Aetna CMO: UDIs in claims forms necessary to improve care

Transparency when it comes to doctors and hospitals tracking the devices that go into patients is necessary to improve quality and reduce costs, according to Harold Paz, executive vice president and chief medical officer at Aetna. Read more here.

By |2015-03-16T15:52:43+00:00March 16th, 2015|Regulatory|Comments Off on Aetna CMO: UDIs in claims forms necessary to improve care

Regulators, Experts Outline Plan for New National Medical Device Surveillance System

Medical devices—and the patients who use them—would substantially benefit from a National Medical Device Postmarket Surveillance System (MDS), charges a new report authored by the Brookings Institution's Engelberg Center for Health Reform with support from the US Food and Drug Administration (FDA). Read more here.

By |2015-03-02T07:51:17+00:00March 2nd, 2015|Government, Regulatory|Comments Off on Regulators, Experts Outline Plan for New National Medical Device Surveillance System

Joint Commission releases requirements for imaging services

The Joint Commission has released updated accreditation requirements for diagnostic imaging service providers in U.S. hospitals and ambulatory care centers. Although the new rules emphasize imaging safety in positive ways, more specific guidance is needed, according to safety advocates. Read more here.

By |2015-01-22T12:36:53+00:00January 22nd, 2015|Government, Regulatory|Comments Off on Joint Commission releases requirements for imaging services

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

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

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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