O&P Ten Years Later, Part Two: The Economics of Outcomes

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By Judith Philipps Otto

In early 2009, O&P experts identified trends most likely to impact the profession during the next decade and discussed challenges that lay ahead for O&P professionals and suppliers. In the first of a new three-part series, our January 2019 issue revisited their predictions and shared fresh insights for the next decade.

In Part II of our 2019 survival guide, we asked O&P leaders to examine the evolution of patient care since 2009, and we compared their concerns and expectations—then and now. Their answers focus on what's impacting today's outcomes for better or for worse—and consider ways to remove barriers to improve care in the decade ahead.

Perhaps the most significant change is seen in the patients themselves—who arrive not only better informed, but also more articulate, active, and involved in their care.

"Today we're right in the middle of the baby boomer generation aging and needing care," observes Kevin Carroll, MS, CP, FAAOP(D), vice president of prosthetics, Hanger Clinic, headquartered in Austin, Texas. "The population of patients has never, in the history of medicine, been so well educated and had access to so many areas of information regarding available procedures and devices. Gone are the days of the patient coming in with no information or expectations; now they come equipped with data about their particular ailment—whether they're getting heart surgery or a prosthetic device. I embrace this and think it's very positive that patients are so involved in their own care."

Michelle Hall, MS, CPO, FAAOP (D), former American Academy of Orthotists and Prosthetist (the Academy) president, Gillette Children's Specialty Healthcare, St. Paul, Minnesota, agrees that one of the greatest changes she has seen in providing care is the dramatically increased awareness of patients, who arrive with questions about new devices. "I always praise their research as a trigger for discussion and an opportunity to explore their preferences—what they like about a device and what they wish might be different, and why. We can talk about it and make sure we get a really good outcome."

Patients now have full access to the recent explosion of different characteristics and claims by manufacturers, which has led to her different approach to treatment: "My thinking has changed just in the last few years—a lot of it driven by patient requests," she reflects. "I used to order only one foot—choose whatever I thought was best for that patient. Now I order two or three feet—maybe from different manufacturers, with similar or different features—based on what the patient was telling me, what their perceived needs were."

Despite the restocking fees for the unused foot or feet, Hall feels this is only reasonable and practical. "Think about the cost of a myoelectric arm or even a body-powered prosthesis with different terminal devices and similar lower-limb prostheses costs," she suggests. "A patient wouldn't purchase even a used car without first driving it—and most would try driving two or three cars or more to compare. So why wouldn't we allow our patients to test-drive more than one foot to discover what's best for them?"

Scott Bretl, CPO,program director, Alabama State University,worries that economic considerations may make it less likely for patients to realize best outcomes. "Patients increasingly come in with higher expectations of us as practitioners—which is certainly not a bad thing," he says. "It's up to us to manage those expectations by advising them what is possible to achieve, stressing their participation."

Even with ideal communication and commitment from both sides, however, he believes that diminishing reimbursements and reduced coverages are creating a barrier to certain technologies. "Practitioners come to a conclusion of what's best for the patient—and I think that reductions in reimbursements and coverage definitely impact that decision. Often there's a secondary option that meets financial or coverage requirements, but I believe most would agree that in many situations it's not what's most ideal for the patient."

While insurance companies argue that patients who don't get the top-of-the-line device will do just fine with the other version, Bretl frets that we still don't have enough specific research available to counter such insurance company arguments, presenting evidence for the practitioner's judgment that solution B is truly better for the patient.

Are Economics Putting Patient Outcomes at Risk? 

In 2009, respondents were facing a major economic crisis, and were primarily concerned with the many and far-reaching ways it might impact patient outcomes. Despite the improved economy, concerns remain.

Ten years ago, David McGill, JD, vice president, reimbursement and compliance, Össur Americas, Foothill Ranch, California, correctly identified and predicted the growing popularity of high-deductible, high-out-of-pocket health plans as "the single biggest issue I would expect to see as a result of the economics of the last few months."

Others, including Chris Hovorka, PhD, CPO/L, FAAOP, assistant professor, University of Pittsburgh, also expressed or concurred with predictions that reimbursement, as driven and controlled by the Centers for Medicare & Medicaid Services (CMS) and private insurers, would continue to be reduced, and a greater number of patient care services restricted—particularly those involving higher-priced solutions utilizing new technology. Efforts to develop more efficiently delivered, evidence-based care would achieve new urgency, most believed, since this would become critical in the decade to come.

"The quality of patient care has certainly risen in the last ten years," confirms Jim Rogers,CPO, FAAOP, Academy past president, Pinnacle Orthotics and Prosthetics, Chattanooga, Tennessee, "because more and more people are using evidence to deliver care, and they're measuring the patient at baseline and using outcome measures to determine the efficacy of their care. They're also incorporating patient goals and desires in the treatment plan. Those are all hallmarks of patient-centered care, which Medicare has been working on for a decade or more."

Dennis Janisse, CPed, president and CEO, National Pedorthic Services, headquartered in Brookfield, Wisconsin, however, reports concerns expressed by orthopedic foot surgeons frustrated because their patients no longer get the kind of care they used to receive ten to 15 years ago—largely because patients can't or won't pay for it. "Insurance company deductibles are so high that people are choosing not to pay $3,000—or in some cases, a deductible of $10,000 or $12,000. If they're going to have a foot surgery that costs $10,000, they may have to pay the whole thing."

And when patients delay or decline needed surgeries, their condition is likely to deteriorate further, causing their overall health to suffer—resulting in more extensive and expensive conditions and solutions.

Evidence bears out the benefits of timely and preventive care. Rogers points to Medicare-published data confirming that the Medicare Diabetic Footwear Quality Restoration Act of 2007 has resulted in a measurable decrease in the number of limb amputations secondary to diabetic complications.

Yet the cost of timely intervention remains a barrier.

Like Janisse, who has gone to a self-pay model for many of his pedorthic patients, McGill believes "we're approaching the maximum levels of what consumers can reasonably be expected to bear [in terms of high deductibles]. Many of them can't bear it already. If we assume this will continue to track the way it has historically, then basically everyone is going to be paying for 100 percent of their health insurance.

"I think consumer-driven healthcare as a category of plan is going to become increasingly dominant, but I don't think we'll see the same levels of cost-shifting going forward that we've seen over the last decade," he concludes. 

Janisse also worries that we are no closer to getting preventive care coverage to battle diabetes than we were ten years ago, despite the skyrocketing global threat. "Some countries are expected to see a 100 percent increase in the number of people with diabetes by 2025; and unless we've taken steps to stop it, one in three people in the United States could have diabetes then, as well."

Some hospital groups and networks, however, have begun to recognize that cost savings can be achieved—if not by reducing the number of people with diabetes, then decreasing the complications through increased pedorthic care. "There has been some activity in that direction," he notes.

Barriers to What's Best

In addition to the prohibitive costs of care, patients' lack of access to new, high-technology solutions was a prime concern then, and continues to be troubling today. "Since the audits began in 2012, we've definitely seen a decline and a shift away from certain high-value technology to lower-value technology," observes Brad Ruhl, past president of the American Orthotic and Prosthetic Association (AOPA) and managing director, Ottobock North America, headquartered in Austin, Texas. "The rate of growth in Medicare expenditures, according to historical measures, has slowed dramatically; the data supports that.

"I'm really concerned about whether technological innovations and advancements are going to be embraced by the payer community," he notes. "Because the barriers to creating new reimbursement pathways are greater than they have ever been.

"If this doesn't change, then we may actually return to the days of end users only having access to basic devices, because anything that's not basic may not be covered under the rules of reimbursement. End users, unable to rehabilitate to their full potential, are the ones that are going to suffer. And that's just not right."

He points to an apparent unwillingness on Medicare's part to create new codes for higher technology O&P solutions, even when there is evidence of cost savings on the back end that more than offset the upfront costs to treat the patient. 

McGill agrees that getting new codes approved remains a challenge for most, although Össur has been very fortunate with multiple applications over the last ten years.

In general, "the total number of submissions for code applications has dropped significantly over the last several years," he reports. "I suspect that's in part because people don't believe they can get a code, so they aren't even trying. Success rates for code applications have always been low, and that remains the case today."

That creates an issue with access to care for new technology and no easy answer is available, according to McGill. While some code applications are simply improperly prepared, he admits that many applications for good and valid technology not covered by current codes have inexplicably failed to earn new code approval—and thus effectively precluded delivery of state-of-the-art devices to Medicare patients.

"There are many ways in which a coding application can go sideways, most of which the person applying doesn't control," he adds, citing code approvals granted, but at fees lower than the cost of manufacturing the product; and codes and appropriate fees assigned, but with coverage restrictions that make the product unavailable to the targeted patient population. 

Despite these potential pitfalls, "it's easier to obtain access to new technology in the United States than in the rest of the world," he says, supported by his 12 years of experience in global manufacturing. "And that is a huge benefit for individuals with limb loss or other mobility impairments. Anything that decreases access to technology to people like me, who rely on these products to function, is obviously a concern to me."

Rogers believes that although the original intent of the L-Codes, when implemented in the 1970s, was to cover reimbursement for time spent in patient consultation and service, as well as for fabricating, fitting, and adjusting the device—current reimbursements have been and will continue to be reduced to the cost of the commodity provided—i.e., the durable medical equipment-style billing model rather than the intended service-oriented billing model.

"I think it's going to be a very difficult challenge for orthotics and prosthetics to differentiate themselves in an era of patient-centered care, so that we have a position in that circle of professionals providing care for the patient rather than working for somebody."

Contributing to this problem is CMS' apparent inability to accurately define or recognize "qualified providers"—an issue that continues to trouble the profession and has kept AOPA busy on Capitol Hill and beyond for the last decade, Eve Lee, MBA, CAE, AOPA executive director, reports. AOPA's efforts toward promoting legislation designed for patient protection have measured progress in two areas of perpetual interest to those serving patients:

BIPA 427 was approved in statute as the Benefit Improvements and Protection Act of 2000. Section 427 instructed Medicare to refuse reimbursement for orthotic and prosthetic devices and services to anyone who was not a "qualified provider." Seventeen years later, CMS obeyed the mandate, and on January 11, 2017—just nine days before the end of the Obama administration, issued a proposed rule for enacting the regulation, Lee explains. "The rule, as written, had some unfortunate overreach: It required any physician, PT, or OT to be either licensed (in a licensure state) or (in the other 32 states) accredited in orthotics and prosthetics by a certifying body."

Since physicians and therapists are already licensed in most states to perform within their scope of practice—which is exceptionally broad for physicians, and subject to interpretation and debate for therapists—it was unrealistic for CMS to propose that anyone from either of those two groups would have to receive additional credentialing, especially since both groups have many more members than orthotics and prosthetics, and each has powerful lobbying representation.

"Instead of fixing this proposal, which could have been easily done, the administration withdrew the proposal entirely after registering and reviewing some 5,000 comments," notes Lee.

The Medicare Orthotics & Prosthetics Improvement Act of 2017 (S.1191) was a bill originally introduced in Congress in 2008 to link eligibility for reimbursement under the L-code system to the credentials and certification of the practitioner. It has since been reintroduced in each subsequent Congress, with minor adjustments:

(1) to address the issue of whether the prosthetist/orthotist's records would be considered part of the medical record, on which Medicare bases its determination of medical necessity for a specified treatment or device (Enacted in 2018); (2) to correctly redefine an off-the-shelf orthotic device as "one that can be used by the patient with minimal self-adjustment." This was done in response to Medicare exceeding their authority by amending the statute and striking the word "self," to say "with minimal adjustment." (Since this drastically changed the meaning, allowing virtually anyone to fit the device wearer, it raised significant controversy before being corrected.*); and (3) to clearly differentiate orthotics and prosthetics from durable medical equipment; still in process.*

*As of this writing, new bills are under review for reintroduction in the 2019 Congress.

The AOPA Staff Report (www.aopanet.org/members/aopa-staff-reports) chronicles a lengthy list of legislative and regulatory progress during the past decade and reflects achievements on behalf of the profession and in defense of the best in patient care and outcomes. According to Lee, AOPA's ongoing efforts to increase the profession's knowledge base and to support the economic efficacy of orthotic and prosthetic intervention include the following:        

  • Continued support of future legislative efforts to serve O&P patient needs better through O&P PAC fundraising.
  • The formation of an Orthotics 2020 Medical Advisory Board, currently underway, with the goal of advancing non-branded studies and data to assess outcomes across identified categories of treatment. These projects will help protect the orthotic services upon which patients depend, by populating a stronger research base around issues on the value of orthotic services.
  • AOPA's continued commitment to the Prosthetics 2020 initiative, working with the Center for Medicare and Medicaid Innovation on a three-part proposal that would explore the health economic benefits of allowing patients with activity level designations lower than K3 to receive microprocessor-controlled prostheses. (The CMS Innovation Center allows the Medicare and Medicaid programs to test models that improve care, lower costs, and better align payment systems to support patient-centered practices.)
  • The Outcome Assessment Reporting System (OARS), currently in beta testing, offers an online application that walks a clinician through an outcome measure with written and video guidance, then creates a report that includes what the result means for the patient and provides references to the science supporting the measure. This report can then be printed or downloaded as a PDF for the patient's record.

Not Just Legislation, But Litigation?

Rogers describes a case in which one insurer has adopted the Medicare LCD for knee braces but misunderstands or misinterprets Medicare's stated parameters. Where Medicare specifies that the patient must have one of six different diagnoses, the insurer is denying claims for a knee brace unless the patient has all six diagnoses. Attempts to clarify by citing the statute have failed, and other patients' claims are being denied for the same reason. Since O&P practices typically don't have the time, training, or funding to pursue such disputes, must they simply absorb such losses?

"We certainly could use a legal assistance fund—or an orthotic and prosthetic watchdog that's funded through the industry," Rogers believes. "We could benefit from that hugely. Because it wouldn't take much—just a couple of precedents."

In Part III of this series, we'll look at how raising the bar in O&P education has changed our standards of professionalism and raised our expectations for patient care in the future.

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.