Two separate insider trading tips involving a biopharma acquisition and trial results for Pfizer Inc.’s COVID-19 antiviral, Paxlovid, allegedly netted millions of dollars in “ill-gotten” trading profits, according to U.S. SEC complaints announced June 29.
The U.S. Office of Inspector General (OIG) reported June 28 that it had launched a series of enforcement actions against perpetrators of a variety of forms of health care fraud, including in the areas of telemedicine and opioid abuse. The 78 individuals arraigned in this crackdown are said to be responsible for $2.5 billion.
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
Fraud perpetrated on U.S. federal health care programs is the stuff of nightmares among U.S. enforcement agencies, and yet another pair of fraudsters have been rounded up by the Department of Justice (DOJ).
More than one U.S. federal government agency is tasked with keeping track of fraud and abuse of federal health programs, but a new report by the Government Accountability Office (GAO) suggests there is more work to be done. The GAO report said that one of the key issues with fraud and abuse writ broadly is that the terms and definitions are used inconsistently, and that a fix for this and other problems might capture more fraud, which may in turn indirectly put more medical device makers at risk for such allegations.
Long before the U.S. Congress approved a path for importing prescription drugs from Canada to take advantage of their cheaper price, Poornanand Palaparty, an oncologist in Ohio, purchased cancer drugs from a Canadian distributor from 2004 to 2009. Now, nearly a decade after Palaparty pleaded guilty in 2013 to introducing misbranded drugs into the U.S., the FDA is debarring the doctor based on that federal misdemeanor.
Upholding a 2021 jury verdict against a hedge fund adviser accused of making fraudulent statements to drive down Ligand Pharmaceuticals Inc.’s stock price, the U.S. Court of Appeals for the First Circuit shot down Gregory Lemelson’s arguments that his statements related to the company and its lead drug, Promacta (eltrombopag), were opinions protected by the First Amendment and that they were not material.
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.
The U.S. Federal Trade Commission (FTC) has moved decisively in the area of mergers and acquisitions recently, but the agency also has a footprint in the enforcement space for health data disclosure. The FTC’s Ronnie Solomon said in a Dec. 1 public meeting that the agency will begin “thinking outside the box about what health information is in the 21st Century,” adding that the FTC is eyeing a more stringent enforcement regime regarding personal health data disclosures in the coming new year.
The U.S. Government Accountability Office (GAO) recently published a report on the pandemic-driven expansion of telehealth for Medicare beneficiaries, and pointed to some privacy and security risks of which patients may be unaware. However, GAO also noted that the CMS does not yet have a good handle on the rate of telehealth fraud and has not yet collected reliable data on telehealth outcomes, two gaps that will have to be filled if Congress is to comfortably vote to make permanent some of these pandemic-driven telehealth policies.
