Section 340B

News & Analysis as of

340B Program Ceiling Price and CMP Final Rule Delayed Until May 22

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Rule (the Final Rule)...more

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the...more

The Uncertain Future of the 340B Drug Discount Program

Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more

The 340B Program Omnibus Guidance: Not Ready for Prime Time

On January 30, 2017, the proposed 340B Drug Pricing Program (the “340B Program”) Omnibus Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of 2015 was withdrawn from...more

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

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

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

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

340B Update: Trump Administration Withdraws Omnibus Guidance, Delays Final Rule on 340B Drug Pricing and CMPs

The new administration has had an immediate impact on the federal 340B Drug Discount Program (“340B Program”) with two significant developments in the first days since President Trump took office: (1) the withdrawal of the...more

340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

340B Program Rules to Remain Unclear

As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more

340B Mega Guidance Withdrawn

On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance). The guidance addressed a number of significant issues under...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more

HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties

The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act. In...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more

HHS Publishes Final Rule for 340B Drug Program Ceiling Prices and Civil Monetary Penalties

On January 5, 2017, the HHS Health Resources and Services Administration (HRSA) published a final rule updating the price structure that drug manufacturers participating in the 340B Drug Pricing Program may charge to covered...more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

HRSA Releases Ceiling Price and CMP Final Rule

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Final Rule for Penalties Relating to 340B Drug Pricing Program Nears Release

On December 23, 2016, the White House Office of Management and Budget (OMB) completed review of a final rule for penalties under the 340B Drug Pricing Program for drug manufacturers that intentionally charge a 340B covered...more

HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties

Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule...more

21st Century Cures Act: Who Does the “Mid-Build” Exception Help?

The exception helps a number of hospitals with their provider-based sites that had been under construction in November 2015, but not as many as may initially appear. Read on if you are interested in understanding the...more

What a Trump Administration Could Mean for the 340B Drug Program

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

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

CMS Announces Final Rule Implementing Site-Neutral Payment Rule for Certain Off-Campus Hospital Outpatient Provider-Based...

On November 1, 2016, the Centers for Medicare & Medicaid Service (“CMS”) released the pre-publication form of its much-anticipated Hospital Outpatient Prospective Payment System (“OPPS”) CY 2017 final rule with comment period...more

214 Results
|
View per page
Page: of 9
Cybersecurity

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×