The Need for PAPs

One of my favorite phrases is, "Necessity is the mother of invention." Said another way, need drives innovation. And this could not be truer than with positive airway pressure (PAP) interface technology. The number and types of interfaces on the market is staggering. As such, following the evolutionary thread of interface technology goes well back in time, even before continuous positive continuous positive airway pressure (CPAP), was a treatment for obstructive sleep apnea (OSA).

Before OSA was recognized as a severe threat to the health and lifestyle of many, other lung conditions prompted the use of CPAP namely, atelectasis. This condition of lung collapse was common after major surgery, caused primarily by a patient's bed-ridden status and inhibition to breathe deep due to pain. As a result, a respiratory therapist would visit the patient two to four times a day, strap on a full-face mask and monitor the patient as they breathed through a positive pressure mask prophylactically or in an effort to re-inflate the lungs. Since the treatments were periodic and usually less than 15 minutes long, mask comfort was not a main concern. The other areas of medicine that used a full-face mask were anesthesia and advanced pulmonary function. These were also intermittent and of short duration, so comfort was not a main concern.

The next evolutionary wave was due to an increasing prevalence and recognition of OSA. And, as is common with many new endeavors, getting the job done was the main concern; little focus was placed on comfort or preference. For OSA, this means getting positive pressure to the upper airway. Therefore, much of the emphasis was on the PAP machine and not the interface. And since many of those initially identified had the grave choice of a PAP with an uncomfortable interface or a tracheotomy or other invasive surgical procedure, tolerating an uncomfortable interface was the easy choice.

As the PAP devices matured in design and the number proliferated, more attention was turned toward the interface, or mask. Masks, subsequently, have been one of the greatest challenges for the end user and are rapidly becoming the most prolific of PAP products. As such, it is estimated that 2.6 million masks were sold in North America in 2000. The PAP market is growing at a 33 percent clip, well above the overall sleep market growth rate. Finally, the mask to PAP unit ratio is approximately 3:1, that is three masks are sold for every PAP device sold.

Masks, subsequently, have been one of the greatest challenges for the end user and are rapidly becoming the most prolific of PAP products.

This incredible mask growth comes as no surprise since this is the piece that comes in direct contact with the face and it is often times felt to be the reason for treatment failure. Variations of the mask are frequently driven by the clinical community and end-user, and by the primary patient complaint, whether that is tightness, bulkiness, claustrophobia or the inability to see. Whatever the case, manufacturers see facial masks as a primary focal area and each has developed unique mask properties to overcome patient complaints and improve compliance to therapy.

The three primary categories of masks are nasal, nasal pillows and full-face. The most common is the nasal mask. All of the major PAP therapy device manufacturers also manufacture nasal masks. There are also a couple of manufacturers that make nasal masks only.

The Breeze, by Nellcor Puritan Bennett, has been the mainstay nasal pillow device. ResMed and Respironics are PAP therapy device manufacturers that offer the widest range of full-face mask options. Hans-Rudolph, a long-standing manufacturer of pulmonary diagnostic interfaces recently introduced a full-face mask line in addition to their nasal masks. The Oracle mask, a unique oral mask, is made by Fisher Paykel. These other mask types are thought to be niche products and represent approximately five to 10 percent of the interfaces sold. Despite this lower utilization, these options are important to those who are claustrophobic or have significant mouth leak.

Materials used in masks have remained relatively stable. Mask frames are usually polycarbonate and the cushion is silicone. Headgear is usually made with Velcro and Breathoprene. The introduction of gel has offered a unique and comfortable feel and has seen reasonably broad use. Gel was extended to forehead pads, and has been well received because of its unique stabilizing properties. Some manufactures have experimented with foam cushions with minimal success because of disintegration caused by facial oils and the inability to clean.

What has changed most significantly in masks recently are the adjustment options, whether that be with the mask itself or with headgear. The movement to self-anchoring headgear has made masks much easier to assemble and adjust. The FlexAire by DeVilbiss and the Vista by ResMed each offer this option. The next generation of masks offers the user the ability to make minor adjustments in order to improve the comfort, feel and seal. This feature is currently offered with the DeVilbiss FlexAire by the utilization of a foam-filled air bladder with a Nike type pump. These mask features also are beneficial to the provider since they offer the patient the ability to easily adjust from day to day. The benefit to the dealer is that their return trips to the home are minimized since the patient can make minor adjustments without provider intervention.

So with the plethora of masks on the market, the challenge to the provider is determining which masks to include in their offering and why. More so than with PAP devices, sleep labs and physicians often dictate their preferred mask. This is usually based on their experience with the mask. However, as the 21st century PAP user matures, they recognize the options available, which can create an inventory and cost nightmare for the provider. Therefore, managing what masks to maintain in their inventory and how many is paramount.

Given this challenge, consider the following three options:

1. Create a written policy on mask purchases that is provided at the time of service. Getting the patient's acknowledgement with initials or signature is recommended. Let them know that additional mask costs are the responsibility of the patient. Use the Advanced Beneficiary Notice ABN (ABN) provision for Medicare clients. Make certain that your managed care agreements include this similar provision.

2. Have a sample available for the more popular masks as well as the masks with which you have had the best results. Having these available for the client to touch and size will help your clients to be satisfied with their purchasing decisions. You can then offer the patient the option of ordering a particular mask instead of keeping several masks in your inventory.

3. Keep a list of proactive and engaged PAP users. When a new mask becomes available, get their input. They are usually willing to try a mask to see how well it works. Your list of PAP users can be extended to a monthly, PAP therapy group meeting to address issues and give individuals with similar circumstances the opportunity for discussion. Side benefits of this activity include building credibility with your sleep referrals and giving you the opportunity for cash sales of sleep masks and accessories. Invite your referral sources as well as share the results of their mask trials.

Some providers are beginning to realize the revenue potential through PAP therapy supply replenishment. Below are the Medicare codes for PAP therapy products and the approved replacement schedule. Exploring a process optimized, automatic and efficient supply replacement program could be the boost your program needs to enhance profitability. Based on this schedule and utilizing the Medicare floor, a PAP therapy could generate approximately $200 in additional revenue a year.

While referral source demands can often times steer equipment selection, there are still opportunities to make equipment choices based on sound clinical and business judgment. However, if sound clinical and business judgment are not used, you can often end up with excesses of the product that can easily be gathering dust on a shelf in six months.

As shrinking reimbursement challenges all health care organizations, I strongly encourage providers to look at their processes as they explore mask choices. If it isn?t truly better for your patients and your organization's way of providing care, such as mask comfort and flexibility, business efficiency, then maybe it's not a good choice. But even more so, I encourage providers to explore whether the mask will improve their processes such as improving efficiencies that ultimately lead to improvements in patient care. Odds are your CPAP compliance rates, and thus patient and referral source satisfaction, will improve accordingly.

This article originally appeared in the October 2003 issue of HME Business.

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