In an address to the National Press Club on 10 May, former FDA Commissioner Scott Gottlieb pointed to some of the challenges that CMS would face in supplying coverage for new technology, should a "Medicare for All" bill be adopted by Congress and signed by the president. Medtech Insight analyzed provisions that could impact industry in some of the proposed bills, in a comparative chart.
Former US FDA Commissioner Scott Gottlieb, now an American Enterprise Institute scholar, told reporters at a National Press Club luncheon on 10 May that the device industry has good reason to be highly skeptical of expanding Medicare – as some so-called "Medicare for All" bills would do – and changing private coverage.
“I think it could squelch innovation and medical progress,” said Gottlieb, who left the top post at the agency on...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Multi-cancer diagnostics can help get oncology patients the treatment they need more quickly, but lack of reimbursement has kept such tests out of reach for many patients. Bills providing coverage have passed or are under consideration in more than half of the states and have been introduced in both houses of US Congress.
A government report requested by US lawmakers Debbie Dingell and Anna Eshoo to review the FDA’s postmarket surveillance of medical devices stresses that strengthening the system is critical to addressing adverse events linked to devices after they hit the market.
A bipartisan bill now in the US Senate seeks to change the classification of implantable hearing aid devices to allow Medicare to reimburse for the devices, potentially expanding access for many Americans who require them.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
