Revised - Power Mobility Device Independent Testing Requirements (PDAC Article)

Posted February 28, 2013

The original version of this article can be found on the PDAC web site at: https://www.dmepdac.com/resources/advisory_articles.html

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. Wheelchairs are classified under HCPCS coding based on the direct results of tests that meet RESNA standards. No other tests or testing standards may be used. If it is found that the testing is not compliant with RESNA standards, the PDAC coding verification application will be rejected. NOTE: The following exception applies:

The drop test and the fatigue test may 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 instruments 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 multi-drum and curb drop 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 latest RESNA methods, formulae, and protocols. The latest RESNA test procedures are : RESNA WC-1:2009 - RESNA American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (Including Scooters) and RESNA WC-2:2009 - RESNA American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems.

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 are identified on the RESNA website as being RESNA capable Powered Mobility Device testing facilities:

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/

 

Ammer Consulting

1050 Saxonburg Blvd.

Glenshaw, PA 15116

Phone: 412.389.4429

bill@ammerconsulting.com

http://ammerconsulting.com/_wsn/page3.html

 

Beneficial Designs Inc

PO Box 69

Minden, NV 89423

Phone: 775.783.8822

http://beneficialdesigns.com/

 

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 required are listed for reference 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. The manufacturer may perform only Section 8, Tests 10.4(Multi-Drum) and 10.5(Curb Drop) from Volume 1. All other tests are to be performed by an independent test facility. Each test report must contain a photograph of each configuration of the wheelchair during testing and minimum of one photograph of each test setup. The test report shall also include a list of equipment used.(meters, gauges, measuring instruments). Calibration data for all equipment must also be supplied.

Copies of the Resna Standards 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

Pivot Width - Section 5 - 8.11 - Pivot width - this is the turning radius for a power wheelchair with joystick steering.

Reversing Width - Section 5 - 8.12 - This is a three-point turn and applies to a POV with tiller 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 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 POVs

 

Published by Palmetto GBA as the SADMERC, December 2007.

Republished by NAS as the PDAC, August 2008.

Revised by NAS as the PDAC, March 2010.

Revised by NAS as the PDAC, February 2013

 

            Last Updated Thu, 25 Oct 2018 15:18:26 +0000