Category: Regulatory

340B Provides Benefits, Needs Reform, Says Literature Review

November 28, 2023 Tom Mirga, Editor at Large Views

A JAMA Health Network literature review found that the 340B program provides a range of benefits but needs reforms.

The 340B program has provided a range of benefits but also needs reforms, according to a recent review of published [...]

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Two Drugmakers Offer Refunds for 340B Overcharges

November 28, 2023 Tom Mirga, Editor at Large Views

Two drugmakers, Mallinckrodt's subsidiary SpecGx and Novo Nordisk, owe refunds to 340B providers for certain overcharges.

Two drugmakers will offer refunds to 340B providers for overcharges in recent years. Drug manufacturer Mallinckrodt’s SpecGx generic pharmaceutical subsidiary [...]

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Apexus Asks Appeals Court to Affirm Dismissal of Contract Breach Lawsuit

November 17, 2023 Tom Mirga, Editor at Large Views

AHF has asked a federal appeals court to reverse an earlier court's decision to dismiss a case against Apexus over its provision of 340B sub-ceiling price discounts on drugs.

Apexus, the 340B prime vendor, asked a federal appeals court to affirm a lower court’s dismissal of claims that it [...]

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Jazz Pharmaceuticals Posts Refund Notice on HRSA Website

November 17, 2023 Rich Daly, Editor in Chief Views

Jazz Pharmaceuticals owes refunds to 340B providers, according to a notice posted on HRSA's website.

Jazz Pharmaceuticals owes refunds to 340B providers, according to a notice posted on the Health Resources and Services Administration’s Office [...]

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Hospitals to Meet with White House, HHS About 340B Dispute Resolution Process

November 15, 2023 Tom Mirga, Editor at Large Views

The White House plans to release a revised administrative dispute resolution process for the 340B program this month.

Hospital groups will meet with federal executive branch officials to discuss coming changes to the 340B program’s administrative dispute resolution [...]

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GlaxoSmithKline Posts Refund Notice on HRSA Website

November 9, 2023 Rich Daly, Editor in Chief Views

GlaxoSmithKline and Pfizer announced updates to their 340B contract pharmacy policies to comply with new state laws that will take effect in July.

GlaxoSmithKline owes refunds to 340B providers, according to a notice posted on the Health Resources and Services Administration’s Office of [...]

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Genesis Ruling Could Expand 340B-Eligible Prescriptions, Say Some Attorneys

November 7, 2023 Rich Daly, Editor in Chief Views

Kyle Vasquez, an attorney for Polsinelli, said the Genesis ruling was "limited in reach" but could create obstacles for other HRSA enforcement activity.

A recent ruling by a federal district judge in South Carolina potentially could expand 340B-eligible prescriptions, say some provider advisers. [...]

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Hospitals Urge CMS to Reconsider Future Cuts in 340B Lump Sum Final Rule

November 7, 2023 Rich Daly, Editor in Chief Views

Tom Kraus, a vice president of the American Society of Health-System Pharmacists, said he was "deeply concerned" with future cuts in CMS' 340B lump sum final rule.

Hospital advocates praised the recent Medicare final rule implementing a $9 billion lump sum payment to 340B hospitals but worried [...]

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HRSA, Hospital Settle Lawsuit Over Termination from 340B

November 7, 2023 Tom Mirga, Editor at Large Views

The hospital Insight Chicago and federal regulators have agreed to dismiss a case before a federal district court over the hospital's 340B eligibility.

A federal district judge in Illinois has dismissed a Chicago hospital’s apparently successful lawsuit challenging its termination from the 340B [...]

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Senate Finance Committee Republicans Oppose CMS Plan to Redefine Medicaid Best Price

November 7, 2023 Tom Mirga, Editor at Large Views

A group of Republicans on the Senate Finance Committee have called on CMS to withdraw its plan to rewrite the definition of Medicaid best price.

A group of Senate Republicans recently urged federal regulators to withdraw a plan to change the definition of a drug’s [...]

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