Healthcare Empowered
The FDA issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products. CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment […]
On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19. Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health […]
CMS is changing its payment methodology to encourage higher throughput of COVID-19 diagnostic testing. Previously, CMS would reimburse $100 per test Starting January 1, 2021, Medicare will pay lower the base rate to $75. However, if the laboratory can complete the test within two (2) calendar days from the date the specimens is collected, CMS […]
Since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without the appropriate certifications under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA, which verifies that labs meet […]
On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on October 23 (the date the PHE was previously scheduled to expire) and extending through January 20, 2021. Source: Renewal of Determination That A […]
The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, […]
There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. It wasn’t the products that got […]