Manufacturers of beds and support surfaces have slept easily over the years, but they're about to face a wake-up call. New FDA guidelines for reduced
by Marjory Garrison

Manufacturers of beds and support surfaces have slept easily over the years, but they're about to face a wake-up call. New FDA guidelines for reduced entrapment and cutbacks in Medicare reimbursement expected early next year look to shake up this normally cozy market — known as the “bread and butter” for many DME providers.

Traditionally, the market for home care beds has enjoyed steady, predictable growth. “After respiratory, bed rentals represent the next largest revenue source to most dealers,” says Mike Norby, senior vice president of sales and marketing for Graham-Field.

Support surfaces, too, have proffered lucrative opportunity, which has increased as suppliers learn more about the role these products play in the care of bedridden patients.

“Everybody puts emphasis on the bed, and it should be highly emphasized,” says Norby. “But what a lot of folks forget about is the mattress. Prevention [of pressure sores] is the name of the game both in long-term care and in home care,” he continues. “It's our feeling that every bed that goes out into either market should at least be a pressure-reducing mattress because everyone that's confined to a bed is highly susceptible to pressure sores.”

While he notes that a “good” pressure-reducing mattress can cost more than twice as much as a standard mattress, Norby says that some technologically advanced products on the market now — which monitor and control pressure in certain parts of the mattress — can optimize pressure relief for high-risk patients. This specialized area is a natural expansion opportunity for providers, he says.

“The [therapeutic support surfaces] market is really taking off,” agrees Mike Irvine, product manager for beds at Invacare. “There are a couple of different technologies out there, but overall those haven't changed dramatically. I think what's changed among dealers is an increase in knowledge about these products, how to apply them and how to get the reimbursement they're due.”

Experts also attribute growth in the beds and support surfaces market to the country's large aging population. “People are living longer with more debilitating diseases, and people are lying down for a longer period of time,” says Gregg Garland, vice president of wound care sales for The Roho Group and former owner of AirCare Therapy.

Entrapment Guidelines

Baby boomers are aging, and as more of them fall ill and seek medical care, the population needing home care beds continues to grow, manufacturers point out. For this reason, they speak confidently of the opportunity that the new entrapment guidelines will offer the market. Final guidelines are expected in the first quarter of next year, and “almost every major player in the industry has helped draft them,” says Irvine.

In fact, the guidelines have been a collaboration between the industry and the FDA, according to leading manufacturers. The current Hospital Bed System Dimensional Guidance to Reduce Entrapment — a document that, at press time, was in a 90-day comment period for industry and FDA staff — outlines recommendations for lowering the risk of patient entrapment.

The draft identifies seven zones of entrapment in “hospital bed systems” and recommends dimensions for each zone to prevent entrapment or injury to three key, at-risk body parts: the head, neck and chest. It draws heavily on information and recommendations from the Hospital Bed Safety Workgroup (HBSW), which includes government, industry and patient representatives, and current International Electrotechnical Commission (IEC) standards.

Industry leaders applaud the draft guidelines and say the final recommendations will likely move the market in the right direction: toward growth. “New regulatory issues represent growth opportunities,” says Gary Platzman, vice president of sales for Posey. The recommendations for reducing entrapment will make beds “safer in the future, spurring manufacturers to create new types of products,” he maintains. The guidelines will also “leave two-and-a-half million beds already out there needing to change or be addressed,” notes Platzman.

Some manufacturers are concerned about how providers will adjust to the new guidelines. “A lot of different facilities that have made capital purchases in the past will look at the new guidelines and not be sure which standards apply to them,” Platzman continues. “Providers should educate themselves on the new regulatory environment and avail themselves of all the options out there, because there's a lot out there.”

“The guidelines have been under discussion for a long time,” adds Norby, “and providers should look at whether the beds they are considering are in tune. Many companies have already incorporated [the guidelines] into their products because they make sense.”

“I encourage every dealer to become familiar with [the new guidelines] and ask the tough questions about whether their products are compliant,” says Invacare's Irvine.

Reimbursement Cuts

While manufacturers seem pleased by the new entrapment recommendations, they don't share the same enthusiasm for the 2005 reimbursement cuts set for hospital beds and air mattresses as mandated by the Medicare Modernization Act. While the figures are preliminary (at press time, final figures were set to be released with CMS' standard fee schedule update), at a Sept. 22 Open Door Forum a spokesperson for CMS said the agency is considering payment cuts to hospital beds (E0260) of 13 percent, and cuts to power pressure air mattresses (E0277) of 5 percent.

“It is unfortunate that such a cost-effective therapy is on the line,” says Norby, speaking specifically of pressure-management systems. “There are few preventive therapies that contain such potential cost savings for the government and better quality of life for the user. Too much is based on reimbursement and not patient outcomes,” he says.

The scheduled reimbursement cuts are certain to disrupt the steady growth of the beds and support surfaces market, according to most observers. But many believe that disruption will be brief, and that providers will rebound fast.

“In the short term, there's going to be a decrease in sales as dealers react to [the cuts], even if we and everybody else hold their prices. But [the reimbursement cuts] will drive dealers to understand the total product lifecycle cost versus the acquisition cost,” explains Irvine. Providers' “knee-jerk reaction” will be replaced by a greater understanding of the long-term value of higher-quality products, he believes.

“We're already very competitively priced,” says Garland of The Roho Group. “Even with some cuts, [beds] still will be a lucrative piece of equipment for a DME dealer to provide.”

Ultimately, demand for beds and support surfaces will supercede the cuts, experts say. “Bed purchases will slow down in light of reimbursement cuts, but, long term, there's not going to be a slowdown in the number of people who need beds,” Irvine states.

Focus on Safety

As for the products themselves, manufacturers of beds and support surfaces say they are only getting better. In a market that pays attention to new technology, more focus is being directed to the safety of both the patient and caregiver, these experts say. Particularly in bariatrics, innovation in new bed systems is centered on preventing injury. “With a bariatric patient, you need all the efficiency you can get,” says DuWayne Kramer, president of Leisure-Lift.

“It takes four or five nurses to move one of these [bariatric] beds,” adds Jim Ernst, Leisure-Lift's COO, explaining that the company's new impulse drive system “allows a caregiver to push a switch, and the bed goes whatever direction you want. It's a complete patient management system. It's an issue of manpower, because one nurse or aid is able to move a patient around” instead of the many tasks required before.

In standard beds and support surfaces, too, the direction is toward “more complex, more sophisticated, smaller and quieter systems” that draw attention to patient safety, says Garland. “The evolution of technology is being applied here, going from point A to point F,” he says.

While most manufacturers say they expect to see little dramatic change in bed products, they note that the trend toward safety is industry-wide. “There's nothing near on the horizon that's radically new in beds, but we are seeing a couple of smaller trends,” relates Irvine of Invacare. “First, we're seeing a move toward more full electric beds, driven by a growing awareness in the medical community of lower back problems for caregivers.”

The cost of lower back injuries to caregivers in the industry is severe, according to Leisure-Lift's Kramer. “Caregivers worry about career-ending injuries. There are more than 40,000 nursing injuries a year in the United States, and more than 50 percent of nurses leave the profession because of back injuries. The average cost of treating a back injury is $24,000,” he says.

Full electric beds can help prevent such injuries, says Irvine. One of the company's new beds has a floor-to-deck height of 9 inches at the low position and 20 inches at the high position. The low height provides protection against patient injuries caused by falling out of bed in circumstances where rails are not appropriate, while the high height helps to alleviate caregivers' lower back strains.

“We're seeing the demand for electric beds with height adjustment cross over into the home care market where there is a need because of the condition of the patient or the caregiver,” adds Graham-Field's Norby. The company has recently introduced a full electric version of one of its semi-electric beds that can be modified with the addition of a snap-in-place motor.

But some providers question why they should sell full electric beds when there is no additional reimbursement versus that for a semi-electric bed. “The minor increased cost of going to full electric beds offsets the cost of caregivers suffering from lower back problems,” Irvine says.

Adds Kramer, “Not only do we have to take care of the patient but we have to take care of the caregiver.”

Experts Interviewed

Jim Ernst, COO, and DuWayne Kramer, president, Leisure-Lift, Kansas City, Kan.; Gregg Garland, vice president of wound care sales, The Roho Group, Belleville, Ill.; Mike Irvine, product manager for beds, Invacare, Elyria, Ohio; Mike Norby, senior vice president of sales and marketing, Graham-Field, Atlanta; Gary Platzman, vice president of sales, Posey, Arcadia, Calif.; Sandy Thomas, national sales director, Flex-A-Bed, Long Beach, Calif.

Sell Beds with Display, Knowledge and Exceptional Service

Beds and support surfaces will sell themselves, according to industry manufacturers, as long as providers keep three key points in focus with these products: They must be well-displayed, customers must be educated about the products and assured of exceptional service.

Industry experts recommend advertising in local papers and fostering contacts at hospitals. “Don't wait for someone to come to you,” says Jim Ernst of Leisure-Lift. “Make them aware of what's available that you can provide to them. Dealers with quality beds need to make people aware of why their products are better.”

Once customers are in the store, “display is really important because folks want to try [the product],” according to Sandy Thomas, national sales director for Flex-A-Bed. From there, she says, “the bed can sell itself.”

But it's also important for providers and all sales personnel to be well-educated about the products they sell. This is especially true for providers of pressure management systems, says Mike Norby, vice president of sales and marketing for Graham-Field. “A provider must become knowledgeable about pressure management. They must understand what pressure relief is, what pressure management is.” This, according to Norby, includes an understanding that pressure management is not a product but a therapy — “a solution to a very real, costly and terribly painful problem.”

Once patients understand what they're being sold and why, service is the final component to the formula for success in beds and support surfaces sales. Mike Irvine, product manager for beds at Invacare, advises dealers to “be known for taking care of people and doing things the right way. Once you get that reputation, the referrals will just keep coming.”

Even a provider offering stellar displays in this market cannot succeed if service is overlooked, experts say. “This is a very, very competitive industry, and service is king,” says Gregg Garland, vice president of wound care sales for The Roho Group. “Everybody has come to expect quality products with exceptional service.”

For More Information

To read more about the Hospital Bed System Dimensional Guidance to Reduce Entrapment, and to submit comments, visit www.fda.gov/cdrh/beds.

For information about Medicare's January 2005 reimbursement cuts to beds, air mattresses and other DME, included among the provisions of the Medicare Modernization Act (MMA), visit www.cms.hhs.gov/medicarereform.