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

arrangements, and the likelihood of continued<br />

future innovation in the structure and method of<br />

these programs. <strong>This</strong> variety and complexity make<br />

it difficult to craft a “one-size-fits-all” set<br />

of conditions that are sufficiently “bright line”<br />

to facilitate compliance and enforceability, yet<br />

sufficiently flexible to permit innovation<br />

without undue risk of program or patient abuse.<br />

Our goal in establishing an exception or exceptions for<br />

incentive payment and shared savings programs is “to<br />

promulgate an exception that is as broad as possible” yet<br />

consistent with the statutory requirement that any<br />

arrangement excepted under an exception issued using our<br />

authority in section 1877(b)(4) of the Act pose no risk of<br />

program or patient abuse (73 FR 38548). Although we<br />

received thoughtful and instructive comments, we did not<br />

receive through the initial public comment process<br />

sufficient information or agreement among commenters<br />

regarding possible modifications to the proposal to allow<br />

us to finalize an exception that expands the proposed<br />

exception in any meaningful way. Therefore, we are<br />

reopening the public comment period to obtain the specific<br />

information described below. We believe that, if<br />

ultimately provided through the extended public comment<br />

process, the additional information we are requesting will<br />

assist us in finalizing an exception or exceptions for<br />

incentive payment and shared savings programs. The comment<br />

387

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