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2015 National Defense Authorization Act Requires New Cyber Breach Reporting - "Operationally Critical Contractors" Are Required to...

Congress passed the Carl Levin and Howard P. "Buck" McKeon National Defense Authorization Act for Fiscal Year 2015 (NDAA or Act) on Dec. 12, 2014. The NDAA for 2015 creates a new cyber breach reporting requirement affecting...more

Cybersecurity Monday: Who Is Shopping for Your Data?

At this time of year, everyone is shopping for a good bargain. And with “Cyber Monday,” the internet has become the place to go for the best deals. The shift to online and cloud-based information systems and data storage has...more

SBIR/STTR Policy Directive Update: What’s Ahead for Data Rights

On November 7, the Small Business Administration (SBA) released an advanced notice of Policy Directive amendments and a request for comment on revisions to Small Business Innovation Research (SBIR) and Small Business...more

California Environmental Law and Policy Update - November 2014 #3

Environmental and Policy Focus: New dust control method ends L.A.'s longtime feud with Owens Valley: Los Angeles Times - Nov 14: The City of Los Angeles ended a bitter dispute with Owens Valley on Friday with the...more

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

Weekly Update Newsletter - December 2014 #1

GOVERNMENT CONTRACTS - DoD, GSA, and NASA Issue Proposed Rule to Amend FAR, Information on Corporate Contractor Performance and Integrity - The Department of Defense (DoD), General Services Administration (GSA),...more

Cyber-Breach & NISPOM Conforming Change 2 – It’s What’s on the Inside That Counts

Most companies are worried about external threats – things that are coming at their people, their group, their company, their government, all from an outside actor. Like government’s with an eye on counter-intelligence,...more

Shopping for the Cloud Made Easy – GSA’s Special Item Number Project for Cloud Computing and Request for Comments

On November 18, 2014, the General Services Administration (“GSA”) hosted an Industry Day seeking feedback on its proposal to add a Cloud Computing Special Item Number (“SIN”) on its IT Multiple Award Schedule 70 (“MAS...more

Seventh Circuit Holds Pharmacy Billing Medicaid For Drug Prices Above Private Rates Is Not Fraudulent

On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...more

Maryland Jurisdictions Expanding P3 Strategies Despite Political Uncertainty

Despite perceived uncertainty as to the future of two, prominent transportation P3 projects, it appears that jurisdictions within Maryland are looking to P3 structures to solve a wider array of infrastructure issues in the...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more

"U.S. v. Novartis: Reaffirming the Importance of Updating and Adhering to Corporate Policies"

A recent decision in a false claims act case, United States ex rel. Bilotta v. Novartis Pharmaceuticals Corporation (Novartis), underscores the importance of policing employee adherence to corporate policies and industry...more

Intro to Cybersecurity Framework: New Mandatory NIST Standards for Government Contractors?

Cybersecurity remains one of the most important and least understood issues of the day. Last week, the National Institute of Standards and Technology (NIST) hosted a workshop in Tampa, Florida, to receive private sector...more

Stanford University v. Roche Molecular Systems, Inc.’s Impact on Government Contracts

A decision by the Supreme Court of the United States on June 6, 2011 has a great impact on the interpretation of the Bayh Dole Act as well as assignment of contracts relating not just to the Bayh Dole Act but to assignments...more

White Collar Watch - October 2014

In This Issue: - Government demonstrates willingness to enforce Affordable Care Act provision that could cost providers millions of dollars - Words can come back to haunt you: Boilerplate pleading could lead...more

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Certifications Under the Trade Agreements Act: 10 Tips to Avoid TAA Traps for the Unwary

On September 3, 2014, U.K.-based medical device maker Smith & Nephew (the ‘‘Company’’) agreed to pay $8.3 million (plus an additional $3 million in attorney’s fees) to resolve a lawsuit filed under the federal civil False...more

$840 Million Available to Drive Practice Transformation

After a fairly quiet year in terms of new funding announcements, the Center for Medicare and Medicaid Innovation (CMMI) has released an $840 million solicitation that seeks to drive 150,000 clinicians toward delivering...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

New York Specialty Pharmacy Settles FCA Case

On October 9, 2014, New York’s Attorney General Eric T. Schneiderman announced an $846,000 settlement with New York specialty pharmacy Sorkin’s Ltd Rx. d/b/a CareMed Pharmaceutical Services (“Sorkins”) to resolve allegations...more

Third Circuit Tightens “Original Source” Requirement for Whistleblowers

Back in 2003 Karl Schumann filed a whistleblower suit alleging that as an executive with benefits company Medco, he learned that Bristol-Myers Squibb and AstraZeneca paid kickbacks to Medco to buy and recommend brand name...more

Patent Rights in Government Contracts

Patents are often a company’s most important asset. Thus, when a company is contracting with the federal government, that company needs to proceed with caution to avoid loss of patent rights. Government contracts can cover...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Federal and New York State False Claims Act Case Against Novartis Survives Motion to Dismiss

Last week, a New York district court found that the government alleged with sufficient detail that Novartis violated federal and state false claims acts by paying doctors kickbacks to prescribe drugs. See U.S. ex rel. Bilotta...more

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