BMN Blog

The United States Environmental Protection Agency (“EPA”) regulates pharmaceutical hazardous waste. Under the EPA, unused and disposed of pharmaceuticals are evaluated, managed and disposed of as potential “hazardous waste” under the Resource Conservation and Recovery Act (RCRA) Regulations. The RCRA establishes procedures and standards for hazardous and solid waste material management and disposal. Under the RCRA, solid waste includes “solids, liquids and gases and must be discarded to be considered waste.”[i]

Regulation Background

The False Claims Act (“FCA” or “Act”) is a federal anti-fraud statute that protects against persons and companies defrauding the government. The Act has been dubbed the government’s “primary litigation tool for recovering losses resulting from fraud.”[1] The FCA imposes civil liability on any one who “knowingly presents…a false or fraudulent claim for payment or approval” to the federal government.[2] It is used extensively to protect against fraud in healthcare.[3]

Studies have shown that almost 9 out of 10 adults have difficulty using the health information they receive.[1]  This difficulty reflects a gap in patients’ capacity to obtain, process, and understand basic health information and the services needed to make appropriate health decisions. In other words, the studies reflect a gap in health literacy. 

It is especially important for smaller practices to be mindful of Electronic Protected Health Information (ePHI) security regulations – a breach of ePHI can lead to costly notification requirements and potential monetary penalties under the HITECH Act.[1]  Managing physicians of small independent practices hold many responsibilities, including the duty to comply with the Security Rule within HIPAA regulations.  This article provides a brief overview of federal ePHI compliance safeguards required in a practice.  While not meant to be a comprehensive discussion of all requirements, it highlights legal considerations and safeguards a practice must implement to comply with HIPAA ePHI regulations.  The federal Security Rule under HIPAA requires a health care provider (typically known as a Covered Entity[2]) to have the minimum ePHI safeguards, listed below.

On Friday, January 19, 2018, the Department of Health and Human Services (HHS) issued a proposed rule that will complicate the issues healthcare providers face in providing treatment to LGBTQ patients.