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CMS-1403-FC policies for therapy services in §409.17. Section 485.635(e) describes therapy services when furnished at the CAH as those that “are provided as direct services by staff qualified under State law, and consistent with the requirements for therapy services described in §409.17.” The reference in the regulation to “direct services” was not intended to address the employment status of staff providing those services, but we now recognize that it could be interpreted as such. Therefore, we are making a technical correction to the regulatory language at §485.635(e) to remove the words “as direct services.” 384

CMS-1403-FC N. Physician Self-Referral and Anti-Markup Issues 1. Exception for Incentive Payment and Shared Savings Programs (§411.357(x)) a. Introduction In the CY 2009 PFS proposed rule (73 FR 38502), we proposed a new exception to the physician self-referral law for incentive payment and shared savings programs. The proposed exception covered various types of hospital- sponsored pay-for-performance (P4P), shared savings (for example, gainsharing), and similarly-styled programs that offer financial incentives to physicians intended to foster high quality, cost-effective care. The exception, as proposed, would provide more flexibility than existing physician self-referral exceptions available for such programs (73 FR 38548). When establishing a new exception to the physician self-referral law, we rely on the authority granted to us in section 1877(b)(4) of the Act, which mandates that financial relationships permitted under an exception, such as the types of compensation arrangements contemplated by the proposed exception, not pose a risk of program or patient abuse. As described more fully in the CY 2009 PFS proposed rule, in order to ensure that we did not exceed this authority, the proposed exception was targeted and 385

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

policies for therapy services in §409.17. Section<br />

485.635(e) describes therapy services when furnished at the<br />

CAH as those that “are provided as direct services by staff<br />

qualified under State law, and consistent with the<br />

requirements for therapy services described in §409.17.”<br />

The reference in the regulation to “direct services” was<br />

not intended to address the employment status of staff<br />

providing those services, but we now recognize that it<br />

could be interpreted as such. Therefore, we are making a<br />

technical correction to the regulatory language at<br />

§485.635(e) to remove the words “as direct services.”<br />

384

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