Administrative Action Archives - Experienced Health Care and FDA Attorneys

15 Sep

Appeal of UPIC Audit Overpayment Determinations – A Multi-Step Approach

Mr. Gaitan is available to discuss his strategies and legal costs, including hourly and contingency fee arrangements with provider’s who have received a records request or have received an overpayment determination and demand letter from their MAC or would like to more about the process. Initial consultation fee is waived. Feel free to contact Rafael (Ralph) Gaitan, Esq. at (786) 440-8115 or via email at [email protected]

27 Jun

Appeal of CMS Revocation and Enrollment Bar – Physicians Take Note.

The Centers for Medicare & Medicaid Services allows for the enrollment of various types of providers to participate in the Medicare program for reimbursement of medical services provided to beneficiaries. Typically, physicians get credentialed into the Medicare program through their employers. The employer’s staff prepares and assists with the submission of the physician’s initial enrollment

05 Dec

FDA issues over 400 Warning Letters to Tobacco Retailers

In light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has

30 Apr

FDA Warning Letters demand “immediately cease distribution” of dietary supplements with BMPEA

On 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

07 Apr

Pesticide Companies Selling Antimicrobial Pesticide with Unapproved Claims to Pay Civil Penalties to EPA

Integrated 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

06 Apr

U.S. government sues food manufacturer after Listeria outbreak

On April 3, 2015, the U.S. government filed suit against Wholesome Soy Products of Chicago, to stop the company from distributing food products after an outbreak of Listeria was linked to the company’s mung bean and soybean sprouts, associated with several illnesses last summer. That same day, Wholesome Soy Products Inc. accepted a consent degree outlining conditions it

21 Jan

FTC target deceptive advertisers of weight-loss products

On January 7, 2014, the Federal Trade Commission (FTC) announced a law enforcement initiative to stop deceptive advertising claims to relating to weight- loss products, from food additives and skin cream to dietary supplements. Recognizing that Americans spend billions of dollars every year on supplements, foods and devices in hopes of improving their health and

21 Jan

FDA issues warning letter to dietary supplement for illegal drug claims and unapproved dietary ingredients

On December 31, 2013 the U.S. Food and Drug Administration (FDA) issued a warning letter to Star Scientific, Inc. covering two dietary supplement products bearing illegal drug claims and unapproved new dietary ingredients — Antabloc and CigRx The U.S. Food and Drug Administration (FDA) has warned Star Scientific that the therapeutic claims made in association

23 Jul

FDA issues Warning Letters against dietary supplement products making diabetes claims

The 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

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.

Tag Archives: Administrative Action