LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Molecular Diagnostic Tests (MDT) (L36807)

A55391

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A55391
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Article Title
Response to Comments: MolDX: Molecular Diagnostic Tests (MDT) (L36807)
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Response to Comments
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02/16/2017
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) MolDX: Molecular Diagnostic Tests (MDT)(L36807). Thank you for the comments.

Response To Comments

Number Comment Response
1 Registration of our assays and submission of a complete technical assessment for our assays will result in undue burden that will prevent us from providing tests for our clinicians in a timely manner, delaying patient care. I recommend removing these requirements from this proposed draft. The locally-associated, personal care of the patient cannot be measured in dollars. I would ask that academic labs, in addition to large reference labs, be used to determine reimbursement. Test registration is a straight forward process on McKesson DEX. MolDX does not require a TA on single genes represented by AMA CPT Tier 1 codes, and rarely for Tier 2 codes. TAs are primarily limited to new multi-analyte tests coming to market. “New” refers to tests with multiple genes with or without algorithmic analysis with diagnostic and/or prognostic purposes that have not received FDA companion diagnostic status or been universally recognized by recognized authorities such as NCCN, ASCO or other professional societies. For claims adjudication, contactors can request data when indicated. For these “new tests/assays”, MolDX formalized the process of obtaining coverage by requiring the provider to submit a formal technical assessment (TA). For molecular laboratory providers who submit a complete TA, the review process is very short. The “lengthy reviews” result from the fact that many TAs have insufficient evidence of analytical and clinical validity (AV/CV), and no clinical utility (CU). Academic labs have always contributed to reimbursement determinations. AMP even published a costing analysis provided by a number of academic labs.
2 The lack of my ability to present my comments during the discussion was due to poor technology and the presenter/staff's lack of recognition of the issue. After multiple tries and 2 repeat calls I was able to present my comment-quite late in the discussion. I do want to present the following comments:
    1) Inadequate evidence to support current expedited roll out 2) HIPAA and AMA CPT noncompliant Z codes 3) Considerations for Implementation of Cancer Molecular Diagnostics Into Clinical Care
The Molecular Diagnostic Testing policy does not involve scientific data. It is a “process” policy that specifies two points:
  1. All labs must register their molecular assays and obtain unique Z-code identifiers for each assay; WPS GHA has specified the date that claims submitted without a Z-code will reject. This allows Medicare to pay claims appropriately.
  2. All “new” (multi-analyte) tests coming to market must obtain a TA. This allows Medicare to determine tests that are “reasonable and necessary” based on scientific data.
Z-codes were never meant to be HIPAA or AMA CPT compliant. They are not billing codes. Z-codes are merely a means to correctly adjudicate a claim. MolDX has been very instrumental in incorporating clinically well vetted (AV/CV/CU) molecular diagnostics into clinical care.
3 MolDx program and its extension to other Medicare contractors create serious concerns about Medicare beneficiaries’ access to medically necessary testing. MolDx circumvents the existing LCD procedure and does not allow the opportunity for adequate stakeholder input in the coverage process. The CAP continues to have significant concerns about the unique test identifier requirement and believe that it is duplicative of existing processes, including that of the AMA CPT Editorial Panel. We understand the challenges that existed under the old CPT “stacking” codes of matching a lab test with a specific CPT code. The new tier 1 CPT codes, however, are very specific for what is being tested, and include the analyte in the name of the code. For Tier 2 codes, they have been grouped by Level to include those tests that represent similar levels of complexity and resources for testing. The specific analytes are listed and can be reported on the claim form in the same areas as would be used for the unique identifier. Given this existing test code specificity, we continue to question the need for a system that assigns a unique identifier for each test performed by a lab. The commenter disagrees with the position that a separate review of the analytic validity of each LDT or modified IVD by Palmetto is needed. If a lab is not CLIA certified, the test cannot be paid for by Medicare. CLIA certification should be sufficient, eliminating the need for a unique identifier. However, if there is doubt that these CLIA lab reviews do not adequately address analytic and clinical validity, tests that have been through the CPT process have had yet another level of review. The commenter states that the unique identifier process should not be required to include an evaluation of clinical utility. This is essentially an evaluation of the medical literature and a decision as to whether a test meets the “reasonable and necessary” criteria for a specific condition. This should not be done by an outside organization. As per the PIM Chapter 13, it should go through the LCD process, which requires presentation of the medical evidence and Palmetto’s conclusions to be subject to review and public comment by the medical community. Palmetto is currently not adhering to this process. A unique identifier allows the payer to correctly pay claims. With roughly 650 genes represented by 9 codes, the AMA CPT Tier 2 codes provide no specificity for claim adjudication. Commenters argue that levels of complexity and resources for testing for each Tier 2 code are similar. However, neither levels of complexity or resources used establish medical necessity. Coverage for a gene is based on medical necessity which is based on published clinical utility. MolDX has never circumvented the existing LCD process, and it is a total misunderstanding of the LCD process to claim there is not opportunity for adequate stakeholder input. In fact, all policies to date have been developed with national and international experts in pathology, oncology, or other medical specialties, as indicated, and all policies have at least 45 days for comment followed by publication of response to comments. Additionally, reconsideration requests with new data are assessed upon receipt. There is no basis for concerns about beneficiary access because access is universally available throughout the US from sole source labs, academic and reference labs. While the commenter disagrees that separate review of analytical validation (AV) of each LDT or modified IVD is needed, CAP is again mistaken. MolDX does not require AV assessment of assays billed with Tier 1 or Tier 2 assay codes or modified IVD. Clinical utility is based on analytically and clinically validated tests. Due to the absence of CAP standards and/or proficiency samples for advanced, complex multi-analyte tests with methodogies that have yet to be addressed by CAP, it is incumbent on payers to assess AV for multi-analyte tests. CLIA certification does not address validation of LDTs. CLIA does, in fact establish a minimal standard that labs are expected to comply with such as expired reagents, proficiency testing, employee qualifications, etc. Lab quality does not determine AV/CV, nor does not determine medical necessity. The commenter suggests that the AMA CPT process includes a review of AV/CV to determine whether it is sufficient to support its positon as part of medical practice but, again, use of test in a medical practice does not determine a Medicare benefit or medical necessity. The commenter is misunderstanding the purpose of unique identifiers and the LCD process. Unique identifiers allow payers to pay claims correctly. Unique identifiers are issued upon registering an assay. The assignment of a unique identifier is not based on evaluation of AV/CV or CU. Evaluation of clinical utility is established via the submission of a dossier by the test developer/manufacturer and is performed on multi-analyte assays with or with algorithms. No outside organization determines Medicare’s “reasonable and necessary” criteria. Non-coverage, limited coverage, and coverage with data development and coverage policies (LCDs) go through the CAC process which includes public comment. Even after a policy is final, reconsideration requests can be submitted with supporting data that can change the policy. MolDX is in absolute compliance with the LCD process.
4 I am writing regarding the MolDx Draft Local Coverage Determinations under consideration by WPS GHA. Our initial comments were submitted earlier in the comment period and asked for a delay in implementing the MolDx policies. We requested a delay to enable pathologists to engage with oncology colleagues and provide more meaningful comments. Due to the nature of these policies, I believe comments with input from experts in both molecular diagnostics and oncology management will insure the most appropriate coverage policy. WPS GHA had published a current news article on our website in May of 2016 notifying our providers that MolDX was expanding to Jurisdictions 5 and 8. On June 1, 2016 a MolDX webpage was posted to our website and included links to the MolDX Contractor’s website. The draft LCDs were posted to our website September 1, 2016 and will become effective 02/16/2017. We think adequate notification was given to the provider community and are moving forward with these policies. Providers can request an LCD be modified by submitting an LCD reconsideration request to us. Information on this process can be found on our website:
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36807 - MolDX: Molecular Diagnostic Tests (MDT)
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