health care compliance
The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) have guarded controlled substances zealously since the inception of the Controlled Substances Act (CSA), passed in the 1970s. However, the coronavirus (COVID-19) pandemic challenged nearly all of society’s conventional protocols, and the federal government responded to concerns that patients wouldn’t receive care by loosening its regulations for healthcare services. In 2020, the DEA permitted health providers to prescribe schedule II-controlled substances to patients via telehealth appointments instead of in-person visits. Now, two years later, the FDA has confirmed an Adderall shortage, which is a schedule II controlled substance that is in high demand and used to treat attention-deficit/hyperactivity disorder (ADHD). The Justice Department’s DEA division has initiated probes against various online mental health companies and worries that the drug is overprescribed and abused by young adults.
The Employee Retirement Income Security Act (“ERISA”) regulates the administration of employee benefit plans. ERISA aims to protect the interest of employee-beneficiaries by setting minimum standards for employee benefit plans and voluntarily established pensions. The Act’s preemption clause works to prevent states from regulating these same plans. Initially, a state statute was considered to violate the preemption clause when it possessed, “a connection with, or reference to, covered employee benefit plans.” A few years later the standard was modified, states were considered to have violated ERISA preemption if the state, “mandates employee benefit structures or their administration.”
On November 3, 2020 new rules from the Health and Human Services Department concerning information blocking in healthcare will come into effect. The rules are an implementation of the 21st Century Cures Act (“Act”) which is the latest in the government’s effort to lower costs and allow for greater patient access to electronic health information (“EHI”). The Act aims to prevent covered healthcare providers from restricting the flow of EHI in inappropriate ways. Violations of the new Act may result in considerable civil fines.
Every time we turn on the news, someone is either talking about immigration reform or health care reform. Health care and immigration are two major areas that President Trump promised to address and is attempting to tackle within his first two years in office. Although most would not consider that these two issues would overlap, in today’s American health care system, Americans need immigrants. Immigrants contribute a great deal to our medical research, make up a large percentage of our health care providers, and subsidize health insurance premiums.
Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.
In October 2015, the tenth revision of the International Classification of Diseases (ICD-10) was implemented in the United States. Three years earlier, however, ICD had already begun beta testing for its eleventh revision (ICD-11). The ICD-10 implementation came after repeated delays and substantial requirements for healthcare organizations to reach compliance with the new codes. The United States trudged through training and compliance struggles as it transitioned to ICD-10. The threat of ICD-11’s release in 2018 promises to have drastic and far-reaching effects on the compliance actions of healthcare organizations.
States looking for flexibility or creativity in implementing Medicaid programs can apply for waivers from the Secretary of Health and Human Services (HHS). According to the Medicaid and CHIP Payment Access Commission (MACPAC), waiver use is quite extensive—resulting in “wide variations in program design, covered services, and eligible populations among states and even within states.” As of September 2017, 33 states account for 41 approved waivers, and 18 states have 21 total pending waivers. The scope of these waivers traditionally broadens eligibility and creates new programs in states where Medicaid needs are not expressly recognized by federal law. Current pending applications suggest, however, that states seeking waivers now do so as a means to circumvent Medicaid program requirements they disagree with.
This summer I had the opportunity to intern with the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) in Washington, DC. I thoroughly enjoyed my time with OIG, and I learned a great deal about health care fraud, waste, and abuse. In spending my summer with OIG, I had a glimpse into the powerful regulatory bodies that protect the health care market from abuse. As I move forward with my career in regulatory work, I will take with me the invaluable experiences and skills from my internship.