Blog

The FDA Overhaul on Dietary Supplements

On February 11, 2019, the FDA announced that it will likely undertake a massive overhaul of the regulation of the dietary supplements. Congress passed the Dietary Supplement Health and Education ACT (DSHEA) in 1994 granting FDA an oversight of the dietary supplements. At the time, this only required minimal reporting and labeling from the manufacturers. Throughout the years, however, the dietary supplement industry has become a $40 billion market comprising...

Frier Levitt Successfully Defends Two Physicians Before the NJ Board of Medical Examiners

Recently, Frier Levitt successfully represented two New Jersey-based physicians facing disciplinary actions before the New Jersey Board of Medical Examiners. In one case, the physician, a pain management specialist, was being investigated by the Board concerning the practices of opioid prescribing. The physician was facing greater scrutiny due to the prescribing of cancer breakthrough pain medication. Frier Levitt reviewed the physician’s standard operating procedures for opioid prescribing and presented evidence...

Pharmacy ALERT: Amending Rate Schedules in the Middle of a Contract Term

It has been widely reported that Express Scripts has recently issued rate amendments to its Pharmacy Provider Contracts. These purported rate amendments in many instances come on the heels of multiyear contracts that were executed just a few months ago, sometimes after strenuous back and forth negotiating between the pharmacy and the PBM. Moreover, these rates are set to become effective in the very near term, smack dab in the middle of...

Why Physicians Need to Challenge Audit Findings and Overpayment Demands: Lessons Learned from 2018

In 2018, many physicians' fears and suspicions were confirmed as discovery from lawsuits against insurers and reports from the Office of Inspection General (OIG) shed light on the glaring flaws, and the sometimes unscrupulous nature of, payor audits. The year began with a bang when in February 2018 it was revealed that Aetna’s former Medical Director, Dr. Jay Ken Iinuma, admitted under oath that he "never looked at patients' records...

Pharmacies Face Expanded “Effective Rate” Withholdings from PSAOs

Late last year, Epic Pharmacy Network, Inc. (Epic) sent demands to network pharmacies notifying its members that it will withhold future payments because of a Generic Effective Rate (GER) adjustment. The adjustments surprised many pharmacies that were unaware of any withholding resulting in multiple state and federal court lawsuits. Now, in 2019, pharmacies must be as diligent as ever to ensure that Pharmacy Services Administration Organizations (PSAOs) and Pharmacy Benefit...