Since the DEA has changed its regulations on reporting theft or significant loss of controlled substances, numerous pharmacies have been making reporting errors, subjecting themselves to unnecessary penalties. For example, I am currently representing a pharmacy that was cited for not following the required reporting procedure. And this is not the first case in my
Starting January 1, 2026, pharmacies will be reimbursed under a different model for dispensing certain Part D Medicare drugs. These changes are a part of the implementation of the Inflation Reduction Act of 2022 (P.L. 117-169), which provides Medicare the ability to directly negotiate the prices of certain high expenditure, single source drugs without generic
I am pleased to announce that I will be speaking in an upcoming Strafford live video webinar, “DEA Prescription Audits and Investigations: Triggering Events; Process Navigation; Mitigating Noncompliance Risks” scheduled for Wednesday, November 5, 12:00pm-1:30pm EST. Because of your affiliation with our firm, you are eligible to attend this program at half off. As long as
While California amended its regulations on pharmacy closure earlier this year, many pharmacy owners are still confused regarding the requirements when they are selling files, filing for bankruptcy, or simply closing their doors. So what does California require?
Patient notices:
If the pharmacy closes (sells its files or goes out of business), it must notify
Within the last two weeks, AstraZeneca sent numerous letters to pharmacies requesting information regarding dispensing and purchasing FARXIGA® in 2024. These letters inform pharmacies that AstraZeneca has identified data discrepancies in billing and purchasing FARXIGA® for each flagged pharmacy.
AstraZeneca alleges that it had perform reconciliation of purchase and dispensing data for each identified pharmacy.
Business and Professions Code (BPC) § 4113.1 established requirements for a community pharmacy to report medication errors to an entity approved by the California State Board of Pharmacy (“Board”) within 14 days of discovery. The Board approved Institute for Safe Medication Practices (“ISMP”) as the entity to receive and review medication error reports under BPC
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
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
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 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
