News & Analysis as of

HRSA

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans return to Washington this week after a 10-day recess facing a key inflection point in their effort to repeal and replace the Affordable Care Act (ACA) as GOP leaders will outline policy options they hope...more

340B Update: Trump Administration Calls for New Legislation and Regulatory Authority; HRSA Delays Regulations on 340B Pricing &...

by K&L Gates LLP on

Recent developments from the Trump administration relating to the 340B Drug Pricing Program (“340B Program”) could have a significant impact on covered entities, drug manufacturers, and others. In particular, the President’s...more

HRSA Pushes Back 340B Rule Implementation Until October 1, 2017

by Reed Smith on

Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the...more

Trump Administration Releases Fiscal Year 2018 Budget Proposal

by Baker Donelson on

On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more

Trump Administration FY 2018 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more

FY 2018 President’s Budget May Signal Challenges for Health Programs on the Horizon

by McDermott Will & Emery on

Eric Zimmerman, along with McDermott+Consulting Vice Presidents Adaeze Enekwechi and Piper Su, wrote this +Insights publication detailing the possible effects of the Trump Administration's 2018 budget on health programs and...more

340B Coalition Urges HHS to Implement Final Rule Regarding Ceiling Price and Manufacture Civil Monetary Penalties

by Arnall Golden Gregory LLP on

On April 19, 2017 a coalition of hospitals and safety-net providers, known as the 340B Coalition, submitted correspondence urging the government to implement regulations that would subject pharmaceutical manufactures to civil...more

MIECHV: A Minibus Rider

In a recent post we noted that the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program is one of the many potential riders on the health care minibus. In contrast to an omnibus bill, the “minibus” refers to a...more

Complicated Landscape Awaits New FDA Commissioner

by Holland & Knight LLP on

A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more

2017 Omnibus Agreement: Key Health Provisions

by Polsinelli on

Congress has completed action on H.R. 244, the “Consolidated Appropriations Act for FY 2017” [P. L. 115-31]. This bipartisan legislation, which funds the Federal government for the balance of the fiscal year, passed the House...more

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

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