Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
On March 5, 2012, The U.S. Food and Drug Administration (FDA) issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the
Read MoreThe U.S. Food and Drug Administration (FDA) has asked a federal court to prevent Mexicali Cheese, a New York cheese manufacturer, from continuing to operate because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. According to a complaint for permanent injunction filed by the U.S. Department
Read MoreThe Agency for Health Care Administration (AHCA) is implementing the Medicaid Diagnostic Imaging Prior Authorization program on February 1, 2012. Claims for diagnostic imaging submitted with a date of service on or after February 1, 2012, will deny if the procedure has not been prior authorized by MedSolutions, Inc., (the company selected to manage this
Read MoreJanuary 17, 2012. Today, the House Health & Human Services Quality Subcommittee passed a bill aimed at giving the Surgeon General more power to stop doctors who over-prescribe narcotics, but only after a rewrite removing the word “suspension” — a compromise worked out between the Florida Medical Association and Department of Health. Under the rewritten version of
Read MoreThe FDA announced today that it will begin sampling import shipments of orange juice and will deny entry to shipments that test positive for carbendazim. In a letter to industry, the FDA informed that it received information on December 28,2011, that low levels of carbendazim (in the low parts per billion range) was detected in currently marketed finished orange juice products, and orange juice concentrate. The FDA traced the issue back to the 2011 crop of oranges from Brazil, where the carbendazim is a legally used fungicide to combat black spot, a type of mold that grows on orange trees.
Read MoreThe U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters in December 2011 to seven companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. The letters warn the companies that they are violating federal law by selling unapproved new drugs, and by making
Read MoreCMS has announced that it will postpone its Recovery Audit (RAC) Prepayment Review demonstration project that would have held up payments to hospitals until the Medicare RAC reviews the claim to ensure that the provider complied with all Medicare payment rules. The Medicare RAC Prepayment Review demonstration called for the RACs to conduct prepayment review of claims for 15 procedures that historically result in high rates of improper payments. Many doctors were unhappy with the proposed program, especially cardiologists, who would be most affected since 11 of the 15 procedures identified for Medicare RAC prepayment review affect cardiologists.
Read MoreManufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.
Read MoreFor the purposes of HIPAA, any person or business providing particular services to a covered entity involving “protected health information” (PHI) is known as a “business associate”; in fact anyone who would have occasion to encounter PHI in the course of their work for a HIPAA-covered entity—is a “business associate” and is not only under the same duty as the covered entity to comport itself by the dictates of HIPAA, but must also have a Business Associate Agreement (BAA). At Gaitan Morales, we regularly counsel health care entities and their subcontractors on such regulatory issues as HIPAA, the HITECH rule, the Red Flag rules and numerous other laws and regulations that govern the health care industry. To protect your medical practice or associated health care business from a regulatory mishap, call Rafael A. Gaitan, Esq. today at 305.329.1462, to schedule a free initial consultation and learn more about how the law firm of Gaitan Morales can help you.
Read MoreThe Florida Attorney General’s office (AG), along with State regulators, are investigating two process servicing companies that deliver foreclosure notices to homeowners, on civil allegations of slipshod business practices. Process servicers are persons who have been certified to administer “service”, that is the official delivery of legal papers on parties, witnesses or other people involved in a case. Failure to deliver these documents to the defendant homeowner, can result in the homeowner losing its home without the benefit of the judicial process. Attorney Rafael A. Gaitan, at Gaitan Morales, PLLC, represents homeowners at risk of losing their homes.
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