Greg Fosheim

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

Photo of Kyle GregoryPhoto of Emily CrosbyBy Kyle Gregory, Greg Fosheim and Emily Crosby on Posted in Uncategorized
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 secondary infections associated with cancer chemotherapy and organ transplants. However, sub-therapeutic use of antimicrobial agents in livestock, over-prescription, bacterial evolution and myriad other factors have contributed … Continue Reading

The Deeper Dive: Section 1557 Attempts to Return the “Care” to “Healthcare”

Photo of Amy FoutsPhoto of Kyle GregoryBy Amy Fouts, Greg Fosheim and Kyle Gregory on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) moved to the forefront of anti-discrimination measures when it released a final rule, titled “Nondiscrimination in Health Programs and Activities” (Final Rule), implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the grounds of race, color, national origin, sex, age or disability in … Continue Reading

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

Photo of Kristen McDermott WoodrumBy Kristen McDermott Woodrum and Greg Fosheim on Posted in Uncategorized
CMS is building momentum with its bundled payment programs and upping the stakes for hospitals. 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 of Medicare payments to quality … Continue Reading

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

By Greg Fosheim on Posted in Uncategorized
An overview of stakeholder comments on proposed revisions to informed consent forms and the posting of informed consent forms within 60 days after closure of enrollment 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 … Continue Reading

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

By Greg Fosheim and Payal Cramer on Posted in Uncategorized
An overview of stakeholder comments on the redefinition of “biospecimen” as a “human subject” and the consent requirements for secondary use of these biospecimens. 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 … Continue Reading

It’s About Time (But Not Quite Yet)

Photo of Rob RozierBy Greg Fosheim and Rob Rozier on Posted in Uncategorized
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 additional 30 days to January 6, 2016.  Only the Department of Health and Human Services (HHS) has received any comments on … Continue Reading

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

Photo of Rob RozierBy Greg Fosheim and Rob Rozier on Posted in Uncategorized
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. But until now, the rules and regulations governing human subjects research (the “Common Rule” at 45 C.F.R. Part … Continue Reading

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

By Payal Cramer and Greg Fosheim on Posted in Uncategorized
“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 involving a patient, provider, or industry, the government closely scrutinizes quid pro quo arrangements when the government foots the bill. Clinical trial sponsors … Continue Reading
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