The Supreme Court Aftermath: What Comes Next in Fight Over Medicare Part B Drug Payments to 340B Hospitals?

The U.S. Supreme Court building and entrance plaza
Yesterday's U.S. Supreme Court's opinion about deep cuts in 340B hospitals’ Medicare Part B drug reimbursement ended Phase 1 of the debate. Phase 2 gets underway next month in lower federal courts in Washington, D.C., and in the pages of the Federal register.

Yesterday, the U.S. Supreme Court ruled that huge cuts in 340B hospitals’ Medicare Part B drug reimbursement in 2018 and 2019 were unlawful. It marked the end of Phase 1 of the debate over the cuts.

Phase 2 is gearing

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Bipartisan U.S. House Group Renewing Pressure on HHS to Punish Drug Makers Over 340B Pricing Denials

Headshots of U.S. House gang of six Representatives Spanberger, Axne, McKinley, Matsui, Katko, Johnson
Clockwise from top left, Reps. Abigail D. Spanberger (D-Va.), Cindy Axne (D-Iowa), David McKinley (R-W.Va.), Doris Matsui (D-Calif.), John Katko (R-N.Y.), and Dusty Johnson (R-S.D.) are urging fellow House members to sign a letter urging HHS to begin 340B enforcement actions against drug companies.

Six U.S. House members—three Democrats and three Republicans—are urging fellow representatives to sign a letter asking U.S. Health and Human Services (HHS) Department leaders “to begin enforcement actions against pharmaceutical companies that refuse to honor 340B discounts on prescription drugs.”

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Drug Manufacturer 340B Overcharge Notices Reach New Record, Novo Nordisk Is the Latest

Fiasp insulin bottle
Novo Nordisk announced refunds for 340B overcharges on six NDCs including one for Fiasp insulin.

With more than six months to go in the year, the number of refunds that drug manufacturers have had to provide to 340B providers has already topped the previous annual record of 17.  Drug manufacturer Novo Nordisk becomes the 21st manufacturer to 

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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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