You Are Now Free to Use Your Portable Electronic Devices
Chronic obstructive pulmonary disease (COPD) used to be viewed as a disease of frail, homebound elderly men. The reality is that more than half of the 1 million diagnosed COPD patients are under age 65, active and women. This misperception of people with COPD was so prevalent that men used to be accurately diagnosed with COPD while women, complaining of the same symptoms, were diagnosed as asthmatics. While knowing your audience is key to the success of most businesses, it's critically important for HMEs and the COPD patients they serve. When COPD patients use products that support an active and ambulatory life, they can live longer.
As of Aug. 11 of this year, the Federal Aviation Administration (FAA), under the Special Federal Aviation Regulation (SFAR) 106, permits passengers to use certain portable oxygen concentrator devices onboard commercial aircraft during flight. The ruling reflects the real demographic of COPD patients who want to remain active and travel despite their diagnosis. In the past, many oxygen users who wanted to travel may have chosen not to due to the complexities of finding an airline carrier that offers supplemental oxygen for passenger use and other logistic problems such as not having oxygen for ground support and needing confusing written documentation requirements. But all that has changed.
Oxygen users now can take off on a moment's notice, without having to watch the clock or guess at how long their oxygen will last. |
Currently two manufacturers have received approval from the FAA: The Inogen One from Inogen Inc., Goleta, Calif., and the Lifestyle from AirSep, Buffalo, N.Y. The ruling has left it up to the discretion of the individual air carriers to determine whether they will accept these oxygen concentrators onboard. The ruling eliminates the 60-day notice requirement for passengers, lifts the Hazmat exemption to allow oxygen use, makes oxygen users self-responsible and removes some logistical hurdles for both providers and airlines.
On Sept. 7, 2005, the Department of Transportation (DOT) published a proposed rule seeking comment on changes in federal policy. Originally DOT planned the comment period to end Nov. 7, 2005, but later extended the comment period to Jan. 1. (The Docket number is OST-2005-22298 at http://dms.got.gov.) Even though the FAA rule allowed the use of the two approved POCs, the DOT-proposed rule would require most airlines to permit the use of these devices. The ruling, which required airlines to allow POCs as personal assistive devices, presents a significant training issue for all domestic and international air carriers.
Both Airsep and Inogen have put in a lot of time to make sure airlines are onboard with their products.
"We have been working with all major carriers, as well as many of the regional and charter airlines, to provide training and answer any questions. This has involved at times, many site visits from members of our staff," says Kathy Sanchez, director of marketing for AirSep.
"This week alone, we have two meetings scheduled with carriers based in the Southeast. At one of the meetings alone, 25 will be in attendance for the training session. Typically, we provide manuals, CDs about our product and a background about all of AirSep's vast experience with manufacturing oxygen concentrators."
"Inogen discarded existing paradigms to design and build an oxygen concentrator that redefines how oxygen therapy is delivered," says Byron Myers, founder and director of marketing for Inogen.
Northwest Airlines, U.S. Airways and America West have already taken the necessary steps to adopt the Inogen One. "Inogen One continues to work with other airlines throughout the country to provide assistance and training materials. Overall, Inogen has been very pleased with the response from the airline industry and their willingness to evaluate the Inogen One," says Myers.
Inogen has customizable training videos and oxygen therapy backgrounders regarding the use of the Inogen One as well as weighted demonstration shells, created to assist the airlines in their training needs. "We have supplied technical reports which describe the Inogen One in detail as well as a review of regulatory tests which qualify it for safe use onboard aircraft," Myers says.
Did You Know?
The Americans with Disabilities Act never accounted for airline travel, which led to the Air Carrier Access Act. The Air Carrier Access Act prohibits air transportation discrimination by domestic and foreign air carriers against qualified individuals with physical or mental impairments. The act applies only to air carriers that provide regularly scheduled services for hire to the public. Requirements address a wide range of issues including boarding assistance and certain accessibility features in newly built aircraft and new or altered airport facilities.
Regarding AirSep's Lifestyle, Sanchez says, "Overall this has been a very positive experience, and the exchange of information and training among the airlines and AirSep has been beneficial for all. Some of the commercial carriers, such as U.S. Air, America West and Midwest have already completed this training process, and notified the public that Lifestyle use is now permitted onboard airlines. We have word that several more will join this growing list by January and are happy to do so."
AirSep has also made international strides. "As our product is also CE-marked for use overseas and we are an ISO-approved company, we have already had foreign-based carriers such as Air France, Qantas and Lufthansa airlines permitting its use for supplemental oxygen patients as well. This is especially appealing to those who are taking European holidays, trips to Australia and Caribbean cruises," Sanchez says.
What Providers Need to Know to Help Consumers
The most important things for dealers to know is that these products are safe and have nothing pressurized on the devices. Although both Airsep and Inogen are working to educate airline personnel, including gate personnel, the burden of end user training is on providers.
Oxygen users who board aircraft with oxygen are required to obtain a signed statement or prescription from their physician that includes:
- Their ability to see and hear alarms and respond appropriately
- Whether oxygen use is necessary for all or only part of the trip including whether the oxygen needs to be on during takeoff
- Maximum flow rate corresponding to the pressure in the cabin under normal operating conditions.
"This statement needs to be kept with the user at all times during their flight," says Myers. A new statement will be necessary each time they fly, but the statement should be available during every flight. Inogen has prepared a draft physician statement that may be used as a template, at www.inogen.net/faa.
AirSep recommends that providers and patients make certain that they have notified their airline carrier's medical oxygen desk as far in advance of their travel date as possible. "It is important that the airlines that allow POC use can have adequate time for all the preparation necessary to make the patient's trip as smooth as possible," Sanchez says.
"We do attempt to assist when home care companies, patient advocates or industry support groups ask for intervention, such as in the form of speaking at joint community health fairs, etc., or in the form of support materials to mail or hand out as literature on Lifestyle," Sanchez says.
According to Sanchez, it is extremely important for home care providers to not be excluded from the proper promotion of this POC from the manufacturer to the general public and patients in their own service areas.
"For example, it is really a disservice to patients when products such as portable oxygen concentrators or any oxygen concentrators are sold over the Internet," Sanchez says. This skips the necessary testing of both the equipment after shipment and the testing of the patient and their optimal flow settings with the equipment."
While portable concentrator technology is ideal for highly active patients, it's critically important to ensure that the device is appropriate and the settings are proper for all aspects of ambulation and sleep. "The patient needs to be thoroughly instructed on the use of the device and properly supported by their local oxygen provider," Sanchez says.
The more clients are active and the more they use their oxygen, the longer they are likely to live.
"Hundreds of thousands of Americans alone need supplemental oxygen during ambulation but especially when traveling by air, and most would all love to travel more if they could," says Sanchez. "This is the essence of some of the continuing work being done through the American Disabilities Act in paving the way for the implementation of one of these patients' rights issues. The American Medical Association as well as other key influential groups have come out in favor of this enforcement. It's only a short matter of time for patients as many of the air carriers are announcing that they are enabling oxygen to fly by approving Lifestyles on their airlines."
The proposed rule is likely to encourage patients to maintain a quality of life they were accustomed to prior to diagnosis.
"For patients, the Inogen One presents an opportunity for spontaneity and more active life both at home and on the road. For providers, the system can provide improved business efficiency," Myers says.
"From a clinical standpoint, it's been long accepted that the more ambulatory a patient is enabled to become, the greater their longevity," says Sanchez. "Lifestyle makes a patient round-the-clock ambulatory."
Portability has resulted in increasing opportunities for patient travel. "Long voyage cruises seem to have become a favorite pastime for supplemental oxygen patients as well as educated automobile trips, and Lifestyle makes it so easy to lighten the equipment burden that formerly made some of this travel prohibitive," Sanchez says.
Having this type of portable oxygen device allows patients to be independent and travel. "Not just for running errands, or short trips out of the house, it achieves true spontaneity," says Myers. "Oxygen users now can take off on a moment's notice, without having to watch the clock or guess at how long their oxygen will last."
"While the advantages of an independent oxygen device are clear for the patient, the advantages offered to the HME provider are no less noteworthy," Myers says. "The Inogen One was designed to offer independence to the HME provider by addressing the business challenges of today's marketplace. Decreasing reimbursement means new technologies must eliminate non value-added operating costs such as frequent and unscheduled service calls. Increasing patient expectations means patients want the technologies serving them to be up-to-date and as user-friendly as other devices they utilize. The need for increased business efficiency makes old ways of thinking and operating inadequate to assure the viability of today's oxygen therapy providers," Myers says.
The Products
The Future
According to Myers, the FAA conservatively estimates that 47,000 more people will fly now that the ruling is in place. However, it is possible that the number of new travelers could be much more significant.
"Statistics show that nearly 20 percent of all travelers are 55 and over and that percentage is increasing," Myers says. "However, data suggests that only 5 to 10 percent of oxygen users travel by air each year. Now that the burden and difficulty of arranging oxygen during flight has been removed, we expect that travel among oxygen users will begin to resemble that of their peers."
As baby boomers, a generation that demands more, age, the result is consumers with higher expectations than generations before them. "The baby boomer oxygen patients symbolize the changing face of the oxygen industry, and their arrival brings both opportunities and challenges," Myers says.
"These challenges … in government reimbursement policies, increasing operating costs, aging equipment and outmoded delivery systems, add to the complexity of the oxygen provider's business. In an increasingly competitive marketplace characterized by rising health care costs and an uncertain health care climate, the world of the HME provider has never demanded more solutions. The provider who is ready to face this new day is the provider who is ready for the Inogen One," Myers says.
Nearly everyone in the medical profession thinks about the significance of quality of life issues that come into play when technology exists to assist patients and their caregivers on a higher level, according to Sanchez. When products exist to help oxygen users ambulate more, it benefits the HME company, the patient, the caregiver and family members.
"This week alone, more than 1,500 people need oxygen therapy for the first time. These new patients do not know anything about oxygen therapy; they know nothing of cylinders, or concentrators or of liquid oxygen. They do not think daily about the home health care market, about HME providers and about reimbursement codes. All they know is that their life has changed and they now need to have a supply of oxygen with them whenever and wherever they are, home or away," Myers says.
The Products
AirSep's Lifestyle
The AirSep Lifestyle Portable Oxygen Concentrator is a truly portable POC, as it weighs less than 10 lbs. and runs on multiple power sources: AC household electric, 12-volt DC from an automobile or boat, a rechargeable battery and even a multiple battery pack. It combines two technologies: concentrator and conserving device in one.
The Inogen One
The Inogen One is a departure from current mainstream technologies: both the standard, large, bulky, stationary oxygen systems and the inefficient and impractical portable devices. Inogen's engineers developed, tested and delivered a technology that eliminates the need to choose between a stationary or portable oxygen system.
This article originally appeared in the January 2006 issue of HME Business.