Skip to main content
Keeping you afloat amidst the rising sea of regulations

New Final Regulations Provide Overdue Guidance on Permissible Arrangements Between Providers, Financial Relief for Patients

Over two years after proposing rules for comment, the Office of Inspector General for the Department of Health and Human Services (OIG) just published a final rule which revises and adds new safe harbors to the Anti-Kickback Statute (AKS) and amends the definition of “remuneration” under the Civil Monetary Penalty (CMP) rules.

The Drug Pricing Conundrum Explained

Counsel Lanhee Chen recently authored “The Drug Pricing Conundrum Explained” for RealClear Health. The article describes the recent significant discussions on drug pricing and the reality that employers, pharmacy benefit managers (PBMs), and health plans are working to ensure a competitive marketplace and hold down costs for consumers. Lanhee states that the US continues to be a center for pharmaceutical innovation and a leading source of new cures that improve human quality of life and longevity.

US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.  

OIG 2017 Work Plan Lists New Enforcement Priorities

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for fiscal year 2017 (2017 Work Plan), which furnishes key guidance to providers and suppliers (collectively referred to here as “providers”) and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

California Approves First-In-The-Nation Regulation Specifically Addressing the Threat of Workplace Violence in Healthcare Facilities

Recently, the California Division of Occupational Safety & Health Standards Board approved a new safety standard designed to provide comprehensive regulatory protections for workers exposed to workplace violence in healthcare settings.

FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which is available here. In this document, FDA sets forth the Agency’s expectations for parties involved in contract drug manufacturing, specifically that they delineate—in written quality agreements—each party’s roles and responsibilities to ensure compliance with FDA’s current good manufacturing practice (CGMP) requirements.

FDA Announcement on Guidance for Industry, Generic Drug User Fee Amendments of 2012

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, available here. 

Podcast: What's Next For Obamacare (Part 2)

With President-elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?

Podcast: What's Next For Obamacare (Part 1)

With President-Elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?

Key Issues for the California Cannabis Industry

In the wake of the legalization of cannabis in the state of California following last week’s election, it is important for businesses to take stock of several legal issues as opportunities within this burgeoning market continue to grow. Outlined below are just a few of the areas cannabis businesses in California need to be aware of to avoid legal problems down the road.Real Estate & Land Use