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Federal regulators released their long-awaited “mega-guidance” for the 340B Drug Pricing Program to clarify who is eligible to participate. It comes amid mounting criticism that the program has become overly broad with insufficient oversight. In the draft omnibus guidance, the Health Resources and Services Administration proposed several changes that could limit the types of care delivery that would trigger eligibility for a patient's drugs to be purchased under the program. (Johnson, 8/27)

HHS on Thursday proposed a rewrite of the rules for a rapidly expanding drug discount program that has become a flashpoint between hospitals and the drug industry. The long-awaited draft “mega-guidance” on the 340B program seeks to tighten controls on which patients, drugs and providers qualify for the deep manufacturer discounts. (Norman, 8/27)