Section 340B

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Also In The News - Health Headlines - September 2016 #2

340B Program Final “Mega Guidance” at OMB – On September 1, 2016, the White House Office of Management and Budget (OMB) received final omnibus guidance for review from HHS regarding the 340B Drug Pricing Program. ...more

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

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

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

HHS Proposes 340B Dispute Resolution Process

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

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

HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

Mid-Year 340B Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the...more

CMS Issues Proposed Rule Addressing Off-Campus Outpatient Departments

The Centers for Medicare and Medicaid Services (CMS) published its 2017 Medicare Outpatient Prospective Payment System (OPPS) proposed rule on July 14, 2016 (the Proposed Rule). In part, the Proposed Rule addresses CMS’s...more

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more

CMS Proposed Rule Implements Limitations on Medicare Payments for Off-Campus Outpatient Hospital Departments

In Depth - Background - On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the CY 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes proposed regulations to...more

Also In The News - Health Headlines - June 2016 #3

OMB Reviewing Proposal on Handling of 340B Disputes -- On June 15, 2016, the Office of Management and Budget (OMB) started its review of a proposed rule under the 340B discount program, according to the OMB’s website. Under...more

Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

OIG Faults State Efforts to Identify 340B Drug Claims; Cites Risk of Duplicate Discounts, Forgone Rebates

The OIG recently examined how states that pay for drugs through Medicaid managed care organizations (MCOs) identify and exclude 340B drug claims when collecting Medicaid rebates, since states are prohibited from collecting...more

OIG Recommends that CMS Require States to Use Claim Modifier on Medicaid Claims to Identify 340B Drug Claims

On June 8, 2016, OIG issued a report in which it recommended that CMS require states to use a claim-level method to identify 340B claims in order to prevent duplicate discounts for drugs and unclaimed rebates to which states...more

Delays in 340B Mega-Guidance and a Recap of the Latest 340B Updates

Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the...more

Also In The News - Health Headlines - June 2016

HHS recently announced delays to several rules and policies related to the 340B Drug Pricing Program. Policies postponed for later publication include the final 340B Omnibus Guidance, the Civil Monetary Penalties and Ceiling...more

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

Provider-Based Update: Congress Offers Encouraging Step to Reduce Scope of BBA Reimbursement Reductions

On Wednesday, members of the House Ways and Means Health Subcommittee introduced bipartisan legislation that would provide some welcome relief to hospitals who had already invested resources to develop new provider-based...more

CMS Update to Medicaid Managed Care Regulations Should Prompt Significant Change

The Centers for Medicare & Medicaid Services (“CMS”) has released the final version of its much anticipated revisions to the regulations governing Medicaid managed care (the “Final Rule”). First proposed in May 2015, the...more

Also In The News - Health Headlines - April 2016

CMS Extends Participation in Bundled Payments for Care Improvement by Two Years – CMS has offered awardees the opportunity to extend participation in Models 2, 3, and 4 of the Bundled Payments for Care Improvement program...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...more

HRSA Reopens Comment Period on 340B CMP Proposed Rule

On April 19, 2016, the Health Resources and Services Administration (HRSA) is publishing a notice reopening for 30 days the comment period on its June 17, 2015 proposed rule entitled “340B Drug Pricing Program Ceiling Price...more

340B Proposed Pricing Rule Reopened for Comment: Penny Pricing, New Drug Pricing and Definition of “Knowing and Intentional” Back...

On Monday, April 18, the Health Resources and Services Administration (“HRSA”) published a Notice reopening comment on its June 17, 2015 Proposed Rule regarding 340B pricing and manufacturer civil monetary penalties....more

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