News & Analysis as of

Clinical Laboratory Testing New Guidance

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

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15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

King & Spalding

HHS Announces New COVID-19 Testing Laboratory Data Reporting Guidance

King & Spalding on

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

McGuireWoods LLP

FDA’s Emergency Use Authorization Process for COVID-19 Tests May Alleviate Shortage

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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

Bricker Graydon LLP

COVID-19 developments in employee medical insurance

Bricker Graydon LLP on

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

Pullman & Comley - Labor, Employment and...

IRS Guidance: High Deductible Health Plans May Waive Deductible for COVID-19 Testing

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

Littler

IRS Issues High Deductible Health Plan Guidance Related to COVID-19

Littler on

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

Cozen O'Connor

IRS Announces High Deductible Health Plans Can Cover COVID-19 Expenses Without Applying a Deductible

Cozen O'Connor on

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

Ballard Spahr LLP

States Waive Cost-Sharing for Screening and Testing in Face of COVID-19 Pandemic

Ballard Spahr LLP on

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

Ballard Spahr LLP

IRS Provides Relief for High-Deductible Health Plans to Cover COVID-19 Testing and Treatment Without Deductibles

Ballard Spahr LLP on

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

Akerman LLP - HR Defense

IRS Issues Helpful Coronavirus-Related Guidance for Employers with High Deductible Health Plans

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

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

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

Proskauer - Employee Benefits & Executive...

IRS Loosens HSA Rules for Coronavirus

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

Polsinelli

IRS Issues Guidance on COVID-19 Coverage for High Deductible Health Plans

Polsinelli on

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 Shaw LLP

More Viral Benefits News

Seyfarth Shaw LLP on

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

Stinson LLP

IRS Issues Coronavirus Relief for High-Deductible Health Plans

Stinson LLP on

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

Morgan Lewis - ML Benefits

IRS Modifies HDHP Rules in Response to Coronavirus Concerns

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

Hogan Lovells

FDA issues expanded testing policy for novel coronavirus to address public health emergency

Hogan Lovells on

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

Knobbe Martens

FDA Provides Guidance on 3D-Printed Medical Device Products

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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

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