Health Care Fraud and Abuse: Lessons From One of the Largest Scandals of the 21st Century in the Field of Spine Surgery.

Up to hundreds of billions of dollars are annually lost to fraud and abuse in the US health care, making it a significant burden on the system. This study investigates a specific instance of health care fraud in spine surgery, in which a medical device company ended up paying $75 million to settle violations of the False Claims Act. We review the surgical background regarding the kyphoplasty procedure, as well as its billing and reimbursement details. We also explore the official legal complaint brought by the US Department of Justice to tell the story of how one of the most significant medical innovations in spine surgery in the 21st century turned into a widespread fraudulent marketing scheme. In the sequence, we provide a detailed root cause analysis of this scandal and propose some proactive measures that can be taken to avoid such type of unfortunate events. Ultimately, this historical health care scandal constitutes a valuable lesson to surgeons, health care administrators, medical device companies, and policymakers on how misaligned incentives and subsequent unscrupulous practices can transform a medical innovation into an unfortunate tale of fraud and deceit.

Insider Threats to the Military Health System: A Systematic Background Check of TRICARE West Providers.

Background: To address the pandemic, the Defense Health Agency (DHA) expanded its TRICARE civilian provider network by 30.1%. In 2022, the DHA Annual Report stated that TRICARE's provider directories were only 80% accurate. Unlike Medicare, the DHA does not publicly reveal National Provider Identification (NPI) numbers. As a result, TRICARE's 9.6 million beneficiaries lack the means to verify their doctor's credentials. Since 2013, the Department of Health and Human Services' (HHS) Office of Inspector General (OIG) has excluded 17,706 physicians and other providers from federal health programs due to billing fraud, neglect, drug-related convictions, and other offenses. These providers and their NPIs are included on the OIG's List of Excluded Individuals and Entities (LEIE). Patients who receive care from excluded providers face higher risks of hospitalization and mortality. Objective: We sought to assess the extent to which TRICARE screens health care provider names on their referral website against criminal databases. Methods: Between January 1-31, 2023, we used TRICARE West's provider directory to search for all providers within a 5-mile radius of 798 zip codes (38 per state, ≥10,000 residents each, randomly entered). We then copied and pasted all directory results' first and last names, business names, addresses, phone numbers, fax numbers, degree types, practice specialties, and active or closed statuses into a CSV file. We cross-referenced the search results against US and state databases for medical and criminal misconduct, including the OIG-LEIE and General Services Administration's (GSA) SAM.gov exclusion lists, the HHS Office of Civil Rights Health Insurance Portability and Accountability Act (HIPAA) breach reports, 15 available state Medicaid exclusion lists (state), the International Trade Administration's Consolidated Screening List (CSL), 3 Food and Drug Administration (FDA) debarment lists, the Federal Bureau of Investigation's (FBI) list of January 6 federal defendants, and the OIG-HHS list of fugitives (FUG). Results: Our provider search yielded 111,619 raw results; 54 zip codes contained no data. After removing 72,156 (64.65%) duplicate entries, closed offices, and non-TRICARE West locations, we identified 39,463 active provider names. Within this baseline sample group, there were 2398 (6.08%) total matches against all exclusion and sanction databases, including 2197 on the OIG-LEIE, 2311 on the GSA-SAM.gov list, 2 on the HIPAA list, 54 on the state Medicaid exclusion lists, 69 on the CSL, 3 on the FDA lists, 53 on the FBI list, and 10 on the FUG. Conclusions: TRICARE's civilian provider roster merits further scrutiny by law enforcement. Following the National Institute of Standards and Technology 800, the DHA can mitigate privacy, safety, and security clearance threats by implementing an insider threat management model, robust enforcement of the False Claims Act, and mandatory security risk assessments. These are the views of the author, not the Department of Defense or the US government.

Radiology residency oversight: A Qui Tam wake-up call.

Like every physician practice, academic radiology practices must pay heed to all governmental regulations. The federal False Claims Act serves to protect US taxpayers and requires strict adherence. Violations, often brought forth by whistleblowers, can carry steep financial repercussions.

Federal Enforcement of Pharmaceutical Fraud under the False Claims Act, 2006-2022.

CONTEXT: The False Claims Act is the US federal government's primary tool for identifying and penalizing pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs. METHODS: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions. FINDINGS: During fiscal years 2006-2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs. CONCLUSIONS: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation.

False Claims Act and Anti-Kickback Statute: Avoiding Legal Landmines.

Health care entities doing business with the federal government may run afoul of the False Claims Act and Anti-Kickback Statute not only when they directly submit fraudulent claims for government reimbursement but also when they create schemes that manipulate others into submitting (whether knowingly or unknowingly) illegal claims. In recent years, the Department of Justice is deploying these statutes to ensure that electronic health records are built and maintained with appropriate cybersecurity protections.

Industry Payments to Physicians Are Kickbacks. How Should Stakeholders Respond?

Payments from the pharmaceutical industry to US physicians are common. In determining which payments rise to the level of an illegal kickback under the Anti-Kickback Statute (AKS), the Department of Health and Human Services' Office of Inspector General (OIG) has stated in nonbinding guidance that influencing or "swaying" physician prescribing is key. OIG has highlighted as a compliance standard the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Professions, which stipulates that permissible payments are those that do not interfere with prescribing. However, recent evidence has shown that most payments influence physician prescribing, driving higher prescription drug costs by increasing use of brand-name and low-value drugs. This evidence implies that many payments that are currently commonplace could be subject to prosecution under AKS. Given that these payments increase costs to patients and the health care system, there is a public interest in curtailing them. This article proposes a range of actions available to stakeholders-including industry, providers, regulators, and payers-to mitigate the cost-increasing effect of industry payments to physicians.

Deterrence effects of antifraud and abuse enforcement in health care.

Estimates of the benefits of antifraud enforcement in health care typically focus on direct monetary damages. Deterrence effects are acknowledged but unquantified. We evaluate the impact of a Department of Justice investigation of hospitals accused of billing Medicare for unnecessary implantable cardiac defibrillator (ICD) procedures on their use. Using 100 % inpatient and outpatient procedure data from Florida, we estimate that the investigation caused a 22 % decline in ICD implantations. The present value of savings nationally over a 10 year period is $2.7 billion, nearly 10 times larger than the $280 million in settlements the Department of Justice recovered from hospitals. The investigation had a large and long-lasting effect on physician behavior, indicating the utility of antifraud enforcement as a tool for reducing wasteful medical care.

False Claims Act Liability for Overtreatment.

CONTEXT: Overtreatment is costly, but is it fraud? In a growing number of False Claims Act cases, the Department of Justice has sought and received multimillion dollar settlements from providers accused of billing Medicare for unnecessary care. This article evaluates the use of the False Claims Act as a tool for reducing overuse. METHODS: The author reviewed (1) recent cases where litigants sparred over the applicability of the False Claims Act to overtreatment, and (2) criticisms of the expanding use of the False Claims Act in health care. FINDINGS: Some judges have dismissed suits on the grounds that expert testimony regarding the necessity of treatment is insufficient for concluding Medicare claims were false or fraudulent. Other judges have let cases proceed, especially in instances where clinicians appear to have overstated the severity of patients' illnesses to justify treatment. Cases that lead to changes in medical practice may result in substantial savings to the Medicare program. CONCLUSIONS: Courts have struggled with how to apply the False Claims Act to overtreatment. False Claims Act cases that address unnecessary care are potentially less problematic than other types of cases that address technical violations with few implications for costs or quality.

Encouraging and Rewarding the Whistleblower in Research Misconduct Cases.

There are many pressures that militate against work colleagues "blowing the whistle" or "ringing the bell" on each other in respect of research misconduct. These pressures result in a significant proportion of such conduct not coming to light at all or coming to light later or less straightforwardly than is desirable. There need to be meaningful incentives for colleagues to draw to the attention of authorities concerns that they have about adherence by others to their obligations in relation to research integrity. The United States has a distinctive process under the False Claims Act which provides significant financial encouragement to such persons, known as "relators" under the qui tam scheme, including in the context of proven research misconduct. This editorial reviews prominent occasions on which qui tam actions have been taken and considers the ramifications of a US$112.5 million settlement arrived at in 2019 involving research misconduct at Duke University. It discusses the advantages and disadvantages of the incentives that lie at the heart of the United States False Claims Act and canvasses whether it should be emulated in other countries.

Health care fraud and abuse: market change, social norms, and the trust "reposed on the workmen".

Health care fraud and abuse reportedly account for 10 percent of total spending on health care, or about $120 billion per year. Not surprisingly, Congress has granted fraud control personnel sweeping powers with which to attack the problem. Unfortunately, effectively addressing health care fraud is exceedingly complicated, particularly in light of recent major changes in the medical marketplace and the social context of such conduct. Broadly speaking, physicians view such conduct as essential to ensure high-quality care; program administrators view it as the price of the program; fraud control personnel view it as criminal misconduct; and the public's view depends greatly on who is benefitting. Social norms regarding health care fraud vary among these groups as well. The article examines the practical and theoretical challenges associated with attacking health care fraud and the merits of the current fraud control regime in light of these considerations.

Health care fraud and abuse.

In recent years, health care fraud and abuse have become major issues, in part because of the rising cost of health care, industry consolidation, the emergence of private "whistle-blowers," and a change in the concept of fraud to include an emerging concern about quality of care. The 3 types of conduct that are generally prohibited by health care fraud laws are false claims, kickbacks, and self-referrals. False claims are subject to several criminal, civil, and administrative prohibitions, notably the federal civil False Claims Act. Kickbacks, or inducements with the intent to influence the purchase or sale of health care-related goods or services, are prohibited under the federal Anti-Kickback statute as well as by state laws. Finally, self-referrals-the referral of patients to an entity with which the referring physician has a financial relationship-are outlawed by the Ethics in Patient Referral Act as well as numerous state statutes. Consequences of violations of these laws can include, in addition to imprisonment and fines, civil monetary penalties, loss of licensure, loss of staff privileges, and exclusion from participation in federal health care programs. Federal criminal and civil statutes are enforced by the US Department of Justice; administrative actions are pursued by the Department of Health and Human Services' Office of Inspector General; and all state actions are pursued by the individual states. In addition, private whistle-blowers may, acting in the name of the United States, file suit against an entity under the False Claims Act. Enforcement of health care fraud and abuse laws has become increasingly commonplace and now affects many mainstream providers. This trend is likely to continue.