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INDEPENDENCE iBOT 4000 Mobility System: An Interactive Balancing Mobility System

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Date:

01/26/2006

Public Comment Period:

04/28/2006 - 05/30/2006   

Title:           INDEPENDENCE iBOT 4000 Mobility System: An Interactive Balancing Mobility System

Issue:

The INDEPENDENCE iBOT 4000 Mobility System is an all in one mobility device for Medicare beneficiaries with long-term mobility impairments whose functional status is severely compromised by the limitations of existing mobility technology. The iBOT Mobility System is a power mobility device with the following features: (a) a standard function that operates similar to a traditional power wheelchair; (b) seat elevation/vertical ambulation in a standing eye-level position; (c) automatic balancing and stabilization; (d) reach and extension capabilities; (e) ability to climb stairs, curbs, and other obstacles; (f) ability to maneuver in confined spaces; (g) 4-Wheel functions to travel across a wide range of variable surfaces; and (h) mobility on flat, hard surfaces.

The iBOT functions of stair and curb climbing, 4-Wheel functions, and seat elevation are all reliant upon its iBALANCE Technology. The iBALANCE Technology is an electronic balance system of sensors, gyroscopes, and software components that work together to mimic the principles of human balance to provide dynamic stabilization. The iBALANCE Technology maintains balance in the forward and backward direction but does not electronically maintain side-to-side stability.

The FDA’s pre market approval process imposed restrictions specific to the iBOT device. Patients must: (a) weigh no more than 250 pounds; (b) be able to bend his or her knees and hips such that the patient’s back and feet fit on standard rests the backrest does not recline to accommodate users who cannot sit in a standard wheelchair; (c) meet drivers licensing criteria established in 1996 by the Epilepsy Foundation of America; (d) have sufficient use of at least one upper extremity; (e) not require mechanical ventilation; (f) not currently require use of a tilt or recline seating system as a mechanical method of pressure relief; and (g) be able to use their current postural supports and these supports are compatible/comparable with the postural supports on the iBOT device. Additionally, the device must be ordered by the treating physician, requires a prescription, an assessment completed by a trained clinician, and the beneficiary must complete a comprehensive training program on how to safely operate the multiple functions of the device.

We have received a formal and complete request to develop a NCD providing for coverage of the iBOT 4000 Mobility System under the DME benefit and under the generic term “Interactive Balancing Mobility Systems.” We have not made a benefit category determination for the Interactive Balancing Mobility System. As determinations of benefit categories are a prerequisite for determinations of reasonableness and necessity, we are opening a formal review of the benefit category determination as part of the NCD process.

Benefit Category:          To be determined

Requestor Name(s):          Independence Technology, LLC a Johnson & Johnson Company

Requestor Letter(s):          View Letter

Expected Completion Date:          October 26, 2006

PDM Due Date:          July 26, 2006

Lead Medical Officer(s):          James Bowman, MD

Lead Analyst(s):

Linda Smith, RN, MSN, MBA
410-786-5650
Linda.Smith@cms.hhs.gov

Actions Taken

January 26, 2006

CMS opens NCD process. 30-day public comment period begins.

February 22, 2006

CMS extends comment period 1 week due to delay in posting complete request ans systems problems.

April 28, 2006

May 26, 2006

CMS extends comment period 2 days due to Federal Holiday.

July 27, 2006

CMS posts decision memo.

National Coverage Determination(s):           280.15


Proposed Decision Memo

To:                   Administrative File:
                        INDEPENDENCE iBOT 4000 Mobility System


From:               Laurence Wilson
                        Director, Chronic Care Policy Group

                        Carol Blackford
                        Division Director, Community Post Acute Care

                        Linda D. Smith, RN, MSN, MBA
                        Lead Analyst

                        James Bowman, MD
                        Lead Medical Officer


Subject:           Proposed Coverage Decision Memorandum for the INDEPENDENCE iBOT 4000 Mobility System


Date:                April 28, 2006

I. Proposed Decision

The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on our proposed determination that there is: a) sufficient evidence to conclude that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment (DME); b) insufficient evidence to conclude that the 4-Wheel, Balance, Stair, and Remote Functions of the equipment meet the definition of DME; and c) sufficient evidence to conclude that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary for Medicare beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home.

Accordingly, we propose to provide Medicare coverage of the INDEPENDENCE iBOT 4000 Mobility System, Standard Function only, under the DME benefit when it is reasonable and necessary to treat or improve a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. We also propose that the determination of a personal mobility deficit for which the provision of the INDEPENDENCE iBOT 4000 Mobility System is appropriate will use the algorithmic process, Clinical Criteria for Mobility Assistive Equipment (MAE), as outlined in the National Coverage Determination (NCD) for MAE (Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.1).

We are requesting public comments on this proposed determination pursuant to section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). After considering the public comments and any additional evidence, we will make a final determination and issue a final decision memorandum.

II. Background

Independence Technology, a Johnson & Johnson company, submitted a formal request to the CMS to develop a NCD providing for coverage of the INDEPENDENCE iBOT 4000 Mobility System under the DME benefit and under the generic term “Interactive Balancing Mobility Systems.” Since Medicare benefit categories are a prerequisite to determinations of reasonableness and necessity for a NCD, we posted a tracking sheet that, as part of the NCD process, solicited public comment on the benefit category determination (BCD) for the INDEPENDENCE iBOT 4000 Mobility System.

The INDEPENDENCE iBOT 4000 Mobility System is a battery-powered mobility device that relies on a computerized system of sensors, gyroscopes, and electric motors to allow indoor and outdoor use on stairs as well as on level and uneven surfaces.1 The INDEPENDENCE iBOT 4000 Mobility System incorporates a number of different functions, including: a) Standard Function that provides mobility on smooth surfaces and inclines at home, work, and in other environments; b) 4-Wheel Function that provides movement across obstacles, uneven terrain, curbs, grass, gravel, and other soft surfaces; c) Balance Function that provides mobility in a seated position at an elevated height; d) Stair Function that allows for ascent and descent of stairs, with or without assistance; and e) Remote Function that assists in the transportation of the product while unoccupied.

In Standard Function, the INDEPENDENCE iBOT 4000 Mobility System does not use the iBALANCE Technology (described below). In this function, the mobility system behaves like a traditional power wheelchair. The seat is at the lowest available position. The casters attached to the base of the seat are in contact with the ground and the front drive wheels are raised off the ground. The casters provide good turning performance in this function. The maximum speed is 6.8 miles per hour with a maximum drive range of 12.4 miles. The mobility device can be programmed for Standard Function only to meet the assessed needs of the user.

The INDEPENDENCE iBOT 4000 Mobility System operates in the 4-Wheel, Balance, Stair, and Remote Functions by using an integrated combination of gyroscopes, sensors, and computer processor systems that are customized to the user’s size, weight, and center of gravity. This is known as iBALANCE Technology. The mobility device is programmed and calibrated to allow it to realign and customize itself to the movements of the user. When the gyroscopes sense movement, a signal is sent to the computer, which processes the information and tells the motors how to adjust the wheels to maintain stability and balance. The iBALANCE Technology maintains balance in the forward and backward direction. It does not electronically maintain lateral or side-to-side stability. Potential users of the INDEPENDENCE iBOT 4000 Mobility System are required to have an initial assessment by a specially trained health care practitioner, who determines whether the user is a good candidate for the device and which operating functions to activate, depending on the assessment results. All users currently receive a mobility device programmed to operate in Standard Function, 4-Wheel Function and Remote Function.

In 4-Wheel Function, the INDEPENDENCE iBOT 4000 Mobility System enables users to traverse inclines up to 10 degrees and over soft, uneven terrain such as sand, gravel, dirt, grass, etc. In this function, the device can also navigate over obstacles up to 5 inches. The 4-Wheel Function uses the iBALANCE Technology, which processes the sensor data and user commands so that the device reacts to changes in pitch caused by the changes in terrain, external impacts, and other factors.

In Balance Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to move the user from a seated position where the four wheels are in contact with the ground to an elevated seated position where the four wheels rotate to a vertical position balancing on two wheels while the user remains in a seated position. This is accomplished by the combined weight of the device and the user shifting over the back wheels. The device reacts to this center of gravity change by transitioning up onto two wheels. The seat height can be raised and lowered to facilitate the reaching of objects on shelves or having an “eye-level” conversation with a standing person. Balance Function is used on firm surfaces with an incline up to 5 degrees and obstacles up to 1 inch.

In Stair Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to ascend and descend stairs. Stair climbing is achieved by the rotation of the clusters over the stairs using a similar closed-loop control algorithm that uses pitch and sensor data to control the cluster motors. The device strives to keep the center of gravity of the system over the ground contacting wheels. When a user leans either forward or back (or an assistant leans the device), shifting the center of gravity, the device will rotate the clusters in response, which will result in the device climbing down or up one stair respectively. The user will climb up or down a staircase facing down the stairs with the direction of the weight shift (lean) determining the direction of climbing. The user or assistant is the input device during stair climbing since he or she controls the rate of climbing and provides stability (by the user holding the stair handrails or the assistant holding the assist handles).

In Remote Function, the user can operate the INDEPENDENCE iBOT 4000 Mobility System when it is not occupied by removing the user control panel, which is connected to the armrest through a retractable cable. Remote Function uses the iBALANCE Technology to assist the user in maneuvering the device for transfers, parking the device after a transfer, driving the device into a vehicle for transport and for other purposes.

III. History of Medicare Coverage

Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Title XVIII of the Social Security Act (Act) governs the Medicare program. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. The scope of benefits under Part B is defined in the Act under section 1832. Section 1861(n) lists items that are included as durable medical equipment (DME)), and section 1861(s) defines the term “medical and other health services.” Section 1861(n) of the Act specifically identifies wheelchairs as DME. In addition, 42 CFR 414.202 of our regulations defines DME as equipment which: (a) can withstand repeated use; (b) is primarily and customarily used to serve a medical purpose; (c) generally is not useful to a person in the absence of an illness or injury; and (d) is appropriate for use in the home. For items to be considered DME, all requirements of the definition must be met.

The CMS policies for determining whether an item meets the 4-prong definition of DME are outlined in our regulations and in the Medicare Benefit Policy Manual, Chapter 15, Section 110.1, Publication 100-02. In evaluating whether the first prong is satisfied, we will generally consider an item to be durable if it can withstand repeated use. Under the second prong, equipment is considered to be medical equipment if it is primarily and customarily used to serve a medical purpose. Equipment that is primarily and customarily used for a nonmedical purposes may not be considered “medical” equipment for which payment can be made under the Medicare program, even if the item has some remote medically related use. For example, equipment used for environmental control and to enhance the environmental setting in which the beneficiary is placed are not considered to be medical equipment and are not covered DME. Under the third prong, the item must be useful to a person for the treatment of an illness or injury, and expected to make a meaningful contribution to the treatment of the individual’s illness or injury or to the improvement of his or her malformed body member. Finally, under the fourth prong, equipment is appropriate for home use when the individual has a medical need for the use of the item in the home. Additionally, the Medicare Benefit Policy Manual, Chapter 16, Section 20, Publication 100-02, describes the general exclusions from Medicare coverage. Items and services, which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, are not covered.

The Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Publication 100-03 addresses coverage of items and medical equipment within the benefit category of DME. Section 280.1 of this manual, “Durable Medical Equipment Reference List,” provides a quick reference tool for determining the coverage status of certain DME. Even if an item falls within the definition of DME, it cannot be covered unless it is necessary and reasonable for treatment of an illness or injury, or to improve the functioning of a malformed body member.

An NCD is defined to be a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Act, but does not include a determination about which code, if any, is assigned to a particular item or service covered under Title XVIII, or a determination with respect to the amount of payment for a particular covered item or service (see 68 FR 55634, September 26, 2003).

CMS has issued several NCDs regarding various mobility assistive equipment. We most recently issued a NCD for Mobility Assistive Equipment (MAE) on May 5, 2005, which concludes that MAE is covered under the benefit category of DME if it is reasonable and necessary to treat or improve a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Determination of the presence of a mobility deficit uses an algorithmic process outlined in the Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.3, Publication 100-03.

IV. Timeline of Recent Activities

January 26, 2006

CMS opened an NCD to evaluate coverage of the INDEPENDENCE iBOT 4000 Mobility System in the Medicare population in response to a formal NCD request. The initial 30-day public comment period began. Due to website problems, we extended the public comment period an additional week.

March 6, 2006

End of public comment period. 146 comments received.

April 28, 2006

Proposed decision posted for a 30-day public comment period.

V. FDA Status

On March 14, 2005, the FDA, using its premarket approval (PMA) process, approved generational changes to the INDEPENDENCE iBOT 3000 Mobility system under the trade name INDEPENDENCE iBOT 4000 Mobility System. The INDEPENDENCE iBOT 3000 Mobility System approval by the FDA, in August 2003, was based on a review of extensive bench testing and a clinical study by the manufacturer, Independence Technology, a Johnson and Johnson (J&J) company. The FDA approval of the INDEPENDENCE iBOT 4000 Mobility System was based on non-clinical bench tests that, according to the FDA, demonstrated that the modified device is safe and effective. The FDA approved the INDEPENDENCE iBOT 4000 Mobility System with the following labeled indication:

“for individuals who have mobility impairments and the use of at least one upper extremity.”2

In addition, the FDA imposed restrictions specific to the INDEPENDENCE iBOT 4000 Mobility System. Patients must: (a) weigh no more than 250 pounds; (b) be able to bend his or her knees and hips such that the patient’s back and feet fit on standard footrests; (c) meet drivers licensing criteria established in 1996 by the Epilepsy Foundation of America; (d) have sufficient use of at least one upper extremity; (e) not require mechanical ventilation; (f) not currently require use of a tilt or recline seating system as a mechanical method of pressure relief for activities of daily living; (g) be able to use his or her current postural supports and these supports are compatible/comparable with the postural supports on the iBOT device; (h) have good enough function to dial a push button telephone or operate a hand operated joystick; (i) not have experienced a loss of consciousness or had a seizure in the past 90 days; and (j) not have severe osteoporosis, osteogenesis imperfecta or metastatic bone cancer. Additionally, the device must be prescribed by the treating physician and cannot be dispensed unless an assessment is completed by a trained clinician. In addition, the beneficiary must complete a comprehensive training program on how to safely operate the multiple functions of the device.

VI. General Methodological Principles

As part of the NCD process, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will diagnose or treat an illness or injury or improve the functioning of a malformed body member for patients. An improved functioning of a malformed body member is one of several considerations in determining whether an item or service is reasonable and necessary.

A detailed account of the methodological principles of study design that CMS utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix A. In some situations in making benefit category determinations, we may use the methodological principles in Appendix A in determining the scope of Medicare benefits. In general, features of clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, and the blinding of readers of the index test, and reference test results.

VII. Evidence

A. Introduction

We are providing a summary of the evidence we considered during our review. We will consider additional evidence submitted through the public comment period. The evidence reviewed to date in this proposed decision memorandum includes the published literature on the INDEPENDENCE iBOT 4000 and 3000 Mobility Systems; the Medicare statutes, regulations, and policies pertinent to mobility equipment and Medicare coverage; clinical studies; and technology assessments.

B. Discussion of Evidence Reviewed

1. Assessment Questions

To assess Independence Technology’s request, CMS posed the following questions:

Is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment for purposes of assigning it to the DME benefit category?

If the quality of evidence is sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System can be assigned to the DME benefit category, is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member for Medicare beneficiaries?

2. External technology assessments

CMS searched PubMed Central, International Network of Agencies for Health Technologies Assessment (INAHTA), Cochrane Library, and the National Guidelines Clearinghouse databases to identify external technology assessments conducted on the INDEPENDENCE iBOT 4000 Mobility System. Search terms included iBOT 4000, technology assessment mobility equipment, assistive technology, and iBOT 3000. We identified one external technology assessment conducted on the INDEPENDENCE iBOT 3000 Mobility System; however, we did not find external technology assessments for the INDEPENDENCE iBOT 4000 Mobility System. Since the FDA, using its PMA review process, approved the INDEPENDENCE iBOT 4000 Mobility System as a generational change to the INDEPENDENCE iBOT 3000 Mobility System, we considered information from the INDEPENDENCE iBOT 3000 Mobility System technology assessment in our review.

The TARGET database (2004) cited a technology assessment of the INDEPENDENCE iBOT 3000 Mobility System that was conducted by ECRI. ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services research agency designated as an Evidence-based Practice Center (EPC) by the U.S. Agency for Healthcare Research and Quality. ECRI described the INDEPENDENCE iBOT 3000 Mobility System as closely resembling a conventional wheelchair with four main drive wheels, two on each side. The drive-wheels are called “clusters” and pivot around a central axle. The user relies on a position-sensing joystick and a control panel attached to the armrest to operate the system in one of five modes (Standard, 4-Wheel, Stair, Balance, and Remote Functions). ECRI concluded that available data were insufficient to conclude whether the iBOT 3000 improved a patient’s mobility, independence, and quality of life. Additionally, ECRI concluded that the study submitted to the FDA for marketing approval had a small sample size, short duration, and nonstandardized functional measures. ECRI further found that the primary effectiveness measures used to test the device primarily focused on the capabilities of the iBOT Mobility System (e.g., climbing stairs, going up curbs, negotiating an elevator, traveling up an incline, elevating user to retrieve a book off a high shelf), rather than functional tasks (e.g. eating, toileting, bathing and maneuvering in the home) encountered by users of the iBOT Mobility System.

3. Internal technology assessments

CMS searched the PubMed Central, International Network of Agencies for Health Technologies Assessment (INAHTA), Cochrane Library, National Guidelines Clearinghouse databases and used the Google Internet search engine to find research related to the INDEPENDENCE iBOT 4000 Mobility System and how its function provided a medical benefit. We did not find articles specific to the INDEPENDENCE iBOT 4000 Mobility System. Since the FDA, using its PMA review process, approved the INDEPENDENCE iBOT 4000 Mobility System as a generational change to the INDEPENDENCE iBOT 3000 Mobility System, we considered information on the INDEPENDENCE iBOT 3000 Mobility System in our review.

Independence Technology submitted as part of its NCD request the results of the clinical trials conducted on the INDEPENDENCE iBOT 3000 Mobility System, which was part of the premarket approval package to the FDA. The FDA (2003) used this information in its pivotal study assessing the safety and effectiveness of the mobility device. The FDA’s objectives of the study were to demonstrate that individuals with a variety of mobility skills would be able to safely and effectively use the device in real world environments, and to demonstrate that subjects would improve with respect to objective and subjective measures of functional activities. The study reported on a single center, prospective, balance, open label evaluation that utilized participants as their own control. The subjects ranged between 18 and 80 years of age and used a manual wheelchair, a power wheelchair with a hand-operated joystick control, or a scooter as the primary mobility device. Twenty subjects completed the study. Data were collected on safety, accessibility, operational problems, and mechanical problems on a daily basis through telephone contact with each subject. The primary effectiveness of the device was accomplished through data collected after the subjects completed a Community Driving Test that found the iBOT Mobility System to be more difficult to maneuver in the home compared to outdoors and more difficult to maneuver than other personal mobility equipment. Additional information related to the usage, failures, and alerts, in connection with the mobility system were downloaded over the telephone line daily. The study did not include findings to demonstrate how the 4-Wheel, Balance, Stair, or Remote Functions of the INDEPENDENCE iBOT 3000 Mobility System were primarily and customarily used to meet a medical benefit.

The FDA approved the INDEPENDENCE iBOT 4000 Mobility System based on generational changes to the INDEPENDENCE 3000 Mobility System and used non-clinical bench tests to demonstrate that the modified device was safe and effective. Additionally, the FDA determined that additional clinical testing was not necessary for the types of changes made.  The generational changes made from the original iBOT 3000 to the new iBOT 4000 included the following:

  • A lower seating height, allowing the user to maneuver more easily when seated at a table or desk.
  • Allows the user to occupy the device while it is being transported in a wheelchair-accessible vehicle.
  • The power button repositioned to make it more accessible to the user.
  • Swing-away footrests, making entry and exit easier.
  • A modified automotive-style seating system, in addition to the standard rehab seat.
  • A lighting system for night visibility, lighted directional signals (blinkers), and a horn.
  • A new caster wheel design.
  • A higher capacity battery, allowing longer use on a single battery charge.
  • Device can be sold with stair-climbing function turned off.
  • 4-Wheel Function: Maximum incline of 10 degrees
  • 4-Wheel Function: Maximum obstacle height of 5 inches
  • Balance Function: Maximum obstacle height of 1 inch
  • Standard Function: Maximum obstacle height of 1 inch
  • Remote Function: Maximum incline of 20 degrees
  • Remote Function: Dynamic stabilization not active
  • Maximum speed: 6.8 mph in Standard Function
  • Maximum drive range: 12.4 miles in Standard Function

4. MCAC

A Medicare Coverage Advisory Committee (MCAC) meeting was not convened on this issue.

5. Evidence-based guidelines

No evidence-based guidelines were identified with respect to making Medicare benefit category determinations. However, we identified the MAE NCD as an evidence-based guideline on the appropriate prescription of mobility assistive equipment, including wheelchairs, which fall under the DME benefit category.

6. Professional Society Position Statements

A search for published professional society position statements on the appropriate designation of a Medicare benefit category and the medical benefit for 4-wheel, power seat elevation, and stair climbing assistive technology were conducted. No professional society position statements were identified prior to the public comment period.

We received three professional society position statements through public comment:

  • The American Academy of Neurology supports coverage of the INDEPENDENCE iBOT 4000 Mobility System, as it believes the device significantly enhances the functional status of neurology patients.
  • The American Academy of Physical Medicine and Rehabilitation advocates for the greater coverage of a broad array of enhanced wheelchair options that better meet the environmental challenges facing those with significant mobility limitations. The Academy supports coverage of the INDEPENDENCE iBOT 4000 Mobility System and states that denial will discourage inventors and manufacturers from investing in new rehabilitation solutions to alleviate the daily burdens associated with disabilities.
  • The Rehabilitation Engineering and Assistive Technology Society of North America supports coverage for the INDEPENDENCE iBOT 4000 Mobility System as MAE consistent with what it claims to be other “federal policies,” such as the ADA and New Freedom Initiative. The society believes that these policies enable individuals with disabilities to participate in activities at home and in the community.

7. Public Comments

Initial public comments

Initial Comment Period: January 26, 2006 - March 6, 2006

CMS received 146 comments during the initial public comment period. Forty-eight comments (33%) were from patients, family members, or acquaintances of patients using an INDEPENDENCE iBOT 3000 or 4000 Mobility System, other powered wheelchair equipment, or manual wheelchairs. Fifty-seven comments (39%) were from advocacy groups for persons with disabilities, State offices, and other interested parties representing persons with disabilities. Forty-two comments (28%) were from physicians, physical therapists, neurology and rehabilitation practitioners, or other health professionals. The majority 142 (97%) of these comments supported coverage of the INDEPENDENCE iBOT 4000 Mobility System under the DME benefit. No published scientific evidence was submitted, other than that which was received in the NCD request.

Public comments received as of March 6, 2006, are summarized below:

  • Patients, family members, or acquaintances of patients using a powered or manual mobility assistive device stated that the INDEPENDENCE iBOT 3000 and 4000 Mobility System assisted them or had the potential to assist persons with disabilities to reach their cabinets or closets, go up and down stairs, have an eye level conversation, attend community activities outside the home, work in their yards, and obtain employment. Many of the commenters requested that the INDEPENDENCE iBOT 4000 Mobility System be covered as DME under a new benefit category “Interactive Balancing Mobility Systems.”
  • Physicians and other health professionals treating persons with mobility deficits reported that the INDEPENDENCE iBOT 4000 Mobility System has functions that other wheelchairs do not have (i.e., stair climbing, seat elevation to standing eye level and reach maneuvers) and should be covered as DME. They acknowledged the extensive training required of the beneficiary and that the device needs to meet the needs of the beneficiary. No health professionals provided evidence of how all the functions of the iBOT primarily served a medical purpose.
  • Four persons opposed the coverage of INDEPENDENCE iBOT 4000 Mobility System under a new benefit category “Interactive Balancing Mobility Systems” and supported the coverage only of the Standard Function as DME. In particular, these commenters expressed concern over the fact that there is other medical equipment on the market that provide standing, reach and seat elevation functions but are not covered under Medicare. Two commenters stated that the beneficiary is always in a sitting position, which poses a risk of pressure ulcer development. Two commenters stated that coverage of a manufacturer’s product would allow manufacturers to develop technology just to get their product covered.

Some of the public comments related personal experiences submitted by wheelchair users who test drove the INDEPENDENCE iBOT 4000 Mobility System or purchased one for personal usage. Most of the comments related to support of the device based on a review of the literature and research presented by Johnson & Johnson. We recognize that they are reporting positive reviews of the device. However, individual anecdotal reports, without scientific evidence of its relation to the improvement of mobility deficits in serving a medical purpose, do not constitute sufficient evidence to disregard more methodologically rigorous data.

VIII. CMS Analysis

National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act, § 1869(f)(1)(B). Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. The scope of benefits under Part B is defined in the Act under sections 1832. Section 1861(n) lists items that are included as durable medical equipment (DME), and section 1861(s) defines the term “medical and other health services.”

The CMS uses the definitions in the Act and our regulations, as well as other established policies, to determine if an item or service falls within one or more Medicare benefit categories. Medicare payment is contingent upon a determination that an item or service falls under a benefit category, is not specifically excluded from coverage, and is ‘‘reasonable and necessary.’’ In conducting our analysis of whether an item or service falls within the DME benefit category, the CMS reviews the functions, features of the item or service, as well as applicable research and clinical studies that demonstrate how it meets the definition of DME, and serves a medical purpose.

CMS assesses relevant health outcomes, above and beyond the safety and effectiveness regulatory mandate of the FDA. Although medical equipment must generally receive FDA approval or clearance for at least one indication to be eligible for Medicare coverage, FDA approval/clearance alone does not entitle that equipment to Medicare coverage. The equipment must fall under a Medicare benefit category, be reasonable and necessary for the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body member, and not otherwise be excluded from coverage to be covered by Medicare.

Question #1:

Is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment for purposes of assigning it to the DME benefit category?

As stated in Section III, Section 1861(n) of the Act specifically identifies wheelchairs as durable medical equipment. In addition, 42 CFR 414.202 further defines DME as equipment which: (a) can withstand repeated use; (b) is primarily and customarily used to serve a medical purpose; (c) generally is not useful to a person in the absence of an illness or injury; and (d) is appropriate for use in the home. For items to be considered DME, all requirements of the definition must be met.

Much of the reported research on the INDEPENDENCE iBOT 4000 Mobility System appears in the NCD request and the FDA Summary of Safety and Effectiveness Data and has not yet been published as full peer-reviewed journal articles. In general, we give greater evidentiary weight to data from peer-reviewed, published clinical trials, with statistically robust samples of subjects representative of Medicare beneficiaries, to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would be limited in terms of its application to Medicare beneficiaries.

We did not find published clinical evidence on the INDEPENDENCE iBOT 4000 Mobility System and how it serves a medical purpose, including improving a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Specifically lacking are large clinical trials studying the medical benefits achieved by the 4-Wheel, Balance, Stair, and Remote Functions in a population representative of Medicare beneficiaries. As stated above, we reviewed for purposes of this analysis the available published literature, clinical studies, and technology assessments for both the INDEPENDENCE iBOT 4000 and 3000 Mobility Systems, since the iBOT 4000 is approved as a generational change to the iBOT 3000. The clinical trials had many limitations, including a small sample size. In addition, the effectiveness measures focused on the capabilities of the iBOT Mobility System and did not correlate the findings to demonstrate the medical benefit to the user. While the study results identified user reported data related to stair and curb climbing, reaching high objects, and outdoor usage, these are not measures of functionality that meet the prong of the DME definition that requires that an item be primarily and customarily used to serve a medical purpose.

The evidence reviewed supports the conclusion that the INDEPENDENCE iBOT 4000 Mobility System operates in Standard Function similar to a traditional power operated wheelchair and serves the same medical purpose of improving a beneficiary’s performance of mobility related activities. For these reasons, we believe that the Standard Function is properly classified as DME. Historically, Medicare has covered power-operated wheelchairs as DME, but if the wheelchair includes other enhancing features, such as a 4-wheel drive and/or remote function, Medicare has limited its coverage only to the wheelchair, since the enhancing features do not serve a medical purpose or are generally inappropriate for use in the patient’s home (and, thus, are not DME). Therefore, consistent with our long-standing policy, we believe we can conclude that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System, which can be programmed independently of the iBALANCE Technology, is DME without necessarily reaching the same conclusion with respect to the other enhancing features of the equipment which, in this case, are described as four functions (4-Wheel, Balance, Stair, and Remote). The fact that the underlying technology has been built into one device does not guarantee coverage of features that are considered noncovered items under the Medicare program. We have separately analyzed below whether any of the remaining four functions meet the definition of DME.

In 4-Wheel Function, the INDEPENDENCE iBOT 4000 Mobility System enables users to traverse inclines up to 10 degrees and over soft, uneven terrain such as sand, gravel, dirt, grass, etc. In this function, the device can also navigate over obstacles up to 5 inches. The 4-Wheel Function uses the iBALANCE Technology, which processes the sensor data and user commands so that the device reacts to changes in pitch caused by the changes in terrain, external impacts, and other factors. We have previously said that equipment used for environmental control and to enhance the environmental setting in which the beneficiary is placed do not constitute medical equipment and are not considered covered DME. As evidenced in the Independence Technology clinical trials, the purpose of the 4-Wheel Function is more useful for outdoors in maneuvering curbs and terrains. We recognize that beneficiaries will sometimes purchase power-operated wheelchairs with 4-wheel drive functions; however, Medicare only provides coverage of the power operated wheelchairs (and not the 4-wheel drive function). The 4-Wheel Function does not meet the definition of DME in serving a medical purpose.

In Balance Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to move the user from a seated position where the four wheels are in contact with the ground to an elevated seated position where the four wheels rotate to a vertical position balancing on two wheels while the user remains in a seated position. The seat height can be raised and lowered to enable the user to reach objects on shelves or have an “eye-level” conversation with a standing person. As stated above, equipment used for environmental control and to enhance the environmental setting in which the beneficiary is placed does not constitute medical equipment and is not considered covered DME. Seat elevation serves the same purpose as other equipment that assist all persons in reaching items out of reach or having an “eye-level” conversation with a standing person. We believe that these are common needs among many persons and that a seat elevation function that assists a patient in accomplishing these activities is not presumptively medical in nature. In addition, the clinical trials did not demonstrate how the Balance Function serves a medical purpose to treat an illness or injury, or to improve the functioning of a malformed body member. Moreover, the user is not able to stand or move from the seated position when the INDEPENDENCE iBOT 4000 Mobility System is in the elevated height position. We recognize that Medicare provides coverage for certain seat lift mechanisms as DME since they provide a medical benefit in assisting the user to stand up and sit down while promoting ambulation to improve health outcomes. However, the Balance Function on the INDEPENDENCE iBOT 4000 Mobility System is different from a Medicare-covered seat lift mechanism. Whereas a Medicare-covered seat lift effectively assists a patient in standing up and sitting down without other assistance, the Balance Function maintains the user in a seated position while the mobility device is elevating to a higher position. Therefore, we do not believe that the Balance Function meets the definition of DME in serving a medical purpose.

In Stair Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to ascend and descend stairs. Consistent with our policy, equipment that basically serves comfort or convenience functions or is primarily for the convenience of a person caring for the patient, such as elevators, stairway elevators, and posture chairs, do not constitute medical equipment. The clinical trials show that the Stair Function on the INDEPENDENCE iBOT 4000 Mobility System serves the same purpose as other stair elevators, stair glides, and elevators that we have previously said are not DME since we do not believe that the act of maneuvering from one level of the home to another via stairs confers a medical benefit. Instead, we believe that the Stair Function is primarily intended to provide convenience for the caregiver or user based on the structure of the user’s physical environment. Therefore, we do not believe that the Stair Function meets the definition of DME in serving a medical purpose.

The Remote Function of the INDEPENDENCE iBOT 4000 Mobility System does not meet the definition of DME because it does not primarily serve a medical purpose. As presented in the NCD request, this function serves a purpose common to other mobility equipment of making it convenient for users to transfer the device, park the device after a transfer, drive the device into a vehicle for transport and for other purposes. Additionally, the evidence shows that the Remote Function was not tested during the clinical trials. Therefore, we do not believe the Remote Function meets the definition of DME in serving a medical purpose.

As stated in Section III, Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Based on our analysis of the evidence to date, CMS proposes that only the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System that enables the device to operate like a traditional motorized powered wheelchair with programmable control parameters should be included in the DME benefit category.

Question #2:

If the quality of evidence is sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System can be assigned to the DME benefit category, is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member for Medicare beneficiaries?

An NCD is defined to be a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Act, but does not include a determination about which code, if any, is assigned to a particular item or service covered under Title XVIII, or a determination with respect to the amount of payment for a particular covered item or service (see 68 FR 55634, September 26, 2003).

CMS assesses relevant health outcomes, above and beyond the safety and effectiveness regulatory mandate of the FDA. Although equipment must generally receive FDA approval or clearance for at least one indication to be eligible for Medicare coverage, FDA approval/clearance alone does not entitle that device to Medicare coverage. The equipment must fall under a Medicare benefit category, be reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member, and not otherwise be excluded from coverage to be covered by Medicare.

CMS has issued several NCDs regarding various mobility assistive equipment. We most recently issued a NCD for Mobility Assistive Equipment (MAE) on May 5, 2005, which concludes that MAE is covered under the benefit category of DME if it is reasonable and necessary for treating or improving a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Determination of the presence of a mobility deficit uses an algorithmic process outlined in the Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.3, Publication 100-03.

When the INDEPENDENCE iBOT 4000 Mobility System is operating in Standard Function, we believe that the device is operating similar to a traditional motorized power wheelchair. Since the algorithmic process set forth in the MAE NCD is the appropriate process to follow when determining if a motorized power wheelchair is reasonable and necessary for an individual beneficiary, we believe that this process would also be the appropriate process to follow when determining if an INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary to treat or improve personal mobility deficit in a beneficiary.

The clinical studies by Independence Technology used a Community Driving Test as the primary effectiveness measure and self-reported data from users as secondary effectiveness measures. There were no further studies found or submitted to demonstrate how the INDEPENDENCE iBOT 4000 Mobility System 4-Wheel, Balance, Stair, and Remote Functions improved a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. These weaknesses create substantial concerns about the medical benefit associated with the use of the 4-Wheel, Balance, Stair, and Remote Functions of this mobility device.

Since we are proposing that the 4-Wheel, Balance, Stair and Remote Functions of the INDEPENDENCE iBOT 4000 Mobility System do not meet the definition of DME, we do not believe that a reasonable and necessary analysis is necessary with respect to these functions. However, even if we were to conclude that these functions met the definition of DME, we still do not believe that they are reasonable and necessary because as described above, there is insufficient evidence demonstrating that these functions offer clinical benefits to Medicare beneficiaries beyond environmental and self-help assistance.

IX. Proposed Conclusion

The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on our proposed determination that there is: a) sufficient evidence to conclude that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment (DME); b) insufficient evidence to conclude that the 4-Wheel, Balance, Stair, and Remote Functions of the device meet the definition of DME; and c) sufficient evidence to conclude that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary for Medicare beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home.

Accordingly, we propose to provide Medicare coverage of the INDEPENDENCE iBOT 4000 Mobility System, Standard Function only, under the DME benefit when it is reasonable and necessary to treat or improve a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. We also propose that the determination of a personal mobility deficit for which the provision of the INDEPENDENCE iBOT 4000 Mobility System is appropriate will use the algorithmic process, Clinical Criteria for Mobility Assistive Equipment (MAE), as outlined in the National Coverage Determination (NCD) for MAE (Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.1).

We are requesting public comments on this proposed determination pursuant to section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). After considering the public comments and any additional evidence, we will make a final determination and issue a final decision memorandum.

APPENDIX A

General Methodological Principles of Study Design
(Section VI of the Decision Memorandum)

When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary. The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve net health outcomes for patients.

We divide the assessment of clinical evidence into three stages: 1) the quality of the individual studies; 2) the generalizability of findings from individual studies to the Medicare population; and 3) overarching conclusions that can be drawn from the body of the evidence on the direction and magnitude of the intervention’s potential risks and benefits.

The methodological principles described below represent a broad discussion of the issues we consider when reviewing clinical evidence. However, it should be noted that each coverage determination has its unique methodological aspects.

Assessing Individual Studies

Methodologists have developed criteria to determine weaknesses and strengths of clinical research. Strength of evidence generally refers to: 1) the scientific validity underlying study findings regarding causal relationships between health care interventions and health outcomes; and 2) the reduction of bias. In general, some of the methodological attributes associated with stronger evidence include those listed below:

Use of randomization (allocation of patients to either intervention or control group) in order to minimize bias.

Use of contemporaneous control groups (rather than historical controls) in order to ensure comparability between the intervention and control groups.

Prospective (rather than retrospective) studies to ensure a more thorough and systematical assessment of factors related to outcomes.

Larger sample sizes in studies to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population. Sample size should be large enough to make chance an unlikely explanation for what was found.

Masking (blinding) to ensure patients and investigators do not know to which group patients were assigned (intervention or control). This is important especially in subjective outcomes, such as pain or quality of life, where enthusiasm and psychological factors may lead to an improved perceived outcome by either the patient or assessor.

Regardless of whether the design of a study is a randomized controlled trial, a non-randomized controlled trial, a cohort study or a case-control study, the primary criterion for methodological strength or quality is the extent to which differences between intervention and control groups can be attributed to the intervention studied. This is known as internal validity. Various types of bias can undermine internal validity. These include:

Different characteristics between patients participating and those theoretically eligible for study but not participating (selection bias).

Co-interventions or provision of care apart from the intervention under evaluation (performance bias).

Differential assessment of outcome (detection bias).

Occurrence and reporting of patients who do not complete the study (attrition bias).

In principle, rankings of research design have been based on the ability of each study design category to minimize these biases. A randomized controlled trial minimizes systematic bias (in theory) by selecting a sample of participants from a particular population and allocating them randomly to the intervention and control groups. Thus, in general, randomized controlled studies have been typically assigned the greatest strength, followed by non-randomized clinical trials and controlled observational studies. The design, conduct and analysis of trials are important factors as well. For example, a well designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size. The following is a representative list of study designs (some of which have alternative names) ranked from most to least methodologically rigorous in their potential ability to minimize systematic bias:

Randomized controlled trials
Non-randomized controlled trials
Prospective cohort studies
Retrospective case control studies
Cross-sectional studies
Surveillance studies (e.g., using registries or surveys)
Consecutive case series
Single case reports

When there are merely associations but not causal relationships between a study’s variables and outcomes, it is important not to draw causal inferences. Confounding refers to independent variables that systematically vary with the causal variable. This distorts measurement of the outcome of interest because its effect size is mixed with the effects of other extraneous factors. For observational, and in some cases randomized controlled trials, the method in which confounding factors are handled (either through stratification or appropriate statistical modeling) are of particular concern. For example, in order to interpret and generalize conclusions to our population of Medicare patients, it may be necessary for studies to match or stratify their intervention and control groups by patient age or co-morbidities.

Methodological strength is, therefore, a multidimensional concept that relates to the design, implementation and analysis of a clinical study. In addition, thorough documentation of the conduct of the research, particularly study selection criteria, rate of attrition and process for data collection, is essential for CMS to adequately assess and consider the evidence.

Generalizability of Clinical Evidence to the Medicare Population

The applicability of the results of a study to other populations, settings, treatment regimens and outcomes assessed is known as external validity. Even well-designed and well-conducted trials may not supply the evidence needed if the results of a study are not applicable to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would suffer from limited generalizability.

The extent to which the results of a trial are applicable to other circumstances is often a matter of judgment that depends on specific study characteristics, primarily the patient population studied (age, sex, severity of disease and presence of co-morbidities) and the care setting (primary to tertiary level of care, as well as the experience and specialization of the care provider). Additional relevant variables are treatment regimens (dosage, timing and route of administration), co-interventions or concomitant therapies, and type of outcome and length of follow-up.

The level of care and the experience of the providers in the study are other crucial elements in assessing a study’s external validity. Trial participants in an academic medical center may receive more or different attention than is typically available in non-tertiary settings. For example, an investigator’s lengthy and detailed explanations of the potential benefits of the intervention and/or the use of new equipment provided to the academic center by the study sponsor may raise doubts about the applicability of study findings to community practice.

Given the evidence available in the research literature, some degree of generalization about an intervention’s potential benefits and harms is invariably required in making coverage determinations for the Medicare population. Conditions that assist us in making reasonable generalizations are biologic plausibility, similarities between the populations studied and Medicare patients (age, sex, ethnicity and clinical presentation) and similarities of the intervention studied to those that would be routinely available in community practice.

A study’s selected outcomes are an important consideration in generalizing available clinical evidence to Medicare coverage determinations. One of the goals of our determination process is to assess net health outcomes. These outcomes include resultant risks and benefits such as increased or decreased morbidity and mortality. In order to make this determination, it is often necessary to evaluate whether the strength of the evidence is adequate to draw conclusions about the direction and magnitude of each individual outcome relevant to the intervention under study. In addition, it is important that an intervention’s benefits are clinically significant and durable, rather than marginal or short-lived. Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits.

If key health outcomes have not been studied or the direction of clinical effect is inconclusive, we may also evaluate the strength and adequacy of indirect evidence linking intermediate or surrogate outcomes to our outcomes of interest.

Assessing the Relative Magnitude of Risks and Benefits

Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits. Net health outcomes are one of several considerations in determining whether an item or service is reasonable and necessary. CMS places greater emphasis on health outcomes actually experienced by patients, such as quality of life, functional status, duration of disability, morbidity and mortality, and less emphasis on outcomes that patients do not directly experience, such as intermediate outcomes, surrogate outcomes, and laboratory or radiographic responses. The direction, magnitude, and consistency of the risks and benefits across studies are also important considerations. Based on the analysis of the strength of the evidence, CMS assesses the relative magnitude of an intervention or technology’s benefits and risk of harm to Medicare beneficiaries.


1 Independence Technology, 2005

2 FDA 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA for iBOT 3000 Mobility System that is also applicable to the iBOT 4000 Mobility System.



Bibliography

FDA Summary of Safety and Effectiveness Data 2003, “INDEPENDENCE iBOT 3000 Mobility System.” Last accessed April 2006 at: http://www.fda.gov/cdrh/pdf2/P020033b.pdf

Kennedy J. Unmet and undermet need for activities of daily living and instrumental activities of daily living assistance among adults with disabilities Med Care. 2001 Dec; 39(12):1305-12

Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Services (Rev. 48, 03-24-06), Section 110.1 “Definition of Durable Medical Equipment,” Publication 100-02. Last accessed April 2006 at: http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf

Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage (Rev. 39, 11-10-05), Section 20 “Services Not Reasonable and Necessary,” Publication 100-02. Last accessed April 2006 at: http://www.cms.hhs.gov/manuals/Downloads/bp102c16.pdf

Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.1 “Durable Medical Equipment Reference List (Effective May 5, 2005),” Publication 100-3. Last accessed April 2006 at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf

Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.3 “Mobility Assistive Equipment (MAE) (Effective May 5, 2005),” Publication 100-3. Last accessed http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf

TARGET [database online]. Plymouth Meeting (PA): ECRI; [updated 2004 May 1]; [cited 2004 Apr 12]. Climbing/lifting powered wheelchair (iBOT Mobility System). Available:http://www.ecri.org

DECISION MEMO

To:                   Administrative File:
                        INDEPENDENCE iBOT 4000 Mobility System


From:               Laurence Wilson
                        Director, Chronic Care Policy Group

                        Martha Kuespert
                        Acting Division Director, Community Post Acute Care

                        Linda D. Smith, RN, MSN, MBA
                        Lead Analyst

                        James Bowman, MD
                        Lead Medical Officer


Subject:           Decision Memorandum for the INDEPENDENCE 4000 iBOT Mobility System- Scope of Benefits §1862(a)(1)(A)


Date:                July 27, 2006

I. Decision

The Centers for Medicare and Medicaid Services (CMS) has determined the following:

CMS finds that the evidence is sufficient to determine that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment (DME) and is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Determination of the presence of a mobility deficit will use an algorithmic process, as outlined in the National Coverage Determination (NCD) for MAE (Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.1).

CMS finds that the evidence is insufficient to conclude that the 4-Wheel, Balance, Stair, and Remote Functions of the INDEPENDENCE iBOT 4000 Mobility System meet the definition of DME under Section 1861(n) or that these functions offer clinically significant benefits in mobility-related activities of daily living.

II. Background

Independence Technology, a Johnson & Johnson company, submitted a formal request to the CMS to develop a NCD providing for coverage of the INDEPENDENCE iBOT 4000 Mobility System under the DME benefit and under the generic term “Interactive Balancing Mobility Systems.” Since Medicare benefit categories are a prerequisite to determinations of reasonableness and necessity for a NCD, we posted a tracking sheet that, as part of the NCD process, solicited public comment on the benefit category determination (BCD) for the INDEPENDENCE iBOT 4000 Mobility System.

The INDEPENDENCE iBOT 4000 Mobility System is a battery-powered mobility device that relies on a computerized system of sensors, gyroscopes, and electric motors to allow indoor and outdoor use on stairs as well as on level and uneven surfaces.1 The INDEPENDENCE iBOT 4000 Mobility System incorporates a number of different functions, including: a) Standard Function that provides mobility on smooth surfaces and inclines at home, work, and in other environments; b) 4-Wheel Function that provides movement across obstacles, uneven terrain, curbs, grass, gravel, and other soft surfaces; c) Balance Function that provides mobility in a seated position at an elevated height; d) Stair Function that allows for ascent and descent of stairs, with or without assistance; and e) Remote Function that assists in the transportation of the product while unoccupied.

In Standard Function, the INDEPENDENCE iBOT 4000 Mobility System functions like a traditional power wheelchair. The seat is at the lowest available position. The casters attached to the base of the seat are in contact with the ground and the front drive wheels are raised off the ground. The casters provide good turning performance in this function. The maximum speed is 6.8 miles per hour with a maximum drive range of 12.4 miles. The mobility device can be programmed for Standard Function only to meet the assessed needs of the user.

The INDEPENDENCE iBOT 4000 Mobility System operates in the 4-Wheel, Balance, Stair, and Remote Functions by using an integrated combination of gyroscopes, sensors, and computer processor systems that are customized to the user’s size, weight, and center of gravity. This is known as iBALANCE Technology. The mobility device is programmed and calibrated to allow it to realign and customize itself to the movements of the user. When the gyroscopes sense movement, a signal is sent to the computer, which processes the information and tells the motors how to adjust the wheels to maintain stability and balance. The iBALANCE Technology maintains balance in the forward and backward direction. It does not electronically maintain lateral or side-to-side stability. Potential users of the INDEPENDENCE iBOT 4000 Mobility System are required to have an initial assessment by a specially trained health care practitioner, who determines whether the user is a good candidate for the device and which operating functions to activate, depending on the assessment results. All users currently receive a mobility device programmed to operate in Standard Function, 4-Wheel Function and Remote Function.

In 4-Wheel Function, the INDEPENDENCE iBOT 4000 Mobility System enables users to traverse inclines up to 10 degrees and over soft, uneven terrain such as sand, gravel, dirt, grass, etc. In this function, the device can also navigate over obstacles up to 5 inches. The 4-Wheel Function uses the iBALANCE Technology, which processes the sensor data and user commands so that the device reacts to changes in pitch caused by the changes in terrain, external impacts, and other factors.

In Balance Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to move the user from a seated position where the four wheels are in contact with the ground to an elevated seated position where the four wheels rotate to a vertical position balancing on two wheels while the user remains in a seated position. This is accomplished by the combined weight of the device and the user shifting over the back wheels. The device reacts to this center of gravity change by transitioning up onto two wheels. The seat height can be raised and lowered to facilitate the reaching of objects on shelves or having an “eye-level” conversation with a standing person. Balance Function is used on firm surfaces with an incline up to 5 degrees and obstacles up to 1 inch.

In Stair Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to ascend and descend stairs. Stair climbing is achieved by the rotation of the clusters over the stairs using a similar closed-loop control algorithm that uses pitch and sensor data to control the cluster motors. The device strives to keep the center of gravity of the system over the ground contacting wheels. When a user leans either forward or back (or an assistant leans the device), shifting the center of gravity, the device will rotate the clusters in response, which will result in the device climbing down or up one stair respectively. The user will climb up or down a staircase facing down the stairs with the direction of the weight shift (lean) determining the direction of climbing. The user or assistant is the input device during stair climbing since he or she controls the rate of climbing and provides stability (by the user holding the stair handrails or the assistant holding the assist handles).

In Remote Function, the user can operate the INDEPENDENCE iBOT 4000 Mobility System when it is not occupied by removing the user control panel, which is connected to the armrest through a retractable cable. Remote Function uses the iBALANCE Technology to assist the user in maneuvering the device for transfers, parking the device after a transfer, driving the device into a vehicle for transport and for other purposes.

III. History of Medicare Coverage

Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Title XVIII of the Social Security Act (Act) governs the Medicare program. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. The scope of benefits under Part B is defined in the Act under section 1832. Section 1861(n) lists items that are included as durable medical equipment (DME)), and section 1861(s) defines the term “medical and other health services.” Section 1861(n) of the Act specifically identifies wheelchairs as DME. In addition, 42 CFR 414.202 of our regulations defines DME as equipment which: (a) can withstand repeated use; (b) is primarily and customarily used to serve a medical purpose; (c) generally is not useful to a person in the absence of an illness or injury; and (d) is appropriate for use in the home. For items to be considered DME, all requirements of the definition must be met.

The CMS policies for determining whether an item meets the 4-prong definition of DME are outlined in our regulations and in the Medicare Benefit Policy Manual, Chapter 15, Section 110.1, and Publication 100-02. In evaluating whether the first prong is satisfied, we will generally consider an item to be durable if it can withstand repeated use. Under the second prong, equipment is considered to be medical equipment if it is primarily and customarily used to serve a medical purpose. Equipment that is primarily and customarily used for a nonmedical purposes may not be considered “medical” equipment for which payment can be made under the Medicare program, even if the item has some remote medically related use. For example, equipment used for environmental control and to enhance the environmental setting in which the beneficiary is placed are not considered to be medical equipment and are not covered DME. Under the third prong, the item must be useful to a person for the treatment of an illness or injury, and expected to make a meaningful contribution to the treatment of the individual’s illness or injury or to the improvement of his or her malformed body member. Finally, under the fourth prong, equipment is appropriate for home use when the individual has a medical need for the use of the item in the home. Additionally, the Medicare Benefit Policy Manual, Chapter 16, Section 20, Publication 100-02, describes the general exclusions from Medicare coverage. Items and services, which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, are not covered.

The Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Publication 100-03 addresses coverage of items and medical equipment within the benefit category of DME. Section 280.1 of this manual, “Durable Medical Equipment Reference List,” provides a quick reference tool for determining the coverage status of certain DME. Even if an item falls within the definition of DME, it cannot be covered unless it is necessary and reasonable for treatment of an illness or injury, or to improve the functioning of a malformed body member.

An NCD is defined to be a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Act, but does not include a determination about which code, if any, is assigned to a particular item or service covered under Title XVIII, or a determination with respect to the amount of payment for a particular covered item or service (see 68 FR 55634, September 26, 2003).

CMS has issued several NCDs regarding various mobility assistive equipment. We most recently issued a NCD for Mobility Assistive Equipment (MAE) on May 5, 2005, which concludes that MAE is covered under the benefit category of DME if it is reasonable and necessary to treat or improve a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Determination of the presence of a mobility deficit uses an algorithmic process outlined in the Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.3, Publication 100-03.

IV. Timeline of Recent Activities

January 26, 2006

CMS opened an NCD to evaluate coverage of the INDEPENDENCE iBOT 4000 Mobility System in the Medicare population in response to a formal NCD request. The initial 30-day public comment period began. Due to website problems, we extended the public comment period an additional week.

March 6, 2006

End of public comment period. 146 comments received.

April 28, 2006

CMS posted the proposed decision memo online at http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=5

The second public comment period began on this date.

May 30, 2006

The second public comment period closed on this date. 44 comments received.

V. FDA Status

On March 14, 2005, the FDA, using its premarket approval (PMA) process, approved generational changes to the INDEPENDENCE iBOT 3000 Mobility system under the trade name INDEPENDENCE iBOT 4000 Mobility System. The INDEPENDENCE iBOT 3000 Mobility System approval by the FDA, in August 2003, was based on a review of extensive bench testing and a clinical study by the manufacturer, Independence Technology, a Johnson and Johnson (J&J) company. The FDA approval of the INDEPENDENCE iBOT 4000 Mobility System was based on non-clinical bench tests that, according to the FDA, demonstrated that the modified device is safe and effective. The FDA approved the INDEPENDENCE iBOT 4000 Mobility System with the following labeled indication:

“for individuals who have mobility impairments and the use of at least one upper extremity.”2

In addition, the FDA imposed restrictions specific to the INDEPENDENCE iBOT 4000 Mobility System. Patients must: (a) weigh no more than 250 pounds; (b) be able to bend his or her knees and hips such that the patient’s back and feet fit on standard footrests; (c) meet drivers licensing criteria established in 1996 by the Epilepsy Foundation of America; (d) have sufficient use of at least one upper extremity; (e) not require mechanical ventilation; (f) not currently require use of a tilt or recline seating system as a mechanical method of pressure relief for activities of daily living; (g) be able to use his or her current postural supports and these supports are compatible/comparable with the postural supports on the iBOT device; (h) have good enough function to dial a push button telephone or operate a hand operated joystick; (i) not have experienced a loss of consciousness or had a seizure in the past 90 days; and (j) not have severe osteoporosis, osteogenesis imperfecta or metastatic bone cancer. Additionally, the device must be prescribed by the treating physician and cannot be dispensed unless an assessment is completed by a trained clinician. In addition, the beneficiary must complete a comprehensive training program on how to safely operate the multiple functions of the device.

VI. General Methodological Principles

As part of the NCD process, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will diagnose or treat an illness or injury or improve the functioning of a malformed body member for patients. An improved functioning of a malformed body member is one of several considerations in determining whether an item or service is reasonable and necessary.

A detailed account of the methodological principles of study design that CMS utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix A. In some situations in making benefit category determinations, we may use the methodological principles in Appendix A in determining the scope of Medicare benefits. In general, features of clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, and the blinding of readers of the index test, and reference test results.

VII. Evidence

A. Introduction

The evidence reviewed in includes the published literature on the INDEPENDENCE iBOT 4000 and 3000 Mobility Systems; the Medicare statutes, regulations, and policies pertinent to mobility equipment and Medicare coverage; clinical studies; and technology assessments.

B. Discussion of Evidence Reviewed

1. Assessment Questions

To assess Independence Technology’s request, CMS posed the following questions:

Is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment for purposes of assigning it to the DME benefit category?

If the quality of evidence is sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System can be assigned to the DME benefit category, is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member for Medicare beneficiaries?

2. External technology assessments

CMS searched PubMed Central, International Network of Agencies for Health Technologies Assessment (INAHTA), Cochrane Library, and the National Guidelines Clearinghouse databases to identify external technology assessments conducted on the INDEPENDENCE iBOT 4000 Mobility System. Search terms included iBOT 4000, technology assessment mobility equipment, assistive technology, and iBOT 3000. We identified one external technology assessment conducted on the INDEPENDENCE iBOT 3000 Mobility System; however, we did not find external technology assessments for the INDEPENDENCE iBOT 4000 Mobility System. Since the FDA, using its PMA review process, approved the INDEPENDENCE iBOT 4000 Mobility System as a generational change to the INDEPENDENCE iBOT 3000 Mobility System, we considered information from the INDEPENDENCE iBOT 3000 Mobility System technology assessment in our review.

The TARGET database (2004) cited a technology assessment of the INDEPENDENCE iBOT 3000 Mobility System that was conducted by ECRI. ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services research agency designated as an Evidence-based Practice Center (EPC) by the U.S. Agency for Healthcare Research and Quality. ECRI described the INDEPENDENCE iBOT 3000 Mobility System as closely resembling a conventional wheelchair with four main drive wheels, two on each side. The drive-wheels are called “clusters” and pivot around a central axle. The user relies on a position-sensing joystick and a control panel attached to the armrest to operate the system in one of five modes (Standard, 4-Wheel, Stair, Balance, and Remote Functions). ECRI concluded that available data were insufficient to conclude whether the iBOT 3000 improved a patient’s mobility, independence, and quality of life. Additionally, ECRI concluded that the study submitted to the FDA for marketing approval had a small sample size, short duration, and nonstandardized functional measures. ECRI further found that the primary effectiveness measures used to test the device primarily focused on the capabilities of the iBOT Mobility System (e.g., climbing stairs, going up curbs, negotiating an elevator, traveling up an incline, elevating user to retrieve a book off a high shelf), rather than functional tasks (e.g. eating, toileting, bathing and maneuvering in the home) encountered by users of the iBOT Mobility System.

3. Internal technology assessments

CMS searched the PubMed Central, International Network of Agencies for Health Technologies Assessment (INAHTA), Cochrane Library, National Guidelines Clearinghouse databases and used the Google Internet search engine to find research related to the INDEPENDENCE iBOT 4000 Mobility System and how its function provided a medical benefit. We did not find articles specific to the INDEPENDENCE iBOT 4000 Mobility System. Since the FDA, using its PMA review process, approved the INDEPENDENCE iBOT 4000 Mobility System as a generational change to the INDEPENDENCE iBOT 3000 Mobility System, we considered information on the INDEPENDENCE iBOT 3000 Mobility System in our review.

Independence Technology submitted as part of its NCD request the results of the clinical trials conducted on the INDEPENDENCE iBOT 3000 Mobility System, which was part of the premarket approval package to the FDA. The FDA (2003) used this information in its pivotal study assessing the safety and effectiveness of the mobility device. The FDA’s objectives of the study were to demonstrate that individuals with a variety of mobility skills would be able to safely and effectively use the device in real world environments, and to demonstrate that subjects would improve with respect to objective and subjective measures of functional activities. The study reported on a single center, prospective, balance, open label evaluation that utilized participants as their own control. The subjects ranged between 18 and 80 years of age and used a manual wheelchair, a power wheelchair with a hand-operated joystick control, or a scooter as the primary mobility device. Twenty subjects completed the study. Data were collected on safety, accessibility, operational problems, and mechanical problems on a daily basis through telephone contact with each subject. The primary effectiveness of the device was accomplished through data collected after the subjects completed a Community Driving Test that found the iBOT Mobility System to be more difficult to maneuver in the home compared to outdoors and more difficult to maneuver than other personal mobility equipment. Additional information related to the usage, failures, and alerts, in connection with the mobility system were downloaded over the telephone line daily. The study did not include findings to demonstrate how the 4-Wheel, Balance, Stair, or Remote Functions of the INDEPENDENCE iBOT 3000 Mobility System were primarily and customarily used to meet a medical benefit.

The FDA approved the INDEPENDENCE iBOT 4000 Mobility System based on generational changes to the INDEPENDENCE 3000 Mobility System and used non-clinical bench tests to demonstrate that the modified device was safe and effective. Additionally, the FDA determined that additional clinical testing was not necessary for the types of changes made.  The generational changes made from the original iBOT 3000 to the new iBOT 4000 included the following:

  • A lower seating height, allowing the user to maneuver more easily when seated at a table or desk.
  • Allows the user to occupy the device while it is being transported in a wheelchair-accessible vehicle.
  • The power button repositioned to make it more accessible to the user.
  • Swing-away footrests, making entry and exit easier.
  • A modified automotive-style seating system, in addition to the standard rehab seat.
  • A lighting system for night visibility, lighted directional signals (blinkers), and a horn.
  • A new caster wheel design.
  • A higher capacity battery, allowing longer use on a single battery charge.
  • Device can be sold with stair-climbing function turned off.
  • 4-Wheel Function: Maximum incline of 10 degrees
  • 4-Wheel Function: Maximum obstacle height of 5 inches
  • Balance Function: Maximum obstacle height of 1 inch
  • Standard Function: Maximum obstacle height of 1 inch
  • Remote Function: Maximum incline of 20 degrees
  • Remote Function: Dynamic stabilization not active
  • Maximum speed: 6.8 mph in Standard Function
  • Maximum drive range: 12.4 miles in Standard Function

4. MCAC

A Medicare Coverage Advisory Committee (MCAC) meeting was not convened on this issue.

5. Evidence-based guidelines

No evidence-based guidelines were identified with respect to making Medicare benefit category determinations. However, we identified the MAE NCD as an evidence-based guideline on the appropriate prescription of mobility assistive equipment, including wheelchairs, which fall under the DME benefit category.

6. Professional Society Position Statements

A search for published professional society position statements on the appropriate designation of a Medicare benefit category and the medical benefit for 4-wheel, power seat elevation, and stair climbing assistive technology were conducted. No professional society position statements were identified prior to the public comment period.

We received three professional society position statements through public comment:

  • The American Academy of Neurology supports coverage of the INDEPENDENCE iBOT 4000 Mobility System, as it believes the device significantly enhances the functional status of neurology patients.
  • The American Academy of Physical Medicine and Rehabilitation advocates for the greater coverage of a broad array of enhanced wheelchair options that better meet the environmental challenges facing those with significant mobility limitations. The Academy supports coverage of the INDEPENDENCE iBOT 4000 Mobility System and states that denial will discourage inventors and manufacturers from investing in new rehabilitation solutions to alleviate the daily burdens associated with disabilities.
  • The Rehabilitation Engineering and Assistive Technology Society of North America supports coverage for the INDEPENDENCE iBOT 4000 Mobility System as MAE consistent with what it claims to be other “federal policies,” such as the ADA and New Freedom Initiative. The society believes that these policies enable individuals with disabilities to participate in activities at home and in the community.

7. Public Comments

CMS received 146 comments during the initial public comment period. In the second public comment period, CMS received 44 additional comments regarding the proposed decision memo. The commenters represented interested groups that include family members or acquaintances of users of an INDEPENDENCE iBOT 3000 or 4000 Mobility System; advocacy groups for persons with disabilities; State offices; representatives for persons with disabilities; and physicians, physical therapists, neurology and rehabilitation practitioners, and other health professionals. Ninety-seven (97%) of the commenters support coverage of the INDEPENDENCE iBOT 4000 Mobility System under the DME benefit. No published scientific evidence was submitted, other than that which was received with NCD request and part of the Food and Drug Administration Safety and Effectiveness studies for the INDEPENDENCE iBOT 3000 Mobility System.

SUPPORT FOR COVERAGE AS DME

Many commenters support the coverage of the INDEPENDENCE iBOT 4000 Mobility System under the DME benefit category and under a new benefit category entitled “Interactive Balancing Mobility System.” Commenters objected to CMS separating the features of the device (i.e., 4-wheel drive, stair climbing, balance, and remote) as part of its coverage decision. Commenters reported that the device would improve the life, well-being, and independence of many stroke survivors. Many commenters stated that individuals who live in homes where floors are separated by a flight of stairs or several steps should be approved for this device. Users and family members and acquaintances of an INDEPENDENCE iBOT 3000 and 4000 Mobility System reported the device assist them or had the potential to assist them to reach their cabinets or closets, go up and down stairs, have an eye level conversation, attend community activities outside the home, work in their yards, and obtain employment. The CMS uses the definitions in the Act and our regulations, as well as other established policies, to determine if an item or service falls within one or more Medicare benefit categories. This process involves us reviewing the features and functions of devices to make this determination. We agree that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System meets the definition of DME and is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Medicare will cover the standard function of the device like other power operated mobility devices. The additional functions, 4-Wheel, Balance, Stair, and Remote Functions, are categorized as accessory items for other power operated mobility devices. These features are not assigned to a benefit category. As with all power-operated wheelchairs, we cover the devices for use in the home. However, this does not preclude Medicare beneficiaries from using the devices to meet their personal community needs.

NONSUPPORT FOR COVERAGE

Four persons opposed the coverage of INDEPENDENCE iBOT 4000 Mobility System under a new benefit category “Interactive Balancing Mobility System” and support only the coverage of the Standard Function as DME. In particular, these commenters expressed concern over the fact that there is other medical equipment on the market that provide standing, reach, and seat elevation functions that are not covered under Medicare. We recognize that there are many devices on the market that function as power seat elevators, standers, 4-wheel drive, and assist in the user’s reach ability. The Medicare program has not covered these devices or assigned them a benefit category. We have determined that the Standard functions of the INDEPENDENCE iBOT 4000 Mobility System, that functions as a power-operated wheelchair meets the definition of DME.

RELATIONSHIP OF PROPOSED DECISION TO MOBILITY ASSISTIVE EQUIPMENT (MAE) NATIONAL COVERAGE DETERMINATION (NCD)

Many commenters state the proposed decision is contradictory to the principles outlined in the MAE NCD. They believe that the underlying concept of the MAE NCD is to consider reimbursement for devices that allow patients to accomplish their mobility related activities of daily living (MRADLs) in customary locations within their homes. The customary locations in the home have been attributed to a single level. Interior structural modifications can be made if a beneficiary or caregiver prefers the option to move about from one level to the next in multi-level dwellings. This option might be based on personal choice and preference of the beneficiary or caregiver, but these types of home improvements are not reasonably financed by the Medicare health insurance program. Consistent with our policy, equipment that basically serves comfort or convenience functions or is primarily for the convenience of a person caring for the patient such as elevators and stairway elevators do not constitute medical equipment.

Many commenters believed that CMS’s decision not to cover the iBOT Mobility System would likely influence private health insurers’ decisions regarding the coverage of the device, as these insurers take cues from the Medicare program. In any event, Medicare decisions are grounded by our specific statutory and regulatory provisions that may not be identical to those used by other governmental programs or insurers.

Some commenters provided a copy of the research that was presented to the Food and Drug Administration (FDA) as part of the iBOT’s Pre-Market Authorization (PMA) application. The research study is published in the American Academy of Physical Medicine and Rehabilitation Archives of Physical Medicine. We appreciate the submission of the research. These same studies were submitted as part of the national coverage request and as part of the FDA safety and effectiveness studies. We previously reviewed these studies in determining the proposed decision.

Many commenters stated that, since Medicare covers therapies and equipment designed to improve an individual’s ability to climb stairs, and mobility and reach for beneficiaries who have the potential to walk, then the iBOT device should be covered. We are not denying Medicare coverage of the iBOT device. Medicare covers the Standard function of the INDEPENDENCE iBOT 4000 Mobility System, which improves beneficiaries’ ability to perform MRADLs.

A few commenters stated that it is discriminatory that Medicare reimburses for prosthetic devices and not for mobility devices that perform the same level of independent function. Section 1861(s) (8) of the Medicare statute defines medical and other health services as prosthetic devices, which replace all or part of an internal body organ. 42 CFR 414.202 provides Medicare’s definition of prosthetic and orthotic devices to mean devices that replace all or part of an internal body organ and artificial legs and arms. The iBOT seat elevation/standing and stair/curb climbing features do not qualify for coverage as either a prosthetic device or artificial limb. These features do not meet the definition of a prosthetic device because they do not replace the function of an internal body organ in that they do not provide stimulation to the malfunctioning nervous system. In contrast to the iBOT, a prosthetic device, as a replacement for an internal body organ, functions independently and does not require ongoing attention and direction from the beneficiary for the item to provide the medical services for which it is being used. For an item to qualify as a device that is replacing a malfunctioning body organ, the device should be primarily medical in nature rather than a self-help item. Additionally, the prosthetic device benefit is for items that are attachable or implantable rather than non-attachable or non-implantable equipment or machinery that is used for patients for self-help purposes. In addition, the iBOT accessory features do not qualify for coverage as artificial limbs. Coverable artificial limbs are appliances that attach to a person and imitate the appearance or operation of the person's arms or legs. None of the features or accessory functions of the iBOT meet the criteria for prosthetic devices or artificial limbs. The iBOT does not attach to the person’s body as an artificial limb does. Rather, the patient sits on the iBOT like a wheelchair. Neither does the iBOT imitate the operation of the person’s arm or leg. Instead, the iBOT performs like a seat-elevating device and a stair-climbing device to allow for reach and extension capabilities of the beneficiary’s functional extremity.

VIII. CMS Analysis

National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act, § 1869(f)(1)(B). Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. The scope of benefits under Part B is defined in the Act under sections 1832. Section 1861(n) lists items that are included as durable medical equipment (DME), and section 1861(s) defines the term “medical and other health services.”

The CMS uses the definitions in the Act and our regulations, as well as other established policies, to determine if an item or service falls within one or more Medicare benefit categories. Medicare payment is contingent upon a determination that an item or service falls under a benefit category, is not specifically excluded from coverage, and is ‘‘reasonable and necessary.’’ In conducting our analysis of whether an item or service falls within the DME benefit category, the CMS reviews the functions, features of the item or service, as well as applicable research and clinical studies that demonstrate how it meets the definition of DME, and serves a medical purpose.

CMS assesses relevant health outcomes, above and beyond the safety and effectiveness regulatory mandate of the FDA. Although medical equipment must generally receive FDA approval or clearance for at least one indication to be eligible for Medicare coverage, FDA approval/clearance alone does not entitle that equipment to Medicare coverage. The equipment must fall under a Medicare benefit category, be reasonable and necessary for the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body member, and not otherwise be excluded from coverage to be covered by Medicare.

Question #1:

Is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment for purposes of assigning it to the DME benefit category?

As stated in Section III, Section 1861(n) of the Act specifically identifies wheelchairs as durable medical equipment. In addition, 42 CFR 414.202 further defines DME as equipment which: (a) can withstand repeated use; (b) is primarily and customarily used to serve a medical purpose; (c) generally is not useful to a person in the absence of an illness or injury; and (d) is appropriate for use in the home. For items to be considered DME, all requirements of the definition must be met.

Although there is no published research on the INDEPENDENCE iBOT 4000 Mobility System, we reviewed and considered the research (e.g., Uustal, H; Minkel, J. “Study of the Independence iBOT 3000 Mobility System: Arch Phys Med Rehabil Dec/2004 85(12):2002-10) submitted to the FDA and reported in the FDA Summary of Safety and Effectiveness Data. In general, we give greater evidentiary weight to data from peer-reviewed, published clinical trials, with statistically robust samples of subjects representative of Medicare beneficiaries, to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would be limited in terms of its application to Medicare beneficiaries.

We did not find published clinical evidence on the INDEPENDENCE iBOT 4000 Mobility System and how it serves a medical purpose, including improving a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Specifically lacking are large clinical trials studying the medical benefits achieved by the 4-Wheel, Balance, Stair, and Remote Functions in a population representative of Medicare beneficiaries. As stated above, for purposes of this analysis we reviewed the available published research, literature, clinical studies, and technology assessments for the INDEPENDENCE iBOT 3000 Mobility Systems, since the iBOT 4000 is approved as a generational change to the iBOT 3000. The clinical trials had many limitations, including a small sample size. In addition, the effectiveness measures focused on the capabilities of the iBOT Mobility System device (i.e stair and curb climbing, reaching high objects, and outdoor usage) and did not correlate the findings to demonstrate the medical benefit to the user.

The evidence reviewed supports the conclusion that the INDEPENDENCE iBOT 4000 Mobility System operates in Standard Function similar to a traditional power operated wheelchair and serves the same medical purpose of improving a beneficiary’s performance of mobility related activities. For these reasons, we believe that the Standard Function is properly classified as DME. In accordance with Medicare policies, power-operated wheelchairs meet the definition of DME, but if the wheelchair includes other enhancing features, such as a 4-wheel drive and/or remote function, Medicare has limited its coverage only to the wheelchair, since the enhancing features do not serve a medical purpose or are generally inappropriate for use in the patient’s home (and, thus, are not DME). Therefore, consistent with our long-standing policy, we believe we can conclude that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System, which can be programmed independently of the iBALANCE Technology, is DME without necessarily reaching the same conclusion with respect to the other enhancing features of the equipment which, in this case, are described as four functions (4-Wheel, Balance, Stair, and Remote). The fact that the underlying technology has been built into one device does not guarantee coverage of features that are considered noncovered items under the Medicare program. We have separately analyzed below whether any of the remaining four functions meet the definition of DME.

In 4-Wheel Function, the INDEPENDENCE iBOT 4000 Mobility System enables users to traverse inclines up to 10 degrees and over soft, uneven terrain such as sand, gravel, dirt, grass, etc. In this function, the device can also navigate over obstacles up to 5 inches. The 4-Wheel Function uses the iBALANCE Technology, which processes the sensor data and user commands so that the device reacts to changes in pitch caused by the changes in terrain, external impacts, and other factors. Our long-standing policy has been that equipment used for environmental control and to enhance the environmental setting in which the beneficiary is placed do not constitute medical equipment and are not considered covered DME. As evidenced in the Independence Technology clinical trials, the purpose of the 4-Wheel Function is more useful for outdoors in maneuvering curbs and terrains. We recognize that beneficiaries will sometimes purchase power-operated wheelchairs with 4-wheel drive functions; however, Medicare only provides coverage of the power operated wheelchairs (and not the 4-wheel drive function). The 4-Wheel Function does not meet the definition of DME in serving a medical purpose.

In Balance Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to move the user from a seated position where the four wheels are in contact with the ground to an elevated seated position where the four wheels rotate to a vertical position balancing on two wheels while the user remains in a seated position. The seat height can be raised and lowered to enable the user to reach objects on shelves or have an “eye-level” conversation with a standing person. As stated above, equipment used for environmental control and to enhance the environmental setting in which the beneficiary is placed does not constitute medical equipment and is not considered covered DME. Seat elevation serves the same purpose as other equipment that assist all persons in reaching items out of reach or having an “eye-level” conversation with a standing person. We believe that these are common needs among many persons and that a seat elevation function that assists a patient in accomplishing these activities is not presumptively medical in nature. In addition, the clinical trials did not demonstrate how the Balance Function serves a medical purpose to treat an illness or injury, or to improve the functioning of a malformed body member. Therefore, we do not believe that the Balance Function meets the definition of DME in serving a medical purpose.

In Stair Function, the INDEPENDENCE iBOT 4000 Mobility System uses the iBALANCE Technology to ascend and descend stairs. As noted above (under Section III, History of Medicare Coverage), according to the NCD for MAE (May 5, 2005), one of the criteria that must be met for an item to be covered under the benefit category of DME is that it must be reasonable and necessary to treat or improve a personal mobility deficit sufficient to impair a beneficiary's participation in mobility-related activities of daily living (ADLs) in customary locations in the home. Although home living arrangements can be configured in a variety of ways in a multi-level dwelling, ranging from single story, to split level, to two or more levels, it is not unreasonable to attribute those mobility-related ADLs within customary locations in the home to a single level. The currently available clinical evidence does not support the claim that expansion of the customary locations in the home to multiple levels will result in improved clinical outcomes. That is, the capability to move back and forth from the first floor to the second, or vice versa, has never been demonstrated to be clinically superior to performing those same mobility-related ADLs while on the same floor. Interior structural modifications can be made if the beneficiary or caregiver prefers the option to move about from one level to the next in multi-level dwellings. This option might be based on personal choice and preference of the beneficiary or caregiver, but these types of home improvements are not reasonably financed by the Medicare health insurance program. These home improvements are not included within the scope of the Medicare health insurance program. Consistent with our policy, equipment that basically serves comfort or convenience functions or is primarily for the convenience of a person caring for the patient, such as elevators, stairway elevators, and posture chairs, do not constitute medical equipment. The clinical trials show that the Stair Function on the INDEPENDENCE iBOT 4000 Mobility System serves the same purpose as other stair elevators, stair glides, and elevators that we have previously said are not DME since we do not believe that the act of maneuvering from one level of the home to another via stairs confers a medical benefit. Instead, we believe that the Stair Function is primarily intended to provide convenience for the caregiver or user based on the structure of the user’s physical environment. Therefore, we do not believe that the Stair Function meets the definition of DME in serving a medical purpose.

The Remote Function of the INDEPENDENCE iBOT 4000 Mobility System does not meet the definition of DME because it does not primarily serve a medical purpose. As presented in the NCD request, this function serves a purpose common to other mobility equipment of making it convenient for users to transfer the device, park the device after a transfer, drive the device into a vehicle for transport and for other purposes. Additionally, the evidence shows that the Remote Function was not tested during the clinical trials. Therefore, we do not believe the Remote Function meets the definition of DME in serving a medical purpose.

As stated in Section III, Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Based on our analysis of the evidence to date, CMS proposes that only the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System that enables the device to operate like a traditional motorized powered wheelchair with programmable control parameters should be included in the DME benefit category.

Question #2:

If the quality of evidence is sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System can be assigned to the DME benefit category, is the quality of evidence sufficient to conclude that the INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member for Medicare beneficiaries?

An NCD is defined to be a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Act, but does not include a determination about which code, if any, is assigned to a particular item or service covered under Title XVIII, or a determination with respect to the amount of payment for a particular covered item or service (see 68 FR 55634, September 26, 2003).

CMS assesses relevant health outcomes, above and beyond the safety and effectiveness regulatory mandate of the FDA. Although equipment must generally receive FDA approval or clearance for at least one indication to be eligible for Medicare coverage, FDA approval/clearance alone does not entitle that device to Medicare coverage. The equipment must fall under a Medicare benefit category, be reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member, and not otherwise be excluded from coverage to be covered by Medicare.

CMS has issued several NCDs regarding various mobility assistive equipment. We most recently issued a NCD for Mobility Assistive Equipment (MAE) on May 5, 2005, which concludes that MAE is covered under the benefit category of DME if it is reasonable and necessary for treating or improving a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Determination of the presence of a mobility deficit uses an algorithmic process outlined in the Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.3, Publication 100-03.

When the INDEPENDENCE iBOT 4000 is operating in Standard Function, we believe that the device is operating similar to a traditional motorized power wheelchair. Since the algorithmic process set forth in the MAE NCD is the appropriate process to follow when determining if a motorized power wheelchair is reasonable and necessary for an individual beneficiary, we believe that this process would also be the appropriate process to follow when determining if an INDEPENDENCE iBOT 4000 Mobility System is reasonable and necessary to treat or improve personal mobility deficit in a beneficiary.

The clinical studies by Independence Technology used a Community Driving Test as the primary effectiveness measure and self-reported data from users as secondary effectiveness measures. There were no further studies found or submitted to demonstrate how the INDEPENDENCE iBOT 4000 Mobility System 4-Wheel, Balance, Stair, and Remote Functions improved a personal mobility deficit sufficient to impair a beneficiary’s participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. These weaknesses create substantial concerns about the medical benefit associated with the use of the 4-Wheel, Balance, Stair, and Remote Functions of this mobility device.

Since we have determined that the 4-Wheel, Balance, Stair and Remote Functions of the INDEPENDENCE iBOT 4000 Mobility System do not meet the definition of DME, we do not believe that a reasonable and necessary analysis is necessary with respect to these functions. However, even if we were to conclude that these functions met the definition of DME, we still do not believe that they are reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member.

IX. Decision

The Centers for Medicare and Medicaid Services (CMS) has determined the following:

CMS finds that the evidence is sufficient to determine that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System meets the definition of durable medical equipment (DME) and is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. Determination of the presence of a mobility deficit will use an algorithmic process, as outlined in the National Coverage Determination (NCD) for MAE (Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 280.1).

CMS finds that the evidence is insufficient to conclude that the 4-Wheel, Balance, Stair, and Remote Functions of the INDEPENDENCE iBOT 4000 Mobility System meet the definition of DME under Section 1861(n) or that these functions offer clinically significant benefits in mobility-related activities of daily living.

References

FDA Summary of Safety and Effectiveness Data 2003, “INDEPENDENCE iBOT 3000 Mobility System.” Last accessed April 2006 at: http://www.fda.gov/cdrh/pdf2/P020033b.pdf

Kennedy J. Unmet and undermet need for activities of daily living and instrumental activities of daily living assistance among adults with disabilities Med Care. 2001 Dec; 39(12):1305-12

Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Services (Rev. 48, 03-24-06), Section 110.1 “Definition of Durable Medical Equipment,” Publication 100-02. Last accessed April 2006 at: http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf

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APPENDIX A

General Methodological Principles of Study Design
(Section VI of the Decision Memorandum)

When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary. The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve net health outcomes for patients.

We divide the assessment of clinical evidence into three stages: 1) the quality of the individual studies; 2) the generalizability of findings from individual studies to the Medicare population; and 3) overarching conclusions that can be drawn from the body of the evidence on the direction and magnitude of the intervention’s potential risks and benefits.

The methodological principles described below represent a broad discussion of the issues we consider when reviewing clinical evidence. However, it should be noted that each coverage determination has its unique methodological aspects.

Assessing Individual Studies

Methodologists have developed criteria to determine weaknesses and strengths of clinical research. Strength of evidence generally refers to: 1) the scientific validity underlying study findings regarding causal relationships between health care interventions and health outcomes; and 2) the reduction of bias. In general, some of the methodological attributes associated with stronger evidence include those listed below:

  • Use of randomization (allocation of patients to either intervention or control group) in order to minimize bias.
  • Use of contemporaneous control groups (rather than historical controls) in order to ensure comparability between the intervention and control groups.
  • Prospective (rather than retrospective) studies to ensure a more thorough and systematical assessment of factors related to outcomes.
  • Larger sample sizes in studies to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population. Sample size should be large enough to make chance an unlikely explanation for what was found.
  • Masking (blinding) to ensure patients and investigators do not know to which group patients were assigned (intervention or control). This is important especially in subjective outcomes, such as pain or quality of life, where enthusiasm and psychological factors may lead to an improved perceived outcome by either the patient or assessor.

Regardless of whether the design of a study is a randomized controlled trial, a non-randomized controlled trial, a cohort study or a case-control study, the primary criterion for methodological strength or quality is the extent to which differences between intervention and control groups can be attributed to the intervention studied. This is known as internal validity. Various types of bias can undermine internal validity. These include:

  • Different characteristics between patients participating and those theoretically eligible for study but not participating (selection bias).
  • Co-interventions or provision of care apart from the intervention under evaluation (performance bias).
  • Differential assessment of outcome (detection bias).
  • Occurrence and reporting of patients who do not complete the study (attrition bias).

In principle, rankings of research design have been based on the ability of each study design category to minimize these biases. A randomized controlled trial minimizes systematic bias (in theory) by selecting a sample of participants from a particular population and allocating them randomly to the intervention and control groups. Thus, in general, randomized controlled studies have been typically assigned the greatest strength, followed by non-randomized clinical trials and controlled observational studies. The design, conduct and analysis of trials are important factors as well. For example, a well designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size. The following is a representative list of study designs (some of which have alternative names) ranked from most to least methodologically rigorous in their potential ability to minimize systematic bias:

  • Randomized controlled trials
  • Non-randomized controlled trials
  • Prospective cohort studies
  • Retrospective case control studies
  • Cross-sectional studies
  • Surveillance studies (e.g., using registries or surveys)
  • Consecutive case series
  • Single case reports

When there are merely associations but not causal relationships between a study’s variables and outcomes, it is important not to draw causal inferences. Confounding refers to independent variables that systematically vary with the causal variable. This distorts measurement of the outcome of interest because its effect size is mixed with the effects of other extraneous factors. For observational, and in some cases randomized controlled trials, the method in which confounding factors are handled (either through stratification or appropriate statistical modeling) are of particular concern. For example, in order to interpret and generalize conclusions to our population of Medicare patients, it may be necessary for studies to match or stratify their intervention and control groups by patient age or co-morbidities.

Methodological strength is, therefore, a multidimensional concept that relates to the design, implementation and analysis of a clinical study. In addition, thorough documentation of the conduct of the research, particularly study selection criteria, rate of attrition and process for data collection, is essential for CMS to adequately assess and consider the evidence.

Generalizability of Clinical Evidence to the Medicare Population

The applicability of the results of a study to other populations, settings, treatment regimens and outcomes assessed is known as external validity. Even well-designed and well-conducted trials may not supply the evidence needed if the results of a study are not applicable to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would suffer from limited generalizability.

The extent to which the results of a trial are applicable to other circumstances is often a matter of judgment that depends on specific study characteristics, primarily the patient population studied (age, sex, severity of disease and presence of co-morbidities) and the care setting (primary to tertiary level of care, as well as the experience and specialization of the care provider). Additional relevant variables are treatment regimens (dosage, timing and route of administration), co-interventions or concomitant therapies, and type of outcome and length of follow-up.

The level of care and the experience of the providers in the study are other crucial elements in assessing a study’s external validity. Trial participants in an academic medical center may receive more or different attention than is typically available in non-tertiary settings. For example, an investigator’s lengthy and detailed explanations of the potential benefits of the intervention and/or the use of new equipment provided to the academic center by the study sponsor may raise doubts about the applicability of study findings to community practice.

Given the evidence available in the research literature, some degree of generalization about an intervention’s potential benefits and harms is invariably required in making coverage determinations for the Medicare population. Conditions that assist us in making reasonable generalizations are biologic plausibility, similarities between the populations studied and Medicare patients (age, sex, ethnicity and clinical presentation) and similarities of the intervention studied to those that would be routinely available in community practice.

A study’s selected outcomes are an important consideration in generalizing available clinical evidence to Medicare coverage determinations. One of the goals of our determination process is to assess net health outcomes. These outcomes include resultant risks and benefits such as increased or decreased morbidity and mortality. In order to make this determination, it is often necessary to evaluate whether the strength of the evidence is adequate to draw conclusions about the direction and magnitude of each individual outcome relevant to the intervention under study. In addition, it is important that an intervention’s benefits are clinically significant and durable, rather than marginal or short-lived. Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits.

If key health outcomes have not been studied or the direction of clinical effect is inconclusive, we may also evaluate the strength and adequacy of indirect evidence linking intermediate or surrogate outcomes to our outcomes of interest.

Assessing the Relative Magnitude of Risks and Benefits

Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits. Net health outcomes are one of several considerations in determining whether an item or service is reasonable and necessary. CMS places greater emphasis on health outcomes actually experienced by patients, such as quality of life, functional status, duration of disability, morbidity and mortality, and less emphasis on outcomes that patients do not directly experience, such as intermediate outcomes, surrogate outcomes, and laboratory or radiographic responses. The direction, magnitude, and consistency of the risks and benefits across studies are also important considerations. Based on the analysis of the strength of the evidence, CMS assesses the relative magnitude of an intervention or technology’s benefits and risk of harm to Medicare beneficiaries.


1 Independence Technology, 2005

2 FDA 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA for iBOT 3000 Mobility System that is also applicable to the iBOT 4000 Mobility System.

James Bowman, MD
410-786-0009
linda.smith@cms.hhs.gov
410-786-5650
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