Tag:Journal of Regulatory Compliance
Telehealth Services Amid a Global Pandemic
With COVID-19 rapidly spreading, telehealth services have been seeing an explosion of demand. On March 17, 2020, President Trump announced during a White House press briefing an unprecedented expansion of telehealth services for the 62 million Medicare beneficiaries who are amongst the most vulnerable to the disease. The Department of Health and Human Services (“HHS”) and Centers for Medicare and Medicaid Services (“CMS”) have since vowed to work with the administration by temporarily relaxing certain HIPAA, altering licensure, cost-sharing, and auditing requirements. As the number of patients increases, compliance and privacy risks associated with telehealth also surge.
Tiger King and Zoo Auditing
Libby Meadows Associate Editor Loyola University Chicago School of Law, JD 2021 Like many people during this quarantine, the majority of my days are spent switching through different streaming sites trying to find anything entertaining to watch. Towards the end of March Tiger King: Murder, Mayhem and Madness was released on Netflix. It instantly took …
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Prescribing Online with COVID-19
COVID-19 has rapidly changed the healthcare field unlike anything has before. With the continued spread, healthcare providers have started to adopt telehealth as a way to access patients and continue to provide quality care, without breaking their self-isolation. One avenue that has long been closed off for physicians has been online prescribing, but COVID-19 appears to be changing even that.
Action Against Individuals Regarding Fraudulent Genetic Testing
Michael Manganelli Associate Editor Loyola University Chicago School of Law, JD 2021 In October 2019, The Department of Justice (“DOJ”) announced a multi-agency and multi-state coordinated law enforcement action against 35 individuals involved in an alleged $2.1 billion genetic cancer testing scheme. The alleged scheme involved the payment of illegal kickbacks and bribes to medical professionals …
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Revamping America’s Organ Transplant System
In December of 2019, two new rules were proposed by the federal government to increase the number of organ transplants in the United States. As of July 2019, 113,000 Americans sat on the national transplant waiting list. The first proposed rule would change the way Organ Procurement Organizations (“OPO”) report data on the number of organs procured. The second proposed rule creates new legislation to assist living donors after their transplant procedures. Both rules were proposed by the Health and Human Services Department (“HHS”) as a follow up to President Trump’s Executive Order on Advancing American Kidney Health.
Financial Fair Play’s Impact on European Football
In the past 12 years, Manchester City has seen a dramatic rise to the European Elite. In 2008, Sheikh Mansour, who has ties to the United Arab Emirates’ royal family, took over ownership of the club. Following the take-over, Manchester City has gone on to win 10 major trophies. On February 14, 2020, Manchester City was handed a two year ban on European competitions, as well as a $32.5 million fine. This is the largest fine ever by Union of European Football Associations (“UEFA”), the governing body of European Football. The UEFA found that Manchester City overstated its sponsorship revenue in its accounts. This, according to the Adjudicatory Chamber of the Club Financial Control Body, is a “serious breach” of Licensing and Financial Fair Play. If the ban is upheld, Manchester City would be fined approximately $232.5 million, a sum of the initial fine plus potential winnings in European Football competitions. According to Simon Chadwick, director at the Centre for the Eurasian Sport Industry, “UEFA must win this ban, if it doesn’t then its position on Financial Fair Play beings to unravel.” This is a pivotal moment in UEFA’s history as a governing body.
FDA Finalizes Enforcement Policy Against Vaping
Amid the epidemic levels of youth use of e-cigarettes, the U.S. Food and Drug Administration, released a policy on January 2, 2020, requiring enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. According to the policy, the FDA intends to prioritize enforcement against fruit and mint flavored, cartridge-based electronic nicotine delivery system (“ENDS”). The FDA looks to regulate all ENDS products that manufactures have failed to make safe for use, as well as any ENDS product marketed for use by minors. The 2019 National Youth Tobacco Survey (“NYTS”), a survey conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, shows approximately 1.6 million youths were using ENDS products frequently, with nearly one million using e-cigarettes daily. The FDA’s enforcement policy is not a “ban” on flavored cartridges. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considerations on how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.
Emerging Risks Associated with AI and Machine Learning
Today the healthcare industry is being transformed using the latest technology to meet the challenges it is facing in the 21st century. Technology helps healthcare organizations meet growing demands and deliver better patient care by operating more efficiently. As the world population continues to grow and age, artificial intelligence (AI) and machine learning will offer new and better ways to identify the disease and improve patient care.
Facing Facial Recognition Technology
In March 2019, Senator Brian Schatz and Senator Roy Blunt introduced a bill to Congress designed to provide oversight for facial recognition technology, known as the Commercial Facial Recognition Privacy Act. If passed, this law could change the way Americans deal with privacy.
Stark and Anti-Kickback Statute Get Modern Updates to Account for Value-Based Arrangements
On October 17, 2019, the U.S. Department of Health and Human Services (HHS) published two proposed rules in the Federal Register that could potentially transform key federal laws restricting health care arrangements. These rules address perceived or actual barriers to care coordination and value-based care under Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty (“CMP”) law. The proposals are intended to “modernize and clarify” the regulations that implement and interpret these laws in order to drive innovation and more towards a more affordable health care delivery and payment system, while also maintaining barriers to prevent fraud and abuse. The proposed rules “will improve outcomes by moving away from the old modes of inpatient hospitalizations.”