News & Analysis as of

HRSA

HRSA Delays Final 340B Penalty Rule until July 1, 2018; Additional Rulemaking in the Works

by Reed Smith on

The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B “ceiling price” that may be charged to covered entities and...more

HRSA delays 340B CMP and Ceiling Price Rule to July 1, 2018 and intends to reopen rulemaking

by Hogan Lovells on

Last week, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties Rule (the...more

HRSA Proposes Delaying 340B Drug Pricing Program Reforms until July 1, 2018

by Reed Smith on

The Trump Administration is proposing to once again push back the effective date of a January 2017 final rule making changes to the calculation of the 340B “ceiling price” that may be charged to covered entities and related...more

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

by K&L Gates LLP on

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

Health Centers: The Federal Government Delivers a Big Win

by Farrell Fritz, P.C. on

On August 15, 2017, the Secretary of Health and Human Services, Tom Price, issued a press release reporting that almost $105 million dollars will be bestowed upon 1,333 health centers across the United States, including its...more

Update on Successes and Hurdles in Improving 340B Program Oversight

On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent...more

House Energy And Commerce Committee Hearing Holds Oversight Hearing on the 340B Drug Price Program

by King & Spalding on

On July 18, 2017, the House Energy & Commerce’s Oversight and Investigations Subcommittee held a hearing on “Examining HRSA’s Oversight of the 340B Drug Pricing Program.” The hearing featured a single panel of three federal...more

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

Capitol Hill Healthcare Update

by BakerHostetler on

Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable? Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’...more

Health Care Weekly Preview from ML Strategies – July 2017 #2

Welcome back everybody. The absence of Senator John McCain (AZ) – who is recovering at home from a craniotomy – has caused Senate Republicans to delay consideration of the Better Care Reconciliation Act (BCRA) previously...more

340B Update: CMS Proposes to Reduce 340B Drug Reimbursement; Draft Executive Order Could Mean Further Changes to the 340B Program

by K&L Gates LLP on

The Trump administration is considering significant changes relating to the 340B Drug Pricing Program (“340B Program”), which allows certain categories of safety net providers to access discounted pricing on covered...more

House Committee Issues Letter to HRSA Requesting Audit Documentation Regarding 340B Drug Pricing Program

by King & Spalding on

The House Committee on Energy and Commerce (Committee) sent a letter dated June 1, 2017, to the Health Resources and Services Administration (HRSA) Administrator expressing concerns about the growth and oversight of the 340B...more

House Bill Would Narrow Orphan Drug Exception

by Arnall Golden Gregory LLP on

A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more

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

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