The U.S. House and Senate have passed separate versions of the Prescription Drug User Fee Amendments Act of 2012 and the bills now move to a joint conference committee to hash out a final version.
The Premier provider alliance has sent a letter of recommendations to conference committee leaders. The organization strongly supports a House provision to enable health care systems to repackage drugs in shortage and distribute them to affiliate hospitals. It also applauds both bills requiring implementation of a unique device identifier system, but asks for hard deadlines and firm requirements for implementation as soon as possible. Other suggestions:
* Adopt language that establishes a uniform national tracing network with traceability at the lot level and federal preemption of state pedigree laws; and
* Reconsider Senate language that changes the classification of specific doses and combinations of certain pain medication from Schedule III to Schedule II. “This would have the effect of requiring a new prescription, rather than a refill, for each dispensing,” Premier notes in its letter. “In turn, this change would create significant obstacles for patients who legitimately require this medication and be problematic for long-term care facilities, such as nursing homes, that may not have on-site physicians at their facilities on a full-time basis.”
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