On January 10, 2022, the Departments of Labor, Health and Human Services, and Treasury (collectively the “Departments”) issued Affordable Care Act FAQs Part 51 which addresses, in relevant part, payment for over-the-counter...more
On Feb. 4, 2022, in response to a number of questions from various stakeholders about FAQs Part 51, regarding the requirement for individual and group health plans to cover over-the-counter (OTC) COVID-19 tests, the U.S....more
Update Feb 10: This advisory has been updated to include the latest information on the requirement that employer group health plans must pay for over-the-counter COVID-19 tests....more
As we previously discussed, federal regulators released FAQs on January 10, 2022 (“January FAQs”), requiring health plans to cover over-the-counter (OTC) COVID-19 tests for all participants during the pandemic, without...more
As indicated in our January 11, 2022 blog post and alert, the Department of Labor, the Department of Health and Human Services, and the Treasury (the “Agencies”) issued FAQs Part 51 on January 10, 2022, requiring group health...more
On December 2, 2021, President Biden announced new actions to combat COVID-19, given the emergence of the new Omicron variant. As part of his nine-point plan, the President included a directive that “the more than 150...more
A few short weeks ago we told you in a blog post that, with only four days’ notice, the Departments of Labor, Treasury, and HHS (the Departments) required that, starting January 15, 2022, group health plans cover FDA-approved...more
In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more
Effective January 15, 2022, employer group health plans must pay for at-home COVID-19 diagnostic tests purchased during the public health emergency. Given that the requirement to cover over-the-counter (OTC) COVID-19 tests is...more
The January Monthly Minute highlights the new OTC COVID-19 test coverage mandate (eff. January 15, 2022), group health plan provider compensation disclosure rules, and updated standards for ERISA plan financial statement...more
Seyfarth Synopsis: Since March 18, 2020, group health plans have been required to provide benefits for certain items and services related to testing for or diagnosis of COVID-19 during the applicable emergency period - see...more
On Monday, the government issued frequently asked questions (FAQs) requiring employer group health plans (Plans) and health insurance issuers to cover certain over-the-counter (OTC) COVID-19 tests at no cost to the...more
Effective January 15, 2022, health plans are required to cover the cost of over-the-counter (“OTC”) COVID-19 test kits obtained without a health care provider’s prescription or clinical assessment. This new requirement was...more
I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests - On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris...more
Beginning January 15, 2022, and through the duration of the public health emergency, insurers and group health plans must cover at-home COVID-19 diagnostic tests available over-the-counter (OTC) without imposing cost-sharing,...more
Looking forward to the weekend? Many employers and plan administrators may also have been . . . up until yesterday, when the government issued new requirements that take effect on Saturday. ...more
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more
With all of the challenges to public health during the Summer of 2020, there is some comfort in the Centers for Disease Control’s (CDC) recommendation that fresh air and sunshine is beneficial. For decades, sunscreen has been...more