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.
On July 25, 2023, the Departments of Labor, Health and Human Services, and the Treasury (the agencies) proposed new rules placing heightened compliance standards on health insurers and plans regarding the use of Non-Quantitative Treatment Limitations (NQTLs) for mental health and substance abuse disorder (MHSUD) services. These new rules amend the current reporting requirements with the intent to establish ongoing reporting that more clearly demonstrates whether MHSUD services are provided in compliance with the law.
The capabilities of generative artificial intelligence (AI) could completely transform our healthcare system as we know it. For better or for worse, the technology advancements in healthcare are rapidly growing. Given the accelerated rollout, experts have yet to predict all the risks associated with such high-functioning computations in the healthcare system. Even though the Food and Drug Administration (FDA) regulates software being used as medical devices (SaMD), there is an overall lack of urgency, agency oversight, and sufficient regulations to tame AI technology in the healthcare system.
The United States Securities and Exchange Commission (SEC) has announced that they have awarded upwards of $37 million to one whistleblower in 2022. This individual gave important information to the SEC that led to a successful enforcement action against a large European healthcare company. This award took the cake for being the highest payout to a whistleblower in 2022. What does a whistleblower program look like from the regulator’s point of view and why is it important?
Ransomware attacks are one of the largest threats to the healthcare industry and a tough cybersecurity problem to address. From 2016-2021, there were almost 400 ransomware attacks on healthcare organizations in the US. It is estimated that such attacks exposed the personal healthcare data of over 40 million patients. Since these attacks cannot typically be resolved without paying the ransom, it is important to invest in preventative measures to protect healthcare data from potential breach.
During the COVID-19 pandemic, the federal government and the Drug Enforcement Agency (DEA) temporarily lifted the Ryan Haight Act’s mandate that imposes federal prohibition on online prescribing of controlled substances. The DEA waived its in-person medical examination requirement and set forth different criteria for controlled substances. For as long as the duration of the public health emergency (which was extended through January of 2023 this month), a patient can receive a controlled substance prescription without an in-person examination if the communication was conducted in a two-way, audio-visual, and real-time interactive communication. Covid highlighted the increased use of telehealth and digital health platforms. However, as telehealth surged, public policy has failed to move at the same speed.
Thanks to a new FDA final rule, published in August of this year, Americans can soon purchase specific hearing aids over-the-counter (OTC) without a hearing exam, prescription, or fitting. Although this rule will improve access to hearing aid devices and lower the costs for those with hearing impairments, many critics are convinced the rule will do more harm than good.
Cyberattacks on the healthcare industry have reached a fever pitch. In 2020 alone, there was a drastic increase in healthcare organization cybersecurity breaches. In 2021, the average cost of a healthcare data breach increased by over $2 million to $9.23 million. Healthcare providers continue to be the most targeted industry for cybersecurity breaches, with over ninety-three percent of healthcare organizations experiencing a data breach over the past three years. 306 breaches of unsecured protected health information (“PHI”) impacting 500 or more individuals were reported to the U.S. Department of Health and Human Services (“HHS”) in 2020. Yet healthcare organizations continue to be ill-equipped to handle this growing problem.
Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
The Public Charge Rule perpetuates anti-immigrant sentiment and keeps poor, disabled migrants who were often Black, Brown, and ethnically oppressed out of the United States. It makes pathways to citizenship contingent upon wealth and the absence of disability. As the Autistic Self Advocacy Network puts it, the Public Charge Rule is a “clear echo of the racist and ableist policies of the eugenics era.”