Delivery Dilemma Solved

On July 22, CMS issued instructions specifically allowing suppliers to deliver oximetry testing equipment on behalf of Medicare Independent Diagnostic Testing Facilities (IDTFs). The instructions explain the conditions and logistics of HME suppliers’ involvement in assisting beneficiaries with obtaining home oxygen therapy qualifying testing results.

There are several new technologies available in the market that facilitate an IDTF’s ability to test a beneficiary, in the beneficiary’s home, for oxygen saturation levels. These test results can then be used to qualify the beneficiary for coverage of home oxygen therapy.

Because there are strict rules about Medicare Part B DMEPOS suppliers not being able to test beneficiaries, there has been considerable confusion about the arrangements suppliers can have with IDTFs and companies that sell or lease these units.

The CMS instruction provides clarity to suppliers, IDTFs and physicians who prescribe oximetry testing for their beneficiaries, to determine whether the beneficiary qualifies for oxygen therapy under the Medicare coverage criteria.

CMS has provided a series of parameters that all suppliers should understand and comply with when delivering the testing units to the beneficiary’s home. Following is an explanation of the criteria:

• First, as with all lab tests, the beneficiary’s treating physician must order an overnight pulse oximetry test. Importantly, Medicare will only pay for the tests when the test units are used for purposes of overnight testing. Spot testing and testing a beneficiary during exercise are not covered tests. (Be sure to check with other payer sources about their particular coverage policies for the various types of tests.) The reason that CMS limited coverage to overnight testing is primarily because of the difficulty many beneficiaries had in obtaining access to an IDTF for overnight testing.
• Second, the test must be “performed under the direction and/or instruction of a Medicare-approved IDTF.” According to CMS, it is the beneficiary who must self-administer this test. Therefore, CMS requires that the IDTF provide clear written instructions to the beneficiary on the proper operation of the test equipment and must include access to the IDTF in order to address other concerns that might arise. This is important because Medicare policy prohibits DME suppliers from performing these tests, so the DME supplier cannot create this instruction nor participate in the conduct of the test. CMS specifically addressed this issue in its instructions, explaining that “because the DME supplier cannot access the test results, and is acting merely as a courier of the 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 240.2.C: ‘A DME supplier is not considered a qualified provider or supplier of laboratory services for purposes of these guidelines.’”
• Third, CMS requires that the test unit be “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.” At the same time, CMS recognized that the DME supplier “may use related technology to download test results from the testing unit and transmit those results to the IDTF.” But in no case may the DME supplier access or manipulate the test results in any form.

Confusion has also existed over whether suppliers can lease and/or own these test units. Importantly, CMS clarified that it “does not intend to regulate the ownership of either the testing unit or the technology used to transmit test results.” That means there is no prohibition on suppliers owning these testing units.

The physical location of the IDTF determines the appropriate Medicare Part B carrier to which the IDTF submits the test claim.

The implementation date for the instructions is Jan. 1, 2006, by when Medicare Part B carriers should have their systems in compliance to accept these lab claims.

A specialist in health care legislation, regulations and government relations, Cara C. Bachenheimer is vice president, government relations, for Invacare Corp., Elyria, Ohio. Bachenheimer previously worked at the law firm of Epstein, Becker & Green in Washington, D.C., and at the American Association for Homecare and the Health Industry Distributors Association. You can reach her by phone at 440/329-6226 or by e-mail at [email protected].