WHISTLE-BLOWERS
The Latin term qui tam essentially means "he who sues on behalf of the 'king' as well as for himself." Although the term is Latin, the legal practice has its origins in English law, which is now referred to as the "Common Informers Act of 1951." In the United States, the equivalent is termed the False Claims Act, which was instituted in 1863 because of "price gouging" during the US Civil War. Today, those who file a suit on behalf of the Federal Government and themselves under the False Claims Act may be referred to as "whistle-blowers," and they are entitled to potentially 20% to 30% of the moneys recovered by the federal government.
MARKETING AND SAFETY
In September 2009, a former Pfizer Inc sales representative was awarded $51.5 million for his role as a whistle-blower in the investigation of Pfizer's marketing practices of Bextra, a nonsteroidal anti-inflammatory drug. Pfizer pled guilty to various civil and criminal charges and paid in total $2.3 billion to the government, ostensibly the largest criminal fine ever paid in the United States for any circumstances. In the case of Bextra, significant harm and the potential for infringement on patient safety were evidenced and Bextra was subsequently removed from the market.
OFF-LABEL USES
Another vantage point from which to blow the whistle is the practice of "off-label" uses for Food and Drug Administration (FDA)-approved drugs. For example, Botox was approved by the FDA only for very narrow and specific medical uses. Yet recently, Allergan, Inc, the maker of Botox, was fined $600 million as part of a settlement for marketing practices that were aimed at influencing physicians to utilize Botox for off-label uses, such as migraine headaches.
WOUND CARE
The justice department reports that a fine of $641 million from HCA, Inc (formerly known as Columbia/HCA and HCA-The Healthcare Company) for cost report fraud, the payment of kickbacks to physicians, and overbilling Medicare for HCA's wound care centers. This settlement concluded litigation in numerous qui tam lawsuits, as well as separate investigations initiated by the government. Along with an earlier civil settlement and criminal guilty plea reached in 2000, as well as a related administrative settlement with the Department of Health and Human Services, HCA has paid the United States $1.7 billion, with whistle-blowers receiving a combined share of $154 million-by far, record recoveries by both the United States and whistle-blowers.
THIRD-PARTY ADMINISTRATORS
One method the government is using to monitor the cost and safety of patient care is through so-called third-party administrators (TPAs) or intermediaries. Essentially, these TPAs have contracts with the payers to ensure the services are medically necessary, are covered by the plan, and are coded and billed in an appropriate manner. The TPAs have been labeled by some as "bounty hunters." The ability to pay them for their services is rooted in the savings to the payers through oversight and denying unneeded services. This practice may preclude all of the behaviors that lead a minority of practitioners and organizations to skirt the rules.
SUMMARY
Obviously, these cases are complex and to say they are expensive to litigate is an understatement. The resources involved in these cases are huge with less than ample information as to how these netted resources are redirected back into education, research, and most importantly, to enhanced patient benefits. While the aforementioned cases are not specific to wound care, they frame the issues. Overenthusiasm about healthcare products and the sources of revenue linked with ambitious marketing of the product, the revenue associated with the excessive delivery of the product, and the division of rewards, as with qui tam actions, are depriving our patients full access to the "healthcare dollar." Healthcare practitioners and healthcare organizations operate under the public trust and the honor system; however, new checks and balances will "trust but verify," as the popular phrase goes.
"Poverty wants much; but avarice, everything." -Publilius Syrus (Roman author, 1st century BC)
Richard "Sal" Salcido, MD
Selected References