Blog

Identifying and Avoiding High-Risk and Potentially Illegal Business Arrangements

Physicians and other industry participants are approached with new business opportunities in the healthcare space all the time. Some of these business opportunities are legitimate and perfectly legal. Many of them are not. Identifying and avoiding opportunities that are high-risk and potentially illegal can be challenging for physicians and non-lawyers, particularly because the healthcare...Read More

CMS Proposed Rule: Providing National Medicare Coverage for Approved Breakthrough Devices & Defining “Reasonable and Necessary”

Medical device companies face many economic and regulatory challenges with successfully bringing a new device to market. Two of those challenges include obtaining regulatory authorization to market a device and obtaining coverage from payors post-authorization. FDA implemented its Breakthrough Devices Program in 2018 to help manufacturers obtain quicker authorization. The program is designed...Read More

With History as Our Guide, Expanding Telemedicine in Response to the Pandemic Will Likely Result in a Hotbed of Enforcement

Telemedicine has been around well before the covid-19 public health crisis, but regulatory impediments and economic realities have stifled its widespread adoption. However, in response to the pandemic, many regulatory hurdles and economic roadblocks at the state and federal level have been temporarily waived or changed in an effort to promote access to care, protect patients and providers,...Read More

Paycheck Protection Program Fraud

The federal government enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in March of 2020 to address the economic impacts of the COVID-19 pandemic. As part of the CARES Act, Congress authorized up to $349 billion dollars in forgivable loans to small businesses through the Paycheck Protection Program (PPP). Soon after its passage, Congress authorized an additional $300...Read More

Enforcement Trends During Covid-19

Just as Covid-19 has interrupted businesses and imposed restrictions on industries throughout the economy, it is also having a major impact on healthcare enforcement actions brought by the DOJ and other agencies.  Even as regulations have loosened and social distancing restrictions have interrupted the progress of existing cases and slowed the rate at which new cases are being brought, other...Read More

Laboratory Advertising and Marketing After EKRA

The Eliminating Kickbacks in Recovery Act (the “EKRA”) has caused considerable consternation for laboratory industry participants and healthcare attorneys alike.  It represents a new, powerful enforcement tool for the federal government, and the extent of its reach and application have not yet been fully explored. One of the greatest areas of confusion is the effect that the EKRA will have on...Read More

Paid Leave Provisions Under the Families First Coronavirus Response Act: Exception for Employers of “Health Care Providers”

On March 18, 2020, President Trump signed into law the Families First Coronavirus Response Act (“FFCRA”), which became effective on April 1, 2020. Among other things, the FFCRA amends and expands the Family Medical Leave Act and also creates the Emergency Paid Sick Leave Act. The FFCRA establishes two new forms of paid leave that covered employers must provide to certain employees in response...Read More

Largest Fraud Enforcement Action in History

Attorney General Jeff Sessions and Department of Health and Human Services Secretary Alex M. Azar III announced today the largest health care fraud enforcement action in Department of Justice History. The takedown charged 601 individuals, across 58 federal districts for their alleged participation in health care fraud schemes involving more than $2 billion in false billings. Among the 601...Read More

Texas Medical Board Enforcement Process General Overview

  The Texas Medical Board’s Mission Statement is: “to protect and enhance the public’s health, safety, and welfare by establishing and maintaining standards of excellence used in regulating the practice of medicine and ensuring quality health care for the citizens of Texas through licensure, discipline, and education.” Every one of the 7,000 complaints the TMB...Read More

Fighting Onerous PBM Audits

Jay Adzema runs Adzema Pharmacy in McCandless, Arizona. It is a one-store pharmacy that processed 20,000 prescriptions over the past two years. 90% of those scripts cost less than $50 a piece. Recently, Express Scripts, a leading Pharmacy Benefits Manager (PBM) audited Adzema Pharmacy. The PBM was only interested in 19 of the 20,000 prescriptions. These 19 prescriptions cost between...Read More