3. What laboratories will be affected?
All private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare in J1 on a CMS 1500 Claim Form or electronic claims on a 5010-837P are affected by this program. 

4. What molecular diagnostic assays/tests are included in MolDx?
To help laboratory providers determine if a test should be registered for a unique identifier and submitted for a TA, see MolDx: 2013 HCPCS and CPT Code Changes. Submit questions about specific tests/assays not described in this chart, to MolDx@PalmettoGBA.com.

5. Is the MolDx Program national in scope?
Although the MolDx Program covers J1 (CA, NV, HI), labs that bill J1 services performed by a lab that is not located in J1 will have to register MDTs to identify the service.

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? 
Instructions are provided in MolDx Test Registration on the Palmetto GBA website.

8. What is the obligation or benefit to submit the MolDx Registration prior to the receipt of a coverage determination?
To identify the service and apply correct coverage for reimbursement.

9. 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 ExchangeTM for the online test registry and tech assessment components of the MolDx program. The McKesson Diagnostics Exchange is a web-based service designed to identify tests and help establish transparent and evidence-based coverage for them. This tool enables labs to share test information with Palmetto GBA online.

10. 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 consistent with the public/private indications therein. Palmetto GBA has no plans to publish a PTI registry. Each data item represented by a spreadsheet column in the PTI and Z-Code Identifier application is labeled with a public/private indicator. Only publicly available information will be visible in the registry for tests assigned a Z-Code Identifier.

11. Will Palmetto GBA expand the MolDx Program to other jurisdictions?
At this time Palmetto GBA has no indication that the MolDx program will be expanded. However, Palmetto GBA will administer active LCDs and articles published in J11.

MolDx Registration (PTI/Z-Code applications)

1. The information requested by Palmetto GBA to support analytical validity may be considered proprietary intellectual property. How will Palmetto GBA assure the security and confidentiality of that information?
Only Palmetto GBA will review proprietary information.

2. Are there options in lieu of two published articles that support clinical utility?
In the absence of two published articles, Palmetto GBA will consider a single well-designed study with appropriate study subjects to establish significance, we will consider the following published documentation in evaluating clinical utility:

• Retrospective studies
• White-papers written by national societies and recognized experts
• Virtual or theoretical models that have been vetted in the scientific literature 
• Abstracts

The onus is on the laboratory provider to make their best case using any and all evidence to support clinical utility.

3. Who will perform the technical assessments (TA)?
Subject matter experts (SME) from academia and industry will assess the scientific literature. Palmetto GBA will perform the assessment for all other components.

4. Will Palmetto GBA share the conclusions of one SME with other SME?
No. A 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 Palmetto GBA. Only Palmetto GBA will review proprietary information.

5. What are the conflict of interest principles that will guide Palmetto GBA 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.

6. 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.

7. 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. However, once the determination has been made, Palmetto GBA will not reconsider a determination for six months after the initial determination. At that time the lab may submit another request if substantive 'new' information is available.

8. Will laboratories and/or manufacturers be allowed to resubmit a coverage request after they have received a non-coverage determination?
Yes. If a new request includes substantive new information that was not included in the initial request, the lab may submit anew request six months after the non-coverage determination was issued.    

9. If the State of New York (NYS) has certified a test, does a lab need to submit the test for a MolDx TA?
No, if this is an industry accepted test. However, we may request the package used to determine the NYS certification to make a coverage decision. It is not our intent to burden laboratory providers. If you have received tech assessments through another entity, please submit this information through MolDx@PalmettoGBA.com.

10. What documentation is required to demonstrate the NYS approval for a test?
The approval letter or in the case of multiple test approvals, you may send a copy of your NYS listing.

11. 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.

12. 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. The issue, NOC code or stacking code, in some cases will be the data we may need to determine reimbursement.

13. Since the clinical and economic utility data will be reviewed as part of the coverage determination (and not during the TA), will our clinical utility evidence be sent out for subject matter expert review or will that evidence be reviewed within Palmetto GBA only? What about our 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 Palmetto GBA will review it.

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

15. Is a MolDx test application required before a TA submission?
Yes.

16. 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.

17. 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.

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

19. Are manufactures 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 .

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

21. 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).

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

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

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

25. Will Palmetto GBA make components of the TA available to the public?
Only information that is publicly available from the manufacture’s website will be available through the TA software. Only the final approval synopsis will be published. Proprietary information will not be included in this summary.

26. During the TA process, when should a laboratory submit pricing information to support a payment rate determination?
The instructions for the TA are published on Palmetto GBA’s website.

27. When will Palmetto GBA make the pricing determination?
A pricing determination will be made once the TA is complete and the service is determined to be reasonable and necessary for Medicare beneficiaries.

28. How will Palmetto GBA 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. Palmetto GBA will review the pricing method with the individual lab upon completion of the TA.

29. When should labs submit the clinical data dossier (TA) to Palmetto GBA?
Palmetto GBA will accept a TA after an identifier has been assigned. For labs that do not submit the clinical data, Palmetto GBA will prioritize according to claims data and make requests.

30. If a test requires a TA and is performed by a laboratory outside Palmetto GBA's jurisdiction that does not bill Palmetto GBA directly, how is the TA submission to be completed?
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.

Billing and Coding

1. Can labs continue to bill the stacking codes once the unique identifier is assigned?

• If the assay was billed prior to assignment, you may continue with the same stack and the unique identifier in the comment/narrative field
• If the assay has never been billed, you must submit a TA and a coverage determination prior to submission

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

3. 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
  • Contain further claim submission errors
• Consider Self-Disclosure Protocol
  • Self-disclosure guidelines available on the OIG website

4. Where do I enter the assigned MolDx test identifier on my claim?
If you are submitting a 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 to provide the unique identifier for all lines related to the test indicated by the identifier. 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).

5. If the lab submits a MolDx covered test without a unique identifier after the implementation date, will Palmetto GBA 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.

6. 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?
No. Laboratory providers may submit multiple assays per claim. The SV701-7 narrative field on the 837P claim is limited to one unique identifier per claim line. Therefore, you must report the complete code stack and unique identifier for each test. In many cases this will require labs to repeat a CPT code on the claim and append with the 91 CPT modifier to indicate the additional service(s) is not a duplicate.

Claim Example

8. Will CCI edits continue to be in effect on MolDx services?
Yes. Because the PTI/Z-Code Identifier only acts to label the specific test and are 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.

Example:

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?
Answer: 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 stack for that identifier on the claim. Remember: You may only file one test per paper claim submission.