Frier Levitt's Life Sciences Department is pleased to share our bi-weekly publication "Life Sciences Legal Insights" with the goal of providing content to our clients and the life sciences industry as a whole to help them navigate the complex regulatory and transactional hurdles they face and to be proactive in preparing for and fighting PBM audits.
With the New Year upon us and hope in the form of the COVID-19 vaccine, the Frier Levitt team wants to acknowledge and thank all of our clients in the healthcare and life sciences community who play such an integral role in the success of this unprecedented immunization roll-out. We are grateful for you.
What's Impacting the Industry this Week?
CVS Caremark recently issued an updated Aberrant Product List that went into effect January 1, 2021. The Updated List contains nearly double the number of drugs included in the original list. The number of new drugs and the therapeutic class of the drugs added to the Update List are highly concerning and will impact the pharmacy’s ability to treat patients and the day-to-day operation. In their current Alert, Frier Levitt Life Sciences Attorneys Dae Y. Lee, Pharm.D., Esq., CPBS and Harini Bupathi, Esq. detail what pharmacies need to know. Read the full Pharmacy Alert here.
In mid-2020, several large payors began to require that in-office infused medications be filled at their wholly-owned specialty pharmacies, and placing limitations, or removing the ability altogether, on providers’ ability to source and seek reimbursement for medications administered in their facilities. Beyond financial impacts, mandatory “white bagging” exposes facilities and practices to legal and regulatory risk. Frier Levitt Clinician-Attorney Martha Rumore, Pharm.D., Esq. and Partner Jesse Dresser, Esq. discuss these emerging trends and options for hospital-based infusion centers and physician practices that have been negatively impacted by these policies. Read more here.
The DOJ and Bartell Drugs have reached a settlement in the amount of $800,000 resolving alleged violations of the Controlled Substances Act. As enforcement efforts to combat the opioid epidemic increase, every participant along the supply chain continuum potentially faces liability and, therefore, discipline by professional boards and regulatory agencies, civil liability, and/or criminal prosecution. In their latest alert, Frier Levitt Life Sciences Attorneys Martha Rumore, Pharm.D., Esq., Kendra E. Pannitti, Esq. and Daniel Giaquinto, Esq. detail this enforcement and the corresponding responsibility pharmacists have under the CSA. Read the full alert here.
Upcoming Virtual Event
We remain committed to providing our clients and contacts with the most up-to-date resources and information regarding the impacts of COVID-19 on their businesses and operations. Visit our COVID-19 resources page here for all of the latest.
Very truly yours,

Jonathan E. Levitt, Esq.
Co-Founding Partner
Frier Levitt LLC
973.618.1660