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Navigating the Latest 340B Manufacturer Restrictions As of 12/16/2023




ESP Restrictions 12.16.23
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The 340B Drug Pricing Program is a critical lifeline for covered entities serving low-income patients, allowing them to

ESP Restrictions 12.16.2311.17
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procure outpatient drugs from pharmaceutical manufacturers at significantly reduced prices.


However, the landscape of the 340B program is evolving, with manufacturers imposing various restrictions on drug dispensation and utilization.

As of the most recent update on December 16, 2023, we break down the current 340B restrictions implemented by 28 manufacturers. This overview delves into contract pharmacy and data reporting requirements, additional drug-specific restrictions, exceptions for safety net providers, and the most recent changes.


Contract Pharmacy and Data Reporting Requirements

Many manufacturers now require covered entities to designate a single contract pharmacy location within a specified distance, typically 40 miles, for dispensing 340B drugs. The covered entities are also mandated to report 340B claims data for transactions at both in-house and designated contract pharmacy locations.

Manufacturers, including AbbVie, AstraZeneca, Bayer, Biogen, Bristol-Myers Squibb, Eli Lilly, EMD, Exelixis, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi, UCB, and United Therapeutics, have instituted these requirements. The data reporting level varies, ranging from voluntary to specified fields submitted through the 340B ESP platform.


Exceptions for Safety Net Providers

Some manufacturers, including AbbVie and AstraZeneca, make exceptions to their restrictions for specific safety net provider types such as 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 obligations.


Latest Changes

ESP Restrictions 12.16.23
.xlsx
Download XLSX • 26KB
ESP Restrictions 12.16.2311.17
.pdf
Download PDF • 118KB

The documents provides a detailed table of the most recent changes effective for each manufacturer.


Noteworthy Changes and Stringent Restrictions

Eli Lilly - Arkansas-Specific Modifications

  • Effective Date: November 16, 2023

  • Unique Feature: Eli Lilly implemented changes specifically for Arkansas, signaling a nuanced approach to regional program adjustments.

Bristol-Myers Squibb - Stringent Dispensing Expectations

  • Effective Date: November 1, 2023

  • Notable Requirement: Bristol-Myers Squibb expects all dispensing to 340B-eligible patients to occur at properly designated contract pharmacy locations. This includes shipping drugs directly to those locations, either by BMS or an authorized distributor.

Pfizer - Varied Restrictions on Oncology Drugs

  • Effective Date: November 1, 2023

  • Differential Approach: Pfizer maintains no restrictions on certain oncology drugs while requiring data for others.

Anticipating Future Changes

This comprehensive overview illuminates the nuanced landscape of 340B program integrity efforts initiated by pharmaceutical manufacturers. As stakeholders navigate these changes, the industry anticipates further evolution in restrictions. Stay attuned to the dynamics of the 340B program to proactively address challenges and ensure the continued success of covered entities. The future promises both challenges and opportunities, demanding a vigilant approach to stay ahead of the curve.

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