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A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge

December 23, 2015 | Blog | By Dionne Lomax

Last week, the Federal Trade Commission ("FTC" or "Commission") authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the proposed merger of Advocate Health Care Network (Advocate) and NorthShore University HealthSystem (NorthShore) in the Chicago area.
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Telemedicine – 2015 Year in Review

December 22, 2015 | Blog | By Ellen Janos, Carrie Roll

As the year winds down, we look back on the significant developments in telemedicine in 2015 as well as look forward to what 2016 will bring.
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Antitrust Suit Continues to Stymie New Texas Telemedicine Regulation

December 17, 2015 | Blog | By Dionne Lomax

A federal district court denied the Texas Medical Board’s (the Board) motion to dismiss an antitrust suit filed by a telemedicine company (Teladoc), finding that the Board is not entitled to state action immunity because its actions are not actively supervised by the state.
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FTC Alleges “Three-to-Two” Hospital Merger Will Reduce Competition

December 16, 2015 | Blog | By Dionne Lomax

Last week the Federal Trade Commission (FTC) authorized an action to block a proposed hospital merger pending an administrative trial. Last week the Federal Trade Commission (FTC) authorized an action to block a proposed hospital merger pending an administrative trial.
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Mintz Advisory Analyzes Health Care Qui Tam Litigation Trends

December 15, 2015 | Blog | By Samantha Kingsbury

Last week, my colleague Kevin McGinty published a fascinating advisory that provides a detailed analysis of data recently released by the Department of Justice (“DOJ”) in its annual report on False Claims Act (“FCA”) filings.
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FDA Legal and Regulatory – 2015 Year In Review

December 14, 2015 | Blog | By Joanne Hawana

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products.
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HIPAA and Health Care Data Privacy – 2015 Year in Review

December 11, 2015 | Blog | By Dianne Bourque, Ryan Cuthbertson

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. 
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The Pharmacy Industry - 2015 Year In Review

December 8, 2015 | Blog | By Theresa Carnegie, Lauren Moldawer

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. 
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DOJ Recovers $3.5 Billion in False Claims Act Cases in FY2015 and Pays Record Amount to Qui Tam Relators

December 8, 2015 | Blog | By Laurence Freedman

Late last week, the Department of Justice (DOJ) announced that in FY2015 it obtained more than $3.5 billion in settlements and judgments from civil cases involving allegations of false claims against the government.
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OIG Proposes Alternative Part B Payment Methodologies for 340B Drugs: Is This the End of 340B As We Know It?

December 2, 2015 | Blog

Last week, under the cover of the impending Thanksgiving Holiday, OIG lobbed another grenade at the 340B Drug Discount Program. The means of delivery was an OIG Report on Medicare Part B payments for 340B drugs.
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Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

November 30, 2015 | Blog

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s Thanksgiving dinner.
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FDA Commits to Moving Forward with LDT Regulation

November 24, 2015 | Blog | By Joanne Hawana

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that FDA would move forward with finalizing its plan to regulate laboratory developed tests (LDTs) sometime in 2016.
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HHS Drug Pricing Forum Highlighted in ML Strategies' Health Care Update

November 24, 2015 | Blog | By Bridgette Keller

This week’s ML Strategies Health Care Update highlights the recent Department of Health and Human Services (HHS) forum on prescription drug costs, which featured players from every corner of the industry, including top government officials.
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Congressional Hearing Examines Competition in the PBM Industry

November 23, 2015 | Blog | By Theresa Carnegie

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining the state of competition in the pharmacy and PBM marketplace.
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ML Strategies Health Care Update - DNA Sequencing Workshop and Drug Pricing Developments

November 20, 2015 | Blog | By Samantha Kingsbury

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics.
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CMS Eases Regulatory Burdens and Creates New Exceptions in “Phase V” of the Stark Regulations

November 17, 2015 | Blog

On November 16, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published the most significant changes to the physician self-referral law ("Stark Law" or "Stark") regulations since 2008.
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Genetic Testing, Genome Sequencing, and the FDA

November 13, 2015 | Blog | By Joanne Hawana

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the rapidly developing world of genetic and genomic testing services.
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FTC Challenges Hospital Merger Despite Conduct Remedy Accepted by State AG

November 9, 2015 | Blog | By Dionne Lomax

Last week the Federal Trade Commission (“FTC” or “Commission”) issued an administrative complaint challenging the merger of two West Virginia hospitals that had earlier been cleared by the state’s Attorney General (“W.V. AG”) following the entry of two agreements between the hospitals and the W.V. AG (“Agreements”).
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CMS Issues Final Rule for Fraud and Abuse Waivers in the Medicare Shared Savings Program

November 6, 2015 | Blog

On October 29th, 2015, the Centers for Medicare and Medicaid Services ("CMS") issued its final rule ("Final Rule") for waivers of fraud and abuse laws in the context of the Medicare Shared Savings Program ("Shared Savings Program").
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ML Strategies: Ways & Means Leadership Changes – Health Policy Implications Looming

November 6, 2015 | Blog | By Lauren Moldawer

On Monday November 2, 2015, ML Strategies released another edition of its Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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