Government Investigations and the False Claims Act

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Hall Render’s attorneys are experienced in resolving many compliance-related issues before they grow into aggravated litigation matters with the government. Our attorneys have successfully assisted health care clients in a wide range of areas, including government investigations and regulatory compliance. We have also resolved issues with the government under the False Claims Act and other...Read More

Hall Render's attorneys are experienced in resolving many compliance-related issues before they grow into aggravated litigation matters with the government. Our attorneys have successfully assisted health care clients in a wide range of areas, including government investigations and regulatory compliance. We have also resolved issues with the government under the False Claims Act and other civil enforcement statutes to avoid further action by the government. If the case does turn into litigation, however, our trial and appellate attorneys have the experience to aggressively represent our clients' interests. Our counsel regularly assist and guide clients through the complex maze of health care statutes, rules and regulations that are increasingly becoming the focus of investigations by the government.

Value Proposition: Litigators Paired with Health Care Experience

Hall Render’s Government Investigations and FCA Task Force offers a value proposition by combining experienced litigators with deep subject matter knowledge. With the government’s ever-increasing focus on the health care sector, and the higher stakes for both entities and individuals resulting from the Supreme Court’s decision in the Escobar case and the Department of Justice’s Yates Memo, having experienced health care counsel to assist in such matters is critical and cost-effective, as it allows for more nuanced and sophisticated arguments grounded in the law and derived from prominent health care attorneys already familiar with the issues being raised.

The issues confronting targeted providers in these cases include, but are not limited to, complex and vague Medicare and Medicaid reimbursement regulations, Stark Law and Anti-Kickback Statute matters, questions of medical necessity, FDA requirements, usual and customary pricing matters, teaching physician supervision regulations, clinical trials and federal research grant compliance, clinical laboratory regulations, DME compliance, coding issues and other health care laws and regulations.

Hall Render’s team includes reimbursement attorneys as well as former clinicians, which provides a significant advantage in developing arguments and defenses related to complex reimbursement matters, reviewing medical records and understanding potential defenses from a clinical perspective. This, in turn, assists in defending providers against enforcement activity and minimizing potential financial exposure.

We assist health care providers and entities in navigating these investigations from the initial receipt of a subpoena, civil investigative demand, informal inquiry letter or other contact from the government and extending through the negotiation and final case resolution, including parallel criminal inquiries.

Vast Amount of Experience with OIG, DOJ and CMS

Our experience includes inquiries originating from the Department of Justice, United States Attorney Offices, the Office of the Inspector General, the Centers for Medicare & Medicaid Services, the Health Resources and Services Administration, the Drug Enforcement Administration, the Federal Bureau of Investigation, Medicaid Fraud Control Units, state offices of inspector general and state attorneys general.

We also have extensive experience representing many provider types involving a broad range of conduct that includes self-disclosures to the Office of the Inspector General, the Centers for Medicare & Medicaid Services, the Department of Justice, the Health Resources and Services Administration and other appropriate government agencies.

Internal Investigations: Getting Ahead of the Issue

When conducting internal investigations, we regularly work through the attorney-client privilege and work product doctrine, as appropriate, to internally investigate compliance issues with the provider. We have experience performing independent investigations for Boards of Trustees/Directors and Audit Committees who may have concerns regarding certain conduct within a health care entity’s organization. This includes work under Sarbanes-Oxley for Boards of publicly traded companies.

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Areas of Focus

  • False Claims and Reverse False Claims
  • FCA Retaliation Actions
  • Fraud Enforcement and Recovery Act (FERA)
  • Regulatory Compliance Issues
  • Relators and Qui Tam Actions
  • State False Claims Acts
  • Whistleblower Suits

Representative Cases

  • Represented three hospitals in two states in a nationwide whistleblower case alleging improper use of cardiac devices. The case was dismissed by the United States District Court for the District of Connecticut after successful appeal to the Second Circuit Court of Appeals. United States ex rel. Cosens v. The Baylor University Medical Center, et al.

  • Represented a large physician practice and multiple physicians in a qui tam case alleging improper billing. The matter was resolved through favorable settlement in mediation. United States ex rel. Anderson v. Indianapolis Neurosurgical Group, et al.

  • Represented a physician in a qui tam suit alleging violation of the False Claims Act by billing without proper supervision in “incident to” billing. The case was dismissed by summary judgment. United States ex rel. Tucker v. Nayak.

  • Represented a physician practice group accused of violating the False Claims Act by failure to properly document venous ultrasound studies at the trial level, on appeal and in practice before the Supreme Court. United States ex rel. Swafford v. Borgess Medical Center, et al.

  • Represented a hospital in a qui tam suit alleging improper multi-dosing from single vials of insulin in the inpatient setting. The case was dismissed at the trial level, the dismissal affirmed by the Eleventh Circuit Court of Appeals and review denied by the United States Supreme Court. United States ex rel. Walters v. Daughters of Charity.

  • Represented a sleep laboratory in claims alleging fraudulent billing and retaliation under the False Claims Act. United States ex rel. Howze v. Sleep Centers of Fort Wayne.

  • Represented an Arizona hospital in a qui tam case alleging improper inpatient admission of observation patients. The case was favorably resolved in settlement negotiations. United States ex rel. Huey v. Summit Healthcare Association.

  • Represented hospitals in a qui tam case alleging improper laboratory billing. The case was dismissed with prejudice and the dismissal affirmed on appeal to the Seventh Circuit Court of appeals. United States ex rel. Camillo v. Ancilla Systems, Inc.

  • Represented a physician group before the trial court in a whistleblower case alleging Medicare fraud for physician billing in a teaching hospital. The case was dismissed with prejudice. United States ex rel. Wilson v. Emergency Medical Associates of Illinois, Inc.

  • Represented a hospital in obtaining a dismissal with prejudice of a False Claims Act claim based upon allegations of Stark Law and Anti-Kickback Statute violations. United States ex rel. Chomer v. Logansport Memorial Hospital.

  • Represented a hospital in obtaining a dismissal of a whistleblower case alleging Stark Law and Anti-Kickback Statute violations, upcoding of services and the use of false diagnostic codes. United States ex rel. Coots v. Reid Memorial Hospital.

  • Represented a physician practice in a settlement and partial dismissal related to a whistleblower claim alleging violations of the Stark Law and the Anti-Kickback Statute. United States ex rel. Beck v. Midwest Eye Consultants.

  • Represented a national health care provider in connection with receipt of Civil Investigative Demands related to Stark group practice matters in connection with its operations in Michigan; government declined to proceed with inquiry. United States ex rel. (Sealed) vs. (Sealed).

  • Assisted in representation of nationwide provider of health care diagnostic testing services in a qui tam action alleging that the laboratory billed the state Medicaid programs in violation of the state Medicaid regulatory rules and violated the Anti-Kickback Statute through its discounting practices. United States ex rel. Clausen v. Laboratory Corporation of America.

  • Assisted in representation of hospital district in a qui tam action where a community orthopedic surgeon alleged that the hospital paid in excess of fair market value to employed physicians, in part, for their referrals to hospitals and clinics. United States ex rel. Reilly v. North Broward Hospital District.

  • Settled a retaliation claim, with all fraud claims dismissed, in a whistleblower case alleging Stark Law and Anti-Kickback Statute violations. United States ex rel. Schulten v. Gibson Memorial Hospital.

  • Represented a physician group in an action pursued by the relator alleging that the organization presented false claims and participated in a conspiracy with the university to defraud the government in connection with Medicare charges and federal grants. United States ex rel. Kreipke et al v. Wayne State University and Wayne State University Physician Group.

  • Represented an institutional review board is obtaining a dismissal in federal court and in getting that dismissal affirmed by the Seventh Circuit Court of Appeals in a whistleblower case alleging mismanagement of federal research grants. United States ex rel. Gross v. AIDS Alliance.

  • Defended a hospital against a claim of retaliation under the False Claims Act, which was dismissed with prejudice. Shah v. Porter Memorial Hospital.