Health Antitrust & Trade Regulation

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Managing the Transition to Transformation: Antitrust Considerations When Forming Provider Contracting Networks

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

Aetna and Humana Go to Battle With Regulators Over Multi-Billion Dollar Merger

The trial over Aetna and Humana's $37 billion proposed merger kicked off today in a Washington, D.C. federal court. At issue is whether the companies' merger would substantially lessen competition in the market for...more

FTC Announces New Guidance on Ransomware

On November 10, 2016, the U.S. Federal Trade Commission (FTC) released new guidance for businesses and consumers on the impact of, and how to respond to ransomware. Ransomware is a form of malicious software that infiltrates...more

Guest Post — Do It If It Makes You Feel Good: FTC’s Report on Homeopathic Medicine Advertising

What follows is a guest post by John Feldman, a partner in Reed Smith’s Entertainment and Media Industry Group. John closely follows all things Federal Trade Commission and approached us when he saw the FTC weighing in a...more

FTC Addresses Homeopathic Drug Advertising

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

Health Update - November 2016

Post-Election Analysis: Healthcare Antitrust in a Trump Administration - In a Republican sweep of all the elected branches of the federal government, Donald Trump won the presidential election and Republicans retained...more

Health Care E-Note - November 2016

You just formed your medical practice inAlabama, and you either chose a professional corporation (a “PC”) or an LLC. If you went with a PC, you got to choose between an “S” corporation (“S corp”) or a “C” corporation (“C...more

Appeals Court Decisions Strengthen FTC's Hand in Hospital Merger Challenges

The fall of 2016 has proved to be a difficult time for hospitals seeking to complete mergers in the face of antitrust challenges brought by the Federal Trade Commission (FTC). After failing initially to persuade federal...more

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more

"Looking Ahead: The U.S. Legal and Regulatory Environment Under a Trump Administration"

Election Day brought an end to a long period of uncertainty that caused market fluctuations and delayed business planning decisions. As we navigate the post-election landscape, many questions remain regarding the potential...more

FTC Wins Hospital Merger Challenge in the Seventh Circuit

On October 31, 2016, the U.S. Court of Appeals for the Seventh Circuit overturned a district court decision that denied a motion by the Federal Trade Commission (FTC) and Illinois Attorney General (IL AG) to block the...more

FTC's Winning Streak Restored: Seventh Circuit Reverses Denial of Preliminary Injunction in Chicago Hospital Merger, Competition...

Recent appellate decisions confirm the uphill battle hospitals face when merging with other hospitals. On October 31, the U.S. Court of Appeals for the Seventh Circuit overturned the district court’s ruling in Federal Trade...more

FCC adopts proposed $21,691,499 fine of Network Services Solutions for violations of the USF Rural Health Care Program

In the first major FCC enforcement proceeding involving its Rural Health Care Program, the FCC on November 4, 2016 adopted an NAL for nearly $22 Million against telecommunications reseller Network Services Solutions, which...more

FTC Issues Compliance Guidance for Organizations that Share and Collect PHI

The Federal Trade Commission (FTC) recently issued Guidance to remind HIPAA compliant organizations that share and collect protected health information (PHI) for commercial activities that they must also comply with FTC Act...more

NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more

ANDA Update - Volume 2, Number 3

On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more

Confusing Joint Guidance published by OCR and FTC on HIPAA Authorization Forms

There are arguments that there is a dearth of guidance by both the Office for Civil Rights (OCR) and Federal Trade Commission (FTC), so when guidance comes out, we listen. But the most recent guidance jointly issued by the...more

FTC Again Finds Success in High-Profile Hospital Merger Appeal

For the second time in recent weeks, the Federal Trade Commission (FTC) prevailed in its challenge of a high-profile hospital merger. This time, the appeal stemmed from a June 14, 2016, order by Judge Jorge Alonso of the...more

Seventh Circuit Hands FTC Another Geographic Market Definition Victory in Chicago Hospital Merger Case

On October 31, 2016, the US Court of Appeals for the Seventh Circuit handed another important victory to the Federal Trade Commission (FTC) and the State of Illinois in a hospital merger case in Chicago, Illinois. This...more

Cybersecurity and Data Privacy: Federal Agencies Issue New Guidelines and Rules for Data Breaches and Online Security (11/16)

After recent high profile data breaches and threats to online privacy—ranging from Yahoo Inc.’s data breach of approximately 500 million accounts to the hacking of Hillary Clinton’s campaign manager, John Podesta’s email...more

What Covered Entities Should Know About the FTC Act and Their Obligations Beyond HIPAA

The Federal Trade Commission and Department of Health and Human Services Office for Civil Rights (OCR) recently announced the release of new guidance for businesses on the Health Insurance Portability and Accountability Act...more

Anthem and Aetna Prepare for Merger Trials Against the DOJ Antitrust Division

In late July, the DOJ Antitrust Division filed actions in federal district court seeking to derail both the Anthem/Cigna and Aetna/Humana mergers. In each case, the DOJ contended that consumers would face higher insurance...more

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

FTC Scores Another Victory in FTC v. Advocate Health Care Network

The Federal Trade Commission (FTC) won another decisive victory in its effort to fight health care provider consolidation when the U.S. Court of Appeals for the Seventh Circuit reversed a district court’s decision denying the...more

Antitrust M&A Snapshot - October 2016

UNITED STATES: Continuing an active first half of 2016, the Federal Trade Commission (FTC) and US Department of Justice (DOJ) have challenged several large mergers and acquisitions. In fact, trials for the two...more

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