Recently, the Centers for Medicare and Medicaid Services (CMS) announced the list of the first ten drugs that will be subject to Medicare price negotiations under the Inflation Reduction Act (IRA), signed into law by President Biden in 2022. Under the Act, Medicare can directly negotiate the prices of certain high expenditure, single source drugs …
California requires pharmacies, wholesalers, and manufacturers to comply with regulations that facilitate consumer disposal of pharmaceutical and home-generated sharps waste. The program, administered through CalRecycle, requires manufacturers and wholesalers to identify themselves and their products and to engage with approved stewardship organizations to implement disposal programs. Although the bulk of responsibility lies with wholesalers and …
Continue reading “Pharmacy Compliance with CalRecycle Pharmaceutical and Sharps Stewardship Program”
Navigating a Pharmacy Benefit Manager (PBM) audit or enrollment application on your own can be overwhelming. PBM audits rely on voluminous requests for documentation under strict and tight deadlines. Incomplete or late responses will guarantee financial chargebacks and risk more catastrophic consequences, including payment suspensions or network terminations. Successfully navigating PBM enrollment applications is critical …
Boesen & Snow Convinces Arizona State Board of Pharmacy to Rescind June 2023 Vote to Enforce November 1, 2023, Compendial Publication of USP General Chapters ‹795›, ‹797›, and ‹800› and Assign a Task Force to Evaluate Phoenix, AZ — “If 90 percent of the compounding pharmacies decide not to compound anymore, close their doors, Arizona …
Continue reading “Boesen & Snow Convinces Arizona State Board of Pharmacy to Rescind Vote”
In an era of ever-evolving technology and data management, the Health Insurance Portability and Accountability Act (HIPAA) remains a cornerstone of protecting patient privacy and safeguarding sensitive medical information. As healthcare practices continue to digitize their operations and patient records, Health and Human Services’ Office of Civil Rights has proposed new HIPAA privacy rules to …
Continue reading “Proposed HIPAA Rules Pose New Challenges to Healthcare Providers”
In the fast-paced and competitive business landscape, safeguarding your company’s intellectual property and confidential information is of utmost importance. When engaging a consultant to protect your work product, ensuring that their communications and findings are privileged and not discoverable can provide a significant advantage. Let’s explore the key benefits of this approach and why it …
In the world of Pharmacy Benefit Manager (PBM) enrollment, guilt by association is one of the most common reasons PBM’s deny new pharmacy owners network access. Boesen & Snow often represents new clients who come to the firm with PBM enrollment denials due to alleged common associations with persons or entities with significant audit findings …
Continue reading “PBM Enrollment Denials for Common Association Regardless of Acquisition Structure”
Novo Nordisk filed lawsuits against multiple med-spas that are distributing compounded versions of Semaglutide. Semaglutide is the main ingredient in Ozempic, Wegovy, and Rybelsus—popular weight-loss medications. Their popularity resulted in nationwide shortages and the FDA listing Ozempic and Wegovy on the shortage list. Under certain conditions, compounding facilities can manufacture drugs identical, or near identical, …
The Role of Pharmacy Benefit Managers In Prescription Drug Markets Earlier in March, Boesen and Snow had the privilege of meeting with members of the House Committee on Oversight and Accountability including Chairman of the House Oversight Committee James Comer (R-KY.), Raja Krishnamoorthi (D-IL.), and Andy Biggs (R-AZ) to discuss the role PBMs play in …
Can a law in your home state protect you from prosecution or a civil suit in another state? Recently, several states such as California, New Mexico, Massachusetts, New York, and Vermont passed laws designed to shield healthcare entities that provide abortion services from criminal and civil liability in states that restrict such services. These laws …
Continue reading “Can Your Home State Protect You from Neighboring States’ Laws”