The Art of Compliance
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?
Ever since the Facebook and Cambridge Analytica scandal, concerns surrounding data privacy and protection have been growing. Both government agencies and individual users have particularly been concerned on how their data is being collected and used on social media websites such as Facebook. Germany has taken action in response to such concerns and recently took a step against Facebook’s collection of data in a decision that outlawed Facebook’s entire advertisement regime.
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?
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.
In December 2018, Dr. Christopher Duntsch lost his appeal and the court upheld his life sentence. The name may not sound familiar, but to the medical community in Dallas, Texas, Christopher Duntsch represents what happens when every part of the medical regulatory system fails to protect patients. Christopher Duntsch was given the nickname “Dr. Death” in November 2016 when the DMagazine ran a cover story on him and his victims. In 2018, Wondery produced a six-part podcast series named “Dr. Death” detailing Duntsch’s educational and medical history and the acts that led him to incarceration.
In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.
Cheryl Miller is the Director of Risk, Compliance and Legal – and Chief Compliance Officer for Presbyterian Homes, a Life Plan Community (formerly branded as a Continuing Care Retirement Community (CCRC)) in Skokie, Illinois. Ms. Miller worked as a corporate paralegal for several years before and during law school, first at a large law firm and then at Brookdale Senior Living. She moved into healthcare regulatory work, and from there learned about the Health Care Compliance Institute and went to the annual meeting. “The preciseness of Stark and Anti-Kickback and the other multitude of regulations enthralled me. I was on-site at a client (Presbyterian Homes) two days per week providing risk management services. I asked about their compliance program and gave (what I thought was) constructive criticism. A year or so later, Presbyterian Homes hired me away from the firm.” Ms. Miller was recently invited by Professor Larry Singer to speak to his Health Care Business and Finance class about the Long-Term Care industry. Her discussion enlightened many of the students and inspired enrollment in Loyola’s Long-Term Care course. The following is an interview that highlights her insight and experiences about her work in an often-overlooked area of healthcare.
Most major American corporations develop and implement an ethics and compliance (E&C) program. However, too often, the ethics division of these programs falls to the wayside, with companies putting more focus on legal compliance rather than creating an ethical corporate culture. While it is true that compliance can technically function without an ethics component, a robust ethics program can be an extremely efficient way for a company to promote legal compliance, as well as consumer trust and loyalty.
Earlier this year, Bitcoin, and cryptocurrencies writ large, occupied many financial headlines as onlookers began to divert their attention to the “unexplained” rise, and subsequent fall in the price of one the more popular (and maiden) cryptocurrencies: Bitcoin. Naturally, because many of the onlookers didn’t realize what Bitcoin was (or is), the media took lead on the story. Earlier this month, Bitcoin began to make its appearance in headlines, once again.
Since the enactment of the Affordable Care Act, hospitals have faced strict and substantial regulations regarding the provision of financial assistance to patients in the form of “charity care.” An essential element in a hospital’s ability to maintain tax-exempt status and financial solvency, charity care has worked to serve uninsured and indigent patients while helping charitable hospitals serve their mission and retain the benefits that come with it. The state of Pennsylvania recently passed legislation requiring more explicit and affirmative acts to provide charity care to more eligible patients. The change is unprecedented, and other states look to be slowly responding in their own ways. Compliance with these changes is most beneficial with proactive measures and risk assessments even before change comes through the doors.