Q: Why did CMS convene this MEDCAC to focus on the prognostic values of these molecular pathology tests for cancer?

LR: CMS convened this MEDCAC as a follow-on to a previously conducted technical assessment on molecular pathology tests. While some of the tests considered in the technical assessment have little to no prognostic value information available, several of the tests included in this study are being used for prognostic indication with or without FDA approval. This MEDCAC was to bring to bear the state of play of where these tests are in their ability to accurately predict outcome, risk recurrence and overall prognosis of the patients under treatment.

Q: What were the main items discussed at the meeting? Was there any discussion on the FDA regulation of laboratory developed tests?

LR: The MEDCAC did go through the important difference between the predictive and prognostic values for a given test and how they are separable. However, even for tests with obvious predictive value associated with them, in physician practice some of them are also being used as prognostic indicators of risk of recurrence. The panel considered the literature and evidence review conducted by the Technical Assessment to score which of these may have more evidence associated for such a use than others. There was discussion about FDA regulation of laboratory developed tests. The panel focused on the importance of analytical and clinical validity of a test. The FDA regulatory process rigorously reviews evidence to support the analytical and clinical validation of a given diagnostic. The Panel was concerned that, in some instances, almost 70% of all tests conducted are using a non-FDA approved or cleared device and with a diversity of technologies for which analytical validation may still be wanting.

Q: What do you think will be the likely outcomes of this meeting from a national or local Medicare coverage view?

LR: This MEDCAC meeting was really a start to discuss the growing presence of molecular pathology tests and their clinical use in directing treatment therapy and physician management of cancer patients. It is expected that CMS will continue to discuss how to introduce some evidentiary standards and their impact on clinical utility. It is not outside the realm of possibility that a local coverage analysis plan would want to incorporate some learnings from this discussion – for example, the importance of analytical and clinical validity.

Q: How do you think this meeting will impact coverage of these tests from other payers, such as commercial and Medicaid plans?

LR: It is hard to speculate if there will be a direct or immediate impact on coverage of these tests by Medicare. Typically commercial payers and Medicaid plans take their lead from Medicare or at least are influenced in their own decision making by how CMS decides. The impact this MEDCAC does have is an awareness that CMS at the national level is becoming interested in understanding the role these diagnostic tests play in guiding treatment. This varies from the past where diagnostic tests are mostly covered and paid for at the local coverage level by Medicare Administrative Contractors (MACs).

Q: Do you think the Panel was able to answer the key questions of focus for this meeting, or will it warrant further discussion?

LR: The panel was slightly hamstrung by the confusion over predictive v/s prognostic and in some cases the conflation of the two. There was some clear discussion around the prognostic value or lack thereof for some of the tests both FDA cleared and those that are laboratory developed and not reviewed by the FDA. So yes, the Panel was able to answer some of the questions, but certainly there is room for more discussion of these issues. Watch this space.