Sheryl D. Rosen

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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 … 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 … 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 … 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 … 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 … 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 … 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 … 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 … Continue Reading

HHS and Florida Reach “Agreement in Principle” for Medicaid Waiver

We previously reported that the U.S. Department of Health and Human Services (“HHS”) granted a Medicaid waiver allowing Florida to implement its Medicaid Long-Term Care Managed Care Program.  On February 20, 2013, HHS issued a letter stating it has reached an “agreement in principle” to grant a second Medicaid waiver – this one for Florida’s Managed Medical … Continue Reading

FDA Warns Against Unproven Flu Drug Claims

The Food and Drug Administration (“FDA”) recently issued a series of warning letters to companies marketing products unapproved by the Agency that claim to prevent the flu.  Some companies advertised  the product would “Safeguard you from deadly flu viruses” or “fight off influenza.”  Others claimed to be generic Tamiflu or “the most effective alternative to … Continue Reading

Florida Medicaid Managed Care Receives Green Light From HHS

Florida has been working on a plan to shift the state’s Medicaid population into managed care for nearly two years – ever since the Florida Legislature directed the change in 2011. On Monday the state received the approval it needed from the federal government. By letter dated February 1, 2013, the U.S. Department of Health and … Continue Reading

Calorie Labeling Requirements Unlikely to Affect Hospitals or Nursing Homes

Pretty soon, when you sink down into that cushy restaurant booth or roll up to the drive-through, you’ll see something new next to your favorite menu items – calorie contents. But healthcare establishments such as hospitals and nursing homes will be generally exempt. New Nutrition Labeling Requirements While some restaurant chains, such as Panera Bread, … Continue Reading