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Home Infusion Therapy

Home Infusion Therapy & Immunoglobulin

Presented below are some commonly inquired questions regarding home infusion and IVIG.

We understand that for individuals recently diagnosed with a chronic illness necessitating infusion therapy, the experience can be overwhelming, bewildering, and anxiety-inducing.

Our aim is to offer a valuable source of information for patients and their loved ones seeking insights into potential treatment options.

Infusion therapy entails the delivery of medication via a needle or catheter. It is recommended in cases where a medical condition is so severe that conventional oral medications prove ineffective or when there are no oral treatment options suited to the patient’s needs.

Usually, infusion therapy involves the intravenous administration of medication, although it can also encompass subcutaneous infusions.

Infusion therapy often includes the delivery of prescription drug treatments such as intravenous immunoglobulin (IVIG), antibiotics, antifungals, antivirals, chemotherapy, hydration, pain management, and parenteral nutrition.

Additionally, infusion therapy is extended to patients dealing with a diverse range of chronic and occasionally rare conditions. Specialty infusion medications have proven efficacy when administered on a weekly or monthly basis for the treatment of these conditions.

Home Infusion Therapy

Infusion therapy entails delivering medication through a needle or catheter, typically prescribed when a medical condition is too severe for effective oral treatment or when suitable oral therapies are unavailable. While infusion therapy often involves intravenous drug administration, it may also encompass subcutaneous infusions.

Commonly prescribed prescription drug therapies administered via infusion include intravenous immunoglobulin (IVIG), antibiotics, antifungals, antivirals, chemotherapy, hydration, pain management, and parenteral nutrition.

Additionally, infusion therapy serves patients with a diverse range of often chronic and occasionally rare diseases, with specialty infusion medications proving effective when administered on a weekly or monthly basis.

Infusion therapy is often necessary for a range of medical conditions, such as neuromuscular, dermatological, and immune disorders, as well as infections that don’t respond to oral steroids or antibiotics. This includes conditions like cancer and cancer-related pain, severe dehydration, gastrointestinal issues that hinder normal digestive function, among others.
Additionally, specialized infusion therapies may also be employed to manage conditions like congestive heart failure, Crohn’s disease, hemophilia, and rheumatoid arthritis, among others.

Specialty infusion therapy refers to the administration of specialized infusion medications. In this context, “specialty” signifies that the drug therapy necessitates extensive pharmacy expertise to ensure safe administration at home, secure third-party payment for the treatment, and effectively manage the interactions between the home infusion pharmacy and home health nursing services.

The process of specialty infusion therapy encompasses intricate tasks such as ordering, shipping, compounding, storing, delivering, and monitoring.

Prior to the 1980s, patients undergoing infusion therapy were confined to inpatient hospital settings throughout their treatment. However, a growing emphasis on cost containment within healthcare, coupled with advancements in the clinical administration of infusion therapy, prompted the development of strategies for its delivery in alternative settings. For those in need of long-term therapy, inpatient care not only incurred exorbitant costs but also hindered individuals from resuming their normal daily lives and work commitments, potentially increasing the risk of hospital-acquired infections.

The evolution of home infusion therapy into a comprehensive medical service stems from technological breakthroughs that enabled the safe and effective administration of infusion therapies in the home environment. This transformation was driven by patients’ aspirations to return to their regular routines and workplaces during their recovery, along with the cost-effectiveness of home-based care, which provides a significantly more economical option compared to inpatient hospital treatment.

Extensive evidence supports the safety and efficacy of home infusion as a preferable alternative to inpatient care across various disease states and therapeutic interventions. Many patients express a strong preference for receiving treatment in the comfort of their own homes or in an outpatient infusion suite, as opposed to a hospital setting.

To ensure the suitability of home care, a comprehensive assessment of the patient’s condition and home environment is conducted before initiating infusion therapy at home. This assessment ensures that the patient is well-suited for home-based care.

Typically, an infusion therapy provider is a state-licensed pharmacy, often referred to as a “closed-door” pharmacy, specializing in delivering infusion therapies to patients at their homes or other non-hospital locations.

The initiation of infusion therapy always begins with a prescription order from a qualified physician responsible for the patient’s care. These providers offer a comprehensive range of professional pharmacy services, care coordination, infusion nursing services, as well as supplies and equipment to ensure optimal treatment effectiveness and patient compliance.

Qualified infusion pharmacies must meet stringent licensing requirements mandated by state pharmacy boards and adhere to accreditation standards commonly mandated by most third-party payers. In addition to their core services, home infusion pharmacies may also offer various supplementary professional therapies and services.

Regarding the medications used, the infusion pharmacy plays a crucial role in ensuring that infusion drugs are:

1. Prepared in a sterile environment.
2. Stored under controlled temperature and air quality conditions to maintain both sterility and drug stability.
3. Administered at precisely the correct dose and on the prescribed schedule by highly trained home IV Nurses.
4.Delivered using suitable drug delivery devices, typically electronic pumps.

5. Flushed with the appropriate solution between doses to ensure the functionality of the IV catheter.

Monitored for adverse reactions and therapeutic effectiveness.

Furthermore, infusion pharmacies offer an extensive range of professional services, including:

1. Patient assessment and admission.

2. Patient education and training.

3. Care planning and coordination with physicians, nurses, and the patient’s payor.

4. Clinical infusion pharmacists overseeing care management.

5. Problem-solving and oversight of treatment plans, among other services.

All of these services are essential in achieving optimal outcomes for patients undergoing infusion therapy. Additionally, infusion pharmacies supply the specialized equipment (such as infusion pumps) and various administration supplies (including IV sets, syringes, and more) required for infusion therapy. They also provide maintenance and servicing for the equipment as needed.

In order to guarantee the safe and proper administration of infusion drugs, infusion pharmacists deliver a comprehensive range of services, including:

1. Conducting a thorough assessment that encompasses patient history, current physical and mental status, lab reports, cognitive and psychosocial conditions, family/care partner support, prescribed treatment, concurrent oral prescriptions, and over-the-counter medications.

2. Adhering to stringent procedures for compounding and distributing sterile infusion products, in compliance with national standards, as well as state and federal regulations.
3. Vigilantly monitoring drug interactions and identifying potential issues like drug compatibility, dose appropriateness, or catheter compatibility.
4. Carrying out comprehensive admission procedures that involve patient education on the use of medical and disposable equipment, proper medication storage and handling, emergency protocols, vascular access device management, and recognizing/reporting adverse drug reactions.
5. Developing comprehensive care plans that address actual or potential drug or equipment-related concerns, therapy monitoring with specific patient goals, and coordination of activities with other healthcare providers, such as home health agencies and physicians.
6. Continuously monitoring and reassessing patients to evaluate treatment response, detect drug-related complications, identify adverse reactions, and ensure patient adherence.
7. Reviewing relevant laboratory reports and, when necessary, consulting with healthcare professionals to adjust medication orders.
8. Maintaining appropriate physical facilities for the storage, preparation, dispensing, and quality control of all infusion medications and equipment.
9. Ongoing employee education and validation of competence activities.
10. Sustaining an active accreditation status with a recognized accrediting body, which is a significant commitment that attests to the infusion pharmacy’s delivery of high-quality services. It is typically required to provide therapy for insurance companies and to comply with state and federal regulations.
11. Implementing performance improvement programs that encompass the collection of clinical outcomes data, patient feedback, analysis of trends and other performance metrics, as well as conducting root cause evaluations for all sentinel events.
12. It’s important to note that the majority of health insurance plans cover these essential specialized services.

Depending on local regulations, practices, and the availability of skilled infusion nurses, infusion nursing services can be delivered either directly by the infusion pharmacy or through an affiliated or separate nursing agency. Infusion nurses play a crucial role within the infusion care team, working closely with the infusion pharmacy staff and the prescribing physician to coordinate care plans and various activities.

In cases where infusion therapy is administered in a patient’s home, the infusion nurse assumes responsibility for ensuring proper patient education and training while monitoring the patient’s care within their home environment. These specialized infusion nurses receive specific education, training, and expertise in administering drugs and biologics via infusion in home or alternate-site settings.
The services provided by infusion nurses typically encompass evaluation and assessment, patient or caregiver education and training, inspection and assessment of the home environment, as well as catheter insertion and patient evaluation.
Medicare Part B provides coverage for certain IV, enteral nutritional, and cancer treatment drugs when administered at home. However, the criteria for ensuring payment approval are intricate and often challenging to meet in real clinical scenarios for many patients. It’s worth noting that most infusion drugs, including those not covered under Part B, may potentially be covered by Medicare Part D, which is the prescription drug benefit.

Nevertheless, it’s important to be aware that the Centers for Medicare & Medicaid Services (CMS) has ruled that Part D does not possess the authority to cover the services, equipment, and supplies related to infusion therapy under its provisions.

Consequently, it is strongly recommended that individuals consult directly with a reimbursement specialist to ascertain their eligibility for individually prescribed medications and services. The Medicare approval process, encompassing both Parts B and D, can be intricate and challenging to navigate.

Reference:

Adapted from information provided by the National Home Infusion Association (NHIA): Infusion FAQs. Available at: http://www.nhia.org/faqs.cfm. Accessed January 10, 2011.

IVIG

Infusion therapy entails delivering medication through a needle or catheter, typically prescribed when a medical condition is too severe for effective oral treatment or when suitable oral therapies are unavailable. While infusion therapy often involves intravenous drug administration, it may also encompass subcutaneous infusions.

Commonly prescribed prescription drug therapies administered via infusion include intravenous immunoglobulin (IVIG), antibiotics, antifungals, antivirals, chemotherapy, hydration, pain management, and parenteral nutrition.

Additionally, infusion therapy serves patients with a diverse range of often chronic and occasionally rare diseases, with specialty infusion medications proving effective when administered on a weekly or monthly basis.

Infusion therapy is often necessary for a range of medical conditions, such as neuromuscular, dermatological, and immune disorders, as well as infections that don’t respond to oral steroids or antibiotics. This includes conditions like cancer and cancer-related pain, severe dehydration, gastrointestinal issues that hinder normal digestive function, among others.
Additionally, specialized infusion therapies may also be employed to manage conditions like congestive heart failure, Crohn’s disease, hemophilia, and rheumatoid arthritis, among others.

Specialty infusion therapy refers to the administration of specialized infusion medications. In this context, “specialty” signifies that the drug therapy necessitates extensive pharmacy expertise to ensure safe administration at home, secure third-party payment for the treatment, and effectively manage the interactions between the home infusion pharmacy and home health nursing services.

The process of specialty infusion therapy encompasses intricate tasks such as ordering, shipping, compounding, storing, delivering, and monitoring.

Prior to the 1980s, patients undergoing infusion therapy were confined to inpatient hospital settings throughout their treatment. However, a growing emphasis on cost containment within healthcare, coupled with advancements in the clinical administration of infusion therapy, prompted the development of strategies for its delivery in alternative settings. For those in need of long-term therapy, inpatient care not only incurred exorbitant costs but also hindered individuals from resuming their normal daily lives and work commitments, potentially increasing the risk of hospital-acquired infections.

The evolution of home infusion therapy into a comprehensive medical service stems from technological breakthroughs that enabled the safe and effective administration of infusion therapies in the home environment. This transformation was driven by patients’ aspirations to return to their regular routines and workplaces during their recovery, along with the cost-effectiveness of home-based care, which provides a significantly more economical option compared to inpatient hospital treatment.

Extensive evidence supports the safety and efficacy of home infusion as a preferable alternative to inpatient care across various disease states and therapeutic interventions. Many patients express a strong preference for receiving treatment in the comfort of their own homes or in an outpatient infusion suite, as opposed to a hospital setting.

To ensure the suitability of home care, a comprehensive assessment of the patient’s condition and home environment is conducted before initiating infusion therapy at home. This assessment ensures that the patient is well-suited for home-based care.

Typically, an infusion therapy provider is a state-licensed pharmacy, often referred to as a “closed-door” pharmacy, specializing in delivering infusion therapies to patients at their homes or other non-hospital locations.

The initiation of infusion therapy always begins with a prescription order from a qualified physician responsible for the patient’s care. These providers offer a comprehensive range of professional pharmacy services, care coordination, infusion nursing services, as well as supplies and equipment to ensure optimal treatment effectiveness and patient compliance.

Qualified infusion pharmacies must meet stringent licensing requirements mandated by state pharmacy boards and adhere to accreditation standards commonly mandated by most third-party payers. In addition to their core services, home infusion pharmacies may also offer various supplementary professional therapies and services.

Regarding the medications used, the infusion pharmacy plays a crucial role in ensuring that infusion drugs are:

1. Prepared in a sterile environment.
2. Stored under controlled temperature and air quality conditions to maintain both sterility and drug stability.
3. Administered at precisely the correct dose and on the prescribed schedule by highly trained home IV Nurses.
4.Delivered using suitable drug delivery devices, typically electronic pumps.

5. Flushed with the appropriate solution between doses to ensure the functionality of the IV catheter.

Monitored for adverse reactions and therapeutic effectiveness.

Furthermore, infusion pharmacies offer an extensive range of professional services, including:

1. Patient assessment and admission.

2. Patient education and training.

3. Care planning and coordination with physicians, nurses, and the patient’s payor.

4. Clinical infusion pharmacists overseeing care management.

5. Problem-solving and oversight of treatment plans, among other services.

All of these services are essential in achieving optimal outcomes for patients undergoing infusion therapy. Additionally, infusion pharmacies supply the specialized equipment (such as infusion pumps) and various administration supplies (including IV sets, syringes, and more) required for infusion therapy. They also provide maintenance and servicing for the equipment as needed.

In order to guarantee the safe and proper administration of infusion drugs, infusion pharmacists deliver a comprehensive range of services, including:

1. Conducting a thorough assessment that encompasses patient history, current physical and mental status, lab reports, cognitive and psychosocial conditions, family/care partner support, prescribed treatment, concurrent oral prescriptions, and over-the-counter medications.

2. Adhering to stringent procedures for compounding and distributing sterile infusion products, in compliance with national standards, as well as state and federal regulations.
3. Vigilantly monitoring drug interactions and identifying potential issues like drug compatibility, dose appropriateness, or catheter compatibility.
4. Carrying out comprehensive admission procedures that involve patient education on the use of medical and disposable equipment, proper medication storage and handling, emergency protocols, vascular access device management, and recognizing/reporting adverse drug reactions.
5. Developing comprehensive care plans that address actual or potential drug or equipment-related concerns, therapy monitoring with specific patient goals, and coordination of activities with other healthcare providers, such as home health agencies and physicians.
6. Continuously monitoring and reassessing patients to evaluate treatment response, detect drug-related complications, identify adverse reactions, and ensure patient adherence.
7. Reviewing relevant laboratory reports and, when necessary, consulting with healthcare professionals to adjust medication orders.
8. Maintaining appropriate physical facilities for the storage, preparation, dispensing, and quality control of all infusion medications and equipment.
9. Ongoing employee education and validation of competence activities.
10. Sustaining an active accreditation status with a recognized accrediting body, which is a significant commitment that attests to the infusion pharmacy’s delivery of high-quality services. It is typically required to provide therapy for insurance companies and to comply with state and federal regulations.
11. Implementing performance improvement programs that encompass the collection of clinical outcomes data, patient feedback, analysis of trends and other performance metrics, as well as conducting root cause evaluations for all sentinel events.
12. It’s important to note that the majority of health insurance plans cover these essential specialized services.

Depending on local regulations, practices, and the availability of skilled infusion nurses, infusion nursing services can be delivered either directly by the infusion pharmacy or through an affiliated or separate nursing agency. Infusion nurses play a crucial role within the infusion care team, working closely with the infusion pharmacy staff and the prescribing physician to coordinate care plans and various activities.

In cases where infusion therapy is administered in a patient’s home, the infusion nurse assumes responsibility for ensuring proper patient education and training while monitoring the patient’s care within their home environment. These specialized infusion nurses receive specific education, training, and expertise in administering drugs and biologics via infusion in home or alternate-site settings.
The services provided by infusion nurses typically encompass evaluation and assessment, patient or caregiver education and training, inspection and assessment of the home environment, as well as catheter insertion and patient evaluation.
Medicare Part B provides coverage for certain IV, enteral nutritional, and cancer treatment drugs when administered at home. However, the criteria for ensuring payment approval are intricate and often challenging to meet in real clinical scenarios for many patients. It’s worth noting that most infusion drugs, including those not covered under Part B, may potentially be covered by Medicare Part D, which is the prescription drug benefit.

Nevertheless, it’s important to be aware that the Centers for Medicare & Medicaid Services (CMS) has ruled that Part D does not possess the authority to cover the services, equipment, and supplies related to infusion therapy under its provisions.

Consequently, it is strongly recommended that individuals consult directly with a reimbursement specialist to ascertain their eligibility for individually prescribed medications and services. The Medicare approval process, encompassing both Parts B and D, can be intricate and challenging to navigate.

Reference:

Adapted from information provided by the National Home Infusion Association (NHIA): Infusion FAQs. Available at: http://www.nhia.org/faqs.cfm. Accessed January 10, 2011.

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