News & Analysis as of

Department of Health and Human Services (HHS) Omnibus Guidance

Mintz - Health Care Viewpoints

Five Suggested Updates for 340B Covered Entities Facing COVID-19 Challenges

The Health Resources and Services Administration (HRSA) recently published guidance regarding the evolving impact of COVID-19 on 340B stakeholders. This new guidance is one part of the U.S. Department of Health and Human...more

Mintz - Health Care Viewpoints

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies - October 2017 #3

With 24 bipartisan cosponsors in the Senate, the emerging Alexander-Murray stabilization package is a significant step forward in the health reform debate. However, after months of dominating the airwaves, health care is now...more

Mintz - Health Care Viewpoints

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more

Baker Donelson

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

Baker Donelson on

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

King & Spalding

HRSA Withdraws 340B Program “Mega Guidance” from OMB Review

King & Spalding on

On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the...more

Mintz - Health Care Viewpoints

Forty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking

Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still...more

King & Spalding

Also In The News - Health Headlines - September 2016 #2

King & Spalding on

340B Program Final “Mega Guidance” at OMB – On September 1, 2016, the White House Office of Management and Budget (OMB) received final omnibus guidance for review from HHS regarding the 340B Drug Pricing Program. ...more

Mintz - Health Care Viewpoints

Delays in 340B Mega-Guidance and a Recap of the Latest 340B Updates

Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the...more

McDermott Will & Emery

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

McDermott Will & Emery on

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Foley & Lardner LLP on

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

Baker Donelson

Drastic Changes in "Patient" Definition as HHS Releases the Long-Awaited Proposed 340B Omnibus Guidance

Baker Donelson on

After years of fits and starts, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) has finally released its proposed omnibus guidance for the 340B Drug Discount...more

Cooley LLP

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

Cooley LLP on

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

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