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DMERCs Release Draft Mobility LCD
BALTIMORE--After months of waiting for additional guidance on Medicare's power wheelchair and scooter coverage, the home medical equipment industry got what it was asking for when the DMERCs issued their draft LCD on Wednesday. But some stakeholders say their questions remain unanswered--and that the power mobility policy changes are too many and coming too fast for the industry to adjust.

The LCD expands on CMS' national coverage determination for mobility assistive equipment, issued May 5. Posted on the DMERC Web sites, the document addresses medical conditions required for coverage, proof of medical necessity, coverage of accessories and phase-out of the power mobility certificate of medical necessity.

After a comment period that ends Oct. 31, the final LCD is expected to be released in December, and is set to take effect Jan. 1, 2006, to coincide with new power mobility codes and pricing. The LCD is identical for all four DMERC regions, but there may be some discrepancy among the DMERCs in the amount of review, a CMS official said.

Both HME providers and manufacturers had looked for the draft to give more guidance about claims documentation and other aspects of the agency's new interim final rule, such as the 30-day timeframe involved for physician prescription of equipment. But the LCD raises other questions, according to Seth Johnson, director of government affairs for Exeter, Pa.-based Pride Mobility. "The LCD did provide some additional information, but certainly these additional documents [on coding and testing] that were released do raise significant questions and further support the need for delay in implementation for power mobility to at least April 1. We know that the LCD will not be finalized until at least December.

"How can you implement the PMD rule without the LCD being finalized [and without] additional guidance the industry needs?" questioned Johnson.

The Region B and D DMERCs will hold a meeting Oct. 11 from 1 p.m. to 3 p.m. at 6375 Castleplace Drive in Indianapolis to get comments on the draft LCD. To teleconference into the meeting, send an e-mail to draft.dmerc.lcd.comments@anthem.com for Region B, and to Mary.Rheinecker@CIGNA.com for Region D.

To view the LCD and submit comments, visit:
www.palmettogba.com/palmetto/palmetto.nsf/(News)/2EB6E2A61F1255568525707C0074CE62?OpenDocument.

For information on the NCD, which replaces "bed or chair-confined" language with a functional approach to prescription of power mobility equipment for Medicare beneficiaries, see HomeCare Monday, May 9.

CMS Changes Power Mobility Codes, Testing Requirements
BALTIMORE--In February, CMS unveiled a plan to implement 49 new power wheelchair and scooter codes--scheduled to take effect Jan. 1--that break down the broad K0011 code to specific configurations. But last week, the agency upped the number, announcing that the codes and testing standards need even more revisions to differentiate among some types of equipment. The first-of-the-year implementation date, however, remains.

"For example, the testing requirements established for the 'standard use' power wheelchair created too high a bar for some types of chairs and did not allow us to make a [meaningful] distinction (based on levels of durability and performance) between the numerous categories," a CMS statement noted.

Originally set for Sept. 1, the product testing deadline has been extended to Nov. 15 to allow power mobility manufacturers more time to conduct tests under the revised standards. If products have already been tested and the results have been submitted to the statistical analysis durable medical equipment regional carrier, "every effort" will be made to determine the proper code placement, according to CMS. But for products currently undergoing testing, or for those that are untested, manufacturers must test according to the new guidelines.

Other changes to the code sets and testing requirements announced on Wednesday by CMS and the SADMERC include:

• Adding a new "standard use" category for power mobility devices.
• Revising the characteristics of the previous categories of power mobility devices.
• Revising the testing requirements for all categories of power mobility devices to be consistent with current Rehabilitation Engineering & Assistive Technology Society of North America (RESNA) standards.
• Establishing a reliable testing strategy that will allow CMS and the SADMERC to consistently assign power wheelchairs to specific codes.
• Revising testing requirements so that CMS and the SADMERC are able to differentiate among the various levels of equipment in terms of durability and level of performance.

Open Door Session Opens Power Mobility Can of Worms
BALTIMORE--HME stakeholders and CMS officials engaged in a heated discussion about the agency's overhaul of Medicare's mobility benefit at a special Open Door Forum on Tuesday.

More than 500 callers jammed the phone lines and 45 to 55 appeared in person at the three-hour session, which focused on an interim final rule released last month that eliminates the current power mobility CMN. Instead, the proposed rule requires providers to submit a physician's prescription with their reimbursement claims--and, if asked, to supply documentation from the prescribing practitioner about the patient's condition that supports medical necessity for the equipment. (See HomeCare Monday, Aug. 29).

With a number of other new mobility policies set to take effect--including the implementation of new codes and pricing on Jan. 1--some meeting attendees said CMS is rushing the rule, which is currently scheduled to become effective Oct. 25.

Implementation should be delayed until at least April 1, 2006, according to Dan Meuser, president of Exeter, Pa.-based Pride USA. "Folks, providers cannot adapt to this rapid change in this time period," Meuser told CMS officials, citing provider concerns about retooling billing systems to the new requirements, concerns the DMERCs will not be able to adjust their own claims processing systems and a widespread lack of education in the medical community about physicians' new role in the process. "We need for you to truly consider a delay so we transition again in an orderly way as opposed to a rush to disorder," Meuser said.

CMS' Richard Lawler said the agency is "listening" to that request.

Another forum attendee said it is inappropriate to require equipment providers who are not medically trained to gather patient medical records from physicians, and then to hold providers responsible for deciding whether the prescription and documentation physicians supply is appropriate.

As "laymen," non-clinician suppliers are not qualified to make these medical evaluations, said Doug Harrison, president of The Scooter Store, New Braunfels, Texas, the nation's largest power mobility supplier. "Imagine the outcome if pharmacists first requested physician's chart notes from a patient, then analyzed those notes, and finally, refused to fill the prescription based upon his or her reading of the chart notes," he said. "Neither the patients nor doctors would tolerate that outcome at a pharmacy, nor should they in the instance of the prescription of power mobility devices."

But Lawler responded that the agency has no intention of changing the requirement. "We're not asking the supplier to make a diagnostic information or to write the prescription," he said. "But you do have to find between the time the prescription is made and it is supplied an ability to translate that prescription into a physical piece of equipment. That's your business that you're in."

John Warren of CMS also noted that there are no plans to perform random medical reviews, but they will be conducted by the DMERCs in response to "billing anomalies." He said he had no estimate as to what percentage of power mobility claims would be reviewed.

Others at the meeting were concerned that the role of clinicians is not addressed in the policy language, leaving the burden on physicians who may--or may not--have the training necessary to prescribe appropriate equipment.

"It's not been my experience that there are a lot of physicians who feel confident to provide the detailed prescription that's necessary. They neither have the time nor the expertise in the MAE that's necessary in order to have the whole thing turn out right for the beneficiary in the end," commented Ginger Walls, outpatient clinic director at National Rehab Hospital in Washington, D.C. "It's been my experience that I've had to go back and try to fix more patients' problems who had improper devices prescribed for them."

Laura Cohen, a clinical research scientist at the Shepherd Center in Atlanta and co-coordinator for the Clinician Task Force, said because few physicians document the detailed type of information necessary to prescribe the right equipment, the rule should be amended to recognize that it is appropriate for physicians to refer to independent physical or occupational therapists who can then evaluate the patient and work with the supplier to find the appropriate device. "The multi-disciplinary team isn't addressed in this [rule]. And knowing when and where to refer on is not talked about, and I think that that's a problem with the system as it is today," Cohen said.

Steve Furrough of CMS said it would be "appropriate in many cases" for physicians to refer a beneficiary to someone who can assist with the evaluation and prescription, but "we don't feel that's an appropriate thing to regulate through a rule.

"Just like in any other health care provision, we expect providers who are going to order power mobility devices to be competent in ordering those power mobility devices," he said. "We expect [physicians] to do the appropriate evaluation, answering those questions [as outlined in the NCD], and if they are uncomfortable doing that, then we certainly expect them to ask for some assistance."

To help educate physicians about the changes, the agency is planning meetings with physician groups, publishing Medlearns and using DMERCs to get the word out, CMS' Warren said, adding that suppliers also should take responsibility for informing their referral sources about the new rule and its requirements. "This is a huge educational campaign, and I would expect that as suppliers that you have relationships with the physicians that you deal with, and part of that relationship would be educating [them] on what their responsibilities are," he said.

Still other forum participants, such as Phil DiLernia, president of Flemington, N.J.-based Cornell Healthcare Corp., said the interim final rule does not provide the clarity necessary for suppliers to follow its requirements. "All suppliers have asked for for four years consistently is clarity in the guidelines, no ambiguity. If you want to reduce fraud and abuse, it seems ultimately imperative that you make things more clear rather than less clear. The more clear things are, the more easy it is to go after fraudulent providers," he pointed out.

The fact that the equipment prescription is required within 30 days of a face-to-face physician exam also disturbed a number of stakeholders, who said that it could take a much longer time for patients to shuttle among doctors, clinicians and an HME provider. Furrough said that the 30-day clock does not start the first time a patient sees the physician, but the date the prescription for a mobility device is written, which may be a date after the initial exam. Other officials said CMS would have to provide clarification on this point.

"This is not new medicine, new science," Furrough said. "It's just putting a name on what has always been expected to occur. So the actual term 'face-to-face examination' and the requirement that a face-to-face examination happened becomes effective the day the rule ... becomes effective. But it should not, in the larger sense, really change practice. [Physicians] were required by good medical practice to see patients before they wrote a prescription. That doesn't change."

CMS officials at the forum said they will take the comments they heard into consideration before the final rule is issued.

To view the interim final rule, click here.

To comment on the policy, click here.

To participate in HomeCare's monthly Web poll on CMS' new interim final rule for power mobility equipment, visit www.homecaremag.com.

RAMP: 'We Are Heading Towards a Train Wreck'
WASHINGTON--Following last week's Open Door Forum and release of the DMERCs' LCD on power mobility equipment, a strong response from the Restore Access to Mobility Partnership, an industry coalition of powered equipment manufacturers and providers, emphasized that the scheduled Oct. 25 implementation of CMS' new interim rule on power mobility should be delayed.

"CMS has a responsibility to clarify procedural guidelines, as well as outline clear and concise documentation responsibilities," a RAMP statement said. "Failure to do so could cause the collapse of the power mobility industry, creating layoffs, forcing suppliers to stop selling mobility products and leaving thousands of Medicare beneficiaries without a means to obtain mobility equipment."

"We are heading towards a train wreck," stated Pride USA's President Dan Meuser. "We spent more than a year working with CMS to come up with a new coverage policy. But now all that hard work is in jeopardy if the coverage policy is not accompanied by a clear and concise set of regulations to govern how power wheelchairs and scooters get to the Medicare beneficiaries who need to address mobility deficits. CMS needs to review the many, many implications that have not been thoroughly considered. There is no way these new procedures are ready to be implemented by October 25, as is currently planned."

The coalition and its members, which include the American Association for Homecare, Invacare Corp., The Med Group, Mobility Products Unlimited, Pride Mobility and Sunrise Medical, also expressed other concerns.

"How can CMS possibly think about implementing new procedures when there are so many indications that they are not ready, and there are important missing pieces?" questioned Mal Mixon, Invacare's chairman and CEO. "There needs to be an extensive education process for doctors and other stakeholders, but that cannot begin until all the pieces are finalized. The Open Door Forum was an opportunity for stakeholders ... to raise our concerns about the new procedures. Now, CMS needs to slow down, carefully listen to our concerns and respond with a revised rule that is shaped with our input."

One of the coalition's biggest concerns is "CMS' decision to place more responsibility for documentation with physicians, and to rely on their chart/patient notes for documentation of medical necessity for mobility equipment. ... This scenario assumes that the physician has extensive knowledge of the range of mobility equipment," the statement said.

"Traditionally, this has been a team approach with the doctor, clinician and supplier working together on providing the best piece of equipment for the patient," said Michael Hammes, chairman and CEO of Sunrise Medical. "CMS is shifting much of the burden to doctors, whose primary responsibility is to look at the broader health of the patient."

Yet another issue is how to make the transition from the old coverage policy to the new one, according to RAMP. At the Open Door Forum, details about the 30-day period cited in the interim rule as the timeline from a physician face-to-face exam to a decision on the equipment being delivered were left unclear. "There also seemed to be an assumption by CMS that physicians are familiar with the new coverage policy that was introduced in the spring, even though there has been no education program to inform them," the statement said.

"Since the new coverage policy was released, we have said that clear documentation requirements have to be established. That has yet to happen," said John Ward, CEO of Mobility Products, adding that the interim rule "that CMS is trying to rush into place by October 25 is an attempt, but it lacks the kind of details that are needed. CMS must take the time to consider all the consequences and get this right."

Study: Gap-Filling Method Problematic for Power Wheelchairs
WASHINGTON--CMS' gap-filling methodology, if it is used to set prices for power wheelchair codes, could result in an average payment reduction of 25 percent, according to a new study conducted by Muse & Assoc.

AAHomecare, which commissioned the study, presented the findings during a meeting with CMS officials last Wednesday.

The gap-filling formula is used by CMS to price new DME codes by estimating what the price would be if it were on the Medicare fee schedule in 1987. That price is then trended forward to 2004 using actual increases in fee schedule payments.

The study recommends that CMS use 1992 as the historic pricing year for all power wheelchair equipment, since much of the technology for today's wheelchairs was developed after 1987. The study found that of the power wheelchair products that were examined, only nine had historic price information before the year 2000.

To view an executive summary of the study, visit www.aahomecare.org.

CMS Meetings and Forums
The location of the next meeting of the Program Advisory and Oversight Committee (PAOC)--the industry panel advising CMS on the implementation of competitive bidding for DME--has been changed. The Sept. 26-27 meeting will now take place at the Hilton Hotel, 1726 Reisterstown Road, Pikesville, Md., from 8:30 a.m. to 4:30 p.m. both days. CMS will host a Special Open Door Forum from 4 p.m. to 5:30 p.m. on Sept. 26 to share a draft proposal regarding the implementation of quality standards for Medicare DMEPOS suppliers. To participate by phone, call (800) 837-1935 and reference Conference ID number 8914408. For a meeting agenda, visit www.cms.hhs.gov/suppliers/dmepos/compbid/paoc.asp.