Drug Enforcement Administration extends COVID-19-Based Controlled Substance Prescribing Policy In a document scheduled published in the Federal Register May 10, 2023, the Drug Enforcement Administration (“DEA”) extends through November 11th the so-called “COVID” exception to the Ryan Haight Act and DEA’s implementing regulation (21 U.S.C. 802(54)(D)). The regulation at issue requires a prescriber to conduct …
Boesen & Snow recently helped a client after a competitor posted a false, negative review online. Our client, a physician with her own practice, worked hard to establish a stellar reputation among her clients and was the recipient of multiple professional and community awards. She was shocked to discover that more than one person gave her …
The cosmetic services industry is booming. While these businesses can be lucrative, they are full of hidden perils for licensed professionals. Today’s Medical Spas are, as the name suggests, engaged in the practice of medicine, and are governed by the same laws that regulate “medically necessary” prescriptions and procedures. A physician or nurse practitioner considering …
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PBMs are constantly expanding and changing the scope of their audits to find new avenues for revenue generation and new grounds for network termination. One area that seems ripe for expanded scrutiny by the PBMs is Drug Supply Chain Security Act (DSCSA) track and trace documentation. In addition to checking the license status and FDA registration, …
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Is Your Pharmacy Ready for the DSCSA Full Implementation Deadline of Nov. 27, 2023? Don’t wait until the last minute to ensure your pharmacy is compliant with the DSCSA full implementation deadline. In an effort to protect patients from illegitimate, counterfeit, or otherwise harmful drugs, this DSCSA imposes some new responsibilities on pharmacies. By this …
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In successive weeks, Boesen and Snow has obtained two favorable decisions through a PBM’s Appeal Hearing Process that reversed Network Terminations due to audit findings. The firm collaborated with each client to prepare thorough responses to initial and final audit findings and termination appeal hearing presentations that convinced the PBM to quickly rescind the decisions …
Continue reading “Boesen and Snow Secures Back-to-Back PBM Network Termination Reversals.”
Independent pharmacies and other small healthcare businesses are often at a disadvantage when competing with large pharmacy chains and businesses. Larger chains can leverage their size to secure substantial discounts from manufacturers and suppliers not available to smaller businesses. However, tools such as Group Purchasing Organizations (GPOs) can help small businesses level the playing field. …
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)”
Don’t Wait! Build a relationship with an Experienced Pharmacy Law Team One of the more stressful parts of going through Pharmacy Benefit Manager (PBM) audit is that, by the time the average pharmacy hires experienced pharmacy law attorneys to defend their business, there may only be two weeks or less to formulate a successful response. …
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Compliance Issues Associated With Infusion Therapy Services In-home infusion therapy services in major metropolitan centers are trendy and popular. Some of these business ventures serve traditional patient populations. Others market themselves as “wellness services” and offer rehydration and custom vitamin cocktails for people who are working or playing hard. While these businesses can be profitable, …
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