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Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...
CMS-1403-FC add-on percentage of 15.5 percent. As such, the drug add-on adjustment to the composite rate for CY 2009 would be equal to 1.155 * 0.996 = 1.15 or 15.0 percent. We solicited public comment on our proposal of a zero update, as well as the alternative approach presented above, so that we could make an informed decision with respect to the final update to the CY 2009 drug add-on adjustment to the composite rate. Comment: Commenters were uniformly opposed to any decrease in the drug add-on adjustment, citing the plain reading of the statute which calls for an annual “increase” in the adjustment. As support for the reliance on the plain reading of the statute, several commenters cited case law examples in which courts have relied on dictionary definitions, biblical text, and common usage of terms for purposes of interpreting statutory text. One commenter disagreed with CMS’ alternative reading of 1881(b)(12)(F) of the Act, under which an increase in the drug add-on could not be implemented when estimated drug growth is negative, pointing to MMA Conference Report language that referenced a payment update that would be based on a “growth” in drug spending and “drug cost increases.” Commenters further argued, citing case law the priority on 174
CMS-1403-FC plain language over policy arguments and cautioned against identifying gaps in statutes. One commenter suggested that we should use the methodology to estimate growth in ESRD drug expenditures that yields a positive adjustment as required by the statute. Another commenter stated that if we believe ESRD drug expenditures will decline, this would indicate that the spread between AWP and ASP pricing will widen in CY 2009, thus justifying an increase in the drug add-on adjustment. Response: We agree that the plain reading of the statute would preclude any decrease in the drug add-on adjustment and would not support a negative growth update. Specifically, section 1881(b)(12)(F) of the Act states in part that “the Secretary shall annually increase” the drug add-on amount based on the growth in expenditures for separately billed ESRD drugs. We interpret the statutory language “annually increase” to mean a positive or zero update to the drug add-on given that the statute also requires that the annual “increase” to the drug add-on adjustment reflect our estimate of the growth in ESRD drug expenditures. Since our analysis indicates a projected reduction in ESRD drug expenditures for CY 2009, we do not 175
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<strong>CMS</strong>-1403-FC<br />
add-on percentage of 15.5 percent. As such, the drug<br />
add-on adjustment to the composite rate for CY 2009 would<br />
be equal to 1.155 * 0.996 = 1.15 or 15.0 percent.<br />
We solicited public comment on our proposal of a zero<br />
update, as well as the alternative approach presented<br />
above, so that we could make an informed decision with<br />
respect to the final update to the CY 2009 drug add-on<br />
adjustment to the composite rate.<br />
Comment: Commenters were uniformly opposed to any<br />
decrease in the drug add-on adjustment, citing the plain<br />
reading of the statute which calls for an annual “increase”<br />
in the adjustment. As support for the reliance on the<br />
plain reading of the statute, several commenters cited case<br />
law examples in which courts have relied on dictionary<br />
definitions, biblical text, and common usage of terms for<br />
purposes of interpreting statutory text. One commenter<br />
disagreed with <strong>CMS</strong>’ alternative reading of 1881(b)(12)(F)<br />
of the Act, under which an increase in the drug add-on<br />
could not be implemented when estimated drug growth is<br />
negative, pointing to MMA Conference Report language that<br />
referenced a payment update that would be based on a<br />
“growth” in drug spending and “drug cost increases.”<br />
Commenters further argued, citing case law the priority on<br />
174