Author Archives: admin

17 Apr

HHS reaches $100,000 settlement with Phoenix Cardiac Surgery for Lack of HIPAA Safeguards

Phoenix Cardiac Surgery, P.C., of Phoenix and Prescott, Arizona, has agreed to pay the U.S. Department of Health and Human Services (HHS) a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients. The settlement with the physician practice follows an extensive investigation by the HHS Office for Civil Rights (OCR) for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. For assistance developing a HIPAA compliance program or responding to a HIPAA breach, contact Rafael A. Gaitan, Esq. Mr. Gaitan has over 15 years experience in the health care industry and regularly counsels physician practices on regulatory matters including HIPAA and the HITECH rules.

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17 Apr

Community Pharmacy Re-permitting Required Before July 1, 2012

Section 465.018, Florida Statutes was amended in 2011, by HB 7095 to require every community pharmacy that dispenses Schedule II and Schedule III controlled substances to be re-permitted by July 1, 2012. All owners, officers, and prescription department managers of the community pharmacy will need to submit fingerprints to the Department of Health as part of the permitting process; and the community pharmacy must implement written policies and procedures for preventing controlled substance dispensing based upon fraudulent representations or invalid practitioner-patient relationships. To avoid disruptions to a business, community pharmacies are advised to begin the permitting process immediately. For assistance and guidance with applying for a community pharmacy permit, developing policies and procedures for preventing controlled substance dispensing fraud and abuse, or to appeal a permit denial or revocation, contact Rafael A. Gaitan, Esq. Mr. Gaitan has over 15 years experience in the health care industry, regularly representing pharmacies and pharmacist before regulatory bodies like the Florida Department of Health, and the Board of Medicine. Mr. Gaitan can be reached via e-mail at rgaitan@gaitanmorales.com or via telephone at 305.329.1462.

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08 Mar

FDA issues warning letter to makers of AeroShot “caffeine inhaler”

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

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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

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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

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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.

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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.

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28 Jul

FDA issues draft guidance on device changes that warrant new premarket review

Manufacturers 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.

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