Local Coverage Article Response to Comments

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


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Response to Comments: MolDX: Molecular Diagnostic Tests (MDT)
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Response to Comments
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Article Text
Noridian’s Response to Provider Recommendations (for comment period ending 03/30/2015):

Response To Comments

1MolDX program and expansion to other MACs creates beneficiary access concerns. Commenter states that the actions taken by some Medicare contractors follow neither the letter nor the spirit of the law which requires that coverage decisions be transparent and based on medical evidence. This commenter expressed concern that Medicare assumes that tests performed primarily in pediatric populations would never have other uses in adults that would be covered by Medicare, particularly younger disabled beneficiaries. The commenter states that this adverse impact can be magnified in that Medicaid and private payers emulate Medicare coverage determinations. Inconsistent coverage policies from one MAC to another create beneficiary access concerns. Medicare supports consistent policies for consistent access. All policies have been developed and comply with Medicare requirements. Based on similar concerns raised by this same commenter, CMS has reviewed the molecular diagnostic policies developed to date, and found all have complied completely with both the spirits and the letter of the law. The Medicare benefit applies to the aged (>65 years) and the disabled. For the unusual situations where genetic testing for genes predominately used in perinatal, pediatric or adolescent assessment is medically indicated for a disabled or aged person, the provider can appeal this decision with submission of medical records supporting the medical necessity for testing and how the results change medical management in cases that would be exceptions to the core policy. Medicaid and private payers are responsible for determining their own coverage decisions. Medicare contractors establish coverage within the reasonable and necessary criteria of the Medicare program and they do not make coverage or payment determinations for other entities.
2MolDX circumvents LCD process and does not allow input in coverage process. The commenter states “the program lacks the transparency that the LCD process creates in determining coverage policy. The MolDX program by way of the Technical Assessment (TA) process is making local coverage determinations for each TA request and posting the decision on-line on the Program webpage. This does not follow the LCD process of presenting coverage for a medical procedure as a draft decision to the public, the medical community, and the CAC, and providing a Comment and Notice Period as required. The use of an internal technical assessment process by the MolDX program does not replace the established requirements that define the LCD and the LCD process.” The commenter goes on to state “This is in contrast to the Article format, which is associated with a LCD and provides additional educational information about the LCD and the coding guidelines. The coding guidelines could include definitions of codes, lists of items that may be billed under a particular code and minimum requirements that providers must meet in order to bill using a certain code. It could also include a product classification list that would inform providers about which specific products meet the requirements of a specific code.” The commenter provides no specific LCDs or articles that have not complied with the LCD process. In fact, this commenter has responded to every MolDX, laboratory and pathology LCD put forth by the CMS MolDX Contractor and/or Noridian. The current policy does not address “reasonable and necessary” criteria for a specific test. This policy defines the process by which this contractor (Noridian, and previously the CMS MolDX Contractor ) makes a coverage determination. Specifically, it requires that 1) all molecular testing within the contractor’s jurisdiction will require a unique identifier to uniquely identify every molecular tests, and 2) that all new tests coming to market must submit documents for a technical assessment (TA). The commenter indicates that the policy refers to the website for specific coding and billing information which is correct and expressly forbidden from being in the text of the policy.
3The action proposed in this policy represents a withdrawal of coverage for Molecular Pathology Testing. The commenter wants molecular testing to be covered unless there is evidence the testing is NOT safe and effective. The commenter also wants Noridian to retract its position that all molecular testing will not be covered, or cover on a case-by-case basis until the TA is completed. Historically, when a lab developed an assay, it marketed to providers who ordered the test and the labs submitted a claim. The MDT policy is a restatement that tests must meet “reasonable and necessary” criteria for coverage. This is not new information to providers but what is new is that the enforcement (submission of data to support reasonable and necessary) is being applied. There is no coverage of new tests until a TA is submitted and reviewed. Testing that is “safe and effective” can be likened to an assay having analytical and clinical validity. CMS requires that a test must be “reasonable and necessary” as demonstrated by the test’s clinical utility in that it improves patient outcomes or changes physician management decisions that improve patient outcomes. Noridian will not retract its position, nor cover new tests on a cases-by-case basis until the TA is completed. Once the TA is completed and the test approved, Noridian will, upon request, allow coverage from the effective date established by the CMS MolDX Contractor. The commenter is incorrect with their statement that the CMS MolDX Contractor covers these tests on a case-by-case basis until the TA is complete.
4Unique Test Identifier Requirement Difficulty identifying tests performed from the claim form; the commenter believes Tier 1 codes are sufficient. Commenters expressed concern regarding the need for the unique identifier. Tier 1 codes add a level of specificity, but not enough to discern and apply coverage. Unique identifiers allow the necessary specificity to establish edits to provide the differential reimbursement.
5Unique Test Identifier Requirement Need to verify AV/CV of test performed; the commenter states that “CLIA established quality standards for laboratories to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed. Analytical validity is already addressed by CLIA regulations, which require laboratories to demonstrate analytical validity and regular proficiency testing.” CLIA does not require AV or CV review of each new test introduced into a lab’s test menu. A CLIA inspection is a general overview of the lab – not the individual characteristics of a given test. CLIA looks at QC, proficiency testing, SOPs, educational qualifications of employees, criteria of the lab director, space, expired reagents, etc. Furthermore, CLIA allows a lab to perform testing for upwards of 2 years prior to a lab inspection. Nothing within a CLIA certification would provide evidence of clinical utility that establishes the ‘reasonable and necessary’ expectation of any specific test performed by that lab.
6Unique Test Identifier Requirement Ensure claims are not being paid on asymptomatic persons – commenter agrees that this is an importance issue but disagrees that a unique identifier helps address the problem. A unique identifier does help address the problem by providing additional information that can be applied via claim system editing rules.
7Need to address Clinical Utility of a test; this should not be done by an outside organization; CU should go through the LCD process; accused the CMS MolDX Contractor of not adhering to the process. The LCD process is being used as prescribed and specifically it is used to summarize the review of all evidence that was conducted in formulating the policy as it pertains to the reasonable and necessary standard of which part of that is the test’s ‘clinical utility’ as presented by the developer lab. This review is posted for public and specific CAC membership comment as required. As we are doing here, any comments are addressed as part of that process. If the commenter(s) provides significant and actionable additional information that should have been considered in the formation of the policy, a policy revision would be noted.
8Performing 3 or more test creates “new test” to be reviewed for medical necessity.There is no language in the MDT draft LCD policy that 3 tests performed in a series (reflex testing – next test depends on the result of the previous test) is considered a new test that requires AV/CV/CU.
9Will the test results provide the clinician with information that will improve patient outcomes and/ or change physician care and treatment of the patient?” and “Will risk assessment change management of the patient?” It is unclear in the draft policy whether a test must meet all or only some of the listed bullet points to qualify for coverage or whether these are simply listed considerations in arriving at coverage decisions. Regardless, we have significant concerns about the proposed coverage of some of these tests. We are not aware that the following tests listed have met the above stated standards in prospectively randomized appropriate clinical trials published in peer reviewed medical journals which would allow physicians to reasonably answer affirmatively the above two questions. We suggest therefore that for the listed tests below, they prima facie do not meet the statutory requirement for coverage as “reasonable and necessary”. If these tests have indeed in your judgement met this standard, we would ask for the publication references justifying such appropriate clinical use of the following listed tests which are proposed to be covered: a) Afirma b) Allomap c) Avise PG d) ConfirmMdx Epigenetic e) Progensa PCA3 f) Tissue of Origin g) Vectra DA h) Vysis. These tests may in fact have been covered, either by policy or lack thereof, prior to the development of the MolDX program. Contractors routinely review claims and other data (i.e. technology changes, clinical publications, professional association guideline updates) to determine impacts to existing policies and coverage. They can and will review the existing coverage criteria to determine if changes to that coverage are needed based on new evidence. This can include new or revised LCD development that would follow the LCD process should the change result in a limitation/restriction of any existing coverage. Commenters wishing to address the coverage of these tests can do so by following the LCD reconsideration process, available on all Medicare contractor websites.

Associated Documents

Related Local Coverage Documents
L35160 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
07/21/2015 10/01/2015 - N/A Currently in Effect You are here


  • Molecular
  • Diagnostic
  • MDT
  • MolDx