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

effective with the effective date of this final rule with<br />

comment period.<br />

Comment: Several commenters supported our proposal to<br />

require mobile diagnostic service providers to enroll in<br />

Medicare as IDTFs and to be required to bill Medicare<br />

directly for the TC services they furnish.<br />

Another commenter stated that this provision creates a<br />

single, universal quality standard for outpatient imaging<br />

that eliminates any possible inequity in standards that<br />

could exist between office-based imaging and IDTF imaging.<br />

Several other commenters support the concept that all<br />

providers and suppliers serving Medicare beneficiaries must<br />

be enrolled to be eligible to receive payments from<br />

Medicare, directly or indirectly.<br />

Response: We agree with these comments and thank the<br />

commenters for their support.<br />

Comment: One commenter stated that this provision<br />

would eliminate two distinct and unfair competitive<br />

advantages that mobile cardiac nuclear imaging providers<br />

enjoy under existing regulations. One advantage is the<br />

ability to operate under a “mobile” Nuclear Regulatory<br />

Commission Radioactive Materials license, which does not<br />

require the same regulatory filings as fixed-site cardiac<br />

nuclear medicine laboratories, and in the case of some<br />

212

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