Health Antitrust & Trade Regulation

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Health Update - May 2016

Actions to Advance Infant and Early Childhood Mental Health - Editor's Note: Children's earliest experiences—both positive and negative—impact their brain formation and in turn their social and emotional, physical,...more

Legal Issues Associated with Multi-Provider Alternative Payment Model

Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...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

Unacceptable Geographic Market Definition Dooms FTC Effort to Enjoin Hospital Merger; Will Affordable Care Act Goals Create New...

A Pennsylvania federal district judge recently denied injunctive relief that would have blocked a merger between Penn State Hershey Medical Center and PinnacleHealth System. The Court’s denial of injunctive relief was built...more

District Court Blocks FTC and PA AG Challenge to Hershey-Pinnacle Merger

On May 9, 2016, the US District Court for the Middle District of Pennsylvania denied the motion by the Federal Trade Commission (FTC) and Pennsylvania Office of Attorney General (together, the agencies) for a preliminary...more

The Penn State Hershey–Pinnacle Merger: A Turning Point in FTC’s Enforcement Authority, or Just a Temporary Setback?

As we have reported previously, the Federal Trade Commission recently has taken an aggressive stance in regulating mergers in the healthcare sector. The Commission has racked up a string of victories, but last week the...more

OIG Issues Favorable Advisory Opinion Regarding Proposed Ownership Structure of Group Purchasing Organization

On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more

District Court Denies Preliminary Injunction in FTC Challenge to Merger of Pennsylvania Hospitals

On May 9, 2016, Federal District Court Judge John E. Jones III denied a motion by the U.S. Federal Trade Commission (FTC) for a preliminary injunction blocking the consummation of a merger between the Penn State Medical...more

FTC Suffers Setback in Campaign to Slow the Rising Tide of Healthcare Consolidations

The FTC just suffered a major setback in its concerted efforts to challenge the ever growing number of consolidations in the healthcare industry, failing to secure a preliminary injunction to block a hospital merger in...more

A Sweet Win for Hershey Medical Center's Proposed Merger: District Court Denies FTC's Attempt to Block Pennsylvania Hospital...

The district court’s decision may mark a turning point away from purely formulaic reliance on the FTC’s preferred approach and the testimony of self-interested payers....more

FTC Granted 2-Week Reprieve in Effort to Block Pennsylvania Hospital Merger

The Federal Trade Commission (“FTC”) and the state of Pennsylvania have two weeks to persuade the Court of Appeals for the Third Circuit that the pending merger of Penn State Hershey Medical Center (“Hershey”) and Pinnacle...more

Federal Judge Refuses FTC Request to Block Hershey/Pinnacle Deal; FTC to Appeal

Hospitals and other providers who have been tracking Federal Trade Commission (FTC) and Department of Justice Antitrust Division hospital merger challenges over the last several years will want to take note of the federal...more

Federal Court Relies on “Evolving Landscape of Health Care” Post-Affordable Care Act to Reject FTC Challenge to Hospital Merger

Judge takes “the healthcare world as it is, and not as the FTC wishes it to be.” “We find it no small irony that the same federal government under which the FTC operates has created a climate that virtually compels...more

FTC Enters into Consent Agreement Regarding Company's Use of Exclusive Contracts

The Federal Trade Commission (FTC) recently announced that Invibio, which sells high-performance polymer for medical implants, has settled charges that the company monopolized sales to medical device makers through unlawful...more

FTC Weighs-in on Telehealth: Providing Comments Regarding Alaska’s Proposed Licensure and Standard of Care Requirements

In March 2016, the US Federal Trade Commission (“FTC”) staff submitted public comments regarding the telehealth provisions of a proposed state bill in Alaska demonstrating the FTC’s continued focus on health care competition...more

FTC Finally Loses a Hospital Merger Challenge … Now What?

Handing the Federal Trade Commission (FTC) its first defeat in a federal court hospital merger challenge in more than a decade, a federal district court judge yesterday denied the joint request of the FTC and the Attorney...more

Proposed West Virginia Hospital Merger Could Have Nationwide Effects

West Virginia recently passed legislation aimed at shielding an in-state hospital merger from antitrust review by the Federal Trade Commission, and if the West Virginia Health Care Authority and West Virginia Attorney General...more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...more

Health Alert (Australia) - May 9, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: JUDGMENTS Commonwealth. Federal Court 29 April 2016 - Australian Competition and Consumer Commission v Reckitt...more

Did drug maker fuel abuse by insisting that OxyContin works for 12 hours?

OxyContin in two decades not only has become a highly profitable, exceedingly popular prescription, it also has become one of the nation’s most abused painkillers-for a crucial reason, the Los Angeles Times says. The paper...more

Breaking: Third Circuit Dismisses Antitrust Suit Concerning Marketing of Lovenox

Earlier today, the Third Circuit Court of Appeals upheld the decision of the District of New Jersey trial court dismissing the antitrust claims lobbed against Sanofi-Aventis by its rival pharmaceutical company Eisai. The...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – May 2016

Special Focus on “Safe Harbor 2.0,” Privacy Shield and E.U. Data Transfers: Alston & Bird’s privacy team has been closely following the development of Privacy Shield, the proposed successor to the E.U.-U.S. Safe Harbor...more

Tobacco Cases Expose Tension Between Antitrust and Public Health

A recent decision of the European Court of Justice (“ECJ”) regarding the sale of tobacco products highlights a long-standing tension between two sets of laws: antitrust/competition laws, which seek to keep products affordable...more

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a...more

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

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