News & Analysis as of

Section 340B

CMS Proposes Reimbursement Reduction for 340B Drugs

by Baker Ober Health Law on

When CMS issued its proposed rule for OPPS and ASC Payment System on July 13, the agency included a proposal to substantially scale back reimbursement for Part B drugs to hospitals participating in the federal 340B Drug...more

Significant Cuts Proposed to Medicare Payments for 340B Drugs

by McDermott Will & Emery on

As part of the CY 2018 proposed updates to the Medicare Hospital OPPS, the US Department of Health and Human Services has proposed to decrease Medicare Part B payments to hospitals for 340B drugs by almost 30 percent. The cut...more

New Medicare Proposals that Reduce Payment to Hospitals for 340B Drugs in 2018

by Dorsey & Whitney LLP on

On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule which, among other proposals, could have a significant impact on 340B...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

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...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

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug...

by Dorsey & Whitney LLP on

On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more

Capitol Hill Healthcare Update

by BakerHostetler on

With only 10 legislative days before Senate Republicans’ self-imposed deadline, GOP lawmakers face growing obstacles in their quest to vote on replacing the Affordable Care Act (ACA) before the beginning of their scheduled...more

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

by Dorsey & Whitney LLP on

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

HHS Further Delays Effective Dates of Final Rules for 340B Drug Pricing Program and Cardiac, Orthopedic Bundled Payment Models

by King & Spalding on

On May 19, 2017, HHS further delayed the effective dates concerning two final rules issued during the Obama administration. First, HHS delayed until October 1, 2017 the effective date of a January 5, 2017 final rule for the...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

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

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

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