What is the federal 340B Program?

What is the federal 340B Program?

The 340B Program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices.

Who qualifies for 340B?

In order to be eligible, the patient must receive health care services other than drugs from the 340B covered entity (although a sole exception exists for patients that are part of an AIDS drug purchasing assistance program that has ties to the government).

What is 340B and how does it work?

The federal 340B Program is a drug price control program that allows qualifying providers, generally hospitals, specialty clinics and their associated outpatient facilities serving uninsured and low-income patients in rural communities, to purchase outpatient drugs from manufacturers at discounted prices.

Who benefits from 340B Program?

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.

Who can use a 340B pharmacy?

The 340B Program is limited to patients of the covered entity and has never been a general employee pharmacy benefit or self-insured organization pharmacy benefit. Evidence of an employer relationship or insurer relationship alone is insufficient to determine 340B patient eligibility.

How is 340B pricing determined?

The 340B ceiling price is calculated by taking the Average Manufacturer Price (“AMP”) and subtracting the Unit Rebate Amount (“URA”). Manufacturers submit the AMP and URA amount to the Center for Medicare and Medicaid Services (“CMS”). The HRSA then uses that data to calculate the ceiling prices.

Is the 340B Program going away?

Congress approved 340B to help safety-net hospitals stretch scarce resources and serve more patients. These cuts undermine the 340B program’s purpose and do nothing to lower overall costs for Medicare patients.”

Who is eligible for 340B drug pricing?

Manufacturers who participate in Medicaid are required to participate in the 340B Program and provide a 340B ceiling price for all covered outpatients drugs.

How do I start a 340B clinic?

What should you do before you register for the 340B Program?

  1. Setup your account.
  2. Identify your Authorizing Official and Primary Contact.
  3. Know your hospital classification.
  4. Know what clinics/services are registered.
  5. Be aware of the registration dates and deadlines.
  6. Prepare to complete registration in one session.

Who determines 340B pricing?

Manufacturers. Currently, manufacturers submit the AMP and URA to CMS for quarterly Medicaid Drug Rebate Program reporting, which HRSA uses to calculate 340B ceiling prices.

How do you bill 340B drugs?

Discarded drugs that were acquired through the 340B program should be billed with both the “JW” modifier (used to report the amount of drug discarded) and the appropriate 340B modifier.

Is 340B only outpatient?

The 340B Program is an outpatient drug program. Enrolled covered entities have the responsibility to ensure that drugs purchased under the 340B Program be limited to outpatient use and provided to individuals who meet the requirements of the current patient definition.

What is the 340B program, how does it work?

The 340B Program simply allows eligible health care providers that serve a large number of low-income patients to purchase medications at a special discount from drug makers. That savings can, in turn, be used by these eligible providers to fund services and care for their patients, and at no cost to taxpayers.

Who is eligible for 340B pricing?

Only “outpatients” are eligible to receive prescription drugs at 340B discounted prices because the program is an outpatient program. In 1996, HRSA issued guidance for an individual to qualify as a patient of a 340B facility.

What is the 340B Drug Pricing Program?

340B Pricing/Covered Outpatient Drugs. Overview: The 340B Drug Pricing Program is a federal program that requires drug manufacturers participating in the Medicaid drug rebate program to provide covered outpatient drugs to enrolled “covered entities” at or below the statutorily-defined ceiling price.

What is the 340B discount drug program?

Jump to navigation Jump to search. The 340B Drug Discount Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices.

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