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
As the retail pharmacy industry responds to the COVID-19 pandemic, companies in this space have had to keep in mind a variety of regulatory and enforcement concerns. Top among those are the threat of both government enforcement actions and private party civil litigation raising allegations of price gouging. In addition to forcing operational modifications to
The U.S. health care system does not work well for patients or providers. We now pay twice as much as other developed countries for health care, and the Centers for Medicare & Medicaid Services (CMS) expects Americans will spend $1 out of every $5 on health care by 2025. Our country does not get much
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
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
The January 20, 2017, inauguration of President Trump as the nation’s 45th president is certain to bring with it changes in the health care environment, which may impact pharmacy in a variety of ways. As important as the new administration, however, is the fact that a “unified” government will take over in Washington, with Republicans
A regulatory inspection by the Drug Enforcement Administration or a state board of pharmacy can be a high stakes event. Penalties for violations of the federal Controlled Substances Act may include criminal penalties, significant civil monetary fines and administrative action up to and including a “show cause” proceeding to suspend or revoke a pharmacy’s controlled
On February 1, 2016, the Centers for Medicare & Medicaid Services (CMS) released its Final Rule interpreting the provisions of the 2010 health care reform law that address the Medicaid Drug Rebate Program (MDRP). While much of the Final Rule speaks to drug manufacturer rights and responsibilities in the MDRP, significant portions are directly applicable
