January 2012 - Experienced Health Care and FDA Attorneys

31 Jan

FDA seeks permanent injunction against cheese manufacturer for failure to correct violations despite federal & state warnings

The 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

31 Jan

Florida Medicaid Diagnostic Imaging Prior Authorization Starts February 1, 2012

The 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

17 Jan

House subcommittee passes bill authorizing the Surgeon General to restrict the license of doctors who over-prescribe narcotics

January 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

11 Jan

FDA to sample imports of orange juice and deny entry to shipments adulterated with carbendazim

The 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.

09 Jan

FDA warns that over the counter HCG products marketed for weight loss are illegal

The 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

09 Jan

Medicare delays RAC demonstration program intended to hold back payments to hospitals

CMS 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.

Monthly Archives: January 2012