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U.S.-Japan regulatory reform

This article was originally published in The Gray Sheet

Executive Summary

AdvaMed is working with the Commerce Department to prepare the federal government's September/October submission of issues to be addressed by the Regulatory Reform Initiative. Released June 26, the1 U.S. Trade Representative/Japan's first annual report on the initiative represents "solid first steps in solving the current health care crisis in Japan," according to the association. Absent from the report, which lists such planned reforms as increasing the frequency of reimbursement price redesignations, are U.S. industry's concerns with Japanese foreign reference pricing. A Commerce official noted that the topic of reference pricing was excluded from the final report because the U.S. did not want to lend credence to a policy it opposes...

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AdvaMed may work with the Commerce Department to address premium pricing concerns via the second report on the Regulatory Reform Initiative by the U.S. Trade Representative and Japan, expected by October. The first annual report was released June 26 (1"The Gray Sheet" July 1, 2002, In Brief). The effects of the policy, which allows devices to receive a temporary price within 90 days of launch and guarantees a permanent price within six months, should become clearer following several months of implementation and a "working level" AdvaMed trip to Japan in July. The trade group also will help guide the agenda of a health economics conference in Tokyo, currently scheduled for Sept. 19...

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