Baucus Healthcare Bill Amends Medicare Anti-Kickback Provision

We at FCDB read H.R.3200, “America's Affordable Health Choices Act of 2009,” earlier this year (well okay, perhaps we didn’t “read” it all, maybe skimmed is a better description) and were surprised to find that it appeared to add nothing to our nation’s ever-growing corpus of criminal provisions. Well, yesterday, Montana Senator Max Baucus released the long-awaited America’s Healthy Future Act, better known as the “Baucus Bill,” the text of which can be read here, which does contain an alteration of note to existing criminal law . We’ll leave it to others to outline all the proposed changes to the nation’s healthcare industry.
 

The most notable change by the Baucus Bill is amends the Medicare Anti-Kickback statute, 42 U.S.C. § 1320a-7b(b), which makes it illegal to “knowingly and willfully” solicit or receive any remuneration for referring an individual to a person for the purpose of furnishing any item or service for which payment may be made in whole or in part under a Federal health care program; or in return for purchasing, leasing or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program; or to “knowingly and willfully” refer an individual to a person for the furnishing any item or service for which payment may be made in whole or in part under a Federal health care program; or purchase, lease or order any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program. The Bill proposes to “amend the Anti-kickback statute to add language defining “willfully” as “a person acted voluntarily and purposefully to do what the law forbids and the person need not have actual knowledge of the law or specific intent to violate that law.” The Bill does not give the reason for the change, but it is undoubtedly to foreclose some defense or close some loophole which has arisen in practice or actual cases.

 

Pfizer Enters Largest Healthcare Fraud Settlement in U.S. History

Pharmaceutical giant Pfizer, inc., will pay $2.3 billion to the Federal government and 49 States to settle allegations that it violated federal regulations in promoting several drugs, as reported by the Atlanta Journal-Constitution. The settlement is the largest in U.S. history to date in a healthcare fraud case. 

Georgia will receive $21.7 million as part of the settlement. A spokesperson for the Georgia Attorney General's office told the media that Georgia's portion of the settlement funds would be earmarked for Georgia's Medicaid program.

The U.S. Department of Justice had accused the New York-based pharmaceutical company and its subsidiaries of conducting marketing campaigns to promote drugs including Geodon, Lyrica, Zyvox, and no longer marketed Bextra, for uses not approved by the U.S. Food and Drug Administration. The government also alleged that Pfizer gave kickbacks such as cash, travel and entertainment to members of the healthcare industry in order to persuade them to prescribe these drugs and others, including Lipitor, Zyrtec and Viagra. The only State which did not join in the suit was South Carolina.

Pharmacia & Upjohn Co., a subsidiary of Pfizer, has pled guilty to a felony charge of violating the Food, Drug and Cosmetic Act, and will pay a fine of $1.3 billion.