Retired - Power Mobility Device Independent Testing Requirements
Overview
The Pricing, Data Analysis and Coding (PDAC) contractor is providing this additional information to clarify the Medicare code verification process for Power Mobility Devices (PMDs).
The requirements for safety and performance-testing of PMDs, or power wheelchair models and power operated vehicle (scooter) models, changed effective January 1, 2008.
The PDAC requirements assure Medicare and its beneficiaries have access to verifiable safety and performance test results when selecting an appropriate power wheelchair or scooter to meet their clinical needs. For Medicare, independent testing assures appropriate payment based on quantifiable safety and performance test results for each product model. Safety and performance testing of power wheelchairs and scooters is part of the current Healthcare Common Procedure Coding System (HCPCS) code verification process. The PDAC uses the device test results, device characteristics, power options, patient weight capacity, and seating options to assign products to the PMD HCPCS codes implemented on November 15, 2006.
Independent Testing Requirements
Code verification applications for PMDs that were submitted and completed prior to January 1, 2008, were allowed to have safety and performance testing conducted at manufacturer test facilities.
Code verification applications submitted on/or after January 1, 2008, are required to have Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) tests conducted at a RESNA-capable testing facility in the United States with the following exceptions:
The drop test and the fatigue test may continue to be conducted at manufacturer testing facilities.
Manufacturer Testing of Power Mobility Devices
Code verification applications submitted to the PDAC must contain thoroughly documented RESNA test data. Test results are subject to review and observation by CMS and its contractors, including requests for additional documentation; such as testing instrument utilized, testing instrument calibration records and/or reports, certification and training qualifications of personnel performing the tests, and the RESNA standards observed.
Manufacturers may continue to perform drum and fatigue cycle testing as long as the tests are conducted using the latest RESNA protocols, and conducted in a testing facility with equipment and personnel capable of performing the testing in accordance with RESNA standards and parameters. Manufacturers shall continue to provide an attestation from senior management (CEO and/or President or Vice President only) that the manufacturer has performed the PMD testing in accordance with RESNA testing standards. The manufacturer must further certify that the personnel who performed the tests had the training and qualification necessary to be fully knowledgeable of RESNA testing standards, and were capable of conducting the tests in accordance with the required RESNA testing standards. This certification must accompany the code verification request.
Power Mobility Devices Submitted for Independent Testing
For all new PMD models, a full production model PMD available for sale to the public must be submitted to an independent testing facility.
PMD prototypes, customized models, pre-production models and any other design phase type models are not acceptable for Medicare safety and performance testing, nor may any of these be furnished to Medicare beneficiaries.
All new PMD models are required to be tested according to the new RESNA methods, formula, and protocols. All PMDs must be tested at the maximum patient weight capacity for the base. RESNA has defined the chair configuration for testing and clarified test protocols. All parameters and technical information needed to conduct the testing may be obtained from RESNA at www.resna.org.
Medicare does not specifically endorse the following testing facilities, however the facilities below have conducted Power Mobility device testing. If a manufacturer has questions regarding a specific testing facility not listed below, especially with regard to whether they are a RESNA-capable testing facility, they should contact the PDAC at 877.735.1326.
| University of Pittsburgh School of Health and Rehabilitation Sciences Department of Rehabilitation Sciences and Technology 4020 Forbes Tower Pittsburgh, PA 15260 Phone: 412.383.6558 http://www.shrs.pitt.edu/ |
MET Laboratories, Inc. 914 W. Patapsco Ave. Baltimore, MD 21230 Phone: 410.354.3300 http://metlabs.com/ |
| Beneficial Designs Inc PO Box 69 Minden, NV 89423 Phone: 775.783.8822 http://beneficialdesigns.com/ |
Ammer Consulting 1430 Lakeside Drive Allison Park, PA 15101 Phone: 412.389.4429 http://ammerconsulting.com/index.html |
Supplemental PMD Safety and Performance Testing Information
The following RESNA test protocols are listed for your convenience. The bolded and underlined titles represent the subsections required to be tested and results that must be submitted to the PDAC. Some RESNA test sections that are not listed as required may be referenced in the test protocols for the purposes of clarity. Other RESNA test sections are listed only for convenience. The protocol documents to be used are always the most recent RESNA standards, including those in draft form. The manufacturer may perform only Section 8, Tests 10.4 and 10.5 from Volume 1. All other tests are to be performed by an independent test facility.
Copies may be ordered from:
RESNA
1700 N. Moore St., Suite 1540, Arlington, VA 22209-1903
PHONE: 703/524-6686 FAX: 703/524-6630 TTY: 703/524-6639
WEB SITE: www.resna.org EMAIL: publications@resna.org
Volume 1: Requirements and Test Methods for Wheelchairs (including POVs)
Section 1: Determination of Static Stability
Static Stability of Chairs with Power Options:
Section 1 – 10.3: Rearward Stability with wheels locked (If there are non- locking casters to the rear, use 10.2 Rearward Stability with wheels unlocked)
Section 1 - 11.2: Rearward Anti-tip stability with wheels locked (could be rearward, forward, or both depending on where the anti-tip devices are placed)
Section 5: Determination of Dimensions, Mass and Maneuvering Space
Length – Section 5 – 8.2 - Full overall length – including a foot space gauge on the foot supports. The new test procedure includes feet on the chair to simulate the space required by user with feet on the foot supports. Record and disclose the length with and without the foot space gauge.
Width – Section 5 – 8.3 - Full overall width
Three point turn – Section 5 – 8.12 - Reversing width – this is the turning radius for a POV with tiller steering.
Pivot Turn Radius – Section 5 – 8.11 - Pivot width – this is the turning radius for a power wheelchair with joystick steering.
Corridor Turn test – Section 5 – 8.15 - Width of angled corridor required to determine the minimum width of hallway needed for the device to turn around.
Section 7: Method of Measurement of Seating and Wheel Dimensions Seating Measurements for Coding – Section 7 –
7.3.2 Seat Plane Angle
7.3.3 Effective Seat Depth
7.3.4 Effective Seat Width
7.3.6 Seat Surface Height at Front Edge
7.3.7 Back Support Angle
7.3.8 Back Support Height
Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
Fatigue Test on Level with Slats – Section 8:
10.4 Multi-Drum Test
Drop Cycles – Section 8:
10.5 Drop Test
Section 11: Test Dummies
Section 13: Determination of Coefficient of Friction of Test Surfaces
Section 15: Requirements for Information Disclosure, Documentation and Labeling
Section 16: Resistance to Ignition of Upholstered Parts-Requirements and Test Methods
Section 19: Requirements and test Methods for Wheelchairs (including POVs): Wheelchairs Used as Seats in Motor Vehicles (selected models only)
Section 20: Determination of the Performance of Stand-Up Type Wheelchairs
Section 22: Set Up Procedures
Section 26: Vocabulary
Volume 2: Additional Requirements for Wheelchairs (including POVs) with Electrical Systems
Section 2: Determination of Dynamic Stability of Electric Wheelchairs
Dynamic Stability Incline
Section 2 – Driving Tests on Slopes and Level – Maximum slope the chair passes all tests with a score of 2 or better.
Clause 8 Tests for rearward dynamic stability – 3 tests –
8.2 Starting forwards
8.3 Stopping after traveling forwards
8.4 Braking when traveling backwards
Clause 9 - Tests for forward dynamic stability - 2 tests –
9.2 Braking when traveling forwards
9.3 Traveling forward down a slope onto a horizontal surface
Clause 10 - Tests for dynamic stability in lateral directions – 2 tests –
10.2 Turning on a slope
10.3 Turning in a circle at maximum speed (applies only to POVs) Disclosure
10.4 Turning suddenly at maximum speed (applies to PMD with joystick steering)
Section 2 – Step Transition Tests – Maximum step transition height that chair can pass all related stability tests with a score of 2 or better.
Clause 8 Tests for rearward dynamic stability – 2 tests –
8.5 Traveling forward up a step transition from a standing start,
8.6 Traveling backward down a step transition from a standing start
Clause 9 – Tests for forward dynamic stability – 2 tests-
9.4 Traveling forward up a step transition at maximum speed,
9.5 Traveling forward down a step transition from a standing start
Clause 10 – Tests for dynamic stability in lateral directions – 1 test
10.5 One side of the wheelchair drops down a step transition
Section 3: Determination of Effectiveness of Brakes
Section 4: Energy Consumption of Electric Wheelchairs and POVs for Determination of Theoretical Distance Range
Theoretical Driving Range – Section 4 – 7.1 – this test calculates the maximum distance potentially available on a fully charged battery under ideal conditions.
Theoretical Maneuvering Range – Section 4 – 7.2 Maneuvering test – this test simulates range of the device when required to turn.
Section 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric Wheelchairs
Minimum Top End Speed – Flat – Section 6 – 6.1 Determination of Maximum speed on a horizontal surface
Maximum Top End Speed On Slope – Section 6 – 6.5 Maximum speed on a slope. Testing is done on the same slope used for the dynamic stability slope.
Section 9: Climatic Tests for Electric Wheelchairs
Section 10: Determination of Obstacle-Climbing Ability of Electrically Powered Wheelchairs
Obstacle Height – Section 10 – Clause 7 - Maximum obstacle height to ascend and descend with technique described.
Section 14: Power and Control Systems for Electric Wheelchairs-Requirements and Test Method
Maximum Thermal Drive Test – Section 14 – 6.18 Maximum Thermal Drive-Test discloses maximum driving time and driving distance uphill
Maximum Power Stall Condition – Section 14 – 6.14 Stalled Condition
Protection –This test ensures that the device has protection at the controller for the motors if someone tries to drive when stuck.
Section 21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized POVsPlease note that links in this document were accurate at the time of original publication and may change over time and are no longer active.
|
Date |
Update |
|---|---|
| December 2007 | Published on SADMERC website |
| 05/13/2010 | Revised by PDAC |
| 02/25/2013 | Revised |
Please note that links in this document were accurate at the time of original publication and may change over time and are no longer active.