Examination of Health Care Laws

Purdue Pharma's Role in the Opioid Crisis
Introduction
The court case of US v. Purdue Pharma is a case that focuses on the Anti-Kickback Statute, which holds it a felony for an entity to accept kickbacks for providing services or items that are reimbursable by a federal program (Baird, 2021). Part of the problem with this case and others like it is that not everyone agrees on what constitutes a kickback. For example, Illiparambil (2020) writes in the Brookly Law Review that pharmaceutical “donations” should not be viewed as kickbacks—even though prosecutors could and have made the case that they act as such. However, kickback laws have been in existence for decades, the first going all the way back to 1931 (Raspanti, Roberts & Bosick, 2017). Today, the Anti-Kickback Statute has led to prosecutions and settlements with pharmaceutical companies like Purdue Pharma for over half a billion dollars (Kraschel & Curfman, 2019). Indeed, the Anti-Kickback Statute is a costly one to violate, with offenders liable for $100,000 per violation if convicted (Gore, 2020). Part of the problem is that the culture of health care today focuses so much on treatments that industries like the pharmaceutical industry thrive because they know there is a market for their drugs, which serves as treatments for illnesses. It therefore becomes just a matter of getting their drugs into the hands of health care providers who then prescribe them to patients—and to do that requires some incentive, such as a rebate or donation.
The Anti-Kickback Statute’s Importance
When judged with respect to the Anti-Kickback Statute it becomes a controversial practice, and one that Purdue Pharma has engaged in for years to get OxyContin into the hands of prescribers. The Anti-Kickback Statute makes it illegal for a company to deliberately provide payment in return for referral of patients or services—such as the prescription of a drug that a company makes (Gore, 2020). This statute is in place to prevent any conflict of interest from arising in the health care industry. The industry is supposed to put people first—not profit—but when there are for-profit companies like Purdue Pharma with billions invested and billions more on the line, it does become about profits. Making the most profit by getting health care providers to prescribe a drug like OxyContin is the name of the game for these companies. They try to get around the Anti-Kickback Statute by claiming that their rebates or donations are charitable or good-will actions and have no bearing on whether the provider prescribes the drug the company produces.
The statute is important because patients have a right to know that they are receiving care that is in their best interest as opposed to the best interests of a for-profit company that looks to exploit their illness so that it can sell a drug to them. In a free market system, the best treatments will naturally be in demand; but because it is a competitive industry, companies try to push their products in the market by getting providers to prescribe them—and this is where the kickbacks come into play. Purdue Pharma was sending its sales reps to providers and making arrangements with them to push OxyContin onto patients in exchange for kickbacks; Purdue Pharma was just one of many pharmaceutical companies engaging in this practice throughout the 2000s as the opioid epidemic grew (Rios, 2019).
Purdue Pharma
Yet for Purdue Pharma, whose case is currently in the courts, it is clear to many observers that the company has violated the Anti-Kickback Statute. Many journalists have reported on the actions the company took to get its drug to market. The drug itself was so potent that it helped to spawn the opioid crisis that ravaged the nation a decade ago. Today, Purdue Pharma is facing lawsuits in several states for its role in perpetuating that crisis. Its alleged violation of the Anti-Kickback Statute is but one part of a much larger story about the pharmaceutical industry taking advantage of the illness of patients to market and profit from the prescription of a drug that many observers say is unnecessarily potent (Rios, 2019).
Purdue Pharma took advantage of the pain that patients were in to sell a powerful drug—that is the allegation and the consensus view of the public, looking back on the opioid crisis that ravaged the nation (Rios, 2019). As Purdue Pharma faces a host of corruption charges, the Anti-Kickback Statute violation is one that appears to be especially pernicious, yet also one that is all too often occurring because of the very nature of the industry today. It is an industry that is too focused on treatment and not focused enough on prevention.
What a Hospital Could Do to Protect Itself
In order for a facility to protect itself from violating a law like this, the first thing to pay attention to is culture. What culture has the hospital cultivated? Are its employees susceptible to bribes or kickbacks from companies like Purdue Pharma? These are questions that must be asked.
The best way to prevent this kind of crime from occurring is to address the culture that makes it possible for this type of activity to gain traction. The health care industry should be in the business of administering preventive care rather than always focusing on treating illness. In fact, the Affordable Care Act specifically mentioned the need to increase preventive health care. Yet because the pharmaceutical industry produces drugs like OxyContin that it can only sell if the climate is geared towards “treating” illness rather than preventing it, the environment in which kickbacks become a temptation is simply fostered. That environment has to be neutralized. It can be neutralized by shifting the focus of the industry as a whole towards preventive care.
Patients should be put first in the hospital, and that should be an organizational aim, stated clearly in the hospital’s vision and mission statements, and made essential to the code of ethics that the hospital promotes. It is when organizational culture erodes and people began putting their own interests first that problems emerge. When people begin engaging in Ethical Egoism, the organization is in trouble.
Purdue Pharma has fallen afoul of the law because it has lost sight of the need to put people before profits, and the providers who took kickbacks from Purdue Pharma lost sight of that mission as well. Health care is about looking out for the patient—not about enriching oneself through exploitative practices. The Affordable Care Act deliberately targeted that notion of self-enrichment.
How Organizational Leadership Could Move Forward
Purdue Pharma’s organizational leadership has all but abandoned the mission to move forward as the company now appears to be sunk under the weight of its legal troubles. However, were it still able to climb out from under the many lawsuits holding it down, its organizational management would have to address the culture situation at the heart of the problem. To ensure that the health care law of the Anti-Kickback State is not violated again in the future, the company would have to be very careful about how it engaged providers and how it promoted the prescription of its products.
Clearly it could not go back to its old methods. What then could it do in a competitive industry? This is a problem for many pharmaceutical companies because so many of them are focused on treatment rather than on prevention. Preventing poor health is not on their radar because if everyone is assisted in maintaining their health, the entire “treatment” industry would collapse and so too would the profits. It is therefore a matter of the organizational culture recognizing the true aim of health care and finding a way to pivot within that aim to give providers what they need so that they can help patients engage in preventive care.
Conclusion
Protecting the health of patients and securing their rights are the reasons health care laws are passed in the first place. The Anti-Kickback Statute was passed to prevent companies from taking advantage of patients by way of providers who might accept payoffs in order to push a drug or service or device onto a patient even if the patient did not need it. That appears to have been the case with Purdue Pharma, which sought to market the ultra-strong OxyContin by getting providers to prescribe it even though it was not needed by patients. The public began to notice when the opioid abuse spun out of control and people became addicted to the drug that Purdue Pharma was creating and using kickbacks to get to market. Underlying this problem, however, is the problem of culture: health care needs to get back to preventive medicine rather than focusing so much on treatments. That was one of the goals of the Affordable Care Act and it is one that hospitals need to embrace so that they do not become ensnared in violations of the Anti-Kickback Statute.
References
Baird, J. (2021). Recent federal case—Medicare AntiKickback Statute. Retrieved from https://medtrade.com/news/billing-reimbursement/Recent-Federal-Cases-Medicare-Anti-Kickback-Statute/
Gore, A. (2020). Exposing the Middlemen in Rising Drug Costs: Modifying Safe Harbor Protections for Pharmacy Benefit Manager Rebates Under Federal Anti-Kickback Statutes. Or. L. Rev., 98, 297.
Illiparambil, T. (2019). Pharmaceutical Philanthropy Or Resisting Regulations?: Why Pharmaceutical Donations Do Not Violate the Anti-Kickback Statute. Brook. L. Rev., 85, 571.
Kraschel, K., & Curfman, G. (2019). Patient Assistance Programs and Anti-Kickback Laws. Jama, 322(5), 405-406.
Raspanti, M. S., Roberts, D. E., & Bosick, P. G. A. (2017). A Practitioner’s Primer on the History and Use of the Federal Anti-Kickback Statute. Retrieved from https://www.falseclaimsact.com/wp-content/uploads/2018/02/MSR-DER-A-Practitioners-Primer-on-History-and-Use-of-Federal-Anti-kickback-Statute.pdf
Rios, K. S. (2019). Combatting the Opioid Epidemic in Texas by Holding Big Pharma Manufacturers Liable. . Mary's LJ, 50, 1353.