The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

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DOJ announces $5.5 Million Settlement Concerning Allegations of Undisclosed Grants

On December 19, 2019, the Department of Justice (DOJ) announced that Van Andel Research Institute (VARI) has agreed to pay $5.5 million to resolve allegations that it violated the False Claims Act by submitting grant applications to the National Institute of Health (NIH) without disclosing Chinese government grants for involved researchers. VARI is an independent… Continue Reading
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DOJ Releases FY 2019 False Claims Act Statistics with Numbers that Highlight the Focus on the Healthcare Industry

The U.S. Department of Justice (DOJ) Office of Public Affairs recently released a report detailing the settlements and judgments from civil cases involving fraud and abuse claims obtained in fiscal year 2019.  In total, the DOJ reports that it obtained more than $3 billion during FY 2019, the substantial majority of which ($2.6 billion) involved… Continue Reading
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OIG Issues Advisory Opinion Approving Supermarket Pharmacy Loyalty Program

On December 17, 2019, the Office of Inspector General (OIG) issued an Advisory Opinion regarding a proposed supermarket loyalty program that would have provided customers with rewards points on out-of-pocket costs related to the purchase of pharmacy products. OIG determined that while the proposal would implicate the Federal anti-kickback statute (AKS) and the prohibition on… Continue Reading
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HHS to Ease Fraud and Abuse Rules Part 5: CMS Proposes Value-Based Arrangement Stark Exceptions

As discussed in an Oct. 9 alert, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute and the Civil Monetary Penalties Law. This client alert, the fifth in McGuireWoods’ summary series on these proposed rules, focuses on the Centers for… Continue Reading
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OIG Redesigned Hotline Webpage

The Office of Inspector General (“OIG”) recently launched a new, redesigned hotline webpage to better guide the public through the tip and complaint reporting process. The OIG hotline operations accepts tips and complaints from all sources regarding potential fraud, waste, abuse, and mismanagement in the U.S. Department of Health and Human Services’ (“HHS”) programs. The… Continue Reading
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Updated Civil Monetary Penalties

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to adjust civil monetary penalties for inflation annually. Effective November 5, 2019, the Department of Health and Human Services released updated civil monetary penalties for the regulations its agencies are responsible for enforcing. Below are key changes applicable to healthcare providers. The… Continue Reading
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Changes to CMS’ Conditions of Participation Regulations for Providers Take Effect Nov. 29

Healthcare providers should begin finalizing plans to implement the Centers for Medicare and Medicaid Services’ Omnibus Burden Reductions (conditions of participation) final rule, which becomes effective Nov. 29, 2019. The final rule, issued Sept. 26, 2019, is intended to remove Medicare regulations, contained primarily in providers’ conditions of participation that CMS has identified as unnecessary,… Continue Reading
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HHS to Ease Fraud and Abuse Rules Part 4: Proposed Revisions to the Stark Law

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the fourth in McGuireWoods’ summary series on these proposed rules,… Continue Reading
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HHS to Ease Fraud and Abuse Rules Part 3: Flexibility for EHR Items and Services, Donated Cybersecurity Tech

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. This client alert, the third in McGuireWoods’ summary series on these proposed rules, focuses… Continue Reading
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HHS to Ease Fraud and Abuse Rules Part 2: Civil Monetary Penalty Law Changes, In-Home Dialysis Telehealth

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services (HHS) announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the second in McGuireWoods’ summary series on these proposed… Continue Reading
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HHS to Ease Fraud and Abuse Rules Part 1: Proposed Revisions to Existing Anti-Kickback Statute Safe Harbors

As discussed in a previous McGuireWoods alert, on Oct. 9, 2019, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. This client alert, the first in McGuireWoods’ summary series on these proposed rules,… Continue Reading
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HHS Proposed Rules Seek to Remove Stark Law, Anti-Kickback Burdens on Providers

On Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. The proposed rules intend to further incentivize value-based arrangements and patient care coordination by expressly permitting certain activities that could… Continue Reading
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OIG Releases Its 2019 Top Recommendations for Health and Human Services Department to Reduce Fraud

Last month, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) released its annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Recommendations. This publication outlines the OIG’s top 25 unimplemented recommendations that, in OIG’s view, would most positively affect HHS programs in terms of cost… Continue Reading
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“Health Care Fraud Impacts Everyone”: Miner Emphasizes DOJ’s Ongoing Dedication to Combatting Fraud

Matthew S. Miner, Deputy Assistant Attorney General of the Criminal Division at the U.S. Department of Justice, gave the keynote speech at the 29th Annual National Institute of Health Care Fraud, held in New Orleans, LA. In his speech, Miner, who supervises the Criminal Division’s Fraud and Appellate Sections, emphasized the DOJ’s continued commitment to… Continue Reading
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Diligence and Documentation in Private Equity Healthcare Transactions — Five Key Points

The healthcare private equity market continues to see high transaction multiples and unprecedented competition for transactions. These trends, along with continued growth in False Claims Act or qui tam cases, create interesting dynamics for investors performing diligence and documenting transactions, as discussed during a panel presentation at McGuireWoods’ 6th Annual Healthcare Litigation and Compliance Conference on… Continue Reading
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HHS “Sprints” Toward New AKS Safe Harbors and Penalty Exceptions

The U.S. Department of Health and Human Services (HHS) has launched its “Regulatory Sprint to Coordinated Care” to accelerate the healthcare system’s transformation to a value-based system rewarding coordinated care. This “regulatory sprint” focuses on identifying regulatory provisions that may act as unnecessary obstacles to coordinated care and issuing guidance to address such obstacles. Specifically,… Continue Reading
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DOJ Memorandum Sets Out FCA Dismissal Factors

A January 10 internal memorandum from the director of the fraud section of the DOJ’s civil division commercial litigation branch, which has recently become public, sets out the factors the government should consider in dismissing False Claims Act (FCA) cases in which it has declined to intervene, and may suggest a greater possibility that the… Continue Reading
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Pleading with Particularity: Sixth Circuit Upholds Stringent Pleading Requirements in FCA Cases

In an effort to avoid transforming the FCA into “an all-purpose antifraud statute,” the Sixth Circuit recently reaffirmed that relators must plead a connection between the alleged fraud and an actual claim made to the government.  The Sixth Circuit’s decision in United States ex rel. Ibanez v. Bristol-Myers Squibb confirms the long-held rule that absent… Continue Reading
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Seventh Circuit Looks to “Separate the Wheat from the Chaff” by Adopting a New FCA Causation Test

In United States v. Luce, the Seventh Circuit overturned a two-decade precedent by holding that proximate causation, and not “but for” causation, was the proper standard to employ in FCA cases.  In so holding, the Seventh Circuit undid the 25-year circuit split it had created through use of “but for” causation in FCA cases. In Luce, the… Continue Reading
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Holding Executives Personally Responsible: An Increasing Government Priority

Earlier this month, we covered the Spectocor action which involved an executive and his company’s agreement to pay $10.56M of a $13.45M total settlement to resolve allegations involving medically unnecessary Medicare reimbursements. In another stark reminder that the Department of Justice has increased its focus on individual liability for corporate executives, as per the directive… Continue Reading
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New CMS Guidance on Inpatient Engagement Necessary for Hospital Certification

On Sept. 6, 2017, the Centers for Medicare and Medicaid Services (CMS) issued an advanced copy of guidance to state survey agency directors that is intended to clarify how to determine whether a hospital seeking Medicare certification, or going through a continuing certification survey, is “primarily engaged in providing inpatient services” under the Social Security… Continue Reading

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