Home and specialized infusion encompasses a broad range of pharmacological treatments delivered in an outpatient environment, often in the patient’s home or in an infusion suite. The bulk of these drugs are supplied through needle or catheter, a process known as infusion, but some are provided via intramuscular, epidural, or self-injectable ways. Infusion drugs are administered for both acute and chronic conditions for whom oral treatments alone are ineffective.
The majority of home and specialized infusion providers are closed-door pharmacies licensed in one or more states. Providers are classed as single-site, multiple-site, or health system-affiliated. Accreditation for pharmacies is granted by a variety of accrediting organizations (AOs), including The Joint Commission, ACHC, and URAC.
Infections, gastrointestinal ailments and disorders, dehydration, congestive heart failure, multiple sclerosis, rheumatoid arthritis, hemophilia, immunological deficiencies, and neurological problems are all prevalent conditions that need home and specialist infusion treatment. According to a recent NHIA research, home infusion and specialty providers catered for almost 3 million patients in the United States in 2019, a 300 percent increase over the 2008 industry study.
Since the 1980s, this business has grown at a breakneck pace, despite the limitations associated with Medicare’s comprehensive coverage. Medication administration in the home or infusion suite has been proved to be a safe and cost-effective approach of treating the majority of patients with the least amount of disruption to their daily life. There has been a grassroots campaign in recent years to lobby legislators to enhance patient access to home and specialized infusion pharmacy services in various settings of care. Commercial payors have lately implemented policies that shift high-priced infusions to the home environment, resulting in significant cost reductions.
For a range of treatments and illness states, both acute and chronic, home infusion has been shown to be a safe and effective alternative to inpatient care. Treatment at home or in an infusion room is often preferable to inpatient care for many individuals. This sector is expected to continue growing in the future as additional medicines are authorized and improved results for home infusion patients are seen.
What is intravenous treatment (IVT)?
Infusion treatment is the process of administering medicine through a needle or catheter. It is administered when a patient’s disease is so severe that oral drugs cannot properly cure it. Typically, “infusion treatment” refers to the administration of a medicine intravenously, although the word may also apply to instances in which pharmaceuticals are supplied by non-oral methods such as intramuscular injections or epidural injections (into the membranes surrounding the spinal cord). Antibiotic, antifungal, antiviral, chemotherapy, hydration, pain management, and parenteral nutrition are all examples of “traditional” prescription medication treatments that are often provided by infusion. Additionally, patients get infusion treatment for a variety of often chronic and sometimes uncommon conditions for which “specialty” infusion drugs are beneficial. While some have been accessible for a long period of time, others are more recent medications and biologics. Among the many examples are blood factors, corticosteroids, erythropoietin, infliximab, inotropic cardiac medicines, growth hormones, immunoglobulin, and natalizumab.
Infusion treatment is used to treat which diseases?
Infusion treatment is often used to treat infections that are resistant to oral antibiotics, cancer and cancer-related discomfort, dehydration, gastrointestinal illnesses or disorders that impair the gastrointestinal system’s normal function, and others. Additionally, malignancies, congestive heart failure, Crohn’s disease, hemophilia, immunological deficiencies, multiple sclerosis, and rheumatoid arthritis may be treated using specialised infusion therapy.
By far the most common kind of home infusion therapy is IV antibiotics, which are often administered for cellulitis, sepsis, and osteomyelitis; other common illnesses include urinary tract infections, pneumonia, and sinusitis.
Why are infusions administered at the patient’s residence?
Until the 1980s, patients undergoing infusion therapy were required to stay in a hospital facility during their treatment. Increased focus on cost conservation in health care, along with advancements in the clinical administration of the medication, necessitated the development of systems for administering infusion therapy in alternative locations. Inpatient treatment is prohibitively costly for persons seeking long-term rehabilitation and also inhibits the individual from resuming regular lifestyle and employment activities.
The advancements in technology that permitted safe and successful infusion therapy administration at home, the desire of patients to continue regular lives and job activities while recuperating from sickness, and the cost-effectiveness of home care are all critical. As a result, home infusion therapy has developed into a full medical treatment option that is far less expensive than inpatient care in a hospital or skilled nursing facility.
For a variety of illness states and treatments, home infusion has been shown to be a safe and effective alternative to inpatient therapy. Treatment at home or in an outpatient infusion suite environment is often preferable to inpatient care for many patients. Before commencing infusion treatment at home, a complete patient and house evaluation is undertaken to confirm that the patient is an acceptable candidate for home care.
What is a supplier of home infusion therapy?
A provider of infusion treatment is often a “closed-door,” state-licensed pharmacy that specializes in administering infusion therapies to patients in their homes or other alternative locations. Infusion treatment is always initiated by a prescription from a skilled physician who is also supervising the patient’s care.
A technical definition of a home infusion treatment pharmacy that is widely recognized on a national level is as follows:
Pharmacy-based, decentralized patient care organization with expertise in USP 797-compliant sterile drug compounding that cares for patients with acute or chronic conditions that require parenteral administration of drugs, biologics, and nutritional formulae via catheters and/or needles in the home and alternate sites. To maximize effectiveness and compliance, extensive professional pharmacy services, care coordination, infusion nurse services, supplies, and equipment are given.
Qualified infusion pharmacies must adhere to state board of pharmacy licensure and other regulatory criteria, as well as the accreditation standards needed by the majority of third-party payers. Additionally, home infusion pharmacies may offer expert treatments and services such as enteral nutrition therapy, inhalation therapy using nebulizers, and disease status and care monitoring.
Local, regional, and national pharmacy groups provide infusion treatment. Several are independently owned pharmacies. Others are associated with hospitals, home nursing agencies, conventional retail pharmacies, suppliers of respiratory treatment, or other health care providers.
What alternate-site care venues, in addition to the patient’s home, are suitable for infusion therapy?
When infusion treatment can be administered in other locations such as patients’ homes or ambulatory infusion clinics, patients may be able to reduce or eliminate hospital and nursing home visits.
Numerous home infusion therapy providers run a health care facility known as the home infusion therapy provider’s Ambulatory Infusion Suite, or AIS. The AIS is an environment in which clinical care is controlled and delivered according to physician instructions by registered nurses and pharmacists who are highly competent in infusion/specialty medication administration. Due to the cost-effectiveness of this treatment and its suitability for particular patient-therapy settings, there has been a noticeable increase in the number of new AIS facilities launching.
AISs are one of three different kinds of Ambulatory Infusion Centers (AICs):
The home infusion treatment provider’s ambulatory infusion suite (AIS).
Infusion clinic staffed by physicians.
Infusion clinic located inside a hospital.
What highly specialized services, supplies, and equipment must an infusion pharmacy have to assure excellent practices and outcomes?
Concerning the pharmaceuticals themselves, the infusion pharmacy ensures that infusion medications are:
In a sterile atmosphere, compounded.
Sufficient conditions are maintained to assure sterility and stability.
Administered precisely at the prescribed dosage and on the prescribed schedule.
Administered through the proper vascular access device (typically a long-term device) in the suitable anatomical region depending on the predicted length of treatment, the medication’s pH, osmolarity, and osmolality.
Administered with the use of a suitable medication delivery device.
Between doses, flush with the appropriate flushing solution.
Adverse reactions and treatment effectiveness are closely monitored.
Notably, infusion pharmacies offer a broad range of professional services—patient assessment and admission, education and training, care planning and coordination, care management by clinical infusion pharmacists, troubleshooting and treatment plan oversight, and much more—all of which are critical for achieving high-quality outcomes for patients receiving infusion therapy.
Additionally, infusion treatment requires specific equipment (infusion pumps and poles) and many administration supplies (such as IV sets, syringes, and more). Additionally, the infusion pharmacy distributes them to the patient and maintains the equipment as needed.
What professional services do infusion pharmacies provide?
Infusion pharmacy offer the following services to guarantee the safe and appropriate delivery of infusion drugs:
Comprehensive examination that takes into account the patient’s history, present physical and mental health, lab results, cognitive and psychosocial status, support from family/care partners, recommended therapy, concurrent oral prescriptions, and over-the-counter drugs.
Maintaining suitable processes for the formulation and delivery of sterile infusion products in accordance with applicable national standards, state and federal legislation, and industry guidelines.
Drug interaction monitoring includes detection of possible incompatibilities between drugs, doses, or drug catheters.
Comprehensive admission protocols that include teaching of patients on the proper use of medical and disposable equipment, medication storage and handling, emergency procedures, vascular access device management, and the detection and reporting of adverse drug reactions.
Comprehensive care planning that takes into account current or anticipated medication or equipment-related difficulties, treatment monitoring in conjunction with specified patient objectives, and coordination of activities with other providers such as home health agencies and doctors.
Continuous monitoring and review of patients to determine therapy response, medication complications, adverse reactions, and patient compliance.
Review of laboratory reports, if appropriate, and subsequent consultations with care specialists to change prescription orders as needed.
Maintaining adequate physical facilities for storing, preparing, dispensing, and monitoring the quality of all infusion drugs and equipment.
Employee education and competency validation initiatives are ongoing.
Performance improvement initiatives that involve the collecting of clinical outcomes and patient perception data, the tracking and analysis of these and other performance measurement data, and the investigation of the underlying causes of all sentinel events.
The majority of health insurance companies reimburse for these critical specialist treatments, as well as a variety of additional services, equipment, and supplies required for infusion therapy, on a per diem basis. The NHIA’s National Definition of Per Diem includes an exhaustive list of all items covered under per diem payments.
Who offers infusion nursing care and what specialties do these nurses possess?
Infusion nurses are supplied directly by the infusion pharmacy or by an associated or independent nursing agency, depending on local norms, regulations, and the availability of competent infusion nurses. Along with the infusion pharmacy personnel, infusion nurses are critical members of the patient’s infusion care team and collaborate closely with the infusion pharmacy on care plans and other activities. When infusion treatment is administered in the patient’s home, the infusion nurse is responsible for ensuring adequate patient education and training, as well as monitoring the patient’s care in the home.
Infusion nurses will have specialized education, training, and experience administering medicines and biologics by infusion at home or in other alternative locations. They generally offer evaluation and assessment, patient and caregiver education and training, aseptic home environment inspection and consultation, catheter placement, and patient assessment. Many caregivers or patients are effectively able to administer their infusion medications without the presence of the infusion nurse.
Are accredited home infusion pharmacies available?
While certification is optional, the majority of commercial insurers need certified infusion pharmacies to serve their customers. Accreditation of home infusion pharmacy is often granted by organizations such as:
The Commission Mixte (www.jointcommission.org)
Commission d’agrément des soins de santé (www.achc.org)
Program of Accreditation for Community Health (www.chapinc.org)
Accreditation by the Healthcare Quality Association (http://www.hqaa.org/).
(http://www.nabp.net/) is the website of the National Association of Boards of Pharmacy.
The Compliance Team (http://www.thecomplianceteam.org/) is a non-profit organization dedicated to promoting compliance.
What standards must authorized infusion pharmacies meet?
Home and alternate-site infusion treatment include much more than the administration of medications. To manage infusion medication therapy effectively, specialist knowledge, clinical and supporting services, and specialized facilities are required.
Most third-party payers require infusion therapy pharmacies to undergo a voluntary accreditation process to verify that they are in compliance with applicable state and federal regulations and professional standards of practice, as well as that they are providing clinical and supportive services in a manner that ensures patient safety and quality of care.
Do public and private insurance policies cover infusion treatment administered in the home or at other alternative locations?
Due to the variety of variables that must be managed by the infusion pharmacy to ensure safe and appropriate administration, nearly all commercial health plans now treat home infusion therapy as a medical service, reimbursed under their medical benefit (rather than their prescription drug benefit), and paid for clinical services, supplies, and equipment via a per diem, with separate payments for drugs and nursing visits. Additionally, it has prompted the majority of commercial plans to mandate certification of infusion pharmacies by nationally recognized accrediting bodies. Commercial plans have actively used this concept to drive down total health care costs while maintaining a high level of patient satisfaction.
Government health programs such as Medicaid, TRICARE, and the Federal Employees Health Benefits Program also cover home infusion treatment, however the level of coverage varies by state for Medicaid. Unfortunately, the Medicare program is a significant exception to the rule of coverage completeness.
Commercial insurers are rapidly recognizing the suitability of this infusion setting and its cost-competitiveness with other Ambulatory Infusion Center settings for infusion treatment offered in Ambulatory Infusion Suites. The extent to which Medicaid is covered varies by state. While Medicare’s prescription drug benefit (Part D) may pay the cost of infusion medications, it does not cover the cost of AIS services, supplies, equipment, or nursing. Prior to initiating treatment, the infusion therapy provider will verify patient coverage and advise on the level of coverage and patient responsibilities.
Is home infusion treatment covered by Medicare?
Regrettably, Medicare’s fee-for-service program (Parts A, B, and D) is the only major health plan in the US that has failed to realize the obvious advantages of appropriately covering infusion treatments provided in the patient’s home. Due to the fact that the majority of Medicare beneficiaries are enrolled in the fee-for-service model, when seniors and handicapped individuals discover they may need infusion treatment, it is sometimes pricey to obtain this care in the comfort of their own home. According to the NHIA, between 17 and 24 million Medicare patients lack access to a full home infusion program.
Home infusion treatment includes not just medicine delivery, but also expert services, specialized equipment, and supplies to guarantee the therapy is administered safely and effectively. While the majority of infusion medications are covered under the Medicare Part D prescription drug benefit, the Centers for Medicare & Medicaid Services (CMS) has concluded that it lacks the jurisdiction to cover infusion-related services, equipment, and supplies under Part D. As a consequence, many Medicare beneficiaries are essentially refused access to home infusion treatment and are forced to get it in hospitals or skilled nursing facilities, which is much more expensive for Medicare and causes major discomfort for patients. NHIA is now working on a vital piece of legislation to address this scenario.
Certain treatments provided using durable medical equipment are covered in part B of Medicare (a mechanical or electronic external infusion pump). Regrettably, only a limited number of treatments are covered, and only under extremely particular circumstances. These include certain anti-infectives, some chemotherapeutic agents, some inotropic agents (e.g., dobutamine), some pain medications, and subcutaneous immune globulin. Part B coverage is available for parenteral and enteral nutrition treatments only if the necessity for the therapy is shown to be for at least 90 days and other coverage conditions are satisfied. While intravenous immune globulin (IVIG) may be covered for individuals with primary immune insufficiency, supplies and equipment are not. Contact the Medicare entity known as Durable Medical Equipment Medicare Administrative Contractors for more particular information (DME MACs). All contractors must adhere to the coverage standards for home infusion as determined by a DME MAC.
Medicare Part A coverage under Medicare’s home health benefit is available for home nursing visits required for beneficiaries receiving infusion therapy only if the patients are served by a Medicare-certified home health agency and are considered to be homebound and in need of intermittent (not 24 hour) home nursing. NHIA’s Medicare legislative proposal aims to reduce this coverage gap as well.
Certain Medicare fee-for-service plan members may have additional insurance that will pay part of the expenses of home infusion therapy that Medicare does not cover. Medicare Advantage (Part C) enrolls a small percentage of the Medicare population. As is the case with the majority of commercial health plans, many Medicare Advantage plans include home infusion therapy because they know that it will help them lower total health care costs and improve patient satisfaction.
The majority of providers of home infusion treatment are knowledgeable with Medicare’s coverage specifics and will inform prospective patients of their individual coverage and expected out-of-pocket expenses if they choose to get home infusion therapy.
What is the market size of alternate-site infusion treatment in the United States?
The alternate-site infusion treatment industry continues to develop as a result of increased attention on cost-effectiveness and cost reduction, as well as the desire of patients to resume regular lives and job activities while recuperating from sickness. By 2020, the National Health Insurance Administration projects that home and specialized infusion would be a $19 billion business with over 900 providers servicing 3.2 million patients yearly.
However, home infusion therapy’s total contribution to the health care system is unquestionably considerably greater. Infusion therapy done in the home or other place of care is much less expensive than inpatient treatment.
Where can I get market research on the alternate-site infusion industry?
For a high-level overview of the industry’s size and breadth, as well as a detailed examination of how the
Consider buying Infusion Industry Trends, the most complete collection of industry information, to see how the home and specialized infusion industries have grown over the previous decade.
There is no reason to avoid doing your own local research. Utilization of home care and home infusion, as well as coverage regulations and reimbursement rates, vary significantly throughout the nation.
To make an educated choice about expanding into infusion treatment in a certain market or specialist area, it’s critical to analyze your present income base and historical revenue patterns, as well as your competitors and referral sources.