Trump administration withdraws 340B mega-guidance: 6 things to know
The Trump administration has withdrawn guidance on the 340B Drug Pricing Program that was under review at the end of the Obama administration.
Here are six things to know about the guidance.
1. HHS' Health Resources and Services Administration released the omnibus guidance on the 340B Drug Pricing Program in August 2015. The 340B Drug Pricing Program allows certain safety-net healthcare organizations to purchase outpatient drugs at discounted prices.
2. The guidance addressed a broad range of topics within the 340B program, including the definition of patient, contract pharmacy compliance requirements, hospital eligibility criteria and eligibility of off-site outpatient locations.
3. On Jan. 30, the White House Office of Management and Budget marked the final guidance document as withdrawn.
4. Although the pharmaceutical drug industry generally supported the guidance, hospitals raised concerns about the proposal. The American Hospital Association previously expressed concern about the guidance, arguing that redefining patient eligibility for the 340B program would have inappropriately narrowed the number of drugs that qualify for 340B pricing.
5. On Wednesday, AHA Executive Vice President Tom Nickels said, "We are pleased that the administration chose not to finalize the Health Resources and Services Administration's guidance, which, if enacted, would have jeopardized hospitals' ability to service vulnerable populations, including low-income and uninsured individuals and patients receiving cancer treatments."
6. For HRSA's guidance to move forward, it would have to be resubmitted to the Office of Management and Budget.
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