Life Sciences

Physician Fee Schedule rule proposes reimbursement changes for devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, July 14, 2008

Last week’s issue of Device Regulation Alert covered CMS’s proposals for cost sharing arrangements and how they would affect devices. But CMS’s proposed rule for the 2009 Physician Fee Schedule includes other proposals that affect device reimbursement.
 
These two reimbursement issues could affect device manufacturers and suppliers:
           
Sleep apnea devices. CMS recently issued a revised National Coverage Determination extending Medicare coverage for continuous positive air pressure (CPAP) devices for treatment of obstructive sleep apnea when the apnea was diagnosed using specific home testing. Previously such treatment was only covered when the apnea was diagnosed in a facility.
 
CMS agreed with comments indicating a risk of abuse due to this extended coverage exists when the provider testing for apnea benefits financially when there is a positive diagnosis. Thus, if the provider of the sleep apnea test or device also has a financial interest in or is a provider of CPAP devices used to treat the apnea, there is a risk of over utilization and false reporting. When the provider has an interest in the outcome of a test, the provider might test more frequently or infrequently and interpret tests with a “bias that favors self interest.”
           
Therefore CMS proposed changes to remove the financial incentive to abuse Medicare coverage for CPAPs to treat apnea diagnosed at home. CMS proposes to bar Medicare payment to the supplier of a CPAP device when that supplier or its affiliate is “directly or indirectly the provider of the sleep test” used to diagnose the obstructive sleep apnea. The change will be implemented in Section 424.57 of the regulations regarding DMEPOS supplier enrollment safeguards.
           
Stress testing devices. CMS proposed replacing the existing treadmill testing devices assigned to CPT® code 93025 with the specific Micro-volt T-Wave testing equipment, which is priced at $40,000. CMS also proposed assigning a 53-minute service period for the treadmill testing equipment and exam table.
           
CMS invites comments on all areas in the fee schedule rule. Comments must be received by August 29, 2008. The physician proposed rule is published in the July 8 Federal Register.

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