Key device updates in CMS's latest payment rules include reforms to the hospital outpatient pass-through payment process for new technology, the agency's continued march forward on "comprehensive" outpatient procedure payments, scaled-back physician cuts for radiation oncology and reimbursement for transoral GERD procedures.
Health care providers and product manufacturers are poring over CMS' recently released 2016 payment system rules. Here are a few key takeaways for device companies from the Medicare hospital outpatient prospective payment system and physician fee schedule final rules.
CMS decisions on awarding bonus hospital outpatient "pass-through" payments to new technology will be subject to a stricter "newness" standard...
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
