Publications & Podcasts
November 9, 2022The PHE is Ending: Do You Know Where Your Waivers Are?
June 29, 2022New DOJ Task Force Announced Will Impact Health Care Providers & Prescribers in Northern New England
June 24, 2022Hospitals Win 340B Medicare Rate Cut Suit, But When, How, and How Much They Will Recoup Remains Unclear
January 31, 20222021 Medicare Cost Report Preparation, Reminders and New Developments for Hospitals
December 16, 2021 Published WorksJames Roosevelt, Jr. Published in ScienceDirect
December 3, 2021 Published WorksHow Growing Cyber Scrutiny Affects Corporate Compliance
March 15, 2021 Published WorksFraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.
January 20, 2021Massachusetts Health Care Bill Makes Several Significant Changes
January 8, 2021The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?
January 5, 2021HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies
December 14, 2020340B 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, 2020Hospital Price Transparency Rule: Full Steam Ahead
August 27, 2020News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs
July 17, 2020EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?
June 18, 2020FDA 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, 2020FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency
April 23, 2020OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency
April 1, 2020Updated FDA COVID-19 Guidance for Conduct of Clinical Trials
March 20, 2020Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services
March 20, 2020COVID-19: FDA Clinical Trial Guidance
March 19, 2020COVID-19 Expanded Access Template
March 17, 2020Responsible Research During the COVID-19 Pandemic
February 20, 2020Two Proposed Rules Aim to Increase Organ Donation in the U.S.
January 15, 2020More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries
December 10, 2019Avoid Rejection: Make Sure Your Medicare Cost Report is Properly Completed
October 31, 2019Keep Medicare Enrollment Information Correct and Current or Suffer Consequences
September 19, 2019CMS Cracking Down on Health Care Fraud and Abuse
September 10, 2019BORIM Issues Guidance on Recent Changes to Practice of Medicine Regulations
August 23, 2019Massachusetts Final Budget: How the Act Will Affect Pharmaceutical Companies
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