News & Analysis as of

Section 340B

Capitol Hill Healthcare Update

by BakerHostetler on

The chairman of a Senate healthcare committee outlined a key test for stabilizing the Affordable Care Act’s (ACA) shaky individual marketplace: Both Republicans and Democrats will have to give a little. That formula has...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

CMS Outpatient Advisory Panel Speaks Out Against Planned 340B Cuts

by King & Spalding on

On August 21, 2017, a CMS advisory panel consisting of provider representatives recommended that CMS not finalize its proposed rule to reduce payments for outpatient drugs to hospitals under the 340B Drug Pricing Program....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

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program

by K&L Gates LLP on

cmsThis episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B...more

K&L Gates Triage: 340B Eligibility - Hospital Covered Entities

by K&L Gates LLP on

This podcast focuses on the eligibility requirements for hospitals participating in the 340B Drug Pricing Program. Factors affecting eligibility include a hospital’s licensure status, patient population, and Medicare...more

AGG Food and Drug Newsletter - August 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

by Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Manatt on Health: August 2017

Next Steps on Healthcare Reform - Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more

CMS Proposes Substantial Payment Reductions in CY 2018 for Off-Campus Hospital Outpatient Departments Subject to the Site-Neutral...

by K&L Gates LLP on

On July 20 and 21, 2017, respectively, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule addressing changes to the hospital Outpatient Prospective Payment System (“OPPS Proposed Rule”) and Medicare...more

CMS’s 340B Proposal Is Likely Unlawful—Here’s Why

by Morgan Lewis on

The agency’s recent proposal to reduce certain drug reimbursement is unprecedented and not based on a reasonable interpretation of its statutory authority....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

CMS Proposes Medicare OPPS, ASC Update for CY 2018

by Reed Smith on

CMS has published its proposed rule to update Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system rates and policies for calendar year (CY) 2018. In addition to...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

Proposed Rule Would Slash Medicare Payment for 340B Drugs

by Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more

House Committees Examine Health Care Policy Issues

by Reed Smith on

Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following: Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug...more

2018 Proposed Rules: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System

by King & Spalding on

On July 13, 2017, CMS issued the Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System (ASCPS) proposed rule (Proposed Rule). CMS proposes to update OPPS...more

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

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