GOP Senators Send Letter to CMS, Requesting MA Changes
In a recent letter to the CMS Administrator, Republican Senators highlighted specific policy recommendations they would like to…
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Yearly Archives
2017
Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the…
Current State of Telemedicine
As we previously reported, the CHRONIC Care Act of 2017 was introduced by Senate Finance Committee Chairman Orrin Hatch and…
A Port in Any Storm – Adding New Safe Harbors to the Anti-Kickback Statute
On December 7, 2016, the HHS Office of the Inspector General ("OIG") approved new safe harbors to the federal anti-kickback…
Citizen Petitions to Come Front and Center
In February, the Federal Trade Commission filed a complaint in federal district court charging Shire ViroPharma Inc. with…
Drug Prices Are Growing at Slowest Rate in Years
You’d think, from listening to politicians and news anchors, that the cost of prescription drugs is the highest it has ever been,…
Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce…
Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a…
FDA Public Meeting on Training Health Care Providers on Pain Management and…
In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that…
California Senate Passes Ban on “Gifts” to Physicians
Late last week, California passed legislation in the state senate that restricts pharmaceutical companies from giving gifts and…
The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion
The purpose of this article is to give manufacturers some initial background on the topics and some tools that could be…