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<strong>CMS</strong>-1403-FC<br />

plain language over policy arguments and cautioned against<br />

identifying gaps in statutes.<br />

One commenter suggested that we should use the<br />

methodology to estimate growth in ESRD drug expenditures<br />

that yields a positive adjustment as required by the<br />

statute. Another commenter stated that if we believe ESRD<br />

drug expenditures will decline, this would indicate that<br />

the spread between AWP and ASP pricing will widen in<br />

CY 2009, thus justifying an increase in the drug add-on<br />

adjustment.<br />

Response: We agree that the plain reading of the<br />

statute would preclude any decrease in the drug add-on<br />

adjustment and would not support a negative growth update.<br />

Specifically, section 1881(b)(12)(F) of the Act states in<br />

part that “the Secretary shall annually increase” the drug<br />

add-on amount based on the growth in expenditures for<br />

separately billed ESRD drugs. We interpret the statutory<br />

language “annually increase” to mean a positive or zero<br />

update to the drug add-on given that the statute also<br />

requires that the annual “increase” to the drug add-on<br />

adjustment reflect our estimate of the growth in ESRD drug<br />

expenditures. Since our analysis indicates a projected<br />

reduction in ESRD drug expenditures for CY 2009, we do not<br />

175

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