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Health Alert (Australia) July 11, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth 30 June 2016 - Prain v Comcare[2016] AATA 459 In early 2011, Mrs Prain accepted a position at...more

Senate Committee Releases Report on Potential Stark Law Changes, Hearing Scheduled

On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law,...more

Injunction Enjoining Enforcement of HHS Attestation Rule Affirmed

The Court of Appeals for the District of Columbia affirmed the District Court’s decision in Central United Life v. Burwell on July 1, 2016. This decision is very significant for those assessing the future strength of, and...more

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

Court Declines to Prevent Merger of Washington Medical and Recreational Marijuana Markets

Over the last year, the Washington state marijuana industry has anticipated the transition from an unregulated medical marijuana market to an integrated, medical-recreational market on July 1, 2016, under the Cannabis Patient...more

DOJ Rule Increases FCA Penalties to Over $20,000 Per Claim

Effective August 1, 2016, the False Claims Act’s (FCA) civil penalty will double.  As it currently stands, the FCA’s civil penalty ranges from $5,500 to $11,000 per violation.  But as of August 1, the FCA’s civil penalty...more

Hospice Requests Supreme Court Review of Medicare Hospice Annual Cap

On June 8, 2016, Southeast Arkansas Hospice, Inc. (SEARK) filed a petition for a writ of certiorari to the Supreme Court to review an Eighth Circuit decision that upheld the annual Medicare payment cap for hospice services. ...more

Hospital Mergers: Is the FTC’s Winning Streak Over?

Following a winning streak dating back to its 2007 win in Evanston, the Federal Trade Commission (FTC) has suffered two losses over the last month in two of its three pending hospital merger challenges. On June 14, 2016, a...more

FTC Loses Another Hospital Merger Challenge

On June 14, 2016, Illinois federal judge Jorge L. Alonso denied the Federal Trade Commission (FTC) and state regulators’ efforts to block the merger of Advocate Health Care (Advocate) and NorthShore University Health System...more

Health Alert (Australia) June 20, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales 17 June 2016 - Mace v Justice and Forensic Health Network; The Geo Group Australia Pty Ltd v AAI...more

Second Circuit Affirms Dismissal of False Claims Act Suit Based on “Off-Label” Marketing

The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more

FTC Suffers Another Hospital Merger Loss in Advocate-NorthShore

On Tuesday, June 14, 2016, the U.S. District Court for the Northern District of Illinois declined to temporarily block the proposed merger of Advocate Health Care Network and NorthShore University HealthSystem in the Chicago...more

Federal Trade Commission Suffers Setback in Major Hospital Merger Case

On Tuesday, June 14, 2016, U.S. District Judge Jorge Alonso of the Northern District of Illinois declined to grant the Federal Trade Commission (FTC) a preliminary injunction to temporarily stop a merger between Downers...more

Court Halts FTC’s Bid to Block Chicago-Area Hospital Merger

On June 14, 2016, in FTC v. Advocate Health Care et al., No. 15-cv-11473, the District Court for the Northern District of Illinois denied the Federal Trade Commission’s attempt to stop the merger of Advocate Health Care...more

Court Orders Cigna to Pay Out-of-Network Surgical Claims

On June 1, 2016, the United States District Court for the Southern District of Texas ordered Cigna to pay nearly $13.7 million to Humble Surgical Hospital, LLC (“Humble”). Of the nearly $13.7 million, almost $11.4 million...more

Medical Litigation Newsletter - Spring 2016

Reducing Monetary Recovery in “Lost Chance Of [Medical] Recovery” Cases - In medical malpractice cases involving solely “iatrogenic” loss (e.g., harm of or relating to medical treatment), plaintiff bears the burden of...more

A Recent Illinois Decision Explains How to Deal with Medical Staff Claims

The Illinois Supreme Court released a decision on May 19, 2016 that provides useful guidance in defending and protecting a claim by a medical staff member against a hospital for improperly failing to appoint or reappoint or...more

FTC Wins Stay of Pennsylvania Hospital Merger Pending Appeal in Third Circuit

The Third Circuit granted on Tuesday the Federal Trade Commission’s (“FTC”) request for an injunction pending appeal of the proposed merger between Penn State Hershey Medical Center and Pinnacle Health System. The injunction...more

New ADA and GINA Wellness Regulation Changes Complicate Wellness Program Compliance Analysis and Risks

Wellness programs should all be reviewed considering the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”) regulatory changes because noncompliance with the new requirements do...more

Court Finds Faulty Funding Provisions in Affordable Care Act Affect Low-Income Affordability Provisions

On Thursday, May 12, 2016, a federal district court judge ruled against the Obama administration, finding that no appropriations have been made to fund payments under Section 1402 of the Affordable Care Act to reimburse...more

Judge rules HHS can't pay cost-sharing subsidies to QHPs, but allows funding to continue

More than six years after the Affordable Care Act (ACA) was enacted, legal challenges continue to thread their way through the judicial system. In a May 12, 2016 decision, US District Court Judge Rosemary M. Collyer, an...more

FTC Loses Pennsylvania Merger Challenge in District Court and Seeks Emergency Appeal to Third Circuit

On May 9, 2016, a Pennsylvania federal judge denied efforts by the Federal Trade Commission (FTC) and state regulators to block the merger of Penn State Milton S. Hershey Medical Center (Hershey) and Pinnacle Health System...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Surprising Result in Supreme Court Contraceptive Decision

The U.S. Supreme Court issued an unusual decision in the latest legal challenge to the Affordable Care Act (ACA) to reach the high court. In Zubik v. Burwell, the Court consolidated appeals filed by religious nonprofit...more

House Republicans Win Challenge to ACA Cost-Sharing Subsidies

On May 12, 2016, the U.S. District Court in Washington, D.C. ruled in favor of House Republicans, concluding that the government wrongly spent billions reimbursing insurance companies for providing discounted health coverage...more

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