Anyway, Messrs. Ubi and Nexon assert in HealthAffairs that the medical- innovation ”eco-system” is “severely stressed” and they say that policy improvements are essential.
They write that the biggest problems include: reduced investment; reduced revenue growth; flight of clinical trials and first-product introduction out of the United States; increasing difficulty in getting public and private insurers to cover patient costs to use new medical devices and diagnostics, and disincentives for providers to adopt new technology.
*”The FDA and the Centers for Medicare and Medicaid Services (CMS) should adopt a seamless, accelerated process for approval of breakthrough products that offer the promise of significant improvements in treatment or diagnosis of serious illnesses.”
*”The FDA needs to continue to progress toward the goal articulated in the device center’s recent vision statement that patients in the U.S. will have first in the world access to new medical devices.”
*”CMS needs to view encouraging medical innovation as part of its mission and review all its policies with this goal in mind.”
* “U.S. tax policy needs to be reformed to put knowledge-based, high- value-added industries on a level playing field with competitor countries. Prior to the enactment of the medical-device tax, medical technology companies paid an effective federal tax rate of 31 percent on activities …taxed in the U.S., but an average effective rate of 14 percent on activities located and taxed abroad.”