OIG Issues Rare Special Fraud Alert Targeting Pharmaceutical and Medical Device Speaker Programs

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on fraud and abuse risks “associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies.” The OIG generally defines speaker programs as company-sponsored events at which a physician or other health care professional (HCP) “makes a speech or presentation to other HCPs about a drug or device product or a disease state” on behalf of a manufacturer.…
Continue reading...

FDA Approves First COVID-19 Drug: Veklury

The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older. Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial…
Continue reading...

New York’s Emergency Disaster Treatment Protection Act Provides Broad Immunity for Hospitals and Nursing Homes Related to Treatment of COVID-19 Patients and Other Residents

On March 25, 2020, New York’s Department of Health issued an Advisory to nursing home administrators, hospital discharge planners and others regarding nursing homes pertaining to the expedited receipt of residents returning to nursing homes from hospitals. The Advisory prohibited nursing homes in New York from denying admission or re-admission to a resident based upon a confirmed or suspected positive COVID-19 diagnosis. The full text of the Advisory is available here. The Advisory was of great concern to nursing home administrators and owners, who were…
Continue reading...

What is THC (Δ-9-Tetrahydrocannabinol)?

Many people associate cannabis with, “getting high” and in part, they are not wrong. The most commonly known active component of Cannabis sativa and Cannabis indica—two of the most common variants of herbal cannabis, is delta-9-tetrahydrocannabinol. In its natural state, THC is not psychoactive! However, this is a slight chemical misnomer—THC in its natural state on the plant is actually THCa or tetrahydrocannabinolic acid. Merely taking a bite out of cannabis plant material should not have an effect on the consumer aside from providing…
Continue reading...

Employer/Employee Relationships Under Medical Marijuana Laws

I’ve recently been on a kick writing about Missouri’s recent passage of State Constitutional Amendment Two legalizing the use of medical marijuana within the state. Past posts discussed some of the specifics of the law and some of the problems that may develop when Missouri, like other states, has problems with conflicting federal laws (Second Amendment and gun ownership). Continuing on my Missouri kick as they are one of the more recent states to legalize medical marijuana, I thought we’d next address another thorny topic…
Continue reading...

FDA Alert Concerning Consumption of Certain Food Products Infused with Liquid Nitrogen

The U.S. Food and Drug Administration (FDA) has recently issued an advisory about the potential harmful effects of a new food trend – the consumption of food and/or beverages infused with liquid nitrogen when the infusion is performed at the point of sale.  According to the FDA, examples include infused solid food products, such as cheese puffs, and beverages.  The infused products emit a smoke-like vapor or fog effect.   The liquid nitrogen is infused just before they are served and are often available at food…
Continue reading...

Update on Medical Cannabis for Veterans

As we recently noted in our last blog post, Senators Nelson and Schatz from Florida and Hawaii introduced The Veterans Medical Marijuana Safe Harbor Act.  The legislation provided our military veterans access to medical cannabis if they were found to be suffering from chronic pain, PTSD and other serious medical conditions, as well as funding clinical trial research within the Department of Veterans Affairs. As quickly as it was introduced and actually approved in the Senate by a vote of 85-9, it was also quickly…
Continue reading...

Health Care Organizations Seek Regulatory Changes To Improve Access To Cybersecurity Tools

Cybersecurity presents thorny problems specific to healthcare organizations. Not only are their protection of personal health information strictly regulated by the HIPAA and HITECH laws, but such organizations are also more frequently the targets of cyberattacks due in part to the highly personal information collected by such organizations, and in part due to the relative lack of resources available to battle cyber-threats. One set of healthcare regulations not directly related to cybersecurity, the Stark anti-kickback law, has potentially hindered healthcare organizations in adapting to an…
Continue reading...

The End of Marijuana as a Schedule I Banned Substance?

On January 4, 2018, Attorney General Jeff Sessions rescinded what is commonly referred to as “The Cole Memorandum.” The Cole Memo was drafted in 2013 by United States Deputy Attorney General James M. Cole and governed federal prosecution of offenses related to marijuana/cannabis. Under the memo, U.S. attorneys generally refrained from prosecuting state-licensed cannabis businesses unless they violated state as well as federal law. For the most part, this was not an issue, as those states which had legalized marijuana heavily regulated its use, and…
Continue reading...

Appeals Courts Vacate Half a Billion in Verdicts Against Johnson & Johnson

Johnson & Johnson (J&J) has successfully challenged two talc verdicts and has mitigated nearly $500 million in damages in less than a week. The largest verdict to date, the $417 million  Echevarria verdict, was reversed and a new trial has been ordered. This decision comes at the heels of J&J convincing a St. Louis appeals court to vacate a separate $72 million verdict. Superior Court Judge Maren Nelson concluded that the evidence presented during Echevaria’s trial didn’t support the large verdict.  Judge Nelson wrote that…
Continue reading...