Health Care Fraud: Enforcement and Compliance

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Robert Fabrikant, Paul E. Kalb, M.D., Mark D. Hopson, Pamela H. Bucy, James C. Stansel

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Health Care Fraud: Enforcement and Compliance is the most complete, essential and up-to-date guide for criminal and civil lawyers, law enforcement officials, health care providers and anyone interested in the health care industry. You'll find discussion of: the latest anti-fraud initiatives from Congress, enforcement agencies and the private bar; advice on criminal law and procedures that health care lawyers cannot afford to ignore; and point-by-point analysis of key decisions, laws and regulations.

This deskbook also helps you decide on the right pretrial and trial strategies for clients who have already run afoul of the rules. It features cutting-edge discussions of such topics as: the use of health care fraud laws to enforce clinical care standards; voluntary and involuntary disclosure obligations; expanded treatment of the Federal Anti-kickback Statute—including “Safe Harbor” regulations—and the False Claims Act; proving billing fraud for rendering medically unnecessary services and other fraudulent schemes; obstruction of criminal investigations of health care offenses; and mandatory and permissive exclusion of professionals from health care programs.

Health Care Fraud: Enforcement and Compliance also includes detailed coverage of two important areas: compliance issues, including an analysis of Corporate Integrity Agreements; and marketing and pricing fraud in the pharmaceutical industry, including off-label, pricing, Medicaid rebate and kickback concerns.

Book #00636; looseleaf, one volume, 1,195 pages; published in 1996, and updated as needed; no additional charge for updates during your subscription. Looseleaf print subscribers receive supplements. The online edition is updated automatically. ISBN: 978-1-58852-073-9

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  • Availability: Available
  • Brand: Law Journal Press
  • Product Type: Books
  • Edition: 0
  • Page Count: 1195
  • ISBN: 978-1-58852-073-9
  • Pub#/SKU#: 636
  • Volume(s): 1

Author Image
  • Robert Fabrikant
Robert Fabrikant is a partner in the Washington, D.C. office of Manatt, Phelps & Phillips, LLP, and is the Distinguished Practitioner-in-Residence at Howard University School of Law. Following law school, Mr. Fabrikant was the Senior Law Clerk to Chief Justice Warren E. Burger. Since 1982, Mr. Fabrikant has been a trial lawyer focusing on complex civil and criminal litigation in the health care industry, with an emphasis on antitrust, RICO, False Claims Act, and other fraud and abuse issues. Prior to entering private practice, Mr. Fabrikant was Assistant Chief of the Energy Section, Antitrust Division, U.S. Department of Justice; an Assistant U.S. Attorney for the District of Columbia; and a Faculty Member, University of Singapore Law School; Counsel, Monetary Authority of Singapore. He is a member of the New Jersey, District of Columbia and California Bars and the American Bar Association, where he has founded and headed subcommittees on health care fraud and abuse and the False Claims Act and qui tam issues. Mr. Fabrikant is the author of numerous articles on fraud and abuse issues in the health care area and the False Claims Act.

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  • Paul E. Kalb, M.D.
Paul E. Kalb, M.D., is a partner in the Washington D.C. office of Sidley Austin LLP where he co-heads the firms Global Life Sciences practice and heads the firm's national health care practice. He principally represents health care providers and pharmaceutical and medical device manufacturers in criminal, civil and administrative litigation and enforcement actions arising under the various health care fraud statutes. His practice includes both general and appellate (including Supreme Court) litigation. He is the author of numerous articles in both legal and medical literature. He is Board-certified in Internal Medicine and a graduate of Yale Law School. He is a member of the District of Columbia State Bar and the American Bar Association.

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  • Mark D. Hopson
Mark D. Hopson is a partner in the Washington D.C. office of Sidley Austin LLP and a co-chair of the firm's national White Collar and Internal Investigation practice. His practice involves complex civil and criminal trial litigation, as well as the conduct of internal investigations and compliance-related counseling. He has substantial experience in the representation of health care providers and consultants in connection with criminal and civil investigations and litigation, particularly with respect to claims under the False Claims Act. Mr. Hopson has written numerous articles and participates often in conferences on white collar crime and health care. He is a member of the District of Columbia Bar and the American Bar Association.

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  • Pamela H. Bucy
Pamela H. Bucy is the Bainbridge Professor of Law at the University of Alabama School of Law. Prior to entering teaching, she served as an Assistant United States Attorney, Criminal Division, E.D. Missouri. In this capacity, Professor Bucy prosecuted white collar crimes, including health care fraud. She also established and served as the first coordinator of a health care fraud task force comprised of attorneys and investigators from federal, state and private offices. Professor Bucy has written extensively in the area of health care fraud and white collar crime, including a casebook used in law schools around the country. Professor Bucy is a member of the American Bar Association and the Alabama and Missouri Bars. She has served on many ABA and state and local bar committees and has served as Co-chair of the ABA subcommittee on Health Care Fraud.

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  • James C. Stansel

Overview of Health Care Fraud

§ 1.01 Introduction
[1] Health Care Fraud: The Problem
[2] Health Care Fraud: Criminal, Civil and Administrative Law
[3] The Consequences of Being Found Liable for Health Care Fraud
§ 1.02 Historical Development of American Medicine
[1] The Nineteenth Century
[2] The Twentieth Century
[3] The Twenty-First Century
§ 1.03 Economics and Health Care
[1] The Changing Economics of American Health Care
[2] Impact of Changing Economics on Health Care Fraud
§ 1.04 Characteristics of Health Care Fraud
[1] Hybrid Civil/Criminal Nature
[2] Difficulty of Investigating and Proving Health Care Fraud
§ 1.05 Investigatory and Enforcement Agencies and Organizations
[1] Federal Agencies
[2] State Agencies
[3] Private Insurance Companies
§ 1.06 Bibliography

Types of Fraud by Health Care Providers

§ 2.01 Introduction
§ 2.02 Program Integrity Fraud
[1] National Provider Identification Numbers
[2] Medicare Fee-for-Service (Parts A and B)
[3] Medicare Managed Care (Parts C and D)
[4] Medicaid
§ 2.03 Fraudulent Billing
[1] Billing for Services Not Provided
[2] Billing for Services Not Reasonable and Necessary (the “Medical Necessity” Requirement)
[3] Misrepresentation of Services–Upcoding, Unbundling, and Duplicate Billing
[4] Cost Report Fraud
[5] Retaining Overpayments
[6] Medicare Secondary Payor
[7] Off-Label Promotion
§ 2.04 Kickbacks and Self-Referrals
[1] Overview of the Antikickback and Stark Laws
[2] Miscellaneous Prohibitions of Improper Remuneration
§ 2.05 Research Fraud
[1] Federally Funded Research
[2] Special Issues Relating to Human Subjects
[3] Reimbursement in Connection with Research Patients
[4] Antikickback Issues in Research
[5] Conflicts of Interest in Medical Research
[6] Other Forms of Fraud

Criminal Causes of Action

§ 3.01 Introduction
§ 3.02 Offenses Against Federal Health Care Programs
[1] The Health Care Antikickback Statute: 42 U.S.C. § 1320a-7b(b)
[2] False Statements Relating to Health Care Matters
[3] Health Care Fraud: 18 U.S.C. § 1347
[4] Theft or Embezzlement in Connection with Health Care Fraud: 18 U.S.C. § 669
[5] False Statements Relating to Health Care Matters: 18 U.S.C. § 1035
[6] Obstruction of Criminal Investigations of Health Care Offenses: 18 U.S.C. § 1518
§ 3.03 Other Federal Offenses
[1] Submitting False Claims: 18 U.S.C. § 287
[2] False Statements: 18 U.S.C. § 1001
[3] Mail Fraud and Wire Fraud: 18 U.S.C. §§ 1341 and 1343
[4] The General Antikickback Act: 41 U.S.C. § 53
[5] Money Laundering: 18 U.S.C. §§ 1956, 1957
[6] RICO: 18 U.S.C. §§ 1961 et seq.
[7] Conspiracy
[8] Theft of Government Property: 18 U.S.C. § 641
[9] Obstruction of Justice
[10] Federal Program Fraud: 18 U.S.C. § 666
[11] The Travel Act: 18 U.S.C. § 1952
§ 3.04 Sentencing for Federal Offenses
[1] Sentencing Individuals
[2] Sentencing Organizations
[3] Forfeiture
§ 3.05 State Offenses
[1] Conspiracy
[2] Medicaid Fraud
[3] Antikickback and Anti-Self-Referral Statutes
[4] Theft, Larceny, etc.
[5] Difficulties Encountered in State Prosecutions
[6] Sentencing
[7] Federal Jurisdiction for Violations of State Law
§ 3.06 Criminal Liability for Corporations
[1] The Standards of Corporate Criminal Liability
[2] The Doctrine of Collective Intent
[3] Criminal Liability of Successor Corporations
[4] Department of Justice Guidelines Regarding the Federal Prosecution of Corporations
[5] Deferred Prosecution Agreements
§ 3.07 General Defenses
[1] The Fair Warning Requirement
[2] Advice of Counsel
[3] The Rule of Lenity
§ 3.08 Bibliography

Civil Causes of Action

§ 4.01 The False Claims Act: Elements of an FCA Action
[1] Introduction
[2] Application of FERA Amendments of 2009
[3] FCA Elements
§ 4.01A  FCA Qui Tam Provisions
[1] Background
[2] Constitutionality
[3] The Public Disclosure Bar and Original Source Exception
[4] Reconciling Sections 3730(e)(4) and 3730(d)(1)
[5] Jurisdictional Bar: First-to-File Rule
[6] Government Employees as Qui Tam Plaintiffs
[7] Rights of the Parties in Qui Tam FCA Lawsuits
§ 4.01B Other FCA Provisions and Consequences
[1] Whistleblower Protection Provisions
[2] FCA Procedure
[3] Damages and Penalties
[4] Collateral Estoppel: Relationship to Criminal Prosecutions and Administrative Proceedings
§ 4.01C Enforcement by State Attorneys General
[1] State False Claims Acts
[2] State Consumer Protection Statutes
[3] Use of Contingency Fee Counsel by State Attorneys General
§ 4.02 RICO
[1] The RICO Elements
[2] Civil Damages and Penalties
§ 4.03 Injunctive Relief
§ 4.04 Civil Asset Forfeiture
[1] Unique Characteristics of Civil Forfeiture
[2] Background
[3] How Civil Forfeiture Works
[4] Relation Back Doctrine
[5] Constitutional Considerations
§ 4.05 The “Stark” Laws
[1] Background of the Stark Laws
[2] Key Elements of Stark’s Prohibitions on Referrals and Billing
[3] Exceptions to the Stark Prohibition
[4] Key Standards in the Stark Exceptions
[5] Consequences of Stark Violations
[6] The Stark Reporting Provisions
[7] Application of the Stark Statute to Medicaid
[8] Overlap with Antikickback Statute
[9] CMS Stark Advisory Opinions
§ 4.06 Program Fraud Civil Remedies Act
§ 4.07 Miscellaneous Causes of Action
§ 4.08 Civil and Administrative Liability of Successor Corporations
§ 4.09 Bibliography

Administrative Sanctions and Collateral Consequences

§ 5.01 Introduction
§ 5.02 Exclusion
[1] Background
[2] The Grounds for Exclusion
[3] Procedure for Imposing Exclusion
[4] Effect of Exclusion
[5] Reinstatement
[6] Exclusion Action by Medicaid Agencies
[7] Exclusion Actions by a Quality Improvement Organization
[8] Suspension of Payments Pending Exclusion
§ 5.03 Civil Monetary Penalties
[1] Intent
[2] Grounds for Imposing CMP
[2A] Exceptions for Charitable and Innocuous Programs
[3] Determining the Amount of Penalties and Assessments
[4] Joint and Several Liability
[5] Imposition of CMP as Grounds for Exclusion
[6] Procedure for Imposing CMP
[7] Statute of Limitations
§ 5.04 Debarment and Suspension
[1] Introduction
[2] Procurement Debarment and Suspension
[3] Non-Procurement Debarment and Suspension
§ 5.05 Licensing
[1] Introduction
[2] Conviction as Grounds for Licensure Discipline
[3] Other Fraud-Related Grounds for Licensure Discipline
[4] Procedures Before State Licensing Boards
§ 5.06 Staff Privileges
[1] Background
[2] Impact of Fraud and Abuse
§ 5.07 Special Sanctions Considerations for Nursing Facilities
§ 5.08 The Beneficiary Inducements Statute
§ 5.09 Bibliography

Pretrial Strategies in Health Care Fraud Cases

§ 6.01 Introduction
§ 6.02 Undercover Investigations
§ 6.03 Grand Jury Investigations
[1] Grand Jury Secrecy
[2] Scope of Grand Jury Investigations
§ 6.04 Inspector General Subpoena
§ 6.05 Civil Investigative Demands
§ 6.06 Search Warrants
[1] Introduction
[2] Particularity and Overbreadth in Search Warrants
[3] Administrative Warrants in Criminal Investigations
[4] Private Party Searches
§ 6.06A Asset Freezes and Pre-Judgment Attachments
§ 6.07 Contacts with Represented Persons
§ 6.08 Privileges
[1] Privilege Against Self-Incrimination
[2] Attorney-Client Privilege
[3] Work Product Privilege
[4] Changes Between Waiver for the Attorney-Client and Work Product Privileges
[5] Crime Fraud Exception to Attorney-Client and Work Product Privilege
[6] Attorney-Client and Work Product Privileges in a Corporate Setting
[7] Privileges in Joint Defense Agreements
§ 6.09 Protections for Medical Records and Communications
[1] Constitutional Privacy Rights
[2] Statutory and Regulatory Protections
[3] Patient-Provider Privileges in Federal Courts
[4] Patient-Provider Privileges in State Courts
§ 6.10 Conflicts of Interest
§ 6.11 Injunctive Relief
§ 6.12 Bibliography

Evidence and Trial Strategies in Health Care Fraud Cases

§ 7.01 Expert Witness Testimony
[1] Federal Rules and Daubert
[2] Billing Experts
[3] Damages Experts
§ 7.02 Use of Exhibits
[1] Exhibits Created for Trial
[2] Patient Records
[3] Provider Manuals
[4] Computerized Records
§ 7.03 Special Issues Relating to Scienter Evidence
[1] Advice of Counsel Defense
[2] Reliance Upon a Consultant’s Advice
[3] Evidence of Other Bad Acts
[4] Character Evidence
§ 7.04 Jury Instructions
[1] “Willfully”/Specific Intent
[2] Knowingly 
[3] Deliberate Ignorance
[4] Mistake
[5] Reasonable Interpretation of Confusing Law
§ 7.05 Bibliography

Internal Investigations When Fraud Is Suspected: Issues of Strategy

§ 8.01 Introduction
§ 8.02 Who Should Conduct the Investigation
[1] The Client
[2] In-House Counsel
[3] Regular Outside Counsel
[4] Outside Counsel Specializing in Health Care Fraud/Internal Investigations
§ 8.03 Advising the Client
§ 8.04 Conducting Interviews
§ 8.05 Maintaining Privileges
[1] Fifth Amendment Privilege
[2] Attorney-Client Privilege
[3] Work Product Privilege
[4] Provider-Patient Privilege
§ 8.06 Voluntary and Mandatory Reporting
[1] Preparing a Report
[2] Duty to Report under the Sarbanes-Oxley Act
§ 8.07 Seeking a Stay or Procurement of a Protective Order in Parallel Civil Actions
§ 8.08 Protecting the Internal Investigator
§ 8.09 Pleas of Guilt
[1] Collateral Consequences of a Guilty Plea
[2] The Settlement Amount
[3] Deferred Prosecution Agreements as an Alternative to a Guilty Plea
§ 8.10 Establishing a Corporate Integrity Program (CIP)
§ 8.11 Voluntary Disclosure of Wrongdoing
[1] 1995 OIG Pilot Voluntary Disclosure Program
[2] 1998 Voluntary Disclosure Protocol
[3] Self-Referral Disclosure Protocol
[4] Benefits and Risks of Voluntary Disclosure
[5] 2015 Yates Memo
§ 8.12 Bibliography

Corporate Compliance Plans

§ 9.01 Introduction
§ 9.02 The Importance of Corporate Compliance Plans
§ 9.03 Establishing an Effective Corporate Compliance and Ethics Program for a Health Care Provider
[1] Standards of Conduct
[2] Oversight by the Organization’s Governing Authority
[3] Oversight by High-Level Personnel in the Organization
[4] Due Diligence in the Selection of Employees and Agents Who Possess Substantial Discretionary Authority
[5] Training and Communications
[6] Monitoring and Auditing
[7] Rewards and Discipline
[8] Reasonable Response to an Occurrence of Noncompliance
[9] Documenting the Corporate Compliance Plan
[10] Acquiring Companies
§ 9.04 OIG Compliance Program Guidances
[1] Hospitals
[2] Supplemental Compliance Program Guidance for Hospitals
[3] Clinical Laboratories
[4] Home Health Agencies
[5] Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
[6] Third-Party Medical Billing Companies
[7] Hospices
[8] Nursing Homes
[9] Supplemental Compliance Program Guidance for Nursing Facilities
[10] Individual and Small Group Physician Practices
[11] Pharmaceutical Manufacturers
[12] Recipients of Extramural Research Awards from U.S. Public Health Service Agencies
§ 9.05 Corporate Integrity Agreements
[1] Preamble
[2] Parties Covered by Agreement
[3] Term
[4] Corporate Compliance Function
[4A] Compliance Obligations of the Board of Directors, Executives, and Managers
[5] Written Standards
[6] Training
[7] CIA Monitor
[8] Independent Review Organization (IRO)
[9] Cost of Independent Audit if Necessary
[10] Confidential Disclosure Program
[11] Ineligible persons
[12] Notification of Proceedings
[13] Reporting Requirements
[14] New Locations
[15] Implementation and Annual Report
[16] OIG Inspection and Audit Rights
[17] Document and Record Retention
[18] Disclosure and Privileges
[19] Stipulated Penalties
[20] Exclusion for Material Breach
[21] Appellate Rights
[22] Effect on Successors and Assigns
§ 9.06 Bibliography

Fraud and Abuse Issues in the Pharmaceutical Industry

§ 10.01 Introduction
§ 10.02 Pharmaceutical Reimbursement
[1] Background
[2] Overview of Medicare Program
[3] Medicaid
[4] “Public Health Service Act” Prices
[5] The Federal Supply Schedule and Federal Ceiling Prices
§ 10.03 Liability for Setting and Reporting Prices
[1] Inflated AWP or Direct Prices
[2] False Medicaid Rebates
[3] PHS Pricing
[4] FSS Pricing
[5] Direct Price Reporting
[6] ASP Reporting
§ 10.04 False Claims Act Liability for Claims Relating to Drugs That Are Not Approved or That Should Not Have Been Approved
[1] “Off-Label” Promotion
[2] Fraud in the FDA Approval Process
§ 10.05 Liability for Marketing Products
[1] Marketing the “Reimbursement Spread”
[2] Grants
[3] “Switch Fees” to Physicians, Pharmacists, or Pharmacy Benefits Managers (PMBs)
[4] Consulting and Other Personal Service Arrangements
[5] Samples, Vouchers, and Coupons
[6] Discounts and Rebates
[7] Gifts and Business Courtesies
[8] Fees and Rebates to Group Purchasing Organizations and Pharmacy Benefits Managers
[9] “Value Added” Services, Including Health Management and Reimbursement Services
[10] Purchase of Data or Goods
[11] Commission Sales Arrangements
[12] Charitable Contributions
§ 10.06 Liability for Pharmacies
§ 10.07 Bibliography

Table of Abbreviations