April 30, 2021 by Shannon Cox and Stephen Cummings
King & Spalding
April 26, 2021, Opinion
Retail pharmacy operations present significant regulatory risks. In particular, most pharmacies are enrolled as Medicare and Medicaid providers and are therefore subject to complex requirements governing the submission of claims to these government health care programs. Failure to comply with these requirements can result in civil monetary penalties and even exclusion from participation in federally
July 27, 2020 by Amy Boring and Stephen Cummings
COVID-19, opioid epidemic
July 27, 2020, Opinion, Uncategorized
As prescription drug abuse has grown into the “opioid epidemic” we are currently faced with, the Drug Enforcement Administration and state regulatory and law enforcement authorities have significantly ramped up their enforcement efforts across the entire pharmaceutical supply chain. For pharmacists, there has been an increased focus on a pharmacist’s “corresponding responsibility” to prevent the
May 1, 2020 by Shannon Cox and Stephen Cummings
COVID-19, retail pharmacies, Shannon Cox, Stephen Cummings
April 27, 2020, Opinion
The rapid spread of the COVID-19 virus has placed an enormous strain on the U.S. health care system, and we can expect that the pandemic will continue to impact retail pharmacies for the foreseeable future. In addition to the wide range of operational challenges facing retail pharmacies, the COVID-19 virus has sparked a number of
August 15, 2019 by Shannon Cox and Stephen Cummings
2018 Farm Bill, cannabis, Epidiolex, Food and Drug Administration
August 12, 2019, Opinion
There is a growing public focus on the potential for legitimate pharmacological uses of cannabis. Much of this focus has been directed toward medical marijuana — the use of marijuana in plant form or its basic extracts. Although some states have legalized its use, the Food and Drug Administration has not approved marijuana in plant
May 11, 2018 by Stephen Cummings and Shannon Cox
pharmacy regulatory issues, Shannon Cox, Stephen Cummings
Opinion
In the current regulatory environment, it is imperative that a pharmacy maintain a robust regulatory compliance program in order to avoid the potentially significant legal and regulatory pitfalls. Because state boards of pharmacy act as a pharmacy’s primary regulator, the state pharmacy laws and pharmacy board rules are the regulatory requirements that pharmacy staff and
August 15, 2017 by Shannon Cox, Stephen Cummings and Chain Drug Review
controlled substance diversion and abuse, Controlled Substances Act, King & Spalding, pain medication abuse, pharmacy industry, prescription drug abuse, Shannon Cox, Stephen Cummings
Opinion
The United States is battling what the Centers for Disease Control and Prevention (CDC) has labeled an epidemic of prescription drug abuse. According to CDC data, drug overdose deaths more than doubled between 2002 and 2015 (the latest year for which information is available). In 2015, drug overdose deaths exceeded 50,000 — which is more
May 9, 2017 by Shannon Cox, Stephen Cummings and Chain Drug Review
DIR fees, direct and indirect remuneration, H.R. 1038, King & Spalding, Medicare Part D, S. 413, Shannon Cox, Stephen Cummings, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act
Opinion
Direct and indirect remuneration (DIR) is one component of the complex Medicare Part D payment system. In the past several months, the issue of DIR increasingly has become a source of contention between various players in the Part D program. Pharmacies, the Centers for Medicare and Medicaid Services (CMS), and members of Congress have expressed