Blog

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

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