Medical Devices

Pacific Research Institute released a report critiquing CMS' competitive bidding program for durable medical equipment shortly after the agency proposed a rule putting the program on hold as it makes changes that are viewed by suppliers as the strongest examples to date of the agency taking their concerns into account.

The Advanced Medical Technology Association was delighted by a 283-132 vote in the House of Representatives Tuesday (July 24) to repeal the 2.3 percent excise tax on medical devices that had been included as a funding source for the Affordable Care Act. Scott Whitaker, the association’s president and CEO, called the vote a win for American innovation, jobs and patients, and urged the Senate to quickly pass the legislation.

House Majority Leader Kevin McCarthy (R-CA) on Thursday revealed plans to bring a permanent repeal of the medical device tax, a two-year delay of the health insurance tax, a reversal of the ACA's ban on using tax-preferred accounts for over-the-counter medicine and tweaks to health savings accounts (HSAs) to the floor next week, but sources say he doesn't plan a vote on legislation that would delay the 40 percent tax on high-cost plans (known as the Cadillac tax) or mitigate the employer mandate at this time.

FDA Commissioner Scott Gottlieb called for the creation of a national resource to coordinate the development and use of real-world evidence (RWE) in medical product development and regulatory science in a recent FDA Voice blog post.

A lawyer familiar with Supreme Court nominee Brett Kavanaugh and his jurisprudence said the judge, should he be appointed to the high court, would avoid deferring automatically to FDA or other federal regulatory agencies on cases involving matters where Congress has not given clear instructions.

Top FDA officials, including FDA Commissioner Scott Gottlieb, reaffirm the need for a new regulatory framework for software as a medical device (SaMD), which they hope will help ease the regulatory uncertainty surrounding such products, increase consumer confidence in the technology, help payers and investors understand the technology, and allow the agency to keep up with the fast pace of software development.

A major hospital group says FDA needs to step up and mandate cybersecurity for medical devices, a move intended to address risks related to legacy products that can't be updated or adequately patched as Congress considers steps to protect patients from cyber attacks.

A representative of an independent device service organization called out other ISOs for servicing medical devices without proper equipment or training, a concern which FDA said in a report released last month did not have enough evidence to be considered a widespread public health risk.

FDA's decision to adopt a hands-off approach on medical device servicing has refueled congressional interest in legislation to beef up federal oversight of the industry, a spokesperson for the House Energy and Commerce Committee told Inside Health Policy.