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Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Bradley Arant Boult Cummings LLP

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Cozen O'Connor

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Cozen O'Connor on

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

Fisher Phillips

What’s the Real Effect of OSHA’s Revamped Inspection Process, the “Enforcement Weighing System?”

Fisher Phillips on

On October 1, OSHA started its “Enforcement Weighing System,” which means that OSHA Compliance Officers and Area Offices will be under less pressure to complete a number of inspections and will receive credit for separate...more

Polsinelli

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Polsinelli on

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

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