News & Analysis as of

HRSA

HHS Further Delays Effective Date of Final Rule for 340B Drug Pricing Program’s Drug Ceiling Prices and Civil Monetary Penalties

by King & Spalding on

On March 20, 2017, HHS issued an interim final rule further delaying until May 22, 2017, the effective date of a January 5, 2017, final rule for the 340B Drug Pricing Program that addresses the calculation of drug ceiling...more

340B Update: HRSA Further Delays Regulations on 340B Pricing & Penalties for Drug Manufacturers

by K&L Gates LLP on

On March 20, 2017, the Health Resources and Services Administration (“HRSA”) published in the Federal Register an Interim Final Rule delaying the effective date of regulations relating to drug pricing and civil monetary...more

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

by Hogan Lovells on

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”

by Reed Smith on

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Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of 2015 was withdrawn from...more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

by Baker Ober Health Law 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

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

by 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

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

by K&L Gates LLP on

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

21st Century Cures Act Includes Several Noteworthy Mental Health and Substance Use Provisions

by Stinson Leonard Street on

The 21st Century Cures Act (Act), enacted in December 2016, has received widespread coverage for funding biomedical research and streamlining the drug approval process. The Act also includes the Helping Families in Mental...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

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

by Reed Smith on

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

President Trump’s Regulatory Review to Impact Recent Health Rules

by Reed Smith on

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect. In a January...more

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

by Polsinelli on

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

by K&L Gates LLP on

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

by Foley & Lardner LLP on

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

by King & Spalding on

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

by McDermott Will & Emery on

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

HRSA Releases Ceiling Price and CMP Final Rule

by Hogan Lovells on

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

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

by King & Spalding on

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

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

by K&L Gates LLP on

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

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

by King & Spalding on

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

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

by Polsinelli on

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

HHS Proposes 340B Dispute Resolution Process

by Faegre Baker Daniels on

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

by Foley & Lardner LLP on

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

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