The Department of Justice’s “Yates Memo” sets forth regulatory principles, applicable to both civil and criminal investigations, to ensure that individuals are held accountable for corporate wrongdoing. While several U.S. Attorney Offices had been applying many of these principles already, the Yates Memo now establishes the principles expected to be followed by all U.S. Attorney Offices and … Continue Reading
In a post on our Life Sciences Legal Update blog here, we discuss the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case, which was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al. the court ruled in favor of … Continue Reading
The OIG has released its Medicaid Fraud Control Units (MFCU) Fiscal Year 2014 Annual Report, which highlights statistical achievements of the 50 MFCUs nationwide, along with related OIG oversight activities. With regard to criminal cases, the report notes: MFCUs reported 1,318 criminal convictions, most frequently involving home health care aides, certified nursing aides, and other medical support; … Continue Reading
The OIG has issued its Semiannual Report to Congress for the period of April 1 – September 30, 2014, in which it highlights significant investigation, audit, and enforcement activities and achievements across HHS programs during the six-month period and for all of FY 2014. The OIG reports expected recoveries exceeding $4.9 billion during FY 2014, consisting … Continue Reading
The U.S. Department of Justice (DOJ) has announced a record $5.69 billion in civil False Claims Act settlements and judgments for FY 2014, including almost $3 billion in recoveries related to qui tam lawsuits. The DOJ reports $2.3 billion in health care fraud recoveries in FY 2014, primarily involving the Medicare and Medicaid programs.… Continue Reading
On September 19, 2014, the Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) in which it identified several potential regulatory risks to federal health care programs as the result of coupon programs used by drug manufacturers to reduce or eliminate patient copayments for brand-name drugs. In the SAB, the OIG explains that coupon program sponsors and pharmacies will risk the receipt of penalties if they do not take steps to actively prevent federal health care program beneficiaries from using the coupons. According to the OIG, these coupon programs qualify as examples of remuneration offered to consumers to encourage the purchase and use of specific items, and therefore implicate the federal Anti-Kickback Statute. In addition, a claim that includes items or services resulting from such a kickback violation would constitute a false or fraudulent claim under the False Claims Act.… Continue Reading
The OIG has posted guidance on its contractor self-disclosure program, which provides a means for contractors to self-disclose potential violations of the False Claims Act and federal criminal laws involving fraud, conflict of interest, bribery, or gratuity. The Federal Acquisition Regulation (FAR) requires federal contractors with contracts valued over $5 million to disclose to the … Continue Reading
The OIG published a notice July 11, 2014 announcing that it is considering revising its nonbinding criteria, established in 1997, outlining the circumstances under which the OIG may exercise its permissive authority under Section 1128(b)(7) of the Social Security Act to exclude an individual or entity from participation in the federal health care programs for engaging … Continue Reading
While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies - with potential False Claims Act (FCA) implications.
Specifically, last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act. In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data. With some exceptions, CMS will be making these data public by September 1, 2014. While the publicly-available data are intended to provide more transparency for patients, to allow them to have a better understanding of the financial relationships between physicians and pharmaceutical and medical device companies, patients will certainly not be the only group interested in this public information. It is likely that the Department of Health and Human Services Office of the Inspector General, Department of Justice, and relators' attorneys will utilize these data to initiate investigations and support complaints under the federal FCA.… Continue Reading
The Department of Justice (DOJ) recently announced that it recovered $3.8 billion in settlements and judgments in civil False Claims Act cases in fiscal year (FY) 2013, including health care fraud recoveries totaling approximately $2.6 billion. The DOJ notes that about $1.8 billion in recoveries involved alleged false claims for drugs and medical devices under … Continue Reading
The OIG has issued its Semiannual Report to Congress for the period of April 1 – September 30, 2013, in which it highlights significant investigation, audit, and enforcement activities and achievements across HHS programs. For all of FY 2013, the OIG reports expected recoveries of more than $5.8 billion, consisting of almost $850 million in audit … Continue Reading
The OIG has issued its latest Semiannual Report to Congress, covering the period of October 1, 2012 to March 31, 2013. For the first half of FY 2013, the OIG reported expected recoveries of about $3.8 billion, consisting of more than $521 million in audit receivables and about $3.28 billion in investigative receivables (which includes … Continue Reading
This post was also written by Andrew C. Bernasconi. Yesterday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would dramatically increase the potential reward to an individual who provides a tip leading to the recovery of Medicare funds from a current maximum of $1,000 to a maximum of $9.9 million under … Continue Reading
The OIG has updated its 2006 guidelines on how it determines whether a state false claims act law meets certain federal standards. By way of background, to encourage improved state efforts to fight Medicaid fraud, the Deficit Reduction Act (DRA) enables states that adopt state false claims acts to retain a greater portion of Medicaid overpayments. … Continue Reading
On February 11, 2013, the Obama Administration announced that anti-fraud efforts under the Health Care Fraud and Abuse Control Program (HCFAC) recovered a record-breaking amount of $4.2 billion in FY 2012. More specifically, in 2012 the Justice Department opened 1,131 new criminal health care fraud investigations involving 2,148 potential defendants, and a total of 826 … Continue Reading
The Department of Justice recently announced that it secured a record $4.9 billion in settlements and judgments in civil fraud cases in FY 2012, including health care fraud recoveries totaling more than $3 billion. The Department notes that some of the largest recoveries during the year – representing nearly $2 billion — involved false claims … Continue Reading
On November 27, 2012, the HHS Office of Inspector General (OIG) released its fall Semiannual Report to Congress, which summarizes significant OIG enforcement, investigation, and audit activities for the period of April 1 – September 30, 2012, along with summary information for all of FY 2012. Most notably, the OIG reports approximately $6.9 billion in … Continue Reading
Reed Smith’s Life Sciences Legal Update blog discusses a recent decision by the United States District Court for the Southern District of Ohio that may make it much harder for qui tam relators to rely upon stolen medical records or patient information in False Claims Act (“FCA”) whistleblower actions. In the decision, Cabotage v. Ohio … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a post on the Fifth Circuit’s ruling in United States ex rel. Little v. Shell Exploration & Production Co., in which the Court held that government employees are entitled to bring qui tam actions under the False Claims Act (FCA) – even if their federal job function is … Continue Reading
Providers and suppliers have until April 16, 2012 to comment on the proposed rule to implement provisions of Section 6402(a) of the Affordable Care Act that require “persons” receiving Medicare and Medicaid funds to report and return overpayments no later than 60 days after the date on which the overpayment was identified or, if applicable, … Continue Reading
This post was written by Matthew R. Sheldon and Alexander Y. Thomas. The Second Circuit Court of Appeals is reviewing a lower court decision disqualifying a former in-house attorney from acting as a False Claims Act qui tam relator against his former employer. The relator was formerly general counsel to Unilab, a subsidiary of Quest … Continue Reading
On February 16, 2012, CMS published a proposed rule to implement an ACA provision requiring enrolled providers and suppliers (and certain other enrollees) receiving Medicare funds to report and return Medicare overpayments by the later of 60 days after the date on which the overpayment was identified or, if applicable, the date any corresponding cost … Continue Reading
The Department of Justice (DOJ) has announced more than $3 billion in False Claims Act (FCA) recoveries in FY 2011, including $2.4 billion in recoveries involving federal health care program fraud. The pharmaceutical industry was the source of the largest recoveries — the DOJ reports almost $2.2 billion in civil claims against the pharmaceutical industry in FY … Continue Reading
The OIG has created a central listing of “quality of care” corporate integrity agreements (CIAs) that providers have entered into as a part of False Claims Act settlements resolving allegations of fraud that impact the quality of patient care. The OIG requires that providers under a quality of care CIA retain an independent quality monitor to … Continue Reading
