The Development of Coverage Policy for Lower Extremity Prosthetics: The Influence of the Payer on Prosthetic Prescription

Deanna Fish, MS, CPO

With more than 12 million people in the United States with extremity absence or limb loss,¹ lower extremity prosthetic coverage benefits are an important aspect in both acute rehabilitation and long-term functioning of affected individuals. Many factors play a role in medical coverage positions and policies. Utilization management and technology assessment are often based on a variety of definitions relating to prostheses and prosthetic care. Limited outcomes research from the prosthetic community fails to identify and quantify the benefits derived from various components, designs, and comprehensive rehabilitation programs. The absence of randomized controlled trials in peerreviewed journals further contributes to the lack of understanding of prosthetic prescription criteria and quality prosthetic care for persons with amputation. Historically, the prosthetic community has not been challenged to establish or demonstrate scientific evidence proving the effectiveness of prostheses in improving health outcomes for the user. This article provides insight into the payer perspective, provides an overview of utilization management, outlines technology assessment processes, and discusses mandated health benefits legislation. Efforts from the prosthetic community to enhance the value and validity of prosthetic prescription recommendations must be made for the benefit of all persons with amputation.

CLASSIFICATION

Defining an idea or a theory is the first step in scientific advancement. Without common classification or characterization, it becomes impossible to communicate effectively, document change, or report and reproduce success. Lack of definition from both the clinical and manufacturing realms has contributed to the confusion regarding new and established prosthetic technology within the payer community. Terminology such as medical necessity, prosthesis, prosthetic devices, durable medical equipment, and medical appliances are both narrowly and widely construed. The result is an ongoing inability to effectively communicate and substantiate the services and products provided in the prosthetic patient care setting. Table 1 ^2-18 lists common words and terms used by payers regarding prosthetic care and prosthetic rehabilitation and emphasizes the need for the development and acknowledgment of basic definitions. As evidenced in Table 1 , verbiage used to define a prosthesis is vague, varied, and confusing.

From the clinician's perspective, payers also share responsibility for confusion with unique qualifiers lacking consistent definition in individual benefit plans, such as predetermination, prior authorization, prior approval, precertification, pre-existing condition, coverage exclusions, plan benefit limitations, retroactive authorization, experimental or investigational, (not) medically necessary, qualified provider, benefit determinations, contractual limitations, etc. ^{2,4-7,9-11,19-33} Careful consideration of each payer's medical coverage guidelines, group contracts, member benefit information, and individual subscriber certificates is required before providing service to the individual. Coverage is subject to the terms and conditions of each individual's benefit package, but approval and/or payment is not guaranteed, even with prior contact with the payer. This severely affects the rehabilitation process for new patients and significantly delays the receipt of a replacement prosthesis for an existing user. The development of consistent prosthetic terminology, definitions, and medical review processes would serve to streamline rehabilitation efforts and improve the prosthetic care of persons with limb loss or absence.

UTILIZATION MANAGEMENT

Coverage positions and policies are the result of the findings of utilization management programs and the recommendations of technology evaluation committees. Utilization management evaluates the medical necessity and appropriateness of care for inpatient and certain outpatient services.³⁴ Utilization management programs also evaluate the settings in which the provision of services occurs. Clinical review of relevant medical information determines benefit eligibility relative to the individual's health plan and current medical needs. Medical review programs (i.e., retrospective review) evaluate prior services for coding/billing irregularities, overuse of codes/ procedures, procedures determined to be not medically necessary (e.g., cosmetic), contractual limitations or benefit exclusions, and noncompliance with established administrative procedures (i.e., lack of prior authorization).

These types of programs are the basis for the development of coverage policy for lower extremity prostheses and prosthetic care procedures. Some payers may consider a prosthesis to consist of a socket, suspension mechanism, knee joint, pylon, and foot. Additional prosthetic services covered in the basic coding procedures include patient evaluation, gait assessment, casting/scanning the residual limb, fitting the prosthesis, repairs and adjustments for 90 days after delivery attributable to normal wear and tear, and repairs and adjustments for 90 days after delivery not attributable to significant changes in the residual limb or patient's functional ability.⁹ Components or additions are considered with supporting documentation of medical necessity; however, a small number of payers may be reluctant to provide coverage for what are arbitrarily and inconsistently considered to be "enhanced" features.

TECHNOLOGY EVALUATION

Technology evaluation committees are given the task of reviewing "currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence- based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors)."³² Evaluation of the supporting documentation must reveal a scientific basis for positive health outcomes, substantially equivalent benefits as established alternatives, and reproducible improvements beyond the research setting.^31,35 A technology assessment report often includes the following components: background, reason for required review, Food and Drug Administration (FDA) status, indications for use, literature review, similar treatments, associated costs, other payer policy positions, and final recommendations. Ultimately, the goal of the technology assessment program is to produce timely and scientifically credible reports on new technology to assist in the development of policy decisions that promote consistent coverage decisions.³⁶ These reports are also used for case management, risk management, quality management, and utilization management.

In recent years, the lack of peer-review, randomized controlled trials has hindered the prosthetic community and limited the ability to prove the efficacy of various prosthetic components and designs. The few published studies that exist report single cases or are limited to small groups of highly selected individuals. From the payer perspective, this type of reporting makes it difficult to develop coverage policy decisions without sound clinical guidelines or established selection strategies for individuals who would most benefit from the technology. Few published articles represent structured research, and descriptive support for particular components is common. The lack of sufficient scientific evidence may limit the clinical application of available prosthetic technology for persons with amputation.^{9,20,25,32,37} Ultimately, a clinical paradox has been created within the prosthetic community. Valid comparison of new to accepted technology cannot be made in the absence of existing standards of care and clinical guidelines.

Insurance companies historically have accepted the Medicare L-Code system as the foundation for component acceptance and reimbursement levels. During the past few years, denial for coverage of particular components has been made by a small number of payers on the basis of "experimental, investigational, and/or unproven." ^{9,20,22,23,25,29,32} This initiates an appeal process that delays care to the individual and increases operating costs to both the payer and provider. Denials can be overturned with substantive documentation and perseverance on the part of the provider. Other payers have collaborated to develop specific coverage criteria for the implementation of new prosthetic technology.^38,39

COVERAGE POLICY

As an example, the coverage and reimbursement status of microprocessor knee units continues to evolve. Microprocessor knee units are included in the Healthcare Common Procedure Coding System, are covered by Medicare, and have received recognition from the FDA. The US Department of Veterans Affairs has developed specific prescription criteria based upon recommendations of the VA Technology Assessment Program.³⁸ The State of Washington Department of Labor and Industries studied microprocessors and created a coverage policy largely based on the VA's findings.^36,37 Other groups have followed suit and created coverage policy based upon utilization management review and technology assessment programs. Documented scientific evidence produced by the prosthetic community will dramatically increase the level of understanding and appropriateness of care that this new prosthetic technology provides the person with limb loss.

From the patient perspective, consideration of prosthetic coverage policy is important relative to employment opportunities and health care program choices. Specifically, persons with lower limb amputation need to understand how prosthetic coverage is determined or defined. Some policies consider prosthetic care as part of durable medical equipment and may impose an annual dollar limit. Other policies may provide coverage for the initial prosthesis but not for ongoing repairs beyond the warranty period, or they may place an annual dollar limit for repairs. Prosthetic benefits may stipulate one prosthesis per lifetime or require that an extended period of time pass before covering a new prosthesis, regardless of the degree of changes in the residual limb or person's functional ability. It is also a good idea to consider contractual relations with prosthetists or prosthetic companies in terms of geographic accessibility and the company's ability to accommodate after-hours and emergency services. Finally, it is important to understand the appeals process when claims are denied, the number of prosthetic appeals occurring in recent years, and the outcome of those appeals. An informed consumer can select health care plans that best meet the needs of the individual.

MANDATED PROSTHETIC HEALTH PLAN BENEFITS

Several states have recently passed prosthetic parity legislation that requires all insurance companies provide coverage for prostheses. Other states and organizations such as the Amputee Coalition of America are working to pass similar legislation in a number of states. This type of legislation ensures that, at a minimum, the coverage should "equal the coverage and payment for prosthetic devices provided under federal laws and regulations for the aged and disabled." ¹⁵ The covered prosthetic benefits may include "a prosthetic device determined to be the most appropriate model that adequately meets the medical needs of the enrollee" and may exclude "a prosthetic device that contains a microprocessor or that is designed exclusively for athletic purposes." ^15,40

Proponents of this new legislation hope to increase the availability of prosthetic products and services and also to decrease the financial burden on persons with congenital or acquired limb loss. Based upon national statistics, prosthetic parity legislation potentially affects approximately 0.21% of the orthotic and prosthetic user population younger than 65 years, and most of these individuals already have some form of coverage.⁴¹ The mandated health benefits simply ensure appropriate and ongoing coverage for persons with such physical challenges. Opponents of the legislation are concerned about the cost of the mandated benefits, the potential for some people to lose insurance coverage, and determinations made by the physician versus the payer as more technologically advanced devices tend to increase the overall cost to the health care system.

DISCUSSION

Technology is evidenced each day and enhances the lives of all people. For persons with disabilities, technology not only enhances basic life experiences but also allows or promotes functional capabilities, employment opportunities, participation in family or social activities, and independence from others for basic and advanced life care skills. It becomes the responsibility of providers of prosthetic care and producers of prosthetic components to create the body of work necessary to allow the consumer maximum access to this technology. Because of the overwhelming lack of scientific research from the prosthetic community, the following recommendations are provided for consideration:

1. Development of clear and uniform definitions for prosthetic rehabilitation.

2. Development and implementation of objective measures of patient evaluation to determine appropriateness of care.

3. Development and implementation of objective measures of prosthetic quality and function.

4. Development of structured interaction between clinical practice and research processes.

5. Randomized controlled trials must be performed to document efficacy and efficiency of new and existing prosthetic technology.

6. Development and implementation of clinical guidelines for prosthetic prescription criteria to improve the uniformity and consistency of prosthetic outcomes.

7. Establishment of evidence-based practices for the reliable and reproducible use of prosthetic components and designs.

Correspondence to: Deanna Fish, CPO, Linkia, 1508 West Elm Hill Circle, Taylorsville, UT 84123; e-mail: .

DEANNA FISH, MS, CPO, is chief clinical officer of Linkia in Taylorsville, UT.

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