I have been researching the national coverage decision from CMS regarding next generation sequencing. I had been chatting with the folks from the Personalized Medicine Coalition, and trying to learn what it would take to get more uniform reimbursement for laboratory-designed tests for cancers other than breast and ovarian cancer. Another interesting thing about this area is that the FDA has been asking some companies for proof that these molecular assays work! If widespread, this could a significant departure from the agency's historical exercise of regulatory discretion for these tools.
I also had been researching an article on insulins, inflation, biosimilars and immunogenicity. Will the FDA's pathway switch for insulins and other biosimilars be enough to encourage companies to file applications for insulin biosimilars? What about the relaxation of the requirement for data about immunogenicity, as expressed in the FDA's recent proposed guidance? Will that be enough?
Somewhat related to the insulin question is a topic involving organ transplants. Before the quarantine, the Trump administration recently announced a couple of changes that had the advocates in kidney disease organizations cheering. The first is a change that would allow reimbursement of certain costs experienced by living organ donors, such as foregone wages, and costs for child care and elder care during a period of donor hospitalization. The second rule proposed certain alterations to federally-certified organ procurement organizations. The changes seem intended to encourage more competition by these organizations. I'm not 100% sure that's the right approach; do we really want hospitals to harass patients on their death beds, with the goal of convincing them to give up their kidneys upon death? Another part of the rule seems to encourage organizations to make greater use of organs, even if they aren't in perfect shape. But do we really want to take that decision away from doctors?
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