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Healthcare › Over The Counter Drugs (OTC) › New Regulations

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Stinson - Benefits Notes Blog

Agencies Issue Additional Guidance Regarding Over-the-Counter COVID-19 Test Coverage

Stinson - Benefits Notes Blog on

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

Proskauer - Employee Benefits & Executive...

There’s More! Tri-Agencies Provide Clarifying Guidance on Group Health Plan Coverage of Over-the-Counter At-Home COVID-19 Tests

Proskauer - Employee Benefits & Executive... on

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

Venable LLP

Employer Group Health Plans Must Cover Over-the-Counter COVID Tests

Venable LLP on

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

Polsinelli

Group Health Plan Coverage Requirements Expanded to Include Non-Prescribed Over-the-Counter COVID-19 Testing

Polsinelli on

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

Robinson+Cole Health Law Diagnosis

New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

Robinson+Cole Health Law Diagnosis on

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

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