Akin Gump Strauss Hauer & Feld LLP brings together lawyers from our health care, litigation, global investigations and antitrust practices to represent a variety of clients in health care disputes and investigations. Our clients, ranging from hospitals, health systems, academic medical centers, insurance companies and private equity funds to medical technology and pharmaceutical companies and executives, benefit from the multidisciplinary approach that the firm brings to these representations. We represent clients in matters arising under the False Claims Act (FCA), in Medicare and Medicaid reimbursement actions, and under the Administrative Procedure Act (APA). Our lawyers also have substantial experience representing health care entities in internal and government-facing investigations and in trial and appellate matters, several of which have resulted in precedent-setting victories. Our team includes lawyers with prior experience in the Department of Justice (DOJ) and the Department of Health and Human Services (HHS), including at the Centers for Medicare and Medicare Services (CMS).
Our areas of experience include:
False Claims Act Litigation and Investigations
Our lawyers have represented businesses from multinational corporations to nonprofit companies, including academic medical centers, hospital networks and health care systems, insurance providers, medical technology manufacturers, pharmaceutical companies, physician groups and specialty associations, in FCA matters and in related civil, criminal and congressional investigations. We have proven experience in handling the most complex and high-stakes FCA matters, and our team includes lawyers who have recently worked at the DOJ enforcing the FCA.
Representative matters include the following:
- defended a national skilled nursing facility in an $895 million FCA action alleging violation of the Anti-Kickback Statute and supplier standards, marking a rare instance of a large health care company successfully trying an FCA case against the government (United States of America ex rel. Jamison v. McKesson Corp., 900 F. Supp. 2d 683 (N.D. Miss. 2012))
- obtained summary judgment on behalf of one of the country’s largest providers of rehabilitation therapy and skilled nursing providers in an FCA case alleging delivery of medically unnecessary services (United States ex rel. Lawson v. Aegis Therapies, Inc., 2015 U.S. Dist. LEXIS 45221 (S.D. Ga. Mar. 31, 2015))
- obtained affirmance of summary judgment on behalf of a global management consulting company in a $50 million FCA lawsuit alleging that our client caused excessive outlier payments at a medical center whose operations it controlled (United States ex rel. Assoc. Against Outlier Fraud v. Huron Consulting Grp., Inc., 567 Fed. Appx. 44 (2d Cir. 2014); 929 F. Supp 2d 245 (S.D.N.Y. 2013))
- obtained summary judgment in an FCA case that the government filed against durable medical supply company and skilled nursing facility alleging that they knowingly created and operated a supply company in violation of Medicare 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 the defendant supply company was entitled to payment (United States of America ex rel. Jamison v. McKesson Corporation, et al., 784 F. Supp. 2d 664 (N.D. Miss. 2011))
- obtained dismissal on summary judgment on behalf of a multispecialty physician group practice that the government accused of FCA violations seeking $20 million in FCA damages, and secured $500,000 in legal fees for our client after the court found that the government FCA action lacked substantial justification (United States v. Prabhu, 442 F. Supp. 2d 1008 (D. Nev. 2006)).
Akin Gump’s reimbursement litigation practice is best known for big wins in cutting-edge and lead cases, including negotiating the largest Medicare reimbursement settlement in history. Our team has successfully represented more than 1,000 entities in cases involving Medicare, Medicaid and other federal program reimbursement denials, including in multiple cases of first impression. Our lawyers have prosecuted numerous Medicare appeals from the administrative level through the federal appellate courts, including the following representative cases:
- successfully litigated the first case to ever decide that a generally overlooked provision of the Medicare statute requires notice-and-comment rulemaking even when the APA otherwise would not require it (Allina Health Services v. Price, 2017 WL 3137996 (D.C. Cir. July 25, 2017))
- prevailed in a significant appeal affirming the invalidation of a Medicare rule on disproportionate share hospitals (DSH) that fundamentally changed payment calculations without proper notice (Allina Health Services v. Sebelius, 746 F.3d 1102 (D.C. Cir. 2014))
- after litigating the lead case, structured and negotiated a settlement valued at more than $4 billion that not only benefited the firm’s 700 hospital clients, but also had wide-ranging implications for hospitals across the country(Cape Cod Hospital v. Sebelius, 630 F.3d 203 (D.C. Cir. 2011))
- litigated for more than 400 hospitals in a suit challenging the CMS rule reducing the base Medicare payment rate for inpatient hospital services by 0.2 percent in connection with the adoption of the “two-midnight” coverage rule, which has an aggregate impact of $220 million per year for all U.S. hospitals (Shands v. Burwell, Case No. 14-263 (D.D.C.))
- pursuing a first-of-its-kind federal court challenge to the substantive and procedural validity of a 2003 amendment to the Medicare regulations governing hospital payments for extraordinarily costly “outlier” cases (Clarian Health West, LLC v. Burwell, Docket No. 1:14-cv-339 (D.D.C. March 3, 2014))
- obtained a ruling, in a first-ever decision from a federal court, requiring the HHS to correct previously undisclosed errors and omissions in the calculation of the Medicare Part A/SSI fraction for a DSH (Baystate Medical Center v. Leavitt, 545 F. Supp. 2d 20, amended, 587 F. Supp. 2d 37 (D.D.C. 2008))
- won the lead case among 270 consolidated federal court suits involving more than 600 hospitals seeking additional DSH payments for eligible-but-unpaid Medicaid patient days, a decision that led to subsequent negotiations of a global settlement that secured payment of more than $660 million to hospitals involved in the consolidated cases; we also successfully opposed the U.S. Solicitor General’s petition for review by the Supreme Court. (In Re Medicare Reimbursement Litigation, 309 F. Supp. 2d 89 (D.D.C. 2004), aff’d, 414 F.3d 7 (D.C. Cir. 2005), cert. denied, 126 S. Ct. 1672 (2006)).
Commercial and Class Action Litigation
Akin Gump litigators have extensive courtroom experience in a variety of commercial matters in the health care industry, including provider-class Racketeer Influenced and Corrupt Organizations (RICO) Act claims, director’s and officer’s (D&O) derivative suits, consumer protection suits, provider-class fiduciary duty claims and class breach-of-contract claims involving TRICARE providers, Employee Retirement Income Security Act (ERISA) fiduciary duty claims and ERISA disclosure claims, among others. Our litigation experience also encompasses defending clients against class action claims brought by subscribers, providers and medical associations, and our team is well-versed in minimizing the economic impact of class action litigation on clients, from the early substantive stages through procedural challenges.
Representative examples of our experience include the following matters:
- defeated a putative multistate class action against a health care provider for low-income patients involving a breach-of-contract clause and application of TRICARE regulations
- defended a major health insurance plan against medical providers’ class claims for breach of contract and insurance subscribers’ class claims for breach of fiduciary duty and violation of the Pennsylvania Unfair Trade Practices and Consumer Protection Law
- represented a health insurance plan in a $15 million litigation involving allegations that managed-care companies failed to timely reimburse clean claims under the Texas Prompt Pay Act
- negotiated on behalf of a major national health plan one of the most favorable settlements achieved by any health insurer in the country in a RICO case seeking triple damages arising out of a wide range of practices allegedly engaged in by the defendants related to provider reimbursement
- obtained summary judgment on behalf of a specialty pharmaceutical company in a protracted patent infringement battle with a generic competitor finding that our client’s allegedly infringing quality-control methods in the production of its generic drug were protected by the Hatch-Waxman safe harbor
- represented a major insurance company in a putative class action brought by an individual and the plaintiff’s employer alleging that our client’s disability policy requires an annual increase in disability payments by seven percent.
Akin Gump’s nationally recognized appellate practice comprises lawyers who are respected and exceptionally experienced figures in the courtroom. Members of the practice include a former long-term assistant to the Solicitor General, a former federal appellate court judge and a former state appellate court judge, as well as many former clerks from almost every level of the judicial system, including the U.S. Supreme Court, state supreme courts, federal appellate circuit courts, federal district courts and bankruptcy courts, and the U.S. Court of Federal Claims. Our lawyers have been involved in a number of high-profile health care litigation appeals, including the following:
- secured a victory for a health care services provider with the federal court of appeals’ affirmation of the dismissal of an FCA suit arising from alleged Medicare fraud in our client’s provision of nutritional products to nursing homes
- obtained affirmance of dismissal for a major insurance company of a putative nationwide civil RICO class action alleging that the insurers conspired to defraud dentists through the use of computer programs that were alleged to improperly reduce payments to the dentists
- obtained an appellate reversal under the Anti-SLAPP statute in favor of the largest operator of health care facilities in the world, as well as a board member of one of its facilities, in a substantial multimillion-dollar contract dispute alleging defamation, tortious interference with prospective contractual relations, conspiracy and criminal conduct
- obtained dismissal and affirmance in state and appellate court in New Jersey on behalf of two health insurance companies against an action brought by a state medical society alleging violation of public policy, tortious interference with contract, violations of the Consumer Fraud Act and violation of the Health Information Networks and Technology Act
- obtained affirmance in the 6th Circuit of denial of attempt to intervene by a member of a purported class of nurses claiming to have been damaged by an alleged wage-fixing conspiracy among local hospitals and hospital systems
- obtained affirmance by the 7th Circuit of a summary judgment ruling in favor of one of the largest health insurers in the world, which was accused of participating in an antitrust conspiracy with a competitor that it was in the process of acquiring
- represented a trade association in connection with the filing of an amicus brief on its behalf at the merits stage and then filing a cert-state amicus brief on behalf of the association urging the Supreme Court to grant review of the court of appeals’ decision in the case.
Situated across our global investigations and compliance, congressional investigations and crisis management practices, our lawyers provide counsel to health care-related clients in both internal and government-initiated investigations, helping them navigate the increasing pressure from federal, state and congressional regulators. With broad and deep experience advising health industry clients, we have successfully represented various pharmaceutical and medical device companies, trade associations, hospitals, health practices and systems, and individual executives in high-profile and critical congressional, civil and criminal investigations and related enforcement actions.
As former senior government officials in agencies such as the HHS Office of Inspector General (OIG), Food and Drug Administration (FDA), DOJ, Securities and Exchange Commission (SEC) and as assistant U.S. attorneys, our lawyers bring to bear a robust understanding of both the health care delivery system and the legal framework governing it. Our representative experience includes the following:
- represented a trade association in connection with congressional investigations regarding issues under the Patient Protection and Affordable Care Act
- represented several pharmaceutical companies in a congressional investigation concerning product safety
- represented nutritional supplement companies in congressional investigations and investigations by the New York Attorney General
- represented the chief executive officer (CEO) of a large public health care company in connection with DOJ and SEC investigations in which we successfully persuaded the government not to bring criminal charges or enforcement action against the CEO
- represented a large medical device company in responding to congressional investigations concerning payments made to physicians
- represented a CEO of an electronic health records company in a federal grand jury investigation in Mississippi under the Anti-Kickback Statute; no charges were brought.
Akin Gump lawyers litigate disputes between competitors, class actions by individuals and cases against the various federal and state antitrust enforcement agencies. We have represented a variety of clients on antitrust issues, including pharmaceutical companies, health care professionals, pharmacies, health industry organizations, medical device manufacturers, hospitals, nursing homes, health insurers and other health care providers. Our lawyers have handled cases involving merger litigation, intellectual property, price fixing, monopolization, gun jumping, information exchanges, exclusive arrangements and refusals to deal. We have decades of experience litigating these issues and have team members who served at the Federal Trade Commission (FTC), the Antitrust Division of the DOJ, and the Antitrust Bureau of the New York Attorney General’soffice. Our experience includes the following:
- defended a large pharmaceutical company in a class action lawsuit in which the plaintiffs attacked four “reverse payments” patent litigation settlements, accusing the defendants of antitrust conspiracy and monopolization
- defended a major health insurer in a civil antitrust action alleging a conspiracy of a major urban health care system and health plans
- defended a health care equipment company in a monopolization suit arising from a distribution arrangement involving another company’s patented bone mill, a device used to grind bone for use in spinal fusion surgeries
- defended a large pharmaceutical company in proceedings brought against it by a small pharmacy in a class action antitrust lawsuit
- obtained summary judgment on behalf of a bioscience company accused by a competitor of improperly monopolizing, or attempting to monopolize, the relevant market by virtue of various exclusive agreements with purchasers.