The Blog

11 Feb

Home Health Agencies no longer under CMS moratorium

As of January 30, 2019, there are no active Medicare Provider Enrollment Moratoria in any State, including Florida, or U.S. territories. On July 31, 2013, the the Centers for Medicare and Medicaid Services (CMS) first issued a temporary moratorium which affected providers who desired to or where in the process of enrolling as a home

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11 Feb

How to respond to a Final Audit Report (FAR)

Florida health care providers that provide services to Medicaid recipients are likely, at some point, to receive an audit of their claims submitted to the Medicaid program for reimbursement. Some providers will, for any number of reasons, receive a preliminary audit report detailing the Agency for Health Care Administration’s (Agency) findings as well as setting

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07 Feb

Responding to Record Requests on a Timely Basis.

Health care providers are increasingly seeing request for records from all types of payors including but not limited Medicaid, Medicare and commercial insurance providers. The basis for receiving a requests for records could be as a result on any number of reasons, including compliance, aberrant billing practices or as a result of a ZPIC audit

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07 Feb

Florida Behavior Analysis Services – Overpayments

The Florida Agency for Health Care Administration (Agency), Medicaid Program Integrity (MPI) has and is undergoing review of several Behavior Analysis Services providers regarding their Medicaid reimbursement claims for services rendered. MPI is reviewing said claims in order to insure compliance with the program’s Florida Medicaid Behavior Analysis Services Coverage Policy dated October 2017, including

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19 Feb

FDA Issues Warning Letter to U.S. Importer for FSVP violation

U.S. Food and Drug Administration (FDA) issued a Warning Letter to  U.S. food  importer, B&I Overseas Trading Inc., for failing to implement supplier verification protocols, as required under the “Foreign Supplier Verification Program” (FSVP), to assure that fish imported by the company into the U.S. was produced in accordance with U.S. food safety regulations. In the FDA

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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

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01 Aug

One More Week to Go: FDA’s New Tobacco Rules Go Into Effect on August 8, 2016

Retailers, manufactures and retailer/manufacturers of tobacco products should take note that compliance with the U.S. Food and Drug Administration (FDA) new tobacco rules is rapidly approaching.  Certain provisions of the final rule become effective Monday, August 8, 2016.   On May 10, 2016, the FDA issued its final rule expanding the FDA’s definition of “tobacco

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22 Jun

FDA Targets Online Sales of Illegal Prescription Drugs

On June 9, 2016, The U.S. Food and Drug Administration (FDA) announced that it took action against 4,402 websites illegally selling unapproved prescription drugs to U.S. consumers. With the assistance of U.S. Customs and Border Protection, the FDA conducted inspections at International Mail Facilities (IMFs) and served formal complaints on domain registrars “requesting the suspension

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22 Jun

New FDA Guidance Targets Electronic Health Records in Clinical Trials

On 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

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22 Jun

FDA issues Draft Guidance on 3D Printing of Medical Devices

On 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

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