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BioWorld - Sunday, January 4, 2026
Home » Authors » Mark McCarty

Articles by Mark McCarty

Washington roundup: GAO urges CMS to evaluate private-sector doc pay ideas

Jan. 2, 2013
By Mark McCarty

Washington roundup: Mindray recall followed by FDA warning for monitors

Dec. 27, 2012
By Mark McCarty

Washington roundup: Invacare, FDA sign consent decree for Elyria, Ohio plant

Dec. 26, 2012
By Mark McCarty

Washington roundup: Doc fix drama back in play, but long-term deal unlikely

Dec. 21, 2012
By Mark McCarty

Fiscal cliff and the device tax: a second take

Dec. 20, 2012
By Mark McCarty
As discussed previously, a repeal of the device tax faces longish odds. Opponents of the tax have punted to a suspension of the tax as was disclosed by a letter from nearly 20 members of the U.S. Senate, a move purportedly prompted by the short turn-around from the date of the IRS’s final rule to the effective date of the tax. Despite the disclaimers, it’s important to point out that you clearly don’t believe a repeal has any chance in the short term if you’re arguing for a suspension. So let’s ask ourselves what sort of headwinds the device tax...
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Washington roundup: CMS eyes allowing carriers to deal with PET oncology drugs

Dec. 19, 2012
By Mark McCarty

Washington roundup: Obama says no to device tax delay, argues 'new customers'

Dec. 18, 2012
By Mark McCarty

Washington roundup: Maker of dental pastes warned for unapproved claims still at website

Dec. 13, 2012
By Mark McCarty

Meet the New CED

Dec. 12, 2012
By Mark McCarty
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance. Interesting item #1: The passage stating that CMS is examining the question of “whether local contractors should have the discretion to apply CED in local coverage” is pretty close to an earthquake. I’m assuming that most CED trials will have to span more than one Medicare carrier’s jurisdiction, which suggests a patchwork of CED coverage or a need to get...
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Washington roundup: Expected warning to St. Jude for Sylmar audit yet to surface

Dec. 12, 2012
By Mark McCarty
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