Instead, under an interim final rule to take effect Oct. 25, providers need only submit a physician's prescription for reimbursement of Medicare claims for power wheelchairs and scooters. They will, however, be responsible for producing patient records supplied by physicians that document medical necessity if asked.

"This interim final rule is a critical step in ensuring that people with Medicare have access to appropriate technology to assist them with mobility," CMS Administrator Mark McClellan said at a Wednesday press conference announcing the new rule, calling it "a comprehensive strategy to help Medicare beneficiaries get the mobility assistance equipment they need while avoiding unnecessary administrative burdens and inappropriate Medicare spending."

According to CMS, the agency decided to drop the certificate of medical necessity because it "did not work as well as originally hoped. The CMN did not serve to help physicians better document their patient's clinical needs for a power wheelchair, it did not serve to ensure that beneficiaries always received appropriate equipment, nor did it serve as an effective deterrent to fraud and abuse."

Previously, only specialists in physical medicine, orthopedic surgery, neurology or rheumatology could prescribe a power mobility device, but McClellan told reporters the restriction was "out of step with modern medical practice."

The new rule allows physicians and treating practitioners to prescribe PMDs, and also requires them to perform a face-to-face exam before writing a prescription. According to Kimberly Brandt, director of CMS' Program Integrity Group, this will allow questions to be asked about changes in the patient's health or about progression of the clinical condition that warrants the equipment.

Under the new claims process, before billing Medicare, providers must have a written prescription, signed and dated by the physician or practitioner who performed the face-to-face exam, within 30 days of the examination. Providers also are required to gather clinical information supplied by the doctor or practitioner that proves medical necessity before delivering a power wheelchair or scooter. CMS reasons it is simpler for doctors to give providers copies of existing documentation from the patient's medical records rather than having to transcribe that information onto a separate form.

"The physician is in the best position to document and evaluate clinical and medical need," said McClellan, who called the power wheelchair and scooter CMN "extra paperwork."

While physicians already can file for payment for the office visit to evaluate patients, he said CMS is authorizing an additional physician payment of about $21 for 2005 for preparing and providing the documentation to suppliers.

McClellan said the documentation does not need to be submitted to the DMERCs with every claim, but suppliers should keep it on file to supply upon request. According to CMS, the information could include the patient's history, physical examination, diagnostic tests, summary of findings, diagnoses and treatment plans. McClellan added that the DMERCs will later issue specific guidance about what information is needed from the medical record to document medical necessity.

He also said that he expects draft local coverage determinations--which providers have been waiting on since the release of the agency's national coverage determination for Medicare's mobility benefit in May--will be "coming out very soon" from the DMERCs.

CMS said it plans to issue billing instructions to suppliers before the Oct. 25 implementation date, and will hold a special Open Door Forum Sept. 13 to address power wheelchair and scooter issues. The agency will accept comments on the interim rule until Nov. 25. A final rule is expected to be issued shortly thereafter.

To view the interim final rule, click here.

To comment, click here.

To nominate any individual whose dedication and commitment has served to better the HME community, visit www.homecaremag.com and click on the "HomeCaring Award(TM)" button to download a nomination form. A hard-copy form is available in both the July and August issues of HomeCare magazine. Mail your nominations to HomeCare at 6151 Powers Ferry Rd. NW, Ste. 200, Atlanta, GA 30339, or fax to (770) 618-0204. Nominations must be received in the magazine's editorial offices by Wednesday, Aug. 31.

The agency has devised 49 new billing codes for PMDs to take effect Jan. 1, 2006, and is expected to release new fees for those codes later this year (HomeCare Monday, Feb. 7).

While industry reaction to the policy changes has generally been positive, stakeholders contacted by HomeCare Monday about the new rule had a mixed response. Some said they are concerned there is not enough time to implement the changes. Others say that it is lacking in details and places too much of a burden on physicians. Their comments follow.

--"The new rule presents a series of major issues, which must be resolved by significant changes to the rule and additional clarification," said Cara Bachenheimer, vice president, government relations for Elyria, Ohio-based Invacare Corp. "For example, providers require very clear guidance regarding the types of information that physicians are to chart in their progress notes; this rule provides physicians no guidance whatsoever, and providers will have a difficult time making an assessment of whether the information provided is sufficient. The 30-day time frame is simply unrealistic. We are hopeful that CMS will listen seriously to concerns from all stakeholders--prescribing physicians, other clinicians and providers and consumers, before implementing a final rule."

--"I am concerned about the CMN issue," said John Gallagher, vice president of government relations for Waterloo, Iowa-based VGM. "On the one hand, doing away with the CMN is a good thing. On the other hand, the devil remains in the details. Is the doctor's prescription all that will be required? Or will the dealer still be required to be responsible for the same floating data stream as before?"

--"Like everyone else, we are digesting the information in the interim rule. We acknowledge CMS' efforts to ensure that suppliers receive needed documentation. However, much more information is needed to truly implement the NCD and the face-to-face interim rule. We hope this information will be included in the [local coverage determinations], and we hope this will be released very soon," said Rita Hostak, vice president, government relations for Longmont, Colo.-based Sunrise Medical.

--"I am concerned that it is going to be difficult for providers to ensure that the patient qualifies and can obtain the physician notes they need for medical necessity," said Jane Bunch, vice president of HME consulting for Atlanta-based CareCentric. "Regardless if CMS decides to reimburse physicians for their time to complete this documentation, what guarantees do we as providers have in knowing we are not going to have to return the reimbursement in a post-payment audit? It is leaving the door wide open for issues in the future."

--Because a supplier only needs to submit a prescription with claims, "It seems like it may open up the door for fraud and abuse," said Darren Tarleton, president and CEO of Stockbridge, Ga.-based Mobility Warehouse. "It's going to make it much easier for me as a dealer to serve the patient and get equipment to them in a much more timely manner. With the current process, there is a lot of waiting. There are times that we've never been able to get a CMN back from the doctor. Sometimes it has taken three to four months. As far as the patient is concerned, it's going to be much better for them."

--"I don't think it's going to work. I think they're dreaming," said Tom Lambert, president of Redding, Calif.-based Maximum Comfort, who won a battle with the government earlier this year when a U.S. district judge ruled that a CMN is enough for DME reimbursement (HomeCare Monday, March 21). The provider has been in litigation over the issue for years, and said he is not sure how the new policy might affect the government's current appeal of the court case. "It kind of blows me away. I think we're going to have to wait and see ... I know for us, one of the problems with requiring clinicians' notes was that we're not qualified to read these notes and detect medical necessity. When I started in 1989, all we had was a doctor's prescription. Maybe that's where we're headed--back to the horse and buggy days."

--"Now we have a pretty good idea of what information is needed from a physician in order to determine medical necessity--but pretty good is not good enough," said Dan Meuser, president of Exeter, Pa.-based Pride USA. "Providers need a list, if you will, of what information [CMS] wants. ... We can manage through this change, but there are still questions, and the time frame is absolutely unrealistic. There is not a provider I can talk to--from the most sophisticated to the smallest mom-and-pop--that feels they can be prepared and ready by Jan. 1, or for this new prescription-information program by Oct. 25. It can't be done."

--"It seems to completely eliminate the role of the therapist in documenting an assessment, which is our primary concern as therapists who have been invested in these procedures our whole careers. [CMS] thinks this will limit fraud in the program, but we believe the result is going to be gravely restricted access for patients. If the physician is responsible, in many cases, we don't feel that is realistic [for them to gather documentation], even if they provide them an extra $21. Physicians don't write letters of medical necessity now," said Barbara Crane, assistant professor of physical therapy at the University of Hartford (Conn.). Crain also co-chairs the Clinician Task Force, part of a clinical-focused group formed last year called the Coalition to Modernize Medical Coverage of Mobility.

--"It looks like they are putting a lot of responsibility on physicians, who don't have the training or the time. All sorts of technical questions that need to be answered aren't in the doctor's area of expertise. CMS needs to more clearly define what the physician is responsible for and what he or she can outsource to other people. That is going to be critical. ... Without some standard form the physician can complete, it's going to make it difficult to make sure all this information is going to be captured in the way CMS wants. If there was something that said, 'Here are some basic questions you need to answer,' then clients could work with their referrals," said Don Clayback, senior vice president of networks for Lubbock, Texas-based The Med Group.

--According to a statement from the Restore Access to Mobility Partnership, "While the physician role is critical, the new rule places undue and inappropriate responsibilities on them ... Doctors may not be well versed on the range of mobility assistive equipment options, the factors involved in determining the right equipment for patients or how to correctly document their evaluations. This situation is compounded by the lack of any comprehensive effort by CMS to educate the physicians on their expanded role in this process." What's more, the industry coalition said, "the magnitude of the changes in the interim rule dictate that it will take substantially longer than the stated Oct. 25 implementation date for stakeholders to fully understand and be able to implement the new rules." The statement concluded that "it is a mistake to rush into implementation of a rule that is flawed." RAMP members include the American Association for Homecare, Invacare Corp., The Med Group, Mobility Products Unlimited, Pride Mobility and Sunrise Medical.

Leading the company are CEO Hans Stover, who once headed the home care division of Puritan-Bennett, along with co-chairmen Jerry Jones and Tom O'Donnell. Jones is a former Apria Healthcare chairman and CEO, and O'Donnell has previously served as president of North American operations for Sunrise Medical.

"APM is implementing a strategy of providing high-quality products at lower costs by controlling its own global manufacturing facilities," according to a press release issued last week. The company currently has three manufacturing sites in China and plans to add three more during the next six months.