Maximizing Patient Potential in an Audit-Intensive World

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By Judith Philipps Otto

"Today the research is able to demonstrate the functional value of sophisticated prosthetic feet and the potential reduction of harm to the sound-side limb in people with dysvascular and traumatic amputations."

-Robert Gailey, PhD, PT

Although current conditions, pressures, and penalties imposed by the Centers for Medicare & Medicaid Services (CMS) are providing unprecedented challenges to O&P practices, especially in the area of the decision between fitting a K2- or K3-level device, the practitioner's prime directive remains the same: Provide the best possible care and service to prosthetic, orthotic, and pedorthic patients. (Author's note: To read more about this issue, see "Under Siege: CMS Audits Take Their Toll on O&P," The O&P EDGE, August 2013.)

So how, in such an inauspicious climate, is it possible for practitioners to continue to help patients achieve the successful outcomes everybody wants? We asked O&P leaders to share their insights on maximizing patient potential in the face of contemporary obstacles.

Maximizing Patient Potential through Increased K2 Options

The recent proliferation of Recovery Audit Contractor (RAC) audits has specifically focused attention on the K-level controversy, since K3 prosthetic claims seem to have been more closely scrutinized and frequently denied during the audit process than other devices. As a consequence, some practitioners admit to being wary of fitting K3-level prostheses due to the risk of reimbursement denials, even though their professional training and experience may lead them to believe that the K3 device may best answer the patient's needs.

One result is an increasing demand for K2-level prostheses. In light of that demand, Rob Cripe, senior vice president of global marketing, Freedom Innovations, Irvine, California, has announced plans to further develop the company's line of products that are applicable to K2 patients.

A portfolio of products is in development now, with an anticipated rollout date on the first designs in the near future. "Our goal is to develop higher-functioning products for the K2 patients," Cripe explains. "Our strategy is to build a portfolio of products that can address both our practitioners' needs and those of their patients, giving them the most function possible for the activity level at which they were diagnosed."

Every component-knee, ankle, and foot-is being considered by Freedom for the new portfolio, Cripe notes.

Although the timing and direction of this product development effort would seem to indicate that it is a response to the RAC audit pressure on Freedom customers, Cripe points out that this is really a strategy for Freedom to provide more options for the very large K2 population.

"Conceptually, as a company, Freedom has developed its K3 portfolio very well, and the K2 portfolio needs more work. We believe we have an obligation to serve this patient population, regardless of the marketplace dynamics that we are currently experiencing.

"That would look like developing the highest-functioning products possible for that segment while meeting the business needs of our customers," says Cripe. "We remain committed to providing advanced technology to help ensure patients are able to have an active, healthy, and productive lifestyle."

Justifying Clinical Decisions in the Face of Audits

Others believe that while the current climate does present challenges, the best course of action is to continue to support clinicians' judgment to maximize patient outcomes and document carefully to ensure that it is sustainable from a business perspective. Al Kritter Jr., CPO, FAAOP, vice president, clinical services, Hanger, headquartered in Austin, Texas, says that "any time a business decision drives a clinical recommendation, it can present problems. We all have businesses to run. Though RAC audits are a challenge to our profession, we are encouraging our professionals to be confident in their clinical expertise, provide what's appropriate for the patient, and then be committed to thorough, timely, and compliant documentation."

Hanger finds that thorough documentation has enabled its business to successfully navigate many of the challenges of facing the RACs, says Kritter. "I can appreciate that tying up the money is difficult, but we also feel that we're getting a successful resolution by having proper processes. At Hanger, RAC audits are not impacting patient outcomes. We are providing the most appropriate clinical solutions for patients and diligently documenting the process and the justifications."

That said, he admits that Hanger has sustained losses due to RAC audits, albeit limited, either due to lack of timeliness in the company's responses to the RACs or a flaw in the documentation. "We don't see it as a business decision to avoid the RACs; instead, we consider it an opportunity to improve our processes with compliant documentation and thus avoid [audits] in the future."

Even the physician documentation that many practices find to be problematic is a barrier that can be overcome-or sidestepped-he suggests. "The RAC audit is very literal in its interpretation. So when they say they want to see it in the physician's notes, that's what they mean. They don't want to see a physician attestation. But at all levels of appeal, notes from other professionals, such as justification from a physical therapist, or a nurse, or others that substantiate your claim, may result in a favorable decision for you."

Some reimbursement specialists within the O&P community have speculated that the RAC audits were precipitated by a concern that practitioners may be overprescribing or underprescribing a particular K-level-and potentially impacting patient care adversely. Kritter agrees, "From the Medicare side, I'm sure there is some skepticism. As a taxpayer, I certainly don't want to see overutilization either. But I would caution certified practitioners and accredited facilities against thinking this is all about attacking prosthetic professionals. In the absence of any 'qualified provider' language, Medicare pays prosthetic claims to a lot of different suppliers, many of whom are not certified or accredited, and these nonprofessionals are having a much more difficult time than we are in meeting the documentation and clinical decision requirements. I think the case can be made that Medicare is looking at all prosthetic suppliers and through this process is pressuring out the nonqualified suppliers from the Medicare prosthetic provider roles. That doesn't make it easy for us right now, but overall that might be a good thing for our profession-and for our patients."

Broad Impacts of Underprescribing

The current trend of cautious prosthetic practices to fit more K2-level devices out of very necessary concern for their bottom line may be understandable. But is it a knee-jerk reaction that will weaken and fade away as the temporary critical pressure is alleviated?

Wil Haines, CPO, MaxCare Bionics, Avon, Indiana, doesn't believe so. "In fact," he responds, "I believe the American public needing O&P care will be shocked at the consequences from these criminal-like auditing procedures from CMS. I am sure there is and has been some abuse in O&P, and that should be corrected. But CMS considers everyone guilty until proven innocent, and that will have far-reaching consequences for the O&P patient population."

Haines predicts skyrocketing costs for O&P care due to CMS policies, which will result in rapidly diminishing availability of comprehensive O&P care for the average patient. He foresees O&P services handled in private, affordable healthcare systems that are not involved with Medicare or other private insurance agencies. "Taking these agencies out of the picture will lower the administrative cost of providing O&P care exponentially. It will also let the patient help drive his or her care. That will mean the comprehensive 'Cadillac' O&P systems will likely be used less often simply because of the costs involved."

Less sophisticated systems offer performance levels that are a reasonable match for the average daily prosthesis wearer, he points out. "O&P professionals can maximize O&P care with lower technology options, but it depends upon whether the medical community is prescribing limits for O&P care. If the prescription, for example, is for a device that allows patients to function reasonably in their activities of daily living, then lower technology can fill the need, but if those individuals are capable of doing more in their daily lives, then their potentials are limited by those who are prescribing less sophisticated O&P devices."

The consequence of such limiting prescriptions is that they not only limit the patient's ability to maximize his or her function, but also, Haines notes, "When less sophisticated devices are prescribed, research and engineering facilities will diminish, and O&P will be pushed even further behind in this technological world. Take the high-end comprehensive devices out of the picture, and inflation will likely cause the services rendered to be just as expensive as they are now, except that patients will be receiving low-end devices instead.

"If you take premium gas out of the gas station pumps, regular gas prices would likely skyrocket-the free market would make sure that happens. Take K3 out of the prosthetic world, and I think you fill find that the costs will not go downward nearly as much as CMS and others are anticipating."

Haines says he worries about the effect this might have on O&P patient care at other levels, as well, including peripheral effects not considered by CMS. He provides an analogy between being able to provide the potential for people to progress to a higher level of ambulation with a high-tech device and his experience working with patients with paraplegia.

"I have taken care of many paraplegics," he says, "and nearly all of these folks want to walk again. The vast majority of them resign themselves to using a wheelchair after struggling with prescribed orthotic devices. After sitting in a wheelchair for several years, it is not at all uncommon for those individuals to want to make another stab at walking again. Rarely does it work, but at least they have had the opportunity to figure this out for themselves."

The complexities of the issue are challenging, he explains, and go far beyond the fitting of a functional device.

Although statistically the likelihood that patients with mid- to high-level paraplegia will succeed with long-term walking is slim at this time, Haines points out that it would be inconsiderate and irresponsible to deny the parents of a young child with myelomeningocele the opportunity for that child to walk with orthotic devices and stand upright. Haines describes a poignant moment when a four-year-old patient stood without her parents holding her for the first time in her life. "It was one of the joys of my life," he recalls. "And it gave the family of that child something hopeful."

When a patient is confined to a wheelchair, inactive for five to ten years, it allows atrophy and disuse to weaken bone as well as muscle, Haines says. "If science suddenly develops a fix for paraplegia, but they can't also fix osteoporotic bone, then it's too late; the individual will be unable to safely bear his own weight without fracturing bones. So by denying wheelchair patients the opportunity for healthy activity-whether in a standing frame, in a physical therapy unit, or a brace-CMS' statistics-based denials also rob patients of potential future opportunities for functionality, as well.

"When government officials and other non-O&P-educated folks decide what can and cannot be accomplished with orthotic and prosthetic care, you have just destroyed the opportunity for many of these folks to function at their potential in society," says Haines. By the same token, a K2 ambulator who might progress to K3 with a high-tech device-although there is no guarantee-is likewise being denied the opportunity to use the device and find out if he or she might have succeeded in achieving progress with it.

Dread of CMS denials has been influencing O&P business owners' decisions, even before the RAC audit crisis began.

Robert Gailey, PhD, PT, professor, Department of Physical Therapy, Miller School of Medicine, University of Miami, Florida, published research in 2006 that indicates prosthetists were underprescribing by about 30 percent-fitting K2 prostheses on K3 patients.1 "When asked why, many prosthetists suggested that was the path of least resistance. Claims were processed faster if they were submitted as K2," explains Gailey.

Not only is such underprescription a disservice to the K3 patients, but it is a disservice to some K2 patients as well, he believes. "K2 amputees benefit from K3 prosthetic devices. They have better balance, they can walk faster, there's less abuse to the sound limb. Back when the K system was introduced, what was classified as K3 prostheses-particularly the carbon-fiber J-shaped devices-really offered a great benefit to the K2 individual; we just did not have the research to demonstrate the value. Today the research is able to demonstrate the functional value of sophisticated prosthetic feet and the potential reduction of harm to the sound-side limb in people with dysvascular and traumatic amputations," Gailey et al. say.2

In a recent published study, Gailey and his colleagues suggest that the current categorization of prosthetic feet may not be consistent with functional capabilities because both K2 and K3 subjects benefited from a K3-category foot with balance and mobility.3

Gailey fears that by pursuing the path of least resistance and downgrading their patient population to K2, although they would benefit from K3 prosthetic devices, O&P practitioners may be allowing insurance payers to perceive that their original suspicions were correct-prosthetists had been overprescribing K3-level devices to patients who did not merit them.

"The prosthetic community and its organizations-the Academy [American Academy of Orthotists and Prosthetists], AOPA [American Orthotic & Prosthetic Association]-have struggled so long and so hard to elevate care for the amputee, that going down this slippery slope and 'giving in' to the notion that more people should be using K2 devices is very, very dangerous," he says.

"Just like physicians and physical therapists, O&P practitioners have to demonstrate the benefit of what we do. And because proper prosthetic fitting can have a huge impact, the value of its contribution to function in a person with limb loss can be measured and quantified."

A recently completed study demonstrates that after just a few weeks of physical therapy, all K2-level subjects demonstrated K3-level function with the proper training, using their K2 feet. "That was done primarily by teaching them how to maximize their prosthesis-how to balance, use the dynamic properties of their prosthetic foot [and] proper sitting and gait techniques."

By using simple 30-minute assessments to evaluate the patient prior to fitting and again following proper fitting and physical therapy, practitioners should easily be able to quantify the value of their professional contribution to function in a person with limb loss, Gailey believes, not only building credibility and documentation for their reimbursement claims, but demonstrating the significant value of the profession, as well.

"One of the key audit issues with documentation is that the referring physician's notes must match the prosthetist's notes," Gailey points out. "I believe that if the documentation overall improves, and it was demonstrated that the prosthetic community is far better at assessing the prosthetic needs of the amputee, then they can begin to build a case that the secondary notes from the physician are no longer required."

As of July 1, CMS requires physical therapists to accompany any request for reimbursement with a G-Code that indicates the functional limitations of the patient and note the outcome measure system used to determine those limitations. Claims not including this information will be denied, says Gailey. "If Medicare is asking for outcomes documentation from physical therapists, then how long will it be before it is asked of prosthetists?" he wonders.

It's a win-win strategy: While patients appreciate being the focus of a detailed assessment that focuses on their limitations, their goals, and ultimately, their improvement, the O&P practice can also turn the outcome measures into a marketing tool that compares them favorably to local competitors, Gailey stresses.

"This is a great opportunity," he urges. "We have to really turn this around from a scenario where it's gloom and doom to an opportunity to demonstrate to the third-party payers and CMS that what prosthetists do in fact has a huge impact on how people will function and live life to their full potential."

Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer.


  1. Gailey, R. S. 2006. Predictive outcome measures versus functional outcome measures in the lower limb amputee. Journal of Prosthetics and Orthotics 18 (1s):51-60.
  2. Gailey, R. S., K. Roach, I. Gaunaurd, and M. Raya. Effectiveness of an evidence based amputee rehabilitation program. Thranhardt Lecture presented at the 2009 American Orthotic & Prosthetic Association National Assembly, Seattle, WA.
  3. Gailey, R. S., I. A. Gaunaurd, V. Agrawal, A. Finnieston, C. O'Toole, and R. Tolchin. 2012. Application of self-report and performance-based outcome measures to determine functional differences between four categories of prosthetic feet. Journal of Rehabilitation Research and Development 49 (4):597-612.