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Latest From Sue Darcey
The US Centers for Medicare and Medicaid Services March 16 said it will cover next-generation sequencing diagnostic laboratory tests for advanced cancers, broadening its final determination to cover use in relapsed, refractory and stage III cancers, while dropping "coverage with evidence development" conditions.
Geisinger Health has teamed up with Swiss-based device-maker Medacta International in a pilot program guaranteeing lifetime coverage of hip replacement costs for Geisenger patients.
"Right-to-try" legislation aimed at giving severely ill patients access to drug treatments not yet approved by US FDA failed to win support from the needed super-majority in a Tuesday night vote in the US House. Before the vote, the bill's scope was narrowed by removing medical device provisions, and making it applicable only to those facing death within a matter of months. A Senate version still in play retains the device language.
While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.
A wide variety of devices that could either serve as pain-relief substitutes for opioids, help manage opioid addictions or tackle distribution issues with the overly prescribed medications are facing reimbursement challenges at the US Centers for Medicare and Medicaid Services.
While device firms that create lab test kits, clinical laboratories and cancer medicine groups supported US Centers for Medicare and Medicaid Services' proposed national coverage determination for use of next generation sequencing (NGS) for advanced cancer tests in recent comments, they want the agency to modify its approach to the NCD in one way or another and, in many cases, expand it. A final coverage decision is imminent.