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- Media Room
- Our Firm in the News
- Agents Raid 7 Companies in Medicare Fraud Probe
- Big Money, Big Fines – It’s All Hormonal
- Blowing Whistle on Bosses Brings them Millions
- Boca Drug Clinic Bilked Medicaid, Lawsuit Claims
- Boca Rehab Clinics to Pay $7.7 Million in Fraud Case
- Marketing of Genotropin May Still be of Interest to Authorities
- Medicare Fraud Under Attack
- Off-Label Promotion Can Increase Qui Tam Fraud Risk
- Rat Out The Frauds
- Sales Goals, Specialists Detailed May Be Eyed for Off-Label Promotion
- Vencor Whistle-Blower Lawsuit
- Whistle-Blower at NSU will get $538,780 Reward
- Workers to Split Millions-Whistle Blowers get Part of Settlement
- Our Published Articles
Posts
Blog
- A Medicare Fraud Case, and a Battle of the Experts
- A Possible $1 Billion Loss Due to Improper Use of Malnutrition Codes in Medicare Billing
- An Opportunity to be Heard: Improving Transparency and Fairness in Healthcare Enforcement Actions – Part Two
- Drummond v. BestCare: An “Open-and-Shut Case” of Medicare Fraud – Part One
- Drummond v. BestCare: An “Open-and-Shut Case” of Medicare Fraud – Part Two
- False Claims Act and Whistleblower Retaliation – Legal Analysis of United States v. Novartis
- FDA APPROVES FIRST DRUG TO TREAT ALZHEIMER’S IN 17 YEARS
- GAO Finds that Improper Payments in 2019 Exceed $175 Billion
- Healthcare Fraud Risk Framework
- Highly Dependent Residents and Understaffed Nursing Facilities: A Recipe for Major Medicare Fraud?
- Improving Transparency and Fairness in Healthcare Fraud Enforcement Actions – Part One
- Inpatient Psychiatric Facilities are Overpaid for Unnecessary Outlier Payments
- Medicare Hospitals Unsuccessfully Attempt Statutory Surgery to Recoup Lost Profits
- New OIG Report Raises Concerns That Health Risk Assessments May Be Source of Improper Medicare Advantage Payments
- OIG Again Proposes Adding Diagnosis to Prescriptions to Stem Medicare Fraud
- OIG Has Tried to Encourage CMS to Close a Drug Payment Loophole Twice, But CMS Won’t Budge
- OIG Is the Fulcrum in the Fight Against HSS Program Fraud
- Paying Physicians to Draw Blood and Process Samples Can Be an Illegal Kickback – U.S. V. Mallory
- Payment Integrity Remains a Fiscal Concern for Federal Agencies
- Providing Travel and Lodging to Patients Prescribed Certain Drugs is Not Necessarily Pharmaceutical Fraud
- The False Claims Act and the Importance of “Materiality”
- The GAO Has 4 Suggestions to Avoid Improper Medicaid Payments Due to Insufficient Documentation
- The Inspector General’s Strategic Plan for 2020-2025
- The Irony in a Low Error Rate: Is CMS Doing Enough to Avoid Improper Medicaid Payments?
- U.S. Justice Department Takes Tough Stance on MA Medicare Fraud in the Cases Against Kaiser Permanente
- What are the Requirements for Issuing and Using Guidance Documents?
- What Does “Materiality” and “Scienter” Have to Do With the False Claims Act?
- What Does Retaliation Under the False Claims Act Look Like?
- What is Considered Appropriate “Guidance” from CMS?
- What is the Daubert Standard as it Relates to Expert Testimony?
- When is Expert Testimony Considered “Rebuttal” Testimony?
- Whistleblower Resources
Clinical Trials
Diagnostic Test Fraud
False Claims Act
- OIG Is the Fulcrum in the Fight Against HSS Program Fraud
- Paying Physicians to Draw Blood and Process Samples Can Be an Illegal Kickback – U.S. V. Mallory
- The Inspector General’s Strategic Plan for 2020-2025
- U.S. Justice Department Takes Tough Stance on MA Medicare Fraud in the Cases Against Kaiser Permanente
FDA Fraud
- FCA Liability Awaits Medical Device Companies That Submit False 510(k) Notices to Avoid Class III Premarket Approval Process
- Medical Device Manufacturers Marketing Pre-1976 Devices for Unapproved Uses
- Study Shows Whistleblowers Help Curb Fraud
- Unapproved At-Home Genetic Tests Might Run Afoul of the FCA and the FDCA
Healthcare Fraud
- Daiichi Sankyo Whistleblower Case Returns Over $39 Million to the Government
- DME Suppliers Cheat Medicare When They Bill for Skilled Nursing Facility Patients
- DOJ Recovers $2.6 Billion from Health Care Fraud False Claims Act Cases in FY 2013
- DOJ Recovers Funds from Physician Who Allegedly Received Kickbacks
- Healthcare Fraud Doesn’t Only Affect the Federal Fisc
- Hospitals in Trouble for Improperly Billing Medicare and Medicaid Health Care Programs
- Medical Device Manufacturer Triggered False Claims Act Liability by Allegedly Submitting False NIH Grant Application
- More to Come on the Heels of Tenet Healthcare Payout?
- Relator Shares May Still be Viable after Company Self-Reports
- SEC Whistleblower Program Takes Flight with Multimillion Dollar Whistleblower Rewards
- Senator Grassley Pitches Trump on Whistleblowers
- Seven Whistleblowers Team up to Blow the Whistle on Neurosurgeon and Medical Device Supplier for Allegedly Violating the False Claims Act and Anti-Kickback Statute
- Start-Up Medical Device Fraud is Rampant in Silicon Valley
- Study Shows Whistleblowers Help Curb Fraud
- Successful Whistleblower Brian Shields Interviewed by the Los Angeles Times
- U.S. Justice Department Takes Tough Stance on MA Medicare Fraud in the Cases Against Kaiser Permanente
- What Does the latest DOJ Fraud Statistics Overview mean for Medicare Fraud and Medicaid Fraud Qui Tam Whistleblowers?
- Whistleblower Motivations
Hospital Fraud
- Are Some Medical Device Companies Trying to Induce Hospitals to Perform Unnecessary Inpatient Procedures?
- California Hospital Agrees to Settle With Department of Justice for Millions
- DOJ Shows Continued Interest in Ferreting Out Inappropriate Inpatient Care
- Government Encourages Hospital Employees to Blow the Whistle on Improper Compensation Arrangements
- Hospital Fraud: It’s Not Just the Money
- Hospitals in Trouble for Improperly Billing Medicare and Medicaid Health Care Programs
- Is Your Hospital-Employer Sitting on Known Medicaid or Medicare Overpayments?
- More to Come on the Heels of Tenet Healthcare Payout?
- Substantial Whistleblower Rewards are Available for Exposing Hospitals that Ignore National Coverage Determinations
In The News
- 10 Things Medicare Won’t Tell You
- A ‘Game Changing’ Ruling for Whistleblowers
- Allergan Will Pay Fine, Plead Guilty to Misdemeanor
- Are More Pharma cGMP Whistleblower Cases on the Way? Experts Think So
- Attorney: Whistle-Blowers Not Just Whistling ‘Dixie’
- Blowing the Whistle on Healthcare Fraud
- Blowing Whistle on Bosses Brings Them Millions
- Botox Maker Settles Case for $600 Million
- Corporate Crime Reporter
- Criminal Charges Unlikely in MIMA Fraud Case
- Double-billing Settlement Highlights Whistleblower Concerns
- Experts: Increased Individual Fraud Prosecutions, RAC Expansion on Tap for 2012
- Fifth Circuit Reinstates Claims Against Caremark In Medicaid False Claims Act Case
- Fighting Medicare Fraud
- Forest Labs to pay $313 million in DOJ settlement
- Forest Unit Agrees to Plead Guilty, Pay $313 Million
- GSK’s $750 Mil. DOJ Settlement: When GMP Violations Equal Healthcare Fraud
- High Court Ruling on FCA Limitations Period, Bar on Filings Gives Providers Mixed Result
- Jeb White Appears on NPR Affiliate Radio Show
- Maury Regional Pays $2 Million Fraud Claim
- New Texas Laws Fix Loopholes After Retaliation Against Two Nurses
- Novartis to Pay $422.5 Million Settlement Charges Range from “Off-Label” Marketing to Kickbacks
- Novartis Whistleblower Speaks: ‘We Wasted Money’
- Nurse Pleads Guilty to Taking Kickbacks from Drug Maker
- Off-Label Health Care Case Nets U.S. $1.5 Million
- Outlook 2011: Permissive Exclusions, Increase in Oversight Expected in 2011
- Outlook 2012: Compliance Officers Should Prepare for Long, Strange Trip in Year Ahead
- Patient Complaint Triggers DOJ Settlement with Kentucky Hospital
- Pfizer’s Legal Troubles Over Hormone May Grow
- Providers Will Find 2011 Is ‘Big Year’ for Regulations, Recoupment, Whistleblowers
- Qui Tam ‘Jackpot’ Spurs False Claims Suits
- The Prosecution of Pharma Gets Personal
- Third Circuit Reinstates Kickback Claim Against Medicare Managed Care Plans
- U.S. Supreme Court Declines Review of Case on Liability for Causing False Claims
- Vencor Whistle-Blower Suit Charging Medicare Fraud Joined by Government
- Vibra Healthcare Pays $32.7 Million to Settle Medically Unnecessary Services False Claims Allegations
- What Happened After She Helped Nurse at Catholic Healthcare Blow Whistle on her Employer
- Whistle While You Work
- Whistle-blower Case That Started in Tampa Results in $422.5 Million Settlement
- Whistleblower Lawsuit Reveals Unapproved Meds
- Whistleblowers’ Use of FOIA Debated In U.S. Supreme Court Oral Argument
- Winning the cGMP Whistleblower Game
- Workers to Split Millions – Whistle-Blowers get Part of Settlement
Kickbacks
- OIG Is the Fulcrum in the Fight Against HSS Program Fraud
- Paying Physicians to Draw Blood and Process Samples Can Be an Illegal Kickback – U.S. V. Mallory
- The Inspector General’s Strategic Plan for 2020-2025
- U.S. Justice Department Takes Tough Stance on MA Medicare Fraud in the Cases Against Kaiser Permanente
- Whistleblower Motivations
Legal
- Daiichi Sankyo Whistleblower Case Returns Over $39 Million to the Government
- Is Pharma Saying Goodbye to China?
- Medical Device Manufacturer Triggered False Claims Act Liability by Allegedly Submitting False NIH Grant Application
- Study Shows Whistleblowers Help Curb Fraud
- United States Supreme Court’s Acceptance of FCA Cases Continues
- Whistleblowers Can Provide the Evidentiary Catalyst to Criminal Prosecutions
Medicaid Rebates For Physician-Administered Drugs
Medical Device Fraud
- Are Some Medical Device Companies Trying to Induce Hospitals to Perform Unnecessary Inpatient Procedures?
- CMS Starts Collecting Physician Payment Data from Medical Device and Pharmaceutical Manufacturers for Public Website
- DOJ Recovers Funds from Physician Who Allegedly Received Kickbacks
- FCA Liability Awaits Medical Device Companies That Submit False 510(k) Notices to Avoid Class III Premarket Approval Process
- HHS-OIG Work Plan Reveals Government’s Increased Concern for Defective Medical Devices
- Medical Device Manufacturer and Its Former CEO Plead Guilty to Distributing FDA-Rejected Devices to Heath Care Providers
- Medical Device Manufacturer Triggered False Claims Act Liability by Allegedly Submitting False NIH Grant Application
- Medical Device Manufacturers Marketing Pre-1976 Devices for Unapproved Uses
- Medtronic Companies Pay Millions as Devices were Manufactured Outside of the United States
- Seven Whistleblowers Team up to Blow the Whistle on Neurosurgeon and Medical Device Supplier for Allegedly Violating the False Claims Act and Anti-Kickback Statute
- Start-Up Medical Device Fraud is Rampant in Silicon Valley
Medicare
- A Medicare Fraud Case, and a Battle of the Experts
- A Possible $1 Billion Loss Due to Improper Use of Malnutrition Codes in Medicare Billing
- An Opportunity to be Heard: Improving Transparency and Fairness in Healthcare Enforcement Actions – Part Two
- Drummond v. BestCare: An “Open-and-Shut Case” of Medicare Fraud – Part One
- Drummond v. BestCare: An “Open-and-Shut Case” of Medicare Fraud – Part Two
- False Claims Act and Whistleblower Retaliation – Legal Analysis of United States v. Novartis
- FDA APPROVES FIRST DRUG TO TREAT ALZHEIMER’S IN 17 YEARS
- GAO Finds that Improper Payments in 2019 Exceed $175 Billion
- Healthcare Fraud Risk Framework
- Highly Dependent Residents and Understaffed Nursing Facilities: A Recipe for Major Medicare Fraud?
- Hospitals in Trouble for Improperly Billing Medicare and Medicaid Health Care Programs
- Improving Transparency and Fairness in Healthcare Fraud Enforcement Actions – Part One
- Inpatient Psychiatric Facilities are Overpaid for Unnecessary Outlier Payments
- Medicare Hospitals Unsuccessfully Attempt Statutory Surgery to Recoup Lost Profits
- New OIG Report Raises Concerns That Health Risk Assessments May Be Source of Improper Medicare Advantage Payments
- OIG Again Proposes Adding Diagnosis to Prescriptions to Stem Medicare Fraud
- OIG Has Tried to Encourage CMS to Close a Drug Payment Loophole Twice, But CMS Won’t Budge
- OIG Is the Fulcrum in the Fight Against HSS Program Fraud
- Paying Physicians to Draw Blood and Process Samples Can Be an Illegal Kickback – U.S. V. Mallory
- Payment Integrity Remains a Fiscal Concern for Federal Agencies
- Providing Travel and Lodging to Patients Prescribed Certain Drugs is Not Necessarily Pharmaceutical Fraud
- The False Claims Act and the Importance of “Materiality”
- The GAO Has 4 Suggestions to Avoid Improper Medicaid Payments Due to Insufficient Documentation
- The Inspector General’s Strategic Plan for 2020-2025
- The Irony in a Low Error Rate: Is CMS Doing Enough to Avoid Improper Medicaid Payments?
- U.S. Justice Department Takes Tough Stance on MA Medicare Fraud in the Cases Against Kaiser Permanente
- What are the Requirements for Issuing and Using Guidance Documents?
- What Does “Materiality” and “Scienter” Have to Do With the False Claims Act?
- What Does Retaliation Under the False Claims Act Look Like?
- What is Considered Appropriate “Guidance” from CMS?
- What is the Daubert Standard as it Relates to Expert Testimony?
- When is Expert Testimony Considered “Rebuttal” Testimony?
Medicare Fraud
- A Medicare Fraud Case, and a Battle of the Experts
- A Possible $1 Billion Loss Due to Improper Use of Malnutrition Codes in Medicare Billing
- An Opportunity to be Heard: Improving Transparency and Fairness in Healthcare Enforcement Actions – Part Two
- California Hospital Agrees to Settle With Department of Justice for Millions
- Diagnostic Laboratories and Radiology Pays $17.5 Million to Settle Diagnostic False Claims
- DME Suppliers Cheat Medicare When They Bill for Skilled Nursing Facility Patients
- DOJ Investigates Alleged Medicare Advantage Risk Scoring Fraud Scheme
- DOJ Recovers Funds from Physician Who Allegedly Received Kickbacks
- DOJ Shows Continued Interest in Ferreting Out Inappropriate Inpatient Care
- Drummond v. BestCare: An “Open-and-Shut Case” of Medicare Fraud – Part One
- Drummond v. BestCare: An “Open-and-Shut Case” of Medicare Fraud – Part Two
- False Claims Act and Whistleblower Retaliation – Legal Analysis of United States v. Novartis
- FDA APPROVES FIRST DRUG TO TREAT ALZHEIMER’S IN 17 YEARS
- GAO Finds that Improper Payments in 2019 Exceed $175 Billion
- Healthcare Fraud Risk Framework
- Highly Dependent Residents and Understaffed Nursing Facilities: A Recipe for Major Medicare Fraud?
- Hospital Fraud: It’s Not Just the Money
- Hospitals in Trouble for Improperly Billing Medicare and Medicaid Health Care Programs
- Improving Transparency and Fairness in Healthcare Fraud Enforcement Actions – Part One
- Inpatient Psychiatric Facilities are Overpaid for Unnecessary Outlier Payments
- Is Your Hospital-Employer Sitting on Known Medicaid or Medicare Overpayments?
- Medicare Fraud Laws
- Medicare Hospitals Unsuccessfully Attempt Statutory Surgery to Recoup Lost Profits
- New OIG Report Raises Concerns That Health Risk Assessments May Be Source of Improper Medicare Advantage Payments
- OIG Again Proposes Adding Diagnosis to Prescriptions to Stem Medicare Fraud
- OIG Has Tried to Encourage CMS to Close a Drug Payment Loophole Twice, But CMS Won’t Budge
- OIG Is the Fulcrum in the Fight Against HSS Program Fraud
- Paying Physicians to Draw Blood and Process Samples Can Be an Illegal Kickback – U.S. V. Mallory
- Payment Integrity Remains a Fiscal Concern for Federal Agencies
- Providing Travel and Lodging to Patients Prescribed Certain Drugs is Not Necessarily Pharmaceutical Fraud
- Shands Healthcare Pays $26 Million to Settle False Claims Related to Inpatient Procedures
- Study Shows Whistleblowers Help Curb Fraud
- Substantial Whistleblower Rewards are Available for Exposing Hospitals that Ignore National Coverage Determinations
- The False Claims Act and the Importance of “Materiality”
- The GAO Has 4 Suggestions to Avoid Improper Medicaid Payments Due to Insufficient Documentation
- The Inspector General’s Strategic Plan for 2020-2025
- The Irony in a Low Error Rate: Is CMS Doing Enough to Avoid Improper Medicaid Payments?
- U.S. Justice Department Takes Tough Stance on MA Medicare Fraud in the Cases Against Kaiser Permanente
- United States Supreme Court’s Acceptance of FCA Cases Continues
- What are the Requirements for Issuing and Using Guidance Documents?
- What Does “Materiality” and “Scienter” Have to Do With the False Claims Act?
- What Does Retaliation Under the False Claims Act Look Like?
- What is Considered Appropriate “Guidance” from CMS?
- What is the Daubert Standard as it Relates to Expert Testimony?
- When is Expert Testimony Considered “Rebuttal” Testimony?
- Whistleblower Motivations
OIG Compliance Program Guidance for Ambulance Suppliers
OIG Compliance Program Guidance for Pharmaceutical Manufacturers
- Background
- Developing the Compliance Program Guidance for Pharmaceutical Manufacturers
- Endnotes
- II. Compliance Program Elements A. The Basic Compliance Elements
- II. Compliance Program Elements B. Written Policies and Procedures (Page 1)
- II. Compliance Program Elements C. Designation of a Compliance Officer and a Compliance Committee
- II. Compliance Program Elements D. Conducting Effective Training and Education
- II. Compliance Program Elements E. Developing Effective Lines of Communication
- II. Compliance Program Elements F. Auditing and Monitoring
- II. Compliance Program Elements G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
- II. Compliance Program Elements H. Responding to Detected Problems and Developing Corrective Action Initiatives
- II. Compliance Program Elements Reporting
- III. Conclusion
OIG Guidance and Reports
- ABSTRACT
- ACKNOWLEDGMENTS
- Appendix
- APPENDIX A
- Appendix A-Additional Risk Areas
- APPENDIX B
- B. Written Policies and Procedures
- Background
- Background
- C. Designation of a Compliance Officer and a Compliance Committee
- D. Conducting Effective Training and Education
- Developing the Compliance Program Guidance for Pharmaceutical Manufacturers
- E. Developing Effective Lines of Communication
- Endnotes
- EXECUTIVE SUMMARY
- F. Auditing and Monitoring
- FINDINGS
- G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
- H. Responding to Detected Offenses and Developing Corrective Action Initiatives
- I. Introduction
- I. Introduction
- II. Compliance Program Elements
- II. Compliance Program Elements A. The Basic Compliance Elements
- II. Compliance Program Elements B. Written Policies and Procedures (Page 1)
- II. Compliance Program Elements C. Designation of a Compliance Officer and a Compliance Committee
- II. Compliance Program Elements D. Conducting Effective Training and Education
- II. Compliance Program Elements E. Developing Effective Lines of Communication
- II. Compliance Program Elements F. Auditing and Monitoring
- II. Compliance Program Elements G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
- II. Compliance Program Elements H. Responding to Detected Problems and Developing Corrective Action Initiatives
- II. Compliance Program Elements Reporting
- II. Elements of a Compliance Program for Ambulance Suppliers
- III. Assessing the Effectiveness of a Compliance Program
- III. Conclusion
- III. Specific Fraud and Abuse Risks Associated With Medicare Ambulance Coverage and Reimbursement Requirements
- INTRODUCTION
- IV. Conclusion
- IV. Medicaid Ambulance Coverage
- Medicaid Rebates For Physician-Administered Drugs
- OIG Compliance Program Guidance for Pharmaceutical Manufacturers
- Publication of the OIG Compliance Program Guidance for Nursing Facilities
- RECOMMENDATION
- V. Kickbacks and Inducements
- VI. Conclusion
Our Speaking Engagements
Pharmaceutical Fraud
- CMS Starts Collecting Physician Payment Data from Medical Device and Pharmaceutical Manufacturers for Public Website
- Daiichi Sankyo Whistleblower Case Returns Over $39 Million to the Government
- Is Pharma Saying Goodbye to China?
- Medical Device Manufacturers Marketing Pre-1976 Devices for Unapproved Uses
- Novartis Under Scrutiny for Drug Trial Data Manipulation
- Oops! Did St. Jude Do It Again?
- Study Shows Whistleblowers Help Curb Fraud
- Whistleblower Motivations
- Whistleblowers Can Provide the Evidentiary Catalyst to Criminal Prosecutions
Publication of the OIG Compliance Program Guidance for Nursing Facilities
- Appendix
- B. Written Policies and Procedures
- Background
- C. Designation of a Compliance Officer and a Compliance Committee
- D. Conducting Effective Training and Education
- E. Developing Effective Lines of Communication
- F. Auditing and Monitoring
- G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
- H. Responding to Detected Offenses and Developing Corrective Action Initiatives
- I. Introduction
- II. Compliance Program Elements
- III. Assessing the Effectiveness of a Compliance Program
- IV. Conclusion
Stark Anti-Kickback
- Daiichi Sankyo Whistleblower Case Returns Over $39 Million to the Government
- DOJ Recovers Funds from Physician Who Allegedly Received Kickbacks
- Government Encourages Hospital Employees to Blow the Whistle on Improper Compensation Arrangements
- Is Pharma Saying Goodbye to China?
- More to Come on the Heels of Tenet Healthcare Payout?
- Nothing Foreign About Chinese Kickback Allegations Against GlaxoSmithKline
- OIG Is the Fulcrum in the Fight Against HSS Program Fraud
- Oops! Did St. Jude Do It Again?
- Paying Physicians to Draw Blood and Process Samples Can Be an Illegal Kickback – U.S. V. Mallory
- Seven Whistleblowers Team up to Blow the Whistle on Neurosurgeon and Medical Device Supplier for Allegedly Violating the False Claims Act and Anti-Kickback Statute
- The Inspector General’s Strategic Plan for 2020-2025
- Whistleblower Motivations