340B program draft guidance released

The Health Resources Services Administration (HRSA) has released its long-awaited "mega-guidance" for the 340B discount drug program.

The 90-page document provides clearer guidance for the hospitals that participate in the 340B program, which provides drugs steeply discounted to safety net provides. However, the program has led to charges that some providers have been abusing program guidelines to their financial advantage.

One portion of the guidance appears to address the reselling of 340B program drugs. It specifically prohibits the reselling or transfer of drugs to patients who are not being treated by the participating entity. Six specific conditions must be met for the patient to be considered under treatment by the 340B participant, including a requirement that each hospital or clinic site is registered for the 340B program and has been entered into the program's database of participants.

Some hospitals participating in the 340B program have come under fire for purchasing 340B drugs and then rebilling them to insured patients, pocketing the difference. In one case, Duke University Hospital may have earned as much as $69.8 million using this process. And some hospitals participating in 340B have also been criticized for not spending enough on charity care.

However, the hospital sector successfully lobbied Congress not to alter the rules of the 340B program in drug-related legislation passed earlier this year.

Participants are also barred from using a group purchasing organization (GPO) for many 340B purchases, although an exception is in place if the program participant cannot find the drugs in any other manner and it becomes a patient care issue.

HRSA is also proposing a compliance program that would require all program participants to keep records for at least five years. And hospitals would have to match up its records with the dispensing pharmacies on a quarterly basis.

The 60-day comment period for the guidance will end on Oct. 27.

To learn more:
- read the draft guidance (.pdf)