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Breaking Down the Latest 340B Manufacture Restrictions in effect as of 11/6/2023

Updated: Dec 18, 2023

ESP Restrictions
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The 340B Drug Pricing Program allows covered entities like hospitals and clinics

ESP Restrictions
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serving low-income patients to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices. However, manufacturers have been placing various restrictions on how 340B drugs can be dispensed and utilized.

This document provides an overview of the current 340B restrictions put in place by different drug manufacturers as of November 6, 2023. It outlines 28 manufacturers and any contract pharmacy or data reporting requirements they have instituted.

Designated Contract Pharmacy + Data Reporting

Many manufacturers require covered entities to designate a single contract pharmacy location within a certain distance (usually 40 miles) of the covered entity for dispensing 340B drugs. They also mandate the covered entity report 340B claims data for transactions at both the in-house and designated contract pharmacy locations.

Manufacturers with this requirement include AbbVie, AstraZeneca, Bayer, Biogen, Bristol-Myers Squibb, Eli Lilly, EMD, Exelixis, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi, UCB, and United Therapeutics. The level of data required ranges from voluntary to specified fields submitted through the 340B ESP platform.

Additional Restricted Drugs

Some manufacturers apply additional restrictions to specific drugs in their portfolio. For example, Bristol-Myers Squibb requires data submission for orders of IMiDs and Camzyos but not other drugs. Pfizer has no restrictions on certain oncology drugs but requires data for others.

Exceptions for Safety Net Providers

A few manufacturers like AbbVie and AstraZeneca make exceptions to their restrictions for certain safety net provider types like FQHCs, children's hospitals, or Ryan White clinics that may not have in-house pharmacies. These entities can designate an off-site contract pharmacy without data reporting.

In summary, this document outlines the evolving 340B program integrity efforts put in place by pharmaceutical manufacturers. While some maintain open access, most now require covered entities to designate a single nearby contract pharmacy and report claims data for transparency. Continued changes to 340B restrictions can be expected going forward.

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