fraud and abuse
The United States spends more money per person on health care than any other country, approximately $4.2 trillion in 2021. Unfortunately, our complex health care system and the large budget make fraud a significant concern for the U.S. Government, payers, and patients. The National Healthcare Anti-Fraud Association estimates that as much as 10% of annual healthcare spending is lost to scams, resulting in billions in losses yearly. To combat healthcare fraud, the Department of Health and Human Services Office of the Inspector General, in collaboration with state law enforcement and other governmental agencies has created special Strike Forces. These efforts have led to substantial recoveries of federal funds and criminal/civil prosecution of individuals or entities involved in Medicare and Medicaid fraud. Besides avoiding unnecessary or fraudulent claims, individual healthcare payers are motivated to prevent fraud due to severe penalties associated with the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law (Stark Law), and Civil Monetary Penalties Law. How can individual payers detect and try to prevent fraud? The answer is AI.
In January of 2021, Congress adopted substantial changes to the nation’s anti-money-laundering laws, including enacting a new federal statute, the Corporate Transparency Act (CTA or Act), that will establish a centralized database of corporate beneficial ownership. The CTA mandates that by 2025 (or, in some cases, by 2024) all domestic and foreign companies doing business in the U.S. must provide information about the true beneficiaries of their operations by complying with new reporting requirements. The legislation is designed to capture information on an estimated 32 million companies that operate in unregulated areas or are too small to trigger disclosure obligations under other federal laws yet can be used by criminals, terrorists, and other bad actors to hide money laundering and other illicit financial activities. The Treasury Department’s Financial Crimes Enforcement Network bureau (FinCEN) explained the need for a beneficial ownership database, stating, “Illicit actors frequently use corporate structures such as shell and front companies to obfuscate their identities and launder their ill-gotten gains through the U.S. financial system. Not only do such acts undermine U.S. national security, but they also threaten U.S. economic prosperity: shell and front companies can shield beneficial owners’ identities and allow criminals to illegally access and transact in the U.S. economy, while creating an uneven playing field for small U.S. businesses engaged in legitimate activity.” FinCEN issued its final rule on the CTA’s reporting requirements on September 29, 2022. Although the regulations resolve many of the issues that arose after the Act’s passage, a number of compliance challenges and questions still remain.
The process of the criminal trial of the youngest woman self-made billionaire, has recently started up again after being stalled due to Covid restrictions in the past year. Former CEO and founder of Theranos, Elizabeth Holmes, and her former president and one-time boyfriend, Ramesh Balwani, have been accused of misleading investors and raising hundreds of millions of dollars by making false or exaggerated claims in defiance of the anti-fraud provisions of federal securities laws. While she is currently facing a federal indictment on twelve different charges, including two counts of conspiracy to commit wire fraud and ten counts of wire fraud, Holmes has already settled her civil charges, which were brought forth by the Securities Exchange Commission (SEC). The civil charges brought forth by the SEC have now put Silicon Valley on alert by ensuring that technology companies who claim that they have a new groundbreaking technology that can change the world must be based on factual evidence, not purely myths.
The False Claims Act (“FCA”) is one of the United States Government’s most powerful tools for fighting fraud. In fact, the Department of Justice recovered nearly $1.8 billion under the FCA for health care fraud and $1.6 billion in FCA qui tam relator cases in the 2020 fiscal year. Keeping the enforcement of fraud in mind, underlying all FCA qui tam suits is successfully pleading with particularity under Federal Rule of Civil Procedure 9(b). This requirement has led many U.S. District Courts to dismiss qui tam cases at the pleading stage and U.S. Courts of Appeals to affirm those decisions. The upshot is that amid changes to the Stark Law and Anti-Kickback law, the continuation of COVID-19 related fraud, and the continuing splits in the Federal Circuit regarding pleading standards, the ground may begin to shift for compliance officers, attorneys, and general counsels in health care organizations.
After the COVID-19 pandemic spread to the U.S. in February of 2020, there was a surge in fraudulent behavior as criminals took advantage of the fear revolving around the pandemic to profit from selling defective goods and scamming the public. This has resulted in the loss of millions of dollars by the public. Scammers will continue to benefit and take advantage of the public until the government steps in and takes preventative measures to stop this criminal behavior during the pandemic.
Regulation in the financial sector is critical to preventing crimes that include fraud, money laundering tax evasion, human trafficking, aiding drug trafficking, and even financing terrorism. Despite the importance of regulation and banking institutions’ compliance with such regulations, many laws regarding money laundering are outdated and prevent efficient prevention of such crimes. Additionally, enforcement against large financial institutions is a difficult matter because of the harm that penalizing them could have on the economy.
In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.
This summer I had the opportunity to intern with the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) in Washington, DC. I thoroughly enjoyed my time with OIG, and I learned a great deal about health care fraud, waste, and abuse. In spending my summer with OIG, I had a glimpse into the powerful regulatory bodies that protect the health care market from abuse. As I move forward with my career in regulatory work, I will take with me the invaluable experiences and skills from my internship.