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Too Much of a Good Thing?

by Bob McCoy, RRT

In the quest to improve CPAP compliance, the number of new devices can create inventory problems.

 It is no wonder the sleep market is gaining attention. It is one of the fastest growing segments in home health care, and experts anticipate that it will continue growing rapidly for several more years.

Furthermore, unlike many home health care patients, the typical obstructive sleep apnea (OSA) patient who needs continuous positive airway pressure (CPAP) treatment is not severely ill, consents to a diagnostic study and therapy, is under the age for Medicare benefits, and is insured privately. In other words, the typical CPAP customer looks like a perfect HME consumer.

However, because CPAP patients are younger, more independent, and more informed of options for health care than the typical home health care patient, they are also consumers who know what they want and will not tolerate poor or ineffective therapy that gives them little relief from their symptoms. This may explain why CPAP compliance is estimated at less than 50%, depending on your definition of compliance.

CPAP patients are consumers and not slaves to sleep medicine. They have a choice and are exercising their choice when the inconvenience and/or discomfort of the therapy is not worth the benefit. Most patients who gain a noticeable benefit from CPAP therapy are compliant with the therapy. But manufacturers and clinicians still debate how to solve the compliance problem for the majority of patients.

Many Approaches, No Solution

Initially, clinicians and patients thought that CPAP equipment was too noisy, cumbersome, or inadequate at producing air flow to meet the patients’ needs. Manufacturers responded with new products that were small and quiet, and generated adequate flow to be comfortable. But it did not improve compliance.

Manufacturers then wondered if the problem could be that clinicians and CPAP providers spent too little time educating patients on the correct application of the mask, use of the CPAP device, and medical benefits of preventing OSA. They assumed that if the patient just understood the equipment and the need to wear the device, the patient would be more compliant. That did not work either.

Now, manufacturers are focusing on improving compliance through better technology. They have brought a full array of solutions to the market, including new masks, heated or cool air humidification, and humidifiers integrated into the blower unit. Yet compliance rates have remained the same while the boom in CPAP technology has created inventory management problems for providers.

Technology upgrades can occur as often as every 6 months, and as each new device enters the market, HME providers must purchase the product, evaluate it with patients, determine benefit, and finally market the advantage, if there is one.

Furthermore, some sleep therapy product manufacturers have developed equipment with little input from the clinical community and instead create demand through marketing campaigns that target sleep laboratories and consumers.

When advertising teaches referral sources or patients to ask for a certain product that suppliers are then pressured or obligated to provide, it is called pull-through marketing. This ploy works well with consumer products, but CPAP devices are not yet consumer products.

To keep referral sources and customers happy, some HME providers are forced to inventory all the new masks, headgear, humidifiers, and compliance data-gathering devices. This can be expensive, especially since payors are now challenging current CPAP reimbursement and trying to lower the existing payment schedule. The result is predictable. HME providers are squeezed with higher costs of products and services at lower payment rates.

Electronic Monitoring

One of the solutions for improving CPAP compliance is the electronic recording of patient CPAP use. Some new CPAP devices include memory cards that record compliance data for downloading and sending to physicians or modems that email the information directly to the physician.

This is a good use of the technology, yet having more data does not improve compliance by itself. The sleep laboratories or physicians must still do something with the data to improve compliance.

Because the point person in the home usually is the HME provider, sleep laboratories and physicians generally expect that the HME provider is the one who should go out to the home if patient follow-up is required. Unfortunately, these follow-up visits can erode any profit the HME provider might have gained from the CPAP business.

Furthermore, some insurance companies are requesting compliance data to determine if payment will be provided. This means the HME company must purchase more expensive CPAP devices that record patient compliance, provide the best interface equipment, educate the patients on the benefits of CPAP, and provide patient follow-up only to risk being denied payment if the CPAP device tells the insurer that the patient is noncompliant.

It appears that the HME companies have the greatest risk and the payors have the greatest benefit of compliance monitoring, yet payors are hesitant to recognize the added cost to the providers.

Insurers do not require compliance monitoring to determine reimbursement for other home respiratory services. Was CPAP selected simply because CPAP device manufacturers—seeking marketable features—made gathering this information easy?

What works?

The sleep therapy market is growing so quickly that it is difficult to determine what is needed for OSA patients and what product or service has the best outcome. There has been little research on the long-term benefits of CPAP. Furthermore, patients, payors, sleep laboratories, clinicians, and HME providers all have different issues related to the value and cost of CPAP therapy and often are working against each other when solutions are needed.

This conflict is unfortunate because patients should be the focal point of any effective care plan. Patients must buy into the therapy that has been prescribed and want to follow the instructions. If patients do not understand the objective of the therapy, are uncomfortable with the equipment, or do not gain a benefit from the therapy, it is unlikely that they will be compliant with their prescriptions.

Options for devices might help improve compliance, yet the patient should be involved with the decisions regarding options. There should be a buy-in between the patient, payor, and HME provider to determine the best options for CPAP therapy. Both the payor and patient need to understand that the HME provider cannot carry the burden of offering every option available on the market without charging more.

If CPAP evolves to a true consumer product, then consumers can purchase the devices that meet their needs and carry the financial responsibility for evaluating all options on the market. Compliance will be a moot point since the decision to use therapy devices will be the patient’s and not that of ancillary health service personnel.

However, until the compliance puzzle is solved, HME providers should expect to deal with these CPAP market growing pains.

Bob McCoy, RRT, is managing director of Valley Inspired Products, Savage, Minn. Contact him at bmccoy@inspiredrc.com.


Respiratory Insider

Terry O’Brien, the former category manager for respiratory products for Omron Healthcare Inc, Vernon Hills, Ill, is now involved with special projects for the company. He spoke with Dealer/Provider about how Omron is positioned to keep up with the growing respiratory market.

Q  How does Omron distinguish itself from competitors?
A
  Omron’s market focus has been on small, portable nebulizer systems that are convenient for patients of all ages, regardless of respiratory condition. Omron was the first company to market “vibrating mesh technology” with the NE-U03 Micro-Air, and has the only truly handheld, billable compressor/nebulizer in the NE-C21 Comp-Air Elite.

Q  What can Omron offer HME suppliers?
A
  Omron offers HME dealers the opportunity to maximize revenues of existing sales and increase sales through referral sources. Omron’s NE-C21 Comp-Air Elite is a true compressor/nebulizer that is billable under Medicare, but can be portable with the purchase of a battery option. The NE-C21 is supplied with a “reusable nebulizer” that is billable under Medicare. Compressor/nebulizer patients who prefer a smaller, more quiet nebulizer can purchase the Micro-Air from our dealers.

Omron’s clinical studies on new medications, such as budesonide, show the effectiveness of aerosol delivery as required by the pharmaceutical company. Omron realizes that physicians rely on information provided by their suppliers, and works with pharmaceutical companies on testing to design protocols.

Omron also sees the metered dose inhaler (MDI) market as the larger market in aerosol medication delivery and will design products to compete in this market. We believe that with changes to our existing technology platform, we can develop products that have the convenience of MDI medication delivery without the problems associated with MDIs and spacing devices.

Q  What new developments does Omron have in the works?
A
Omron will introduce the new NE-U22 Micro-Air at Medtrade. The NE-U22 is a replacement for the NE-U03, and is a smaller, lighter version of the NE-U03 that features the same proven vibrating mesh technology. The NE-U22 will also be positioned for the hospital market.

Q  How is Omron positioned to keep up with constantly changing technology?
A
  Omron’s operations in Japan have a dedicated technology group for the development of new products in aerosol delivery. Members of this group attend meetings that discuss new technologies as well as new medications and formulations of medications. One such meeting is the Respiratory Drug Delivery 8 (RDD8) Meeting dedicated to new aerosol technologies that took place this year in Tucson, Ariz.

Q  What do you envision for the future of the respiratory market?
A
  I think the future will see simpler devices for patients so they can remain compliant with management programs prescribed by their physicians. The key to patient compliance is how convenient a device is to use. Omron believes that you need to have a convenient device in order to have compliance, which leads to control. The simpler the device, the more compliant the patient, and the more compliant the patient, the better control of the medical condition.


Respiratory News

AARC Congress Focuses On Education
“In today’s health care environment, knowledge is power,” says Margaret F. Traband, MEd, RRT, president of the American Association for Respiratory Care (AARC). And in her words, respiratory therapists “powered up” at the association’s 48th International Respiratory Congress held in Tampa, Fla, on October 5-8. “It is really one of the best programs we have ever put together,” Traband says.

This year’s conference included sessions on respiratory therapy in home health care, the Health Insurance Portability and Accountability Act (HIPAA), and sleep therapy, as well as a broad range of topics for hospital and long-term care respiratory therapists, physicians, and nurses. The keynote was given by Linda Peeno, MD, whose work crusading for improved health care coverage became the subject of the Showtime movie Damaged Care.

For more information, visit the AARC Web site at www.aarc.org or call (972) 243-2272.

Apria’s Fary Wins ARCF Award
The American Respiratory Care Foundation (ARCF) honored Bob S. Fary, RRT, director of respiratory therapy for Apria Healthcare, Costa Mesa, Calif, with the Invacare Award for Excellence in Home Respiratory Care. The award, which was established in 1992 with a grant from Invacare Corp, Elyria, Ohio, recognizes outstanding achievement in home respiratory care. Fary was presented with $500 cash, a crystal sculpture, airfare, 1 night of lodging, and registration to the AARC’s 48th International Respiratory Congress.

“Bob is most deserving of this prestigious award,” says ARCF board member Joseph Lewarski, BS, RRT, president of Hytech Homecare & Medical Supply, Mentor, Ohio. “He has been a tireless advocate for home care respiratory therapists, consumers, and the home care industry as a whole. He is regularly spotted and heard at all major professional and industry gatherings, always voicing his concerns for the advancement of the profession.”

However, Fary said that the real thanks should go to his colleagues at Apria. “I think this recognition is as much due to the excellent work of the Apria respiratory therapists caring for our patients all over this country, and I really accept this on their behalf,” he said. He also thanked Invacare and the ARCF.

ResMed Sues Fisher & Paykel
The ACLAIM and ACLAIM 2 continuous positive airway pressure (CPAP) masks manufactured by Fisher & Paykel Healthcare Corp Ltd, Auckland, New Zealand, infringe on patents held by ResMed Corp, Poway, Calif, says ResMed in a lawsuit filed in the US 9th District Court of Southern California. The complaint charges Fisher & Paykel with the copying of ResMed proprietary mask technology, and alleges trade dress and common law violations relating to the appearance of ResMed mask products.

“ResMed has invested heavily in the development of its mask technology and has taken the appropriate steps to protect that intellectual property,” says Peter C. Farrell, PhD, ResMed’s chairman and CEO. “We are prepared to protect our investment. We will not tolerate the copying of our products by competitors.”

However, Fisher & Paykel refutes the allegation. “We believe that ResMed’s claim against Fisher & Paykel Healthcare is without merit and, if required, we will vigorously defend this suit,” says Michael Daniell, managing director and CEO of the company. “We have contacted ResMed with a view to resolving this dispute without unnecessary litigation.”

A court date had not yet been set.


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