“policymakers and CMS have advanced proposals that would reference prices in other economically comparable countries in determining Medicare beneficiary cost-sharing and/or additional manufacturer rebate obligations (sometimes described as “most-favored-nation” or international reference pricing policies). CMS has proposed mandatory demonstration models—GLOBE (Medicare Part B) and GUARD (Medicare Part D)—that would assess additional manufacturer rebates based on international benchmarks for certain therapeutic categories that include ophthalmology/ophthalmic agents. Because certain of our ophthalmic products are reimbursed under Medicare Part B, and we may develop or acquire additional products reimbursed by government programs, these and similar initiatives could be particularly relevant to our business. Moreover, because we do not own global rights to many of the products we market in the U.S. and generally do not control commercialization or pricing outside the U.S. for those products, we may have limited or no ability to affect non-U.S. pricing that could be used as a benchmark under most-favored-nation or international reference pricing initiatives, which could increase our exposure to such policies.
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