Bill Filed to Repeal Medical Device Excise Tax

January 8, 2015 -- Bipartisan legislation to repeal the 2.3% medical device excise tax has been introduced into the U.S. House of Representatives. The Protect Medical Innovation Act (HR 160) is sponsored by Reps. Erik Paulsen (R-MN) and Ron Kind (D-WI) and was introduced with 254 original co-sponsors. Paulsen and Kind introduced a similar bill to repeal the [...]

By |2015-01-13T10:35:06+00:00January 13th, 2015|Government, Regulatory|Comments Off on Bill Filed to Repeal Medical Device Excise Tax

FDA Expands Medical Device Surveillance Program

After five years, the FDA is transitioning its Mini-Sentinel program to a full-scale Sentinel System.  “We’re on our way to developing a nationwide rapid-response electronic active surveillance system, Sentinel System, for monitoring the safety of FDA-regulated drugs and other products,” wrote Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in [...]

By |2015-01-06T13:40:19+00:00January 6th, 2015|Government, Regulatory|Comments Off on FDA Expands Medical Device Surveillance Program

Concussion legislation yields higher healthcare utilization, but not more imaging

State legislation has played a role in boosting overall healthcare utilization rates in children with concussions, though the laws have done little to change CT scan rates specifically, according to a study published online Dec. 22 in JAMA Pediatrics. Read more here.

By |2014-12-23T14:32:47+00:00December 23rd, 2014|Business, Government|Comments Off on Concussion legislation yields higher healthcare utilization, but not more imaging

Supreme Court to Hear King v. Burwell on March 4

The U.S. Supreme Court has scheduled oral arguments in King v. Burwell for March 4, a court spokesperson confirmed Monday afternoon. Many observers have said the case has the potential to disrupt or even unravel the nation’s new healthcare law. Read more here.

By |2014-12-22T14:29:15+00:00December 22nd, 2014|Business, Government|Comments Off on Supreme Court to Hear King v. Burwell on March 4

FDA pushes forward with UDI system development

The U.S. Food and Drug Administration is pressing "full steam ahead" to develop a unique device identifier (UDI) system for medical devices, according to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. Read more here.

By |2014-12-12T14:35:14+00:00December 12th, 2014|Government, Regulatory|Comments Off on FDA pushes forward with UDI system development

CMS Says Yes to CT Lung Cancer Screening for Seniors

Bucking a negative assessment from its own appointed review panel, the U.S. Centers for Medicare and Medicaid Services (CMS) today approved CT lung cancer screening for Medicare recipients, saying the evidence is sufficient to justify screening high-risk individuals until the age of 74 years. Read more here. 

By |2014-11-11T09:52:19+00:00November 11th, 2014|Government, Regulatory|Comments Off on CMS Says Yes to CT Lung Cancer Screening for Seniors

Supreme Court to Hear Obamacare Subsidy Case

The U.S. Supreme Court announced Friday it will hear King v. Burwell, a case that many say could gut the nation's Patient Protection and Affordable Care Act, leaving millions of Americans uninsured. Read more here.

By |2014-11-10T14:08:15+00:00November 10th, 2014|Government|Comments Off on Supreme Court to Hear Obamacare Subsidy Case

JAMA IM Editorials Weigh in on Lung Cancer Screening

With Medicare on the cusp of a momentous decision about whether to pay for CT lung cancer screening, the issue is the focus of a pair of editorials published October 13 in JAMA Internal Medicine. Taking opposite sides, the articles one last time outline positions that have become solidified as the U.S. government weighs what could [...]

By |2014-10-14T10:29:25+00:00October 14th, 2014|Government, Regulatory|Comments Off on JAMA IM Editorials Weigh in on Lung Cancer Screening

Hillary Clinton hedges on the device tax, says nation must weigh pros and cons

I'm well aware of your concerns about the 2.3% device tax, and I think you have an argument to make," she told AdvaMed CEO Stephen Ubl during her address at the association's annual med tech conference. "I think it [a decision] has to be made within the context of a larger set of issues that [...]

By |2014-10-09T13:39:13+00:00October 9th, 2014|Business, Government, Regulatory|Comments Off on Hillary Clinton hedges on the device tax, says nation must weigh pros and cons
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