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...
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
BD raised its adjusted earnings per share guidance midpoint by $0.18 to a range of $14.30 to $14.45, representing growth of about 9.4% at the midpoint – an increase of approximately 1.4% over prior guidance.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
