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One year later the patient was admitted again, now with refractory ascites and encephalopathy, but without signs or symptoms of a recurrrent hernia, both on clinical and ultrasound examination
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We also proposed that in the absence of specific guidance, manufacturers be required to submit any reasonable assumptions they utilize for manufacturer's ASP calculations (which is currently voluntary), including documentation of the methodology used to determine FMV and periodic reviews of FMV
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