Tag Archives: False Claims Act

DOJ Settles Second 60-Day Overpayment Case, Highlights Broader Reach of the FCA’s Reverse False Claims Provision

A recent False Claims Act (“FCA”) settlement involving an allegedly overpaid Florida medical practice reaffirms the interplay between the 60-Day Overpayment Statute and the FCA, but also highlights the importance for all providers and suppliers to report and return overpayments, regardless of the source of federal funds. According to the Department of Justice (“DOJ”), First … Continue Reading

Regulatory Freeze Notwithstanding, Trump Administration Increases Health Fraud CMPs

The Department of Health and Human Services (HHS) is once again applying an inflation increase to maximum civil monetary penalty (CMP) amounts for HHS agencies and programs – less than five months after the last inflation hike and notwithstanding the Trump Administration’s recently-announced regulatory freeze.  Specifically, in a final rule to be published on February … Continue Reading

OIG Semiannual Report Highlights FY 2016 Fraud Recoveries, Enforcement Actions

The HHS Office of Inspector General’s (OIG) latest Semiannual Report to Congress highlights top audits, investigations, and enforcement activities for the period of April 1 to September 30, 2016 and summarizes overall accomplishments for fiscal year (FY) 2016. Notably, the OIG reports: Expected FY 2016 recoveries will exceed $5.66 billion, including nearly $1.2 billion in audit … Continue Reading

Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives

Observers are digesting what the Trump Administration will mean for the health care and life sciences industry.  Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues.  Today President-elect Trump’s transition team released … Continue Reading

HHS Inflation Adjustment Rule Hikes CMPs Across Department Programs

The Department of Health and Human Services (HHS) is increasing maximum civil monetary penalty (CMP) amounts applicable to HHS agencies and programs, in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (which was part of the Bipartisan Budget Act of 2015).  The magnitude of the individual CMP increases varies depending … Continue Reading

Bigger Apparently is Better in DOJ’s Eyes – DOJ Piles On as False Claims Act CMPs Set to Almost Double on August 1, 2016

Today the Department of Justice published an interim final rule with request for comments that applies an inflation adjustment to civil monetary penalty (CMP) amounts assessed by the Department, as mandated by the Bipartisan Budget Act of 2015.  Notably, the new maximum CMP for False Claims Act (FCA) violations under 31 U.S.C. 3729(a) is $21,563, … Continue Reading

OIG Spring 2016 Semiannual Report to Congress Highlights Enforcement/Investigative Accomplishments

The OIG has issued its Spring 2016 Semiannual Report to Congress, which describes significant enforcement and investigative activities relating to HHS programs during the first half of FY 2016 (October 1, 2015 – March 31, 2016). The OIG reports expected recoveries of more than $2.77 billion ($554.7 million in audit receivables and about $2.22 billion … Continue Reading

Recent Congressional Health Policy Hearings

A number of recent Congressional hearings have focused on health policy topics, including the following: A House Energy and Commerce Subcommittee on Health hearing on “Medicare Access and CHIP Reauthorization Act of 2015: Examining Physician Efforts to Prepare for Medicare Payment Reforms.” A House Judiciary Constitution and Civil Justice Subcommittee hearing on oversight of the False … Continue Reading

DOJ Reports $1.9 Billion in Health Care False Claims Recoveries in FY 2015

The U.S. Department of Justice (DOJ) recently reported $3.5 billion in settlements and judgments from civil cases involving fraud and false claims in FY 2015 – $1.9 billion of which came from companies and individuals in the health care industry. DOJ notes that the $1.9 billion reflects only federal recoveries; in many cases, there were … Continue Reading

OIG Issues Fall 2015 Semiannual Report to Congress

The HHS Office of Inspector General (OIG) has issued its Semiannual Report to Congress covering April 1 – September 30, 2015. The report summarizes significant OIG audits, investigations, and enforcement activities during this period and includes key accomplishments for the full fiscal year (FY) 2015. According to the report, the OIG expects recoveries of about … Continue Reading

Bipartisan Budget Act Jacks Up Civil Monetary Penalties Under the Social Security Act and False Claims Act Penalties

The Bipartisan Budget Act of 2015 (H.R. 1314), signed into law by President Obama November 2, 2015, will increase the civil monetary penalties (CMPs) imposed under the Social Security Act (SSA) in addition to False Claims Act (FCA) penalties (among other civil penalties).  Under an innocuous-sounding provision, entitled “Civil monetary penalty inflation adjustments,” the budget … Continue Reading

Yates Memo Promises to be a Game-Changer for Health Care Executives

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

DOJ Win on ACA 60-Day Overpayment Rule in Kane v. Healthfirst FCA Case

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

OIG Releases Medicaid Fraud Control Units Fiscal Year 2014 Annual Report

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

OIG Issues Fall 2014 Semiannual Report to Congress

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

HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

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

OIG Self-Disclosure Program for Federal Contractors

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

OIG Seeks Input on Potential Revisions to its Permissive Exclusion Criteria

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

Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

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

DOJ Touts $3.8 Billion in FY 2013 False Claims Act Recoveries

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

OIG Issues Fall 2013 Semiannual Report

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

Proposed Rule Would Reward Medicare Fraud Tipsters up to $9.9 Million, Revise Medicare Provider Enrollment Regulations

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
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