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Health Law Diagnosis - January 2023

New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit Hospices - On December 23, 2022, New York Governor Kathy Hochul vetoed Assembly Bill Number A8472 “An Act To Amend The Public Health Law,...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

CMS Finalizes MACRA Rule and Continues Transition Toward Value-based Payments

On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released a final rule with comment period (Final Rule) implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Final Rule...more

Third Circuit Delivers Resounding Victory for FTC in Pennsylvania Hospital Merger Case

On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more

Health Law Pulse - September 2016

DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE - On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more

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