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Boesen and Snow Secures Back-to-Back PBM Network Termination Reversals.

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 …

Group Purchasing Organizations (GPOs) Can Help Small Pharmacies Level the Playing Field

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. …

USP General Chapter Revisions for 795 and 797 Published Today (November 1, 2022)

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 …

PBM Audits Move Fast. Start Preparing Your Defense Today!

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.  …

Discussing Compliance Issues Associated With Infusion Therapy Services

 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, …

Boesen and Snow Successfully Appeals PBM Network Termination.

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 …

FDA Announces Proposed Rule Updating the Current 10-Digit NDC Format to a 12-Digit Standardized Format

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 …

The Post-Roe Reproductive Health Landscape: A Supreme Court Opinion, Executive Order, and Now, Agency Guidance.

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 …

The Importance of Licensees Updating Regulatory Agencies of Certain Events

Has something changed in your life?  Have you moved?  Did you change jobs?  Did you sell all or part of your business or hire a new licensee?  If the answer is yes, the regulatory agency that issued your professional license probably wants to know about it. Address of Record Professional regulatory agencies generally require licensees …

CMS Final Rule Phases Out PBM’s Ability to Retroactively Apply DIR Fees

CMS recently published “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; etc,”, effectively ending the retroactive application of direct and indirect renumeration (DIR) fees by Prescription Benefit Managers (PBM’s). DIR fees will now be required to be included in the negotiated price the patient pays at the …