HRSA

News & Analysis as of

GAO Report Examines Hospital Financial Incentives to Prescribe 340B Drugs to Medicare Beneficiaries

The Government Accountability Office (GAO) has issued a report examining financial and other characteristics of hospitals that participate in the 340B Drug Pricing Program, focusing on disproportionate share hospitals (DSH)...more

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed...more

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

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...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

House Subcommittee Circulates Proposed Legislation Providing Insight on the Future of the 340B Drug Pricing Program

The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more

Final Rule Implements HIV Organ Policy Equity Act

On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation...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

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

Proposed GME Legislation Looks to Increase Residency Slots

Last week, new bi-partisan legislation was introduced to increase the number of graduate medical education (GME) slots over the next five years at teaching hospitals and academic medical centers. If passed, the Resident...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

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

Mother Nature Axes 340B Hearing, But Written Testimony Survives

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But...more

The Importance of HPSA and MUA Designation

Rural communities in Kentucky are still largely underserved by health care providers. With the expanded range of Medicaid and Medicare services now available as a result of the Patient Protection and Affordable Care Act...more

Three Factors Affecting the Mid-Level Practitioner Workforce, Part Two

In the last post, the subjects of collaborative agreements and autonomy were discussed in relation to how they affect mid-level practitioners. Today’s post now turns to how HRSA designation and limited services clinics will...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

Guidance, Not Regulations, Expected for 340B Drug Pricing Program

The long-awaited 340B “mega rule,” promised by the Health Resources and Services Administration (HRSA) to be published last summer, has now been officially nixed. HRSA recently announced that it will not release the...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

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