As discussed in the final rule, any prices provided by manufacturers to 340B covered entities are excluded from AMP and best price. This would include inpatient manufacturer prices provided to children's hospitals, critical access hospitals, rural referral centers, sole community hospitals, and freestanding cancer hospitals, where those entities qualify as 340B entities as described in regulation (see 81 FR 5253, 5257-5258).
For specific questions regarding whether a covered entity meets the definition of covered entity as described in section 340B(a)(4) of the Public Health Service Act, please contact the Health Resources and Services Administration (HRSA) at 340Bpricing@hrsa.gov
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