Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
CMS sought recovery of an alleged overpayment in excess of $730,000 from a diagnostic laboratory, upon the conclusion and recommendation of Safeguard Services (SGS) to deny all claims submitted for 3,006 Medicare beneficiaries. Mr. Gaitan and Mr. Suarez, of our health care practice group, appealed the overpayment claim through the reconsideration (second level appeal),
Read MoreAnn Marie Gaitan will be presenting “Import for Export: How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers” at FIME International Medical Exposition, on August 8 at 2:00 PM, at the Miami Beach Convention Center. Mrs. Gaitan, leads the firm’s FDA Compliance practice group. She represents medical device companies from across the globe,
Read MoreEarlier today, the U.S. Food and Drug Administration (FDA) announced the publication of two proposed rules, as part of the implementation of the Food Safety Modernization Act (FSMA). The proposed rules address the “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (FSVP) and ” Accreditation of Third-party Auditors”, aimed at ensuring
Read MoreThe U.S. Food and Drug Administration (FDA) announced today that it “is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.” The FDA’s announcement comes just days after the agency issued Warning Letters to 15 foreign and
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