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CMS-1403-FC submitted by a specialty to apply to each measure. Rather, we believe this requirement means that in endorsing or adopting measures, a consensus organization must include in its consideration process at least some measures submitted by one physician or organization representing a particular specialty. We also believe that under sections 1848(k)(2)(B)(ii) through (iii) of the Act, the Secretary is given broad discretion to determine which quality measures meet the statutory requirements and are appropriate for inclusion in the final set of measures for 2009. We do not interpret section 1848(k)(2)(B) of the Act to require that all measures that meet the basic requirements of section 1848(k)(2)(B)(i) of the Act be included in the 2009 set of quality measures. The statutory requirements for consensus organizations and the use of a consensus-based process for developing quality measures as they relate to the requirements for the 2009 PQRI measures were discussed in the CY 2009 PFS proposed rule (73 FR 38565 through 38566). As discussed in the proposed rule, consistent with the principle that measures used for 2009 be endorsed or adopted by a consensus organization and developed through the use of a consensus-based process, but without limiting the 2009 PQRI measures to those meeting the definition of a 594

CMS-1403-FC voluntary consensus standard under the National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) (NTTAA), we interpret “consensus-based process for developing measures” as used in section 1848(k) of the Act to encompass not only the basic development work of the formal measure developer, but also to include the achievement of consensus among stakeholders in the health care system. In addition, section 1848(k)(2)(D) of the Act, as added by the MIPPA, requires that for each 2009 PQRI quality measure, “the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.” Eligible professionals have the opportunity to provide input during the development of a measure during the public comment phase of a measure’s development. As part of the measure development process, measure developers typically solicit public comments on measures that they are testing in order to determine whether additional refinement of the measure(s) is needed prior to submission for consensus endorsement. Additional information on the measure development process used by CMS contractors is available in the “Quality Measures Development Overview” document found 595

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

<strong>submitted</strong> by a specialty to apply to each measure. Rather,<br />

we believe this requirement means that in endorsing or<br />

adopting measures, a consensus organization must include in<br />

its consideration process at least some measures <strong>submitted</strong><br />

by one physician or organization representing a particular<br />

specialty.<br />

We also believe that under sections 1848(k)(2)(B)(ii)<br />

through (iii) of the Act, the Secretary is given broad<br />

discretion to determine which quality measures meet the<br />

statutory requirements and are appropriate for inclusion in<br />

the final set of measures for 2009. We do not interpret<br />

section 1848(k)(2)(B) of the Act to require that all<br />

measures that meet the basic requirements of section<br />

1848(k)(2)(B)(i) of the Act be included in the 2009 set of<br />

quality measures. The statutory requirements for consensus<br />

organizations and the use of a consensus-based process for<br />

developing quality measures as they relate to the<br />

requirements for the 2009 PQRI measures were discussed in<br />

the CY 2009 PFS proposed rule (73 FR 38565 through 38566).<br />

As discussed in the proposed rule, consistent with the<br />

principle that measures used for 2009 be endorsed or<br />

adopted by a consensus organization and developed through<br />

the use of a consensus-based process, but without limiting<br />

the 2009 PQRI measures to those meeting the definition of a<br />

594

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