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Getting Started with E-Rate

Public schools and libraries in the U.S. can save a lot of money on Internet service by applying for the Schools and Libraries Program, a federal subsidy better known as E-Rate. E-Rate funding, capped yearly at $3.9...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

Senator Tom Carper Questions Office Of Management And Budget Regarding Emerging Cybersecurity Technologies

On April 8, 2016, U.S. Senator Tom Carper, the ranking Democratic member of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to Shaun Donovan, Director of the Office of Management and Budget...more

DoD Proposes Cost Allowability Rule for Correcting Counterfeit Electronic Parts

The Department of Defense (“DoD”) recently proposed to make specified costs allowable that are associated with discovering and correcting counterfeit or suspect counterfeit electronic parts. DoD’s proposed rule would amend...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Health Care E-Note - April 2016

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurses, technicians, staff, management,...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Abbott Laboratories Prevails in False Claims Act Case

On April 7, 2016, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...more

Appeals Court Confirms that HITECH Violations Do Not Violate FCA

In an important recent decision, the Sixth Circuit Court of Appeals confirmed that a qui tam relator's claim that her former husband improperly accessed electronic protected health information (e-PHI) of her and her relatives...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

340B Proposed Pricing Rule Reopened for Comment: Penny Pricing, New Drug Pricing and Definition of “Knowing and Intentional” Back...

On Monday, April 18, the Health Resources and Services Administration (“HRSA”) published a Notice reopening comment on its June 17, 2015 Proposed Rule regarding 340B pricing and manufacturer civil monetary penalties....more

Data Rights Under Federal Government Contracts: What Are Data rights?

Data rights under federal government contracts create confusion from both the government and the contractor perspectives. There is substantial misunderstanding as to the purpose of the data rights regulations and the limits...more

Sixth Circuit Affirms Dismissal of FCA Claim Based on Health Data Breaches

The U.S. Court of Appeals for the Sixth Circuit recently affirmed the dismissal of a False Claims Act (FCA) case premised on protected health data breaches. In United States ex rel. Sheldon v. Kettering Health Network, the...more

SBA’s New Itvar Size Rule

OVERVIEW - - History and proposed changes to SBA’s ITVAR size rule - What is SBA’s new ITVAR size rule? - Understanding the nonmanufacturer rule and waivers - What should ITVARs do now Please see...more

CMS Delays Effective Date for “5i AMP” Provision in Medicaid Outpatient Drug Final Rule

On March 31, 2016, CMS announced that it was delaying the April 1, 2016 effective date for manufacturers to calculate the average manufacturer price (“AMP”) for the so-called “5i-drugs” – i.e., inhalation, infusion,...more

In 10-1 Verdict, Jury Finds No FCA Violation by Abbott Laboratories

On April 7, 2016, after just three hours of deliberations following a three-week trial, a federal jury dismissed False Claims Act (“FCA”) claims against Abbott Laboratories brought by a whistleblowing former employee.  The...more

Why less means more for PPPs & data – Keys to collecting the right information in Canada

PPP projects have the potential to generate huge amounts of data. In the context of a tolled highway project, for instance, a PPP contract may require the private operator to collect, in real time, information regarding...more

Health Care Update - April 2016

FDA Reform Tops Spring Work Period Agenda - The next work period basically runs from April 4 to May 27, with a both chambers adjourning for a week long recess the week of May 2nd. Following this work period, there will...more

DoD Reveals its Cybersecurity Discipline Implementation Plan (or How 1940s War Department VD Training Can Help Your 21st Century...

“If our country is to successfully defend our right to live the American way, it needs every one of you, and requires you in the best possible condition. Any [company] who willfully, or through neglect fails to maintain...more

CMS Issues Proposed Rule to Establish a Medicare Part B Drug Pricing Demonstration

On March 11, 2016, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that establishes a demonstration to test alternative drug payment approaches under the Medicare Part B...more

Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a...more

Sixth Circuit Rules That EHR Security Breaches Do Not Violate False Claims Act

On March 7, 2016, the Sixth Circuit Court of Appeals ruled that security breaches of individual electronic health records (“EHRs”) do not violate the HITECH Act and cannot support False Claims Act allegations. ...more

Health Law Insights Newsletter - Issue 7 - March 2016

McCarter & English, LLP’s Health Care Group presents Issue 7 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Providers’ Obligation to Report Medicare...more

New Tech, Old Rules: 6 Tips For Tech Cos. Managing FCA Risk

When it was first enacted in 1863, the original purpose of the False Claims Act was to prosecute war profiteers who were selling sick mules and broken muzzle-loaded rifles to the Union Army. In recent years, its use has...more

US Ignite Announces up to $10 Million in Funding for Gigabit Applications

On March 18, 2016, the National Science Foundation (NSF) released a solicitation for up to $10 million for US Ignite: Networking Research and Application Prototypes Leading to Smart and Connected Communities, which funds the...more

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