Category:

Journal of Regulatory Compliance

The Future of Online Prescribing

Telehealth allows for the delivery and facilitation of medical services through technology. It is rapidly evolving as the tech industry grows. Ten years after the passage of the Ryan Haight Act, the Drug Enforcement Agency (DEA) has still not taken any action to assist physicians in their usage of telehealth. Recently, Congress finally stepped in and passed a bill that requires the DEA to take action within the next year. But, the question still remains whether the DEA will finally act, or continue their history of avoidance?

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies.  The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.

The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades   

It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.

The Tumultuous Regulation and Deregulation of Payday Loans  

Each year, approximately twelve million Americans resort to payday loans for quick money to pay off bills and cover emergency expenses.  The small, short-term unsecured loans give borrowers a quick way to get money with little consideration of their creditworthiness. Borrowers are plagued with extremely high annual percentage rates to offset the seemingly substantial risk to the lender. However, many studies have shown that payday loans carry no more long-term risk to the lender than other forms of credit. Lenders are able to gain from the high interest rates that burden borrowers while simultaneously benefitting from the relatively low-stakes gamble of the nature of the loan. This illuminates a harrowing truth: the real victims of exploitative and predatory “cash advances” are the borrowers themselves who continue taking on more and more of these high-interest loans in a vicious cycle to repay small debts.

Charitable Solicitation: Do Threatened Penalties and Sanctions Ever Actually Reach the Non-Profit Organizations Misappropriating Funds?

In order to operate, non-profit organizations rely heavily on the ability to fundraise. The government leaves the regulation of that “charitable solicitation” to individual states, with most requiring formal registration to engage in such activities. With firms vying for organizations’ business to hire consultants to obtain funds, and ethics and oversight firms highlighting the careful approaches that must be utilized to appropriately raise funds for non-profit operations, charitable organizations may find themselves confused and threatened in the space between needing charitable solicitation to survive and maintaining regulatory compliance to engage in the activity itself. While the threats of penalties and sanctions are large and imposing, it appears that few organizations ever face their true weight. Charitable organizations must, of course, comply with each state of registration, but is the fear instilled equal to the reality of the consequences of non-compliance?

The Future of Roe v. Wade

Roe v. Wade has been a controversial Supreme Court decision ever since it was decided in 1973. Critics have tried to overturn it multiple times over the years. Some states have attempted to circumvent the ruling and implement their own abortion laws, while other states have implemented laws to solidify it in the event the decision is overturned. On the 46th anniversary of the opinion, New York passed a new abortion law called the Reproductive Health Act, which has caused an uproar across the country. In addition, this month the Supreme Court ruled to stay on a Louisiana Targeted Regulation of Abortion Providers (“TRAP”) law. The question becomes how will states comply with the ruling of Roe v. Wade when its future seems unknown.

Tax Compliance During the Partial Government Shutdown

On December 22, 2018, for the third time in a year, the United States government shut down. Almost two years into his presidency, President Trump, feeling pressure to accomplish one of his many promises from the campaign trail, requested $5.7 billionfrom Congress to fund his proposed wall at the border of the United States and Mexico. Following negotiation efforts by Senate Democrats, the standoff between the President and the Senate ended in a financial default, triggering a partial shutdown. The shutdown became the longest in U.S. history on January 19, 2019, beating the previous 21-day recordset by the 1995-1996 shutdown. The shutdown left an estimated 380,000 government employeeslocked out of work without pay and an even greater 420,000 employees working for no compensation at all, including employees of the IRS. With one of the United States’ most important governmental bodies being almost completely stalled by a lapse in funding, it begs the question: what happens to taxes during a shutdown?

Pressing Pause: A Survey of Regulatory Recovery After the Government Shutdown

Although the nation’s longest-ever government shutdown has ended, agencies forced to furlough employees and shutter temporarily are still facing the effects of the funding gap. On January 25th, President Trump agreed to sign a continuing resolution that will reopen and fund the federal government through February 15th. The government reboot means that the roughly 800,000 federal employees furloughed or forced to work without pay should expect to receive their back pay soon, but the thirty-five-day suspension of government functions comes with significant aftershock. While various regulatory agencies scramble to address their backlog of work, life for Americans who interact with these agencies has been hindered indefinitely.

The Years Long Process to a Revised Common Rule and Implementation

The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.

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.