Articles by : Tom Mirga, Editor at Large

Non-Hospital Infusion Centers See a Path to 340B Reform that Runs Through the States

May 5, 2022 Tom Mirga, Editor at Large Views

copies of Worcester Business Journal online article and Infusion Access Foundation letter

Infusion Access Foundation's state level 340B outreach includes appeals to Massachusetts' attorney general last month (left) and California's last November (right).

A foundation linked to a trade group that represents non-hospital infusion centers is working to enlist state attorneys general and legislators to push for major 340B program changes at the federal level.

The National Infusion Center Association (NICA) is the

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Sen. Grassley Presses HHS OIG to Punish Drug Makers Over Denials of 340B Pricing

May 3, 2022 Tom Mirga, Editor at Large Views

U.S. Sen. Chuck Grassley (R-Iowa) wants to know if HHS will impose civil monetary penalties on drug companies that deny 340B pricing over multiple contract pharmacy.

Senate Finance Committee ranking Republican Chuck Grassley (Iowa) yesterday asked the U.S. Health and Human Services Department of Inspector General (OIG) if it plans to punish seven drug companies over their denials of 340B pricing when hospitals, health centers, and

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Merck Adds 45-Day Time Limit on Replenishment Orders to its 340B Contract Pharmacy Policy

May 3, 2022 Tom Mirga, Editor at Large Views

Merck has imposed 45-day time limit on replenishment orders under its restrictions on 340B pricing when covered entities use contract pharmacies.

Merck is the latest drug company among the 16 that restrict 340B pricing when covered entities use contract pharmacies to impose a 45-day time limit on replenishment orders under its policy.

Merck disclosed the change last week in the same letter

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Appeals Court Consolidates AstraZeneca, Sanofi, and Novo Nordisk’s 340B Contract Pharmacy Cases

May 3, 2022 Tom Mirga, Editor at Large Views

Seal of the United States Court of Appeals for the Third Circuit

The U.S. Third Circuit Court of Appeals has decided to hear and rule on AstraZeneca, Sanofi, and Novo Nordisk’s 340B contract pharmacy litigation together.

A federal appeals court in Philadelphia, as expected, has decided to consider and rule on AstraZeneca’s 340B contract pharmacy lawsuit in tandem with Sanofi and Novo Nordisk’s 340B contract pharmacy cases.

The U.S. Third Circuit Court of Appeals announced the

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Sen. Manchin Endorses 340B Ally McKinley in Tight GOP Primary Race

May 3, 2022 Tom Mirga, Editor at Large Views

Sen. Joe Manchin (D-WV) and Rep. David McKinley (R-WV) headshots

Conservative Democratic U.S. Sen. Joe Manchin has endorsed moderate Republican Rep. David McKinley in West Virginia's GOP congressional primary election next week against Rep. Alex Mooney, who is backed by ex-President Trump.

Conservative Democratic U.S. Sen. Joe Manchin (W.Va.) has endorsed and appeared in a campaign advertisement for Republican Rep. David McKinley (W.Va.), a moderate being challenged for re-election by a candidate endorsed by ex-President Donald Trump.

The GOP primary between McKinley

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Merck Extends its Conditions on 340B Pricing Involving Contract Pharmacies to Health Centers

April 28, 2022 Tom Mirga, Editor at Large Views

Merck extended its restrictions on 340B pricing involving contract pharmacies to community health centers.

Drug manufacturer Merck today extended its restrictions on 340B pricing involving contract pharmacies to community health centers. The restrictions have applied only to hospital covered entities until now.

Other grantee covered entities remain exempt “at this time,” Merck said, adding

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340B Report Holding May 18 Webinar on Implementing Drug Makers’ New 340B Contract Pharmacy Rules

April 28, 2022 Tom Mirga, Editor at Large Views

Multiple 340B covered entities and consultants say they have hit roadblocks trying to navigate drug manufacturers restrictions on 340B pricing when entities contract with outside pharmacies to dispense 340B drugs.

340B Report, an independent news organization covering the 340B drug pricing program, is holding its first event—a May 18 webinar about implementing drug manufacturers’ controversial new rules on 340B contract pharmacies. It is an exclusive and free

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Providers Alarmed About 45-Day Lookback Clauses in Drug Makers’ 340B Contract Pharmacy Policies

April 28, 2022 Tom Mirga, Editor at Large Views

Covered entities are concerned about 45-day time limits for claims submissions and replenishment orders in drug manufacturers' 340B contract pharmacy policies.

Drug manufacturer Sanofi drew attention this month when it added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.

Pfizer and Amgen also recently added similar 45-day lookback requirements

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HIV/AIDS Clinics Tell FTC that PBMs Usurp 340B Discounts for Themselves

April 28, 2022 Tom Mirga, Editor at Large Views

sculpture of a man and horse outside a federal building

The "Man Controlling Trade" statute outside the FTC's Washington, D.C., headquarters. HIV/AIDS clinics recently submitted comments to the commission about PBMs' business practices.

Pharmacy benefit managers (PBMs) should be stopped from usurping 340B drug discounts from HIV/AIDS clinics and other safety-net providers, Ryan White Clinics for 340B Access (RWC-340B) told the U.S. Federal Trade Commission (FTC) last week.

RWC-340B asked the commission for

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With Retired Sen. Hatch’s Passing, a Legendary 340B Tale is Told

April 26, 2022 Tom Mirga, Editor at Large Views

Retired U.S. Sen. Orrin Hatch (R-Utah), who died this weekend, played a key role in 340B's creation and development.

Retired U.S. Sen. Orrin Hatch of Utah, a conservative Republican icon who helped create and shape the 340B drug pricing program, has died. He was 88.

Hatch personally was responsible for choosing one of the 340B program’s most important covered

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