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

disrupting established integrated sleep management<br />

programs, this final rule with comment period will not<br />

prohibit DME payment to suppliers of CPAP to beneficiaries<br />

who have <strong>been</strong> diagnosed with OSA using attended<br />

facility-based PSG.<br />

We are unaware of a reliable way to prospectively<br />

distinguish bona fide integrated sleep management programs<br />

from other entities for the purposes of this regulation.<br />

As we note below, there is no currently available<br />

accreditation program under which an entity can, under a<br />

single certificate, be accredited for sleep diagnosis and<br />

the supply of CPAP treatment. Thus we considered how to<br />

balance these concerns and minimize disruptions to<br />

continuity of care while maintaining the necessary<br />

protections for the Medicare program and its beneficiaries.<br />

We believe that creating an exception for<br />

facility-based PSG strikes a reasonable balance of these<br />

concerns. In the context of OSA diagnosis and treatment<br />

for Medicare beneficiaries these integrated sleep<br />

management programs have historically (before the March<br />

2008 NCD) used attended facility-based PSG for OSA<br />

diagnosis, as alternative diagnostic strategies did not<br />

support Medicare coverage of the CPAP device.<br />

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