Tag:

COVID-19

Clinical Trials and Human Participants

This past spring the world locked down. Stores were closed, everyone was required to work from home, and masks became the latest fashion trend. This shift occurred because a virus, Covid-19, began making its way around the world. It has been about 4 months since our society locked down for the protection of its people and while it is slowly opening back up there are fears that without a vaccine or cure for Covid-19 it is going to keep spreading and we are going to have to remained locked down. Many pharmaceutical companies are working night and day to create a vaccine that can be widely distributed to help stop the spread of Covid-19. A drug that is for humans needs to be tested on humans to ensure it works before it can be approved and sold.

COVID-19 Break in Regulation of Waivers for State Medicaid Agencies

COVID-19 was an unexpected pandemic that hit the United States, causing Centers for Medicare and Medicaid Services (“CMS”) to rush to make accommodations for the states. States administer their Medicaid programs following a state plan and under the regulation of federal rules. With approval, states are allowed to amend their state plan and apply for waivers to improve the effectiveness of their Medicaid program. During COVID-19, the Trump Administration made available for states to apply for 1115 waivers, creating a new section labeling 1115(a), the 1135 waiver, and Appendix K to amend 1915(c) waivers for national emergencies. As of May 2020, CMS reported over 200 approved waivers across multiple states.

Telehealth in the Age of COVID-19

The Health Insurance Portability and Accountability Act – enacted in 1996 by the U.S. Congress and signed by then-President Bill Clinton – has long served to maintain the standards of electronic health records and patient privacy, among many other provisions. Violating HIPAA can result in both criminal prosecution as well as steep civil penalties. As the healthcare industry transitioned from the use of paper records to storing patient data on electronic health records over the last two decades, health organizations have learned to adapt to HIPAA compliance, with many increasing their compliance programs by hiring full-time compliance officers, designating an individual as the compliance manager, and/or appointing a compliance committee within the organization.

The Regulation of Meat and Poultry Processing Facilities in COVID-19

The meat and poultry packing industry has recently fallen victim to the spread of COVID-19. Among fierce backlash over the federal government’s lack of action to protect meat packing facility workers, the CDC and OSHA released interim guidelines. These guidelines are to be followed by employers not only to keep workers safe, but to avoid a shortage of one of America’s most prized food sources: meat and poultry. The meat packing industry, as one of the most heavily-regulated industries in the United States, now faces increased regulation during a global pandemic.

COVID-19’s Detrimental Impact in Long-Term Care Facilities

According to the Centers for Disease Control (“CDC”), older adults and people with severe underlying medical conditions are at higher risk for developing more serious complications from the COVID-19 illness. For this reason, among others, long-term care facilities have been hit particularly hard by the virus. Although it was difficult to be prepared for this pandemic, there are concerns that many long-term care facilities did not have proper preventative measures in place in even before COVID-19 became an issue. Because of this, long-term care facilities have become hot spots for the viruses spread. As states and the federal government continue to monitor long-term care facilities’ compliance with local and federal laws, regulatory agencies are now also faced with added pressure to not only slow the spread of COVID-19 within the facilities, but also to control the legal environment in the anticipated aftermath of the outbreak.

Employer Compliance with CARES Act

On March 27, 2020, President Donald J. Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (H.R. 748), otherwise known as the “CARES” Act. Originally introduced in January as the Middle-Class Health Benefits Tax Repeal Act, the bill was then revised to address the needs of the United States amid the coronavirus pandemic. The bi-partisan CARES Act, with strong support from the White House, ultimately passed the House of Representatives with a 419-6 roll call and the Senate with 96-0 votes.

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.

The NCAA and COVID-19: How are Student Athletes Impacted?

Sarah Suddarth Associate Editor Loyola University Chicago School of Law, JD 2021   The COVID-19 pandemic has caused disruption to everyone’s lives, and student athletes are no exception. The unprecedented situation has presented many questions and the National Collegiate Athletic Association (“NCAA”) has attempted to answer many of those questions coming directly from the displaced …
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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.