INSIDE COMPLIANCE – Page 69 – Loyola University Chicago School of Law

Establishing Expanded Use Programs

July 17, 2020Drugs & Devices

The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.

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Clinical Trials and Human Participants

July 16, 2020Uncategorized

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.

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Illinois Unemployment Benefits for Academic Personnel

June 29, 2020Uncategorized

During the expedited legislative session on May 20-24, the Illinois General Assembly passed HB 2455 which was signed into law as Public Act 101-633 on June 5, 2020. While well-intentioned, this Act could create a huge liability for school districts depending on how the Illinois Department of Employment Security (“IDES”) interprets the law. School districts are already facing an uncertain financial future and this law is adds more uncertainty and possibly more financial insecurity.

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New Rules for Illinois Firearms Dealers

June 26, 2020The Art of Compliance, Uncategorized

The Firearms Dealers License Certification Act (also known as the Combating Illegal Gun Trafficking Act) was signed into law on January 18, 2019 and requires all Federal Firearms License (FFL) dealers engaged in the business of transferring firearms to have their FFL certified by the Illinois State Police. Nevertheless, many areas of the regulations remain in dispute and strong opposition has led to the delay of dates for required compliance. The Act is also being challenged by the Illinois State Rifle Association and a number of gun dealers in Illinois who deem that the Act is an unconstitutional infringement on their right to keep and bear arms.

Journal of Regulatory ComplianceRegulation

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

June 26, 2020Uncategorized

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.

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Telehealth in the Age of COVID-19

June 18, 2020HIPAA & Health Information, Uncategorized

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.

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

June 4, 2020The Marketplace, Uncategorized

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.

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

May 22, 2020Uncategorized

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.

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Employer Compliance with CARES Act

May 19, 2020Finance & Banking, Uncategorized

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.

#CoronavirusCARES ActCOVID-19Journal of Regulatory CompliancePaycheck Protection ProgramRegulationstudent loans

Telehealth Services Amid a Global Pandemic

May 6, 2020Uncategorized

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.

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