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healthcare

Healthcare Bribery Whistleblower Receives the Highest SEC Award in 2022

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?

AI Nancy Drew, Is That You?

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.

From Chatbots to Diagnosis: The Power and Pitfalls of AI in Healthcare

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. 

New Mental Health Parity Rules on the Horizon

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.

A New FDA Rule Will Change the Future of the Hearing Aid Industry

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.

Kidnapped Data: Healthcare Ransomware Attacks

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.

Post-Pandemic Telehealth and the Fate of Adderall

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.

Newly Added Regional Medicare Fraud Strike Force Targets Opioid Crisis

One month after the largest health care fraud enforcement action was taken, the Assistant Attorney General, Brian A. Benczkowski, of the Justice Department’s Criminal Division, announced the addition of the Newark/Philadelphia Regional Medicare Strike Force. The newly added 11th Medicare Strike Force will largely focus on healthcare fraud that is contributing to the opioid epidemic.

Can Congress Regulate Big Pharma?

Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.

Market Giants Move to Redesign Healthcare

In January 2018, Warren Buffet, Jamie Dimon, and Jeff Bezos announced that Berkshire Hathaway, JP Morgan Chase, and Amazon would partner together to form a non-profit company aimed at improving the United State healthcare system and combating ever-increasing costs. The idea for the project came about from the ongoing discussion between the three CEOs regarding providing healthcare for their, collectively, approximately 840,000 employees. Even though details are scarce, given the importance of the issue and the prominent names attached to this project, the press, the public, and the market have reacted accordingly. In other words, people are scrambling to figure out what this might mean for their companies and our healthcare system as a whole.