Isotretinoin capsules are FDA approved for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Due to the risk of severe life-threatening birth defects and risk of embryo-fetal toxicity, isotretinoin is only available under the iPLEDGE® Risk Evaluation and Mitigation Strategy (REMS) program.
About Sara Hathaway, PharmD
After graduating from UW-Madison's School of Pharmacy with my PharmD, I spent my first eight years at an independent pharmacy dividing my time between both retail and long-term care. I fell in love with the independent pharmacy world and joined the PAAS team to help independents not only survive, but thrive.
I enjoy assisting pharmacy staff both pre- and post-audit and enjoy providing them with knowledge and tools to decrease audit risk going forward. I write articles for Third-Party Newsline each month and answer member questions daily. I look forward to building professional relationships with each of our members and assisting you with your next audit.
Entries by Sara Hathaway, PharmD
Understanding and adhering to the HIPAA Privacy Rule is required for covered entities who handle protected health information (PHI), but because the Privacy Rule was designed to be flexible, implementation of policies and procedures to meet the Privacy Rules can vary from covered entity to covered entity.
According to a November 2023 press release from the Office for Civil Rights (OCR), Saint Joseph’s Medical Center (“Saint Joseph’s”) of New York state agreed to pay $80,000 and implement a corrective action plan in response to their unauthorized release of Protected Health Information (PHI).
BMs require pharmacies to collect patient copayments in full and any deviation from that practice may be considered fraudulent behavior, with limited exceptions.
Creon® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. Claims for these pancreatic enzymes find themselves on audits year after year, and the audit risk has just increased as …
Adequate and thorough training is an essential component to all employee on-boarding and continued employment. One critical topic to discuss is sanctions, because the HIPAA Privacy and Security Rules both require sanction policies.
According to a September 11, 2023 news release from the U.S. Department of Health and Human Services (HHS), “L.A. Care, the largest publicly operated health plan in the country paid $1,300,000 to settle” potential HIPAA Security Rule violations.
Now is the time to ensure staff complete their annual Fraud, Waste & Abuse and HIPAA Compliance training since the December 31st deadline will be here before we know it!
Many pharmacies have made the switch to electronic signature log capture, but paper signature logs have not gone away.
The DEA published a couple rule changes recently which pharmacies need to be aware of. In the September 2023 Newsline, the updated rule regarding partial fills for controlled substances was discussed. The other recent change published in the Federal Register was titled, Transfer of Electronic Prescription for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling.