Category: Regulatory

HRSA To End Waiver for Some Offsite 340B Hospital Locations, Provides Grace Period

October 26, 2023 Tom Mirga, Editor at Large Views

HRSA confirmed it will end a pandemic-era waiver program that allowed 340B drug use in certain offsite hospital locations.

The Health Resources and Services Administration (HRSA) confirmed today it is ending a 340B program waiver issued early in the [...]

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Biocon Announces New NDC for its Lantus Biosimilar

October 26, 2023 Tom Mirga, Editor at Large Views

Biocon has added a new national drug code for its insulin biosimilar, the drugmaker recently notified 340B providers.

Indian biopharmaceutical manufacturer Biocon Biologics has notified 340B covered entities about a new national drug code (NDC) for insulin glargine-yfgn, [...]

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CMS Seeks Input on Contractor to Prevent 340B, Medicare Maximum Price Duplication

October 24, 2023 Tom Mirga, Editor at Large Views

Kelsey Lang, a health policy principal at Avalere, said CMS's request for information affirms its interest in preventing 340B duplicate discounts.

Regulators are seeking input on a contractor to help it shield drug manufacturers from giving duplicate 340B discounts and new [...]

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Congressional Witnesses Urge Medicare 340B Cuts

October 24, 2023 William Newton, Associate Editor/Senior Writer Views

Dr. Debra Patt, executive vice president at Texas Oncology, testified during a House subcommittee hearing that the 340B program was "broken."

Witnesses recently told a U.S. House subcommittee that Congress should cut Medicare payments for 340B drugs. The House Energy and [...]

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340B Dispute Resolution Final Rule Enters Last Stage of Regulatory Review

October 19, 2023 Rich Daly, Editor in Chief Views

HRSA plans to host a webinar for federal grantees in the days leading up to the 2024 340B recertification period.

A final rule to implement the 340B administrative dispute resolution (ADR) process arrived this week at the last stage of [...]

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Five More Providers Owe Drugmakers 340B Repayment: Audits

October 19, 2023 Rich Daly, Editor in Chief Views

HRSA confirmed it will end a pandemic-era waiver program that allowed 340B drug use in certain offsite hospital locations.

A total of 16 covered entities (CEs) owe repayment to drugmakers, five more than reported a month ago, according to [...]

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Paper Warns on Duplicate Discounts from 340B Ceiling Price, Medicare Maximum Price

October 19, 2023 Tom Mirga, Editor at Large Views

An Avalere study suggested 340B duplicate discounts could increase as a result of Medicare drug price negotiations.

Timelines for manufacturers to provide new Medicare “maximum fair prices” (MFPs) and 340B ceiling prices on drugs are misaligned, risking [...]

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Following Response Deadline, Next Steps in Senator’s 340B Probe Unclear

October 17, 2023 William Newton, Associate Editor/Senior Writer Views

Sen. Bill Cassidy, ranking Republican on the Senate HELP Committee, does not appear to have the authority to compel hospitals to respond to his inquiry on 340B revenue.

The deadline has passed for two health systems to respond to an influential senator’s probe into 340B revenue, and at [...]

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CMS Says 340B Lump Sum Payments Fueled Increase in Part B Premiums, Deductibles

October 17, 2023 Rich Daly, Editor in Chief Views

CMS said planned Medicare Part B premium increases are partly the result of the proposed lump sum payment for previous illegal 340B hospital cuts.

Federal regulators recently said planned out-of-pocket increases for Medicare beneficiaries are due, in part, to the proposed lump sum payment [...]

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HHS and HRSA Urge Judge to Reject Health Center’s Take on 340B Patient Definition

October 13, 2023 Tom Mirga, Editor at Large Views

Genesis Health Care building and signage

Genesis Health Care's proposed 340B patient definition would remove all limits on dispensing 340B drugs, HHS and HRSA told a federal district judge.

Federal healthcare agencies recently told a federal district judge that backing a South Carolina health center’s interpretation of the 340B [...]

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