Waiting to Exhale
- By Ellen Z. Harrison, Bob McCoy
- Sep 01, 2006
Ever wonder what happens during an asthma attack?
Mucus production increases. Muscles of the bronchial tree become tight. The lining of the air passages swells. Airflow restricts, and wheezing occurs.
Fortunately, for the approximately 20 million Americans who have asthma, according to the American Lung Association, medications can reduce the occurrence of asthma attacks, preventing this cycle and improving health. Providers of devices like nebulizers and metered dose inhalers (MDIs) play an essential part in medication delivery.
Navigating reimbursement cuts to the respiratory market, however, might cause these symptoms to occur in home health providers' bottom lines. But as technology continues to improve and the market steadily grows, providers are finding that there's plenty of "air" to go around.
Tech Talk from the Top
Respiratory manufacturers agree that improved technology — both with MDIs and nebulizers — continues to push the asthma market forward.
"There's probably been more research on inhalers and delivery devices on inhalers than there have been on aerosol therapy within a traditional nebulizer compressor," says Dennis Cook, Respiratory Division president, Medline Industries, Mundelein, Ill. "The pharmaceutical industry has spent a lot of time developing new ways to deliver inhaled medications, and I think you'll see more of that developing, like the disk inhalers, maybe a different design on the metered dose inhaler."
"If we can reduce one phone call from a patient who doesn't know how to use a device, we've helped the economics at the provider level. If we can put a very clear, concise DVD in with every nebulizer, we've just helped the provider educate that patient, reduce a phone call and reduce the labor intensity on the part of the provider. They can't afford the visits that they used to be able to afford under all of these cuts." —Matt Conlon, director of sales and marketing, Respiratory Drug Delivery, Respironics |
In fact, Cook says that the major developments with metered dose inhalers are a result of work by pharmaceutical companies rather than device manufacturers.
Still, MDIs are sometimes difficult to use, explains Cook, so assist devices, like holding chambers or spacers, make delivery easier for end-users. "It's difficult for a patient to coordinate squeezing the bottle because it does take some muscle strength to squeeze the bottle and inhale at the same time they dispense the medication," explains Cook. "So assist devices have been developed, called holding chambers, where (users) spray the aerosol cloud into the holding chamber and then they put it into their mouth and inhale whenever they're ready to."
Matt Conlon, director of sales and marketing, Respiratory Drug Delivery, Respironics, Murrysville, Pa., believes providers have an opportunity to grow business by way of ancillary products for asthma clients. "While the economics of asthma is really driven by drug therapies, I think there's an enormous opportunity for providers to offer products and education in terms of ancillaries surrounding asthma," he says. "And by that, I mean things like peak flow meters or spacers for the MDIs. (Providers) should be in the physician's office educating clinicians on the appropriate device selection."
A big impact on MDI development came with the implementation of legislation under the Montreal Protocol, officially the Protocol on Substances that Deplete the Ozone Layer, in 1987. A component of the international agreement phases out chlorofluorocarbon (CFC) production, with rare exceptions, by 1996.
"In the past, conventional inhalers have generally been chlorofluorocarbon-based MDI," says Angela Mayfield, director of marketing, Graham-Field Health Products, Atlanta. "As a result of the Montreal (Protocol) phasing out CFCs, the technology has been forced to change, and ozone-friendly hydrofluoroalkane (HFA)-based MDIs and dry powder inhalers (DPIs) have become increasingly common."
HFAs contain neither chlorine nor bromine and therefore have no detrimental effect on stratospheric ozone.
In addition to environmental safety, patient safety continues to influence technology. In the past, clients were unable to determine how much medication remains in an MDI container, short of manually tracking doses. "New MDI formulations are being developed by pharmaceutical companies with integrated dose counters," says Conlon.
"There will still be a number of drugs in canisters that don?t have dose counters," he says. "That's another area that Respironics and others are looking at to ensure the utmost safety to patients.
"The challenge for manufacturers is to make a very simple dose-counting device that meets the economics of the situation as well, both on the (pharmaceutical) side and the patient side," says Conlon.
The major benefit of a metered dose inhaler is portability — a trend that has not gone unnoticed by nebulizer manufacturers. "People are more on the go," explains Cook. "They don't want to be tied down to a machine that needs to be plugged into a power supply somewhere."
"Our healthy, mobile, aging population demands convenience; hence portable nebulizers will continue to be big sellers." —Angela Mayfield, director of marketing, Graham-Field Health Products |
In part, nebulizer manufacturers are competing with metered dose inhalers — a competition that has resulted in the development of compact, battery-operated nebulizers equipped with automobile adapters, says Cook.
No doubt, discerning respiratory clients are demanding lighter, more compact nebulizers that go anywhere. "Our healthy, mobile, aging population demands convenience; hence portable nebulizers will continue to be big sellers," says Mayfield. "Families are busy and must be able to give themselves treatment wherever they are: in the car, for example, on the way to a soccer game."
Though portability eases treatment constraints, particle size is also important, says Brian Groskopf, director of device strategies, PARI Respiratory Equipment, Midlothian, Va. "Portability is a nice and beneficial option for the patient," he says, "but really the true goal of a nebulizer should be to effectively deliver a prescribed medication to the patient taking into account particle size, the percentage of those particles in the respirable range and the number of those particles reaching the lower airways of the lungs to effectively treat an asthmatic type respiratory condition."
Conlon argues that while clinicians might assert that particle size is everything, in fact particle size matters most for certain medications. "Particle size is very important for specific drugs, but the key is specific drugs," he says. "There (are) therapeutic windows, and a therapeutic window means how much drug is required to affect the patient's clinical outcome. And any drug beyond that therapeutic window is more or less either wasted drug, or it would contribute to side effects. So what you want to do is you want to match your drug delivery (system) to specific therapeutic window profiles of each drug."
For nebulizers, Conlon sees newer technologies geared more toward breath-enhanced or breath-activated nebulizers "that enable optimal drug delivery with minimal drug wastage or environmental contamination," he says. "So, as opposed to spewing out the drugs constantly and releasing it into the air where the caregiver might breathe it in as well, breath-enhanced or breath-activated nebs reduce that."
In addition, Mayfield says, "diminishing particle size, higher psi compressors and ultrasonic technology have combined to make nebulizer treatment far less time-consuming" — a benefit that busy asthma clients appreciate.
Conlon also sees technology focusing more on diagnosis and monitoring to meet market needs. "Some of the technologies that we see being worked on involve more precise measurement in diagnosis of airway inflammation for asthmatics," he says. "So, if they can more precisely diagnose … they can titrate the drugs more specifically."
Monitoring is key, says Conlon. Though peak flow monitoring has been the standard for monitoring those with asthma for many years, "we see with the record number of ER admissions for asthma that patients really need to be more strongly encouraged to monitor their condition regularly through peak flow meters," he says.
Because metered dose inhalers and assist devices are not reimbursed or not reimbursed as favorably as nebulizers, says Cook, nebulizer compressors continue to be the preferred method of treatment.
Know the Client
Last January, the journal CHEST released evidence-based guidelines for selecting the proper aerosol device for patients.
"These guidelines tell us … regardless of which technology you use to deliver the drug, the technologies (must) meet key patient-related criteria," says Conlon. Among the eight patient-related criteria were "things like: Will the patient be able to use the device correctly? Is there reimbursement for this device? (What are) the economics of it for the patient? … Is the drug available for that particular device? How durable is it?
"There could be the greatest technology in the world, but obviously, if it doesn't fit the economics and the patient-related factors, it's not going to be very successful," says Conlon.
"While the economics of asthma is really driven by drug therapies, I think there's an enormous opportunity for providers to offer products and education in terms of ancillaries surrounding asthma." —Matt Conlon, director of sales and marketing, Respiratory Drug Delivery, Respironics |
Conlon says, for example, that an 82-year-old client should not be prescribed an MDI just because that client prefers an MDI. Because MDIs are difficult to use, a client of this age might not have the capability of using it. In this case, a nebulizer might be more effective.
As with most segments of HME, the growing baby boom population continues to increase market share. In fact, people who had asthma as a child may have experienced less or milder symptoms as their airways grew. But as the baby boom generation starts to age, asthma may flare up again. "As you get older, your airways actually get smaller once again and less elastic," says Cook. "And those little changes in your airway can have a big impact on how you breathe when you get older. … A lot of medical professionals say that once you have (asthma), you have it all your life; it's just the symptoms may go away in your healthier years and return in your geriatric years."
Environmental factors may also play a role in asthma prevalence.
Awareness of asthma is growing and along with it the segment of nebulizers, says Groskopf. "It's growing really as the prevalence and diagnosis of disease states such as asthma and COPD continue to grow," he says.
Broader use of nebulizers has spurred growth in this segment of respiratory as well. "Nebulizers, once hospital equipment only, are now commonly used for home care asthma and COPD treatment," says Mayfield. "This is a major contributing factor to nebulizer market growth."
Interestingly, a lot of research is being done on inhaled drugs for diabetes, cancer and even antibiotics, says Cook. And of course, some inhaled treatment is provided for COPD patients.
Mayfield agrees. "The ongoing reduction of particle size, coupled with the suitability of many medications for pulmonary delivery, have opened the handheld inhaler market to treatment of migraine, cystic fibrosis, diabetes and many other applications," she says.
Ongoing research on the use of inhaled drugs could mean good news for the nebulizer and metered dose inhaler business.
In addition, market studies show that asthma clients are demanding more environmental products like bed linens that reduce dust mites, air purification systems and laundry additives — and some providers are taking advantage of that segment, says Conlon.
Because environmental products aren't government reimbursed, revenue comes from either private pay or patient out-of-pocket pay. "Currently, providers, for the most part, they're focused on the nebulizers and the respiratory medications," says Conlon. "We know that that's kind of a challenging environment. So, I think they can add to their mix of products and services in order to take advantage of this tremendous growth in the marketplace of asthma."
The Ups and Downs of Reimbursement
Despite the positive outlook for market growth, setbacks in reimbursement continue.
"The prevalence of asthma is increasing dramatically, (and) reimbursement will not cease," says Mayfield. "But the portion of state and federal budgets assigned to asthma reimbursement alone is significant, rendering it subject to ongoing scrutiny. The resulting budgetary constraints, combined with constantly changing reimbursement codes, require that all medical/professional personnel involved with asthma reimbursement remain creative, and that doctors and patients alike remain current and well-informed about asthma treatment."
The last cut in reimbursement came with last year's lowering of the rental cap. "It went from a 15-month cap to a 13-month cap, which obviously hurts the providers as well as the manufacturers because we all feel the pain that goes downhill," says Cook. "So, we've got to find new ways to manufacture at a lower cost without affecting the quality of the product."
Medications for both nebulizers and metered dose inhalers are getting hit the hardest, asserts Groskopf.
"Basically, what's happened is the Medicare reimbursement has gone down to an average sell price of these drugs plus 6 percent," says Conlon. "So, ASP plus 6 creates an enormous challenge for providers who have depended on respiratory medication revenue. In addition, there's a real threat that reimbursement for both DuoNeb and Xopenex, branded, unique formulations of respiratory medications, will be reimbursed at generic alternative rates. Those are the last remaining profitable respiratory medication therapies for the providers."
For both medications and equipment, "there have, in fact, been regular, ongoing cutbacks in this segment of the industry," says Mayfield. "And since reimbursement is controlled by both state and federal governments, cutbacks may happen from any direction. Providers are reacting primarily by demanding price reductions from their suppliers; as a result, Graham-Field has witnessed tremendous erosion in our selling prices."
In fact, many manufacturers have been forced to examine costs. Cook says that manufacturers have to "make sure we build a quality product so (providers) don't have service calls associated with them. That kind of reliability is very, very important first of all for the patient because they rely on that machine to get their medication, and secondly for the provider so they don?t have service costs associated with it. They need something that's going to be pretty robust to handle the rigors of home care use, so it can be pretty challenging."
Groskopf says reductions in reimbursement have hurt technology. "It's a very cost-competitive environment today," he says. "And unfortunately, for nebulizers, a lot of the reimbursement really boils down to (the) least costly alternative, which makes it more and more difficult to provide higher end type products, nebulizers, that provide various benefits in the way of portability and so forth for patients simply because they're just higher cost type products that command higher prices. Yet the reimbursement is very comparable to the lower end type models."
Unfortunately, the drain on providers' bottom lines comes with the toll of a heavy service component. "A lot of providers … are looking at, do we really need to send a respiratory therapist out to see this patient? Can we get by with some manual instructions to get the patient by?" says Cook. "They really look at unfortunately decreasing that interface (with) a professional respiratory therapist because of the costs associated with it. I mean, the reimbursement is not very much on these small items and if you send a respiratory therapist to see the patient, you may actually be in the red. … It costs money to provide professional services. But there is no reimbursement for respiratory therapists in the home."
Conlon says a way manufacturers can help providers reduce the labor intensity of asthma products is through ongoing education for clinicians and physicians on proper device selection. "If we can reduce one phone call from a patient who doesn't know how to use a device, we've helped the economics at the provider level," says Conlon. "If we can put a very clear, concise DVD in with every nebulizer, we've just helped the provider educate that patient, reduce a phone call and reduce the labor intensity on the part of the provider. They can't afford the visits that they used to be able to afford under all of these cuts.
"We have to take the whole picture, and we have to take oxygen reimbursement cuts, unit dose medication cuts, and help where we can to reduce the labor required with the education," he says.
One bright spot for reimbursement is that clients that have never had a nebulizer prescribed are able to get a portable nebulizer reimbursed. Other clients are paying out of pocket for the convenience of portability.
As competitive bidding looms, manufacturers are concerned that nebulizers might be competitively bid. But without more information, the concern is speculation for now.
Still Groskopf is hopeful. "Nebulizer reimbursement in general has remained pretty steady up to this point," he says, "specifically through Medicare, and I think state-by-state Medicaid as well as private insurance is growing in their awareness and their coverage of nebulizer type products."
Understanding the Vital Role of Respiratory Therapists
Understanding the Vital Role of Respiratory Therapists
For many providers, on-staff respiratory therapists have been vital to growing the service delivery model.
"Respiratory therapists do a really good job of finding out what patients respond to the best," says Dennis Cook, Respiratory Division president, Medline Industries, Mundelein, Ill. "If you've got a very ambulatory patient who's going to be up and around all the time (and) who has mild to moderate asthma, an inhaler will work just fine. And they'll push them that way because you don't want to tie a patient down who's very ambulatory and active to a nebulizer compressor that's going to be tied to a wall or power outlet."
Also important for the health of the client, the respiratory therapists plays a vital role in incorporating ancillary products. Respiratory therapists "do a very good job of training patients how to monitor their asthma, much like a diabetic patient uses a glucose meter to monitor their diabetes," explains Cook.
Essentially, the respiratory therapist's role is to instruct patients. In fact, while some home health delivery technicians may be tempted to provide operating instructions for nebulizers, state laws may prohibit such service. Many state respiratory boards mandate that only respiratory therapists instruct patients on the correct usage of medications with home medical equipment — from where to put the medicine in the device to how best to take the medicine.
Though the home care industry may be willing to help a client, in most states, the delivery tech is permitted only to show a client the basics of the equipment including how to turn a nebulizer on and off and how to clean the equipment.
For more information on your state's laws, check out the National Board of Respiratory Care's state licensure agency finder at www.nbrc.org/statelic.
This article originally appeared in the September 2006 issue of HME Business.