Learn the legal underpinnings of self-administered drug regulation
APCs Weekly Monitor, October 24, 2008
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To understand self-administered drugs (SADs), begin by familiarizing yourself with key Medicare concepts that apply to drugs and other services and supplies, said Andrew Ruskin, Esq., a partner at Morgan Lewis’ FDA/Healthcare Regulation Practice in
First, coverage always precedes payment. You won’t receive payment unless the item or service is covered.
“You always have to ask yourself first, ‘Is this covered,’” said Ruskin. “If it’s covered, then payment will follow suit. If it’s not covered… you cannot claim payment for a particular item.”
Coverage and payment rules differ with the setting, Ruskin said, adding that as a general rule, CMS does not cover SADs in the outpatient setting.
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