Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more
News Briefs - Lawmakers Reintroduce Healthcare Workforce Resilience Act - Federal lawmakers are trying again to push through immigration reform that would allow officials to recapture unused visas and reprocess them for...more
For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more
Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more
New York Pharmacy Owners Charged in $30 Million COVID-19 Health Care Fraud and Money Laundering Case - On December 21, 2020, the Department of Justice (DOJ) announced that two owners of over a dozen New York-area...more
On December 3, 2020, the Secretary of the Department of Health and Human Services issued a fourth amended PREP Act declaration expanding the scope of immunity for covered entities engaged in the provision of goods and...more
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including...more
In what has been considered a huge win for community pharmacists, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) issued an Advisory Opinion on May 19, 2020. The Advisory...more
On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more
Experts have repeatedly emphasized the importance of increased testing for COVID-19 in an effort to maintain some control over this pandemic. With this goal in mind, on April 8, 2020, the Office of the Assistant Secretary for...more
The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack...more