If you are a provider of products and supplies designed to treat sleep-disordered breathing, you are in a strong position. Expanding research that focuses on the benefits of treatment as well as the rising number of patients being diagnosed propels this growing market. Yet, an all-too-familiar hurdle presents challenges as CMS has issued new regulations and requirements that will force both manufacturers and providers to focus on technology to remain competitive and keep patients compliant.
The sleep market is still poised for significant growth, according to Michael J. Farrell, senior vice president, sleep strategic business unit, ResMed Corp. He says with only 10 to 15 percent of the 40 million SDB patients currently diagnosed and receiving treatment, there is significant opportunity available.
Kristin Mastin, director of marketing for DeVilbiss Healthcare, notes the company expects to see the sleep market continue grow at an annual rate of roughly 20 percent.
For many, the timing is right. As the industry adjusts to the delay in national competitive bidding, experts agree it is the opportune time to focus on operations and increase profits.
“With the storm having cleared for 18 months regarding competitive bidding, providers have a stronger sense of knowing what their revenue models will look like and can start to focus on what they do best: partnering with sleep labs for referrals from primary care and other physician groups and providing top-quality care with market-leading products to patients,” says Farrell.
Gretchen Jezerc, Respironics' director of U.S. marketing for sleep disordered breathing, says the company continues to be very optimistic about growth, citing the approval of portable sleep testing equipment as well as the bidding delay.
“These will help to fuel that growth and will allow providers to manage their processes more and more effectively. [As an industry], we are now able to focus more on our businesses and growing these businesses,” Jezerc says.
LCD on Hold
In March, CMS issued its long-awaited National Coverage Determination on PAP policy, which gave a green light to home sleep testing. But In July, the regional DME MACs issued a revised Local Coverage Determination on the policy, stunning the industry because, among other things, it prohibited HME providers from conducting the home tests.
The LCD also included additional restrictions on coverage criteria, notably a 12-week patient compliance requirement, that raised a number of questions. Then, in August, the DME MACs announced the original implementation date for the LCD — Sept. 1 — would be delayed.
“The draft version of the LCD placed an unfair administrative and cost burden on the HME provider without offering any scientific evidence that such changes and requirements will alter outcomes or improve patient care,” says Joe Lewarski, vice president of Invacare Corp.'s, respiratory group. “In addition, there were numerous logistical issues that shifted risk to the HME provider and patient, again, without a sound basis for such.
“In some ways, the draft LCDs seemed punitive. It appears that comments from many stakeholders have encouraged the DME MAC medical directors to postpone them. If revised LCDs are issued, I hope there is adequate public review and comment, as I think input from all sleep stakeholders is needed.”
Christian Kiely, marketing manager for Fisher & Paykel Healthcare, emphasizes the substantial burden placed on providers.
“The recent DME MAC PAP policies placed an enormous burden on home care providers in terms of pre-study and adherence to therapy documentation,” says Kiely.
“With the announcement of the delays in the implementation of the policies, we are hopeful that the scope of the policies will be revised to more closely resemble the spirit of the NCD. There were several items in the LCDs that were not previously addressed via a public comment process.”
“The whole point of the NCD that was issued in March was to provide easier and earlier access to care for these patients who were entering the health care system 10 years too late and driving up huge bills because of the present comorbidities due to having their sleep apnea untreated. Now, they are again putting a barrier to treatment,” says Kelly Riley, director of the MED Group's National Respiratory Network, Lubbock, Texas.
Mastin agrees. “We thought the LCD was rather strict on many fronts and are very happy that the DME MACs have delayed implementation of the criteria that was to take effect Sept. 1,” she adds.
According to others, the contrasts are significant but they see a positive outcome.
“From the latest discussions at the LCD level, we now have bookends that mark the two ‘boundary conditions’ of home sleep testing with the NCD at one end and the LCD at the other,” explains Farrell.
“HME providers and sleep labs can now work together on home sleep testing models that fit within that defined space, so that when the final determinations are locked down, they are placed to win with new patient care delivery models.
“The level of interaction and discussion between providers and labs has never been stronger; the uncertainty has forged new partnerships that should help access to top quality patient care in sleep medicine.”
Jezerc says it was a surprise for many, but it encourages providers to be prepared from a cost management and a growth and patient management perspective.
“The approach that we've been taking is to immediately start thinking about what kinds of tools from a program and a product perspective can be offered if indeed this is the way things are going to be, which has to be the assumption,” she says.
“Overall, we're optimistic that this will be good news for patient care but that still remains to be seen,” adds Jezerc.
“That is not in any way meant to be a hit against the provider community, but the changes will most likely force a lot of interaction between the home care company and the patient early on in the process. It's a win all the way around if the patient is compliant, so we're trying to focus on that aspect of the changes.”
Because the LCDs require providers to demonstrate compliance within 90 days, patient education and the appropriate product choices are critical.
“This is a real wake-up call for all of us around the importance of really staying close to patients early in the process,” says Jezerc.
Results through Technology
Regardless of the outcome of the LCD decision, providers must look to functional means of providing products and services that are operationally sound and patient care-focused.
Many manufacturers are offering enhanced programs and products — from machines to masks to data collection tools — that are designed to increase compliance and solidify reimbursement.
Following is a sample:
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DeVilbiss Healthcare — Mastin says DeVilbiss has a number of new products that should both aid and enhance the provider's ability to care for their CPAP patients.
“The first is an enhanced version of the currently available SmartCode, which allows a provider to retrieve CPAP usage data via a code generated by the IntelliPAP system. The provider simply needs to call the patient to retrieve this unique code, and then log onto our IntelliPAP site to generate a report,” she says, adding that “the enhanced version of this software, which will be available in October, will provide additional data off both our IntelliPAP Standard and AutoAdjust units.”
The SmartLink Therapy Management system, which is a module attached to the back of any IntelliPAP unit, “is incredibly easy to use,” according to Mastin. The module automatically logs various parameters of patient usage data. That data is then deciphered via free SmartLink software. Once the compliance monitoring period is concluded, the module can be placed on another IntelliPAP unit.
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ResMed Corp. — Farrell says the company is focused on noise reduction for the comfort of patients and their bed partners, as well as their ability to increase compliance.
“HME providers know that bed partners are one of the key drivers of successful adherence to CPAP therapy. We have brought Easy-Breathe technology to the U.S. market this year and it has achieved great success,” says Farrell.
He says HME providers have started to “make noise about noise,” addressed with the company's S8 Series II products.
“Our AutoSet II and Elite II are great examples of APAP and CPAP therapy with noise ratings that are 70 percent quieter than their nearest market competitor,” according to Farrell. “At the highest-end of the therapy scale with bilevel ST therapy, the competitive ‘noise gap’ widens even further: Our VPAP ST is 90 percent quieter than its nearest market competitor,” he adds.
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Respironics — To increase providers' success in helping patients achieve compliance, Respironics offers the BiPAP Rescue Program, which credits the provider the cost of the A-Flex or C-Flex unit if the patient requires moving up to a bilevel device, says Jezerc.
It also offers the OptiLife with Cradle Cushion that can be used as a nasal pillow or cradle cushion and has reimbursement benefits, allowing a reimbursement as a pillow mask with the second reimbursement for the nasal cushion. The Gel Full mask also has a replacement cushion, which is important as cushions are replaceable more often than a full mask, according to Jezerc.
Encore Anywhere technology, an Internet-based patient compliance therapy usage data system, is not a new product, but it can assist providers in documenting compliance data.
The company also offers a direct shipping program for re-supply.
“We can actually drop ship supplies on behalf of the HME provider, so it appears to be coming from ‘ABC Homecare’,” she says. In addition, Respironics will provide direct mailers that can be customized with providers' information.
DME MACs' LCD Raised Questions
After the DME MACs released their LCD on PAP policy in July, industry stakeholders, the American Association for Homecare among them, had a lot of questions.
The association sent an 11-page comment letter to the four MAC jurisdiction medical directors asking for a delay of the LCD's scheduled Sept. 1 implementation because it made “extensive and substantive revisions to the existing LCD for PAP devices, including new conditions of coverage,” the association said, adding:
“AAHomecare's concern is that the new PAP LCD was published without a comment period even though it contains significant new and detailed coverage criteria that restrict access to PAP therapy and limit who is eligible to furnish diagnostic test interpretations, which are Medicare-covered services.”
Excerpts of AAHomecare's letter follow:
“Specifically, the policy adds new conditions of coverage, including medical necessity criteria without identifying the research sources on which the new coverage criteria are based. The LCD also limits the types of physicians eligible to furnish Medicare-covered services and creates unnecessary hurdles to care for Medicare beneficiaries requiring treatment with PAP devices. We are requesting that the four DME MACs substantially revise the LCD to address our concerns and open the new LCD for public comments so that all stakeholders who are affected by the new policy have an opportunity to comment. We also request a delay in the implementation of the policy in all four DME MAC jurisdictions to ensure that physicians and HME suppliers are educated on the new policies and have sufficient time to achieve compliance for the benefit of their patients …
“It also seems as though the rule strategically picks and chooses when a supplier can and cannot provide clinical and diagnostic data. For example, the rule requires the HME supplier to obtain [data] for proof of adherence and therefore payment but is prohibited from participating in the initial diagnostic home sleep test … Patient services will suffer due to the confusion and contradictions of who is responsible for what regarding the differences between the DME MAC LCDs and the NCD.”
Last month, the DME MACs delayed the LCD implementation.
Items in the LCD originally published with the Sept. 1 effective date that are now subject to the delay include:
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The requirements of the face-to-face clinical evaluation by the referring physician required to include history, Epworth and physical exam including BMI;
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Face-to-face demonstration of the portable testing device by the entity performing the test, not a DME;
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Sleep tests must be read by an MD boarded by AASM or ABMS or by an active employee of a JCAHO or AASM accredited sleep lab or center;
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Continuing coverage of the PAP device beyond 90 days requires a new face-to-face evaluation by the MD;
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Continuing coverage also requires, by direct download, objective compliance measurement of 4 hours or more for 70 percent of the nights (21) in a consecutive 30-day period within the first 90 days; and
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Criteria for switching to RAD device within and after the 90-day trial. RAD requirements in effect prior to 9/1/08 will apply.
According to the DME MACs, “A revised LCD will be published in the near future and will include a new effective date for those criteria.” At press time, a revision had not yet been issued.
LCD Pros and Cons: Providers Share Their Thoughts
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Patrick T. Clevidence, BS, RRT, vice president of respiratory services, Medical Service Company, Oakwood Village, Ohio: “In clear and precise language, the LCDs eliminated HME involvement in home sleep testing. They further stated that only sleep physicians may be involved in the tests. This eliminates involvement by primary care physicians, cardiologists and other physicians. Please note that primary care physicians, cardiologists and other physicians can prescribe the tests; however, these same physicians must defer to a sleep physician and their staff to perform the tests and interpret the results.
“All of this being said, I feel this is a sound decision to maintain the integrity and quality of sleep testing with those specialists who know it best and can make the best therapeutic plan of care for their patients. There is no doubt that many in the HME community are disappointed with this ruling. Many HME providers looked at this as a new revenue opportunity and a way to increase their sleep business. Now it is clear that this will not happen.
“I have always been a proponent of partnering with sleep labs to help improve patient compliance and outcomes. This decision will help foster that between the sleep labs and the HME companies. There are so many ways an HME can help a sleep lab grow their business and thus increase their own business. This kind of creative thinking results in a victory for both businesses but, most important, the patient is the biggest winner of all.”
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Todd Cressler, CEO, CressCare Medical, Harrisburg, Pa.: “The result will be that home testing will move a little slower, but all the labs will eventually offer it to be competitive. Forward-thinking physicians will get on board with this and realize that home testing will get people on therapy that would normally not go into a sleep lab to get their [polysomnography].”
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Carol Laumer, executive director, Rice Home Medical, Willmar, Minn.: “This will be difficult for [HME providers] and will be a blow to their financial bottom line. I see CMS following the rule they have used with home oxygen but in a more stringent manner. The technology is there, and if we can provide infusion medications and can do ventilators in the home, I believe we can do home sleep studies and that they can be accurate.”
Facts and Figures on OSA
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Obstructive sleep apnea with resulting daytime sleepiness occurs in at least 4 percent of men and 2 percent of women.
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About 24 percent of men and 9 percent of women have the breathing symptoms of OSA with or without daytime sleepiness.
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About 80 to 90 percent of adults with OSA remain undiagnosed.
Source: American Academy of Sleep Medicine
Experts Interviewed
Michael J. Farrell, senior vice president, sleep strategic business unit, ResMed Corp., Poway, Calif.; Christian Kiely, marketing manager, Fisher & Paykel Healthcare, Irvine, Calif.; Gretchen Jezerc, director, U.S. marketing, sleep disordered breathing, Respironics, Murrysville, Pa.; Joseph Lewarski, vice president, respiratory group, Invacare Corp., Elyria, Ohio; Kristin Mastin, director of marketing, DeVilbiss Healthcare, Somerset, Pa.; and Kelly Riley, director, National Respiratory Network, The MED Group, Lubbock, Texas.
