I remember times when pharmacies were able to prepare and submit prior authorizations (PAs) on behalf of the prescribers. Then, gears shifted and pharmacies were allowed to fill out PAs but not to submit them. Nowadays, the landscape is much stricter and pharmacies are only allowed to prepopulate some information, such as patients’ data. Adding
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Upcoming Webinar: Disciplinary Actions Against Hospital Pharmacies – Prevention and Mitigation
This webinar is geared specifically towards hospital staff, pharmacists, and compliance teams. I have reviewed and analyzed all California State Board of Pharmacy (“Board”) disciplinary actions against hospital pharmacies for the last five years and this is probably the most extensive and labor intense webinar that I have ever prepared for. I am looking forward…
New California requirements for PICs
As always, California is at the forefront of inventing new requirements for enforcing compliance with pharmacy laws. This time, the new requirement pertains to Pharmacists-in-Charge (PICs).
Effective April 1, 2025, all proposed PICs are required to complete a training course available on the California State Board of Pharmacy’s website, within two years prior to the…
OptumRx eases prior authorization requirements on about 80 drugs
OptumRx has recently announced that it is easing its prior authorization (PA) requirements on about 80 drugs for renewed prescriptions. The program is planned to start on May 1, 2025 and will include various drugs such as Aimovig, Kalydeco, and Praluent. The list of drugs is anticipated to increase based on the success of the…
Upcoming presentation on the impact of the IRA on the pharmacies
I will be speaking at the upcoming American Health Law Association, Institute on Medicare and Medicaid Payment Issues on the impact of the Inflation Reduction Act of 2022 on healthcare providers, specifically pharmacies. Overview of the presentation:
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA)—the law’s “Prescription…
(Very) Short overview of the ASPL conference: Focus on Controlled Substances
Natalia Mazina, Emily Do, Eman Kirolos
This year’s American Society for Pharmacy Law (ASPL) conference was as always full of opportunities to connect with pharmacy leaders, superb lawyers, and government representatives. The lineup of presentations featured a range of topics from the key Supreme Court decisions impacting pharmacies to animal drug compounding (with many more…
Governor Newsom denied a bill aimed at increasing transparency of the PBM market
Our April 29th post discussed the introduction of SB 966 that would have required PBMs doing business in California to be licensed and regulated. The Bill had passed all relevant committees and landed on the Governor’s desk in September of 2024. Surprisingly, Governor Newsom did not sign SB 966.
A wave of extensive Medi-Cal audits overwhelms California pharmacies
On July 26, 2024, the California Department of Healthcare Services (“DHCS”) – which administers California’s Medicaid program – sent Notices of Medi-Cal Desk-Audit (“Audit”) to numerous California pharmacies. It appears that pharmacies that bill expensive specialty medications to Medi-Cal are subjects of these audits.
The Audit requests an overwhelming amount of information: from business ownership/…
Next Webinar: Compliance with the Controlled Substances Act and Highlights from DEA audits of Hospital Pharmacies
I am very excited to announce that Mazina Law has partnered with The California Society of Health-System Pharmacists (CSHP) to offer exclusive benefits for the members of the CSHP. I have previously heard a lot of praise to the CSHP’s annual seminars and their educational webinars and finally we will be a part of it.…
FDA postpones compliance with DSCSA for small dispensers. What does it mean for pharmacies?
Last week, many pharmacy and healthcare industry organizations sent announcements that FDA granted a two-year exemption to small dispenses for complying with the Drug Supply Chain Security Act (“DSCSA”). However, many pharmacies still have questions whether the exemption applies to them and how it affects them.
To remind, the DSCSA was enacted in 2013 with…