Topics

Anti-Kickback Statute

Register Now: 10th Annual Nashville Healthcare Fraud Conference | December 12-13Growing Divide for Causation Standard Under the Anti-Kickback StatuteFraud and Abuse Chapter of Health Law Handbook, 2024-2025 Edition

Business & Industry Focus

Register Now: 10th Annual Nashville Healthcare Fraud Conference | December 12-13The California Insurance Frauds Prevention Act: Recent Developments Regarding California’s Powerful Commercial Health Insurance Fraud StatuteWatch Now | Legal Rx: How to Navigate Controlled Substances Enforcement & Diversion Webinar

C.C. Ill.

Recent Developments in FCA Pleading Standards – Part One

C.C.Cal.

Government Survives Dismissal of Remaining FCA Claims in Managed Care CaseDismissal of Medicare Advantage FCA Suit Marks Significant Defeat for GovernmentSecond DOJ Complaint: Knowledge of Invalid Codes Requires Follow-Through to Avoid Liability

Causation

Growing Divide for Causation Standard Under the Anti-Kickback StatuteCausation Split: First Circuit Pauses Teva Appeal; Regeneron Appeal Going ForwardSeventh Circuit Upholds FCA Judgment Against Constitutional Challenge, Avoids Causation Circuit Split

Civil Investigative Demands

Register Now | How to Respond to a Civil Investigative Demand WebinarFalse Claims Act Fundamentals: How to Respond to a Civil Investigative DemandAn Ounce of Prevention: Effective Corporate Policies for Dealing with Government Investigations and Inquires

Civil Monetary Penalties

District Court Finds that $487 Million False Claims Act Judgment Violates Eighth AmendmentDOJ Releases Annual Civil Fraud Recovery Statistics and ResultsDOJ Releases 2022 FCA Civil Monetary Penalties Inflation Adjustment

Clinical Laboratories

Settlement Roundup: Heart-Valve Replacements, Federal Research Grants, and Clinical Laboratory MarketingFalse Claims Act Settlements to Know from Q1 2022

Complaints

Third Time is Not the Charm – Supreme Court Denies Cert. on Rule 9(b) Split AgainEighth Circuit Affirms Dismissal of Kickback CaseGovernment Files Amended FCA Complaint Against Private Equity Firm and its Portfolio Company

Compliance

Register Now: 10th Annual Nashville Healthcare Fraud Conference | December 12-13Download Now – 12th Annual Healthcare Fraud & Abuse ReviewSecond Circuit Rejects Insufficient Service-of-Process Argument, Adopts Relator-Friendly Rule

COVID-19

Series on Healthcare Fraud Risk for The Compliance & Ethics BlogCOVID-19 Relief Enforcement Actions Highlight Ongoing RiskGovernment Scrutiny of COVID-19 Relief Funds

Cybersecurity

United States Files First Complaint Under the Civil Cyber-Fraud InitiativeSeries on Healthcare Fraud Risk for The Compliance & Ethics BlogThe United States Intervenes in its First False Claims Act Cybersecurity Case

Damages

Fraud and Abuse Chapter of Health Law Handbook, 2024-2025 EditionUnited States Files First Complaint Under the Civil Cyber-Fraud InitiativeSeventh Circuit Upholds FCA Judgment Against Constitutional Challenge, Avoids Causation Circuit Split

Discovery

False Claims Act Fundamentals: How to Respond to a Third-Party SubpoenaFalse Claims Act Amendments Take More Direct Attack at Escobar and Pass Senate Judiciary CommitteeChanges Coming to the FCA?  Proposed Amendments Would Impact Materiality Analysis, Government Discovery, Among Other Issues

District of Vermont

Electronic Health Records Company Pays High Price for Software Shortcomings

Electronic Health Records

First False Claims Act Settlement under DOJ’s Cyber-Fraud InitiativeElectronic Health Records Company Pays High Price for Software Shortcomings

Enforcement

Register Now: 10th Annual Nashville Healthcare Fraud Conference | December 12-13Fraud and Abuse Chapter of Health Law Handbook, 2024-2025 EditionFalse Claims Act Settlements to Know from Q3 2024

Escobar

Cyber Incident Reporting May Be “Material” for Federal ContractorsSDNY Ruling in Anthem Sends a Signal to Medicare Advantage LitigantsFalse Claims Act Fundamentals:  What is Materiality?

Events

Register Now: 10th Annual Nashville Healthcare Fraud Conference | December 12-13Watch Now | Legal Rx: How to Navigate Controlled Substances Enforcement & Diversion WebinarRegister Now | Healthcare Fraud & Abuse Annual Review Webinar Replay

Express/Implied Certification

False Claims Act Fundamentals: What Is a False Claim?FCA Deeper Dive: Express CertificationNorth District of California Misconstrues Express False Certification Liability

False Certification

PPP Enforcement Actions Gather SteamFalse Claims Act Fundamentals: What Is a False Claim?PPP Investigations, Settlements and Litigation on the Horizon

False Statements

Qui Tam Complaint Against Pharmacy Dismissed for Lack of ParticularityJeff Gibson Outlines Investigative Tools in FCA CasesFCA Deeper Dive: Worthless Services as a Theory of Falsity

Falsity

Fraud and Abuse Chapter of Health Law Handbook, 2024-2025 EditionControlled Substances Act and False Claims Act CollideMedicare Advantage Plan Highlights Distinction for FCA Purposes between Clinically Inaccurate Diagnoses and Clinically Accurate Diagnoses that Allegedly Violate Subregulatory Guidelines

FCA Alert

False Claims Act Decisions to Know from Q3 2024Novel Ruling Raises Questions About Timing of Constitutional Challenges to the FCA’s Qui Tam ProvisionsUnited States Files First Complaint Under the Civil Cyber-Fraud Initiative

FCA Deep Dive

Use of Data in False Claims Act Cases and Other LitigationRegister Now | HHS-OIG Year in Review Webinar ReplayDownload Now – 12th Annual Healthcare Fraud & Abuse Review

FCA Fundamentals

Register Now | Healthcare Fraud & Abuse Annual Review Webinar ReplayRegister Now | Healthcare Fraud & Abuse Annual Review WebinarFalse Claims Act Fundamentals: How to Respond to a Third-Party Subpoena

First-to-File

False Claims Act Decisions to Know from Q1 2022False Claims Act Fundamentals: What Is a Relator?  Corporate Maneuvering Leads to Thorny First-to-File Bar Issues

Government Contracts

The United States Intervenes in its First False Claims Act Cybersecurity CaseCyber Incident Reporting May Be “Material” for Federal ContractorsNinth Circuit Limits Damages in Government Procurement Case

Granston Memo

Impact of Supreme Court’s Escobar Decision on Fifth AnniversaryDistrict Courts Hold that DOJ Lacks “Unfettered” Discretion to Preemptively Dismiss Qui Tam ActionsSupreme Court Asked to Review Pleading Standard and Constitutionality of FCA

Healthcare Providers

Drug Diversion within Long-Term Care IndustryControlled Substances Act and False Claims Act CollideSeventh Circuit Signals Ongoing Importance of Compliance with Medicare “Bad Debt” Regulations

HITECH Act

Electronic Health Records Vendor Must Pay Over $150 Million in FCA SettlementSixth Circuit Affirms Dismissal of FCA Action Related to HITECH Meaningful Use Payments

Hospice

Fifth Circuit Affirms Criminal Healthcare Fraud Convictions of Hospice and Home Health ExecutivesHospice Fraud: Eleventh Circuit Court’s FCA Decision in AseraCareUpdate: Healthcare Fraud Cases Against Hospice Providers

Hospitals

Controlled Substances Act and False Claims Act CollideSeventh Circuit Signals Ongoing Importance of Compliance with Medicare “Bad Debt” RegulationsFalse Claims Act Settlements to Know from Q2 2022

Implied Certification

Supreme Court Review Sought on FCA Materiality, Scienter ElementsNo Consensus on Materiality: Courts Continue to Grapple with Escobar’s Key HoldingsNinth Circuit Holds that Escobar Set Forth Exclusive Conditions for Implied Certification Liability

Intent

False Claims Act Decisions to Know from Q3 2024Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” ElementFourth Circuit Adopts Safeco’s Objective Reasonableness Standard for False Claims Act

Knowledge/Scienter

False Claims Act Application in Nevada Worker Classification Fight Against LyftSecond Circuit Clarifies Anti-Kickback Statute’s Scienter RequirementSupreme Court Rejects Safeco, Holds that FCA Scienter Turns on Defendant’s Subjective Belief

Long-Term Care

Drug Diversion within Long-Term Care IndustryIncreased Oversight of Long-Term Care Facilities Related to COVID-19Healthcare Fraud Enforcement in Long-Term Care Industry

Managed Care

Martin’s Point Health Care Inc.’s $22.4M Settlement Illustrates DOJ’s Focus on Part C FraudWatch Now | Healthcare Fraud & Abuse Annual Review WebinarCMS Proposed Rule Addresses Multiple Aspects of Medicare Advantage Program for 2024, Including an Overpayment Rule Update

Materiality

Fraud and Abuse Chapter of Health Law Handbook, 2024-2025 EditionCyber Incident Reporting May Be “Material” for Federal ContractorsRecent False Claims Act Decisions to Know

Medical Necessity

Settlement Roundup: Heart-Valve Replacements, Federal Research Grants, and Clinical Laboratory MarketingFalse Claims Act Fundamentals: What Is a False Claim?Fifth Circuit Affirms Criminal Healthcare Fraud Convictions of Hospice and Home Health Executives

Medicare Advantage

Martin’s Point Health Care Inc.’s $22.4M Settlement Illustrates DOJ’s Focus on Part C FraudDOJ Focus on Medicare Advantage Insurers and FCA LiabilityCMS Proposed Rule Addresses Multiple Aspects of Medicare Advantage Program for 2024, Including an Overpayment Rule Update

Medicare/Medicaid

CMS Publishes New Data on Self-Referral Disclosure Protocol SettlementsWatch On-Demand | How to Submit a Stark Law Self-Disclosure WebinarSeventh Circuit Signals Ongoing Importance of Compliance with Medicare “Bad Debt” Regulations

Original Source

Public Disclosure Bar and Pleading Deficiencies Doom Tennessee FCA CaseEleventh Circuit Holds Secondhand Knowledge Does Not Make Relator an Original SourceFCA Deeper Dive: Original Sources under the FCA’s Public Disclosure Bar

Overpayments

DOJ Focus on Medicare Advantage Insurers and FCA LiabilityProvider Beware: Recent FCA Cases Emphasize the Importance of Diligently Addressing Potential OverpaymentsMedicare Advantage: Recent Developments in FCA Enforcement

Penalties

False Claims Act Fundamentals: DamagesDOJ Releases 2022 FCA Civil Monetary Penalties Inflation AdjustmentEleventh Circuit Becomes First Appeals Court to Hold that Excessive Fines Clause Applies in Declined FCA Cases

Pharmaceutical Manufacturers

Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” ElementCourt Decision Upholding OIG’s Rejection of Pharmaceutical Company’s Drug Co-Pay Assistance ProgramThe California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute

Pharmaceuticals

Rite Aid and OptumRx Settlements Highlight Enforcement Focus on Pharmacy Corresponding Responsibility for Dispensing Controlled SubstancesRecent DOJ Indictment Involving Done Global Telehealth PrescriptionsFalse Claims Act Settlements to Know from Q1 2024

Physician Compensation

Register Now | 8th Annual Nashville Healthcare Fraud ConferenceUpdate: Third Circuit Allows Allegations of Improper Compensation under the Stark Law to Proceed, but Reverses Controversial "Varies with Volume or Value" ReasoningThird Circuit Holds Allegations of Improper Compensation Methodologies under the Stark Law Survive Motion to Dismiss

Physicians

False Claims Act Settlements to Know from Q2 2022False Claims Act Settlements to Know from Q1 2022SC Hospital Pays $17 Million to Resolve FCA Claims of Improper Physician Employment Relationships

Pleading Standards

False Claims Act Decisions to Know from Q3 2024Anti-Retaliation under the False Claims ActFourth Circuit Adopts Safeco’s Objective Reasonableness Standard for False Claims Act

Private Equity

Controlled Substances Act and False Claims Act CollideIncreased False Claims Act Exposure for Private Equity Firms Investing in HealthcareFalse Claims Act Decisions and Settlements to Know from Q4 2021

Public Disclosure Bar

Recent False Claims Act Decisions to KnowSecond Circuit Holds False Claims Act Complaint Is Barred by SEC FilingsNinth Circuit Affirms Broad Scope of False Claims Act’s Public Disclosure Bar

Publications

Download Now – 12th Annual Healthcare Fraud & Abuse ReviewDownload Now – 11th Annual Healthcare Fraud & Abuse ReviewDownload Now – 10th Annual Healthcare Fraud & Abuse Review

Quarterly Case & Settlement Updates

False Claims Act Decisions to Know from Q3 2024False Claims Act Settlements to Know from Q3 2024False Claims Act Decisions to Know from Q2 2024

Relators

Impact of New False Claims Act Qui Tam RulingFalse Claims Act Decisions to Know from Q3 2024Novel Ruling Raises Questions About Timing of Constitutional Challenges to the FCA’s Qui Tam Provisions

Reports

Download Now – 12th Annual Healthcare Fraud & Abuse ReviewDownload Now – 11th Annual Healthcare Fraud & Abuse ReviewDownload Now – 10th Annual Healthcare Fraud & Abuse Review

Retaliation

Third Circuit Holds that Whistleblower Can Still Be Fired for MisconductAnti-Retaliation under the False Claims ActFalse Claims Act Fundamentals: What Is a Relator?  

Reverse False Claims

Second Circuit Addresses “Obligation” Requirement of False Claims Act’s Reverse False Claim ProvisionFalse Claims Act Fundamentals: Reverse False ClaimsProvider Beware: Recent FCA Cases Emphasize the Importance of Diligently Addressing Potential Overpayments

Rule 9(b)

Supreme Court Review of Key FCA IssuesThird Time is Not the Charm – Supreme Court Denies Cert. on Rule 9(b) Split AgainUnited States Says No Supreme Court Review Needed in False Claims Act Cases

Seal Requirement

Relator Cannot Maintain Dismissed Qui Tam Action Under Seal, District Court Rules“Significant Abuses of the Statutory Scheme:" District Court Criticizes Practice of Regular Extensions of the FCA Seal PeriodSupreme Court Rejects Mandatory Dismissal for an FCA Seal Breach

Self-Disclosure

Innovasis Settlement ImplicationsThe Tale of an AKS Self-DisclosureFalse Claims Act Settlements to Know from Q1 2024

Settlement

Rite Aid and OptumRx Settlements Highlight Enforcement Focus on Pharmacy Corresponding Responsibility for Dispensing Controlled SubstancesExpect More Cyber-Enforcement under the False Claims ActCMS Publishes New Data on Self-Referral Disclosure Protocol Settlements

Stark Law

Fraud and Abuse Chapter of Health Law Handbook, 2024-2025 EditionRegister Now | HHS-OIG Year in Review Webinar ReplayDownload Now – 12th Annual Healthcare Fraud & Abuse Review

State and Other Supreme Courts

FCA Deeper Dive: Escobar and Its Aftermath – Part I

State/Local FCA

False Claims Act Application in Nevada Worker Classification Fight Against LyftDownload Now – 12th Annual Healthcare Fraud & Abuse ReviewDownload Now – 11th Annual Healthcare Fraud & Abuse Review

Statistical Sampling

False Claims Act Dangers on Display in RuckhFourth Circuit Takes a Pass on Statistical Sampling, Finds DOJ's Settlement Veto Authority UnreviewableMatt Curley Analyzes Oral Arguments in Fourth Circuit Agape Case

Statute of Limitations

FCA Statute of Limitations Triggered by Notice to DOJ Only, Court RulesFalse Claims Act Fundamentals: Statute of LimitationsSupreme Court Wrestles with “Terribly Drafted” FCA Statute of Limitations

Telehealth

Recent DOJ Indictment Involving Done Global Telehealth PrescriptionsFalse Claims Act Case Unsealed Against Cerebral, Showing Continued Scrutiny of Telehealth PrescriptionsTelehealth Scrutiny Following COVID-19 Pandemic

United States Supreme Court

Register Now: The Supreme Court and the False Claims Act Webinar ReplaySupreme Court Upholds Broad Government Authority to Dismiss Qui Tam False Claims Act LawsuitsSupreme Court Rejects Safeco, Holds that FCA Scienter Turns on Defendant’s Subjective Belief

Whistleblower

United States Files First Complaint Under the Civil Cyber-Fraud InitiativeUse of Data in False Claims Act Cases and Other LitigationSupreme Court Upholds Broad Government Authority to Dismiss Qui Tam False Claims Act Lawsuits

Worthless Services

Tennessee Nursing Home Chain Reaches “Largest Worthless Services Resolution in Tennessee’s History”The Eliminating Kickbacks in Recovery Act: An Unprecedented Expansion of Anti-kickback Liability to Private-Pay Referrals?FCA Deeper Dive: Worthless Services as a Theory of Falsity

Yates Memo

Associate Attorney General Sheds Light on the DOJ’s Application of Individual Liability and Corporate Cooperation Credit in FCA casesA Look Back at Healthcare Fraud Enforcement Efforts from 2015