Sheryl D. Rosen

Sheryl D. Rosen

Sheryl Rosen focuses her practice on healthcare and international trade and customs matters. She assists health insurers, health maintenance organizations, and healthcare providers with regulatory compliance, including obtaining and preserving licensure, establishing new lines of business, acquiring insurance entities, and ensuring compliance with a myriad of state and federal laws and regulations. She also has experience with matters before the Florida Division of Administrative Hearings, the Florida Office of Insurance Regulation, and the Florida Agency for Health Care Administration.

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Dose of Caution Needed When Making Coronavirus Drug Claims

By Sheryl D. Rosen on Posted in Government Affairs, Licensure & Regulatory, Pharmacy, Drugs, Medical Devices & Equipment

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 a result, marketers should exercise … Continue Reading

How the Trump Tariffs Affect Healthcare

By Sheryl D. Rosen on Posted in Government Affairs, Licensure & Regulatory

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, rubber medical gloves, MRI and … Continue Reading

FDA Ponders Health and Safety of Lab-Grown Meat

By Sheryl D. Rosen on Posted in Government Affairs, Licensure & Regulatory

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, lessen the environmental impacts of … Continue Reading

Florida Clinic License Exemptions Subject to Change

By Sheryl D. Rosen on Posted in Hospitals & Health Systems, Physicians

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 existing certificate holders, but businesses … Continue Reading

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

By Sheryl D. Rosen on Posted in Medicare & Medicaid, Physicians

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 in error have until 8 … Continue Reading

Florida Nursing Home Deaths Have Ripple Effects for Facilities Statewide

By Steven Grigas and Sheryl D. Rosen on Posted in Healthcare Law

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 three patients passed away … Continue Reading

DEA Tweaks, Walks Back Changes to Renewal Process

By Sheryl D. Rosen on Posted in Pharmacy, Drugs, Medical Devices & Equipment, Physicians

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. As a result, registrants who … Continue Reading

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

By Sheryl D. Rosen on Posted in Electronic Health Records & Medical Records

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, yet few decisions have so … Continue Reading

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

By Sheryl D. Rosen on Posted in Healthcare Law

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 are no longer deemed healthy.… Continue Reading

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

By Sheryl D. Rosen on Posted in Affordable Care Act and Other Healthcare Reform Legislation, Health Insurers & Managed Care Organizations

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

Protecting the Blood Supply During a Future Ebola Outbreak

By Sheryl D. Rosen on Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems

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 for the collection of blood … Continue Reading

Reimbursement Changes, Shift to Consumerism Discussed at Akerman Healthcare Briefing

By Sheryl D. Rosen on Posted in Affordable Care Act and Other Healthcare Reform Legislation, Hospitals & Health Systems, Physicians

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 discussion. Panelists leading the discussion … Continue Reading

Guidance Helps Medical Device Companies Determine Substantial Equivalence

By Sheryl D. Rosen on Posted in Pharmacy, Drugs, Medical Devices & Equipment

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 for their devices.

The FDA … Continue Reading

FDA Offers Guidance for Choosing Prescription Drug Names

By Sheryl D. Rosen on Posted in Pharmacy, Drugs, Medical Devices & Equipment

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 (“FDA”) shows many considerations go … Continue Reading

Florida Says Can Do To Medical Cannabis

By Martin R. Dix and Sheryl D. Rosen on Posted in Pharmacy, Drugs, Medical Devices & Equipment, Physicians

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 that produces seizures or … Continue Reading

Security Breach May Not be Covered by Your General Liability Policy

By Sheryl D. Rosen on Posted in Electronic Health Records & Medical Records, HIPAA, Privacy, and Data Security

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 more problematic.  Especially given the … Continue Reading

Florida Acknowledges Exemption for Intracompany Sales of Pharmaceuticals

By Sheryl D. Rosen and Martin R. Dix on Posted in Pharmacy, Drugs, Medical Devices & Equipment

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 drug.  However, the new decision … Continue Reading

Thought Leaders: These are “Turbulent,” “Transitional” Times in Healthcare

By Adam R. Maingot and Sheryl D. Rosen on Posted in Electronic Health Records & Medical Records, Hospitals & Health Systems, Physicians

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 Zeiler, Senior Vice President of … Continue Reading

HHS Allows Third-Party Premium Payments by Tribes and Non-Profits

By Elizabeth F. Hodge and Sheryl D. Rosen on Posted in Fraud & Abuse & False Claims Act, Health Insurers & Managed Care Organizations, Hospitals & Health Systems

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 in the Marketplaces.” In other … Continue Reading

Industry Leaders Share Insights into Healthcare Reform and the Future of Healthcare Policy

By Adam R. Maingot, Sheryl D. Rosen and Robert E. Slavkin on Posted in Affordable Care Act and Other Healthcare Reform Legislation, Health Insurers & Managed Care Organizations, Hospitals & Health Systems

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 Bailey, Assistant General Counsel, Florida … Continue Reading

HHS Guidance Clouds Earlier Statement, Discourages Providers From Purchasing Insurance for Patients

By Sheryl D. Rosen and Bruce D. Platt on Posted in Fraud & Abuse & False Claims Act, Health Insurers & Managed Care Organizations, Hospitals & Health Systems

There has been much speculation in the health care community that it may be financially beneficial, under certain circumstances, for hospitals and other large providers to purchase health care coverage for their indigent patients.  U.S. Department of Health and Human Services Secretary Kathleen Sebelius recently stated that Qualified Health Plans, which are sold on the federal health care Marketplace, are … Continue Reading

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