Legal Compliance

EpiPen Maker Strikes Deal with DOJIn October 2016 Mylan N.V. announced that its subsidiary, Mylan Inc., agreed to pay a $465 million settlement to the U.S. Department of Justice (DOJ) to resolve questions surrounding the classification of EpiPen Auto-Injector and EpiPen Jr Auto-Injector (EpiPen) for the Medicaid Drug Rebate Program.
Helping Small Organizations Meet the 340B ChallengeMany smaller organizations rely on the 340B program to continue serving their communities – and they can’t afford penalties for noncompliance.
New CMS Proposed Rule Expands Medicare Reimbursement For Telehealth ServicesThe Centers for Medicare and Medicaid Services (CMS) has once again released its Physician Fee Schedule Proposed Rule for Calendar Year 2017.
CVS pharmacists must check PMP before dispensing opioidsThe agreement between CVS and Massachusetts requiring the PMP check prior to dispensing opioids is believed to be the first in the nation.
FDA expands its authority over tobacco productsAccording to FDA and other sources, tobacco use is the single largest preventable cause of disease and death in the United States.
An overview of FDA’s 503B outsourcing facility requirementsFDA has stated that it intends to continue inspections of compounding pharmacies, and it has taken aggressive action, including enforcement actions, as appropriate to protect the public health.
Pharmacist faces prison sentence for obstructing Medicare auditEarlier this month, the U.S. Department of Justice announced that Rodney Dalton Logan, 63, of Muscle Shoals, Ala. agreed to plead guilty to obstructing a Medicare audit in 2012.
DEA to consider rescheduling marijuana — for the fourth timeWill the DEA finally reclassify marijuana to schedule 2?