Help Wanted Ads Suggest HRSA Reorganization Is in Gear

Recent HRSA job postings suggest that a reorganization announced in late January is finally in motion.

There are signs that the U.S. Health Resources and Services Administration (HRSA) reorganization announced in late January is finally in motion. It is still unknown, though, if the 340B program is moving to a new home in the HRSA administrator’s

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Judge Consolidates Arguments in Two 340B Contract Pharmacy Lawsuits

A federal district judge will hold a joint hearing in October on drug makers’ Novartis and United Therapeutics’ 340B contract pharmacy lawsuits.

A federal district judge will hold a joint hearing in October on drug makers’ Novartis and United Therapeutics’ (UT) lawsuits challenging the government’s findings in May that the two companies’ 340B contract pharmacy policies are unlawful.

In a short unpublished

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United Therapeutics Fleshes Out its 340B Contract Pharmacy Legal Arguments

United Therapeutics told a judge on Friday that the government’s position that the company's 340B contract pharmacies are illegal “contravenes the plain text” of the 340B statute.

The government’s position that United Therapeutics’ (UT) restrictions on 340B contract pharmacies are illegal “contravenes the plain text” of the 340B statute, the drug company told a federal district judge on Friday.

The U.S. Health Resources and Services Administration’s (HRSA)

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Providers Support, Eli Lilly Opposes, Rescinding Trump’s 340B Health Center Insulin Rule

Drug manufacturer Eli Lilly told HRSA is opposes rescinding a Trump-era rule requiring community health centers to pass along savings on insulin and injectable epinephrine to low-income patients.

340B trade associations and covered entities submitted public comments overwhelmingly supporting the Biden administration’s proposal to rescind a Trump-era rule requiring community health centers to pass along savings on insulin and injectable epinephrine to low-income patients.

Drug manufacturer Eli Lilly,

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Evolving Payor Strategies to Control Spending on Specialty Medications

SPONSORED CONTENT by Jerry Buller

The challenges that ‘white bagging’ poses for patients and providers are gaining attention as more health plans mandate these policies. ‘White bagging’ disrupts traditional ‘buy-and-bill’ practices for provider-administered drugs, creating patient safety concerns, operational problems, and financial challenges for covered entities.

Impact of ‘White Bagging’ Policies on Covered Entities

In the traditional ‘buy-and-bill’ model, covered entities maintain control of the drug and its integrity from end-to-end, managing purchasing, storage, and medication administration. With ‘white bagging’ policies however, covered entities are required to receive the drug from an outside specialty pharmacy designated by the patient’s health plan – often, that same pharmacy is also owned by the health plan. This external process inhibits covered entities from ensuring both the quality and integrity of the medication to be administered, and it can cause delays in therapy when drugs are not received on time. The pharmacy management challenges ‘white bagging’ creates are significant, requiring people and resources to address.

Payor-mandated ‘white

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Breaking News

In Surprise Move, Biden Administration Proposes Keeping Trump’s Nearly 30% Cut in 340B Hospitals’ Drug Reimbursement

The U.S. Centers for Medicare & Medicaid Services (CMS) said today it proposes to continue a nearly 30% reduction in Medicare Part B reimbursement for hospitals’ 340B-purchased drugs.

The Biden administration said today it proposes to continue a nearly 30% reduction in Medicare Part B reimbursement for hospitals’ 340B-purchased drugs.

The Trump administration implemented the payment reduction in January 2018. Hospital groups say it costs affected 340B hospitals

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Key Congressional Committee Urges HRSA to Fine Drug Makers Over 340B Contract Pharmacy Denials

U.S. House appropriators are encouraging HRSA to use fines and "any available measures" to hold drug manufacturers accountable for withholding 340B drug discounts.

The U.S. House Appropriations Committee is pleased with the U.S. Health Resources and Services Administration (HRSA) for challenging six drug makers’ denials of 340B pricing when covered entities use contract pharmacies, the committee said in a report released yesterday. It encouraged

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House Appropriators Want an Update from HRSA on its Plans to Clarify 340B Patient Definition and Provider Eligibility Criteria, Calls for New GAO Report

House appropriators want GAO to update its pivotal 2011 report on 340B, and want HRSA to report on its plans to implement the report's remaining two recommendations, which focus on clarifying eligibility criteria for 340B patients and providers.

In addition to weighing in on the ongoing 340B contract pharmacy standoff (see related story), the U.S. House Appropriations Committee has entered the thicket of the highly controversial topics of 340B patient definition and provider eligibility.

In its report

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Law Firm Sues HRSA Over FOIA Request for 340B Contract Pharmacy Documents

Law firm Latham & Watkins says HRSA is impeding its access to records it needs to represent United Therapeutics in its 340B contract pharmacy lawsuit against HRSA and HHS. | Shutterstock

The law firm representing United Therapeutics (UT) in its 340B contract pharmacy lawsuit against the federal government has filed its own related lawsuit against the government.

In a July 13 complaint filed in federal district court in Washington, D.C.,

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Feds, Novartis, and UT Weigh in on Consolidating 340B Contract Pharmacy Lawsuits

U.S. District Judge Dabney Friedrich is expected to rule soon on whether to consolidate Novartis and United Therapeutics’ 340B contract pharmacy lawsuits.

The federal government told a federal district judge yesterday it consents to the judge’s proposal to speed up and simultaneously consider Novartis and United Therapeutics’ (UT) pending motions for preliminary injunctions in the two companies’ 340B contract pharmacy lawsuits. The

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