AT3: AT Reuse & Medicaid Questions and Answers for AT Act Programs (Q&A)
- 1 Q&A
- 2 Questions to Consider
- 3 How the partnerships work
- 4 Benefits of Medicaid partnerships with AT Act Programs
- 5 Models of AT Act Reuse Programs
- 6 Beginning the Conversation
- 7 Talking Points with Medicaid
- 8 Initial Considerations for Developing a Quality AT Reuse Program with Medicaid
- 9 How to Get Started
- 10 Resources for Medicaid AT Reuse Programs
- 11 Ensuring Quality AT Reuse with Medicaid
Questions to Consider
- Have you talked with your Medicaid Program about Reuse?
- Who is pursuing this partnership? (Agency, Legislative, Advocates, AT Act Program)
- Do you currently have
- Legislatively mandated?
- Ownership of DME?
Table Insurance Bowing
Big step before that
How the partnerships work
- The AT Program tracks the Medicaid purchases of specific DME items and recovers the equipment that is no longer being used.
- DME items no longer being used, purchased through other funding sources, are also retrieved.
- The AT Program works with local DME providers and/or trained staff to refurbish the equipment, restoring it to nearly new condition.
- Then this DME can be reassigned to another Medicaid member or any citizen in need.
- Considerable health care savings have occurred in the states where this arrangement exists.
Benefits of Medicaid partnerships with AT Act Programs
Additional benefits of a Medicaid partnership with AT program reutilization activities include:
- . Reusing DME helps manage Medicaid costs while also meeting the needs of persons with disabilities and the increasing aging population.
- . Access to needed technology improves the health and safety of persons with disabling and health conditions.
- . Access to technology helps keep individuals in less restrictive, less expensive environments.
- . The AT Programs providing reutilization programs are effective, efficient programs that receive high marks from the individuals receiving the lightly used equipment.
- . Reuse of quality equipment reduces consumption of natural resources and reduces use of landfills.
Years of experience with different models and the pursuit of improved standards of practice through the Indicators of Quality for Assistive Technology Reuse (IQ-ATR) make the AT Act Programs exceptional partners for Medicaid for safe, effective and appropriate reuse programs. AT Act Reuse Programs in Partnerships with Medicaid Summaries
Models of AT Act Reuse Programs
KANSAS DURABLE MEDICAL EQUIPMENT REUSE PROGRAM RAM, 2003
Program Name: The Kansas Equipment Exchange (KEE) Program Director: Dr. Sara Sack, Kansas University, Assistive Technology for Kansans Kansas has operated a durable medical equipment (DME) reuse partnership between the AT Act program and Medicaid successfully for over a decade. The Kansas Equipment Exchange (KEE) conducts a statewide equipment recovery campaign and accepts donations of lightly used DME obtained through public and private sources. All DME requests for Medicaid beneficiaries are first evaluated for new equipment, in the case that Medicaid coverage requirements are not met, the requested DME may be accessed from the reuse program. DME needs that may be temporary in nature are met by equipment accessed through the KEE program. Since 2003, the KEE program has received more than $10 million of durable medical equipment from private donors, and has refurbished and reassigned more than $8 million of used equipment. More than $1 million of equipment purchased by Medicaid has been recovered through the program, refurbished and reassigned to Kansans.
OKLAHOMA DURABLE MEDICAL EQUIPMENT REUSE PROGRAM RAM, 2012
Program Name: Oklahoma Durable Medical Equipment Reuse Program (OKDMERP) Program Director: Linda Jaco, Oklahoma State University, Oklahoma ABLE Tech Oklahoma’s reuse program, Oklahoma Durable Equipment Reuse Program (OKDMERP) in partnership with the Oklahoma Health Care Authority (Oklahoma Medicaid), began operations in 2012. DME is appropriately matched, reassigned and delivered to an Oklahoma resident in need. Priority is given to SoonerCare members, but other Oklahoma residents are eligible. Since 2012, the OKDMERP has resulted in nearly $3.5 million in healthcare savings to agencies and individuals. Over the period, 5,237 DME devices were reassigned including 2,503 devices to SoonerCare (Oklahoma Medicaid) members resulting in $1,055,581 in Medicaid savings.
SOUTH DAKOTA DURABLE MEDICAL EQUIPMENT REUSE PROGRAM RAM, 2017 Program Name: Program Director: EDIT: Kansas has operated a durable medical equipment (DME) reuse partnership between the AT Act program and Medicaid successfully for over a decade. The Kansas Equipment Exchange (KEE) conducts a statewide equipment recovery campaign and accepts donations of lightly used DME obtained through public and private sources. All DME requests for Medicaid beneficiaries are first evaluated for new equipment, in the case that Medicaid coverage requirements are not met, the requested DME may be accessed from the reuse program. DME needs that may be temporary in nature are met by equipment accessed through the KEE program. Since 2003, the KEE program has received more than $10 million of durable medical equipment from private donors, and has refurbished and reassigned more than $8 million of used equipment. More than $1 million of equipment purchased by Medicaid has been recovered through the program, refurbished and reassigned to Kansans.
Beginning the Conversation
Research shows that access to durable medical equipment (DME) improves health and safety, minimizes doctor visits and returns to hospitals, reduces or delays assisted living and nursing home placements, and enables some people and/or caregivers to keep working. Access to DME is not always available and those who cannot obtain it fail to experience the needed outcomes and quality-of-life improvements that DME can provide. Individuals who lack access may be uninsured or uninsured, or they may have coverage but experience delays in obtaining devices. For all of these individuals, the reutilization of lightly used DME has great value.
- . Who at Mediciad
- . What you can offer
- . How
- . When
- . Where
Talking Points with Medicaid
- Reuse serves the uninsured and the under-insured. It can provide an interim solution for people with coverage who experience delays, or a secondary device to minimize the burden of transporting bulky devices to school or workplace. Safe, appropriate and effective reuse matches the beneficiary to the needed device, not “a device”.
- Customer satisfaction surveys of reuse programs confirm that people in need of a device who lack financial means for timely access are “highly satisfied” to have a lightly used, refurbished device. Of 37,740 persons reporting from 56 states and territories, 89.3% reported that they were “highly satisfied” with the reused device.
- Overall, reuse benefits all citizens by reducing the consumption of natural resources (raw materials and fuel) and minimizes environmental impact by keeping usable devices out of landfills.
- The financial benefits of DME reuse are measurable using return-on-investment (ROI) analysis. Traditionally, this has used only the value of donated equipment and the cost of program operations in the computation. In 2011, the Kansas program returned $3.49 for every dollar spent. Some research has explored the inclusion of the value of preventing additional use of healthcare services into the ROI analysis.
Initial Considerations for Developing a Quality AT Reuse Program with Medicaid
- Reuse programs need clear and concise policies and procedures for assessing whether a particular item is appropriate for reuse.
- It is important to determine the safety and cost effectiveness of reuse of a particular device.
- Factors for consideration include the age of the device, the type of use, the environment of use and possible impact of the method by which the device has been transported.
- The type of repair or refurbishing required to sanitize the device or to restore it to original manufacturer specifications could render reuse financially impractical.
- One category of devices that poses a challenge for reuse is complex rehabilitation technology (CRT). In this category are wheelchairs that are fitted, programmed, adjusted or adapted for the needs of a specific individual. Identifying another individual who requires identical customization is very different from reassigning standard devices without modification. Reusing these devices without a professional evaluation of the precise needs of another individual is unsafe. If a program chooses to reutilize complex rehabilitation technology, policies and procedures should be in place to use appropriate allied health professionals to assure that the equipment is appropriately matched to the needs of the individual.
The Pass It On Center has published Indicators of Quality for Assistive Technology Reutilization (IQ-ATR) that provide a more comprehensive exploration of a range of best practices that, if followed consistently by reuse programs, can provide safeguards to beneficiaries, reuse programs and third-party providers like Medicaid.
How to Get Started
Before starting a program, it is essential to identify legal barriers to reuse under existing laws or Medicaid program regulations. Change sometimes requires legislative action or regulatory changes within an agency. If changes are needed, it may be possible to secure the commitment for change and proceed with planning while those changes are implemented.
- 1) CONVENE A WORK GROUP OF KEY STAKEHOLDERS
Identify the populations that are served through the Medicaid program. The extent of eligibility varies by state; some coverage is mandated. Having done this, it will be possible to identify agencies, organizations, and individuals who serve those populations and might be affected by a reuse program. Including representatives from all stakeholders increases the opportunities for a successful program launch. This group typically includes representatives from:
- Medicaid program
- Assistive Technology Act Program
- Independent Living Council
- Agencies on Aging
- Commercial DME suppliers and/or a representative from the state association of medical equipment suppliers
- Nonprofit suppliers of DME or related services in your state (often Goodwill, Easter Seals, United Cerebral Palsy, or faith-based organizations)
- Advocacy groups for people with disabilities
This group could include representatives from other government agencies that purchase DME, with the goal of gaining support for reclaiming equipment that is no longer needed. In Virginia, for example, the Brain Injury Trust Fund and the Veterans Administration also sticker newly-purchased devices for return to the reuse program. It could also include representatives from hospitals that serve large numbers of Medicaid patients, with the goal of assigned needed DME as soon as possible upon or after discharge. This strategy optimizes recovery (or at least best outcomes) and impacts the Medicaid budget by avoiding return visits to doctors, emergency rooms and hospitals. TIP: An initial step should be acquainting the group with successful models of reuse in Medicaid. The Pass It On Center can provide information and presentations, or the group can invite a representative from an existing Medicaid reuse program.
- 2) DEFINE SCOPE OF SERVICES
The workgroup will need to define the scope of services to be offered. This includes specification of devices or equipment that will be accepted for refurbishing and reassignment. The program may want to limit reuse to devices or categories that represent the greatest return on investment. Bariatric equipment and sleep apnea devices are expensive and in great demand, for example. There are other considerations. A refurbishing program may elect to limit devices to specific manufacturers. For example, if wheelchairs are accepted only from two or three major manufacturers, technicians will be trained for those and repairs can be made more efficiently. Doing so could also limit the range of spare parts needed. As noted earlier, highly customized devices may be less appropriate for reuse for many reasons.
The group should also address supporting services that will be offered. These could include assessment for appropriate equipment (which requires appropriate professionals), matching to appropriate devices (also sometimes requiring professionals such as occupational or physical therapists), and maintenance and repair of the assigned devices. (Some state laws mandate assessment or fitting of specific devices by healthcare professionals with specific credentials. Again, state law is very important in program design.) Optimizing processes and procedures will contribute to financial outcomes. For example, Friends of Disabled Adults and Children, a nonprofit reuse program in Metro Atlanta, adopted a “value stream” production system to streamline program operations.
It will be easier to identify participating organizations or individuals and their potential roles in the program after the scope and proposed operating model has been defined. This model should consider:
- device acquisition strategies,
- safeguards from liability,
- program eligibility,
- priorities for inventory usage, and
- a distribution strategy.
Medicaid covers the entire state, so decisions must be made about how to serve different geographic areas. Reuse programs frequently encounter the issue of transportation for device delivery. Programs often create a network using existing agency resources, volunteers from organizations in the network, or contractual arrangements with commercial suppliers.
- 3) ADDRESS LIABILITY CONCERNS AND PROGRAM OPERATIONS
Most programs face two areas of liability concern:
- issues of organization structure, governance, insurance and human resources, and
- issues related to reuse program operations.
Compliance with all prevailing laws and regulations is critical. This includes compliance with provisions of the Food, Drug and Cosmetic Act (FDA) that apply to some devices, especially the ability to identify the recipient of a specific device to respond to alerts and recalls. Programs also need to require prescriptions for those devices that would require prescriptions for acquisitions from commercial suppliers. Liability arising from program operations can be mitigated by implementing policies, procedures and training that are consistent with the Indicators of Quality for AT Reuse (see http://www.passitoncenter.org ).
Programs should have a protocol in place to ensure that the donor owns the equipment or has the right to donate it. This avoids having items donated that remain the property of some other agency or entity or that were stolen. Other forms of liability are mitigated by having standards for age and condition of donated devices, having the devices repaired and refurbished by qualified technicians, using appropriate replacement parts, and sanitizing the devices properly for the safety of workers and recipients.
Liability follows ownership. In most reuse programs, the reuse program assumes ownership of the donated device, whether purchased by Medicaid or another party. The device is sanitized, repaired and refurbished as needed, then reassigned to a new user who accepts ownership and signs a release from liability.
Intake procedures must include a determination of eligibility based on regulatory or agreed-upon guidelines. HIPAA compliance is essential. Medicaid must determine if it will reserve the right to place priority holds on inventory items, and if so, for how long. The reuse program must determine how long it will hold items in inventory. This could vary by category of device and by available storage space.
Where needed or required by law, appropriate professionals (e.g., physical therapist, occupational therapist or respiratory therapist) should match devices to beneficiary needs. The correct fit or adjustment is a critical factor in acceptance and use of AT.
Liability can take the form of injury or property damage. In over 10 years of operation, the Kansas reuse program has experienced only four incidents that could have resulted in liability issues. A back injury by a staff member, an overturned power chair and a hospital bed collapse were addressed with staff training and clarification of practices. In the fourth incident, gouged vinyl flooring in the customer’s home was replaced.
Customer follow-up helps to ensure that the device is appropriate, acceptable and being used. Programs need to be prepared to dispose of devices that have no more useful life, either through cannibalization for useful parts or environmentally safe disposal by using certified companies for disposal. Reuse programs are cautioned against altering devices from the original manufacturer specifications (remanufacturing) as a serious potential liability. All repair and refurbishing should be consistent with the original manufacturer’s specifications.
- 4) PREPARE A PROJECT PLAN AND PRELIMINARY BUDGET
The Pass It On Center includes a preliminary project plan among its resources , but it might prove useful to review the experience of recently implemented programs. Every project is different because the state, the Medicaid program, and the issues vary. The Medicaid program will need to develop a budget for the agreed-upon activities. For example, in Kansas this includes supporting the database and tracking expenses for all reutilized equipment and compensating suppliers for repairs for those devices reassigned to Medicaid beneficiaries. It might include expense allocations for the use of professionals for other specific activities, and for the pickup or delivery of equipment. The budget would be based on assumptions about the number of patients to be served. Again, recent experience in other programs might offer useful data. In most states, the Medicaid program would need to prepare a request for proposal (RFP) to contract services with other suppliers for the reutilization services. The Oklahoma RFP is available in the Pass It On Center Knowledge Base. Responses to the RFP would be reviewed to identify the reuse partner.
Funding the program is a key concern, and budgeting should be realistic. It may not be practical to expect a return during Year One, but significant benefits should be realized after the program is in place. The acceptance of the program will depend on how well it is explained to prospective beneficiaries.
For start-up budgeting, Dr. Sara Sack, Director of the Kansas Equipment Exchange recommends that Year One and perhaps Year Two assume that the program will be “cost neutral,” that is, that significant savings may not be realized for the first two years. In commercial terms, this would be planning for break-even operations before profitability.
The program will first need to determine how it will operate and the level of funding needed to support the infrastructure. It will take some time to establish a reassignment network – that is a network of organizations that provide intake, eligibility, matching and distribution services. It will also take some time to build a working inventory from donated devices to have the appropriate equipment to reassign. Once the program is established and the public becomes aware of the need and the services, circumstances change rapidly. (For example, Oklahoma experienced a rapid expansion in supporters and voluntary partners shortly after start-up as other agencies and organizations working with people with disabilities recognized the value of the reuse program. At that point, equipment purchased by sources other than Medicaid (insurance, private pay, etc.) is being donated and some Medicaid-purchased equipment is being recovered. When this point is reached, a return of one to two dollars for every dollar spent is probably a safe assumption. The return on investment could be much higher, but this depends on the inventory and distribution model. Each program must analyze the decisions made about the operational model for budgeting assumptions.
- 5) DETERMINE HOW PROGRAM WILL BE FUNDED
There are many models for reuse partnerships, and they should be examined to determine which, if any, are appropriate for the circumstances in a given state. Medicaid can analyze which items or categories of devices represent the greatest potential for successful reuse.
The Medicaid durable medical equipment budget should not be used to start a reuse partnership. The program start-up costs should be budgeted separately. Otherwise, neither funding for new devices nor appropriate used devices might be available for beneficiaries. It is important to build a viable reuse program with an inventory of devices appropriate to the population before assuming the availability of lightly-used devices in the budgeting process.
In some states, the reuse program uses Medicaid funds to refurbish equipment for Medicaid beneficiaries. The refurbishing may be done by a separate reuse facility or by commercial suppliers that partner with Medicaid. In other states, DME refurbishing suppliers offer repair services for Medicaid and the public, and submit the request for reimbursement for Medicaid beneficiaries directly to Medicaid. Medicaid may pay the cost of inventory management for all used devices recovered in exchange for priority claim on devices. Medicaid could identify a specific category (or categories) of devices that it deems more practical or beneficial for reuse.
- 6) IDENTIFY DESIRED RETURN ON INVESTMENT
Each Medicaid program should consider the categories of devices that result in the greatest expenditures and weigh how reuse might impact those categories. This would include consideration of devices that are more generally short-term use and more likely to be recovered or donated to the reuse program. It could be a consideration for a category that is particularly expensive, such as bariatric devices.
In addition to the value of equipment (and money saved), there are other factors that can be included in the calculation of return on investment: 1. Avoided falls and the resulting consequences (physician visit, emergency room visit, nursing home stay, or hospital stay), 2. Increased independence in employment, education, recreation and everyday activities, 3. Prevention of lost earnings by the user, relatives or other caregivers, and 4. Savings from avoided landfill costs related to discarded DME that has a remaining useful life. (See Appendix III.)
- 7) DONATION AND REASSIGNMENT SAFEGUARDS
A first step in safeguarding donations is to ensure that a prospective donor has the right to donate the equipment to the reuse program. Some DME is purchased by organizations that retain ownership and would expect the device to be returned if no longer needed. While reuse programs do not purchase devices (so there is no incentive to donate stolen property), it is still advisable to have policies for ascertaining the right of the donor to give the equipment (IQ-ATR 3.8 - Donated Equipment: Confirmation of Donor’s Ownership).
Reassignment can be safeguarded to ensure that the devices are not being obtained for resale. Appropriate application and intake policies should collect information about the intended user, and that user should be appropriately matched and trained in the device use. This should result in personal interaction with the device recipient.
- 8) DEFINE REIMBURSEMENT MODELS FOR DME SUPPLIERS
In most Medicaid partnerships, DME devices are not sold. However, if approved by change of law or policies, devices could be refurbished by certified suppliers and purchased by Medicaid for reassignment to beneficiaries. Services, such as device repairs either before or after the device is received, may be reimbursed by Medicaid. In these cases, the program will define qualifications for suppliers. In some cases, the suppliers are commercial DME suppliers with certified technicians. In others, the supplier may be a reuse program with appropriately trained technicians.
- 9) EXPLAIN THE ROLE OF REUSE TO BENEFICIARIES
The program will need a public awareness campaign to explain key facets of the reuse program:
- Why used versus new
- What makes this safe and effective
- Who owns the equipment, implications for consumers
- How the beneficiary gets equipment repaired
- Stories from actual users
This information can be disseminated through the network of partners and associated organizations and through the use of public media.
Resources for Medicaid AT Reuse Programs
- A review of existing models can aid the identification of desirable activities and characteristics for the proposed program. The Pass It On Center is a useful resource for implementation resources. The August 2012 webinar on Medicaid is a good starting point for discussions. The slides and audio are available in the webinar archive (accessible from the PIOC website home page. ) *The Knowledge Base (http://www.passitoncenter.org/content/) contains a broad range of information for the operation of a reuse program including a guide to developing a business plan and a three-year financial plan. It also includes an example of a Request for Proposal.
- IQ-ATR Tool
Ensuring Quality AT Reuse with Medicaid
The Pass It On Center has published Indicators of Quality for Assistive Technology Reutilization (IQ-ATR) that provide a more comprehensive exploration of a range of best practices that, if followed consistently by reuse programs, can provide safeguards to beneficiaries, reuse programs and third-party providers like Medicaid. The IQ-ATR developed in 2009, revised in 2017, address all areas of Program Operations. They are cited below in appropriate sections to describe the expected practices.
- PARTNERSHIPS: AGREEMENTS, ROLES, RESPONSIBILITIES
The contract between Medicaid and the AT reuse program will specify roles and responsibilities. These will be clearly defined.
- CONSUMER CHOICE
The customer and direct support provider(s) are informed of all appropriate device options and are allowed to participate in the choice of device (IQ-ATR 4.3 - Customer Choice).
- EQUIPMENT TRACKING
The program should have written policies and procedures and an accurate and efficient method to track the inventory of available devices that includes:
- Unique identification of every donated device (by paper label or bar code)
- The ability to determine the availability of devices by type
- The assignment of an inventory valuation to each device (often based on a percentage of the manufacturer’s suggested retail price)
- The ability to identify devices subject to recall notices
- The ability to identify customers who have received devices subject to recalls, market withdrawals or safety alerts
(IQ-ATR 3.4 - Device Tracking, IQ-ATR 3.5 - Device Valuation and IQ-ATR 3.6 - Management of Device Recalls, Market Withdrawals and Safety Alerts) The inventory system should be capable of capturing detailed specifications for equipment (e.g., manufacturer, model number, serial number, seat height, seat depth, weight limit for a manual wheelchair). This data facilitates the identification of appropriate equipment for specific needs. The program may formulate policies related to priority holds or wait-listing for the Medicaid program or other participants. Appropriate disposal of devices that have no more useful life can present a challenge to the reuse center, especially if those devices are electronic and/or digital. The components of many electronic devices are potential hazards to the environment if not disposed properly. When a device has no more useful life, or if some portions remain after it is cannibalized for spare parts, disposal of the device or parts must be done in a manner consistent with environmental regulations. Reuse programs should identify certified recycling resources. (IQ-ATR 3.17 - End-of-life Recycling).
When devices are acquired by an assistive technology reutilization center, one of the first priorities is to make those devices safe for use by other individuals. Steps should be taken immediately to minimize the potential transmission of disease. The best way to protect all individuals who will come into contact with reutilized equipment is to institute sanitization practices that make the objects safe to handle and to use. The recommended practices are based on manufacturer recommendations, guidelines from the CDC and the practical experiences of reuse programs in implementing these recommendations. (IQ-ATR 3.10 - Sanitization of Donated Equipment)
- REFURBISHING, REPAIRING AND STORING DONATED DEVICES
The program has written, device-specific procedures that are applied consistently for evaluating the repair and refurbishing needs of donated equipment (IQ-ATR 3.9 - Evaluation of Used Devices). Once identified, the refurbishment/repair of equipment must be performed in a manner that is consistent with manufacturer instructions and original specifications (IQ-ATR 3.11 - Refurbishing Donated Equipment). Programs offer a limited warranty on refurbished devices, often a 30-day warranty with a commitment to repair or replace the device if necessary (IQ-ATR 3.14 - Limited Warranty for Refurbished Devices). Appropriate storage facilities are essential to separate sanitized from unsanitized equipment; to organize storage of different types of devices; and to provide proper heating, cooling and ventilation as needed (IQ-ATR 3.15 - Storage of Donated Equipment).
Procedures and training are essential for picking up donated equipment or delivering refurbished devices (IQ-ATR 3.16 - Transportation of Donated Equipment).
- USER SERVICES
User Services address the intake of the consumer at point of application for services, and interactions and services from the time the consumer is assigned a piece of equipment.
- PATIENT INFORMATION PRIVACY COMPLIANCE (HIPAA)
As noted above, program staff should be trained in the privacy provisions of HIPAA.
- INTAKE AND ELIGIBILITY PROCESS
Customer or patient intake may result from referral by a physician, hospital or other professional resource, or it may be the result of self-referral. Each program specifies eligibility requirements. The application for services should gather sufficient detail to determine eligibility (IQ-ATR 4.1 - Customer Intake).
- PRESCRIPTION REQUIREMENTS AND MATCHING DEVICES TO CUSTOMER
As noted earlier, the reuse program should adhere to all prescription requirements. Appropriate device reuse for some categories requires appropriate matching of devices to customers based on medical prescriptions and the services of professionals (e.g., occupational therapists or other AT professionals) (IQ-ATR 4.2 - Matching Device to Customer).
- CONSUMER TRAINING AND TECHNICAL ASSISTANCE
The customer and his direct support provider(s) are given basic training on features, operation, maintenance, safety and troubleshooting for the device at the time the device is reassigned (IQ-ATR 4.4 - Customer Training on Device). The customer is given a trial period with the device (IQ-ATR 4.5 - Customer Trial on Device). If the customer is unable to pick up the equipment, it may be delivered by trained staff. Some programs have limited transportation alternatives (IQ-ATR 4.7 - Equipment Delivery to Customer, IQ-ATR 4.8 - Trained Delivery Staff). If a new user experiences difficulty, he or she should be able to call for and receive technical assistance (IQ-ATR 4.6 - Technical Assistance). Programs should establish a follow-up protocol to ensure that the needed devices are being used and that the customer has not encountered difficulty (IQ-ATR 4.9 - Customer Follow-up).