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Resistance Is Futile: CMS Gets Serious About Antibiotic-Resistant Bacteria

Antibiotics and similar drugs, known more broadly as antimicrobial agents, are an instrumental weapon in the healthcare armory, rendering once-lethal infections treatable, and dramatically reducing instances of sepsis and...more

Year of the Bundle: CMS Proposes New Mandatory Cardiac Bundles and Expansion of CCJR

The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule that furthers the U.S. Department of Health and Human Services’ goal to promote cooperative, value-based care and tie at least 50 percent...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for the Protection of Human Subjects, more...more

It’s About Time (But Not Quite Yet)

The comment period for the Notice of Proposed Rule Making (NPRM) regarding proposed changes to the Human Subjects Protection “Common Rule” issued by 16 federal departments and agencies in September has been extended an...more

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether...more

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