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
Florida has been contemplating ways to increase patient access to care, especially in light of the COVID-19 pandemic and the anticipated increase in cases. Recognizing the accessibility of pharmacies, Florida is now...more
In response to the public health threat of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has formed a special emergency program to expedite development of COVID-19 therapies – the Coronavirus Treatment...more
The Food and Drug Administration (FDA) announced a policy shift on March 16, 2020, to allow state health departments to approve COVID-19 (coronavirus) diagnostic tests without FDA involvement during the current public health...more
The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week. The first authorization was issued to Roche Molecular...more
In the early morning hours of Saturday, March 14, 2020, the House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act (the “Act”), by a bipartisan vote of 363-40. The Senate has postponed its...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
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
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
With the spread of COVID-19, barriers to testing, treating, and getting paid for coronavirus-related care and containment efforts are being identified and addressed by federal and state regulators on a daily basis. ...more
Recognizing the need to eliminate potential administrative and financial barriers to testing for and treatment of the 2019 Novel Coronavirus (COVID-19), in Notice 2020-15, posted today on IRS.gov, the IRS advised that...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
Congress recently passed an $8.3 billion emergency spending bill to fund vaccine development, support for state and local governments, and assistance for affected small businesses. Federal lawmakers are likely to consider...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