Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel

Government Investigations & Litigation

Arent Fox has assembled a formidable team of health care regulatory experts, former federal and state prosecutors, seasoned litigators, and related professionals to help health care providers and suppliers in all types with civil, criminal, and administrative investigations and litigation related to the False Claims Act (FCA) and other federal and state statutes. Our litigators include a former federal district court judge, a US Attorney, the former Chief of Government Fraud Section (Los Angeles), assistant US attorneys, an assistant district attorney, an OIG Senior Trial Attorney, and a JAG Chief Judge. Our regulatory experts also include numerous former government officials, who have spent decades developing expertise on the applicable Medicare, Medicaid requirements, the Stark Law, the Anti-Kickback Statute and other state and federal fraud and abuse laws, and are recognized experts in the field. The resulting combination of regulatory and litigation expertise gives our clients substantial resources to respond to an extremely difficult enforcement environment. In addition, Congressional investigations of health care providers, suppliers, and manufacturers are becoming commonplace. Our firm is based in the nation’s capital, making us a preferred law firm for clients needing Washington, DC experience, and our Government Relations practice includes two former Senators, a former Congressman, and former Congressional senior staff who routinely advise clients on their interactions with Capitol Hill, including in the context of investigations.

We routinely counsel clients under investigation by numerous federal and/or state agencies, including the DOJ — both Main Justice and US Attorneys’ offices throughout the country, the FBI, the OIG, Medicaid Fraud Control Units, and state Attorney General offices. These investigations have involved allegations of billing for medically unnecessary services, allegations of fraudulent billing, upcoding, improper inpatient admissions, kickbacks, Stark Law and kickback violations, wrongdoing during clinical research, and violations of the Prescription Drug Marketing Act. Increasingly, many of these investigations have both a criminal, as well as a civil, component, span multiple years and require the review and production of hundreds of thousands of documents including ESI. Arent Fox attorneys frequently work with the government to limit the scope of the required production to decrease the risk of exposure and dramatically reduce the cost for clients. Further towards this end, we have attorneys and other professionals help identify the best and most cost-effective technology platforms to expedite the document review process. Depending on the needs of the case and client, we also frequently use our trained teams of paralegals and attorneys to perform the document review as expeditiously as possible.

Bringing together experienced advisers from our health care, litigation/white collar, and government relations practices, Arent Fox has helped clients resolve many investigations early in the process through a cooperative effort leading to favorable settlements or, in some cases, no liability whatsoever.


CMS’s Long-Awaited Final 60-Day Repayment Rule Provides Guidance and Eases Some Requirements for Health Care Providers and Suppliers

On Friday, February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited Final Rule and regulations,[1] providing much needed guidance to providers and suppliers on how to meet the Affordable Care Act’s (ACA’s) 60-day overpayment mandate.[2] Specifically, a provision enacted as part of the ACA in 2010 requires that all Medicare and Medicaid overp


CVS Settles Controlled Substances Act Claim for $8 Million

As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).


The End at Last: Tuomey Settles for $72.4 Million

The Department of Justice recently announced that Tuomey Healthcare System has agreed to pay $72.4 million and enter into a five-year Corporate Integrity Agreement to finally resolve the long-running U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc. False Claims Act/Stark Law litigation, a case that has included two jury decisions and two appeals to the Fourth Circuit.


Covered Entities and Business Associates Beware! New HIPAA Audits to Begin in Early 2016

Health care providers and their contractors have been put on notice by the Office for Civil Rights (OCR) that the next round of HIPAA compliance audits will begin in early 2016.  The previous round of HIPAA audits was completed in 2014.  While OCR previously had signaled that the HIPAA audits would be resuming in the near future (such as by noting the upcoming release of a new audit protocol), OCR’s new statement is the most definitive inform


Stark Law is Coming: Adventist Health System Pays $118.7 Million in Third Large September Settlement

On September 21, 2015, the US Department of Justice (DOJ) and whistleblowers’ counsel announced that Florida-headquartered Adventist Health System (Adventist) had agreed to pay $118.7 million to resolve allegations that it violated the False Claims Act (FCA) by submitting claims in v


Deputy AG Branda Provides Insights into Department of Justice Enforcement Priorities at AHLA Fraud and Compliance Forum

Joyce Branda, the Deputy Assistant Attorney General for the Commercial Litigation Branch of the Department of Justice (DOJ), gave the keynote address on September 28, 2015, at the American Health Lawyers Association Fraud and Compliance Forum in Baltimore, providing conference attendees with an update from DOJ. Her speech identified various key issues for DOJ, as well as areas in which the health care industry can expect to see increased scrutiny in the coming year.


Arent Fox Represents North Broward Hospital District in High Profile False Claims Act Settlement

Washington, DC — On September 15, the US Department of Justice announced that it reached a $69.5 million settlement with the North Broward Hospital District to resolve False Claims Act allegations that originated in 2010.


First In Kind False Claims Act Settlement Based Upon Failure to Investigate and Return Overpayment

Earlier this week, BNA’s Health Care Daily Report picked up on the announcement of a settlement in two False Claims Act cases.   (United States ex rel. Odumosu v. Pediatric Servs. of Am. Healthcare, N.D. Ga., No. 1:11-cv-1007; United States ex rel. McCray v. Pediatric Servs. of Am., S.D. Ga., No.


Midsummer Nightmare: Opinion in Continuum Health Partners Case Suggests We Can Identify the Unknown

On Monday, a federal district court judge in New York issued a ruling that, if adopted broadly, will have a significant – and potentially nightmarish – impact on any provider who receives an overpayment from Medicare or Medicaid.  Kane v. Healthfirst, Inc. and U.S. v.


Physicians (and other Providers) Beware! OIG Announces New Enforcement Team Focused on CMPs and Exclusion

Last week, at the annual meeting of the American Health Lawyers Association in Washington, DC, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced the creation of a new litigation team focused solely on using the OIG’s authority to impose civil monetary penalties and exclude individuals and businesses from Medicare and Medicaid. Located within the Office of Counsel to the Inspector General (OCIG), the unit debuted in March and is expected to have 10 attorneys when fully up and running.


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Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.