Sheryl D. Rosen

Sheryl D. Rosen

Sheryl Rosen assists health insurers, health maintenance organizations, and health care providers with regulatory compliance and has experience with matters before the Florida Division of Administrative Hearings and the Florida Office of Insurance Regulation.

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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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FDA Launches Medical Device ID Requirement

On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer, the specific model of a device, and other information such as batch or lot codes, serial numbers, and expiration dates. The UDIs are intended to improve … Continue Reading

Beyond Advance Directives: States Consider New Model for End-of-Life Decision Making

Sixteen states around the country have implemented a new model of advance directives – the Physician Orders for Life Sustaining Treatment (POLST) paradigm – while 27 more states are considering doing the same.  (View a map here.)  POLST provides health care providers with more concrete guidance when determining whether to provide medical interventions to critically ill patients.  Current advance … Continue Reading

Florida Insurers Face September 1 Deadline for Consumer Notices about the Affordable Care Act

Earlier this year, the Florida Legislature passed a law requiring health insurers to tell consumers how much of any premium increase for 2014 is caused by various requirements of the Patient Protection and Affordable Care Act.  See Senate Bill 1842 at section 15, amending section 627.410, Florida Statutes.  Last week, the Financial Services Commission adopted a regulation that includes  a … Continue Reading

Preparing for the Affordable Care Act: New Law Authorizes Florida to Review Insurance Policies for Compliance, Report Violations

The 2013 Florida Legislature passed a number of healthcare-related bills that may impact your business or practice. The bills make changes to Medicaid and affect healthcare providers, hospitals, health insurers, HMOs, and pharmacies.

Most recently, Florida Governor Rick Scott signed one of the bills, Florida Senate Bill 1842, into law on May 31.  The new law conforms parts of … Continue Reading

Requested Chocolate Milk Change Highlights FDA Labeling Authority

Chocolate milk is serious business in school lunchrooms – and at the U.S. Food and Drug Administration (“FDA”). The FDA is calling for public comments about a requested change to milk labeling laws as a potential way to reduce childhood obesity. Currently, flavored milk, such as chocolate milk, that contains artificial sweeteners must be labeled as “no sugar added” chocolate … Continue Reading

Longtime Disagreement Between Florida Optometrists and Ophthalmologists Likely Headed for Conclusion

For years, ophthalmologists and optometrists have been on opposite sides of a proposal to give optometrists greater prescribing authority in Florida.  However, it appears that the sides have finally reached a compromise, and now the Florida Legislature is poised to expand optometrists’ scope of practice.

Optometrists in Florida already have the authority to prescribe topical ocular medications, but bills in … Continue Reading

Supreme Court to Decide Pharmaceutical “Pay for Delay” Case

The United States Supreme Court is set to decide whether a patent holder can pay to keep a challenger out of the market, or whether doing so violates antitrust laws.

Drug manufacturers are granted patents on their products for 20 years, giving them an exclusive right to manufacture and market the patented drug.  In order to bring a generic version … Continue Reading

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