To Pass or to Fail, Is that the Question?

• By Lunzeta Brackens
• Mar 05, 2008

Power wheel chair testing is more than merely passing or failing a series of examinations.

All power wheel chairs were not created equal. Therefore to ensure that manufacturers are producing high quality products, the Centers for Medicare and Medicaid Services has mandated that all new units be tested at independent facilities in accordance with ANSI/RESNA standards. Any new product configuration that was released after Jan. 1 must follow the criteria in order to receive HCPCS codes for reimbursement.

Prior to CMS’s implementation of the 61 codes in November of 2006, where performance and fatigue data were further defined, there was less ability to ensure consistent application of the protocols, said Seth Johnson, vice president of government affairs at Pride in Exeter, Pa. However, this changed with the advent of new codes and testing criteria implemented in 2006.

“The relatively new coding broke up the four previous power wheelchair codes into 61 new codes, which better define the types of products within a code,” he says. “This along with the testing protocols validates the placement of the product in the codes and ultimately provides a much easier framework to compare products.”

What’s in a Code?
ANSI/RESNA standards are used to determine which category a product fits into when establishing the code picked for the proper reimbursement rate, according to Dennis Phillips, an electrical engineer with PaceSaver/Leisure Lift and a RESNA member.

Since 1998 ANSI/RESNA standards have been used as a means to establish performance, durability and safety standards, said DuWayne Kramer, president of PaceSaver/Leisure Lift in Kansas City, Kansas. The tests, he says, have not radically changed.

“We’ve been testing to the standards for many years,” says Kramer. “So there’s nothing new here that people weren’t supposed to be doing.”

Minor modifications are typically made to the standards every five years or so, but luckily the same ones that were used for interdependent testing last year still apply, says Tara Gentile, funding manager at Permobil Inc., in Lebanon, Tenn. The only area companies will largely be affected in is new products.

“Any new product configurations that will be submitted to SADMERC for coding verification will need to have test results from an independent facility,” says Gentile who mentioned that all of Permobil’s chairs are manufactured in Sweden and were previously tested there.

“As part of our quality initiative, we have always had our power chairs tested fully prior to launch,” says Kerry Cronin, wheelchair product manager at Graham-Field in Atlanta. Cronin says all chairs at Graham-Field are tested using ANSI/RESNA requirements including test for stability, drop tests and drum fatigue test.

The drop and drum fatigue tests are the only two that can still be conducted at interdependent facilities. The drop test involves dropping the wheelchair from two inches above the floor for 6,666 cycles without fail at the rated load of the chair, says Phillips, who works with RESNA on new motor standards and controllers. He went on to say that the double drum test involves a wheelchair running on a pair of rollers with a cleat. The cleat on the rollers causes the wheelchair to bounce simulating a rough road. This test runs for 200,000 cycles.

CMS has also added a Thermal Drive and Power Stall Condition test.

Bob Winder, director of funding sources at Golden Technologies in Old Forge, Pa., advised that Golden has always tested products using an independent testing facility.
"And we are happy to see that others will now have to do the same,” he says. “As far as the new test is concerned, we welcome any test requiring our products to be safer for the people who use them.”

Independent Testing— A Positive Move

Although the ANSI/RESNA tests remain the same, performance minimums have been established and must be met in order to secure a HCPCS Code from the SADMERC for all products, said Jerry White, vice president of global power chair products at Pride in Exeter, Pa.

There are many standards to comply with as a manufacturer, including FDA standards for Good Manufacturing Practices, ANSI/RESNA standards for uniform testing protocols, and CMS’s minimum thresholds for code category placement in addition to others, White added.

The biggest change to the testing standards was the requirement to have the testing done by RESNA capable testing facilities in the United States, Winder says. Medicare does not require manufacturers to meet all ANSI/RESNA standards. They have hand picked a few that they feel is important to provide a quality and safe product to their beneficiaries. The ones chosen have to do with safety and performance.
The RESNA labs qualified to do such testing as pointed out by SADMERC are:
• Beneficial Designs
• CITECH
• MET Laboratories, Inc.
• University of Pittsburgh
• William A. Ammer Consulting

With such a small amount of facilities able to conduct testing, Gentile found it challenging to find an agency. SADMERC listed the companies above in a power mobility device independent testing requirements document, but didn’t specifically endorse them. However, it was stated that these were the agencies used in the past for testing.

The length of the testing process is contingent upon the work load of the testing facility, Winder said. And manufacturers will have to plan accordingly to take into account the long lead times prior to the launch of a product, Cronin advises.

The tests could take anywhere from four to six weeks, Gentile says. If something fails, design changes will have to be made and the product would be retested. Long testing periods can also be attributed to lab scheduling, the labs personnel being less familiar with new product designs and transit time for shipment, White added.

Having test conducted independently is a move in the right direction.
“It will bring quality as a standard back to the market place, and that’s something that’s been lacking,” says Jim Ernst, product manager at PaceSaver/Leisure Lift. Ernst, who touted that his company makes wheelchairs and scooters with all U.S. parts, remarked that PaceSaver/Leisure Lift plans to continue to test internally before sending anything out to an independent lab.

Since all products have to be tested to meet specific FDA guidelines, Ernst believes the change was incited after an FDA inspection revealed that some of the test results at interdependent facilities were incorrect.

“With the few inspections of plants that were conducted, they’ve documented the falsification of testing for tests of all types,” Kramer says. “So from my standpoint the reason why they’re bringing the test into the U.S. is because Medicare doesn’t have confidence in the testing that’s coming from foreign sources.”

“As with many of the changes being made regarding HCPCS coding, the root cause is abuse by a few,” Cronin acknowledges. “There is also the need to better clarify and validate information that is being presented, and one way to do this is to put certain procedures in place that are universal for all. It’s a way for all wheelchairs to be put on an even playing field in regards to the testing they go through.”

CMS testing requirements slightly differ from ASNI/RESNA’s
There are a few pass/fail tests but for the most part, Medicare is requiring disclosure of product statistics. Essentially, what a disclosure test says is a unit test tipped over at five degrees or nine degrees or failed a ramp test, Kramer said. There are structural tests, climate test, obstacle test as well as many others. Manufacturers have to disclose what angle of stability under dynamic or static that the units can pass.

“It’s actually a compilation of testing procedures,” Phillips says. “Most of them are disclosures of the results of the testing to the procedure.”

“Whether people do a good job or bad job, a disclosure is up to debate,” Kramer chimed in.

All of these tests are supposed to be at least a six degree stability rating in Group one and 7.5 degrees of incline stability in Group two of a power operated vehicle, and that’s the dynamic stability as opposed to static stability.

“They’re using the disclosure to determine where the product gets categorized,” said Ernst, who does some work with RESNA and will conduct a training session with a Medicare provider on standards. “The speed and incline will help Medicare determine what product code that unit fits.”

In some circumstances, minimum criteria have been placed on performance in order to meet specific code categories, White advises. The testing criteria get progressively higher as the chairs become more complex. There are also differences based on the varying weight capacities in the code categories, he adds.

One of the major challenges that manufacturers are facing is whether or not companies should test to the full ANSI/RESNA standards or test forward to the code since Medicare’s requirements are slightly different from ANSI/RESNA, Gentile said. In some cases, Medicare has modified the RESNA standards, Kramer explains. For instance, ANSI/RESNA would say that they’re going to measure the speed with the typical rider weight of 175 pounds. Medicare is now saying, we want you to rate the speed at the maximum rider weight,” Kramer says. “So if it’s 300 pounds, what’s your maximum speed? They’re basically making a criteria situation, and in some cases they’ve made modifications to the testing standard.”

For those that have not been fully testing their products, the new requirements may seem difficult to meet. However, as all chairs were required last year to undergo full testing, the only hardship should be the amount of time that it takes to complete testing, Cronin says.
“The standard itself isn’t any more difficult,” Kramer adds. “You’ve just got an extra layer of time and money to go through. This is the world standard of testing. Everybody was supposed to be doing this for years. It’s just that people haven’t been doing it in order to make money on imports.”

There’s no doubt that testing independently will be more expensive, said Gentile, whose company has already invested in test equipment and employees to conduct tests in Sweden.

But she realizes that paying extra cost to ensure safe, reliable products for consumers is priceless.

“Whenever one adds more tests or more work, the expense will always increase,” Cronin agreed with Gentile. “You have to look at the overall picture, though, and consider that money spent up front may be money you save down the road.”

Safer products going forward Meeting ANSI/RESNA standards will allow everyone from manufacturers to consumers to have faith that the products are being tested to the fullest before being introduced to the public, Cronin added.

“It will help to insure that the quality of products is higher due to rigorous testing.”

At one point Medicare said that it would go back and review some of the products on the market that have already been approved, Kramer says. Doing so, would mean that a lot of the products on the market would probably disappear or radically change in their cost. Some manufacturers have even hurried to push products through before Jan.1 in fear that the units would not pass testing requirements.

The effect of delayed product launches has yet to be seen as many manufacturers have already had products tested before the deadline, and haven’t introduced a multitude of new products.

However, the limited number of testing facilities does have some wondering whether or not the availability of chairs will be affected down the line, while others believe this won’t be a problem.

Some of the very complex chairs may take a little longer to test, Gentile says. But it’s impossible to test every configuration, especially, when there’s a lot of custom seating to the chair.

“I believe all chairs will take longer to introduce as the initial backlog will be overwhelming to the testing facilities,” Cronin says. “In the beginning, there will probably be less variety in chairs (especially specialty chairs) introduced until everyone figures out how best to work with the new requirements and we see some of the outcomes of these changes.”

The new change also means that providers may initially notice a decrease in the number of new power chair products being introduced into the marketplace, Cronin says.

“Until the kinks are worked out, manufacturers will most likely limit the number of new power chairs that they try to introduce into the market,” she says.

On the other hand, Winder believes that adding another requirement to the process should not limit the number of chairs available. Gentile shared the same thoughts.

“If we had to test every single product out there on the market today,” she commented. “Yes, there would be a huge back log, but there are just not enough independent test facilities to support that.”

The ANSI/RESNA power wheelchair testing protocols also apply to complex rehab products and testing protocols account for additional options and accessories added to these power wheelchairs, Johnson explains.

The additional screening process helps to ensure that home medical equipment providers are purchasing high quality products and providing them to beneficiaries, says Johnson.

The higher end chairs will be under more scrutiny due to the requirements and complexity of these chairs. They’ll have higher marks to reach in regards to testing than others, Cronin said. As it relates to custom chairs, she believes there is question as to whether one testing requirement can encompass all of the differences between these types of chairs.

The intricacies of complex chairs make them difficult to test and even harder to competitively bid. For this reason, manufacturers believe that rehab chairs should be carved out of the competitive bidding process because unlike scooters and some power chairs, one size does not fit all.

“I can’t get the same one you get,” Kramer says. “I need it designed and built for me. And to try to put that in a competitive bidding structure is impossible.”

New standards affect HME providers and consumers in more ways than one
One of the biggest problems that Kramer foresees happening as the new requirements relate to DME providers is not a decrease in the number of chairs available, but instead the trouble of trying to service all of the new products and stay profitable.

“From our standpoint, for many years, every time you do a $50 to $70 service call that’s something you don’t have any money for, so the issue is going to be how are they going to pay for all these service calls down the road?”
But on the flip side, Ernst pointed out that it will provide them with a much higher level of protection and lower level liability risks.

“With some of these products, if the failure results in injury, the HME dealer is a part of the lawsuit chain,” he says. “If you have a product that’s inherently defective or just not all that good and someone is injured, you’re at a liability for that so the increase in the quality of goods helps to protect the HME dealer.

The new standards, however, help consumers determine the chair that will best suit them. Many of Permobil’s chairs fall into the group three and four category, so when people look for products in group three, independent testing assures that people are comparing apples to apples, Gentile says.

“You’re not comparing one of our chairs with chairs in group one,” she adds.

However, Kramer feels that even the new standards could use some tweaking — and it starts with education. Some Medicare providers don’t understand the criteria yet and manufacturers are using that point to their own advantage, he admits.

“Some of these people have never seen what they’re trying to make decisions on,” he says. “Every time you change the carrier or the criteria, you have to reeducate these people about what this stuff really means and what it really is.”

Kramer said he recently provided a group two chair and Medicare mistakingly put it in group three. A major difference between the two categories is that the group three chairs require drive wheel suspension — a feature that Kramer later discovered that many of the manufacturers’ chairs that were placed in this group did not have. The problem, he said, was that Medicare didn’t understand what drive wheel suspension meant.

“We actually asked Medicare to review it and got our product down coded to a lower reimbursement rate,” Ernst chimed in. But everyone won’t be as honest.

New Standards — Level Playing Field? Yes. Perfect? No.
Disclosure issues need to be clearly defined, Kramer believes. In most cases, people don’t deliberately disclose incline ratings unless they have to, Kramer continued. Some are finding ways to get around the truth. Kramer says Medicare requires every POV and wheelchair to rate at a six degree incline stability and in some cases seven. A manufacturer may say that their product rates at a 7.5 degree stability because that’s what it was tested for. But after evaluating the product manual, it reveals that the product actually rates only at a five degree incline stability. Therefore, some are publishing different statistics than what they say the products can do.

“There are still significant improvements that need to be made,” he says. “You should not be able to disclose to Medicare a higher number that you then change to a lower number in your manual. There are ways to manipulate the standards that clearly need to be worked on.”

The ANSI/RESNA standards should be routinely reviewed to see if it is keeping up with the current market needs and requirements, Cronin believes.

“The world and what people need is constantly changing and everything should be reviewed to make sure that it is keeping up with the times,” she says.

Johnson believes that RESNA has done a good job in evolving its testing protocols with the technologies on the market.

“Knowing that they are constantly reevaluating the standards, we are confident that they will continue to improve over time.”

The ANSI/RESNA requirements have leveled the playing field for all manufacturers.
“I think it provides peace of mind,” Winder says. “The consumers and rehab professionals now know that every approved product meets minimal criterion.”

Consumers should feel better that all manufacturers are now testing to the same requirements, and know that it is not the manufacturer relaying the test results, Cronin says, but rather an impartial third party whose testing is in the consumers’ best interest.

The system was designed to give consumers and rehab professionals information to help them make better purchasing decisions. But if manufacturers purposely exclude disclosures from their brochures, then they aren’t fulfilling their jobs, Kramer says.

“Once a consumer has a manual, they’ve already bought the chair,” he says. “There really isn’t a good standard on making sure the consumer gets the information. There is a disconnect there.”

The disclosures are supposed to be printed in a manufacturer’s brochure, where consumer’s can find a list of specific measurements and parameters, says Phillips.

However, disclosures aren’t always readily available at the decision point and often a consumer is simply following what their professionals tell them, particularly in high-end rehab, Kramer adds.

“A consumer has no idea which breathing control or head switch is going to be the best for them or what is the advantage of a motor of this size versus another,” he says. “Most consumers, on the scooter side, say ‘I like the red one because it’s pretty.’ They don’t really have enough information to say the motor’s going to burn out on this thing five times the rate of this other one.”

Having products independently tested helps to remove bias from testing procedures and relay an objective overview about the performance and stability of products, in most cases. However, as with any new procedure, there is always room for improvement.

This article originally appeared in the March 2008 issue of HME Business.