News & Analysis as of

Department of Health and Human Services (HHS) Public Health Service Act

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Wiley Rein LLP

Manufacturers Are “Winning” in the 340B Drug Discount Dispute

Wiley Rein LLP on

Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more

Jones Day

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

Jones Day on

This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more

Davis Wright Tremaine LLP

New FAQs Address No Surprises Act Impact on ACA Maximum Out-of-Pocket Limits and Facility Fee Transparency

Employers should be aware that the No Surprises Act has an impact on the maximum-out-of-pocket ("MOOP") limit for annual cost-sharing under the Affordable Care Act ("ACA") and facility fee transparency. The new set of...more

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more

McDermott Will & Emery

OIG Final Rule Expands OIG Enforcement Authority to Grant and Contract Fraud

McDermott Will & Emery on

On June 27, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule amending OIG’s civil money penalty (CMP) regulations implementing the 21st Century Cures Act...more

Foley Hoag LLP

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

Foley Hoag LLP on

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more

Morgan Lewis

Preparing for the End of COVID-19 Emergency Periods: To-Dos for Plan Sponsors and Administrators

Morgan Lewis on

The COVID-19 pandemic brought multiple temporary changes for ERISA-governed group health and welfare plans. Certain coverage mandates apply for only the duration of the COVID-19 public health emergency (the Public Health...more

ArentFox Schiff

HHS COVID-19 Public Health Emergency Persists as California COVID-19 Policies Are Set To Expire

ArentFox Schiff on

The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more

Mintz - Employment Viewpoints

Health Plan Transparency and the Case for Welfare Plan Fiduciary Committees

The Consolidated Appropriations Act, 2021 (the “Act”) adopted a series of transparency requirements that apply to employer-sponsored group health plans. These transparency rules impose a series of new and complex obligations...more

Mintz - Employment Viewpoints

Report on the January 19, 2022 Three Agency “Listening Session” on Provider Non-Discrimination Rules: The Impact on Group Health...

Section 108, Division BB of the Consolidated Appropriations Act, 2021 requires the Departments of Labor, Health & Human Services and the Treasury (the “Departments”) to issue regulations under Section 2706(a) of the Public...more

Foley & Lardner LLP

The Consolidated Appropriations Act’s Compensation Disclosure Provisions from a Carrier and Plan Service Provider Perspective

Foley & Lardner LLP on

...The Consolidated Appropriations Act, 2021, Public Law 116-260 (CAA) sets forth new compensation disclosure requirements that apply to brokers and consultants with respect to both fully-insured and self-insured group health...more

Cozen O'Connor

US And Tyler Texas Chambers Of Commerce Sue Feds To Block Portions Of The Health Plan Transparency Rule

Cozen O'Connor on

Two chambers of commerce, the Chamber of Commerce the United States of America and the Tyler (TX) Area Chamber of Commerce, filed a lawsuit on August 10, 2021, in the US District Court for the Eastern District of Texas...more

Morgan Lewis - ML Benefits

Departments Release FAQs on HIV PrEP Coverage

On July 19, the US Departments of Labor, Health and Human Services, and Treasury (the Departments) issued Part 47 of their frequently asked questions (FAQs) about Affordable Care Act (ACA) implementation. There are three new...more

Tucker Arensberg, P.C.

What’s Next For The CDC’s Nationwide Eviction Moratorium?

Tucker Arensberg, P.C. on

On June 29, 2021, the Supreme Court refused to end the nationwide eviction moratorium issued by the Centers for Disease Control and Prevention (CDC), leading to quite a bit of confusion among the Courts of Appeal. In Alabama...more

Smith Debnam Narron Drake Saintsing & Myers,...

Has the CDC Overstepped its Authority on Evictions?

It has been over a year since the beginning of the COVID-19 pandemic and although many restrictions are beginning to lift, one that has not is the eviction moratorium. In August of 2020, (after the CARES Act eviction...more

McDermott Will & Emery

HHS Signals Commitment to “Predictability and Stability,” Extends Public Health Emergency Declaration “Likely” for Entirety of...

McDermott Will & Emery on

In a recent letter to state governors, Acting Secretary of Health and Human Services Norris Cochran signaled the US Department of Health and Human Services’ (HHS’s) commitment to “predictability and stability” in the ongoing...more

Jackson Walker

Health Plan Changes in the Consolidated Appropriations Act, 2021

Jackson Walker on

The protections for participants and their beneficiaries in the Patient Protection and Affordable Care Act (ACA) were expanded by the Consolidated Appropriations Act, 2021 (the “Act”). Some of the changes build on concepts in...more

King & Spalding

HHS Advisory Opinion Rejects Drug Manufacturers’ Attempts to Limit Contract Pharmacy Use by 340B Covered Entities

King & Spalding on

On December 30, 2020, the HHS Office of General Counsel (OGC) issued Advisory Opinion No. 20-06 finding the 340B Federal Drug Pricing Program requires drug manufacturers to extend 340B pricing to covered outpatient drugs...more

Foley Hoag LLP

Federal Public Health Emergency Extended to April 21, 2021

Foley Hoag LLP on

On January 7, 2021, Secretary Azar of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, until April 21, 2021. Without this extension, the declaration would have...more

Manatt, Phelps & Phillips, LLP

HHS Renews the COVID-19 Public Health Emergency Through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Manatt, Phelps & Phillips, LLP

HHS Renews COVID-19 Public Health Emergency, Extending Flexibilities and Funding for Another 90 Days

On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more

King & Spalding

Hospital Associations Appeal Decision Upholding Price Transparency Rule; King & Spalding Price Transparency Working Group Helping...

King & Spalding on

On July 17, 2020, the American Hospital Association and several additional associations and individual hospitals filed their opening brief in their appeal of a decision of the district court, which, had upheld CMS’s price...more

Pillsbury Winthrop Shaw Pittman LLP

The Limited Pandemic Federal Liability Protections

Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more

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