- PMA Tests Used for On-Label Cancers.
- These tests are covered for advanced cancers if the cancer is on label for at least one gene. Foundation One CdX is covered for paients who have either breast, melanoma, lung, or colon cancer [at least one gene is CDx in each]. ThermoFisher Scientific Oncomine Target Dx is covered patients with lung cancer.
- PMA Tests Used in Off-Label Cancers *OR* all uses of 510(k) Cleared Tests (such as MSK IMPACT)
- These tests are covered only by concurrently enrolling patient in a detailed, long term clinical registry (CED) including ongoing RECIST objective response and PFS imaging.
- All Other Tests (e.g. LDT NGS)
- Covered only in NCI trials.
How would the NCD play out for solid tumor patients and Keytruda?
In May 2017, FDA approved immuno-oncology therapy Keytruda for all patients with solid cancers. While there are several test methods (NGS, PCR, immunohistochemistry), none to my knowledge are FDA cleared. Nonetheless, use of the cancer drug is on label if used with CLIA MSI testing. In short, currently, FDA approves a major cancer drug for several hundred thousand US patients without an FDA PMA approved diagnostic.
Patients can get (1) non-FDA approved immunohistochemistry testing, (2) non-FDA approved PCR, CPT 81301) or (3) non-FDA approved NGS MSI (MSI is found on the Foundation One test but not with CDx status). For example, the MolDX article for test coverage is here.
Under the NCD, patients with breast, lung, colon, or melanoma have access to MSI testing under the Foundation Medicine test, since the test has one approved gene in each cancer, even though MSI is a supplemental report, not a CDx test.
Using deaths from cancer as a proxy for advanced cancer, I assumed for sketch purposes that half of cancer deaths were in the Medicare population. This yields the numbers shown below, assuming the Foundation CDx test is paid at $2900 (81455) and the MSI PCR test (CLIA) at $356.
64,215 patients with advanced lung, breast, colorectal cancer or melanoma could get the FMI test for MSI, at $186M. (Had they got the PCR test 81301 for MSI, which CMS also covers, $22.8M).
More interesting is the other cancers - endometrial, renal, liver, etc. Here, about 71,470 Medicare patients could get either the FMI or IMPACT tests, at $2900 each, for $207M. Each patient would cost perhaps $10,000 in CED, for an additional $714.7M, totalling $921.9M. (Had these 71,470 patients had PCR MSI testing and no CED, costs would be $25.4M.)
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How Much Does CED Cost? Who pays?
The CED required in the NCD is pretty elaborate, such as RECIST imaging for objective response (OR) and progression free survival (PFS), the latter of which could go on for a year or more. In addition, I'm assuming that it's not rigorous PFS without monthly imaging. The imaging would not be required for clinical care, so it would not be covered by the Clinical Trials NCD. So let's say it is $10,000 per year.
Lab?
No regular lab could afford that (based on $2900 test payments).
Wealthy Centers??
Maybe wealthy medical centers could fund the CED, for a limited number of select patients.
Patient???
Since much of the cost is imaging, it could be coded as imaging and billed to patients under an ABN as "medically unnecessary services," but few patients could pay the cost.
CMS????
I am not an attorney, but it seems like CMS might be able to cover the imaging costs under CED - the whole point of CED under SSA 1862(1)(e) is to cover non medically necessary costs incurred as expenses in health research. However, so far CED has only been used when the service under CED is "the" medical therapy, and RECIST imaging is not "the" medical therapy under CED research. However, it is an expense incurred in health research. But if the imaging was coded with a modifier and paid by CMS, it would probably still trigger copayments.
Medicare Advantage
Rarely, NCDs trigger an exceptions clause in Medicare Advantage plans, which result in the service being billed to Part B even for Medicare Advantage patients. It's hard to estimate utilization under the NCD (maximal cases are shown in the Excel above), but this NCD might trigger the exceptional expenses clause.
The CED required in the NCD is pretty elaborate, such as RECIST imaging for objective response (OR) and progression free survival (PFS), the latter of which could go on for a year or more. In addition, I'm assuming that it's not rigorous PFS without monthly imaging. The imaging would not be required for clinical care, so it would not be covered by the Clinical Trials NCD. So let's say it is $10,000 per year.
Lab?
No regular lab could afford that (based on $2900 test payments).
Wealthy Centers??
Maybe wealthy medical centers could fund the CED, for a limited number of select patients.
Patient???
Since much of the cost is imaging, it could be coded as imaging and billed to patients under an ABN as "medically unnecessary services," but few patients could pay the cost.
CMS????
I am not an attorney, but it seems like CMS might be able to cover the imaging costs under CED - the whole point of CED under SSA 1862(1)(e) is to cover non medically necessary costs incurred as expenses in health research. However, so far CED has only been used when the service under CED is "the" medical therapy, and RECIST imaging is not "the" medical therapy under CED research. However, it is an expense incurred in health research. But if the imaging was coded with a modifier and paid by CMS, it would probably still trigger copayments.
Medicare Advantage
Rarely, NCDs trigger an exceptions clause in Medicare Advantage plans, which result in the service being billed to Part B even for Medicare Advantage patients. It's hard to estimate utilization under the NCD (maximal cases are shown in the Excel above), but this NCD might trigger the exceptional expenses clause.