Beneficiaries may self administer home based overnight oximetry tests under the direction of a Medicare enrolled Independent Diagnostic Testing Facility (IDTF). Further a DME supplier or another shipping entity may deliver a pulse oximetry test unit and related technology used to collect and transmit test results to the IDTF to a beneficiary's home under the following circumstances.
- The beneficiary's treating physician has ordered an overnight pulse oximetry test.
- The test is preformed under the direction and/ or instruction of a Medicare-approved IDTF. Because it is the beneficiary who self-administers this test, the IDTF must provide clear written instructions to the beneficiary on proper operation of the test equipment and must include access to the IDTF in order to address other concerns which may arise. Because CMS Pub. 100-3 section 240.2.C prohibits DME suppliers from performing tests, the DME supplier may not create this instruction nor participate in the conduct of the test.
- The test unit is sealed and tamper- proof such that test results cannot be accessed by anyone other than the IDTF who is responsible for transmitting a test report to the treating physician. The DME supplier may use related technology to download test results from the testing unit and transmit those results to the IDTF. In no case May the DME supplier access or Manipulate the test results in any form.
- The CMS does not intend to regulate the ownership of either the testing unit or the technology used to transmit test results. The carrier jurisdiction for the overnight pulse oximetry test is the location of the IDTF to which the test results are transmitted.
No shipping and/or handling charges may be made to or paid by a beneficiary because such charges are included in the indirect practice expenses for the Medicare physician fee schedule (MPFS) payment for the overnight pulse oximetry test.
Because the DME supplier cannot access the test results, and is acting merely as a courier of equipment, and is not involved in instructing the beneficiary how to perform the test, this does not violate the prohibition found in CMS Pub. 100-3 Section 240.2C "A DME supplier is not considered a qualified provider or supplier of laboratory services for purposes of these guidelines."
Test results obtained under these circumstances will be accepted by DMERCs and will be used for purposes of qualifying the beneficiary for home oxygen therapy.
DMERCs shall accept the results of overnight pulse oximetry tests when determining qualification for home oxygen therapy in cases where the test equipment is delivered by a DME supplier but only when: the beneficiary's treating physician has ordered an overnight pulse oximetry test; the test is preformed under direction or instruction of a Medicare-approved Independent Diagnostic Testing Facility (IDTF); and the test unit is sealed and tamper-proof.