Brian P. Dunphy

Brian P. Dunphy

Mintz Levin

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Another Court Weighs in on Rule 9(b)’s Requirements Under the False Claims Act

A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated...more

8/28/2014 - Anti-Kickback Statute False Claims Act Hospitals Qui Tam Rule 9(b) Stark Law

Acute Care Hospitals Settle FCA Lawsuits for $98 Million

Community Health Systems, Inc. (CHS) and Community Health Systems Professional Services Corporation, together a national owner and operator of acute care hospitals, and 119 of their hospitals, agreed to pay $98 million to...more

8/18/2014 - Acute Facilities False Claims Act Healthcare Hospitals Qui Tam Settlement

CMS Temporarily Closes the Open Payments System

Open Payments is the website through which pharmaceutical and medical device manufacturers (“Manufacturers”) report payments and transfers of value to physicians and teaching hospitals, as required by the Sunshine Act. ...more

8/13/2014 - CMS Healthcare Healthcare Reform Open Payments Sunshine Act

A Recent D.C. Circuit Court of Appeals Decision Calms Employer Fears that Internal Investigations May Not Be Privileged and Lays...

A recent decision from the D.C. Circuit Court of Appeals, one of the most important courts in the nation, reaffirmed that a company’s internal investigations—if structured properly—are protected from disclosure in litigation...more

7/9/2014 - Attorney-Client Privilege False Claims Act Internal Investigations Investigations Kellogg Brown & Root Kickbacks Upjohn Warnings

Lessons to Be Learned from FCA Defendant Who Provided Attorney Work Product to OIG

Health care companies and their counsel handling health care fraud investigations or False Claims Act (“FCA”) cases should consider the potential strategic implications of a decision compelling an FCA defendant to produce...more

6/6/2014

Keeping Legal Advice In-House: Protecting the Attorney-Client Privilege

Given that laboratories operate in a heavily regulated environment, the advice of legal counsel is integral to ensuring compliance with the many laws and regulations that govern the laboratory industry. Luckily the...more

5/30/2014 - Attorney-Client Privilege Corporate Counsel False Claims Act Whistleblowers

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

5/23/2014 - Clinical Laboratories Diagnostic Imaging Services FCA Healthcare Hospitals Laboratories Pharmacies Physicians Prescription Drugs Qui Tam

More Open Questions About Open Payments Under the Sunshine Act

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more

2/11/2014 - CMS GPOs Healthcare Medical Devices Pharmaceutical Sunshine Act

Mintz Levin Health Care Qui Tam Update -- Recent Developments & Unsealed False Claims Act Cases

Trends & Analysis: - We have identified 31 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only six were filed in 2013. The majority (14 cases) were filed in 2011 or 2012, with the...more

1/16/2014

OIG Defines its Priorities in 2014-2018 Strategic Plan

Outlining its high-level priorities and goals for the next five years, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its Strategic Plan for 2014-2018. In the Strategic...more

11/26/2013 - Enforcement Fraud Fraud and Abuse HHS OIG Waste

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases

Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more

11/1/2013 - Anti-Kickback Statute False Billing False Claims Act Healthcare Off-Label Promotion Pharmaceutical Prescription Drugs Qui Tam Relators Sealed Records

Physician Groups Seek Sunshine Act Changes

Seventy-four state and federal physician organizations, including the American Medical Association, recently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal...more

11/1/2013 - CMS Medical Devices Pharmaceutical Reporting Requirements Sunshine Act

The False Claims Act is Not a License to Divulge Employer Confidences

Health care employers concerned that former employees may misappropriate the company’s confidential information to support qui tam lawsuits under the False Claims Act (“FCA”) received guidance from a recent court decision. ...more

10/3/2013 - Compliance Confidential Information False Claims Act Healthcare Internal Controls Qui Tam Relators

Fifth Circuit Joins Chorus to Rein in False Claims Act

Add the Fifth Circuit to the list of jurisdictions questioning the use of the federal False Claims Act (FCA) in instances where – using the theory of implied certification - the alleged falsity is not apparent on the face of...more

8/28/2013 - DOJ False Claims Act False Statements

PRIME Act: New Legislation to Curb Health Care Fraud

The United States Senate and House of Representatives recently introduced bipartisan legislation designed to reduce fraud, waste, and abuse in the Medicare and Medicaid programs. The legislation, entitled “Preventing and...more

6/17/2013 - CMS Fraud HHS Information Sharing Medicaid Medicare Overpayment Proposed Legislation Recovery Audit Contractor Waste

Updated Self-Disclosure Protocol Clarifies Disclosure Process and Obligations

Individuals and entities subject to the Civil Monetary Penalty Law (CMP) have received clarification regarding the process for disclosing and resolving potentially unlawful conduct involving the federal health care programs...more

4/23/2013 - CMS Damages Disclosure Requirements OIG Overpayment Self-Disclosure Requirements

CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions

Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013. The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more

3/7/2013 - CMS Drug Manufacturers Joint Purchasing Programs Physicians Sunshine Act

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

2/5/2013 - CMS Compliance Continuing Medical Education Data Collection Drug Manufacturers Enforcement GPOs Medicaid Medical Devices Medical Supplies Payment Records Physicians Reporting Requirements Sunshine Act

Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

2/4/2013 - Biologics CME CMS Data Collection Drug Manufacturers GPOs Medical Devices Pharmaceutical Reporting Requirements Stark Law Sunshine Act

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