APM Bonuses Given to Vast Majority of Physicians in First Year
According to a Medicare executive, ninety-nine percent of the 100,000 physicians who applied for the advanced alternative payment…
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August 2018
Gottlieb Highlights New Steps to Guide Opioid Prescribing
On August 22, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on…
HHS OIG Solicits Input on Changes in Anti-Kickback Safe Harbors for Value…
The Department of Health and Human Services’ Office of Inspector General (OIG) on Friday announced a new request for information…
California May Pass Legislation to Regulate PBMs
We have previously written about pharmacy benefit managers (PBMs) and the way states are trying to regulate them through…
FDA Issues Draft Guidance on Gathering Patient Input
On June 13, 2018, the United States Food and Drug Administration (FDA) issued draft guidance, “Patient-Focused Drug Development:…
Senate Passes FY 2019 Funding Bill With Bipartisan Vote – Includes Funds…
On August 23, the Senate passed the fiscal year 2019 Departments of Labor, Health and Human Services, Education funding bill with…
United States Joins Lawsuit Over Suboxone
Recently, the Department of Justice (DOJ) filed to join whistleblower lawsuits against Indivior Plc and Reckitt Benckiser Group…
Insys Agrees to Settlement Regarding Opioid Sales Probe
On Wednesday, August 8, 2018, Insys Therapeutics announced a deal to pay $150 million to resolve the United States Department of…
FDA Releases Two Draft Guidance Documents on REMS
In May 2018, the United States Food and Drug Administration (FDA) issued two draft guidance documents focused on developing a…
The Year of the State
Following on the heels of more than 40 state legislatures, the U.S. Congress passed a federal right-to-try law giving patients…