Category:

Regulation

CMS New Regulations Focus on Nursing Facilities Improving Resident Care

The Centers for Medicare and Medicaid Services (CMS) efforts to strengthen the nation’s health care through its oversight of health care programs, including Medicare, has continuously made strides to ensure its beneficiaries receive the quality and affordable health care needed. The U.S. has struggled with the quality of care provided in nursing homes to the most vulnerable citizens for years. Nursing homes have continued to remain highly regulated, but the U.S. government has failed to hold the nursing homes industry accountable for the poor quality of care provided. America’s shortage of nurses has contributed to the poor quality of care that leads to life threatening problems of Medicare beneficiaries living in nursing homes. Furthermore, despite the nursing home industry’s large profitability, and the level of hands on care that the nurses provide, the pay for staff nurses in nursing homes is less than other major employers. Thus, CMS has implemented regulations to guarantee nursing homes are properly staffed in order to improve resident care and safety by monitoring payroll-based data and holding nursing homes accountable for poor care by minimizing reimbursement for conditions that could be averted with better oversight.

Joint Agency Decision Serves Up A New Regulatory Framework For Cell-Based Meat

Following a public meeting in October, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed to share joint regulation of cell-culture “meat” technology. This decision came on the tail end of public squabble between the two regulatory bodies regarding the oversight of cell-culture, or lab-produced meat.  The regulatory framework for this type of quasi-agriculture has been unclear, especially after the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology initiative that attempted to coordinate the roles of various agencies involved in emerging biotechnology. The new, definitive regulatory structure has been thoroughly praised and welcomed by top cell-culture meat companies, who have expressed open frustration with the older, confusing framework, claiming that it hindered both consumer protection and technological innovation.

OIG Work Plan on Nursing Facility Staffing Levels

In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).

Illinois Law Makers Seeking to Curb E-Cigarette Use Among Teens and Children

In the wake of rising e-cigarette use among teens and children, Illinois lawmakers seek a legal solution to protect Illinois youths from smoking-related illnesses and pre-mature death. Illinois’s Congress introduced Tobacco 21, a bill designed to raise the legal age to purchase tobacco products like e-cigarettes to 21 years of age. Despite a lack of support from Governor Bruce Rauner, Illinois politicians continue to fight to save the bill, and with good reason. The United States Food and Drug Administration (FDA) recently announced its Youth Tobacco Prevention Plan, which addresses the rising e-cigarette use among adolescents. The FDA’s plan is two-fold: (1) crack down on the sale and marketing of e-cigarettes and (2) educate teens and children about the dangers of using e-cigarettes. Tobacco 21 provides support for the FDA’s Plan.

Protections for Accused Students or Problems for Victims?

The Trump administration has proposed new rules for schools dealing with sexual assault and harassment allegations that narrow the definition of sexual harassment and offering greater protections for the accused. Under the new rules, the Education Department is altering the procedures colleges that receive federal funding use to adjudicate complaints of assault and harassment. The new proposed rules come during the #MeToo movement, which will likely prove to be very controversial to both those who support the changes and those who oppose the changes. The federal guidelines stem from Title IX, which bars sex discrimination at schools that receive federal funding.

International Concerns Regarding Southeast Asian Aviation

Aviation accidents, though rare, occur all over the world. However, the relatively high frequency of airplane disappearances and fatal incidents in Southeast Asia has been a primary cause of concern within the industry. Most recently, on October 29, 2018, a Boeing 737 Max 8 operated by Indonesian airline Lion Air crashed into the Java Sea off the coast of Jakarta. Just thirteen minutes into a scheduled hour-long flight, all 189 passengers and crewmembers aboard the aircraft lost their lives. Almost immediately,speculation arose regarding the cause of the accident as well as questions regarding the common occurrence of Indonesian aviation disasters.

EU Copyright in the Internet Age

On September 12, 2018, the European Parliament approved amendments to the Directive on Copyright in the Digital Single Market, commonly known as the EU Copyright Directive (the “Directive”). The amendments primarily cover copyright protection over internet resources. There are two parts of the Directive that have caused concern: Articles 11 and 13. Article 11, also referred to as the “link tax,” provides publishers with a method to collect revenue from news content shared online. Article 13, also referred to as the “upload filter,” holds Internet platforms, such as Facebook and Twitter, liable for copyright infringement committed by users. Together, large and small platform providers that would have to comply with these new regulations have declared that the enactment of these articles places a heavier burden on service providers. Critics of these amendments also say the requirements are likely to lead to increased taxation and more lawsuits. The final vote on the directive is scheduled for January 2019.

Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations

The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A).  In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.

SEC, DOL Advance New Fiduciary Rule After Adverse 5th Circuit Ruling

Both the Securities Exchange Commission (SEC) and Department of Labor (DOL) are pushing ahead with fiduciary standards for investment advisers despite the 5th Circuit striking down the DOL’s previous fiduciary rule earlier this year.

Managing Your Health in 2018: Mobile Medical Applications and FDA Regulations

Immediately upon introduction, mobile medical applications became favored by physicians and patients alike because the applications are user friendly and allow the patient to understand their care and participate in more meaningful discussions with their provider about their health. Due to the rapid development of technology and, as a result, a surge of mobile medical applications flooding the market, the Food and Drug Administration has issued three guidances on how they plan to regulate mobile medical applications. In order for mobile medical application manufacturers to remain compliant with the FDA guidances, they must meet the seven categories of requirements that are laid out in Appendix E of FDA’s 2015 guidance and also comply with any further guidance that is released.