How Is Cardiac Overtreatment Regulated?
A substantial portion of my scholarship focuses on the government’s regulation of health care overtreatment—particularly in the context of the Medicare and Medicaid programs—and tackles the thorny problems posed by the challenge of regulating care that is allegedly lacking medical necessity. Specifically, this exercise focuses on how to define, how to prevent, and, finally, how to appropriately regulate, overtreatment. Commonly drawing on lessons from cases featuring cardiology and cardiologists, the legal regulation of overtreatment—typically defined as care that is inefficient, outdated, or unnecessary—primarily relies on application of the federal anti-fraud statutes.
Notably, prosecutors and regulators combat overtreatment through application of potent anti-fraud tools and civil monetary penalty provisions—relying primarily on the 155-year-old federal civil False Claims Act (FCA). As it relates to a typical overtreatment case, the FCA prevents either knowingly presenting a false claim for payment, or making a false statement material to a false claim, to the federal government. In an FCA health care case, the government alleges that when the provider bills Medicare or Medicaid and certifies that all care administered was medically necessary, but, according to federal prosecutors, some aspect of that care was actually lacking in medical necessity, the provider has violated the FCA by knowingly submitting a false claim.
In addition to the task of proving that the provider had requisite fraudulent intent to violate the FCA, overtreatment cases pose the major challenge of demonstrating falsity—that is, of proving that the care provided was lacking medical necessity. In many instances—and, in fact, many cases that feature cardiology—the determination of whether or not fraud took place (and whether the care was medically necessary) is a complicated analysis, one that is dependent upon medical expertise, resources and capabilities, and the individual presentation of the patient. Because the FCA carries with it rather draconian mandatory statutory penalty amounts that often quickly dwarf any amount the provider may have earned from Medicare or Medicaid, these cases can pose a high risk to the provider’s practice and career.
That these cases are difficult to prove illustrates the imperfect fit between the fraud statutes and the pervasive, multifaceted, and complicated problem of overtreatment. Using falsity and intent-based laws with powerful statutory penalties often achieves settlements with providers and institutions, but does not result in orderly legal precedent. A regulatory regime that relies on settlements lacks clear rules and notice, stunting the development of the fraud statutes themselves, and ultimately makes it difficult for providers to know which types of care are appropriate and which are not. This regulatory mechanism may threaten to stifle innovation and freeze the (often-developing) standard of care, further intensifying medical-legal dissonance. And while some providers are legitimately caught up in fraud investigations, providers who allegedly engage in overtreatment may lack the requisite intent to violate the powerful FCA. Because of this fact, and the challenge in proving that the care was not medically necessary, the legal regulation of overtreatment remains complex and murky.
While the anti-fraud statutes are the primary tool available to federal prosecutors to prevent and punish overtreatment, new government-supported initiatives also have an impact on preventing overtreatment. These initiatives include the use of newly-constructed payment models—many created through the embattled ACA—that seek to remove reimbursement incentives that still entice physicians to engage in overtreatment, applying “softer” pressure to physicians and hospitals and pushing them to administer more efficient care. Initiatives that feature the new buzzword of “value-based care” include Medicare’s Shared Savings Program (MSSP), accountable care organizations (ACOs), mandatory bundled payment initiatives, alternative payment models (APMs), and even Medicare’s new Merit-Based Incentive Payment System (MIPS)—that installs a new value-based regime for physicians who bill Medicare Part B. All of these initiatives seek to move providers and hospitals toward a newly-realized reimbursement regime that is primarily concerned with the efficient use of resources, holding down unnecessary cost, and constantly measuring and attending to quality. It is the hope of health policy officials that these new initiatives—through a mix of incentivizes and mandates—will push providers into administering more efficient, higher-quality care. In other words, these moves seek to directly combat the often high-cost, low-value care that characterizes overtreatment.
However, new moves by the Centers for Medicare and Medicaid Services (CMS) under the Trump administration may serve as indications that the federal government may be shying away from the march toward value-based care. Specific to cardiac care, CMS announced the cancellation of the mandatory Cardiac Rehabilitation Incentive Payment Model near the end of 2017, which would have provided additional payments for hospitals whose patients used rehabilitation services following an acute myocardial infarction (AMI) or coronary artery bypass graft (CABG). The now canceled initiative had hoped to save Medicare millions of dollars. The MIPS system also seems increasingly imperiled in 2018.
Nonetheless, while the horizon of value-based payment initiatives seems cloudy, the problem of overtreatment—and the legal responses to the pervasive challenge it poses—will continue to persist through a turbulent time for American health law and policy. The regulation of overtreatment will likely continue to pose challenges well into the future for providers, hospitals, and regulators.
Professor Zack Buck is an Assistant Professor of Law and Wilkinson Junior Research Professor at the University of Tennessee College of Law. He specializes in health law, and his scholarship examines governmental enforcement of laws affecting health and health care in the United States. Most recently, his writing has sought to evaluate how the enforcement of health care fraud and abuse laws impacts American quality of care, with a particular focus on the legal regulation of overtreatment. He has been published extensively in law reviews and journals.
At the University of Tennessee, Professor Buck teaches bioethics and public health seminar, torts, health care finance and organization, health care regulation and quality, and fraud and abuse.
Professor Buck formerly practiced complex commercial litigation at Sidley Austin LLP in Chicago.
He earned his JD at the University of Pennsylvania Law School and his Masters in Bioethics at the University of Pennsylvania School of Medicine.