The U.S. Justice Department is in the early stages of investigating what authorities believe to be roughly $500 million in healthcare fraud perpetrated by companies that sell specialty creams designed to treat pain and other conditions, according to the Wall Street Journal. Under the Federal Food, Drug and Cosmetic Act ("FDCA"), generally, compounding is a practice [...]
A physician in California found out the hard way that knowing her patients' pain management habits is critical information. Dr. Hsiu-Ying frequently prescribed painkillers such as Percocet and Vicodin to her patients. She did not, however, spend enough time determining whether those same patients had drug-seeking behavior or other drug addictions. More than a dozen [...]
Cybersecurity threats are everywhere. Certain medical devices are susceptible to breaches in cybersecurity too. Many modern devices contain software integration allowing for updates in function and communication with healthcare providers. Improper modifications too medical device software may present a serious threat to the device's safety and effectiveness. The Food and Drug Administration recently issued a draft guidance for [...]
The Food and Drug Administration (FDA) regulates dietary supplements products and ingredients. FDA's jurisdiction is granted by the Dietary Supplement and Health Education Act (1994). Manufacturers and distributors of dietary supplements are responsible for evaluating the safety of their products and ensuring that the labeling is compliant with the Federal Food, Drug & Cosmetic Act and [...]
The Food and Drug Administration recently issued an inspection report pertaining to Downing Labs for failing to investigate why its drugs fail sterility tests. Last year, FDA requested that Downing Labs recall some of its drugs after determining that there was contamination. At that time, Downing Labs refused the request. Now, however, the pharmacy has announced a voluntary [...]
Serenity Hospice and Palliative Care will pay $2.2 million to the federal government to settle claims that it falsely billed Medicare. A former employee identified that Serenity flagged patients who were referred by one medical provider to ensure that they were admitted as hospice patients. In turn, Serenity would treat that provider's staff to dinner, concerts and [...]
The debate about specialty drugs involves determining if a new drug will cure a disease, or save lives, what is its proper cost? Some well-intentioned drug products are receiving scrutiny for the price pharmaceutical are looking to sell those drugs. Patients can rarely afford a product that costs nearly $100,000 a year. Insurers are reluctant to cover those [...]
Salads are popular items. Cucumbers are too. Recently though, a Texas woman became the second person to die from tainted cucumbers. A salmonella outbreak has been linked to cucumbers sold by a California company. Strains of salmonella in cucumbers grown in Mexico and distributed out of San Diego have been on health officials' radars in [...]
Recently, the Food and Drug Administration approved OxyContin, an extended-release form of the opioid painkiller oxycodone, for children as young as 11 who need “daily, round-the-clock, long-term” pain relief that can’t be treated adequately with other medications. While some physicians and parents applaud the decision, others have criticized the decision noting that it exposes children [...]
A former top administrator filed claims under the Federal False Claims Act — also known as a qui tam action in Georgia. Columbus Regional Healthcare System and Dr. Andrew Pippas have agreed to settle claims that they fraudulently billed governmental insurers. Dr. Pippas agreed to pay $425,000 to settle billing claims against him. Columbus Regional agreed [...]
