Are You Prepared to Prove TIRF REMS Program Compliance?
If your pharmacy dispenses Actiq®, Fentora®, Subsys®, or other medications which fall under the TIRF program, now is a good time to evaluate your compliance with all TIRF REMS requirements.
Entries by Sara Hathaway, PharmD
Caremark® Expands “Aberrant” Language & Restricts Bulk Purchases
As mentioned in PAAS’ December 2021 Newsline article about PBM provider manual updates, Caremark® traditionally mails a paper hardcopy of their full provider manual on even years, and only amendments on odd years. With 2022 being an even year, contracted pharmacies should have received a full paper copy of the 2022 provider manual.
Top Medications Flagged for Unauthorized Substitutions
PAAS National® analysts have repeatedly seen auditors targeting claims with potentially undocumented substitution issues. They hope to find inappropriate substitutions which may result in recoupment of the claim.
Update: Medicare Part D Mandatory e-Prescribing Requirements
armacies to the delay in enforcement of Electronic Prescriptions for Controlled Substances (EPCS) for Medicare Part D until January 1, 2022.
HIPAA Guidance Regarding COVID-19 Vaccination Status in the Workplace
On September 30th, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) released guidance regarding the Health Insurance Portability and Accountability Act (HIPAA) of 1996 Privacy Rule and its application to the workplace, specifically discussing the disclosure and request of COVID-19 vaccination status.
PREP Act Ninth Amendment – Overview and Audit Guidance for Subcutaneous REGEN-COV
The ninth amendment to the Public Readiness and Emergency Preparedness (PREP) Act was published in the Federal Register on September 14th, 2021, which granted pharmacists the authority to order and administer COVID-19 therapeutics and qualified pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics under the supervision of a pharmacist.
Stark Law and Anti-Kickback Violations –Indictments Handed Down for Medically Unnecessary Claims
According to a September 17, 2021 press release from the Department of Justice (DOJ), a podiatrist was indicted for defrauding Medicare and Medicaid “by prescribing and dispensing medically unnecessary foot bath medications.”
FWA and HIPAA Compliance with Job Shadows and Interns
Students performing a job shadow or internship in the pharmacy need proper FWA/HIPAA training and preparation to be behind the pharmacy counter or you are inviting headaches into your operations (and potential legal complications).
Pitfalls of Transferred Prescriptions
Transferred prescriptions are at high risk for audit recoupments. Every element required by state regulations is one additional pitfall that PBMs utilize to try and recoup on claims.
Updated Dispense in Original Container Chart
Medications that are required to be dispensed in their original container continue to appear in audits.
