When prescribing cures for 'overpriced' drugs, the government's 1st duty is to do no harm
, CMS lacks statutory authority to impose such disclosure, and the speech mandate would violate the First Amendment. If the regulation successfully chills drug advertising, moreover, consumers will be less informed about medical conditions and treatments, which could lead to increases in healthcare costs.
CMMI draws its authority to devise new Medicare drug-reimbursement models from § 1115A of the Social Security Act. The law requires that models be developed in two phases. First-phase tests must be supported by evidence that a defined population is experiencing deficits in care. During first-phase limited testing, CMS can waive the Medicare statutes.
Last, and by no means least, the IPI Model's use of foreign nations' drug prices essentially endorses those nations' extreme price controls, compulsory licensing, and international reference pricing. U.S. government officials have long argued that such policies violate international trade law and chill American pharmaceutical innovation. Through the IPI Model, CMS wants to import the very same policies into U.S. law.
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