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We believe this is a fair and reasonable refinement of our proposed policy as it ties potential financial incentives associated with CCAs with patient outcomes, similar to the distribution of shared savings and losses in ACO models, and thus is sufficiently related to ASM's clinical goal identified at § 512.771(b)(3) to “increase independent physician participation in value-based payment programs.” We did not propose a definition for “value-based payment programs” because it is an industry-acknowledged term that rewards program participants for making improvements in accepted and evidence-based quality standards and processes

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FDA specifically notes that free base, acetate and other salts can have different chemical, pharmacokinetic and safety characteristics