Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the Alert, the “speaker programs” are defined as company-sponsored events at which a health care professional makes a speech or presentation to other health care professionals about a … Continue Reading

On October 28th, the Federal Bureau of Investigation, the Department of Health and Human Services, and the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency alerted hospital administrators and security researchers about a “credible threat” of cyberattacks to American hospitals.  Four hundred American hospitals are being targeted in cyberattacks by the same Russian hackers whom American officials … Continue Reading

An additional $20 billion in “Provider Relief Funds” is being made available pursuant to the Coronavirus Aid, Relief, and Economic Security (CARES) Act through a “Phase 3” General Distribution. However, time is running out for health care providers to apply to the U.S. Department of Health and Human Services for these funds. The application deadline for what may be the … Continue Reading

On October 2, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar II, announced the renewal of the public health emergency declaration due to the continued consequences of the COVID-19 pandemic. The 90-day renewal is effective October 23, 2020, and extends until January 20, 2021.

The renewal impacts a number of regulatory flexibilities and temporary rules applicable to health … Continue Reading

In 2016, the Obama Administration issued a regulation implementing Section 1557 of the Affordable Care Act (ACA) (the 2016 Rule), which redefined sex discrimination to include termination of pregnancy and gender identity. Despite efforts by the U.S. Department of Health and Human Services (HHS) to repeal and revise certain provisions of the 2016 Rule through a new Rule, a … Continue Reading

The U.S. Food and Drug Administration (FDA) issued a flurry of Press Releases and Alerts from mid-June through the end of July warning consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol (or wood alcohol), a substance often used to create fuel and antifreeze that can be toxic when absorbed … Continue Reading

New guidance issued by the U.S. Department of Justice (DOJ) highlights the importance of updating corporate compliance programs to satisfy regulatory requirements.  The 2020 updates pick up where the 2019 guidance left off in addressing the evaluation metrics for compliance.  The key takeaway for 2020 is that companies are encouraged to update and improve compliance programs with the latest in … Continue Reading

Dentists are now able to receive funds from the U.S. Department of Health and Human Services’ Provider Relief Fund, as a result of the American Dental Association’s advocacy.

In a press release dated July 17, 2020, the U.S. Department of Health and Human Services (HHS) extended the deadline to apply for the funds to August 3, 2020, “to ensure … Continue Reading

Widespread testing for the novel Coronavirus is generally recognized as an important tool in combating the spread of the virus. The World Health Organization is an advocate for broad testing, so as to better locate incidents of infection for purposes of isolation, caring, and tracking.

However, the cumulative cost for such testing is significant. In a study commissioned by the … Continue Reading

Medical record requests by payors are commonplace for health care providers. Typically, these requests are received by a front desk employee who responds to the inquiry in short order.  Yet, not all requests should be treated the same.  When a request for documentation is propounded by the “Special Investigation Unit” (S.I.U.)  of an insurance company, special care should be exercised … Continue Reading