Mintz Levin - Health Law & Policy Matters

HHS Drug Pricing Forum Highlighted in ML Strategies’ Health Care Update

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…more
| Health, Science, Computers, & Technology

FDA Commits to Moving Forward with LDT Regulation

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…more
| Consumer Protection, Elections & Politics, Health, Science, Computers, & Technology

Congressional Hearing Examines Competition in the PBM Industry

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…more
| Antitrust & Trade Regulation, Elections & Politics, Health, Science, Computers, & Technology

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

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…more
| Elections & Politics, Health, Science, Computers, & Technology

Genetic Testing, Genome Sequencing, and the FDA

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…more
| Health, Science, Computers, & Technology

FTC Challenges Hospital Merger Despite Conduct Remedy Accepted by State AG

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”)…more
| Antitrust & Trade Regulation, Commercial Law & Contracts, Health, Mergers & Acquisitions

CMS Issues Final Rule for Fraud and Abuse Waivers in the Medicare Shared Savings Program

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…more
| Health

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary names…more
| Consumer Protection, Health, Science, Computers, & Technology

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations…more
| Communications & Media Law, Criminal Law, Health, Privacy, Science, Computers, & Technology

MA Health Policy Updates – Moves to Strengthen HPC and Expand Telemedicine

In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission…more
| Antitrust & Trade Regulation, Elections & Politics, Health, Mergers & Acquisitions, Science, Computers, & Technology

Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying…more
| Consumer Protection, Health, International Law & Trade, Privacy, Science, Computers, & Technology

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement…more
| Health

Yates Memo Discussed at Pharmaceutical Compliance Congress

As readers of Health Law and Policy Matters know, we have covered recent developments in the Department of Justice’s (DOJ’s) commitment to prosecuting individuals involved in corporate misconduct. A flurry of activity on this…more
| Business Organizations, Criminal Law, Science, Computers, & Technology

FTC-DOJ Join Forces: Encourage Repeal/Retrenchment of Virginia CON Laws

The Federal Trade Commission (“FTC”) and Department of Justice Antitrust Division (“DOJ”) (collectively, “agencies”) issued a joint statement to Virginia’s Certificate of Public Need (“COPN”) Work Group, which was recently…more
| Antitrust & Trade Regulation, Health, Mergers & Acquisitions

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule, it…more
| Civil Procedure, Health, Science, Computers, & Technology
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701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys

25-50 Attorneys

This profile may constitute attorney advertising. Prior results do not guarantee a similar outcome. Any correspondence with this profile holder does not constitute a client/attorney relationship. Neither the content on this profile nor transmissions between you and the profile holder through this profile are intended to provide legal or other advice or to create an attorney-client relationship.

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