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Latest From Sue Darcey
The House Energy and Commerce Committee approved four opioid crisis-related bills that call for US FDA meetings and consideration of streamlined pathways for medtech alternatives to opioids, and for a report and action by the US Medicare agency on overcoming payment challenges to device pain control products.
The US Trade Representative office's decision in March to include devices, imaging machines and diagnostics on a list of Chinese imports destined for a 25% tariff has riled up the industry. A half-dozen medtech organizations protested the move in comments and testimony this week, supplying USTR with 12 reasons why the tariffs are a very bad idea.
There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."
More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.
The US Centers for Medicare and Medicaid Service issued an interim final rule to shore up durable medical equipment prices in rural and noncontiguous areas of the US (including Alaska, Hawaii and territories) that are not subject to competitive bidding.
The House Energy and Commerce Committee on May 9 approved, and sent to the full chamber, a bill requiring Medicare Part D drug plans to highlight information for prescribers on covered non-opioid pain devices and alternative medications.