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Keeping you afloat admidst the rising sea of regulations

Bristol-Myers Settlement Illustrates Continuing Enforcement Trend Against Allegedly Deceptive Promotion of Medical Products

Late last week, the Attorneys General of 43 states announced that they reached a $19.5 million dollar agreement with Bristol-Myers Squibb Company to settle allegations that the company engaged in deceptive trade practices with respect to the marketing of a drug intended for treating schizophrenia.

Supreme Court Declines to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal, but instead the district court has discretion to determine the appropriate sanction under the circumstances – whether it be dismissal or a less severe sanction.

Sonja Nesbit Published in AHLA Weekly

Arent Fox’s Senior Government Relations Director Sonja Nesbit was recently published in American Health Lawyers Association (AHLA) Weekly in an article titled “The Outlook on Repealing and Replacing the ACA.” In the article, Sonja addresses the recent presidential election and the future of the Affordable Care Act (ACA).To read the AHLA article, click here. 

AHA and FAH Send Joint Letter to Congressional Leaders on ACA Reform

On December 6, 2016, the American Hospital Association (AHA) and the Federation of American Hospitals (FAH), the two leading national hospital associations, sent a joint letter to Speaker of the House Paul Ryan and Senate Majority Leader Mitch McConnell about Congress’s approach to the ACA after President-elect Trump takes office. Both groups are essentially asking for protection from cuts in reimbursement that might take place in the process of repealing, replacing, or reforming the law.

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.