Get the free 340B MANUFACTURER CHANGE FORM - hrsa

This form is used to update information regarding the 340B manufacturer, including changes to the manufacturer name, address, contact person, and authorizing official.

How to fill out 340b manufacturer change form

How to fill out 340B MANUFACTURER CHANGE FORM

1. Obtain the 340B Manufacturer Change Form from the official website or appropriate resource.
2. Fill in the 'Manufacturer Name' section with the name of the company making the change.
3. Provide the 'Contact Information' including the name, phone number, and email address of the primary contact.
4. Specify the 'Changes Being Requested' in detail, including any relevant dates or specifics.
5. Include a 'Reason for Change' section to explain why the change is necessary.
6. Attach any required supporting documents that validate the request.
7. Review the completed form for accuracy and completeness.
8. Submit the form to the designated 340B program representative or department, according to the instructions provided.

Who needs 340B MANUFACTURER CHANGE FORM?

1. Pharmaceutical manufacturers participating in the 340B Drug Pricing Program.
2. Healthcare providers that are covered entities under the 340B program.
3. Organizations that need to report changes in their drug pricing status or manufacturer affiliations.

People Also Ask about

What is the 35 mile rule for 340B?

Clinic location must also be within a 35-mile radius of new owner hospital. What is 340B? The 340B Program enables hospitals to stretch its resources and use its savings to reach more patients and provide more comprehensive healthcare services, especially to patients in need.

What is 340B mixed use?

Mixed Use Setting You can maintain two distinct and physically separate inventories of drugs, storing the 340B drug inventory in one place and non-340B drug inventory in another. While this option is viable, it requires ample space to accommodate both inventories.

What is the difference between JG and UD modifier?

A “UD” modifier is required for physician administered drug claims (the “JG” or “TB” modifier is required if the claim is billed as Medicare primary), while pharmacy claims require the inclusion of both “08” in field 423-DN, the Basis of Cost Determination field, and “20” in field 420-DK, the Submission Clarification

What is code 20 on 340B?

20 (340B) — Providers who submit a compound or noncompound drug claim for a drug purchased through the 340B Program are required to enter submission clarification code 20 to indicate that the provider determined the drug being billed on the claim was purchased pursuant to rights available under Section 340B of the Public

What is the 340B program for dummies?

Section 340B of the Public Health Service Act requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients.

What are the changes to 340B in 2025?

For example, beginning January 1, 2025, 340B covered entities will need to transition to the TB modifier. This also includes work to identify/strengthen controls related to key 340B program areas — Patient Definition, Location Eligibility, Diversion, Duplicate Discounts, Contract Pharmacy, and more.

What modifier is required for 340B?

The updated CMS billing guidance, which went into effect January 1, 2024, requires all providers and suppliers billing Medicare Part B for status indicator “K” 340B drugs to use the “JG” or “TB” modifier.

What is the modifier 20 for 340B?

20 Modifier: The NCPDP D. 0 standard for retail pharmacy claims submission allows a pharmacy to indicate that a drug that is the subject of the claim was purchased through the 340B program.

For pdfFiller’s FAQs

What is 340B MANUFACTURER CHANGE FORM?

The 340B Manufacturer Change Form is a document used by pharmaceutical manufacturers to report changes in participation in the 340B Drug Pricing Program, which enables eligible healthcare providers to purchase medications at reduced prices.

Who is required to file 340B MANUFACTURER CHANGE FORM?

Pharmaceutical manufacturers participating in the 340B Drug Pricing Program are required to file the 340B Manufacturer Change Form when there are changes to their eligibility or participation status.

How to fill out 340B MANUFACTURER CHANGE FORM?

To fill out the 340B Manufacturer Change Form, manufacturers must provide accurate information regarding their identity, the nature of the change, and any relevant details supporting the change, following the instructions provided with the form.

What is the purpose of 340B MANUFACTURER CHANGE FORM?

The purpose of the 340B Manufacturer Change Form is to ensure that the Health Resources and Services Administration (HRSA) is informed of any changes to manufacturers' participation in the 340B program, maintaining program integrity and compliance.

What information must be reported on 340B MANUFACTURER CHANGE FORM?

The 340B Manufacturer Change Form requires manufacturers to report their name, address, contact information, details about the change in status, and any other relevant information that reflects their participation in the 340B program.