identifier application forms?
Enter the information in the 'contributing component' field.

16. Are labs required to register tests that use a code in the MolDX code range and a code that is not listed in the MolDX range of codes (i.e., CPT codes 87001-87905)?
Yes.

17. When a laboratory modifies an FDA approved kit, will MolDX require a new unique identifier? 
Yes. If a lab modifies a registered test, the resulting test is considered an LDT and will require a separate application.

18.  If a California laboratory is billing for a test referred to a laboratory located outside of the jurisdiction, which lab is responsible for registering the test?
It is the responsibility of the billing provider to obtain a unique identifier.

19. If multiple laboratories purchase the same test and each lab registers the test, how will MolDX notify the laboratory regarding the assigned identifier?
MolDX will follow the registration process. A review of the MolDX database is performed to ensure a unique identifier has not been previously assigned. If a test has been registered, the lab will receive the assigned identifier. The only difference is the identifier for that particular test has already been established prior to the current lab’s application.

20.  Are hospital labs that file institutional claims and providers that file professional claims exempt from the requirement to obtain a unique identifier?
At this time the MolDX Program applies to JE, JF and JM Part B claim submission. J15 Part B claim submission starts in October 2015. Part B includes professional claims or claims submitted by a pathologist for the professional component of a test. Therefore, a pathologist submitting claims for a professional MolDX service would be required to register a test.

Technical Assessment (TA)

1. What types of tests may require a TA?

• Lab developed tests (LDT’s) performed using either established or novel technology with un-established clinical utility 
• Molecular or genetic testing that has not been validated for clinical and analytical validity
• Tests using modified versions of FDA registered kits
• Tests using a new molecular or genetic technological testing platform
• Genetic or molecular target with un-established clinical utility 
• Tests reported with one of the following CPT codes, as well as any billing or tracking codes developed by CMS (HCPCS) or AMA CPT, such as Appendix O and PLA codes for diagnostic testing: 

Tier 2 CPT Codes	81400-81479
Genomic Sequencing Procedures and Other  Molecular Multianalyte Assays (MAA)	81410-81471
*MAA with Algorithmic Analyses	81500-81595
Not otherwise classified (NOC) CPT Codes	81479, 815999, 84999, 85999, 86849,87999, 88199, 88299, 88399, 89398

2. What tests may not require a TA?

• State of New York (NYS) certified tests that are industry accepted and have established clinical utility. However, MolDX may request the package used to determine the NYS certification to make a coverage decision. The approval letter or a copy of the NYS listing may be used to demonstrate NYS approval.
• Test that use FDA approved kits in an unmodified form
• New tests approved under a Premarket Approval (PMA)-(which under FDA policy from the early '90s requires evidence of clinical utility) and the test is reported with the stacking codes, a unique identifier is required, but a TA is not
• Tests that using existing or novel technology for molecular or genetic targets with established clinical utility

3. When should labs submit the clinical data dossier (TA) to MolDX?
MolDX will accept a TA after an identifier has been assigned. MolDX will NOT accept any information prior to registration and assignment of a unique identifier. For labs that do not submit the clinical data, MolDX will prioritize according to claims data and make requests.

4. Where do I find guidance on creating a comprehensive TA dossier for submission?
All guidance information for the creation of a TA dossier and the review process can be found under Technical Assessment (TA) Process (M00095) on the MolDX website.

5. Where do I find information on the level of evidence I need for a full review of my test?
The Clinical Test Evaluation Process (CTEP) (M00096) outlines a process used by the Subject Matter Experts (SME) and the MolDX Executive Committee (EC) to assess new tests.

6. Can I arrange a pre-submission meeting with MolDX to discuss my assay?
Yes. After you have registered your test and received a unique ID for the test, follow the steps outlined in the Pre-submission Review Process (M00117). 

7. How do I submit my dossier to MolDX?
The Technical Assessment Submission Instructions (M00115) provide the steps to submit your dossier through the registry.  

8. Why was an invalid determination issued on my TA submission?
A TA must be submitted with the test ID in the subject line. MolDX will not initiate a TA without an ID.  Additionally, all communication regarding tests MUST have the ID in the subject line. This enables the MolDX staff to accurately track test documents and avoid unnecessary delays and misplaced documents. 

9. How long will it take to complete the TA process and receive a coverage determination?
Upon submission of the dossier, there is a 30 day period to determine if the submission is complete. Once the MolDX Team has determined that the dossier is complete, a 90 day review period begins.

10. The information requested by MolDX to support analytical validity may be considered proprietary intellectual property. How will MolDX assure the security and confidentiality of that information?
Only MolDX and its subject matter experts will have access to proprietary information submitted through the McKesson DEX account.

11. Are there options in lieu of two published articles that support clinical utility?
Review The MolDX clinical Test Evaluation Process (CTEP)-M00096

12. Who will perform the technical assessments (TA)?
Subject matter experts (SME) from academia and industry will assess the scientific literature. The MolDX team will perform the assessment for all other components.

13. Will MolDX share the conclusions of one SME with other SME?
No. An SME will only have access to their assigned TA. Also, each SME will only have access to the scientific literature submitted with the TA. All other components will be reviewed by the MolDX Team.  Only the MolDX Team will review proprietary information.

14. What are the conflict of interest principles that will guide MolDX in determining whether or not an SME should be permitted to conduct a technical assessment?
The conflict of interest principles were developed by Blue Cross Blue Shield of South Carolina and are standard for the industry.

15. What types of disclosures will be required from the SMEs in order to facilitate a conflict of interest determination?
The disclosures required by the SME were developed by Blue Cross Blue Shield of South Carolina for government contractors and are standard for the industry.

16. Will there be an opportunity for a laboratory to comment on a TA report before it is finalized?
Yes. Questions/concerns that surface during the TA will be communicated with the test developer.

17. Will laboratories and/or manufacturers be allowed to resubmit a coverage request after they have received a non-coverage determination?
Yes. If substantive new information, not included in the initial submission, becomes available, a new request may be submitted 6 months after the initial non-coverage determination was issued.

18. What is the difference in the logistical steps to initiate a formal coverage determination and the process to initiate coverage determination with a TA?
It is the same process.

19. When a manufacturer has a new test approved under a PMA (which under FDA policy from the early '90s requires evidence of clinical utility) and the test is reported with the stacking codes, a unique identifier is required, but a TA is not. If the lab billed the same test with an NOC code, both a unique identifier and TA would be required.
The NOC is not the only considered fact about the TA. If, as in your example, a test is vetted for science and clinical utility, the information can be collected at the time the unique identifier is assigned. At that time the lab may bill the NOC with the assigned unique identifier.

20. Since the clinical and economic utility data will be reviewed as part of the coverage determination (and not during the TA), will the clinical utility evidence be sent out for subject matter expert review or will that evidence be reviewed only within MolDX? What about the economic utility evidence?
If the clinical utility and economic data are in the public domain (published), SME will review it. If it is proprietary, then MolDX Team will review it.

21. Is there a difference in the expected timeline for a coverage determination and a TA?
It is the same.

22. Can a lab provide services prior to the TA approval date in anticipation of a favorable determination and then submit the claims after the approval?
To avoid overpayment requests, labs should freeze services until coverage is approved and appropriate billing and coding guidelines are published.

23. If a lab plans to submit a test for FDA approval, can the test be submitted for a TA first?
If the test is currently in the FDA process, please hold the TA request until the FDA has completed its determination. However, if you have not submitted the test to the FDA, you may request a TA. The FDA submission should be done prior to TA request. Once you receive an FDA determination, you may submit a TA request.

24. Should labs submit applications for Research Use Only Reagents (RUO)?
No.

25. Are manufacturers that provide items such as ASR or RUO used in an LDT required to register the items?
No. Only the LDT developer and biller of the LDT are required to register for a unique identifier. However, an LDT developer must disclose the ASR and RUO used in the developed LDT on the application.

26. How should labs outline test reagents in the TA?
Submit the package insert for the kit with the materials.

27. When multiple large numbers of reagents are used in a test, how should labs identify the specific details for the reagents?
Provide sufficient information to identify the manufacturer and the product specifications (PI).

28. Should protocols for technical evaluation be included in the TA submission?
Yes.

29. Will a completed TA be made available on the MolDX website?
Only an approved TA will be published. However, MolDX may publish a coverage/non-coverage article or an LCD based on the TA.

30. How should a laboratory designate proprietary information on the TA submission?
MolDX will consider any information that is not publicly available to be proprietary information.

31. During the TA process, when should a laboratory submit pricing information to support a payment rate determination?
Any pricing information will be requested from the laboratory after a favorable coverage determination has been made.

32. How will MolDX determine reimbursement for a test?
Reimbursement is based on accurate submitted codes regardless of the cost of the platform used. For tests that are reported with an NOC code, pricing will be determined based on the information collected in the TA. Each test will be assessed on an individual basis and priced according to the most appropriate method. the MolDX Team will review the pricing method with the individual lab upon completion of the TA.

33. What is the TA process for labs performing and or submitting tests outside a MolDX jurisdiction?
The TA process is open to all lab developers and their tests regardless of geographic location. In order to receive a coverage determination, it is the responsibility of the billing laboratory to submit a TA. Claims paid for tests that do not meet the mandated reasonable and necessary criteria may be subject to overpayment requests.

34. What resources are available to help me determine the best CPT code to bill my new test?   
All test applications are reviewed for correct CPT mapping by the MolDX Team. If an error or a disparity is identified, the Team will notify the test provider for clarification. After a TA is complete, the Team will notify the test provider with the final coding, billing, coverage, and if applicable allowed fee for the test.

Billing and Coding

1. What are the effective dates of the codes ZSB01 and ZB728?
Z-Code Identifiers are effective at time of assignment.

2. What action should a lab take if they believe they may have incorrectly billed for a MolDX service?
If you believe your practice has made a MolDX billing/coding error, you may take the following corrective actions:

• Complete a Self-Audit
• Identify incorrect submissions
• Prevent further claim submission errors
• Consider Self-Disclosure Protocol
• Self-disclosure guidelines available on the OIG website  

3. Where do I enter the assigned MolDX test identifier on my claim?
If you are submitting a Part B paper claim, this information would be placed in Block 19 of the CMS 1500 claim form. For Electronic claims (5010) 837P (Physician/Professional), use the SV101-7 field adjacent to each CPT code used to report the service. This field maps to the Line item Description (This field is required for NOC codes to avoid rejection by the Common Edit Module Front end).

If you are submitting a Part A paper claim, this information would be placed in block 80 of the UB04 claim form. For Part A electronic claims, the Z-identifier must be reported on line SV202-7 of the 837I (Institutional) claim.

4. If the lab submits a MolDX covered test without a unique identifier after the implementation date, will MolDX reject the claim as 'unprocessable' with no appeal rights or send a denial with a specific or new claim denial message?
Claims received without additional information required to adjudicate the claim will be rejected.

5. If a laboratory performs multiple assays/tests on a single patient on one date of service, will the lab have to split the different assays/tests into multiple claims?
MolDX considers the performance of multiple molecular biomarkers, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample to be a 'panel' of tests. Therefore, each panel should be registered and billed with a single CPT code and a unique MolDX identifier.

6. If a CPT code appears on the claim more than once to report an additional test, is a modifier required?
Yes. Append with CPT modifier 91. See the claim example for question 8.

7. How do I submit a claim for ONLY the professional interpretation of a test?
Although rare, when an additional and separate professional interpretation is needed, the pathologist must obtain the ID for the interpreted test from the performing lab.

Sample Claim:
Lab A performed BCR-ABL, major breakpoint assigned with Z1234.

Clinician interpretation should be submitted as follows:

Service	HCPCS Code	Z-Code Identifier
Interpretation	G0452	Z1234

8. Will CCI edits continue to be in effect on MolDX services?
Yes. Because the Z-Code Identifier only acts to label the specific test and is not a code set, MolDX service providers must append CPT codes within the CCI edits with a 59 CPT modifier to indicate the CCI Column II code is a different test.

Note: The 59 CPT modifier should ONLY be appended to CCI Column II codes.

9. There is only one Box 19 on my paper claim form. How do I identify more than one test or assay on my claim?
Due to the limitations of the paper claim, labs using this form will be limited to only one test/assay/unique identifier per claim. To bill a MolDX test on a paper claim, enter the unique identifier in Box 19 and then enter only the CPT code(s) for that identifier on the claim. Remember: You may only file one test per paper claim submission.

10. I registered a single gene test performed on a Next Generation Sequencing (NGS) platform that is listed on the MolDX approved gene test list. Why is my claim denied?
MolDX does NOT consider the T1 and T2 descriptions appropriate for genes interrogated on an NGS platform. Please reference the coding and billing guidelines in reference article M00130.

Reimbursement

1. Will a microarray service be reimbursed at the same rate for all microarrays or will the diagnosis differentiate payment? For example, will 1800+ genes of one array be viewed differently than an 1800+ array with a different algorithm?
Diagnosis will not differentiate payment. Payment is based on the accurate CPT/HCPCS codes submitted. However, if there are less than 500 probes in an array, CPT code 83999 must be used and MolDX will price the NOC code.

2. Does the DRG segregate the CPT code to a different payment?
No.

3. Will ABN’s be valid with the unique identifier?
The unique identifier is only additional information, not a billing code.

4. Will MolDX pay test services provided prior to the TA approval date?
All new test services will be denied as noncovered until the test completes the TA process and reasonable and necessary criteria is established. Claims submission for tests in the TA process should be suspended until a final coverage determination is made.

5. If I already have a PTI for my test, how do I switch to a Z-Code Identifier so I can use the online TA feature?
Send a request to switch the ID to MolDX@PalmettoGBA.com.

6. Is the reimbursement for a flow cytometry affected by MolDX?
Palmetto GBA has an active LCD for Flow Cytometry and will continue to administer coverage as published in that policy the same as any other active policy.

Coverage Issues

1. Is a confirmatory FISH test a covered benefit?
Confirmatory testing is considered a quality check and is not a covered Medicare benefit.

2. If a lab needs a denial for a noncovered test in order to bill a secondary payor, should they submit the test for MolDX registration?
Yes.

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Last Updated: 11/11/2016