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Health Antitrust & Trade Regulation

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

The DOJ's Case Against North Carolina Anti-Steering Agreements Permitted to Proceed

The Department of Justice's (DOJ) case against Carolinas Healthcare System's (CHS) anti-steering contract clauses has survived initial attempts by CHS to dismiss the case. Despite the reversal of the DOJ's win in the American...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

The Risk Management Process in Compliance

by Thomas Fox on

An exploration of risk forecasting, risk assessment and risk-based monitoring for the compliance profession. ...more

Geotargeting Medical Facilities? Massachusetts Says ‘No Snoop For You!’

by Morgan Lewis on

Geotargeting—delivering content to users based on their geographic location—has become a popular and effective marketing tool. Yet proper implementation may be more nuanced than originally contemplated because certain...more

New York Attorney General Settles Claims against Three Health Apps

by Morgan Lewis on

Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more

New York Attorney General Enters Digital Health App and Privacy Enforcement Fray: Announces Three Settlements with Health and...

by Ropes & Gray LLP on

On March 23, the New York Office of the Attorney General (“NY OAG”) announced Assurances of Discontinuance (“Settlements”) with three developers of health and fitness mobile apps. The Settlements appear to mark the NY OAG’s...more

Mergers and Acquisitions Takeaways From the 2017 ABA Antitrust Law Spring Meeting

by Perkins Coie on

The American Bar Association’s 65th Antitrust Law Spring Meeting held at the end of March included a number of sessions with representatives from federal and state antitrust enforcement agencies. In the first article in a...more

NY AG Enters Mobile Health App Enforcement Arena with Settlements Targeting Health Claims and Privacy Practices

by Kelley Drye & Warren LLP on

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more

Health Alert (Australia) April 10, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 April 2017 - Reckitt Benckiser (Australia) Pty Ltd v Australian Competition and Consumer Commission [2017] HCASL 86 - The High...more

House Passes Bill Repealing Antitrust Immunity for Health Insurers

by King & Spalding on

Last week, the U.S. House of Representatives passed a bill that would end the limited Federal antitrust immunity for health insurers. The Competitive Health Insurance Reform Act of 2017 (H.R. 372) passed the House 416-7 and...more

Court Upholds DOJ Antitrust Lawsuit Challenging Carolinas HealthCare System’s Anti-Steering Provisions

by Hogan Lovells on

Despite a recent decision by the Second Circuit suggesting that anti-steering contractual provisions in other industries may not be anticompetitive, DOJ’s lawsuit (United States v. Carolinas HealthCare System) against...more

House Overwhelmingly Approves Insurance Antitrust Reform Legislation

by Reed Smith on

The House of Representatives has approved HR 372, the Competitive Health Insurance Reform Act of 2017, which would repeal the antitrust exemption for health insurance companies provided under the McCarran-Ferguson Act...more

Antitrust Exemption for Health Insurance Companies May Come to a Close

Recently, the House of Representatives voted to pass H.R. 372, also known as the Competitive Health Insurance Reform Act of 2017, which would close the longstanding antitrust immunity granted to health insurance companies....more

DOJ Anti-Steering Suit Against Carolinas Healthcare Survives Preliminary Motion

by Mintz Levin on

On March 30, 2017, in a closely watched case, a federal district court denied the Motion for Judgment on the Pleadings filed by Carolinas Healthcare against the DOJ Antitrust Division and State of North Carolina’s Complaint...more

Insurers’ Antitrust Exemption in Crosshairs Again as Part of Potential Health Care Overhaul

by Sedgwick LLP on

Just when you thought the health insurance legal and regulatory landscape couldn’t get any more interesting, along comes the Competitive Health Insurance Reform Act of 2017 (the Act). The Act removes a longstanding antitrust...more

House Votes to Repeal Antitrust Exemption for Health Insurers Under the Mccarran-Ferguson Act

by Pepper Hamilton LLP on

On March 22, the U.S. House of Representatives passed the Competitive Health Insurance Reform Act of 2017, which would repeal the current limited federal antitrust immunity for health insurers. The bill would amend the...more

Legal Issues Business Leaders Need to Know in 2017

by Arnall Golden Gregory LLP on

Expanding wage and hour obligations will continue to be a top concern for employers in 2017. As most employers are aware, in May 2016, the United States Department of Labor issued its long-awaited final rule regarding the...more

Healthcare Law Update: March 2017

by Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

The FTC and State of Illinois Solidify Victory Blocking Chicago Hospital Merger

by Mintz Levin on

The Federal Trade Commission (“FTC”) and the State of Illinois successfully concluded their challenge to the proposed merger of Advocate Health Care and NorthShore University Health System earlier this month, when the U.S....more

Repeal of Antitrust Immunity for Insurers: What Does It Mean?

Insurers are among a handful of industries, including Major League Baseball, that have a special exemption from the federal antitrust laws, the so-called "McCarran-Ferguson" antitrust exemption. The exemption has survived...more

Health Update - March 2017

The Future of Essential Health Benefits - Editor's Note: The Essential Health Benefits (EHB) rule may be among the many parts of the Affordable Care Act (ACA) that are on the chopping block as the Trump Administration and...more

Commonwealth Court Dismisses Pennsylvania Attorney General’s Lawsuit against Golden Living

by Tucker Arensberg, P.C. on

Many nursing home operators have been closely watching the litigation between the Pennsylvania Office of Attorney General (“OAG”) and the Golden Living chain of skilled nursing facilities. On March 22, 2017, the Commonwealth...more

Chicago-Area Hospitals Abandon Fight to Save Merger from FTC Challenge

by Holland & Knight LLP on

After the U.S. Court of Appeals for the Seventh Circuit ruled on Oct. 31, 2016, that the district court's refusal to enjoin the merger of two hospital systems in Chicago's northern suburbs was based on an improper antitrust...more

DELAYED: The FDA’s Intended Use Rule

by Strasburger & Price, LLP on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

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