Due to the new policies included in the CMS' local coverage determination issued in September, compliance is now more critical than ever.
by Denise H. McClinton

The market for positive airway pressure therapy for patients with sleep-disordered breathing continues to grow as awareness of the risks associated with the disease increases among both clinicians and consumers.

But the rules of the game have changed. Due to the new policies included in the Centers for Medicare and Medicaid Services' local coverage determination issued in September, compliance is now more critical than ever (see DME MACs Issue 'Kinder' Sleep LCD, HomeCare Monday, Sept. 22, 2008). In addition, patients' understanding of their diagnosis is increasing and they are more involved in their treatment.

"We are witnessing a broader understanding of obstructive sleep apnea, and there has certainly been an increase in public awareness and diagnosis of OSA as well as more media coverage and advertising of the disease and its treatments," says David Giarracco, vice president of home care marketing for Covidien Respiratory & Monitoring Solutions.

"This increased awareness goes hand-in-hand with the more proactive treatment we've been seeing on the part of the patients. Patients are taking charge of their treatment and becoming more knowledgeable about their condition and its treatments and comorbidities."

Unfortunately, the number of those undiagnosed is still remarkably high.

"We continue to face the challenge of the large number of undiagnosed patients with sleep-disordered breathing. Up to 90 percent of the 40 million Americans with sleep-disordered breathing remain untreated with positive airway pressure therapy," explains Michael Farrell, senior vice president of ResMed Corp.'s sleep strategic business unit.

"The cost of treating these patients in the home rather than the acute care setting could save the government [tens of thousands] of dollars in Medicare Part A expenditures over time."

Farrell adds that the "government is focused on attacking Part B codes."

"Without a return-on-investment assessment of Part B expenditures, flawed decisions like the 9.5 percent reductions in home care reimbursement are being executed," he says.

"This is nuts," he continues. "We know treating sleep-disordered breathing in the home reduces acute comorbidity exacerbations and ER and ICU visits. There needs to be more education on the clinical and financial benefits of diagnosing and treating this population and getting those data sets in the hands of payers across the board."

Indeed, with the LCD's requirement for documented compliance, what used to be a value-added benefit for some companies is now a necessity.

"The changes in the guidelines regarding PAP therapy are key right now. The fact is that the provider needs to both achieve and document compliance," says Gretchen Jezerc, director, U.S. marketing, sleep disordered breathing, Philips Respironics.

"We know that a number of providers have done a good job of achieving compliance with their patients in the past but they have not had the requirements to provide proof. Now there is a risk of not getting reimbursement for some patients, which is a significant change."

Documenting Compliance

According to Kristin Mastin, director of marketing for DeVilbiss Healthcare, the requirement to demonstrate compliance has led to a focus on operationally efficient patient therapy monitoring technologies.

"As indicated in the CPAP LCD, compliance must be established within the first 90 days in order for the provider to be reimbursed for the CPAP. To improve the likelihood of long-term adherence, the provider must closely monitor the patient's CPAP usage, especially in the first two weeks of therapy," she says.

Although the requirement presents hurdles for providers, there are clear benefits in terms of referral source satisfaction.

"This represents an opportunity for a home care company to differentiate itself with its referral base, as physicians want their patients to stay on PAP therapy and be successful," points out Jezerc.

Because the window to demonstrate compliance is short, the challenge is to select the right technology to monitor patient's therapy.

"Research has indicated that the first two weeks are important for increasing the likelihood of long-term compliance. If you can hook the patient in that first two weeks, you increase the chance of patient compliance in the first 30 days or so," says Mastin. "Early intervention is critical."

Helping patients adhere to therapy involves a combination of education, support and appropriate product choices, these experts say.

"Currently, design of both PAP devices and masks focuses on comfort, which is a leading indicator of compliance," says ResMed's Farrell. "Humidification, size reduction, noise reduction and work-of-breathing improvements have all led to improved compliance and efficacy."

Giarracco adds that interface and mask design is primarily driven by patient comfort, but pricing is also important.

"PAP equipment design is a result of multiple parameters, including aesthetics, portability, features like volume and battery operation, ease of use and price. But, of course, the underlying thread for all of our products is ensuring that they deliver results," he explains.

Jezerc agrees that each issue, from comfort to efficacy to cost, has to be addressed from a manufacturing standpoint.

"Realistically, we have to deliver all of it. At the same time, we are in a reimbursable environment and we have to acknowledge what the home care companies are being reimbursed for the product and continue to provide cost-effective solutions," she notes. "We are trying to come up with relevant innovation that helps the patient become compliant and helps the HME provider become efficient."

According to Mastin, product development is centered on overall satisfaction for the patient and bed partner.

"We wanted to remove many of the objections associated with the CPAP to increase the likelihood that patients would adhere to their therapy," she says.

Increasing Market Share

Compliance programs not only help patients, they can also help providers satisfy physicians, which, in turn, can lead to increased referrals.

"The primary concern of referrals is keeping patients on their CPAP therapy. Anything providers can do to increase patient satisfaction and adherence will result in a competitive advantage with referral sources," says Mastin.

"For the most part," she continues, the solutions that have been offered to the market are technology-based, but patient education, intervention and follow-up are also important components. Once the provider has a robust protocol for CPAP users, tout that protocol to the referrals and focus on competitive advantages as well as cumulative compliance rates."

Since documented compliance is now a necessity, Jezerc advises providers to use it to their advantage in marketing to referral sources. "In the past, compliance reporting was anecdotal. Providers typically stated around 80 percent while patient studies showed lower numbers," she says.

"Now, you can offer fact-based information about your compliance rates. Use this information to show referral sources how you are taking care of their patients," she advises, adding that the requirement for the data "gives companies an opportunity to be more fact-based about the compliance results they are achieving."

Giarracco recommends providers take a proactive approach to increasing recognition in their communities.

"This includes contracting directly with insurance companies as a provider, becoming more involved in local wellness campaigns where patients actively seek out health screening services and building clinically-based relationships with primary care physicians whose awareness of OSA greatly varies and are often the entry point for our patients into the care cycle," he suggests.

Building Supply Replacement

Providers who are committed to helping patients achieve compliance can ill afford to ignore the benefits of an effective supply replacement program.

"If you are putting the effort into helping patients become and stay compliant, then you should be reaping the benefit of an active supply replacement program. That creates both financial opportunity for the provider and helps the patient in a very real way to stay successful on therapy," says Jezerc.

"There will be a certain percentage of patients for whom the home care companies will not be reimbursed who fall by the wayside after they have put forth the effort to bring them in and get them set up on therapy. To make up for that, there is the opportunity with the patients who are successful to really follow up with them and have an appropriate resupply program."

DeVilbiss' Mastin agrees.

"For many providers, optimizing their patient follow-up protocol and process is a prime opportunity," she notes.

"Part of establishing an adherent CPAP patient is to ensure that all their equipment is in optimal condition, including all the peripherals such as interfaces, tubing and humidifiers. Providers should be diligent in replacing equipment as indicated. Not only can this possibly help boost patient adherence but the revenue potential of the replenishments can be realized."

Experts Interviewed

Michael Farrell, senior vice president, sleep strategic business unit, ResMed, Poway, Calif.; David Giarracco, vice president, homecare marketing, Covidien Respiratory & Monitoring Solutions, Boulder, Co.; Gretchen Jezerc, director, U.S. marketing, sleep disordered breathing, Philips Respironics, Murrysville, Pa.; and Kristin Mastin, director of marketing, DeVilbiss Healthcare, Somerset, Pa.