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»  Posts By   February 2019 

DOJ Position on Off-Label Promotion: What’s Changed and What’s the Same

It is well known that the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device or drug manufacturer who promotes any unapproved uses of FDA-approved devices/drugs is in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA has asserted that off-label promotion leads to misbranding of the product and circumvention of the regulatory approval process that is taken to ensure product...

Billing the Patient’s Plan or Billing the Local Affiliate: Difficulties for Home Infusion Providers Servicing Patients of National Corporations

A recent trend has emerged for home infusion providers seeking to service local patients who may be employed by, or receive healthcare coverage through, a large organization headquartered out of state.  When servicing the local patients, home infusion providers are often instructed to submit major medical claims through the local affiliate of the health insurer, despite the fact that the patient might have a plan issued through another affiliate of...

What Providers Need to Know About NJ DOBI Bulletin NO. 18-14 on the Out-of-Network Act

The New Jersey Department of Banking and Insurance (DOBI) recently released a guidance bulletin, Bulletin NO. 18-14  (the "Bulletin"), in an effort to provide additional guidance to carriers, health care providers, and other interested parties in order to help those entities meet their obligations under the Out-Of-Network Consumer Protection, Transparency, Cost Containment, and Accountability Act, P.L. 2018, c. 32 (codified at N.J.S.A. 26:2SS-1 to -20), (the "Act"). While the Bulletin...

Frier Levitt 2018 Regulatory Liability Annual Report

In 2017, Frier Levitt formed a practice group to defend healthcare providers against a variety of regulatory and billing liabilities that have become all too commonplace in healthcare delivery today. 2018 represented our first full year of gathering data, and we are pleased to reveal our results.   We have seen troubling new trends, such as payors alleging billing fraud (without "intent") to increase the lookback period for potential recoupment. We...

Pharmacies Must Use Caution When Dealing with Third Party Auditing Companies

Over the past few years, PBMs have increasingly hired third party companies – such as SCIO, Xerox, Conduent or others – to conduct pharmacy audits. Many times, these companies are compensated based on the amount of money they recoup on behalf of the PBM (thus, they are incentivized to find as many discrepancies as possible). They are given very little training and certainly are not made aware of applicable audit...
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