Brian P. Dunphy

Brian P. Dunphy

Mintz Levin

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Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2016

Since our last issue, we have identified 31 recently unsealed health care-related whistleblower cases. In this Qui Tam Update, we analyze the trends and take an in-depth look at a few noteworthy cases....more

8/5/2016 - Certificates of Compliance Constructive Trusts Criminal Prosecution DEA False Billing False Claims Act (FCA) Intervenors Kickbacks Medicare Qui Tam Relators State False Claims Acts Unjust Enrichment Whistleblowers

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...more

7/9/2016 - Anti-Kickback Statute Bribery Clinical Laboratories Criminal Prosecution Guilty Pleas Healthcare Fraud Individual Accountability Medicare Physicians Service Agreements Yates Memorandum

The Supreme Court Adopts Broad Scope of False Claims Act Liability

A unanimous Supreme Court issued its long-awaited and closely watched decision today on the scope of the False Claims Act (“FCA”), and the Court affirmed the FCA’s long reach. Universal Health Services, Inc. v. United States...more

6/17/2016 - Conditions of Payment False Claims Act (FCA) False Implied Certification Theory Federal Contractors Fraud Implied Certification Material Misrepresentation Materiality Medicaid Medicare Mental Health SCOTUS Universal Health Services Inc v United States ex rel Escobar Unlicensed Medical Providers

Already Enormous False Claims Act Penalties Set to Increase

The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device...more

5/9/2016 - DOJ False Claims Act (FCA) Health Care Providers Legislative Committees Medicaid Statutory Penalties

The Medicare Overpayment Rule: Implications for Compliance and Health Care Enforcement

As has been widely discussed, the Centers for Medicare & Medicaid Services (‘‘CMS’’) Feb. 12 published the long-awaited final rule governing the return of Medicare Part A and Part B overpayments within 60 days (the...more

3/2/2016 - Affordable Care Act CMS False Claims Act (FCA) Healthcare Fraud Look-Back Measurement Period Medicare Medicare Part A Medicare Part B Overpayment Recovery Time Limits

The Final 60-Day Rule: the Good, the Bad, and the Ugly

As we announced on February 11, 2016, the Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited Final Rule governing the return of Medicare Part A and Part B overpayments within 60 days (the...more

2/15/2016 - 60-Day Rule Civil Monetary Penalty CMS False Claims Act (FCA) Final Rules Medicare Part A Medicare Part B Overpayment

OMB Finalizes Review of 60-Day Overpayment Rule

The Office of Management and Budget completed its review of the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day...more

2/10/2016 - 60-Day Rule Affordable Care Act False Claims Act (FCA) Medicare Part A Medicare Part B OMB Overpayment

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

10/29/2015 - 60-Day Rule Affordable Care Act Anti-Kickback Statute CMS DOJ Enforcement Actions Fair Market Value False Claims Act (FCA) Final Rules Health Care Providers Healthcare Healthcare Fraud Overpayment Physician Compensation Arrangements Qui Tam Relators Safe Harbors Settlements Stark Law Suppliers Third-Party Training

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

8/18/2015 - Commercial Speech FDA FFDCA Free Speech Misbranding Off-Label Promotion Pharmaceutical Industry Preliminary Injunctions Prescription Drugs

Government Announces Health Care Fraud “Takedown”

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712...more

6/19/2015 - Anti-Kickback Statute Health Care Providers Healthcare Fraud Home Health Care Home Healthcare Workers Medicare Medicare Fraud Strike Force Medicare Part D Nurses Physicians

Medicare Part D Data Release Continues Transparency Trend

The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers...more

5/8/2015 - CMS Healthcare Information Sharing Medicare Medicare Part D Physician Medicare Reimbursements Sunshine Act Transparency

CMS Delays 60-Day Rule, But Overpayment Case Law Emerging

The Centers for Medicare & Medicaid Services (CMS) recently announced a one-year delay in finalizing the long-awaited and closely watched rule addressing the 60-day deadline to return Medicare and Medicaid overpayments (the...more

2/24/2015 - Affordable Care Act Civil Monetary Penalty CMS DHS DOJ Financial Conduct Authority (FCA) Medicaid Medicare Overpayment Physician Medicare Reimbursements Qui Tam Relators Social Security Act

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more

11/19/2014 - Appeals False Claims Act (FCA) Medicaid Pharmacies Prescription Drugs Qui Tam

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

11/5/2014 - CMS Final Rules Medical Devices Pharmaceutical Industry Physicians Reporting Requirements Sunshine Act

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 (FCA) 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 (FCA) 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 (FCA) Internal Investigations Investigations KBR (formerly 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 (FCA) 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 Financial Conduct Authority (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 Industry 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 (FCA) Healthcare Off-Label Promotion Pharmaceutical Industry Prescription Drugs Qui Tam Relators Sealed Records

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