Section 340B

News & Analysis as of

HRSA Publishes Proposed Rule on 340B Ceiling Prices and Manufacturer CMPs

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a Proposed Rule that would codify standards for the calculation of ceiling prices by manufacturers for covered outpatient drugs under the...more

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the...more

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

Also In The News - Health Headlines - June 2015 #3

MedPAC Releases June 2015 Report to the Congress – The Medicare Payment Advisory Commission (MedPAC) has today released its June 2015 Report to the Congress: Medicare and the Health Care Delivery System. Next week’s edition...more

HRSA Publishes Proposed Rule on the Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties - Comments Due to...

On Wednesday, June 17, 2015, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a notice of proposed rulemaking entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil...more

Proposed Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more

HHS Issues Spring 2015 Regulatory Agenda

The Administration has updated its regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda lists numerous pending HHS proposed and final rules...more

Also In The News - Health Headlines - June 2015

Senate Finance Committee Seeking Proposals on Medicare Chronic Care Policies – On May 22, 2015, the Senate Finance Committee announced the formation of a bipartisan working group created to explore potential solutions...more

Hospitals Rally to Defend 340B

A consortium of hospitals from across the country has delivered a letter to Congressional leaders, urging them to preserve the federal 340B program in its present form. Neither the content nor the timing of the letter was...more

Also In The News - Health Headlines - May 2015 #2

CMS Publishes Corrected Comment Deadline for FY 2016 IPPS and LTCH Proposed Rule; Comments Due by June 16, 2015 – On May 5, 2015, CMS published in the Federal Register a corrected comment period for the FY 2016 Medicare IPPS...more

New Data on Part D Prescription Drugs Available

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) made available a dataset that provides detailed information on medications that physicians and other healthcare providers prescribed under the Medicare...more

Health Care Update - May 2015 #2

In This Issue: - 340B Drug Discount Program Guidance Nearing Finish Line - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...more

340B ‘Mega-Guidance’ Arrives at OMB

On May 6, 2015, the Health Resources and Services Administration (HRSA) submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review. ...more

OMB Reviewing New HRSA 340B Omnibus Guidelines

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. ...more

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More...more

Congress Holds Hearing on 340B Program

The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more

Also In The News - Health Headlines - March 2015 #4

Congressional Hearing on 340B Program Rescheduled for March 24, 2015 – The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health has rescheduled the hearing on the 340B program for Tuesday,...more

Congressional Health Policy Hearings

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program....more

340B Drug Pricing Program Questioned by Congressional Subcommittee

In This Issue: - Recent Developments for Multiemployer Pension Plans - Witness Statements - Questions & Answers - For More Information - Excerpt from Recent Developments for Multiemployer...more

Health Care Update - March 2015 #2

In This Issue: - Senate HELP Begins Innovation for Healthier Americans Hearings - 340B Hearing Postponed; Written Testimonies Shed Light on Agenda - Implementation of the Affordable Care Act -...more

340B in the Spotlight This Thursday: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more

Upcoming House Hearing on 340B Program

The House Energy and Commerce Subcommittee on Health will hold a hearing on Thursday, March 5, 2015 on “Examining the 340B Drug Pricing Program,” focusing on the functionality of the program and the extent to which it meets...more

Health Reform + Related Health Policy News - December 2014, Issue 1

In This Issue: - Top News ..Congress Passes Omnibus Spending Package ..HRSA Cancels Plan for 340B ‘Mega Reg’; Congress Weighs Options ..Supreme Court to Hear Challenge to ACA...more

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