Publications & Podcasts
July 12, 2023 Podcast
Speaking of Health Law Podcast with David Lazarus
July 10, 2023
CMS Proposes to Make Lump-Sum Payments to Hospitals for Underpayments for Drugs Purchased Through the 340B Program During 2018-2022
November 9, 2022
The PHE is Ending: Do You Know Where Your Waivers Are?
June 29, 2022
New DOJ Task Force Announced Will Impact Health Care Providers & Prescribers in Northern New England
June 24, 2022
Hospitals Win 340B Medicare Rate Cut Suit, But When, How, and How Much They Will Recoup Remains Unclear
January 31, 2022
2021 Medicare Cost Report Preparation, Reminders and New Developments for Hospitals
December 16, 2021 Published Works
James Roosevelt, Jr. Published in ScienceDirect
ScienceDirect
December 3, 2021 Published Works
How Growing Cyber Scrutiny Affects Corporate Compliance
Law360
March 15, 2021 Published Works
Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.
January 20, 2021
Massachusetts Health Care Bill Makes Several Significant Changes
January 8, 2021
The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?
January 5, 2021
HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies
December 14, 2020
340B Providers Get Partial Relief from New Dispute Resolution Regulation
November 23, 2020
“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments
November 9, 2020
Hospital Price Transparency Rule: Full Steam Ahead
August 27, 2020
News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs
July 17, 2020
EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?
June 18, 2020
FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19
April 23, 2020
FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency
April 23, 2020
OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency
April 1, 2020
Updated FDA COVID-19 Guidance for Conduct of Clinical Trials
March 20, 2020
Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services
March 20, 2020
COVID-19: FDA Clinical Trial Guidance
March 19, 2020
COVID-19 Expanded Access Template
March 17, 2020
Responsible Research During the COVID-19 Pandemic
February 20, 2020
Two Proposed Rules Aim to Increase Organ Donation in the U.S.
January 15, 2020
More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries
December 10, 2019
Avoid Rejection: Make Sure Your Medicare Cost Report is Properly Completed
October 31, 2019
Keep Medicare Enrollment Information Correct and Current or Suffer Consequences
September 19, 2019
CMS Cracking Down on Health Care Fraud and Abuse
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