INTRODUCTION
Home infusion is a safe and convenient alternate site of care for individuals who need intravenous medications on a regular basis. It is founded on a unique multidisciplinary approach: infusion nurses, pharmacists, case managers, insurance specialists, and patients/family members all become one team when assessing and determining whether home infusion is appropriate and can be successful. Many times, however, the appropriateness of home care is questioned when an assessment of the situation sheds light on one or more complexities.
The intention in this article is to review the scope of home infusion, the team members who participate in the acceptance process for new patients, and to discuss the 6 areas or considerations that can make home infusion successful. Through the review of the considerations, there will be information on how some potential barriers can be mitigated with planning and preparation. After reviewing the main considerations, case studies are presented to demonstrate how all the elements must come together to make a balanced and safe plan for home infusion therapy.
A high-level overview of home infusion is helpful to set the stage for understanding this service line and the acceptance of patients to service. Home Infusion started in the 1980s and was initially focused on antimicrobial and parenteral nutrition needs.1 Currently, over 3 million patients annually receive home and specialty infusion services.2 Acute therapies, such as antibiotics or parenteral nutrition, include patient or family member involvement to learn to administer their medications. Chronic conditions are often treated with nurse-administered medications on a less frequent basis and are often referred to as specialty medications.
It is important to begin with an understanding that home infusion is, first and foremost, a pharmacy. Some nurses or nurse needs are involved, but it is the pharmacy that is driving the care, licensure, and accreditation. The home infusion team is multidisciplinary and allows all considerations for acceptance to service to be considered. The referral process usually starts with intake staff handling the initial information-gathering steps, including gathering the demographic data, payor details, initial service request, and completing data entry into the electronic medical record (EMR). This team will check the payor status and determine if authorization is required and can start looking at the patient’s potential financial expectations. Pharmacists will be involved in evaluating the medication and appropriateness to the diagnosis and other clinical information available. Nursing will have someone to review the clinical data and start to formulate what will be needed for the patient based on that initial information. Other team members include pharmacy technicians who may be involved in purchasing, inventory controls, and supply management, as well as reimbursement specialists who can help with evaluation of certain payor requirements.
Many organizations include a position located within a hospital or medical center to facilitate referrals to home infusion. This is often referred to as a clinical liaison and can be very valuable in preparing the hospitalized patient to transition to home infusion. This clinician is usually a registered nurse since the position includes clinical evaluation of appropriateness and education for self-administration at home.3
In addition to the home infusion pharmacy team, several other stakeholders are often involved in the referral process. This can include hospital nurse case managers, specialty clinic staff, payor authorization teams, and the physicians or prescribers. As both the internal and external teams collaborate in arranging infusion care at home, they are supporting the INS Infusion Therapy Standards of Practice (Standards), (Standard 3: Scope of Practice, 3.3), which states, “members of the health care team collaborate to achieve the universal goal of safe, effective, and appropriate infusion therapy.”4(S20)
Types of Therapies
Typically, patient cases are grouped by categories and therapies to organize the specific care and cost considerations. The terms used may vary by organization. Most commonly, each drug is assigned a therapy and then therapies are grouped into larger categories that can address acute and chronic disease state management. The first group of therapies is usually referred to as acute therapies. Acute patient referrals often come from a hospital to complete a course of treatment or a physician clinic to avoid hospitalization. These therapies typically include anti-infectives, hydration, electrolyte replacement, parenteral nutrition, inotropes, or pain management, and tend to involve more patient or caregiver participation and include education for independent administration. The nurse will not be present for each dose. These patients will need weekly care of their central vascular access device (CVAD) and, possibly labs, to monitor their progress. This care can be provided in the home by home infusion-employed registered nurses (RNs) or by coordinating care needs with Home Health Agencies (HHA). Patients may also receive the follow-up care required at an outpatient facility if they do not have an HHA option available to them.
The second grouping of therapies is usually referred to as specialty or chronic, and medications are often high-dollar, nurse-administered medications. These therapies usually treat chronic disease states such as immunodeficiency, ulcerative colitis, multiple sclerosis, and many more. The dosing is usually less frequent than the acute medications, such as every 4, 6, or 8 weeks. The administration times can range from 30 minutes to several hours. Since the RN administers and monitors the infusions, the patients may receive their medication via a peripheral intravenous catheter (PIVC). Alternately, some long-term patients with difficult venous access may have an implanted port or other long-term CVAD. The term “specialty” for this group can sometimes cause confusion with another pharmacy type also called Specialty Pharmacy. In organizations that have both a Specialty Pharmacy and a Home Infusion Pharmacy, the differentiating factor can be the need for nurse administration or special supply needs. A self-injectable medication prepared by the manufacturer in easy pens for administration are more likely to come from the Specialty Pharmacy, whereas the medication that needs a pump and/or the nurse for the administration will come from Home Infusion Pharmacy.
Although Home Infusion Pharmacy provides care in the patient’s home, care may also be received at alternate sites like infusion suites or free-standing infusion centers.” These sites are not a direct replacement for hospital or physician-based outpatient settings. They are meant to replicate a patient’s living room and are an alternative to the hospital or physician-based clinics. Together, free-standing infusion suites and homes are considered a lower site of care by payors. These are lower in cost to the payors, and many have identified certain medications as needing to be moved from standard outpatient settings to the lower site of care.5 By using the infusion suite option, home infusion is able to expand their service offerings for those patients who may not feel comfortable with a stranger in their home, or their home may not be a safe option.
Once the type of therapy required has been identified, the appropriateness of home infusion treatment must be determined. There are 6 areas of consideration that each need to be evaluated, as they all need to work together for safe care. Imagine a balance scale, like the scales of justice. If one of these areas is weak or has a deficiency, it may be balanced by another area of strength. By using the framework of these 6 areas of considerations, an organization would be compliant with the standards and practices recommendations outlined in the Home Infusion Therapy section of the Standards (Standard 66).4(S246-249)
Medications
There are very few limits on the medications that can be infused at home; however, each case must be evaluated with the other areas of consideration in mind. The home infusion pharmacy will rely on the stability information in determining the best administration method for the patient and involve the patient in choices, when possible. The stability of the medication may require a certain type of administration method that may be more complicated for the patient. The method of administration and any special handling required may make it more difficult for some patients to be safely independent. For a patient with compromised dexterity or eyesight, that could be a barrier. The stability information may also impact how often the patient needs to receive each shipment of their medication and supplies. The goal is to ship a week’s worth of medication; however, short stability may require 2 or 3 shipments in a week.
There may also be pay0r requirements to use a specific method of administration. One of these examples is Medicare Part B, where it is required that a pump be used for administration, as the coverage is under the Durable Medical Equipment (DME) benefit of that plan. Medicare also only covers certain medications listed under Part B and with very specific criteria that must be met.6 The author has experienced at least 1 state Medicaid program that required administration be ≥15 minutes to qualify as a home infusion covered medication, which would exclude use of IV push for antibiotic administration. Since programs are always changing and evolving, this is mentioned only to caution that clinicians must understand and follow their own state or payor requirements.
Parenteral nutrition (PN) is a therapy that home infusion was created for to address those patients who need long-term nutrition when their gastrointestinal (GI) system is not capable of absorbing or processing food effectively. This is, however, the most complicated and highest risk therapy that is provided at home. Many steps are involved in the daily preparations, and 3-5 home visits are often required to reach independence. Given the steps required, the patient or caregiver will require a higher level of competence than a patient on a single antibiotic dose each day.
Clinical Stability of the Patient
Home infusion is designed for the stable patient who has a predictable and expected response to treatment. It is possible to treat very ill patients, but not until they are stable. If the patient is still requiring daily labs to adjust potassium or magnesium levels, they are not likely to be at that stable state. Once it is determined they need a specific amount of potassium or magnesium to maintain their level, they could be a good candidate for home care. Clinical stability and medical history will both be used to evaluate appropriateness for home care and is especially important when considering first-dose administration.
Clinical Stability Case Study
A 53-year-old female patient with a diagnosis of Pompe Disease receiving Lumizyme 1550 mg IV every 2 weeks had a history of infusion reactions and had an anaphylactic reaction during an infusion at the outpatient infusion center. After her anaphylactic reaction, her infusions were moved from the outpatient infusion center to an infusion space on the main campus of a large health system to be closer to emergency care. She had been undergoing a very complex desensitization regimen at the time of the referral to home infusion. In the assessment of appropriateness to move this care to the home, the current regimen and history was reviewed, and the outpatient infusion center was asked if they would take her back for care at that location until the end of the desensitization. Their answer was, “no.” Given her history, the home infusion pharmacy determined she was not yet safe for home care. The outcome was that the referral was sent to an outside home infusion company that accepted her for care. It is not clear whether they had visibility to the full history. Ultimately, she received her treatment at home until her death 2 months later from overall disease state complications.
This case demonstrates that there is not always a single correct choice for any organization regarding home care. Each organization understands its support network and risk factors. A home infusion pharmacy that is part of a health system may have more information than outside providers. Any home infusion provider can only make its own decisions on acceptance, based on the information available to them.
Access Device
Most acute patients will have some type of CVAD. This is required for stability and reliability of vascular access at home. Some very short-term treatments can be administered via PIVC. There are also many therapies that may be done peripherally for many days in the hospital that would not be done at home. The right device for the right therapy includes considering the length of therapy and who will be providing the care: the patient, a caregiver, or the nurse.
It is also important to note that home infusion can provide a variety of infusion types, not only intravenous. Subcutaneous (SQ) or intramuscular (IM) injections must be given by a health care provider. Clinicians can provide education and supplies for subcutaneous infusions, which can include anti-emetic therapy, deferoxamine for iron chelation, or immune globulin. Subcutaneous or epidural pain management can also be provided at home.
Patient/Caregiver Participation
This is a very important consideration for safe care at home. Even if an RN or family member came every day to connect PN or give an antibiotic dose, the patient would still need to safely engage with their IV access and be able to troubleshoot a pump if one is being used. This is an area where some accommodation may be made regarding how to dispense to assure success. For example, following is a breakdown of how PN is handled in the home:
The ideal PN patient is expected to add multi-vitamins and other additives daily to their PN bag, as well as spike and prime the tubing. The steps of drawing from the vials and adding that additive to the PN bag can be difficult if the patient has dexterity issues. If adding the additives is a barrier, it may be worth a discussion of the risk versus benefit of adding them in the pharmacy and making deliveries 3 times per week so that the patient gets some benefit, even though some of the vitamins may not be at full potency. Spiking the bag may be problematic for a weak patient with arthritis. In some cases, it may be an option to have the pharmacy attach the tubing, but not prime it. The patient can attach it to the pump and use the prime feature.
Another example of accommodation could be with ertapenem for a patient who lives a long distance from the pharmacy. For close patients, it is an option to use elastomeric devices for the patient’s ease in administration. The pharmacy challenge is that in that administration method, the medication only has a 7-day stability. If the patient is local, the pharmacy can compound and ship the same day and still only do 1 delivery per week. If the patient lives farther from the pharmacy, the pharmacy may decide to change the method of administration to mini-bag plus with gravity administration. This is more complicated for the patient. If the patient or caregiver cannot do the gravity administration safely, the pharmacy may be able to revert to the ease of the elastomeric but need to ship twice a week.
There are some treatments for which the only accommodation is a reliable caregiver. Inotrope therapies for advanced heart failure require a higher level of participation due to the continuous infusion. Patients are provided with a backup pump and should always have a backup bag of medication; however, if no one in the home has learned how to attach a new bag to the pump, having those items available is of no help. For nurse-administered specialty medications, patients will still have some level of participation. This may include needing to understand instructions on storing the medication when delivered to the home prior to the infusions and being available for scheduled visits.
Environment
“Where does the patient live?” is usually one of the first considerations. The pharmacy must be licensed in the state they are dispensing to. If the patient is from a nearby state in which the pharmacy is not licensed, the referral will need to be sent to another pharmacy. Knowing there is a nursing component to home infusion, this can also be a factor based on where the patient lives. The pharmaceutical product can be shipped throughout the entire state the pharmacy is licensed in; however, the nursing may be limited in how far travel is reasonable or allowed. This is where partnering with HHAs closer to the patient’s home is of great importance.
For home infusion pharmacies that have their own nursing team, home health licensing may also be required, even if they are not going to be Medicare Certified. It is important to know the licensing requirements for each state. As an example, the author works in an area on the state line between Kansas and Missouri. Kansas requires an HHA license for any nursing provided in the home. Missouri does not and acknowledges that if you are providing only a single service, such as nursing only, no license is required. Some states have a home health license, and when you apply, you identify more specifically that you are doing infusion nursing only.
Medicare certified HHAs must abide by Medicare homebound criteria for their Medicare patients and may not be able to service a patient receiving antibiotic therapy who is returning to work. In those situations, the patients may be able to obtain their labs and catheter care at a local outpatient center or a physician practice willing to assist them. Regarding chronic/specialty medications, the HHA nursing staff may not be competent or comfortable with administration of these medications. The home infusion pharmacy nurses may be able to provide education and support to assist those agencies in being able to provide for those patients in their area.
The next environmental consideration pertains primarily to chronic/specialty medications. How far from emergency services does the patient live? Are they very rural or in town? Many patients who live in rural areas understand that if they are far down a country road and the ambulance can take 90 minutes to reach them, they may not be a candidate for a medication that has a risky reaction profile to be administered at home.
The next level of environmental concern is the patient’s living situation, or their home. Whether there are utilities available to a patient can be screened by asking the patients prior to dispensing the sterilely compounded medications to their homes. Do they have electricity? Do they have enough room in their refrigerator for the medication? This can be of particular concern for large volume PN. There could be other issues that can be mitigated by some additional input from the pharmacy. If the patient does not have electricity for refrigeration, can they store a few doses at a time in a cooler with more frequent deliveries? If the patient does not have hot water, the pharmacy could supply hand sanitizer.
The cleanliness of the home may not be known or assessed until the first home visit by an RN. The RN will assess cleanliness and other safety concerns in the home, such as oxygen safety and fall risk. How the patient lives can impact the decisions going forward to assure safe care. An unclean environment may not be an automatic “no” but can be a deciding factor in how some things are handled. Limiting additional supplies or having the RN bring what is needed could be mitigation strategies. If the RN is administering, they may be able to make a safe zone and take extra care in their manipulations. If it is patient-administered medication, perhaps it can be run continuously rather than intermittently, which would require more breaks in the system and steps for flushes.
The final environmental consideration involves the safety of the staff entering the home. Staff education about their safety is important to assure they know their safety is of great concern. It is best to make other plans if the home is not safe for the staff, such as environmental or behavioral concerns of a patient or others in the home. Staff safety must come first. An alternate care path can be found to assure the patient receives treatment, without jeopardizing others.
Financial Considerations
The last consideration on the list may be one of the first things that moves a patient either away from or toward home infusion. The financials need to be considered and should always be provided to the patient up front so they can make an informed decision.
Acute therapies are usually covered by commercial payors without much extra review or authorization. This is not always the case with Medicare coverage. There is coverage for some home infusion therapy under Medicare part B when the patient meets certain criteria.6 Medicare coverage for antibiotics remains challenging, as the drug may be covered by the patient’s part D plan, but the supplies and pharmacy management are not. The patient may have better coverage with outpatient care, which is only a viable option for every 24-hour dosing.
For specialty medications, many commercial payors are pushing patients to the lower site of care, which includes home infusion or free-standing ambulatory centers. There is usually an authorization requirement because the medications can be rather expensive. Payors may have their own requirements for these medications, and they may have specific formulary requirements regarding use of a biosimilar product or a specific pharmacy.
To understand how these areas of consideration come together, it is helpful to review some specific cases.
Case #1: The first case involves a situation where a payor case manager was asking the question: Can you do pediatric chemotherapy at home? The quick short answer could be “yes,” as some oncology therapies can be done at home. However, when asking about a specific case, there are several questions that need to be addressed. The following framework of considerations provides a realistic view of the needs for a particular patient.
Medication: a continuous infusion, over 3 days, of a hazardous medication = possible with the right supportive care.
Patient stability: a 5-year-old female, has had the treatment in the past and tolerated it well = possible with the right supportive care.
Access device: did not have an established CVAD = would not be a viable plan without an established CVAD.
Participation: willing and capable parents = no issue identified.
Environment: patient lived in a very rural part of the state, 1.5 hours from a major hospital = possible, although it may be difficult to find a home health organization willing to handle hazardous medication and/or pediatrics.
Financials: not a concern, as it was the payor who was seeking alternatives.
Outcome: The outcome of this case is unknown, as the case manager never called back after the initial discussion about the elements that would need to be addressed to make it successful at home.
Case #2: This case involves a 5-year-old male with a unique Mast Cell Disorder. He had experienced severe allergic responses that required his IV medications to be given separately. He had spent several weeks in the hospital, where they determined that he tolerated his PN when it was given separately, but not compounded together. His home regimen was going to require 5 ambulatory pumps programed and labeled for specific medications. At any given time in the day, he would be connected to at least 2 pumps and, for some periods, it could be up to 4 pumps.
Medication: complicated TPN, administration with 5 separate pumps = can be done with the proper support.
Patient stability: patient has been stabilized on a regimen that is working for him = no current issues.
Access device: a double lumen, tunneled, cuffed, CVAD = appropriate for the therapy type and multiple administration needs.
Participation: willing and capable parents with some medical background = no issue identified.
Environment: the patient was discharging from UCLA hospital in Los Angeles, CA, to be driven home to Billings, MT, by way of Seattle, WA = could be managed with a national home infusion provider to accommodate the multiple state licensure concerns.
Financials: all deductibles and out of pocket limits had been reached, and the payor was hoping for a better long-term home solution = no issues identified.
Outcome: This patient plan came together with the support of the home infusion pharmacies at each leg of their journey home. The family was exceptional in carrying out all the details of the necessary care. Once home, the patient was able to remain at home without complications for several months with coordinated efforts between his specialty team at UCLA, his local primary care physician, and the local home infusion pharmacy.
Case #3: In this case, a 91-year-old female with a bacterial infection was leaving the hospital to complete at least 2 weeks of antimicrobial therapy.
Medication: oxacillin 1 gm every 4 hours over 30 minutes for a duration of 2 weeks = CADD pump programmed to the therapy parameters with a medication cassette to be changed every 72 hours based on medication stability.
Patient stability: patient was stable on treatment, although there were some concerns regarding her memory = she was going to be in the care of family to mitigate the memory issues.
Access device: PICC in place = appropriate IV access for the therapy.
Participation: the patient was willing, but known to have memory issues = family were very engaged and wanting the patient to come home with them for a planned family reunion over a holiday weekend. Family was taught and did very well.
Environment: patient lived in an assisted living facility with her spouse who also had memory issues = since she was going home with other family members, she would be in their care and not at her usual home.
Financials: not a concern.
Outcome: This case started off looking like a classic home infusion case. When the patient was with family, everything went well. That gave the family a false sense of security and they thought she could go home to her assisted living apartment. The change in environment and support changed the course of therapy.
On Tuesday afternoon, the son called the home infusion team asking for an RN to visit the couple and determine what was happening. He had gotten a call from his parents who were uncertain about the pump and what they were to do. The RN arrived at the patient’s home to find the pump, fanny pack, and PICC in a neat pile on the end table by the sofa. At first glance, it appeared the patient had pulled out her PICC and, from their recollection, it happened that morning when she first woke up. Upon further assessment, it was determined that the PICC was not the expected length. The patient went in for an x-ray, where it was found that the other half of the PICC was resting in her ventricle. It was safely retrieved by interventional radiology, and treatment was not resumed.
CONCLUSION
This cautionary tale brings us back to the beginning. All the considerations must work together to make for a successful home infusion candidate. In the early days of home infusion, the admission criteria were often a list of must haves: a telephone, running water, electricity, etc. Over time, we learned that there were other considerations, and that many perceived obstacles could be overcome with certain accommodations. With more history and experience, there is now a much better understanding of all the considerations. It is also understood that, as circumstances change throughout care, it is necessary to start over, reconsider what has changed, and adjust to a new successful plan.
This framework can also provide a structured approach to the question of first-dose appropriateness at home. By using this framework prior to starting care and during changes through the treatment course, we can plan for safe and effective treatment with home infusion pharmacy.
Kimberley A. Putzke, MN, RN, CRNI®, has been an RN for over 40 years and held her CRNI® since 1988. Most of her infusion experience has been within the home infusion industry holding positions from Field Nurse to Sr. Director of Operations. She is currently the Nurse Manager for the University of Kansas Hospital Home Infusion Pharmacy, where she has been able to use her skill set to develop the program from proof of concept to an integral part of the health system.
REFERENCES
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- National Home Infusion Foundation. Infusion industry trends report 2020. https://www.nhia.org/nhif_infusion_industry_trends_report/. Accessed January 29, 2024.
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- Nickel B, Gorski LA, Kleidon TM, et al. Infusion therapy standards of practice, 9th ed. J Infus Nurs. 2024;47(suppl 1):S1-S285. doi:10.1097/NAN.0000000000000532
- Kormony KM, Burkett JM, Mensing T, Whaley BA, Robb K, Chen D. Payer site of care mandates with oncology medications: it’s time to demand payer accountability on behalf of patients. Am J Health Syst Pharm. 2023;80(14):939-943. doi:10.1093/ajhp/zxad078
- Centers for Medicare & Medicaid Services. Part B Drugs and Biologics. Last modified 09/06/2023. https://www.cms.gov/cms-guide-medical-technology-companies-and-other-interested-parties/payment/part-b-drugs. Accessed June 27, 2024.
