Focus On: Healthcare's Invisible Giants
The pharmacy benefit manager (PBM) industry is little known and less understood. But PBMs have a significant impact on public health and patient care, both through their ability to determine drug prices for government payers, private third-party payers, and patients, and through their ability to determine which drugs are available and affordable via formularies. Health law practitioners should recognize that PBMs exist and need to understand what PBMs' role is in the industry.
What's Left for Plaintiffs in Off- Label Pharmaceutical Promotion Cases After United States v. Caronia?
In the December 2012 United States v. Caronia
decision, the Second Circuit held that the prohibition and criminalization of certain types of off-label promotional speech by pharmaceutical companies and their representatives violates the First Amendment. In light of the significant settlements achieved by the federal government, third-party payors and consumer plaintiffs based on off-label promotional speech claims, many have wondered whether such claims have a viable future.
Focus On: Hospital Employment of Physicians
Physician employment at hospitals remains on a healthy growth path. Hospitals employed some 211,500 physicians in 2010, a 34 percent increase since 2000, according to the latest annual survey conducted by Merritt Hawkins.
Despite Setbacks, DOJ’s Criminal Enforcement of the False Claims Act and Related Statutes Marches On
The federal False Claims Act, 31 U.S.C. §§ 3729–3733, is a primary enforcement tool used by the U.S. Department of Justice (DOJ) to prevent fraud on the government relating to federal programs. Increasingly, the DOJ is steering its criminal enforcement program toward individuals and stepping up health care fraud investigations.
Pleading "Healthcare Fraud and Abuse" Under the False Claims Act
The healthcare industry alone accounted for over $9.5 billion in recoveries by the U.S. Department of Justice from Jan. 2009–Sept. 2012. Although the False Claims Act dates to the Civil War, the explosion of these types of cases is a more recent phenomenon—in FY 2012, the DOJ recovered nearly $5 billion; however, very specific pleading standards must be met, or the case is subject to dismissal on motion of the defendant.
Focus On: Federal Officer Removal
Under the Federal Officer Removal statute, set forth in 28 U.S.C§ 1442(a)(1), a federal court has jurisdiction over a civil action that is directed at "[t]he United States or any agency thereof or any officer (or any person acting under that officer) of the United States or of any agency thereof, in an official or individual capacity, for or relating to any act under color of such office."