Akin Gump Strauss Hauer & Feld LLP’s health industry practice offers an unrivaled track record of litigation success in precedent-setting fraud and abuse cases. Because our attorneys handle a high volume of fraud and abuse litigation, they also possess informed experience to provide accurate compliance advice. The practice is staffed by recognized thought leaders, including lawyers who have written the American Health Lawyers Association treatise on the False Claims Act (FCA): False Claims Act & The Healthcare Industry: Counseling & Litigation, Second Edition (and Annual Supplements) and the FCA chapter in Health Care Fraud and Abuse: Practical Perspectives in the False Claims Act in Health Care Prosecutions: Application of the Substantive, Qui Tam, and Voluntary Disclosure Provisions, Ch. 3 (2d Ed. BNA Books 2011). Lawyers in the practice have lectured at more than 50 national health care fraud and abuse conferences and authored more than 20 articles regarding health care fraud and abuse law, including several that courts have favorably cited.
Track Record of Proven Litigation Success
The Akin Gump fraud and abuse compliance and litigation team has a proven track record of litigation success. Indeed, almost unique among law firms, the team has prevailed against the government in FCA actions at summary judgment, for example:
- United States v. Prabhu: 442 F. Supp. 2d 1008 (D. Nev. 2006). Represented defendants in an FCA action in which they prevailed on summary judgment in a governmental action alleging more than $20 million in damages, contending that defendants’ claims were not medically necessary. Ultimately, because the United States’ action lacked “substantial justification,” the United States was ordered to pay defendants more than $500,000 in legal fees.
- United States of America ex rel. Jamison v. McKesson Corporation, 784 F. Supp. 2d 664 (N.D. Miss. 2011). Represented Golden Living in an action where the relator and government sued multiple defendants alleging that they created a supply company in violation of the Anti-Kickback Act and operated the company in violation of supplier standards. The district court granted defendants’ FCA summary judgment motion regarding the supplier standards allegations, finding that the government’s prior administrative proceedings demonstrated that defendant was entitled to payment.
Our team has obtained dismissal of several FCA lawsuits at early stages, including:
- United States ex rel. Westlund v. LabCorp, 2012 U.S. Dist. LEXIS 57050 (M.D. Fla. Apr. 24, 2012). Represented LabCorp in obtaining dismissal of qui tam case under Fed. R. Civ. P. 12(b)(6) and 9(b) where relator alleged LabCorp violated the FCA and Anti-Kickback Act.
- United States ex rel. Huey v. Summit Healthcare Ass’n, Inc., 2011 U.S. Dist. LEXIS 26740 (D. Ariz. Mar. 2, 2011). Represented a hospital management company in obtaining dismissal of qui tam case under Fed. R. Civ. P. 12(b)(6) where the relator alleged that the company had discovered that a client hospital had received a substantial Medicare overpayment and then conspired with the hospital to keep the overpayment hidden from the government.
- In re Natural Gas Royalties Qui Tam Litigation: Represented ExxonMobil in a qui tam action alleging that more than 300 defendants undervalued the heating content and volume of gas. The district court dismissed the relator’s action under the FCA public disclosure jurisdictional bar. The 10th Circuit affirmed the district court’s ruling. Also successfully moved the court to award defendants’ their attorney fees based upon the relator filing a frivolous action. Reported decisions: 562 F.3d 1032 (10th Cir. 2009); 467 F. Supp. 2d 1117 (D. Wyo. 2006).
- Our team recently completed a three-week bench trial in an FCA/Anti-Kickback Act, United States of America ex rel. Jamison v. McKesson Corporation (described above). This is one of the extraordinarily rare cases in which a large health care company has tried an FCA/Anti-Kickback Act case against the government.
Informed Compliance Advice
Because of our team’s substantial litigation experience, we are positioned to provide informed compliance advice. For example, whereas in most firms those providing compliance advice are separate from those who actually litigate the cases, Akin Gump furnishes one team that handles both. This results in more accurate and informed advice because those providing the compliance advice have frequently encountered the same issues being tested in court—such as the scope of the FCA’s overpayment mandate, the Anti-Kickback Act’s “knowing and willful” element or the Stark Law exceptions. Thus, we know what facts and evidence a court is most likely to find persuasive and compelling, and we can provide the compliance advice accordingly. We also, through court actions, know what position the government will likely adopt regarding each of these issues.
The team’s pre-lawsuit compliance advice includes:
- responding to Department of Justice civil investigative demands and subpoena requests
- making voluntary disclosures
- conducting internal reviews regarding whether there is a known overpayment and, if so, to whom and what to disclose
Our team also provides extensive counseling concerning compliance with fraud and abuse laws. This experience includes:
- counseling on fraud and abuse issues related to the submission of Medicare and Medicaid reimbursement claims, including compliance with the false claims laws and mandatory disclosures
- designing, implementing and evaluating compliance programs
- negotiating Corporate Integrity Agreements (CIAs) imposed by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and counseling clients in meeting CIA obligations
- conducting internal investigations regarding possible overpayments or other compliance failures
- advising pharmaceutical manufacturers on whether certain discount arrangements and bundled sales of products comport with the federal Anti-Kickback Law
- advising pharmaceutical manufacturers on fraud and abuse compliance policies relating to quality programs, refill reminders and other product support programs
- requesting advisory opinions on behalf of pharmaceutical manufacturers from the OIG, including requests regarding the Anti-Kickback Law compliance implications of proposed discount arrangements and patient assistance programs
- counseling a large retail pharmacy chain on vicarious liability for fraud and abuse violations committed by its employees under state patient brokering and anti-rebate statutes and the Anti-Kickback Law
- counseling a physician practice management company acquiring interests in numerous physician practices and clinical laboratories across the United States on how to structure these transactions to conform with federal and state anti-kickback laws
- evaluating independent patient assistance programs for compliance with the Anti-Kickback Law and other fraud and abuse laws and counseling manufacturers on appropriate safeguards for such programs
- structuring manufacturer-sponsored patient assistance programs to comply with the Anti-Kickback Law and other fraud and abuse laws
- structuring manufacturer marketing programs with providers and managed care organizations to ensure compliance with the Anti-Kickback Law and other fraud and abuse laws
- reviewing a device manufacturer’s consulting and royalty contracts with physician inventors and technical advisers for compliance with the Anti-Kickback Law and the Stark Law
- providing fraud and abuse counseling related to structuring business arrangements among pharmaceutical companies, managed care organizations, physicians, hospitals and other providers
- evaluating corporate compliance programs and practices and compliance risks as part of due diligence reviews.