Medicare proposes not reimbursing sleep labs for xPAP

quote from National Sleep Foundation Alert

CMS Proposes New Limitations on CPAP Reimbursement

The Centers for Medicare and Medicaid Services (CMS) has proposed a rule to prohibit reimbursement for Continuous Positive Airway Pressure (CPAP) devices if the supplier or its affiliate performed the diagnostic sleep test. This rule would go a step further than existing regulations which restrict only suppliers from performing the test. The move is notable considering CMS’s recent decision to allow for home testing for sleep apnea, although the new rule would also cover in-lab polysomnography. CMS will accept comments on the rule for 60 days after its official publication.

* To read the pre-publication notice, click here
* To read about CMS’s approval of home testing for sleep apnea, click here

Date: 7/1/2008

To get to the links, go to

http://www.sleepfoundation.org/site/app ... id=3794041

This sounds like a Good Thing to me.

many sleep labs don't supply DME equipment as it can be seen as a conflict of interest,
sleep doctor owning and operating a sleep lab may also be considered a conflict of interest,

and the best one of all....

the sleep doc that owns the sleep lab and sells equipment and there are a lot of those,

but CMS is going to allow home studies for diagnosis??

leave it to our government to come up with that one, if a DME provides the equipment to use for the "home study" test they cannot then supply the equipment once the diagnosis is obtained,

DME's will be standing in line for that one

sounds pretty stupid to me, like I said before, they need to do away with medicare it screws up the whole healthcare system in my opinion, a cash cow for some inflated healthcare costs for the patient.

Not surprising. The more the gov't gets involved in anything, the more FUBAR it becomes.

Thanks, Mile High Sleeper!!

http://www.cms.hhs.gov/physicianfeesche ... 1403-P.pdf

Pages 413 - 418


(CMS-1403-P 413)
-------------
2. Prohibition Concerning Providers of Sleep Tests
[If you choose to comment on issues in this section, please include the caption “OTHER ISSUES—SLEEP TESTS” at the beginning of your comments.]
a. Background
Obstructive Sleep Apnea Hypopnea Syndrome, also known as Obstructive Sleep Apnea (OSA), is the most common of the three different forms of sleep apnea (obstructive, central, or mixed). OSA is associated with significant morbidity and mortality, including excessive daytime sleepiness, concentration difficulty, cardiovascular disease, and stroke. Untreated OSA is associated with a ten-fold increase in the risk of motor vehicle accidents.
Diagnostic tests for OSA are based on detection of abnormal sleep patterns using sleep test devices that record a variety of cardiorespiratory and neurophysiologic signals during sleep time called polysomnography (PSG). Historically, such sleep tests have been furnished in a sleep laboratory attended by a sleep technologist. More

(CMS-1403-P 414) recently, portable sleep test devices have been developed for the diagnosis of OSA in the home (either attended or unattended). Sleep test devices are classified into four types based primarily on the extent of sleep pattern data recorded. The most comprehensive is designated Type I: attended in-facility PSG. The remaining three types concern portable sleep test devices developed for the diagnosis of OSA and used both in attended and unattended settings, often in the home. Type II devices have a minimum of 7 monitored channels; for example, electroencephalogram (EEG), electro-oculogram (EOG), electromyogram (EMG), electrocardiogram (EKG)-heart rate, airflow, respiratory effort, and oxygen saturation. Type III devices have a minimum of 4 monitored channels including ventilation or airflow, at least two channels of respiratory movement or respiratory movement and airflow, heart rate or EKG, and oxygen saturation. Type IV devices do not meet the technical criteria defining the other types, and many measure only one or two parameters, for example, oxygen saturation or airflow, but some Type IV devices measure three or more parameters. There are other technologies that do not readily fall into the classification above.

(CMS-1403-P 415) Sleep testing, like other diagnostic tests, is subject to the provisions in §410.32. Thus, it must be ordered by the physician who is treating the beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Sleep testing must be furnished under the required level of supervision by a physician. If the sleep testing is furnished by an independent diagnostic testing facility (IDTF) the provisions of §410.33 also apply.
A number of treatment approaches have been recommended for persons diagnosed with OSA, depending on severity of the disorder and other clinical factors. Patients with moderate to severe OSA are usually treated at first with continuous positive air pressure (CPAP) devices. The regular use of a CPAP device in these cases has been shown to improve excessive sleepiness, cognitive performance, and quality of life.
A CPAP device is an item of durable medical equipment (DME) used in the home that typically uses air pressure to maintain an open airway and improve airflow to the lungs.
Medicare currently provides national coverage of CPAP only for beneficiaries whose diagnosis of OSA meets the criteria described in the national coverage determination at 240.4 of the National Coverage Determinations (NCD)

(CMS-1403-P 416) Manual. We recently published a revised NCD that expands coverage of CPAP devices to beneficiaries when OSA has been diagnosed by specified home sleep testing. Prior Medicare policy had covered CPAP devices only for beneficiaries whose OSA had been diagnosed by facility-based attended PSG. During the process leading to the revised policy, we received many public comments expressing concern that financial incentives would lead to abusive practices that would harm Medicare beneficiaries and threaten the integrity of the Medicare program. These concerns were expressed not only with respect to home sleep tests, but also those performed in sleep laboratories and other facilities. Therefore, we are proposing to implement a provision that would limit potential abusive practices by removing a significant financial incentive for those practices.
b. Regulatory proposal
Based on public comment and prior agency experience, we believe that the interests of beneficiaries and the Medicare program can be harmed if the provider of a diagnostic test has a vested interest in the outcome of the test itself. In the specific context of this proposed rule, we believe that the individual or entity that directly or indirectly administers the sleep test and/or

(CMS-1403-P 417) provides the sleep test device used to administer the sleep test (referred to hereinafter as the ‘provider of the sleep test’) has a self-interest in the result of that test if that provider, or its affiliate, is also the supplier of the CPAP device.”
This provides incentive to test more frequently or less frequently than is medically necessary and to interpret a test result with a bias that favors self-interest.
Current medical evidence persuasively demonstrates that treatment with a CPAP device is safe for patients who have OSA. Similar evidence is lacking for treatment with a CPAP device of persons who do not in fact have obstructive sleep apnea. A test interpreted with bias or reported falsely may mislead the beneficiary’s treating physician and divert the beneficiary from medically appropriate treatment. Moreover, supplying a medically unnecessary CPAP device is a waste of Medicare trust funds.
Based on section 1871(a)(1) of the Act, which provides the Secretary with the authority to “prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title,” and due to our concerns with respect to the potential for unnecessary utilization of sleep tests, we are proposing to

(CMS-1403-P 418) prohibit payment to the supplier of the CPAP device when such supplier, or its affiliate, is directly or indirectly the provider of the sleep test that is used to diagnose a Medicare beneficiary with OSA.
As alternatives we had considered requiring pre-authorization for sleep tests or modifying payments for the services when they are furnished by the same entity but believe these options would either generate undue burden on both the Medicare beneficiary and the claims processing systems or be administratively burdensome.
Therefore, we are proposing to revise the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier enrollment safeguards set forth at §424.57 to protect the Medicare program and its beneficiaries from fraudulent or abusive practices that may be related to CPAP devices. We are proposing to add new definitions to paragraph (a) to define “sleep test” and “CPAP device” and to add a new paragraph (f), which would establish a specific payment prohibition that would not allow the supplier to receive Medicare payment for a CPAP device if that supplier, or its affiliate, is directly or indirectly the provider of the sleep test used to diagnose a beneficiary with OSA. (bold red emphasis added)

I think that it is a good thing to separate the sleep clinic from the equipment provider.

Bearded_One wrote:I think that it is a good thing to separate the sleep clinic from the equipment provider.

Because DMEs do such a great job?