Karen Owen Gibbs
Subscribe to Karen Owen Gibbs's PostsKaren Owen Gibbs joined McDermott in 2014 after serving as Vice President and Senior Counsel at CVS Health (formerly CVS Caremark), a Fortune 20 integrated pharmacy company. Karen advises a wide variety of health care companies, investors and lenders on operational, regulatory and enforcement issues related to all aspects of the pharmacy distribution chain. Her practice also covers synergistic areas such as substance abuse/behavioral health, physician and veterinarian office dispensing, evolving requirements related to opioid prescribing and dispensing, and a wide variety of prescription reimbursement issues. Read Karen Owen Gibbs' full profile.
DEA Proposes Regulations for Emergency Medical Services Agencies
By Karen Owen Gibbs on Oct 8, 2020
Posted In Hospitals & Health Systems, Life Sciences
On October 5, 2020, the US Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking establishing a registration category for emergency medical services (EMS) agencies and more generally implementing the requirements of the Protecting Patient Access to Emergency Medications Act of 2017. The majority of the proposed regulations closely track the Act. For example,...
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Bills Ban Gag Clauses in Pharmacy Contracts
By Judith Wethall and Karen Owen Gibbs on Oct 18, 2018
Posted In FDA, Hospitals & Health Systems, Reimbursement
On October 10, 2018 President Trump signed two bills that ban “gag clauses” in pharmacy contracts. Congress passed the two bills—one for Medicare prescription drug plans (“Know the Lowest Price Act”) that will go into effect in January 2020, and another for commercial employer-based and individual policies (“Patient Right to Know Drug Prices Act”) effective...
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Q&A: Shifting Trends in Specialty Pharmacy to Continue in 2018
By McDermott Will & Emery and Karen Owen Gibbs on Apr 10, 2018
Posted In FDA, Health M&A, Health Private Equity, Hospitals & Health Systems, Life Sciences, PPM/ASC
Specialty pharmacy is not going away any time soon – by 2020, it’s expected that the pharmacy industry’s revenue will exceed $483 billion, with almost all growth as a result of specialty drugs (high-cost medications used to treat chronic conditions, such as cancer). It’s also estimated that the next generation of pharmaceutical “blockbusters” will be...
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