Imagine the following scenario—a pregnant woman enters a Medicare/Medicaid-participating emergency room with preeclampsia,[1] threatening both the safety of the mother-to-be and her fetus. After screening the patient, the emergency room doctor determines that the best and most successful stabilizing treatment would be an abortion. Under the Emergency Medical Treatment and Labor Act, if the emergency medical situation falls within the purview of the statute, the doctor must stabilize the patient. However, state law prohibits abortions at all stages of pregnancy, unless the mother is at risk of imminent death. Should the doctor follow state law and risk a less successful method of stabilization that could lead to serious injury to both the mother and the fetus? Or should the doctor follow federal law and perform the abortion, risking criminal indictment punishable by two to five years of prison time? The upcoming Supreme Court decision in Idaho v. United States will determine what the legally correct course of action would be.
Continue reading “EMTALA Post-Dobbs: Interpretations Lead to Emergent Issues and Could Lead to Unnecessary Deaths – by Tarra Olfat”Will the Inclusion of Gender Dysphoria as an ADA-Protected Disability Improve Access to Gender-Affirming Healthcare? – by Phoebe Fisher
Keisha Williams was incarcerated in the Fairfax County Adult Detention Center for six months. Although she is a transgender woman, she was placed in men’s housing, where she experienced harassment, intentional misgendering, and delays in her medical treatment.[i] Williams brought suit under 42 U.S.C. § 1983[ii] alleging that her experience while incarcerated violated the Americans with Disabilities Act (ADA), among other laws. In her complaint, Williams stated that she had gender dysphoria, and she argued that this constituted a disability under § 12102(1)(A) of the ADA.[iii] In Williams v. Kincaid, the United States District Court for the Eastern District of Virginia, Alexandria Division dismissed her case on June 7, 2021.[iv] Williams appealed to the United States Court of Appeals for the Fourth Circuit.[v]
Continue reading “Will the Inclusion of Gender Dysphoria as an ADA-Protected Disability Improve Access to Gender-Affirming Healthcare? – by Phoebe Fisher”Drug Regulation or Innovation: A Comparative Look at the FDA and the CE Mark System – by Tom Romanchek
Not every drug that is researched and developed in the United States makes its way onto the shelves of your local drugstore. This is for good reason: to ensure that Americans may only access drugs with demonstrated efficacy in clinical trials that can safely treat a specified condition or illness.[1] Safety and efficacy concerns can also create certain hurdles to promoting drug diversity and accessibility in the U.S. Limiting the drugs that make it through major clinical-research milestones and approval pathways reduces product variety and options for Americans. On the other hand, lowering safety and efficacy thresholds for introducing drugs into markets could pose greater risks and costs to consumers, but it may also incentivize innovation and greater investments in research from risk-averse pharmaceutical manufacturers.[2] Competition between similarly effective drugs could also drive down product prices to the benefit of consumers.[3] Yet, decreased safety and efficacy standards could lead to needless and increased marketing of drugs with little to no medical benefit, imposing greater costs on patients while incentivizing manufacturer-imposed limitations on drug innovation.[4] In other words, there are clear tradeoffs between lax and stringent regulations. The Food and Drug Administration (FDA) considers these tradeoffs and imposes a controlled review process to limit the number of drug approvals each year. Whether the review is lenient or stringent in the end, the FDA universally cites safety and efficacy concerns under its statutory mandate[5] as reasons for not certifying many drugs.[6]
Continue reading “Drug Regulation or Innovation: A Comparative Look at the FDA and the CE Mark System – by Tom Romanchek”A Quiet But Seismic Impact: Talevski May Deprive Individuals of Their § 1983 Right to Sue – by Chelsea Pardes
Every year, the United States Supreme Court hears blockbuster cases with massive societal implications that are evident to the public. But often, cases whose impact can be just as far-reaching fly under the radar. Health & Hospital Corp. of Marion County. v. Talevski is one such case. On its face, it seems to address only the narrow issue of nursing home care rights. In fact, its impact may undermine our system of providing access to social support program benefits for those in need.
Continue reading “A Quiet But Seismic Impact: Talevski May Deprive Individuals of Their § 1983 Right to Sue – by Chelsea Pardes”Introducing Essential Coverage – by Sonia M. Suter
The Patient Protection and Affordable Care Act or Affordable Care Act (ACA) was enacted in 2010 with the goal of increasing health insurance coverage for the uninsured and helping improve the American health-care system. A fundamental feature of the statute is the requirement that most health insurance plans cover pre-existing conditions and provide minimum essential health coverage, i.e., provision of ten essential health benefits, including pregnancy, maternity, and newborn care; services for mental health and substance use disorders; and preventive, wellness, and chronic disease services. By requiring minimum essential health coverage, the ACA aimed to increase access to health care and encourage preventive care for the nation. Of course, not everyone will agree on what “essential coverage” should require. Some believe it should include only the most basic health insurance coverage necessary to ensure the population’s health. Others would demand more, insisting that “essential coverage” should broaden physical and mental wellness support, expand health-care accessibility and affordability, and reduce the burdens individuals experience when accessing health care.
Continue reading “Introducing Essential Coverage – by Sonia M. Suter”