Power Mobility Device Independent Testing Requirements Effective October 1, 2015 - Revised
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, first 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. As of January 1, 2008 Code verification applications for PMDs were required to be safety and performance tested at independent Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) capable test facilities. Code verification applications submitted on/or after October 1, 2015, are required to have RESNA tests conducted at a RESNA-capable testing facility using the new PDAC Test Report Template and requirements. Wheelchairs are classified under HCPCS coding based on the direct results of testing that is conducted using the RESNA wheelchair standards. No other tests or testing standards may be used. If it is found that the testing is not compliant with RESNA wheelchair standards, the PDAC coding verification application will be rejected.
- All results must be submitted using the most current version of the PDAC Test Report Template. At the date of publication of this article, the 2015 Version of the PDAC Test Report Template is the newest version of the template. PDAC test report templates contain the specific performance requirements that PMD’s must meet when independently tested using the RESNA wheelchair standards.
- Each test report must contain a photograph of each test setup. The test report shall also include a list of equipment used (i.e., Meters, gauges, measuring instruments). Calibration data for all equipment must also be supplied.
Manufacturers are encouraged to provide supplemental independent testing for all PMDs coded prior to October 1, 2015 to verify that all coded PMDs meet the requirements in the most current version of the PDAC Test Report. As the RESNA wheelchair standards are updated, manufacturers are encouraged to independently retest their existing coded products using the newest versions of the RESNA wheelchair standards.
NOTE – The following exception applies:
The Multi-Drum Test and the Drop 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 as of the date of publication of this article 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.
RESNA Wheelchair Test Laboratories
1050 Saxonburg Blvd.
Glenshaw, PA 15116
|Beneficial Designs, Inc.
PO Box 69
Minden, NV 89423
|University of Pittsburgh
School of Health and Rehabilitation Sciences
Department of Rehabilitation Sciences and Technology
4020 Forbes Tower
Pittsburgh, PA 15260
Supplemental PMD Safety and Performance Testing Information
RESNA test protocol clauses are required and results must be submitted to the PDAC.
Copies of the RESNA Standards may be ordered from:
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: firstname.lastname@example.org
NOTE – The most current version of the RESNA standards must always be used for testing. Please refer to RESNA for the most current and up to date standards.
|December 2007||Published on SADMERC website|
|05/13/2010||Revised by PDAC|