Ned Milenkovich, PharmD, JD
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws. Ned Milenkovich is chair of the Healthcare Law practice at Much Shelist PC and vice chair of the Illinois State Board of Pharmacy. Contact him at: 312-521-2482 / [email protected]
Dietary supplements-- an FDA primer
FDA is not authorized to review dietary supplements for safety and effectiveness before they go on the market. But it does provide an electronic safety reporting portal tailored exclusively for dietary supplements.
EpiPen Maker Strikes Deal with DOJ
In 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.
DOJ charges group for generating bogus scripts and cheating government and private insurers
The U.S. Department of Justice charged 16 individuals in Florida federal court as part of an elaborate fraud scheme that allegedly used call centers and kickbacks to generate bogus prescriptions and bilk government and private insurers for $175 million.
New CMS Proposed Rule Expands Medicare Reimbursement For Telehealth Services
The Centers for Medicare and Medicaid Services (CMS) has once again released its Physician Fee Schedule Proposed Rule for Calendar Year 2017.
FDA expands its authority over tobacco products
According 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 requirements
FDA 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.
DEA to consider rescheduling marijuana — for the fourth time
Will the DEA finally reclassify marijuana to schedule 2?
Combating the growing opioid epidemic with the “rescue shot”
The movement to get naloxone into the hands of first responders, drug users, and their family members has found increasing support in state legislatures.
Forthcoming HIPAA audits likely to target pharmacies
Phase 2 of OCR's HIPAA audit program kicked off in March. Pharmacies, among a host of other healthcare providers, health plans, clearinghouses, and business associates, are subject to possible audit.
CMS releases final rule for covered outpatient drugs
AMP, FUL, Medicaid Drug Rebate Program, pharmacy reimbursement see changes and clarifications.