IGIV THERAPY:

THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

A CE monograph based on a symposium at the 2006 INS Annual Meeting*

Target Audience: Infusion Nurses Faculty

Deanne Birch Julie Winton, RN, BSN
The University of Nebraska Medical Center College of Nursing Continuing Nursing Education is accredited as a provider of continuing nursing education by the American Nurses Credentialing Centers Commission on Accreditation. This activity is provided for 1.2 contact hours. Iowa Provider #78. Additionally, provider approved by the California Board of Registered Nursing. Provider #13699 for 1.2 contact hours.

optimizing patient care and ou

*This monograph is not sponsored by, nor a part of, the 2006 Infusion Nurses Society Annual Meeting and Industrial Exhibition.

the nurse's role in balancing costs and quality of care

This program is supported by a continuing nursing education grant from Talecris Biotherapeutics, Inc.

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

optimizing Receive Credit How to patient care and outcomes

Infusion nurses wishing to receive 1.2 contact hours must: 1. Read the monograph (estimated time for completion: 1 hour). 2. Relate the content material to the learning objectives. 3. Answer at least 7 of the 10 self-assessment questions on page 15 correctly. the nurse's role in balancing costs 4. Complete the evaluation form as indicated on page 16. and quality of care Upon successful completion of the requirements, a CE certificate will be mailed to you. A certificate will be mailed within 4 to 6 weeks from the date of receipt of your completed evaluation form. Release date: July 30, 2006 Expiration: To be eligible to earn (or receive) contact hours, required materials must be postmarked or received no later than July 30, 2007.

Disclaimer
The opinions or views expressed in this continuing education activity are those of the faculty and do not necessarily reflect the opinions or recommendations of the Continuing Education Alliance, the University of Nebraska Medical Center College of Nursing Continuing Nursing Education, or Talecris Biotherapeutics, Inc.

Please contact the Continuing Education Alliance at inquiries@cealliance.org for questions regarding this activity. 2006 Continuing Education Alliance Printed in USA CTE32606

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

Goal
To familiarize infusion nurses with immune globulin products, safety and tolerability considerations, and current issues regarding costs and reimbursement.

Learning Objectives optimizing patient care and outcomes

After reading the articles in this monograph, participants will be better able to: Describe the differences among currently available immune globulin products and their impact on safety, tolerability, and economic considerations. Discuss key policies and procedures related to reimbursement for immune globulin therapy in various clinical settings.

Faculty the nurse's role in balancing Dean and lie Winton costsne Birch quality ofJucare, RN, BSN
Director of Reimbursement Managing Member Infusion Innovations, LLC Salt Lake City, Utah Director of Business DevelopmentWest BioRx, LLC Baker City, Oregon

Disclosures
All faculty and planners participating in continuing education activities sponsored by the University of Nebraska Medical Center College of Nursing Continuing Nursing Education are expected to disclose to the audience any significant support or substantial relationship(s) with providers of commercial products and/or devices discussed in this activity and/or with any commercial supporters of the activity. In addition, all faculty are expected to openly disclose any off-label, experimental, or investigational use of drugs or devices discussed in this activity. The faculty and planning committee have been advised that this activity must be free from commercial bias, and based upon all the available scientifically rigorous data from research that conforms to accepted standards of experimental design, data collection, and analysis. Ms Birch: partner: Infusion Innovations, LLC (provider of home infusion pharmacy products). Ms Winton: has no significant relationships to disclose. The Planning Committee for this activity included Catherine A. Bevil, RN, EdD, of the University of Nebraska Medical Center College of Nursing Continuing Nursing Education, and Craig Borders and Ira Mills of the Continuing Education Alliance. The members of the Planning Committee have no significant relationships to disclose.

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

optimizing patient care and outcomes

the nurse's role in balancing Table of Contents costs and quality of care
Introduction..................................................................................................................1 Strategies for Optimizing Patient Care With IGIV Therapy........................................2 Current Issues in Cost Management and Reimbursement for IGIV Therapy ..................................................................9 Self-Assessment Questions ......................................................................................15 Evaluation Form for Nurses ......................................................................................16

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Introduction
Immune globulin therapy is used for antibody replacement and immune system modulation. A wide range of immune globulin products are available. Patients with certain risk factors, however, may be affected by differences in product formulations. In addition, the reimbursement climate continues to change. New policies and procedures have an impact on how immune globulin therapy is coded and what services are covered in various clinical settings. This monograph is based on presentations from a program titled IGIV Therapy: The Nurses Role in Balancing Costs and Quality of Care, which was held during the Infusion Nurses Society Annual Meeting and Industrial Exhibition in May 2006. In Strategies for Optimizing Patient Care With IGIV Therapy, Julie Winton, RN, BSN, addresses key strategies for planning optimal administration of immune globulin intravenous (IGIV) or immune globulin subcutaneous (IGSC), managing the infusion process, monitoring patients for adverse effects, and educating patients and their caregivers. In Current Issues in Cost Management and Reimbursement for IGIV Therapy, Deanne Birch discusses potential cost issues related to IGIV therapy (eg, product manufacturing costs, direct and indirect administration costs, product allocation, and purchasing costs) and the impact of todays reimbursement climate on cost recovery in hospital, physicians office, and home healthcare settings.

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

optimizing patient care and outcomes

Strategies for Optimizing Patient Care With IGIV Therapy

Julie Winton, RN, BSN Director of Business DevelopmentWest Bio nurse's role in balancing theRx, LLC Baker C y, Orego costs itandn quality of care

Immune globulin products, which consist primarily of immunoglobulin G (IgG), are derived from pooled plasma from healthy blood donors.1 Currently, the Food and Drug Administration (FDA) has approved IGIV for multiple indications (Table 1). Early in 2006, IGSC received FDA approval for the treatment of primary immune deficiency (PID). However, more than 50% of patients treated with IGIV products receive them for off-label uses.2

an important consideration, particularly when immune globulin therapy is provided at home.

Nurses Role in Risk Assessment

From their earliest initiation into nursing school, nurses are trained to carefully assess potential and real problems associated with their patients diagnoses and therapies. Accordingly, long hours are devoted to care planning. Similarly, this should be viewed as the basis for the nurses role in risk assessment related to the infusion of IGIV and IGSC. Regardless of the setting (ie, hospital, clinic, or home care), the infusion nurse is responsible for making every effort to minimize the risk to the patient of adverse events during infusion. This in turn minimizes risk for the infusion nurse, the prescriber, the

Planning for Optimal Administration

Patient Risk Assessment
A patient risk assessment tool can help clinicians develop a care plan that matches each patients risk profile with the appropriate immune globulin therapy and thereby minimize infusion reactions (Table 2). At least 70% of the nurses polled during the IGIV Therapy: The Nurses Role in Balancing Costs and Quality of Care program at the 2006 meeting of the Infusion Nurses Society reported that their facility or home healthcare unit does not use a risk-assessment tool to assist in the selection of an immune globulin product. Factors to consider during the risk assessment include the condition for which IGIV or IGSC therapy was prescribed, comorbidities (eg, cardiovascular disease, renal disease, or diabetes mellitus), allergies, history of infusion reactions with immune globulin therapy, and any barriers to intravenous (IV) or subcutaneous (SC) access. The existence of a family or caregiver support system is also

Table 1. FDA-Approved Indications for IGIV and IGSC

IGIV IGSC Primary immune deficiency (PID) PID Idiopathic thrombocytopenic purpura Kawasaki syndrome Chronic lymphocytic leukemia Pediatric HIV infection* Bone-marrow transplantation (allogeneic)*
*Gamimune N, which is no longer manufactured, was the only IGIV product approved by the FDA for pediatric HIV infection and bone marrow transplantation (allogeneic).

Table 2. Patient Risk-Assessment Checklist

Current diagnosis. What is the condition requiring IGIV or IGSC therapy? Current signs and symptoms of condition Changes in signs/symptoms since last infusion Comorbidities. Does the patient have other conditions or health-related concerns? Cardiovascular disease? Diabetes or prediabetes? Renal dysfunction? Selective IgA deficiency? Recent illnesses. Has the patient had any recent illnesses (other than those noted above)? Current medication history. What drugs is the patient using? Is the patient receiving treatment with a nephrotoxic drug? Prescription drugs? Over-the-counter drugs? Nephrotoxic drug use? Allergies. Does the patient have any allergies? Infusion history. Has the patient received prior immune globulin infusions? If yes: Which product? Which administration route? Was the infusion well tolerated? (If not, specify the adverse reaction.) Did the patient receive premedications? (If yes, specify.) Weight. What is the patients current weight? IV or SC access. Are there any barriers to IV or SC access? Support. Does the patient have adequate caregiver support?

Clinical Considerations
Because of differences in manufacturing processes, IGIV product characteristics vary (Table 3). Formulations, concentrations, osmolalities, and pH differ among the available products, as do their sodium, sugar, and immunoglobulin A (IgA) content.3 These differences may have an impact on tolerability in certain patient populations, including elderly patients, neonates, and patients with cardiac impairment or renal dysfunction (Table 4). Production processes used to inactivate or remove bloodborne pathogens also differ among the products.

Volume Load
Preparations of IGIV are available in concentrations ranging from 3% to 12%. When IGIV is given at higher concentrations, the volume load is reduced, and the infusion time is shortened. For example, a 70-kg patient who is administered IGIV at a dosage of 2 g/kg would receive 1400 mL of a 10% solution or 2800 mL of a 5% solution. Minimizing volume load may be appropriate for patients with congestive heart failure, hypertension, renal dysfunction, or vascular disease. Also, neonates and elderly patients (65 years of age or older) may tolerate high volume loads less well than patients in other age groups. Patients who are intolerant of long infusion times may also benefit from reduced volume loads. IGSC is available in a 16% concentration. Volume load is not a consideration with IGSC therapy because it is not infused directly into the circulation and is administered at a very slow rate.

dispensing pharmacist, and the facility where the nurse is employed. If the infusion nurse is aware that IGIV and IGSC products may carry higher risk of adverse event for certain patients (eg, high glucose in a patient with diabetes, high pH in a neonate, large fluid volume in a cardiac patient), the infusion nurse can choose a product that may minimize these potential issues. It is basic nursing practice to incorporate a risk assessment that alerts the infusion nurse to these concerns and to choose a product that best fits the particular patient, thus minimizing risk. Patient history and infusion history are other important items to have available to the infusion nurse.

Sugar Content
Sugar is added as a stabilizer to most IGIV products (only 2 products are stabilized with glycine). Sugar content is an important consideration because it affects osmolality. The use of IGIV preparations containing sugar has been associated with renal adverse events: 90% of the IGIVinduced renal adverse events in the United States that were reported to the FDA between 1985 and 1998 were attributed to products stabilized with sucrose.4 Sugarcontaining IGIV products should be avoided or used with caution in patients at risk for renal adverse events (eg, patients with preexisting renal disease, diabetes, or signs of prediabetes; patients 65 years of age or older).

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

Table 3. Comparison of Currently Available IGIV Products

Gammagard Polygam Gamunex Iveegam EN Liquid S/D (Baxter Gammagard S/D (Baxter Carimune NF Flebogamma (Talecris (Baxter Octagam Healthcare) (Baxter Healthcare) Biotherapeutics)* Healthcare) (Octapharma) Healthcare) (ZLB Behring)* (Grifols) FDA-approved PID, ITP PID PID PID, ITP, CLL, KS PID, ITP KS, PID PID PID, ITP, CLL, indication(s) KS Form Lyophilized Liquid Liquid Lyophilized Liquid Lyophilized Liquid Lyophilized Concentration 3%, 6%, 9%, 12% 5% 10% 5% or 10% 10% 5% 5% 5% or 10% options Sugar content D-Sorbitol, 50 mg/mL Glucose, None 20 mg/mL (stabilized with glycine) (5% concentration) None ~8.5 mg/mL 240-300 mOsm/kg 636 mOsm/L (5%) 1250 mOsm/L (10%) None (stabilized with glycine) Trace 258 mOsm/kg Glucose, 50 mg/mL 3 mg/mL 240 mOsm/L Maltose, 100 mg/mL Glucose, 20 mg/mL (5% solution) 30 mmol/L 8.5 mg/mL (5% solution) 310-380 636 mOsm/L mOsm/kg (5%) 1250 mOsm/L (10%)

optimizing patient care and outcomes

the nurse's role in balancing <3.2 mEq/L costs and quality of care (<0.02%)
Osmolarity/ osmolality mOsm/kg: In sterile water: 192-768 In 0.9% NaCl: 498-1074 In 5% dextrose: 444-1020 6.6 0.2 96% Trace 240-350 mOsm/L

Sucrose, 1.67 g per gram of protein Sodium content <20 mg per gram of protein

pH Gamma globulin IgA content

5-6 >99% <0.05 mg/mL

4.6-5.1 98% 37 g/mL

6.8 0.4 (5% solution) 90% 2.2 g/mL (5% solution)

4.0-4.3 98%

6.4-7.2 95%

5.1-6.0 96%

6.8 0.4 (5% solution) 90%

0.046 mg/mL Trace amounts 0.1 mg/mL 2.2 g/mL (5% solution)

*The manufacturing process for this product provides reasonable assurance that prions associated with transmissible spongiform encephalopathy would be removed if present in donated plasma. Manufacturers package inserts and Siegel J. Pharm Pract News. 2005.

Sodium Content
The sodium content of available IGIV preparations varies widely.3 Infusions of preparations with a high sodium concentration may upset fluid and electrolyte balance in some patients (eg, elderly patients; neonates; patients with hypertension, congestive heart failure, vascular disease, or renal dysfunction).5

of water. A 6% solution of a lyophilized sucrose-stabilized product has an osmolality of 384 mOsm/kg if reconstituted in sterile water or 690 mOsm/kg if reconstituted in normal saline; at a 12% concentration, the osmolality rises to 768 mOsm/kg in sterile water or 1074 mOsm/kg in normal saline. The use of hyperosmolar IGIV solutions should be avoided in patients at risk for renal or thromboembolic complications.5-7

Osmolality
The osmolality of IGIV preparations varies depending on the formulation, concentration, and (if a lyophilized product is used) the reconstitution fluid. Reconstitution of lyophilized products at higher concentrations can result in hyperosmolar solutions. The reference range for physiologic osmolality (serum) is 275 to 295 mOsm/kg

pH
The optimal pH for IGIV in solution ranges from 4.0 to 4.5.8 Currently available IGIV preparations range in pH from 4.0 to 7.2.3 A products pH may be an important consideration for patients (eg, neonates) who are intolerant of acidic loads.9

IgA Content
Patients with selective IgA deficiency, which is characterized by production of immunoglobulin E (IgE)or IgGtype anti-IgA antibodiesare at increased risk of severe immediate hypersensitivity reactions (including anaphylaxis).1,10,11 All immune globulin preparations contain some IgA. Although the risk of complications is extremely rare, IGIV and IGSC are contraindicated in patients with selective IgA deficiency.3

Pathogen Safety
Immune globulin products have an excellent safety record. However, because they are derived from pooled human plasma, they can potentially transmit blood-borne pathogens, such as viruses and prion proteins.12 Various viral inactivation or removal steps have been integrated into the manufacturing process to help ensure product safety. They include preproduction screening, viral inactivation by physical (eg, dry heat and pasteurization) or chemical (eg, solvent/detergent incubation at low pH and caprylate treatment) methods, and viral clearance

(eg, with fractionation, chromatography, or filtration).13 The specific steps used vary by product manufacturer. Efforts to protect against emerging pathogens, such as the prion proteins associated with transmissible spongiform encephalopathy (TSE), are ongoing. The caprylate/chromatography process14 and the precipitation/ depth filtration/nanofiltration process15 provide reasonable assurance of a reduced risk of pathogenic prion transmission. The FDA has approved the inclusion of a statement regarding assurance of TSE-associated prion removal in the labeling for 2 IGIV products (Table 5).

Managing the Infusion Process and Adverse Reactions

IGIV
Before beginning the infusion, the nurse should confirm that the institutions infusion policy and procedures are being followed and that the appropriate risk-assessment forms have been completed. The care plan should include the physicians orders for any premedications and anaphylaxis treatment. If the physician did not specify an IGIV product, the nurse should look carefully at the patients risk factors and history of infusion reactions and at the characteristics of the IGIV product selected, and should consult the pharmacist if any potential problems are identified. Manufacturers guidelines for IGIV administration are available for all products. Infusing IGIV at a slower rate than that recommended by the manufacturer may be

Table 4. Clinical Considerations in IGIV Therapy

If the patient has: Age-related risk Advanced age Consider: Osmolality Sodium content Sugar content Volume load Osmolality pH Sodium content Volume load Osmolality Sodium content Volume load Sugar content IgA content Osmolality Sodium content Sugar content Volume load Osmolality Sodium content Volume load

Young age (eg, neonates/infants)

Cardiovascular disease (eg, congestive heart failure, hypertension, vascular disease) Diabetes or prediabetes IgA deficiency (anti-IgA antibodies) Renal dysfunction

Table 5. TSE Prion Removal Labeling in Currently Available IGIV and IGSC Products
IGIV Carimune NF: Yes* Flebogamma: No Gammagard Liquid: No Gammagard S/D: No Gamunex: Yes* Iveegam EN: No Octagam: No Polygam S/D: No IGSC Vivaglobin: No

Thromboembolic risk factors

*According to the FDA-approved labeling, the manufacturing process for this product provides reasonable assurance that prions associated with TSE would be removed if present in donated plasma.

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

optimizing patient care and outcomes

the nurse's role in balancing costs and quality of care

considered, especially for a patients first infusion. Slowing the infusion rate can help to minimize infusion reactions. The most common infusion raterelated reactions include: blood pressure decreases; pulse rate increases; fever; chills; headache; chest, back, or hip pain; dyspnea; and mild erythema. Other IV medications should not be injected into the IGIV infusion line. The patients vital signs should be assessed at baseline and at regular intervals during the infusion: every 15 minutes during the first infusion hour, every 30 minutes during the second hour, then hourly until the infusion is completed, and once post-infusion. Headache, chills, and back/joint pain were the most common reactions related to IGIV administration, according to a self-administered, self-reported, Web-based survey of 59 randomly selected infusion nurses working in a variety of settings (ie, office, clinic, and home care).16 If the patient experiences a mild IGIV infusionrelated reaction, the nurse should reduce the infusion rate by half and continue to observe the patient closely and to monitor vital signs. In addition, the nurse should ensure that the patient is in a comfortable position (eg, by adjusting the pillows supporting the back if the patient experiences back pain). Any medications ordered for adverse reactions should be administered as appropriate. The attending physician should be notified promptly if the adverse reaction persists. The infusion should be stopped at once if the reaction is severe (eg, anaphylaxis) or if the physician orders treatment discontinuation. Anaphylaxis treatment and supportive care should be administered immediately. The infusion nurse should be aware of his or her workplace policy for anaphylaxis. The nursing basics of ABCs (Airway, Breathing, and Circulation) are critical. Emergency assistance should be called in a home setting, or, if in a hospital or clinic infusion suite, a crisis team should be alerted. It is always valuable to have practiced these procedures beforehand, if possible. Because of the potential for adverse reactions, patients should never be left alone during IGIV infusion. At home, patients should have undergone at least 2 or 3 successful (ie, free of serious adverse effects) infusions before considering infusion administration in the absence of an infusion nurse. A caregiver should always be present during independent IGIV infusion.

The IGIV infusion course and all adverse reactions must be properly and thoroughly documented by the infusion nurse. Documentation ensures that subsequent infusion nurses will have a full understanding of how each patient responded to previous treatment and provides a high-quality continuum of care designed to minimize adverse reactions and maximize therapeutic effect. Accurate documentation of ongoing assessments with each infusion (eg, decreased numbness, increased mobility, no hospitalizations for infections) assists in validating therapy benefit to an insurance provider/payer. This can be critical for the reauthorization often required for some of the most frequent off-label uses of IGIV or IGSC, such as chronic inflammatory demyelinating polyneuropathy (CIDP).

IGSC
Administration of IGSC may be considered for patients who have venous access problems (eg, young children), who want greater autonomy, or who have had adverse reactions to IGIV. IGSC may also provide an alternative immune globulin treatment modality for patients with a central line infection or risk factors that warrant use of smaller infusion volumes. Because IGSC is absorbed more slowly than IGIV, bioavailability may be reduced. IGSC may be administered once every other day, once weekly, or once every 2 weeks; in comparison, IGIV is administered once every 3 to 4 weeks. IGSC is generally performed in the home setting, requiring 2 to 3 training sessions to learn SC needle placement as well as the therapy regimen. Adverse reactions are minimized due to the SC route of administration. Typically, only the actual infusion site has reaction issues such as redness. Irritation and swelling may be minimized with site rotation, keeping in mind the initial placement site and anatomic irregularities (skin folds, scar tissue, recently used sites, etc). IGSC is infused at a steady rate over 1 to 2 hoursdepending on the patients weight and prescribed dose. Usually 2 or more sites are used simultaneously. Infusion sites (eg, abdomen, thighs, upper arms, and lateral hip) should be selected according to the patients body dynamics and rotated periodically.

The infusion nurse must check for blood return after insertion of the SC needle to be sure he or she is not infusing intravenously. The only IG product FDA approved for SC administration clearly indicates in the labeling that it is not to be infused intravenously. Other intramuscular or IGIV products are reconstituted and used subcutaneously, but such use is beyond FDA-approved labeling. In adults, IGSC volumes should not exceed 25 mL per injection site. A good rule to follow is to administer 20 mL at 20 mL/h per injection site (the 20:20 rule). Although most children can tolerate a 10-mL volume per site, very young patients should be given a reduced volume (5 mL or 7.5 mL). Laboratory monitoring includes measurement of an initial IgG level, IgG trough/peak levels at periodic intervals to stabilize medication dose, and liver function tests to monitor for signs of infection. These are ordered per physician preference/protocol. Overall patient health and infection status must also be carefully and regularly monitored. This would include number of infections since last infusion that required a physician visit, antibiotic usage, emergency department visit, or hospitalization. The most common adverse effects associated with IGSC administration are redness, slight swelling, and tenderness at the infusion site. Infusion-site irritation can be minimized by using alcohol, not an iodinebased solution, for cleaning the skin prior to needle insertion; paying close attention to body dynamics when selecting an infusion site; and rotating the infusion sites. If swelling persists beyond 3 to 4 days, the volume infused at each site should be reduced. Other adverse effects reported with IGSC are similar to those seen with IGIV.17

Table 6. Patient and Caregiver Education for IGSC Infusion in the Home Healthcare Setting
Medications used (benefits, risks) IGSC Premedications Equipment Required components Maintenance Infusion Site selection Site rotation Infusion technique Adverse reaction education What to expect during the infusion What to watch for and report after the infusion Measures to take if an adverse reaction occurs Record keeping (treatment diary)

equipment used for the infusion and its maintenance, selection of appropriate infusion sites, infusion techniques, the importance of maintaining a treatment diary to document adverse reactions, and the appropriate measures to take if an adverse reaction occurs (Table 6). (Education on infusion pump maintenance, infusion site selection, and record keeping is also important for patients receiving IGIV at home.) During the course of treatment, nurses must continually reevaluate the extent of patient and caregiver understanding of the provided information. Further education should be provided and reinforced as needed.

References
1. Kazatchkine MD, Kaveri SV. Immunomodulation of autoimmune and inflammatory diseases with intravenous immune globulin. N Engl J Med. 2001;345:747-755. 2. Chen C, Danekas LH, Ratko TA, Vlasses PH, Matuszewski KA. A multicenter drug use surveillance of intravenous immunoglobulin utilization in US academic health centers. Ann Pharmacother. 2000;34:295-299. 3. Siegel J. Intravenous immune globulins: therapeutics, pharmaceutical, and cost considerations. Pharm Pract News. 2005;Jan:19-23. 4. Centers for Disease Control and Prevention (CDC). Renal insufficiency and failure associated with immune globulin intravenous therapyUnited States, 1985-1998. MMWR Morb Mortal Wkly Rep. 1999;48:518-521.

Educating Patients and Caregivers

Patients and their caregivers should be fully informed about the potential benefits of IGIV or IGSC treatment, safety issues, the rationale for any premedications ordered by their physicians, and what to expect during and after the infusion. If IGSC is to be administered at home, patients and their caregivers also need to be instructed in the type of

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

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the nurse's role in balancing costs and quality of care

5. Lemm G. Composition and properties of IVIg preparations that affect tolerability and therapeutic efficacy. Neurology. 2002;59(suppl 6):S28-S32. 6. Reinhart WH, Berchtold PE. Effect of high-dose intravenous immunoglobulin therapy on blood rheology. Lancet. 1992;339:662-664. 7. Evan-Wong LA, Davidson RJ, Stowers JM. Alterations in erythrocytes in hyperosmolar diabetic decompensation: a pathophysiological basis for impaired blood flow and for an improved design of fluid therapy. Diabetologia. 1985;28:739-742. 8. McCue JP, Hein RH, Tenold R. Three generations of immunoglobulin G preparations for clinical use. Rev Infect Dis.1986;8(suppl 4):S374-S381. 9. Ratko TA, Burnett DA, Foulke GE, Matuszewski KA, Sacher RA, for the University Hospital Consortium Expert Panel for Off-Label Use of Polyvalent Intravenously Administered Immunoglobulin Preparations. Recommendations for off-label use of intravenously administered immunoglobulin preparations. JAMA. 1995;273:1865-1870. 10. Dalakas MC. Intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: present status and practical therapeutic guidelines. Muscle Nerve. 1999;22:1479-1497.

11. National Institutes of Health Consensus Development Conference. Intravenous immunoglobulin. Consens Statement. 1990;8:1-23. 12. Miller JL, Petteway SR Jr, Lee DC. Ensuring pathogen safety of intravenous immunoglobulin and other human plasma-derived therapeutic proteins. J Allergy Clin Immunol. 2001;108(suppl):S91-S94. 13. Shah S. Pharmacy considerations for the use of IGIV therapy. Am J Health Syst Pharm. 2005;62(suppl 3):S5-S11. 14. Gamunex [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc; 2005. Available at: http://www.talecris-pi.info/inserts/gamunex.pdf. 15. Carimune [package insert]. Kankakee, Ill: ZLB Behring LLC; 2005. Available at: http://www.zlbbehring.com/ZLBB/binary/CarimunePI.pdf. 16. Davis J, Duff K, Ganio S, et al. Criteria for selecting an IGIV preparation: the infusion nurses perspective. J Allergy Clin Immunol. 2003;111(suppl 2):S121. 17. Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000;20:94-100.

Current Issues in Cost Management and Reimbursement for IGIV Therapy

Deanne Birch Director of Reimbursement Managing Member Infusion Innovations, LLC Salt Lake City, Utah

Therapy with immune globulin intravenous (IGIV) is a life-saving treatment provided to many patients in settings ranging from hospitals to physicians offices and patients homes. Economic issues that affect providers of IGIV therapy include the costs of product purchasing and administration, product availability, reimbursement for off-label use, and fluctuating reimbursement rates. The impact of these issues varies depending on the medical needs and healthcare coverage of the patients being served and the site of administration. With increases in co-payments and caps on reimbursement, cost considerations often play a major role in selection of an IGIV product for a particular patient. More than 70% of the infusion nurses polled during the IGIV symposium at the May 2006 meeting of the Infusion Nurses Society (INS) reported that cost considerations affected their selection of an IGIV product.

Potential Cost Issues

The cost of IGIV therapy is the sum total of product manufacturing costs, administration costs (including equipment and supplies, clinical patient monitoring, and other indirect overhead costs), product allocation, and purchasing costs.

Product Manufacturing Costs

Product acquisition costs for IGIV can vary significantly between the least expensive and the most expensive product. These variations stem largely from differences in the

manufacturing processes; they are also dependent on product availability and shortages. The IGIV products licensed in the United States are all derived from pooled plasma obtained from 3000 to 10,000 healthy blood donorssometimes as many as 100,000 donors.1 However, beyond the source of origin, the manufacturing processes of IGIV products differ widely in methods used to maintain the integrity and biologic activity of immunoglobulins while simultaneously removing or inactivating unwanted viruses and other pathogens to ensure product safety.2 Variability in manufacturing, viral inactivation, and chemical processes used to stabilize the preparations may lead to variations in clinical efficacy, safety from pathogens, and tolerability, as discussed by Ms Winton in Strategies for Optimizing Patient Care With IGIV Therapy. Such variations may also lead to differences in economic benefits. Clinicians must select IGIV products on the basis of the risks and benefits to each individual patient. However, product selection may have an impact on overall healthcare costs by reducing the risk of secondary infection and complications as well as decreasing healthcare resource utilization (eg, hospitalization and associated drug costs). In a retrospective multivariate analysis of results from a 9-month trial, Mahadevia and colleagues3 compared the costs of using an IGIV product manufactured with chromatography and caprylate methods (IGIV-C; Gamunex,

IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

Table 1. Healthcare Resource Utilization in Patients With PID: IGIV-C Compared With IGIV-SD
Healthcare Resource Utilization IGIV-C IGIV-SD (n = 87) (n = 85) 148 876 19 269 15 573 240 26 1 174 1076 39 344 16 677 230 34 7

optimizing patient care and outcomes Resource Category

Physician office/emergency department visits, total number Incident prescriptions, total number For validated infections For nonvalidated infections For adverse events For all other medications Lost productivity, total days* Hospitalizations, total number Attributable to IGIV
*Self-reported. Mahadevia PJ, et al.3

the nurse's role in balancing costs and quality of care

of IGIV therapy must be considered for appropriate reimbursement. These administration costs include nursing time for preevaluation, patient/caregiver education, line insertion with continual monitoring during both the IGIV line insertion and IGIV administration, patient follow-up, clinical documentation, and nursing travel time. Added to this are pharmacy costs to allocate and store the product, to compound in a class 100 clean room, to meet United States Pharmacopeia chapter 797 requirements to ensure sterility and stability, to deliver product as well as supplies and equipment, and for continued monitoring of the patients progress. In addition, there are many other operational costs related to qualifying and admitting the patient, performing insurance screening, and obtaining prior authorization from the payer. All of these costs are typically bundled under 1 or 2 administrative reimbursement codes with a set reimbursement regardless of the actual costs.

10% [Talecris Biotherapeutics, Inc., Research Triangle Park, NC]) with the costs of using an IGIV product produced with solvent-detergent methods (IGIV-SD; Gamimune N, 10% [Bayer Corporation, Clayton, NC]) in patients with primary immune deficiency (PID). For purposes of the cost analysis, the product acquisition costs were assumed to be equivalent. The patients (n = 87) who received IGIV-C had fewer visits to physicians offices and emergency departments, required fewer prescriptions (incident medications), and had fewer hospitalizations than did the patients (n = 85) who received IGIV-SD (Table 1). Such differences translated into lower overall healthcare costs. On average, compared with patients treated with IGIV-SD, patients treated with IGIV-C had significantly lower prescription costs ($302; 95% CI, $598 to $6), hospitalization costs ($1454; 95% CI, $1828 to $1080), and total costs ($1304; 95% CI, $1867 to $742; all P <.05) (Figure). Costs associated with physician and emergency department visits and with lost productivity were similar in the 2 groups.

Product Allocation
In the past year, the American Society of Health-System Pharmacists (ASHP) and various federal agencies received reports of problems with access to IGIV.4 When nurses who attended the IGIV symposium at the 2006 INS meeting were asked which of 5 cost/reimbursement issues has the greatest impact on their practice, product availability ranked first (41% of respondents), followed by product purchasing costs (22%), reimbursement for offlabel use (22%), fluctuating reimbursement rates (11%), and product administration costs (4%). The primary reason for the reported access and supply issue is the change in reimbursement from average wholesale price (AWP) to average sales price (ASP) in the Medicare setting for physicians and hospital outpatients. While in early 2004 physicians were reimbursed at 95% of the AWP for the drug, later in the same year drug reimbursement was reduced to 85% of AWP. In 2005, reimbursement was changed to ASP plus 6%, a significant reduction that led physicians to shift their patients from the physician clinic setting to hospitals, primarily to the hospital outpatient setting. In early 2006, ASP plus 6% reimbursement was implemented to hospital outpatient settings, placing the burden of cost containment

Administration Costs
In addition to the direct cost of the IGIV product, the indirect administration costs incurred by the professional services and supplies associated with all aspects

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and product allocation on these systems, creating an issue of access by reducing hospitals ability to purchase these products. According to a report by FFF Enterprises (a biopharmaceuticals, plasma products, and vaccines distributor based in Temecula, Calif ), 9% of hospitals closed their infusion clinics and services.5 This led to another shift in IGIV delivery to the home healthcare and home infusion setting. Reports continue of inadequate access, with supply not keeping up with demand. At 2 meetings in 2005, the Department of Health and Human Services (DHHS) Advisory Committee on Blood Safety and Availability (ACBSA) recommended that the DHHS secretary declare a public health emergency to address the short-term problems of access to IGIV.6,7 The Centers for Medicare and Medicaid Services (CMS) first responded that there are sufficient supplies available to patients but that CMS will continue to monitor the situation since there might be ongoing marketplace adjustments affecting how inventories are managed.8 The CMS also suggested that increased off-label use might be contributing to rising demand and advised physicians to give first priority to IGIV treatment for Food and Drug Administration (FDA)approved uses.8,9 More recently, a temporary add-on payment code was established for 2006 to reflect the expenses incurred by the additional preadministration-related services required to locate and acquire an adequate product and to prepare for an infusion of IGIV.10 DHHS agencies are working with the various IGIV stakeholders (ie, patients, manufacturers, distributors, physicians, and hospitals) to understand the evolving IGIV marketplace, ensure the continued collection of ASP data, and focus attention on the evidence-based medical necessity of the utilization of IGIV.10 The DHHS Office of the Inspector General is also examining IGIV availability and pricing. The CMS has committed to undertaking a study of the epidemiology of IGIV treatment of Medicare beneficiaries in the outpatient setting.5 (The Immune Deficiency Foundation11 and The Neuropathy Association12 are urging members to ask that their representatives in the US Congress sign the McCrery/Foley/Israel letter to Secretary Leavitt asking that his office declare a public health emergency for patient access to IGIV.)

Physician and emergency department costs Prescription costs Productivity costs Hospitalization costs Total costs
500

Per Patient ($)

34
500

8 302

1000

P <.05

1500 2000

1454 P <.05

1304 P <.05

Figure. Healthcare utilization cost reductions with IGIV-C compared

with IGIV-SD. Multivariate cost comparison shows significant differences in healthcare utilization costs between patients with PID receiving IGIV-C (n = 87) and those receiving IGIV-SD (n = 85). On average, compared with IGIV-SD, treatment with IGIV-C was associated with significantly lower prescription costs, hospitalization costs, and total costs (P <.05). Physician and emergency department costs as well as productivity costs were similar in the 2 groups. From Mahadevia PJ, et al.3

Purchasing Costs
The major class of trade (COT) groups relative to IGIV are physicians; hospitals, long-term care, and skilled nursing facilities; home infusion providers; and retail pharmacies/specialty pharmacies. Each COT group has different buying power. Physicians hold the greatest leverage on purchasing costs because they select which product to prescribe. Hospitals have strong buying leverage because of volume and, thus, historically have enjoyed lower purchasing costs. COT groups with the least purchasing leverage usually pay the highest costs. Specialty pharmacies have entered the distribution market for infusible products like IGIV. They face the challenge of needing to coordinate their high touch service component with a local infusion pharmacy to provide the clinical component (ie, administration and patient care). It is apparent why ASP is an inadequate measure of true cost when provider groups have different purchasing powers.

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IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

Reimbursement Climate
Delivery Models
The 4 IGIV delivery models are hospitals, physicians/ clinics, home infusion providers, and hospital outpatient ambulatory infusion centers. Reimbursement regulations and issues vary by both payer and delivery model. For example, Medicaid varies state by state, adding complexity beyond the scope of this article. However, with the implementation of the Medicare Part D drug benefit, all state Medicaid Dual Eligibles (patients eligible under both Medicaid and Medicare) will look to Medicare Part D or Medicare Part B for IGIV coverage.

Table 3. New HCPCS G Code for IGIV Preadministration Services

Payment Code Rates Changes G0332 Physician New G code applies to preadministration services for each IGIV infusion in the office: physician office or hospital outpatient $69.00 setting Hospital outpatient: Payment is in addition to payment for drug cost or infusion services $75.00 Other G codes are no longer valid in the physician office setting

optimizing patient care and outcomes

the nurse's role in balancing costs and quality of care

Drug Coding and Pricing Healthcare Common Procedure Coding System (HCPCS) versus National Drug Code (NDC)
Two major drug coding methodologies are used for IGIV: the HCPCS and the NDC. With the HCPCS, J codes for IGIV payment are based on the code description, which in 2006 is per 500 mg of IGIV dispensed regardless of which IGIV product is being used. Under Medicare, all reimbursement models are reimbursed using the HCPCS at ASP plus 6%, regardless of the product manufacturer. Commercial payers may require either HCPCS coding, NDC coding, or both. Using the NDC methodology for coding, the IGIV assigns a unique labeler code and product code for each individual IGIV

Table 2. New HCPCS J Codes and Billing Units for IGIV

Billing Unit Changes 500 mg New J code replaces (0.5 g) Q codes (Q9941 and Q9942) New billing unit replaces old billing units of 1 g and 10 mg J1567 Nonlyophilized 500 mg New J code replaces (liquid) (0.5 g) Q codes (Q9943 and Q9944) New billing unit replaces old billing units of 1 g and 10 mg Product Code Description J1566 Lyophilized

product. Typically this system reimburses based on a percentage of the AWP of a specific product. During the patients prequalification and insurance screening, providers should be aware of which methodology the payer requires for the billing unit of measure (HCPCS or NDC). Consider the example of a 10-g vial of IGIV. If the payer uses NDC for the pricing and billing unit, the provider would bill for 1 unit of the product used and is reimbursed on the basis of a percentage of the AWP for that particular 10-g product. If the payer uses HCPCS as the pricing and billing unit, the provider would bill for 20 units (500 mg) and is reimbursed at the allowable rate per unit. Thus, if the payer is reimbursing on an HCPCS code billing unit but the provider bills with an NDC billing unit, the provider would be grossly underpaid.

Key Changes in 2006

Coding changes implemented in 2006 are listed in Tables 2 through 5. New HCPCS J codes (J1566 and J1567) have been assigned to replace the temporary Q codes used in 2005 to differentiate lyophilized and nonlyophilized (liquid) IGIV products (Table 2). The billing units also changed from 1-g and 10-mg units to the 500-mg (0.5-g) unit. The Medicare ASP plus 6% reimbursement rates are updated quarterly. The rates for the third quarter of 2006 (effective July 1, 2006, through September 30, 2006) allow $24.899 per unit of lyophilized IGIV and $30.116 per unit of nonlyophilized (liquid) IGIV. As an example, based on the

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2006 billing unit and the third-quarter reimbursement rates, one 10-g vial of lyophilized IGIV would be reimbursed at $497.98 and 10 g of nonlyophilized IGIV would be reimbursed at $602.32. The new add-on G code for IGIV preadministration services applies to the physician office and hospital outpatient settings (Table 3). The allowable payment rates are per patient per administration and vary by setting. Other G codes are no longer valid in the physician office setting; they have been replaced by current procedural terminology (CPT) codes (Table 4). Also in 2006, new C codes are being used under the Hospital Outpatient Prospective Payment System (HOPPS; Table 5). The CMS no longer recognizes the old CPT codes.

Table 5. New C Codes for IGIV Drug Administration Under HOPPS*

Code C8950 C8951 C8957 Description of Services IV infusion therapy/diagnosis; initial, 1 hour IV infusion therapy/diagnosis; each additional hour Prolonged IV infusion requiring pump

*Old CPT codes for drug administration are no longer recognized by CMS. Should be listed in addition to C8950 for infusions lasting >1 hour.

Factors Affecting Reimbursement for Different Delivery Methods

Under the hospital inpatient delivery model, for most government programs, the prospective payment system wherein everything provided is bundled for reimbursementplaces the burden of cost containment on the provider. In the commercial setting, percentage of charge still exits, wherein the provider bills their usual and customary charges with a percentage discount. The objective of the percentage of charge system is to keep prices as

Table 4. New CPT Codes for IGIV Drug Administration Services (Physician Office Setting)
Code Description of Services 90765 IV infusion therapy/prophylaxis/ diagnosis; initial, 1 hour 90766 IV infusion therapy/prophylaxis/ diagnosis; each additional hour (after the first hour), 8 hours 90767 IV infusion therapy/prophylaxis/ diagnosis; additional sequential infusion, 1 hour 90768 IV infusion therapy; concurrent infusion 90772 Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular Change From 2005 Replaces G code G0347 Replaces G code G0348 Replaces G code G0349 Replaces G code G0350 Replaces G code G0351

high as possible without losing business to competitors. Given these restrictions, it is not surprising that hospitals are moving patients into alternative delivery systems for IGIV administration. Hospital outpatient prospective payment under APCs is seen in government programs for administration of IGIV. Services are billed with the new C codes, the G code for the add-on fee, and IGIV is billed with HCPCS J codes with ASP pricing. Hospital outpatient cost in the commercial payer market is usually covered as a fee for service or billed using the per diem methodology, with IGIV being billed using an HCPCS code or an NDC and reimbursed on the basis of AWP. Because case management is assigned and preauthorization is required, this system usually provides more flexibility with off-label use. There is some concern in the industry that the commercial model will soon move to the government prospective payment model and ASP plus 6% pricing. The most common scenario for home infusion administration of IGIV involves commercial payers because the Medicare benefit for IGIV is not a comprehensive benefit: it lacks coverage for the supplies, equipment, and nursing components. This drug-only coverage applies to both the Medicare Part B durable medical equipment regional carrier (DMERC) benefit and Medicare Part D. Medicare Part B also limits IGIV administration to the treatment of 5 PID diagnoses only. In the commercial setting, billing for home IGIV therapy is usually done on a per diem basis (using an S code) which bundles all supplies, equipment, and

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IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

optimizing patient care and outcomes

The IGIV Reimbursement Future
Proposed changes for 2007 include the establishment of unique HCPCS codes for each brand of IGIV to replace the current system that has only 2 codes, 1 for lyophilized and 1 for nonlyophilized (liquid) products. Another possibility would be to reclassify IGIV as a biologic response modifier so it can be reimbursed at the higher rate associated with that classification. Concerns remain regarding whether these possible payment increases will be sufficient to have a positive impact on patient care because of all the administration costs (discussed above). The infusion nurses primary concern is patient IGIV access and quality care. Clearly, there are serious issues in this area. Hospitals already allocate to the most needy, and physicians have begun to prolong time between infusions.5 Congressional action will be needed to change the Medicare reimbursement formula to cover costs of supplies and professional services associated with IGIV therapy, particularly in the home setting. Concerned clinicians should contact their US representatives and senators to urge them to enact legislation that will improve access to IGIV for all patients who need it.

professional pharmacy services into the S9338 HCPCS code. The drug cost is typically billed using NDC and reimbursed by AWP. The nursing services are billed separately using the 99601 nursing administration code for the first 2 hours and 99602 for subsequent hours. This system usually requires preauthorization.

the nurse's role in balancing costs and quality of care

5. Vogel MB. CMS responds to IVIG availability concerns with add-on payments for outpatient use. Specialty Pharm News 2. 2005. 6. Advisory Committee on Blood Safety and Availability. Recommandation [sic] subject: immune globulin intravenous (IGIV) [letter]. Available at: http://www.hhs.gov/ bloodsafety/resolutions/ressept05.pdf. Accessed May 24, 2006. 7. Brecher ME, for the Advisory Committee on Blood Safety and Availability (ACBSA). Resolutions from the ACBSA Meeting, May 16-17, 2005 [letter]. Available at: http://www.hhs.gov/bloodsafety/resolutions/resmay05.pdf. Accessed May 24, 2006. 8. Beato CV, for the Department of Health and Human Services. Response to Brecher et al: resolutions from the ACBSA May 2005 meeting [letter]. Available at: http://www.hhs.gov/bloodsafety/responses/May2005Response. pdf. Accessed May 24, 2006. 9. US Department of Health and Human Services. Advisory Committee on Blood Safety and Availability: status of immune globulin intravenous (IGIV) products. Available at: http://www.hhs.gov/bloodsafety/igiv.html. Accessed May 23, 2006. 10. Agwunobi JO, for the Department of Health and Human Services. DHHS response to ACBSA September 2005 recommendations [letter]. Available at: http://www.hhs.gov/ bloodsafety/responses/Sept2005Response.pdf. Accessed May 24, 2006. 11. Immune Deficiency Foundation Web site. Available at: www.primaryimmune.org. Accessed May 24, 2006. 12. The Neuropathy Association Web site. Available at: www.neuropathy.org. Accessed May 24, 2006.

References
1. Kazatchkine MD, Kaveri SV. Immunomodulation of autoimmune and inflammatory diseases with intravenous immune globulin. N Engl J Med. 2001;345:747-755. 2. Gelfand EW. Critical decisions in selecting an intravenous immunoglobulin product. J Infus Nurs. 2005;28:366-374. 3. Mahadevia PJ, Strell J, Kunaprayoon D, Gelfand E. Cost savings from intravenous immunoglobulin manufactured from chromatography/caprylate (IGIV-C) in persons with primary humoral immunodeficiency disorder. Value Health. 2005;8:488-494. 4. American Society of Health-System Pharmacists. Drug products with limited availability. Available at: http://www.ashp.org/shortage/availability-notices.cfm. Accessed May 23, 2006.

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Self-Assessment Questions
Please circle your answers on the evaluation form on page 16.
1. Which of the following represents an off-label use of IGIV? a. Primary immune deficiency (PID) b. Chronic inflammatory demyelinating polyneuropathy (CIDP) c. Idiopathic thrombocytopenic purpura (ITP) d. Kawasaki syndrome 2. Which of the following is not considered an important factor in assessing patient risk prior to IGIV or IGSC therapy? a. Current diagnosis b. Comorbidities c. Recent food intake d. Infusion history 3. What percentage of IGIV-induced renal events in the United States reported to the FDA between 1985 and 1998 were attributable to IGIV products stabilized with sucrose? a. 30% b. 50% c. 70% d. 90% 4. IGIV and IGSC are contraindicated in patients with selective deficiency of: a. IgM. b. IgA. c. IgG. d. IgE. 5. The optimal pH range for IGIV in solution ranges from: a. 2.0-2.5. b. 3.0-3.5. c. 4.0-4.5. d. 5.0-5.5. 6. Which of the following procedures is considered to reduce the risk of pathogenic prion transmission in IGIV products? a. Pasteurization b. Fractionation c. Caprylate/chromatography process d. Filtration 7. During the first hour of IGIV infusion, a patients vital signs should be assessed every: a. 10 minutes. b. 15 minutes. c. 20 minutes. d. 30 minutes. 8. The IGIV reimbursement allocation implemented in early 2006 in the hospital outpatient setting for Medicare reimbursement (but not for commercial insurance reimbursement) was: a. 85% of AWP. b. AWP plus 6%. c. 85% of ASP. d. ASP plus 6%. 9. Which group has the greatest leverage on IGIV purchasing costs? a. Physicians b. Hospitals, long-term care, skilled nursing facilities c. Home infusion providers d. Retail pharmacies/specialty pharmacies 10. Medicare ASP plus 6% reimbursement rates are updated: a. Monthly. b. Quarterly. c. Semi-annually. d. Annually.

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IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE
University of Nebraska Medical Center Evaluation Form for Nurses
Photocopy and fax evaluation form to 402.559.6379 or mail it to University of Nebraska Medical Center College of Nursing Continuing Nursing Education, 985330 Nebraska Medical Center, Omaha, NE 68198-5330, prior to July 30, 2007. Please print legibly. This form will be used to generate and mail your certificate within 4 to 6 weeks. First Name Last Name Degree(s) optimizing patient care and outcomes Address City Phone Fax State ZIP Code Middle Initial

E-mail the nurse's role in balancing Activity and Therapy: The Nurses Role care costs Title: IGIV quality of in Balancing Costs and Quality of Care Target Audience: Infusion Nurses Designated Contact Hour(s): 1.2 (with 70% or more correct) Goal: To familiarize infusion nurses with immune globulin products, safety and tolerability considerations, and current issues regarding costs and reimbursement. We would like your opinion regarding this educational activity. Please complete the evaluation form, including the self-assessment answers, and return it to the address or fax number indicated above. 1. As a result of completing this learning activity are you now better able to: a. Describe the differences among currently available immune globulin products and their impact on safety, tolerability, and economic considerations? b. Discuss key policies and procedures related to reimbursement for immune globulin therapy in various clinical settings? 2. Were the objectives of this learning activity as stated in item #1 above related to its overall goal? 3. Was the content of this learning activity clearly written? 4. Was the content of this activity free of commercial bias? 5. Was the information/content relevant to your clinical practice? Yes No Somewhat

If you answered NO or SOMEWHAT to any items above, please explain: ______________________________________ ____________________________________________________________________________________________________ Please rank each of the formats below in order of preference from 1 (highest) to 8 (lowest). __ Teleconferences __ Grand Rounds __ Home Study (printed) __ Symposia __ Home Study (CD-ROM) __ Roundtables __ Internet-based __ Association Meetings

Comments/suggestions for future activities: ________________________________________________________________ I certify that I have completed this activity and the actual time I spent was: 40 min 50 min 60 min 75 min Other (fill in number of minutes: ______) Signature ______________________________________________________________ Date ________________________ ANSWER GRID (please circle 1 answer per question) 1. a b c d 2. a b c d 3. a b c d 4. a b c d 5. a b c d 6. 7. 8. 9. 10. a a a a a b b b b b c c c c c d d d d d

Please contact the Continuing Education Alliance at inquiries@cealliance.org for questions regarding this activity. CTE32606

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NOTES

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IGIV THERAPY:
THE NURSE'S ROLE IN BALANCING COSTS AND QUALITY OF CARE

NOTES

optimizing patient care and outcomes

the nurse's role in balancing costs and quality of care

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IGIV THERAPY:
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