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19.02.2013 Views

CMS-1403-FC have made it virtually impossible for physician practices or suppliers potentially subject to these rules to plan for compliance or alternative arrangements by January 1, 2009. One commenter requested that, if we do proceed with the extension of the anti-markup provision, the effective date of the rule be delayed until regulatory language can be proposed for each of the alternatives under consideration and there has been additional time to understand the impact of each proposal. A commenter recommended that we delay beyond January 1, 2009, the application of any further revisions until we can fully evaluate the effect of such revisions on physician groups and work with the medical community to simplify and streamline the anti-markup provisions, so that their application is clear to all involved. One commenter requested that we consider delaying the proposals until further evaluation is completed on the impact of recent changes affecting physicians such as MIPPA, DRA, “Bottom-Up Methodology” and the proposed IDFT requirements. Another commenter recommended that implementation should be delayed and that we should use the process set forth by the Congress in MIPPA to establish accreditation requirements for medical imaging to assess the appropriate use of imaging services and to examine the perceived 510

CMS-1403-FC overutilization of in-office imaging. A commenter recommended that we defer to the Congress regarding concerns of overutilization of diagnostic testing services. According to the commenter, the directives in MIPPA, released after the current proposed rule, are much clearer on this issue. The commenter noted that the Congress did not amend the anti-markup provision, choosing instead to direct the agency to develop a demonstration project to determine the appropriateness of advanced diagnostic imaging services furnished to Medicare beneficiaries and require accreditation of advanced diagnostic imaging suppliers by 2012. Response: We do not agree with the commenters that suggested a delayed effective date beyond January 1, 2009 for either the revisions made by the CY 2008 PFS final rule with comment period or the revisions that we are making in this CY 2009 PFS final rule with comment period. We have decided to make the finalized revisions effective as of January 1, 2009. When we delayed, until January 1, 2009, the application of the revisions to §414.50 we made in the CY 2008 PFS final rule with comment period (except with respect to certain diagnostic testing arrangements involving anatomic pathology performed in a “centralized building” for which the revisions were applicable January 511

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

overutilization of in-office imaging. A commenter<br />

recommended that we defer to the Congress regarding<br />

concerns of overutilization of diagnostic testing services.<br />

According to the commenter, the directives in MIPPA,<br />

released after the current proposed rule, are much clearer<br />

on this issue. The commenter noted that the Congress did<br />

not amend the anti-markup provision, choosing instead to<br />

direct the agency to develop a demonstration project to<br />

determine the appropriateness of advanced diagnostic<br />

imaging services furnished to Medicare beneficiaries and<br />

require accreditation of advanced diagnostic imaging<br />

suppliers by 2012.<br />

Response: We do not agree with the commenters that<br />

suggested a delayed effective date beyond January 1, 2009<br />

for either the revisions made by the CY 2008 PFS final rule<br />

with comment period or the revisions that we are making in<br />

this CY 2009 PFS final rule with comment period. We have<br />

decided to make the finalized revisions effective as of<br />

January 1, 2009. When we delayed, until January 1, 2009,<br />

the application of the revisions to §414.50 we made in the<br />

CY 2008 PFS final rule with comment period (except with<br />

respect to certain diagnostic testing arrangements<br />

involving anatomic pathology performed in a “centralized<br />

building” for which the revisions were applicable January<br />

511

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