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340B 'Mega-Guidance' Dials Back Patient Eligibility

Law360, New York (August 27, 2015, 8:59 PM EDT) -- The U.S. Department of Health and Human Services on Thursday unveiled highly anticipated "mega-guidance" on important policies in the 340B drug discount program, and experts say that fewer patients will be eligible under the new standards.

The 90-page guidance aimed to eliminate confusion about several topics, including which types of health care providers can participate in 340B, the circumstances in which drugs are eligible for discounts, and how drugs can properly be dispensed through contract pharmacies. But the most significant aspects of the guidance would create narrower definitions of patient eligibility, possibly constraining the ability of providers to generate revenue through...

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