A couple of months ago, the Principal Deputy Inspector General and its Chief Medical Officer wrote a compelling editorial (https://www.statnews.com/2021/03/01/why-drug-prescriptions-should-include-diagnoses/), advocating why prescriptions should include the patient diagnosis for which the prescription is written. They provided, as an example, the spike in hydroxychloroquine prescription prescriptions from March 2020 to July 2020. The article contains some shocking statistics, but the bottom line is, had Medicare known the prescriptions were written for outpatient COVID treatment, it would not have paid the claims because they were not reimbursable-indeed promotion of hydroxychloroquine for such use to physicians, no doubt with misleading information, would have been off-label prescribing violative of the False Claims Act. This is because, at the time (and to date), there lacked authoritative data supporting the use of hydroxychloroquine use for Covid-19, as safe and effective. Seems like an easy fix, doesn’t it? Indeed, as the article points out, the OIG proposed requiring diagnoses for Medicare drug claims in its 2011 Annual Report, but CMS declined to do so, reasoning that it would entail adding diagnosis to prescription forms, an additional step that would need to be implemented state by state.
The trouble with CMS’ reasoning is that anything within the states’ purview would be off limits for any change, from CMS ‘ standpoint. This is nonsense. CMS, by law, is the oversight body for Medicare and Medicaid, among other government healthcare programs. It is CMS’ responsibility to improve oversight of both programs as the steward of taxpayer funds. Up front knowledge of off-label prescribing, for which there was insufficient data to support Medicare or Medicaid coverage as a Covered Outpatient Drug, not only makes sense from a fiscal standpoint, it is a further check and balance to improve patient outcomes. Armed with this knowledge in real time, as opposed to years later, if ever, will enable CMS and the OIG to ward off prescription-writing by the small percentage of physicians who choose to write them for which there is insufficient efficacy and safety data. It sure would have helped to have this information as the opioid crisis was emerging, would’ve it not?