Section 340B

News & Analysis as of

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

OPPS Final Rule Finalizes Limits for Off Campus Departments

Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule...more

CMS Releases CY 2017 Final Rule Implementing Changes to Outpatient Prospective Payment System

The Centers for Medicare & Medicaid Services released the calendar year 2017 final rule implementing changes to the Medicare hospital Outpatient Prospective Payment System, or OPPS, including provisions implementing Section...more

HRSA Announces Two-Day Extension of Fall 2016 340B Registration Period

On September 27, 2016, the Health Resources and Services Administration (HRSA) sent an email announcement that it will extend its quarterly registration period for the 340B Drug Pricing Program (340B Program) by two days...more

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

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

New 340B Dispute Resolution Process: Will It Level the Playing Field?

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

HHS Proposes 340B Dispute Resolution Process

From its inception the 340B program has been the subject of disputes between drug manufacturers and their safety-net hospital customers. On August 12 HHS proposed an administrative process for resolving those...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

Mid-Year 340B Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the...more

CMS Issues Proposed Rule Addressing Off-Campus Outpatient Departments

The Centers for Medicare and Medicaid Services (CMS) published its 2017 Medicare Outpatient Prospective Payment System (OPPS) proposed rule on July 14, 2016 (the Proposed Rule). In part, the Proposed Rule addresses CMS’s...more

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more

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