Office of Pharmacy Affairs Get Slight Funding Bump

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

President Biden on Dec. 29 signed a $1.7 trillion omnibus appropriations bill for fiscal year 2023 that gave the 340B drug pricing program a slight funding boost.

The U.S. Health Resources and Services Administration’s Office of Pharmacy Affairs will get

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CMS Requiring All 340B Entities to Use Claims Modifiers When Billing Part B for 340B Drugs

Screenshot of CMS Part B inflation rebate guidance
CMS is requiring all 340B covered entities by Jan. 1, 2024, to use claims modifiers to identify drugs as having been purchased through 340B when they bill for separately payable Medicare Part B drugs.

The U.S. Centers for Medicare & Medicaid Services starting Jan. 1, 2024, will require all 340B covered entities—hospital and grantee—to use claims modifiers to identify drugs as having been purchased through 340B when they bill for separately payable Medicare Part

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Viatris Providing Credits Due to Problem that Made 340B Pricing Unavailable in August

Viatris About Us page depicted on mobile device
Viatris says it will give credits for drug purchases at higher than 340B ceiling price during early August, when a problem during a system transition made 340B prices unavailable to some entities.

Drug manufacturer Viatris will give 340B covered entities credits on requests for purchases of dozens of NDCs at higher than 340B ceiling price during the first 11 days of August, the company says in a notice on the U.S. Health

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Private Oncologist Group-Funded Study Models Effects of Using CMS’s Controversial 2020 340B Hospital Drug Cost Survey

Screenshot of Avalere web page
A new study models what would happened in 2023 if Medicare paid 340B hospitals for physician administered drugs based on a survey of those hospitals’ drug acquisition costs taken during the COVID pandemic’s darkest days in 2020.

Private practice oncologists have paid for a study to model what would happened in 2023 if Medicare paid 340B hospitals for physician administered drugs based on a survey of those hospitals’ drug acquisition costs taken during the COVID pandemic’s darkest

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Breaking: Congress Wants HRSA Briefing on Action to Safeguard 340B Entities’ “Lawful Access to Discounted Drugs”

Senate Appropriations committee room
The U.S. Senate Appropriations Committee released an omnibus FY 2023 spending bill late yesterday with report language requesting a HRSA briefing on its actions to safeguard providers' access to 340B drug discounts.

U.S. House and Senate appropriations committees want federal healthcare officials to brief them by April “on actions taken to safeguard covered entities’ lawful access to discounted drugs” under the 340B program.

The directive to the Health Resources and Services Administration

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Amgen Sues HHS in Defense of the Company’s 340B Contract Pharmacy Restrictions

Amgen wordmark on building
Amgen yesterday sued HHS and HRSA in defense of its conditions on 340B pricing when hospitals use contract pharmacies.

Biopharmaceutical manufacturer Amgen yesterday became the 10th drug manufacturer to sue the federal government over the government’s position that the 340B statute requires drug companies to provide 340B-priced drugs to multiple contract pharmacies without conditions.

California-based Amgen filed suit

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Merck Providing Refunds for 340B Overcharges During Q4 2019, Q3 2021, and Q2 2022

Merck wordmark on company building
Merck is providing refunds for 340B overcharges during Q4 2019, Q3 2021, and Q2 2022.

Drug manufacturer Merck is providing refunds for charges above 340B ceiling prices on 23 NDCs purchased during Q4 2019, Q3 2021, and Q2 2022.

The U.S. Health Resources and Services Administration posted Merck’s Nov. 21 notice about the repayments on

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340B Report Analysis: Federal 340B Law Gives States Room to Regulate their Own Drug Distribution Systems, Judge Rules in Arkansas Contract Pharmacy Case

U.S. District Court Little Rock, AR court room
A federal judge in Little Rock, Ark., held that the state's novel 340B anti-discrimination law is not preempted by federal laws.

As we reported on deadline on Tuesday, a federal district court ruled this week that Arkansas’ novel 340B antidiscrimination law is not preempted by federal laws governing the 340B program, a decision that strikes down one of two legal arguments

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117th Congress Nears End With No 340B Contract Pharmacy Fix Expected

U.S. Capitol building at sunrise
Five congressional Democrats signed on as co-sponsors to a bill that would bar drugmaker restrictions on 340B contract pharmacy arrangements.

The 117th Congress appears destined to end without further action on the 340B program.

The House and Senate are on track to finish all work for the year by no later than Friday, Dec. 23. According to news reports yesterday,

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340B Registration for First Quarter of 2023 Will Run from Jan. 1 to Jan. 17

Image of pen and clipboard with medical cross symbol
The first quarter 2023 registration period for covered entity enrollment in 340B will begin Jan. 1 and end Jan. 17.

The U.S. Health Resources and Services Administration has slightly adjusted the dates of the first of four periods in 2023 during which eligible entities may register themselves, their child sites, and their contract pharmacies to participate in the 340B program.

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