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Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

Second Circuit Affirms Dismissal of Qui Tam Case Based on Attorney’s Use of Confidential Information

The US Court of Appeals for the Second Circuit recently affirmed the decision of the District Court for the Southern District of New York to disqualify Fair Laboratory Practices Associates (FLPA) from its qui tam suit against...more

McKesson settles with Virginia for $37 million over allegations of inflating Medicaid drug prices

After the State of Virginia declined to participate in a July 2012 settlement that McKesson reached with 29 states over allegations of federal and various state False Claims Act violations, the company has agreed to pay...more

Will Usual and Customary Price be the Next False Claims Act Battleground?

Recently, a federal judge held that a qui tam relator’s allegations that a pharmacy routinely reported falsely inflated “usual and customary” prices for generic medications in claims submitted to federally funded health care...more

The Cybersecurity Framework: Administration, Congress move to incentivize private-sector cooperation, strengthen federal...

The White House has announced its eight preliminary incentives to encourage private sector owners and operators of critical infrastructure (CI) to adopt the final Cybersecurity Framework, now under development by the...more

PODs Beware: OIG Releases Special Fraud Alert

The Office of the Inspector General (OIG) released a Special Fraud Alert on March 26, 2013 warning that physician-owned distributorships (PODs) are "inherently suspect" under the Anti-Kickback Statute (AKS). Generally...more

OIG Unveils Updated Self-Disclosure Protocol

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

OIG Updates Provider Self-Disclosure Protocol

On April 17, 2013, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a revised Provider Self-Disclosure Protocol (SDP) that clarifies the process for healthcare providers, suppliers...more

340B Drug Pricing Program: Recent Developments

The 340B Drug Pricing Program (340B Program) continues to undergo a period of intense scrutiny and debate over how compliance with program rules is enforced. As previously reported in the May 30, 2012 edition of Foley’s Legal...more

CMS to Deny Claims When Ordering/Referring Provider Not Enrolled in Medicare

Effective May 1, 2013, the Centers for Medicare & Medicaid Services (CMS) will begin to deny Part B Durable Medical Equipment (DME) and Part A Home Health Agency (HHA) claims for services or supplies when the...more

Big Changes Are Happening With the 340B Drug Program

Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more

Are Compliance Officers Getting Paid Their Worth?

The NAVEX Global-sponsored 2012 SCCE (Ethics & Compliance Industry) Salary Survey was released this week (download report). In the executive summary, SCCE CEO Roy Snell highlights the necessity that the broader industry has...more

Health Care Enforcement in 2012: A Year in Review

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

10 Fraud and Abuse Enforcement Trends You Can't Afford to Ignore in 2013

To paraphrase a famous quote, "Those who do not learn from history are doomed to repeat it," and providers who ignore the significance of the federal government's healthcare fraud enforcements efforts in 2012 do so at their...more

Health Reform + Related Health Policy News Update - February 6, 2013

In This Issue: - Top News ..CMS Announces Round 2 Competitive Bidding Single Payment Amounts ..CBO Lowers SGR Repeal Cost by $100 Billion ..Republicans Press HRSA on 340B Audits ..HHS Proposes...more

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