Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
Physicians, physician groups and other medical practices please take notice and action to correct, if needed, your compliance programs and credentialing departments. As a regulated individuals or entities participating in the Medicare program, proactive compliance checks or screenings are important to receiving and responding to time sensitive documentation issued by or on behalf of the
Read MoreAttention Medicare providers! if you want to continue receiving Medicare payments without delay please ensure that your practice or billing provider is using MBIs for all Medicare transactions as soon as possible and prior to January 1, 2020. As you may recall, The Centers for Medicare and Medicaid Services (CMS) is requiring that “physicians, providers,
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Read MoreDo not wait to speak to an experienced health care attorney for assistance with filing for a health care clinic license or exemption from licensure with Florida’s Agency for Health Care Administration.
Read MoreOn May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical
Read MoreOn May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through
Read MoreThe Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products. The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products. Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has
Read MoreFeb. 4, 2016 — The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced the finalization of new federal poultry standards to reduce Salmonella and Campylobacter in chicken and turkey products. FSIS estimates that implementation of these new poultry standards will lead to an average of 50,000 prevented illnesses annually. As part of this
Read MoreOn April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss, energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year
Read MoreIntegrated Environmental Technologies (IET), a South Carolina based pesticide registrant, and Seriously Clean, Ltd., of Nixa, Mo., a firm that served as an authorized distributor of IET’s product under a different brand name, have agreed to pay civil penalties of $87,344 and $91,829, respectively, to the Environmental Protection Agency (EPA) to settle alleged violations of
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