Public Health Service Act

News & Analysis as of

The Affordable Care Act—Countdown to Compliance for Employers, Week 34: When Can Carriers Impose Minimum Participation and Minimum...

Commencing with plan and policy years beginning on or after January 1, 2014, the Affordable Care Act amends the Public Health Service Act (“PHS Act”) to make three important changes to the rules governing health insurance...more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

HRSA Publishes Orphan Drug Rule for 340B Program

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

Benefit Issues in Puerto Rico: Impact of the ACA, ERISA and the PBGC

This article highlights some recent developments that employers with Puerto Rico employee benefits arrangements should consider concerning compliance with U.S. federal laws on health care reform and the Patient Protection and...more

A Primer on “Low-Cost” Group Health Plans

A May 10 Wall Street Journal article, “Employers Eye Bare-Bones Health Plans Under New Law” (see the associated video on WSJ Live), highlighted a compliance strategy to minimize employer exposure for assessable payments under...more

Consumer Driven Health Care 2.0: Are Private Health Insurance Exchanges the New ‘Killer App’?

Originally published in Tax Management Weekly Report on 11/05/2012. In a September 27, 2012, front page article, the Wall Street Journal reported that Sears Holdings Corp. and Darden Restaurants, Inc., had adopted a...more

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