Blog

Misinterpreting EKRA and the Dangers of “Flat Fee” Independent Contractor Marketing

Misinterpreting EKRA and the Dangers of “Flat Fee” Independent Contractor Marketing Since the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”), we have a seen a significant industry shift away from labs using an employed and commissioned sales force in favor of “flat fee” sales contracts with independent contractor marketing groups. While generally well-intentioned and in many...Read More

Laboratory Enforcement Trend – Strategic Use of Immediate Jeopardy Findings in Fraud, Waste and Abuse Investigations

In recent years, we have observed an increasing trend of immediate jeopardy findings (nominally based on operational deficiencies) that appear to be stop-gap measures preventing laboratories that are the targets of fraud, waste and abuse (“FWA”) investigations from continuing to bill during a pending investigation. We frequently encounter long-term laboratory industry participants who have...Read More

Private Equity Healthcare Acquisitions: Evaluating and Improving Compliance Programs

Healthcare entities (both physician practices and ancillary service providers) continue to be a major component of many private equity acquisition and investment plans. However, healthcare acquisitions present several unique regulatory challenges and recent enforcement trends suggest that private equity investors face increasing exposure to liability under the False Claims Act (“FCA”), and...Read More

Avoiding Telemedicine Arrangements that Raise Problems with Payors, the Medical Board, and State or Federal Authorities

The Covid-19 pandemic has brought tremendous changes to the way that physicians and other medical providers practice medicine. Nowhere is this change more pronounced than in the expansion of telemedicine services. Covid-19 has forced regulators and the healthcare industry at large to refocus on limiting contagion, and with this new focus comes a growing appreciation for the benefits of...Read More

Victory in the Supreme Court for Independent Pharmacies

States Have More Flexibility to  Regulate Abusive Practices of Pharmacy Benefit Managers On December 10, 2020, independent pharmacies scored a huge victory in the Supreme Court of the United States. The unanimous, landmark decision of Rutledge v. Pharmaceutical Care Management Association will pave the way for states to reign-in the abusive pricing and reimbursement practices that have caused...Read More

Modifications to the Personal Services and Management Contracts Safe Harbor Under the AKS

The Anti-Kickback Statute (AKS) generally makes it illegal to knowingly and willfully solicit, receive, offer, or pay any remuneration in exchange for referrals of services that may be paid by federal health care programs. The AKS is a criminal statute but it can also serve as the predicate for civil cases brought under the federal False Claims Act. The prohibition in the AKS is broad but the...Read More

COVID-19 Enforcement Update

Abbreviated Government Investigations and Permanent Injunctions On May 11, 2020, we posted a blog regarding enforcement trends during Covid-19, which noted the shifting priorities of DOJ and its increased reliance on civil remedies to quickly shut down Covid-19 related frauds. We have continued to see an uptick in the number of these civil Covid-19 enforcement actions, possibly reflecting the...Read More

Payment for Covid-19 Testing

To Submit Claims to Payors or Not to Submit: A Challenging Question COVID-19 cases continue to spike across the country and testing for the virus is likely to remain a fixture of our lives. But who pays for it? Federal law passed in response to the COVID-19 pandemic generally requires insurance companies to provide blanket coverage for all FDA approved or authorized tests without any cost...Read More

Election Challenges and Election Offenses

Covid-19 has, in many ways, changed the voting process for many Americans and a large number of states are likely to see a substantial increase in the number of ballots cast by mail in the 2020 presidential election. As a result, voter fraud and election related offenses are front and center in many news cycles and are a topic of discussion among politicians and parties.  A.  The Election...Read More

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