of sets and alternate depending on their activity.
Infusion set tubing comes in lengths ranging from 18 to 43 inches, depending on the manufacturer and the set. Manufacturers usually offer two or three tubing length options. Some manufacturers offer both clear and colored tubing. The colored tubing may help make it easier for the patient to view the insulin flow and detect air bubbles, which, if large (extending several inches), can account for non-delivery of insulin resulting in unexpected hyperglycemia.
Patients choose tubing length depending on their physical activity, sleeping habits, and clothing. For example, restless sleepers and people who wear their pump in their sock need longer tubing; those who wear the pump at their waist may prefer shorter tubing. Longer tubing may prevent dislodgment of the infusion set when using the bathroom (toilet) while the pump is attached to or in the pockets of pants that have been lowered to the floor. Any excess tubing can be easily tucked into the patient’s clothing and kept out of sight and there are companies that make devices that roll up tubing.
Additionally, some infusion sets allow tubing to be “directed,” i.e., the tubing position on the base can be changed, depending on the direction preferred by the user (right, left, upward, downward). Tying the tubing in knots does not impede the delivery of insulin, as the tubing is co-extruded (i.e., it has an inner small-diameter tube inside an outer tube). Advise the patient that if s/he would like to try different infusion sets or tubing lengths, their next order can include other available options offered by their pump manufacturer. The same is true for infusion set dressings, as some patients may experience an allergic skin reaction to the self-adhesive tape and may need to try another brand.
Customer Service and Other Practical Considerations
The pump manufacturer sales personnel should explain the start-to-finish process to both the potential pump user and to his or her healthcare professional or team. The pump patient must be confident that technical support and assistance are available 24 hours a day, 7 days a week. All pumps should have the company’s toll-free customer service number displayed on the back of the pump and/or remote device and corresponding communication devices (BG meter, CGM device).
Another consideration is the procedure for ordering supplies. The pump wearer should know what types of infusion sets, accessories, batteries, and specific pump items, such as cartridges/syringes, are needed. Most likely, replacement supplies are obtained by mail order from the pump manufacturer or pump supplier as contracted by the patient’s insurance company. Rarely are pump supplies available through a local pharmacy. Some manufacturers or supply companies offer to send the patient supplies routinely and automatically. What role does the manufacturer play in verifying insurance coverage for supplies?
On average, the price of an insulin pump ranges between $6,000 and $8,000, and most come with a 4-year warranty. Some pumps may cost less, as they may have disposable components, thus, less costly “hardware.” Medicare currently allows a pump to be replaced every 5 years (DHHS 2013). Supplies, including batteries, pump cartridges/syringes, infusion sets, skin prep items (and other items such as tape/dressing) can cost in excess of $1,500 each year. Help the patient understand the price of both the pump and supplies. Insurance coverage ranges from 50 to 100%, with most averaging about 80% coverage. Some insurance companies may provide coverage for the pump but not the supplies, or vice versa. Some patients have insurance policies with a high deductible or a low cap, such as $500/year, for durable medical equipment or medical supplies, which may be unfeasible for some patients.
The pump manufacturer should give a detailed cost estimate in writing to the patient and keep in touch with the patient throughout the insurance verification and pump and pump supplies ordering process. Usually, a pump manufacturer insurance specialist handles this process. The patient is required to sign an assignment of benefits document, allowing the pump manufacturer to determine the type and amount of insurance coverage provided. This can take one day to several weeks to process. An insulin pump is a prescription item, and the prescribing physician must provide the prescription and/or an order for an insulin pump and corresponding pump supplies to the patient and/or insurance company. Some insurance companies require a letter of medical necessity from the prescribing physician with additional documentation, which may include:
• Several weeks or months of SMBG records
• Recent A1C levels
• Reasons why an insulin pump may be necessary, e.g., erratic glucose pattern correction, preconception, pregnancy, diabetes complications requiring improvement in control, or lifestyle change
Almost every pump manufacturer has a standard “letter of medical necessity” checklist form. An individualized letter from the healthcare professional is rarely required except in the case of an appeal following a pump coverage rejection.
Some insurance providers may allow only certain contracted brands of insulin pumps. The patient should check with their insurance provider to confirm whether or not this is the case before selecting and ordering a pump. Patients who decide on an alternative brand usually need a letter or certificate of medical necessity from the prescribing physician explaining why another pump brand is preferred or required. Because this delays purchase and shipment of the pump, many clinicians have developed form letters to expedite the insurance approval and appeal process. Even if not initially covered, persistence can lead to a noncontract or nonformulary pump approval. Some patients pursue insulin pump insurance coverage for several brands of pumps and opt to settle for the pump that costs the least amount of money. Other patients are firm in their choice and are willing to provide whatever documentation the insurance company may require to approve a noncontract or nonformulary pump.
Patients can often request that the company ship the insulin pump directly to the home. However, overzealous and excited patients have been known to self-initiate pump therapy without formal training and have ended up in the emergency room in DKA or hypoglycemic shock. For this reason, some clinicians and diabetes educators request that the company ship a new pump to their site rather than to the patient’s home and insist that pump manufacturers provide scheduled formal pump training. Note that some physicians do not want to accept the liability of having a pump shipped to the office, as there is potential for the pump to be misplaced or lost, or to have it opened inadvertently, or even stolen. For this reason, some pump manufacturers prefer to ship the pump directly to the patient requiring a signature upon delivery. When a pump is shipped directly to the patient, advise the patient to check the shipping list for full contents. Direct the patient to review the pump tutorials and materials prior to office instruction. In either instance, reinforce to the patient to NOT initiate pump therapy without both formal training from the pump manufacturer and the presence of a healthcare professional (preferably the pump prescriber or designated HCP).
References
Department of Health and Human Services (DHHS) Centers for Medicare & Medicaid Services: National Coverage Determination (NCD) for Infusion PUMPs (280.14) http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=40&NcaName=Insulin+Infusion+Pump&CoverageSelection=National&KeyWord=insulin+pump&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAA& Accessed 10 February 2013
Roche Insulin Delivery Systems, Inc.: ACCU-CHEK Guide to Infusion Site Management. Fishers, IN: 2012
Scheiner G: Matching patients to devices: diabetes products are not one-size-fits-all. Clinical Diabetes 30:126–129, 2012
Chapter 3 Pump Candidate Basics
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