The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
Cutting-edge technology is desirable to consumers for its ability to deliver innovative solutions, improved efficiency, enhanced user experiences, and the promise of staying ahead in an ever-evolving digital landscape. The...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
EKRA stands for the Eliminating Kickbacks in Recovery Act, and it has become a prominent enforcement tool against fraud in the healthcare and medical testing industries. Although the law was developed in 2018 to help combat...more
The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration...more
Reproductive Biology Associates, LLC (RBA) and its affiliate, MyEggBank, notified approximately 38,000 patients that a data breach involving a ransomware attack had exposed the patients’ full names, addresses, Social Security...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
On June 4, 2020, HHS released new guidance detailing what additional data laboratories must report to HHS along with COVID-19 test results. HHS explained that the new guidance standardizes reporting requirements in an effort...more
HDHP and HSA participants - The IRS has expanded prior guidance to allow health plans to pay first-dollar costs for testing and treatment of COVID-19 without jeopardizing the participant’s HSA eligibility. ...more
The Internal Revenue Service (IRS) issued a notice that allows individuals to participate in a health savings account (HSA) while participating in a high deductible health plan (HDHP) that provides coverage for both the...more
In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more
Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more