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Physicians: Beware of FTC Rules for Product Endorsements

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. ...more

Dose of Caution Needed When Making Coronavirus Drug Claims

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...more

How the Trump Tariffs Affect Healthcare

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. ...more

FDA Ponders Health and Safety of Lab-Grown Meat

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...more

Florida Clinic License Exemptions Subject to Change

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....more

Medicare Providers Face December 1 Deadline to Request Review of Medicare Payment Adjustments

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...more

Florida Nursing Home Deaths Have Ripple Effects for Facilities Statewide

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...more

Rare but Not Forgotten: FDA Speeds Review of Orphan Drug Requests

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. Rare diseases have long had trouble...more

DEA Tweaks, Walks Back Changes to Renewal Process

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...more

New Tools Help Providers Become Smarter Users of Electronic Health Records Systems

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...more

The Changing Meaning of Healthy: FDA Seeks Public Input About Healthy Foods

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...more

Anti-Discrimination, Language Access Rules Compliance Deadline Fast Approaching for Health Insurers

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,...more

Fighting Prescription Drug Abuse Gets a Little Easier for Florida Providers, Pharmacists

Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements. Florida established its Prescription Drug Monitoring...more

Protecting the Blood Supply During a Future Ebola Outbreak

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...more

Food Recalls Increase in First Quarter of 2015

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...more

Reimbursement Changes, Shift to Consumerism Discussed at Akerman Healthcare Briefing

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...more

Guidance Helps Medical Device Companies Determine Substantial Equivalence

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....more

FDA Offers Guidance for Choosing Prescription Drug Names

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...more

For-Profit Corporations Entitled to Religious Exemption from Contraceptive Mandate

On June 30, 2014, the Supreme Court decided the closely watched case Burwell v. Hobby Lobby Stores, Inc. The main question before the court was whether for-profit companies may assert religious grounds to avoid providing...more

Florida Says Can Do To Medical Cannabis

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...more

Security Breach May Not Be Covered By Your General Liability Policy

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...more

Florida Acknowledges Exemption For Intracompany Sales Of Pharmaceuticals

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...more

Thought Leaders: These Are "Turbulent," "Transitional" Times In Healthcare

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...more

HHS Allows Third-Party Premium Payments By Tribes And Non-Profits

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...more

Industry Leaders Share Insights Into Healthcare Reform And The Future Of Healthcare Policy

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...more

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