HRSA

News & Analysis as of

What a Trump Administration Could Mean for the 340B Drug Program

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

HRSA Announces Two-Day Extension of Fall 2016 340B Registration Period

On September 27, 2016, the Health Resources and Services Administration (HRSA) sent an email announcement that it will extend its quarterly registration period for the 340B Drug Pricing Program (340B Program) by two days...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

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

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

An Ounce of Prevention: Employing Foreign National Physicians in Physician Shortage Areas

Sponsoring a waiver for a J-1 “exchange visitor” can be a good way for healthcare employers to attract talented physicians to vacancies in underserved areas. Here is an example of how the J-1 process works and can help...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

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...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

HRSA reveals new tool for rural GME

In the face of rural physician shortages, the Health Resources and Services Administration (HRSA) unveiled a new tool on April 11 to help assess whether a rural hospital is currently a teaching hospital. Knowing whether a...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

340B Drug Discounts: Potential HRSA Policy Shift May Limit Eligibility for Preferred Pricing

The 340B drug pricing program requires drug makers to offer covered outpatient drugs to safety net hospitals and certain other designated healthcare providers at discounted prices. A potential shift in how the governing...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more

Alert: 340B Self-Audits: The Best Defense Is A Good Defense

Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

130 Results
|
View per page
Page: of 6
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×