Manufacturer restrictions and 340B Validate

Support better patient outcomes and reduce the chance of manufacturer audits

Born out of recent changes in the industry, the rise of duplicate discounts has led several manufacturers to restrict access to 340B pricing. 340B Validate is a win-win for both covered entities and manufacturers.

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Manage 340B Rebates with Minimal Impact
Manufacturer Restriction

Optimize your program participation

Manage your 340B rebate compliance with minimal impact

340B Validate provides manufacturers with validation of your 340B prescriptions that generate a rebate request—without revealing your identity or data as a covered entity. The fast-changing 340B drug pricing ecosystem calls for Macro Helix’s reliable solutions to help you engage in the program easily and assist with meeting compliance needs as they arise—so your patients can continue to experience the benefits of 340B.

Manage 340b rebates easily

Who should use 340B Validate and manufacturer solutions?


Pharmaceutical companies that manufacture and distribute 340B-eligible products.

Contract Pharmacies

These pharmacies enter into an agreement with a covered entity to provide services to the covered entity's patients, including dispensing entity-owned 340B drugs.

Health Systems

According to federal guidelines published by the Health Resources and Services Administration, a hospital that is private and non-profit with a contract with a state or local government to provide health care services to low-income individuals who are not entitled to benefits under Medicare or eligible for State Medicaid, is eligible for the 340B Drug Pricing Program.

Solutions you can start using today if you have 340B Architect

Price-based automatic 340B exclusion and DoNotOrder list

We will analyze NDC pricing updates from your primary wholesaler and if we detect that you may have lost contract pricing, we will place the affected NDCs on either your 340B Exclusion list, DoNotOrder(340B) list, or both, based on your settings.

Managing "Manufacturer 45-Day Lookback" requirements

We implemented logic to help our customers maintain an accumulations balance that accounts for a manufacturer's timeliness policies. We continue to update and work through compliance and product requirements to facilitate this feature of our software by soliciting customer feedback about their experiences submitting to manufacturers.

A bridge between manufacturers and covered entities

Macro Helix is at the intersection of proven pharmacy practices and modern methods of running a patient-centered business. We navigate many regulatory and compliance rules associated with 340B programs, making it easier for covered entities to meet patient needs and remain successful. As part of McKesson, we can help you explore additional solutions across our lines of business to further support your pharmacy operations. We also work seamlessly with all 340B entities that utilize any of the national pharmaceutical distributors.

Answers to your questions about 340B Validate

Manufacturer Restrictions FAQs

If you are participating in the 340B federal drug pricing program, you should explore using Macro Helix’s solutions to help make sure you are getting contracted pricing on medications your patients need, or add manufacturers to your exclusion list.

If your organization uses 340B Architect, the 340B Validate solution is already built into the software. All you need to do is opt-in to use this discreet data validation service.

The One McKesson Value

A partner you can rely on for end-to-end solutions

Our team of pharmacy operations and implementation specialists brings real-world experience and subject-matter expertise to every one of our clients. Macro Helix innovation is inspired by nearly 200 years of McKesson healthcare leadership and perspective. Learn more about different solutions across our businesses that can help you achieve your goals, such as advancing health outcomes in your community.

Patient receives a prescription to take home from doctor at an eligible hospital or clinic
340B Pharmacies, Hospitals & Clinics

Patient receives a prescription to take home from doctor at an eligible hospital or clinic

Patient collects medication at the pharmacy and pays copay
Patient Collects Rx

Patient collects medication at the pharmacy and pays copay

Hospital contracts with a pharmacy via Macro Helix Advanced 340B Technology Suite
Advanced 340B Technology Suite

Hospital contracts with a pharmacy via Macro Helix Advanced 340B Technology Suite

340B Covered Pharmacy
Pharmacy Receives Subsidies

Pharmacy bills insurance for the medication’s full value and dispensing fee

Macro Helix Prescriptions
Discounted Medications from Manufacturers

The hospital buys the medication at a discount direct from the manufacturer using Macro Helix Advanced 340B Technology Suite

340B prescription program pharmacy providing the best possible care for every patient
Who Moved My NDC?

May 5, 2022

What happens to my hospital accumulations when an NDC is changed?

340B Architect enables you to develop a 340B prescription program that transfers savings directly to qualifying patients with a reduced or zero-cost copay
Complete Compliance

May 4, 2022

Addressing the complexities and frustrations around 340B compliance with software management solutions for 340B programs.

Manage 340b rebates easily
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May 3, 2022

Tips for covered entities that choose to include radiology products in their 340B program.

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See how 340B Validate can help your organization.

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