The much anticipated USP General Chapter revisions for non-sterile and sterile compounding were published today. New and Updated Notices | USP-NF (uspnf.com) Please let us know if you need our firm of pharmacists, attorneys, and pharmacist-attorney to help your organization understand not just what the changes are, but more specifically how these will affect your …
Continue reading “USP General Chapter Revisions for 795 and 797 Published Today (November 1, 2022)”
Boesen and Snow recently secured the reversal of a major PBM’s decision to terminate a pharmacy from its network. Before the reversal, the PBM had rejected the pharmacy’s documentation refuting the audit findings and had quickly issued its termination letter. Boesen and Snow collaborated with the pharmacy client to obtain and provide overwhelming evidence to …
Continue reading “Boesen and Snow Successfully Appeals PBM Network Termination.”
On July 22, 2022, the FDA announced a proposed rule changing the current 10-digit NDC format to a 12-digit standardized format. This is due to the limited number of new 5-digit Labeler Codes estimated to run out in the next 10 to 15 years. Current regulations require a 5-digit Labeler Code, 3 to 4-digit Product …
Last week, President Biden issued an Executive Order (“Order”) on protecting access to reproductive healthcare services. Part of the Order called upon the Department of Health and Human Service (“HHS”) to identify potential actions to protect and expand access to reproductive healthcare services through outreach, education, promote awareness, and steps to ensure patients receive protections …
Boesen & Snow recently participated as co-counsel for a pharmacy that was the subject of a Board of Pharmacy complaint related to delivering pandemic related, patient-specific medication orders written pursuant to a telemedicine encounter. The concern of the Board of Pharmacy was whether the prescription orders were issued pursuant to a prescription order by a …
Effective January 1, 2022, at least one of the major PBMs has updated language related to the billing of specific NDC numbers the PBM considers “Aberrant.” The revised list of NDCs was sent to network pharmacies and includes a list of “Practices and Trends” prohibiting dispensing activities. The revised language, while vague, creates multiple pitfalls …
Beginning on December 15, 2021, a major PSAO’s network of pharmacies will no longer be part of TRICARE’s pharmacy network, which is managed by Express Scripts, due to a contract dispute between TRICARE and the PSAO. TRICARE members currently receiving prescriptions from affected Pharmacies have already received notification from TRICARE of the upcoming change. If …
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Boesen and Snow successfully assisted an independent specialty pharmacy appeal the findings of a major PBMs desktop audit. The preliminary audit consisted of over $1,000,000 in discrepancies, most of which the PBM considered unappealable. Boesen and Snow utilized a multifaceted argument to appeal the “unappealable” claims including a unique presentation of prescription documentation, prescriber statements, …
FROM APC: Judge rules in favor of compounders, against FDA in lawsuit over MOU A federal district court judge has issued a summary judgment<https://a4pc.org/files/2021-09-21_MOU-Order.pdf> in favor of a group of compounding pharmacies, ruling that FDA’s MOU on interstate shipments of compounded drugs violated the law, and the agency cannot enforce it. The MOU will be …
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Pharmacy Benefit Managers (PBMs) are continuing to fight against state regulation. On Tuesday, the Pharmaceutical Care Management Association (PCMA) filed a new brief with the Eighth Circuit Court of Appeals in opposition to North Dakota Century Code sections 16.1 and 16.2. In 2017, the North Dakota passed legislation to regulate PBM practices including limiting the …
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