Letter to CMS regarding coverage for Next-Gen Sequencing
Oncology practice is at a crossroads. Although it has long been known that cancer is a genetic disease, we did not in the past have the resources or technology to study the causes of cancer for an individual patient. For simplicity’s sake, we supported the mantra of “one biomarker for one disease” although always realizing that reality is far more complicated. Now, with Next-Gen sequencing (NGS) technology, for the first time we really CAN understand what is driving the tumor, not in a generic sense but in THIS SPECIFIC patient. This is the basis of precision medicine, one supported by the decision of the FDA to approve the use of NGS technology for essentially any tumor type that has genetic screening indications. This is a positive step for many reasons, but particularly because NGS allows us to move beyond confirmation bias of single-gene testing while improving sensitivity and adding diagnostic and prognostic value to patient testing. However, it is important to understand that nothing I have noted above is specific to IVD manufacturers of NGS testing, who use the same reagents and tissues and equipment as LDT labs and have not shown any specific value above LDT assays from quality providers.
It is because of this last statement that the CMS NCD is particularly disappointing in signifying that only FDA-approved IVDs are to be reimbursable. It’s like owning a coffee shop that has been inspected and approved by the city but not being able to bill for your coffee because Starbucks has the resources to prove to the FDA that their coffee safe, even though they buy the same beans and brew them in the same pots as you.
NGS testing is generally improperly construed as a lab test. In reality it is a very complex assay that requires professional interpretation to be utilized properly. Think of it as a physical exam of the genes of the cancer cell. The results- what is construed as clinically relevant or significant depends on the clinical and treatment history of the patient, as well as specific features in the test like tumor cellularity and variant allele frequencies. Having a singular or a handful of NGS IVD vendors means that interpretive assessments at the local level will not be possible, as only the lab has access to some of the necessary data and they A) don’t have any clinical information about the patient; and B) use automated processes to spit out reports that do not typically include clinical assessments. Because there currently is not professional billing for such interpretations they simply will not be done, particularly by volume-dependent laboratories. This is bad for patients.
The CMS NCD will force LDTs to either go through the FDA to create IVDs or stop performing services. It should be understood by CMS that these LDTs, which are overseen by existing accrediting agencies, are not inferior in quality to IVDs. As stated, they use the same reagents and equipment. The process of supporting IVDs in this space, and prohibiting LDTs from reimbursement, will not have the effect of improving quality. It will have the effect of creating a monopoly that will eliminate competition from quality labs- who cannot afford to endure the IVD process- including top academic medical centers. In a way, this CMS decision will bypass the lab’s ability to perform services under CLIA ’88. NGS has become standard of care at many facilities across the US, and the proposed NCD will limit access to many patients and potentially destroy clinical research in cancer genetics by monopolizing patient genomic data. This is bad for patients and for researchers.
Genomic knowledge is quickly growing and evolving and testing in this space must change with this knowledge. Because the IVD process is time consuming and expensive, test will be generally rendered obsolete by the time the submission process is completed, and once approved the test cannot be altered without significant additional expenses. Additionally, the current IVD in question considered the genomic data from the patient to be proprietary, meaning that only the manufacturer will have access to lab data and researchers and clinicians will not be able to use it. This is bad for patients and researchers.
In summary, NGS allows us to see the mechanisms of disease in cancer and is becoming a critical component of the practice of medicine. The NCD proposed will severely hamper molecular pathologists’ and oncologists’ ability to treat patients and further refine the future of cancer care. CMS has the ability now to move forward in the right direction at this crossroads, enabling the use of NGS more broadly to maximize our ability to treat the underlying cause of disease in cancer patients and practice medicine with these genomic data; or it can go backwards, treat NGS as a test that is owned by a device manufacturer that owns the genomic data and pretend that there is some value to an IVD that is comprised of all the same “stuff” as the LDTs.