It has become increasingly common for physicians and other healthcare professionals to share medical information with the public via video platforms, blogs, and social media sites. That can be a great public service, especially during the pandemic, but when public communications include a positive review or other favorable mention of medical products or services, such … Continue Reading
Just like the dose makes the poison, the claim makes the drug. With a pandemic well underway, some marketers are offering products that they claim will treat or prevent COVID-19, the disease caused by the novel coronavirus. Without federal approval, however, anyone making claims about unapproved drugs risks is inviting a federal enforcement action. As … Continue Reading
It’s not just pile drivers, combines, and frozen fish. Much of the news coverage has discussed how industrial and agricultural products are subject to new Trump administration tariffs on goods imported from China. However, the list of Chinese products subject to the new tariffs also includes goods more familiar to healthcare providers: items like pacemakers, … Continue Reading
The hamburger of the future might be less Old MacDonald and more sci-fi – and it might be here sooner than you think. Several startups are working to scale up animal cell culture technology to grow meat tissue for human consumption. Proponents hail the nascent industry’s potential to reduce foodborne illnesses such as E. coli, … Continue Reading
Holders of Florida healthcare clinic license exemptions take note. Exemption certificates, which currently bear no expiration date, will expire every two years if a bill recently passed by the Florida Legislature becomes law. Senate Bill 622 will require exemption holders to renew their clinic license exemption biennially. The bill is silent as to treatment of … Continue Reading
Providers have just a couple more days to challenge Medicare’s proposed 2018 value modifier payment adjustments. On September 18, 2017, Medicare released quality reports and measures used to calculate quality-based payment adjustments affecting providers’ 2018 Medicare fees. Physicians, physicians assistants, nurse practitioners, clinical nurse specialists, and nurse anesthetists who believe such proposed payment adjustments are … Continue Reading
Hurricane Irma’s wrath knocked out power to much of Florida. At one South Florida senior rehabilitation center left in the dark, the generator was not powerful enough to sustain the air conditioning system, and a portable cooling system malfunctioned. Indoor temperatures swelled, leading to the deaths of eight patients before the facility was evacuated. An additional … Continue Reading
Ever heard of Hailey-Hailey Disease? How about factor V deficiency or Hemimegalencephaly? These are a few examples of rare diseases, e.g., those afflicting fewer than 200,000 Americans.… Continue Reading
DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be able to renew their expired registrations during a grace period, DEA announced it would instead continue allowing that practice – for now at least. … Continue Reading
Healthcare providers excel at providing care to their patients, not designing IT strategies. Even so, with the trend toward value-based payments increasing, more healthcare providers have turned to electronic health records (EHR) systems to help them fine-tune practice efficiency and improve patient outcomes. The EHR management systems options from which to choose can be dizzying, … Continue Reading
In the 1990s, food had to be low in fat in order to be considered healthy. Those were the days of Snack-Wells cookies and fat-free salad dressings. How times have changed. Now health professionals consider many higher-fat foods such as almonds, avocado, eggs, and salmon to be healthy. Conversely, some low-fat but artificial, processed foods … Continue Reading
Health insurers and HMOs have a limited time to review the new federal meaningful access rules and amend plan documents accordingly. However, many payors still have not revised their plans to include the required language, and others might not be aware the rules apply to them.… Continue Reading
Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements.… Continue Reading
It has been more than a year and a half since the Ebola outbreak began racing across western Africa. According to the U.S. Centers for Disease Control & Prevention (CDC), more than 28,000 people have been infected. Although the United States had very few Ebola patients, the Food and Drug Administration (FDA) recently released guidance … Continue Reading
Food producers are reporting a sharp rise in food recalls so far this year. During the first quarter of 2015, the U.S. Food and Drug Administration (FDA) published notices of 118 food recalls (excluding pet foods), and the U.S. Department of Agriculture published notices of 52 recalls of meat products. Those are almost double the … Continue Reading
Changing reimbursement models and a shift to consumerism were two of the hot topics discussed at Akerman LLP’s recent Healthcare Briefing event titled “Financial and Corporate Implications of the Affordable Care Act: A Look at the Past, Present, and Future”. Health care and financial industry leaders gathered Friday, November 21 in Tampa for the interactive … Continue Reading
When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question. The document is officially directed at FDA staff, but it is equally instructive to companies seeking FDA approval … Continue Reading
If you’ve seen your share of prescription drug commercials, you’ve likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations of letters, but naming a drug requires more than a marketing brainstorm session. A recent draft guidance document from the U.S. Food and Drug Administration … Continue Reading
In the waning days of the 2014 legislative session, the Florida Legislature passed the Compassionate Medical Cannabis Act of 2014. It is a very limited medical marijuana bill with very strict restrictions and conditions on use. The bill allows access to only low-THC (tetrahydrocannabinol) cannabis (so-called “Charlotte’s Web”) for persons with cancer or another condition … Continue Reading
Data breaches are certainly not unique to the healthcare industry. Large data breaches like the one experienced by Target stores in late 2013 seem increasingly common. Retail, financial, and other types of companies hold consumers’ financial information, but the healthcare industry also holds sensitive health information protected by HIPAA, making a data breach all the … Continue Reading
A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals. Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister pharmacy down the street, it had to obtain a type of wholesale drug distributor permit, as well as provide pedigree papers for the … Continue Reading
The phrase “the only constant is change itself” has rarely been so true across an entire industry. The U.S. healthcare sector is having to adjust to rapidly changing times. That whirlwind of change was discussed by industry leaders at Akerman’s recent panel event titled “Healthcare Issues for 2014: What Can You Expect?” Panelists included Karen … Continue Reading
We previously reported that the U.S. Department of Health and Human Services (“HHS”) has discouraged hospitals and other third parties from paying patients’ premiums or cost-sharing. HHS stated in its November 4, 2013 FAQ that it “has significant concerns with this practice because it could skew the insurance risk pool and create an unlevel field … Continue Reading
Current events were top-of-mind last Friday, November 15, 2013, as Akerman LLP’s Healthcare Practice Group and Wells Fargo invited clients and industry professionals to engage in a thoughtful discussion on healthcare reform and the future of the American healthcare system. The Healthcare Briefing featured a distinguished panel of executives and legal advisors that included Gordon … Continue Reading
