It is critical that oxygen suppliers make sure that every oxygen patient has a valid qualifying test. If you get it right, all appropriate charges for the supply of oxygen and related services will be paid in accordance with the Medicare fee schedule. Get it wrong and all charges for oxygen and related services provided pursuant to an improper test are disqualified. A flawed procedure that results in improper qualification testing can result in the repayment of several thousand dollars.

TRANSMITTAL 173

In August 2005, CMS issued Transmittal 173, which made it easier for DME suppliers to obtain qualifying overnight oxygen tests by allowing DME suppliers to deliver a sealed, tamper-proof oximeter to the patient's home on behalf of the independent diagnostic testing facility (IDTF)—and pick up the unit in the morning from the patient—then transmit the test results via the Internet or other software to the IDTF facility. Transmittal 173 basically provided that DME suppliers or other 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:

1. The beneficiary's treating physician has ordered an overnight pulse oximetry test.
2. The test is performed 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 to address other concerns that may arise. Because CMS Pub 100-3, section 240.2.c, prohibits DME suppliers from performing tests, the suppliers may not create this instruction or participate in the conduct of the test.
3. The test unit is sealed and tamper-proof so that test results cannot be accessed by anyone other than the IDTF that 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 cases may the DME supplier access or manipulate the test results in any form.

Transmittal 173 was welcome news for DME suppliers. Shortly after it was released, the Medicare Administrative Contractors (MACs) published information in their fall 2005 Advisory Bulletins related to the provisions of the transmittal.

ADDITIONAL MAC/PSC GUIDANCE

In the summer of 2006, the MACs published a follow-up in their Advisory Bulletins to address some of the confusion concerning what is allowed under Transmittal 173. Many suppliers had questioned whether tests performed in this manner could be used to qualify patients at rest or during exercise. The guidance made it clear that the activity permitted by Transmittal 173 is limited strictly to overnight oximetry tests.

This Advisory Bulletin also contained additional restrictions not included in Transmittal 173. The first stated that the IDTF could send the test results only to the physician, and could not send them to the supplier. The second cautioned that sleep oximetry testing must be based on a request that is initiated by the treating physician, stating that it is inappropriate for a supplier or IDTF to initiate a contact with the physician—either directly or through the beneficiary—to request, suggest, or otherwise seek an order for home oximetry testing.

In the fall of 2006, Advisory Bulletins were published by the MACs stating:

An article titled "Oximetry Testing— Supplier Involvement" was published in the June 2006 Advisory. It provided additional information regarding Change Request 3751, Transmittal 173, published on 8/16/05. One of the statements made in that article was: "The IDTF may send the test results only to the physician. It must not send them to the supplier."

Those statements require further clarification: The IDTF should send the results to the physician. Because this is considered protected health information, the supplier may not receive a copy of the test report until the physician has reviewed the results, made the decision to order oxygen for the patient, and contacted the supplier with that order. The information from the June article, as well as this clarification, has been incorporated in a revision of the Oxygen medical policy which is included in the September 2006 policy updates.

Lisa K. Smith

Although this Advisory Bulletin did clarify the issue concerning the ability of IDTFs to provide copies of test results to the supplier after the physician has contacted the supplier to order oxygen, it did not contain additional clarification addressing suppliers initiating the request for oxygen testing.

THE 12/06 OXIMETRY TESTING FAQ

A document titled "Oximetry Testing FAQ," dated December 1, 2006, was posted on a number of MAC and Program Safeguard Contractor (PSC) Web sites, including the Web site of TrustSolutions LLC, the Jurisdiction C PSC. One of the questions addressed in the document is whether there are any situations in which a supplier is permitted to contact a physician about the need for an oximetry test. That question is answered as follows: Suppliers are reminded that only a physician may order an oximetry test. However, a supplier would be permitted to contact the physician or the beneficiary about the need to obtain an oximetry test under these circumstances:

• A supplier furnishing oxygen to a beneficiary may contact the beneficiary or the physician as a reminder if a recertification oximetry test is needed, or if testing is required for other reasons such as a change in insurance.
• A supplier with an initial order for oxygen where no oximetry test has been performed—or where the tests results are expired or invalid (such as if the test was performed 3 days before discharge instead of 2)—may contact the physician or the beneficiary to inform them that a new test is required.
• As part of a clinical evaluation for patients receiving respiratory services from a supplier, the supplier may communicate the beneficiary's symptoms to the physician. The physician may use this information to determine what further assessment should be performed to evaluate the beneficiary's condition.

NEW LCD OXYGEN MEDICAL POLICY

The LCD Oxygen Medical Policy has recently been revised to incorporate the substance of Transmittal 173 and much of the subsequent guidance. This LCD became effective January 1, 2007, and it states: beneficiaries may self-administer home-based overnight oximetry tests under the direction of a Medicare-enrolled IDTF. A DME supplier or another shipping entity may deliver a pulse oximetry test unit and related technology to a beneficiary's home under the following circumstances:

1. The beneficiary's treating physician has ordered an overnight pulse oximetry test before the test is performed.
2. The test is performed 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 to address other concerns that may arise. The DME supplier may not create this written instruction, provide verbal instructions, answer questions from the beneficiary, apply or demonstrate the application of the testing equipment to the beneficiary, or otherwise participate in the conduct of the test.
3. The test unit is sealed and tamper-proof such that test results cannot be accessed by anyone other than the IDTF that 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 cases may the DME supplier access or manipulate the test results in any form.

The IDTF must send the test results to the physician. The IDTF may send the test results to the supplier if the supplier is currently providing, or has an order to provide, oxygen or other respiratory services to the beneficiary—or if the beneficiary has signed a release permitting the supplier to receive the report.

Oximetry test results obtained through a similar process while the beneficiary is awake, either at rest or with exercise, may not be used for purposes of qualifying the beneficiary for home oxygen therapy.

Lisa K. Smith, JD, is an attorney with the Health Care Group of Brown & Fortunato PC, an Amarillo, Tex-based law firm. Smith is Board Certified in Health Law by the Texas Board of Legal Specialization. She represents DME companies, pharmacies, and other health care providers throughout the United States and Puerto Rico. She can be reached via e-mail: .