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The Oman Update - 1162

Amending MD 174/2014 Issuing the regulations on the work of establishments and companies that operate in contracting. Issued on 31 August 2016. Effective from the day after the date of publication....more

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more

Florida Federal District Court Dismisses Plaintiff’s Qui Tam Action Against Hospice Providers

On September 22, 2016, the United States District Court for the Middle District of Florida granted defendant hospice providers’ motions to dismiss plaintiff-relator’s claims under the False Claims Act, Florida’s False Claims...more

Antitrust-Related Recent Developments: FTC/DOJ Aggressive Merger Enforcement Continues

The Federal Trade Commission and Department of Justice have continued their aggressive stance against proposed mergers that the antitrust agencies perceive as harmful to competition. So far this year, the FTC obtained a...more

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron...more

Top Ten Things To Know About California's Proposition 64

The Basics: Prop. 64 is a voter-initiated statute legalizing nonmedical use/possession of 1 oz. or less of loose marijuana and up to 8 grams of marijuana products for those 21 and older. It also legalizes personal cultivation...more

OIG Updates Corporate Integrity Agreement Independent Review Organization Guidance

The OIG has updated its guidance for providers under Corporate Integrity Agreements regarding the circumstances that might affect the independence and objectivity of independent review organizations (IROs). ...more

Under the Dome: Inside the Maine State House

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Community Health Options to Focus on Maine by Leaving New Hampshire In 2017, New Hampshire...more

DMEPOS Bidding Round 1 2017 Single Payment Amounts Announced

CMS has announced the single payment amounts for Round 1 2017 of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) competitive bidding program. As previously reported, this round...more

3 Essential Steps For Responding To Ransomware Attacks

Likely because most victims comply with their demands, the incidence of attacks by ransomware hackers has exploded in 2016. Guidance issued by the U.S. Department of Health and Human Services (“HHS”) in July notes that, on...more

FDA Announces Public Hearing on Manufacturer Communications Regarding Off-Label Uses

On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices, particularly...more

Eleventh Circuit Finds Mere Existence Of Insurance Contract Satisfies Condition Precedent To Action For Double Damages Under The...

The Eleventh Circuit Court of Appeals recently held that a private insurance company/PART C Medicare Advantage Organization (MAO) may sue a Personal Injury Protection (PIP) insurance carrier for reimbursement of medical...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

[Webinar] Health Care Construction Projects: Avoiding Claims Through Better Coordination - September 21st, 12:00pm EDT | 9:00am...

In January of this year, following frantic talks and a public fight over who was to blame for delays costing close to $100,000 a day in lost revenue, Santa Clara County was finally able to reach an agreement and settle its...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Compounding Pharmacy’s Group Boycott Claim Survives Motion to Dismiss

On August 23, 2016, the District Court for the Eastern District of Missouri allowed claims by a compounding pharmacy to proceed, denying a motion to dismiss filed by the defendant pharmacy benefit manager (“PBM”). In...more

Top Trends in H1 2016 Digital Health Investments

A few months ago, following our fifth annual Digital Health Summit, the attendees made some predictions about product development and investment in the rapidly growing sector. Now that we are more than halfway through the...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Healthcare Compliance: Juggling Risk Mitigation Strategies

Healthcare organizations – ranging from physician practice groups to large, multi-state hospital systems – face a variety of risks, including fraud and abuse, as well as HIPAA privacy issues. Starting from a baseline risk...more

Corporate E-Note - August 2016

In a “Table of Experts” series published on July 15, 2016 by the Birmingham Business Journal, Ed Christian provides his insight into a series of questions related to mergers and acquisitions. Please see full E-note below...more

US Supreme Court False Claims Act Decision in Escobar Has Significant Implications for Contractors

On June 16, 2016, the U.S. Supreme Court ruled in the matter of Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016), changing the legal landscape for False Claims Act qui tam claims...more

Locky Ransomware Continues to Hit Health Care Entities

FireEye Labs has reported that the Locky ransomware continues to hit the health care industry hard, and has increased in the month of August. Although the telecommunications, manufacturing and aerospace/defense...more

11th Circuit Awards Humana Double Damages Under Medicare Secondary Payer Act

Humana Medical Plan, Inc. v. Western Heritage Insurance Co., case number 15-11436. Liability insurers beware, as the 11th Circuit held that Medicare Advantage Organizations (MAO) are entitled to the same rights...more

No Resuscitation of Hospital’s Exclusive Dealing Antitrust Suit against Competing Hospitals and Physicians

The Third Circuit reminds, “[i]n antitrust suits, definitions matter.” Last week, in applying that maxim, the court affirmed a lower court’s dismissal of a suit filed by a hospital against a competing hospital and physician...more

Changes in Cuba May Impact the Insurance Industry

While much remains to be determined, the recent easing of U.S. restrictions on travel to and trade with Cuba may bring opportunities for U.S. and global insurance companies. However, many questions and obstacles remain. This...more

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