Policy & Regulation

Hospitals — and now insurers — to reveal secret rates under latest Trump admin pitch

Industry lobbies are sure to fight back against what would be a landmark shift in healthcare.
By Samantha Liss • Nov. 15, 2019
FDA advisers: Metal implants need beefed up ingredient labels

Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue.
By Maria Rachal • Nov. 15, 2019
FDA overhauls export certificate guidance after negative feedback

AdvaMed said the draft suffered "from inaccuracies and omissions that FDA must correct." The final guidance provides more information on the appeals process and grounds for denials.
By Nick Paul Taylor • Nov. 14, 2019
Hologic wins FDA approval for AI-based breast imaging tech

The imaging company claims the platform saves radiologists one hour per eight hours of interpretation.
By Nick Paul Taylor • Nov. 14, 2019
FDA experts weigh evidence on patients' adverse reactions to common device metals

Suggestions from speakers at Wednesday's advisory panel included conducting comparative effectiveness studies, bolstering the informed consent process and requiring more stringent adverse event reporting.
By Maria Rachal • Nov. 13, 2019
Boston Scientific faces lower reimbursement despite White House lobbying bid

In an Office of Management and Budget meeting days before release of CMS' hospital outpatient payment final rule, execs argued the change would deter doctors from a procedure using a device that could reduce opioid dependence.
By David Lim • Nov. 13, 2019
Paige gets CE mark for prostate cancer detection technology

The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.
By Nick Paul Taylor • Nov. 13, 2019
Eudamed 2-year delay doesn't mean free pass for manufacturers

"The Eudamed project is expensive both in time and resources. It is not just an IT project, this is a change project," said Eudamed.eu CEO Richard Houlihan.
By Dana Elfin • Nov. 12, 2019
FDA grants breakthrough status to AI-based gastric cancer diagnostic

The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.
By Nick Paul Taylor • Nov. 12, 2019
Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says

The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.
By David Lim • Nov. 08, 2019
Medtronic reveals high-risk cyber vulnerability in electrosurgical generators

The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.
By Nick Paul Taylor • Nov. 08, 2019
Deep Dive
Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure'

FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency and override state legislation to get sterilization plants back online, one advisory panel member said.
By David Lim • Nov. 08, 2019
Medicare overpays for certain orthotic devices, OIG finds

Medicare and beneficiaries reportedly paid $341.7 million more than other payers for certain orthotic devices, building on prior investigations' findings that CMS has overpaid for services like radiation and sleep studies.
By Nick Paul Taylor • Nov. 07, 2019
FDA pitched progressive device pathway to Warren and Murray, reversing Gottlieb

The former FDA chief told lawmakers last year that such a framework would not be suitable for human products, but now the agency says it could speed devices for children.
By David Lim • Nov. 06, 2019
7 questions about ethylene oxide as FDA panel convenes

Agency advisers are meeting again Thursday, having already encouraged FDA to incentivize lower industry reliance on EtO, while acknowledging state regulators' potential to strain sterilization capacity and create device shortages.
By David Lim • UPDATED: Nov. 7, 2019 at 9:33 a.m.
As Essure implant return deadline nears, FDA study enrollment inches up

The birth control device, which Bayer stopped selling in December 2018, has been linked to nearly 33,000 reports of adverse events, including 49 deaths.
By Susan Kelly • Nov. 05, 2019
Myriad shares plunge 40% after missing targets, slashing outlook

Investors punished the genetic test maker after it reported double-digit drops in sales of its key cancer and depression products.
By Nick Paul Taylor • Nov. 05, 2019
5 breakthrough devices qualify under finalized faster outpatient payment path

CMS said Medicare spending on the five approved devices, which do not need to meet substantial clinical improvement requirements to qualify for the pass-through payments, will be about $116 million in 2020.
By Susan Kelly • Nov. 04, 2019
Price transparency rule on ice in win for providers

The final outpatient payments rule from CMS did include plans to implement controversial site neutral provisions and cuts to 340B drug payments, both of which have been successfully challenged in court.
By Samantha Liss • Nov. 01, 2019
Trump picks MD Anderson's Stephen Hahn for FDA chief

Pending Senate confirmation, the Texas cancer center's chief medical executive and former American Society for Radiation Oncology board member will fill the agency's top seat.
By Maria Rachal • UPDATED: Nov. 1, 2019 at 3:14 p.m.
New tech add-on payment for innovative dialysis products final in ESRD, DME rule

Following criticism from industry, CMS did not go through with a plan to use technology assessments to determine comparableness to older items to help establish fee schedule amounts for durable medical equipment.
By David Lim • Nov. 01, 2019
Medtronic thoracic stent graft system approved in Japan

The device addresses common attributes and conditions in the Japanese patient population such as greater aortic fragility, smaller anatomy and aortic wall stress, the director of the Japanese Society for Vascular Surgery said.
By Nick Paul Taylor • Nov. 01, 2019
Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority

FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.
By David Lim • Oct. 31, 2019
FDA puts J&J's Ethicon surgical stapler recall in top risk category

Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market.
By Nick Paul Taylor • Oct. 31, 2019
It's official: EC confirms 2-year Eudamed delay

The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects.
By Dana Elfin • Oct. 30, 2019