At first, the story of John Kapoor’s rise to the top of the pharmaceutical industry sounds like the American dream played out in real life. The first to attend college in his family, Kapoor graduated from Bombay University in India with a degree in pharmacy. He came to the United States after securing a fellowship at the University of Buffalo, and earned his Ph.D. in 1972. His scientific and business savvy was evident from the start – in a matter of a decade, Kapoor took over a struggling pharmaceuticals business, turned it around, and netted a personal gain of $100mm. From there Kapoor became a serial entrepreneur, with INSYS Therapeutics marking the pinnacle of his success. The company made him a billionaire, but later made him the target of a criminal racketeering investigation and the face of one of America’s darkest problems.
We are coming up on the end of the 2018-2019 academic year and, for myself and my fellow 3Ls, graduation! I want to take this opportunity to thank the members of our journal, our authors, our faculty advisers, and our readers for their continued support.
Earlier this year, the Medicare Payment Advisory Commission (MedPAC) uninamously voted to recommend removing “incident to” Medicare billing for advanced practice registered nurses (APRNs) and physician assistants (PAs). MedPAC serves as an independent congressional agency that advises Congress on Medicare-related issues by analyzing access and quality of care. If this recommendation is adopted, APRNs and PAs would only be able to bill Medicare directly, thus reducing the amount paid by Medicare from 100% under services billed “incident to” to 85% directly. This recommendation could potentially save the Medicare program up to $250 million annually and would allow for better data collection into the amount of services performed by APRNs and PAs, whose services are often masked under “incident to” billing reports. Though there is still some debate on whether the financial loss of losing this option is too high for primary physicians who may hire APRNs and PAs for their practice, the benefits of billing directly likely outweigh the losses.
The Department of Health and Human Services, along with National Institute for Occupational Health and Safety and the Center for Disease Control have begun a concerted effort to fill the knowledge gaps in defining the hazards, exposures, and risks involved with handling nanomaterials. Investigators are working to provide guidance for those working in the field of nanotechnology to address the risks associated with working with animals exposed to various engineered nanomaterials, epidemiologic research, and exposure limits. The National Institute for Occupational Safety and Health has summarized its progress and recommended risk management strategies for those in the field.
The Health Insurance Portability and Accountability Act (HIPAA) and the Patient Protection and Affordable Care Act (ACA) jointly create national standards for electronic transactions, code sets, and unique identifiers. The ACA introduced Administrative Simplification provisions in 2010 and now the Centers for Medicaid and Medicare Services (CMS) has launched a Compliance Review Program to ensure that HIPAA covered entities are abiding by the Administrative Simplification rules.
Artificial intelligence is all around us. Whether it exists in your iPhone as “Siri” or in complex machines that are detecting diabetic retinopathy, it is constantly growing and becoming a regular part of the modern day. As with any new technology, regulation surrounding artificial intelligence is becoming increasingly problematic. The question facing us now is how do we encourage further development without accidentally hindering its growth? Recently, the Food and Drug Administration has attempted to take steps toward further regulation of artificial intelligence by introducing a review process for medical artificial intelligence. This is just one instance of how regulation may affect the evolution of artificial intelligence.
In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.
Despite all preventive measures that hospitals and health care systems put in place to stop data breaches from occurring, employees at these entities still have unsecured and un-encrypted laptops, which are susceptible to cybersecurity attacks. A report from a cybersecurity protection organization stated that a majority of high-risk scenarios that occur in health care entities were due to unsecure laptops. These unsecured laptops can lead to massive data breaches and can result in hefty fines imposed by the Office of Civil Rights. Proper encryption, tracking software, and rarely leaving laptops unattended are a few ways that employees and organizations can help safeguard protected health information and prevent data breaches.
In addition to enforcement agencies attempting to tame the seemingly untameable world of cryptocurrency trading, agencies continue to tackle issues of market manipulation, including spoofing, as well as push into investigating international corruption in an effort to maintain economic and market integrity. As new developments emerge, compliance directors and operations associates will hopefully gain more guidance on coaching traders on exchange rules.
The Children’s Online Privacy Protection Act (“COPPA”) prohibits unfair or deceptive collection, use, and disclosure of the personal information of children on the internet. COPPA covers both website operators and app developers, and prevents collection of personal information without verified, written consent of parents. On February 27, 2019, the Federal Trade Commission (“FTC”) filed a complaint in U.S. District Court against TikTok, previously known as Music.ly. The complaint alleged that Music.ly knowingly violated COPPA when it collected data from children without written consent of parents. Music.ly settled for $5,700,000.00, the largest civil penalty obtained by the FTC for violations of COPPA.