Author:Janaki Padmakumar
Therano-no: Key CLIA Compliance Issues
Janaki Padmakumar Associate Editor Loyola University Chicago School of Law, JD 2023 In one of the greatest fraud cases of the last decade, Elizabeth Holmes, founder and CEO of Theranos, was convicted of four federal fraud charges on January 4, 2022. Theranos was a private healthcare startup that claimed have invented a novel blood testing …
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What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic
In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.
Talk Kickback to Me: Healthcare Provider Remuneration by Big Pharma
Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
Skewed Success: Self-Regulation of Artificial Reproductive Technology in the US
In the United States, Assisted Reproductive Technology (ART) is predominantly self-regulated by a network of medical agencies that publish guidelines. ART refers generally to any fertility procedure where eggs or embryos are handled. ART clinics are not federally funded, and there is no specific national legislation that establishes a clear regulatory framework about the standard of operations, the quality-of-care patients should be provided with, the permissible uses of ART, or recourse for patients who have not benefited from their financial investments in ART. There are minimum standards set forth by the Food and Drug Administration (FDA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which require strict compliance before patients can consult and use clinics’ ART services including the use of pharmaceutical products. The Federal Trade Commission (FTC) also oversees truthful advertising and marketing practices within ART to ensure that clinics’ reports of success are consistent with their patient data. All states require that physicians obtain a license before providing care, and physicians are subject to investigation by state boards. Aside from this general regulation for safety and transparency, the only explicit regulation targeting the ART industry is the United States Fertility Clinic Success Rate and Certification Act, mandating all US fertility clinics to report their ART cycles performed to the Center for Disease Control (CDC). The data collected through this reporting act is governed by the NASS 2.0 (National Assisted Reproductive Technology Surveillance System), which is a collaborative surveillance system between the CDC, and private stakeholders. Self-reported data to NASS 2.0 is verified by comparing information from a patient’s medical record with data submitted for the report.