Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation.” It also instructed DOJ attorneys that they “may not use noncompliance with guidance documents as a basis for proving violations of applicable law in affirmative … Continue Reading
The Department of Justice’s (DOJ) Office of Legal Council (OLC) released an opinion in May 2019 addressing the Food and Drug Administration’s (FDA) jurisdiction over drugs used in capital punishment. A result of a request by the U.S. Attorney General’s Office, the OLC issued an opinion following years of conflict around the use of sodium … Continue Reading
Michael Granston, the Director of the Commercial Litigation Branch within the United States Department of Justice’s Fraud Section, recently issued an internal memorandum affirming his prior statements that the Department of Justice (DOJ) should consider seeking dismissal of meritless False Claims Act (FCA) suits brought by relators in qui tam cases. Under 31 U.S.C. § … Continue Reading
On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care. The DOJ alleged that HCR ManorCare delivered unnecessary therapy to patients covered under Medicare Part A in its skilled nursing … Continue Reading
Companies, including those in the pharmaceutical and medical device industries, with multinational operations should expect increasing collaboration between U.S. and foreign competition agencies to investigate and prosecute alleged antitrust violations. In light of recent and ongoing investigations by U.S. and UK competition agencies into generic and sole-source drug pricing, the revised guidelines are expected to … Continue Reading
In a case dating back several years, the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al., the court found in favor of the DOJ, denying the defendant hospitals’ motion … Continue Reading
Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading
As mentioned on our Health Industry Washington Watch blog, pharmaceutical and medical device manufacturers and group purchasing organizations (GPO) are currently in the process of submitting detailed 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services. The submission of this data, as dictated by the Physician Payment Sunshine Act, is intended to highlight certain financial relationships between the manufacturers and GPOs and physicians. With some exceptions, this data will become public by September 1, 2014, at which time the Department of Health and Human Services' Office of the Inspector General, Department of Justice, and relators' attorneys will likely analyze the data to initiate investigations and support complaints under the federal False Claims Act.… Continue Reading
Last week, in my capacity as president of the American Health Lawyers Association, I attended the first National Summit on Health Care Fraud, a joint undertaking by the U.S. Department of Health and Human Services and the U.S. Department of Justice. The conference brought together private sector leaders, law enforcement personnel, and health care experts as part of the Obama Administration's coordinated effort to fight health care fraud. This was the first national gathering on health care fraud between law enforcement and the private and public sectors.… Continue Reading
