K&B Pharmacy group is hosting a DIR reform discussion featuring insightful speakers and guests. If your pharmacy is located in Northern California, we would love to see you and discuss the current state of pharmacy affaires. For more information please contact K&B Pharmacy group ..read more

By Bhavesh Desai, PharmD, J.D. DIR fees have been a focus of debate since their implementation and for the past decade, they have been increasingly scrutinized in congress as well as at the state level. The companies (Pharmacy Benefit Manager – PBMs) responsible for reporting true and accurate drug prices to the CMS have used loopholes in legislation to their advantage. A select few PBMs control a vast majority of the prescription volume in our country and they operate with minimal oversight.  This coupled with vertical integration has allowed them to grow their sphere of influence and&n ..read more

Even if your state has legalized cannabis products, it does not mean that your pharmacy can start selling them. This axiom has been tested and proven again and this time in Georgia. Georgia took an interesting approach regarding expanding medical marijuana access. As far as I know, it is the only state that specifically allows its pharmacies to be registered as dispensers of  low-THC cannabis oil (containing under 5% THC). Its Board of Pharmacy has approved about 23 pharmacies to carry and dispense such products in attempt to expand access to medical marijuana (primary to rural patients ..read more

Since the new United States Pharmacopeia (USP) guidelines went into effect on November 1, 2023, I have been receiving many inquiries regarding their impact on compounders. Because the changes are fairly recent, compounders want to know how and when they must be fully compliant, what enforcement vehicles are in the government arsenals, and what types of resources they must have to comply with the new requirements. This post answers some of these questions by summarizing major changes and discussing some of the pitfalls on the way to compliance. On the other hand, this post does not go into any ..read more

Due to the new Medicare Part D requirements effective the next year, direct and indirect remunerations (DIR) fees – that are so favored by PBMs – must be included and deducted from reimbursements at point-of-sale. In other words, starting with 2024 (still unclear when exactly), there will be no more retroactive DIR fees. Currently PBMs recoup DIR fees at a much later date after the actual claim adjudication. In 2024, PBMs will be implementing something known as “Double DIR Cliff” when PBMs will be deducting DIR fees retroactively but at the same time at the point-of-sale. Many experts anticip ..read more

“Climate change is the single biggest threat to our world and health.” The International Pharmaceutical Federation’s address to the WHO A recent episode of “The Business of Pharmacy” podcast made me think about the environmental impact and sustainability of a pharmacy. In the episode, Mike Koelzer interviewed Melinda Su-En Lee – a co-founder of Phill Box – about her company’s mission to make pharmacy packaging more sustainable. This made me think of the environmental impact and all the waste generated by the pharmacy industry. I am very thankful to Mike and Melinda for bringing up this subjec ..read more

This year the American Society for Pharmacy Law (ASPL) is organizing its annual conference in San Antonio November 2-5. To register or to check out the schedule, please go to the conference website. Some of the highlights of the conference: a discussion of the impact of Rutledge v PCMA by Arkansas Lieutenant Governor Leslie Rutledge an overview of pharmacy law changes presented by the Executive Director of the National Association of Boards of Pharmacy a discussion of the post-Dobbs arena a presentation on the 340B program compliance pharmacy pricing compliance. and many more. This is one o ..read more

As many of you know, the U.S. Department of Health and Human Services (HHS) has recently recommended rescheduling marijuana from Schedule I to Schedule III under federal law. The DEA has the final say here but a review of healthcare news shows that most commentators believe that the DEA will follow the recommendation and will start the rescheduling process, which involves a notice and comment period (so it will not happen any time soon). What happens if marijuana is rescheduled? I haven’t considered all the implications involved until I came across an article by Harris Bicken “Marijuana as Sc ..read more

DEA regulations require DEA registrants to notify their local Field Division Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of such. Registrants must complete and submit to their local DEA Field Division a DEA Form 106 regarding the theft or loss. Prior to July 24, 2023, registrants were submitting Form 106 within one business day of discovery of the theft or loss. But effective July 24, 2023, registrants have 45 days to submit the form. An important caveat: registrants must still report the theft or significant loss with ..read more

I recently assisted a pharmacy in a PBM audit where we had to address unauthorized refills. The PBM was recouping a substantial amount of money because a medical assistant was signing refill authorizations. While medical assistants often sign for refills, they need do so with their supervising prescriber’s credentials. California law defines medical assistants as persons who may be unlicensed and who perform basic administrative, clerical, and technical supportive services for a licensed prescriber. This means that they cannot prescribe and cannot authorize a refill. The California Medical Bo ..read more