HRSA Seeks Comments on Proposed Changes to 340B Program Forms

screenshot of HRSA Office of Pharmacy Affairs 340B welcome page
HRSA is seeking comment on plans to revise online forms covered entities must fill when they enroll in the 340B program, recertify their eligibility annually, or update information in 340B OPAIS, the federal 340B program database.

The U.S. Health Resources and Services Administration (HRSA) is seeking comment on plans to revise online forms covered entities must fill out when they enroll in the 340B program, recertify their eligibility annually, or update information in 340B OPAIS, the

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FTC To Investigate PBMs’ Impact on Drug Access and Affordability

screenshot of FTC inquiry on pharmacy benefit managers
Under pressure from small pharmacies, drug makers, 340B providers, and others, the FTC agreed to "shine a light" on PBMs' business practices and their impact on pharmacies, payers, doctors, and patients.

Just months after deadlocking, the U.S. Federal Trade Commission voted unanimously on Tuesday to launch an investigation into pharmacy benefit managers’ business practices to assess their impact on prescription drug access and affordability.

Groups that represent 340B health care providers 

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AstraZeneca and Sanofi Ask 340B ADR Panel to Dismiss Health Centers’ Overcharging Claims

screenshot of HRSA 340B administrative dispute resolution web page
AstraZeneca and Sanofi asked a 340B administrative dispute resolution panel to dismiss NACHC’s claims its members are being overcharged due to the companies’ 340B contract pharmacies policies.

Drug manufacturers AstraZeneca and Sanofi have asked a 340B administrative dispute resolution panel to dismiss the National Association of Community Health Centers’ claims that its members are being overcharged due to the companies’ denied or restricted 340B sales when health

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GlaxoSmithKline Ending Voluntary 340B Pricing on Two Orphan Drugs

three Nucala injectible drug tubes
GlaxoSmithKline is ending voluntary 340B pricing for rural and cancer hospitals on its blockbuster severe asthma drug Nucala and first-line advanced ovarian cancer drug Zejula.

In a blow to rural and cancer hospitals, U.K. drug manufacturer GlaxoSmithKline (GSK) is ending voluntary 340B pricing for them on its blockbuster severe asthma drug Nucala and first-line advanced ovarian cancer drug Zejula.

Drug wholesaler AmerisourceBergen recently posted a

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Generic-drug Maker e5 Pharma Offering Refunds for 340B Overcharges

e5 Pharma wordmark
e5 Pharma is giving 340B covered entities refunds for overcharges on six NDCs of the barbiturate phenobarbital during Q1 2021.

Generic drug maker e5 Pharma is giving 340B covered entities refunds for overcharges on six NDCs of the barbiturate phenobarbital during Q1 2021, according to a public notice on the U.S. Health Resources and Services Administration (HRSA) website.

Florida-based e5

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Groups Blast PBMs’ Discrimination Against 340B Hospitals in Letters to FTC

Federal Trade Commission building
Groups that represent or work with 340B hospitals urged the FTC to take a closer look at PBMs' alleged discriminatory business practices.

Pharmacy benefit managers’ discriminatory business practices against 340B hospitals boost PBMs’ financial bottom lines while hurting the hospitals’ mission to serve vulnerable patients, groups that represent or work with 340B hospitals and their pharmacists recently told the Federal Trade Commission

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NEJM Article Says HIV Prevention Should Rely Less on 340B Revenue

screenshot of a New England Journal of Medicine article
An opinion article in the New England Journal of Medicine says overreliance on 340B drug discount revenues to fund HIV-prevention services incentivizes clinics to prescribe high-cost medicines instead of cheaper effective options. Some HIV/AIDS care providers say high drug prices are the problem, not 340B.

Overreliance on 340B drug discount revenues to fund HIV-prevention services incentivizes clinics to prescribe high-cost medicines instead of cheaper effective options, “with dire consequences for [preexposure prophylaxis] PrEP access, impact, and equity,” says an opinion article published last weekend in

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BMS and Merck Announce Refunds for 340B Overcharges

an extended hand holding a 100 dollar bill
BMS and Merck—both for the second time this year—are giving 340B covered entities refunds for overcharges on select products.

Drug manufacturers Bristol Myers Squibb (BMS) and Merck are giving 340B covered entities refunds for overcharges on select products, according to public notices by the companies posted on the U.S. Health Resources and Services Administration (HRSA) website.

BMS

For the

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340B ADR Proposed Rule Remains at White House 5 Months Past Expected Publication Date

Pages of a calendar
A proposed replacement for the 340B administrative dispute resolution process has been under White House review for more than six months.

A proposed replacement for the 340B administrative dispute resolution (ADR) process has been under White House review for more than half a year. It seems to be no closer to publication for notice and comment than it was when it

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HRSA Announces 340B Enrollment Flexibilities in Fire-Ravished New Mexico

flames and smoke over mountains in New Mexico
HRSA has announced 340B program enrollment flexibilities in New Mexico, which is coping with the biggest wildfire in state history.

The U.S. Health Resources and Services Administration (HRSA) yesterday announced 340B program enrollment flexibilities in New Mexico due to the declaration of a public health emergency in the state.

Wildfires in northern New Mexico that began in early April have

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