The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
On June 4, 2020, HHS released new guidance detailing what additional data laboratories must report to HHS along with COVID-19 test results. HHS explained that the new guidance standardizes reporting requirements in an effort...more
As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more
HDHP and HSA participants - The IRS has expanded prior guidance to allow health plans to pay first-dollar costs for testing and treatment of COVID-19 without jeopardizing the participant’s HSA eligibility. ...more
Employers and health plans that want to provide some relief for participants during the spread of the novel coronavirus (SARS-CoV-2, which causes the disease COVID-19) may waive deductibles for COVID-19 testing without...more
On March 11, 2020, the IRS issued Notice 2020-15, allowing health savings account (HSA)-compatible high deductible health plans (HDHPs) to provide coverage for testing and treatment of COVID-19-related services without an...more
Employers across the country are currently considering what actions to put in place in light of the potential spread of COVID-19 (the coronavirus). Many employers offer their employees high-deductible health plans that can...more
To encourage individuals to seek prompt medical attention for the coronavirus (COVID-19), a number of states have taken, or are considering, action to eliminate the costs associated with testing and treating the virus and to...more
The Internal Revenue Service (IRS) issued a notice that allows individuals to participate in a health savings account (HSA) while participating in a high deductible health plan (HDHP) that provides coverage for both the...more
Benefit plan sponsors are responding to participant questions about the coronavirus/COVID-19. In particular, employers’ HR departments are fielding questions about whether their health plan will pay for any necessary testing...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
On March 11, 2020, the IRS issued Notice 2020-15, to address an important coronavirus issue for high-deductible health plans that are coordinated with health savings accounts (“HSAs”). The guidance paves the way for health...more
In response to the Coronavirus (“COVID-19”), the Internal Revenue Service advised that a health plan that otherwise satisfies the requirements to be a High Deductible Health Plan (“HDHP”) under section 223(c)(2)(A) will not...more
Seyfarth Synopsis: One of many COVID-19 benefits-related concerns focused on the ability of individuals covered under High Deductible Health Plans to have services to diagnose or treat the coronavirus covered before their...more
On March 11, the IRS issued Notice 2020-15. The new guidance permits high-deductible health plans (HDHPs) to pay for 2019 Novel Coronavirus (COVID-19) testing and treatment without a deductible (or with a deductible below the...more
The IRS issued guidance on March 11 that clears the way for employers to offer employees covered by a high-deductible health plan (HDHP) testing and treatment for the 2019 Novel Coronavirus (COVID-19) with no deductible or at...more
On Saturday, 29 February 2020, the U.S. Food and Drug Administration (FDA) issued an “immediately in effect guidance” to swiftly expand testing for the novel coronavirus (2019-nCoV, formally named SARS-CoV-2), the causative...more
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more