Drug Manufacturers Sue HHS Over 340B Advisory Opinion
Three drug companies have filed separate lawsuits to preserve their ability to restrict offerings of 340B-discounted drugs to…
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February 2021
Variation Abounds in Hospital Price Transparency Rule Implementation
On January 1, 2021, hospitals in the United States have been required to make their prices transparent for consumer review. Under…
New Final Rule in Effect Updating AKS Safe Harbors
On January 19, 2021, a final rule promulgated by the Department of Health and Human Services Office of Inspector General (HHS OIG)…
Price Transparency Rule Given the Green Light by D.C. Court of Appeals
On December 29, 2020, the United States Court of Appeals for the District of Columbia Circuit upheld the Centers for Medicare and…
CMS Announces New Voluntary Payment Model
Toward the end of last year, the United States Centers for Medicare and Medicaid Services (CMS) announced a new voluntary payment…
PhRMA Sues Over “Unconstitutional” 340B Rule
In late January, the Pharmaceutical Research and Manufacturers of America (PhRMA) sued the United States Department of Health and…
What Does the Consolidated Appropriations Act Mean to Industry?
On December 27, President Trump signed into law the Consolidated Appropriations Act, 2021, which was passed by Congress the…
Trump Administration Makes Final Proposed Rule Push
Two proposed rules from the last few weeks of the Trump administration may be of note to some of our readers. The first addresses…
FDA Issues Draft Guidance on Proprietary Names
The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of…
Several States Work Together, Reach $40 Million Settlement with Apria…
On January 20, 2021, Florida Attorney General Ashley Moody announced a $40 million settlement between the state’s Medicaid Fraud…