Perspectives on Health Care

Vox recently interviewed Arent Fox Senior Policy Advisor and former Senator Byron Dorgan on how eliminating “lifetime limits” in health insurance policies became a part of the Affordable Care Act.

Responding to requests from the cannabis industry, ASTM International, one of the world’s largest voluntary standards-developing organizations, recently announced plans to develop industry standards that would apply to “the full life cycle of cannabis” and consumable cannabis products.

For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the confidentiality of substance abuse treatment records found in 42 C.F.R. Part 2.

Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

A recent Bloomberg BNA article in the Health Care Daily Report “Former Tenet Executive Indicted in $400M Medicaid Kickback Scheme” describes an ongoing prosecution against a health care industry ex-executive.

Arent Fox LLP is pleased to announce the return of health care regulatory attorney Rachel Hold-Weiss as a partner in the firm’s New York office.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

The recent Bloomberg BNA article in both the Health Care Daily Report and Medicare Report “Health Fraud Rule Withdrawal May Hurt Enforcement Efforts” discussed how fraud enforcement efforts in the health care industry may be hindered by the Trump Administration.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

This is HHS’ first enforcement action against a covered entity that reported a breach, but did not do so timely.

Former Senator and Arent Fox Senior Policy Advisor Byron Dorgan spoke with MSNBC correspondent Kate Snow on Republican plans to repeal the Affordable Care Act (ACA).

The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program.

Please join Arent Fox on Friday, February 3 from 7:00 AM – 5:00 PM Pacific for our annual Medical Staff Leaders and the Law Conference being held at the Avenue of the Arts Hotel in Costa Mesa. 

Health Care partner Linda Baumann was heavily quoted in several Bloomberg BNA publications on the outlook for health care fraud and abuse enforcement in 2017.

Arent Fox LLP is pleased to announce the election of five new partners and two new counsel, effective January 1, 2017.

Just before Christmas, The Joint Commission (TJC) published an update clarifying its previous guidance regarding practitioners’ use of text messaging. TJC now says that practitioners may communicate with each other via secure text messaging systems.

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,

The change to the definition provides for exceptions to the prohibition of the offer or transfer of certain Medicare beneficiary inducements tied to their choice of provider for covered health care items or services. 

Former Representative (R-PA) and Arent Fox Senior Government Relations Advisor Phil English was quoted in the article “Trump Win Gives China Keys to Asian Economic Integration” in the Financial Times.

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 com

The Department of Health and Human Services Office of Inspector General recently published its 2017 Work Plan, which furnishes key guidance to providers and suppliers and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

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

The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence. 

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.