In December 14, 2007, CMS released its second reconsideration decision to allow in-home CPAP qualification. Many predicted this, but none predicted much of the content that CMS included—or did not include—in the ruling. After a 30-day comment period and an additional 60 days, a final ruling came on March 14, 2008. The ruling is still quite vague, but offers a more in-depth look at where CMS plans on taking this program.

The most shocking content related to the equipment that CMS proposed to allow for qualification of a CPAP patient in the home. CMS has proposed to allow type I, II, III, and IV devices. Each type represents the number of channels that are available, with type IV devices being only one channel.

An example of a type IV device would be an oximeter, or an ApneaLink, which is manufactured by ResMed. Most providers are familiar with an oximeter since it has been used extensively to qualify oxygen patients in the home. An oximeter records pulse and oxygen saturation levels, while an ApneaLink records apnea events, hypopnea events, breath limitations, and snoring.

With an optional finger probe, an ApneaLink can also record oximetry data. There have been studies that show that an oximeter is capable, with the right software, of providing data that can diagnose sleep apnea patients. The trick with using an oximeter to diagnose a sleep apnea patient is that this usually takes a qualified individual to recognize the patterns and interpret them as sleep events. On the other hand, the ApneaLink device provides clear reporting related to specific sleep-related events, calculates the AHI (apnea-hypopnea index), which is the qualifying determinant for CPAP, and creates a much clearer picture for the untrained eye as to the true condition and potential diagnosis of the patient.

It is important for HME providers to understand that, as they begin to promote in-home CPAP qualification to primary care physicians, one of the biggest challenges will be educating physicians. Most physicians have been referring patients to sleep labs and will now have to become more familiar with the diagnosis and treatment of sleep apnea patients. For HME providers to be successful, the education burden may become their responsibility. Focusing on the simpler equipment may be the key to this process.

The other key and possible missing component in the CMS ruling was the involvement of a qualified physician or pulmonologist/sleep professional. CMS appears to be allowing the primary care physician the complete authority to diagnose and treat these patients. If this holds for additional rulings, expect the in-home qualification for CPAP patients to get a real jump start as of the effective date of the program.

Without the required involvement of the pulmonologist or sleep physician, the process of diagnosing and qualifying a CPAP patient could be drastically reduced and follow a program very similar to the qualification of an oxygen patient. Don't rule the pulmonologist or sleep physician out even if the CMS ruling does not allow or require their involvement prior to qualification. Many primary care physicians will likely continue to seek their advice prior to ordering the CPAP equipment, even though the patient meets the qualification criteria.

Remember that sleep apnea can be a symptom of a much bigger problem and is not as cut and dried as qualifying an oxygen patient. There will also be concerns by many primary care physicians that the data provided tells the complete and accurate picture of the patient's health. I would expect, at least for the first 6 months or so, that primary care physicians will continue to involve specialists before placing patients on CPAP.

We anticipate that through electronic means, many in-home tests will be automatically forwarded to pulmonologists for their recommendations and comments, and then returned to primary care physicians. This provides the primary care physician with a qualified opinion, along with the specific test data. It also may alert physicians about the health of their patients.

Once they are qualified, we are only part of the way toward fostering a successful CPAP patient. CMS has provided for a 12-week trial period before making the CPAP permanent. During this 12-week process, CMS will expect the patient to show improvement while using the device before continuing to reimburse for it. It will be imperative that the patient is tracked during this period to ensure compliance.

Many systems will offer automated tracking that will download reports monthly from the CPAP device (usage and improvement, or lack of) and thus provide documentation to support the need for continual use of the CPAP. This type of automation could prove to be helpful in ensuring that patients are tracked during the initial 12-week period. Any adjustments to equipment could be made early during the evaluation process to make sure that the patient has a good experience and remains compliant. This automation would populate the patient's electronic file and provide notification should the patient not be compliant with the device.

For all HME providers who are thinking about running out and purchasing these devices, I would advise against it. The current CPT code for billing an in-home sleep study only allows for the testing device owner to bill for the test. Thus, if an HME provider were to purchase a device for home sleep testing, it could not be used in the qualification of a Medicare patient and processed through an independent diagnostic testing facility (IDTF). Why? Because the IDTF must own the device to bill Medicare for the qualification test. It would be a wasted purchase.

Another concern for HME providers who are going to be interested in providing this service is that there will likely be a shortage of equipment. It will likely take the balance of the year for manufacturers of this equipment to catch up with demand. It will be important to become associated with a provider of this service as soon as possible to ensure that devices are available.

Be careful to market this new program cautiously if you currently receive referrals from a sleep lab. Many sleep labs may see this new program as competing with their business, and you could thus lose more referrals than the new in-home testing could produce during the first few months. Providers who are looking to make their entry into the sleep market will likely disregard this word of caution because they will have no previous relationships that could be harmed. Those that are aggressive early on could prove to be the big winners.

Do not move too quickly based on the information available at this point. By the time CMS issues the final rule and implementation for the in-home CPAP qualification, this program could take several more twists and turns.

The type of equipment allowed to qualify the patient and the involvement of the pulmonologist/sleep physician are two of the biggest wild cards that could affect how HME providers wish to proceed in this marketplace. I hate to advise the wait and see philosophy, but it would be the safest at this point. Instead, prepare two different game plans. The first would be how to approach the market should CMS require involvement of the pulmonologist or sleep physician, and the second game plan would center around marketing to the primary care physician.

Mickey Letson is president and founder of Letco Inc, Decatur, Ala. He can be reached via e-mail: .