As the opioid crisis continues to result in devastating consequences throughout the country, the U.S. Department of Justice (the “DOJ”) is broadening its opioid enforcement to all stakeholders involved in the opioid supply chain including,... Read More
Blogs & Articles | Community, Retail Pharmacies | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

On Thursday December 10, 2020, the Supreme Court of the United States (SCOTUS) issued a unanimous decision in the case Rutledge v. PCMA ruling in favor of the Petitioner, Leslie Rutledge, the Attorney General of Arkansas, and against the... Read More
Blogs & Articles | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Life Sciences | Pharmacy Law

On November 20, 2020, the Trump administration announced plans to scrap the Medicare Part D “rebate safe harbor,” which currently permits insurance middlemen called Pharmacy Benefits Managers (“PBMs”) to charge manufacturers substantial fees... Read More
Blogs & Articles | Industry | Life Sciences | Pharmacy Law | Plan Sponsor PBM Contract Services

Compounding pharmacies should be aware of recent developments in the law surrounding bioidentical hormone therapy (cBHT). In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

HHS Permits Out-of-State Telehealth Providers to Render Certain Services Nationwide     On December 3, 2020, the Department of Health and Human Services (“HHS”) announced a fourth amendment to its declaration under the Public Readiness and... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Telehealth and Telemedicine

The current United States marketplace for the regulation of pharmacy benefits is a patchwork of inconsistent (and in some cases non-existent) state laws, state and federal agency regulations, agency manuals and federal laws. Uniform state laws would... Read More
Blogs & Articles | Defending Pharmacies in PBM Audits | Life Sciences | Plan Sponsor PBM Contract Services

The continuing COVID-19 pandemic has caused most business operations to go virtual, and PBMs have followed this trend. Earlier this year, we reported that PBMs had briefly suspended audits of pharmacies in an alleged effort to ensure pharmacies were... Read More
Blogs & Articles | Community, Retail Pharmacies | COVID-19 Resources | Defending Pharmacies in PBM Audits | Life Sciences