Infusion Environments: Comparing Costs, Safety and Privacy

by Kris McFalls and Ronale Tucker Rhodes, MS

Physicians who treat patients who require immunoglobulin (IG) therapy must choose the appropriate site of care. There currently are many different IG infusion environments, including the hospital, physician’s office, infusion clinic and home. And, which site to choose is driven by a variety of reasons. But the chief considerations include cost, safety and privacy. In addition, patient age can be a factor; the choice made for a child or young adult may not be right for an older adult, and vice versa.

Costs

Costs related to the site of care include doctor visits, facility charges, administration fees, supplies, labs and nursing. In general, the costs of infusion in a hospital are highest, followed by slightly lower costs in a doctor’s office and infusion clinic and even lower costs at home.In addition,whetherthe infusions are intravenous (IV) or subcutaneous (SC) influences cost. During IVIG infusions, medical supervision is required, whereas SCIG patients who self-infuse incur no infusion nursing costs. Yet, even for IVIG patients, the cost to infuse at home is less than at a healthcare site.

One of the cost considerations for IVIG patients who prefer home treatment (mostly because it reduces the expense and time of traveling to a clinical setting) is that Medicare Part B will pay only for IVIG preparation in the home for primary immune deficiency (PIDD) patients. Unless these patients are certified as homebound, nursing and supplies in the home are not covered. For indications other than PIDD, IVIG in the home can be covered under Medicare Part D, but again, supplies and nursing are not covered. Since Medicare Part D reimbursement is typically higher, some homecare companies will often bundle the cost of nursing with the cost of the IVIG product if the reimbursement rate is high enough. In addition, many HMOs don’t allow for IVIG home therapy because they are not set up to accommodate it.

Overall, SCIG therapy in the home setting has a more favorable reimbursement rate than IVIG therapy. And, Medicare covers SCIG under the durable medical equipment (DME) benefit because, under the FDA approval, SCIG requires the use of a mechanical pump.

Safety

Protocol requires that patients receive at least their first infusion in a clinical setting, whether infusing subcutaneously or intravenously. However, because IVIG requires monitoring by either an infusion nurse or doctor, choices may be limited for some. Many IVIG patients can be infused safely at home, while others and their doctors may prefer the higher level of safety in a hospital or clinical setting — especially for patients at high risk of anaphylactic reaction or other issues such as myocardial infarction, brittle asthma, renal disease, etc., says Dr. Terry Harville, medical director at the Special Immunology Laboratory at the University of Arkansas for Medical Sciences.

For instance, IVIG patients have a higher risk of thrombosis because infusion is administered through the vein. This risk is further heightened by a health history of diabetes, renal dysfunction, age (65 and older), coronary artery disease, hypertension, cerebrovascular disease, hyperviscosity disorder (including multiple myeloma, macroglobulinemia and polycythemia), thrombotic events and peripheral vascular disease. In addition, any patient who has had a vascular or cardiac episode while receiving IVIG should be infused in a monitored setting.

For some patients, medical status will play a role in the site of care decision. For example, some patients have autoimmune conditions that require higher IVIG dosings that may be difficult to be delivered subcutaneously, thus necessitating IVIG in a clinical setting.

Other patients may be more likely to be noncompliant with therapy. In these instances, clinical infusions allow doctors and/or nurses to interact with patients on a frequent basis and provide a higher level of supervision for monitoring patients’ overall health and response to treatment. This higher level of supervision can protect against desensitization, a lack of awareness many patients can develop when they are so adept at living with chronic disease that they become anesthetized to symptoms that may be precursors of an increased disease state or of oncoming infection. Desensitization causes patients to sometimes fail to be good historians of their disease process, which can lead to less-than-optimal treatment. However, experienced infusion nurses who have monthly contact with patients can quickly spot subtle changes in patients’ health. In fact, these nurses become skilled at asking questions that help the patients become better historians of their health status.

Regardless of whether patients are being treated with IVIG or SCIG, the risk of contaminated products is the same. All IG products must meet certain criteria established by the FDA for purity and safety. Yet, because IG is derived from human plasma, risk of potentially infectious agents cannot be totally eliminated. In the U.S., however, there has never been a documented case of HIV transmitted in IG.

The final safety consideration centers on exposure to infection. Theoretically, there is a higher risk of contracting infection in a hospital or infusion clinic through exposure to other patients who may be sick.

Privacy

Privacy is often an important concern for patients. In a hospital, physician’s office or infusion clinic, visual privacy may be available, but rarely auditory privacy. Typically, infusion clinics consist of one large room, with multiple chairs for patients, screened by curtains. With no solid room dividers, complete privacy is not possible. In contrast, infusing in the privacy of a home offers convenience, autonomy and flexibility not found in the clinical setting.

But privacy is not a concern for some. Many patients appreciate being with other patients going through the same treatment. In fact, they prefer the social opportunity provided at hospitals, physicians’ offices and clinics.

Youth versus adult. While home infusion offers many advantages to patients, there are reasons why it may not be the best treatment or the treatment of choice for children and young adults. Lack of compliance and insecurity about performing treatments are perhaps the biggest drawbacks when it comes to SCIG. Self-infusing can be scary and difficult, especially for young people. When short on confidence, they simply fail to infuse when needed — often without their parents’ or medical providers’ knowledge. Providing adequate supervision during the transition to self-treatment is key to keeping young patients confident and compliant with their therapy.

A Joint Decision

In the end, the site of care is a decision that must be made by both physicians and their patients. Physicians may feel that patients are best treated in a clinical setting due to their high risk of adverse events. On the other hand, physicians may feel that their patients are at no risk and that the home setting would offer them more convenience and privacy. Patients, on the other hand, may prefer a clinical setting because they would rather let someone else take care of them for a while and they appreciate the comfort and safety they experience in that setting. Indeed, home infusions offer many cost and privacy advantages, but there are those who prefer to keep their home a home — without the medical equipment as constant reminders of their disease.

Each patient’s situation is unique, including medical history, response to treatment, compliance with therapy and lifestyle. Therefore, all factors should be weighed to make the decision that best suits the individual needs of the patient.

KRIS MCFALLS was previously the full-time patient advocate for IG Living magazine, written for patients who depend upon immune globulin products and their healthcare providers, and RONALE TUCKER RHODES, MS, is the editor of BioSupply Trends Quarterly magazine.