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
The role of community pharmacies in health care has evolved and expanded in recent years. Many community pharmacies now offer health and wellness services related to identifying, preventing, and monitoring acute and chronic...more
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15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more
Due to expanded COVID-19 diagnostic testing availability, the Missouri Department of Health and Senior Services (MDHSS) is encouraging providers to test both symptomatic and asymptomatic individuals, if the clinician’s...more
Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these...more
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
On March 18, 2020, the Connecticut Department of Public Health (DPH) issued an order requiring laboratories to report negative SARS-CoV-2 test results to DPH using the Electronic Laboratory Reporting System....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
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
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
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
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
Insurance coverage - In a statement on March 6, 2020, the Board of Directors for America’s Health Insurance Plans (AHIP) announced that insurers are voluntarily covering the diagnostic testing of COVID-19 (coronavirus)...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