HRSA

News & Analysis as of

HHS Announces $83.4 Million in Funding to Train New Primary Care Providers

On July 7, 2014, HHS Secretary Sylvia Matthews Burwell announced that HHS would be awarding $83.4 million under the Teaching Health Center Graduate Medical Education (THCGME) program administered by the Health Resources and...more

HHS to Continue Enforcing Orphan Drug Exclusion from 340B Program

The Department of Health and Human Services (HHS) through its Office of Health Resources and Services Administration (HRSA) announced last week that, although a court recently struck down its regulation addressing application...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

$300 Million in Supplemental Funding Available for Expanding Services at Existing Health Centers, Applications Due July 1st

The Health Resources and Services Administration (HRSA) recently announced a supplemental funding opportunity for expanding services at current Health Center Program grantees for fiscal year 2014. Applicants must use at...more

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Health Update - June 2014

In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

Court Invalidates 340B Orphan Drug Rule

In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for...more

340B Drug Discount Program Orphan Drug Rule Vacated: ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs...

The D.C. District Court permanently enjoined the U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan...more

Health Headlines: Also in the News

340B “Mega-Reg” Under Review by OMB – The Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs sent the long-awaited 340B Proposed Rule to the Office of Budget and Management Affairs (OMB) last week...more

OIG Reveals Pervasive Problems in Federal Drug Discounting Program

The 340B drug pricing program was created by Congress in 1992 to make prescription medicines more available to low-income and indigent patient populations. The program has been, and likely will continue to be, fertile ground...more

HHS-OIG Criticizes 340B Drug Discount Program

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more

2014 May Be a Game-Changer for the 340B Drug Discount Program

The year 2014 looks to be a year of major developments for the 340B Drug Discount Program. We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing sanctions on audited entities,...more

340B Drug Pricing Program Developments in the New Year

On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more

Comments Solicited for Draft of Revised Guidebook for National Practitioner Data Bank

The Health and Resources and Services Administration (“HRSA”) of the Department of Health and Human Services has issued notice of a draft revised guidebook for the National Practitioner Data Bank. The Guidebook provides...more

NPDB Guidebook revision would clarify investigation reporting issues

Physicians always have been justifiably concerned about reports to the National Practitioner Data Bank (NPDB) regarding malpractice payments and adverse peer review actions. Two areas of frequent uncertainty have...more

Impact of Government Shutdown on HHS

Health care providers and health care companies are required to work with federal regulatory agencies on a daily basis. As a result, many are wondering exactly how the government shutdown will impact their businesses. The...more

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

’Orphan drug’ rule raises off-label worries for drugmakers

The U.S. Department of Health and Human Services last week clarified when hospitals are allowed to buy socalled orphan drugs at sharply discounted prices, but it left open questions for drug manufacturers about the risk of...more

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

HRSA Clarifies 340B Orphan Drug Exception But 340B Audit Enforcement Remains Murky

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more

HRSA Publishes Orphan Drug Rule for 340B Program

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more

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