Home and specialty infusion is a vast arena of pharmaceutical services provided in the outpatient setting, typically in the patient’s home or an infusion suite. The majority of these medications involve administration through a needle or catheter, otherwise known as infusion, while others are administered via alternate routes of administration such as intramuscular, epidural, and self-injectable means. Infusion medications are prescribed for both acute and chronic illnesses that cannot be effectively treated with oral medications alone.
Most home and specialty infusion providers are considered closed door pharmacies that are licensed in one or multiple states. Providers are classified as single-site organizations, multiple-site organizations, or health system-affiliated organizations. Pharmacies are accredited by one of many accrediting organizations (AOs) including The Joint Commission, ACHC, URAC, and more.
Diseases commonly requiring home and specialty infusion therapy include infections, gastrointestinal diseases and disorders, dehydration, congestive heart failure, multiple sclerosis, rheumatoid arthritis, hemophilia, immune deficiencies, neurological disorders, and more. A recent NHIA study found that in 2019 home infusion and specialty providers cared for more than 3 million patients in the United States, representing a 300% increase since the last industry study in 2008.
Since the 1980s, this industry has seen tremendous growth despite challenges with a comprehensive benefit from Medicare. Administration of medications in the home or infusion suite has been shown to be a safe and cost-effective method of treating most patients with minimal intrusion on their everyday lives. In recent years, there has been a grassroots effort to work with lawmakers to improve patient access to home and specialty infusion pharmacy services in these sites of care. Commercial payors have recently instilled site of care policies moving high-cost infusions to the home setting and as a result are seeing tremendous savings.
Home infusion has been proven to be a safe and effective alternative to inpatient care for a variety of therapies and disease states, both acute and chronic. For many patients, receiving treatment at home or in an infusion suite is preferable to inpatient care. This industry is continuing to grow now and into the future as more therapies are approved and quality outcomes are seen for home infusion patients.
Infusion therapy involves the administration of medication through a needle or catheter. It is prescribed when a patient’s condition is so severe that it cannot be treated effectively by oral medications. Typically, “infusion therapy” means that a drug is administered intravenously, but the term also may refer to situations where drugs are provided through other non-oral routes, such as intramuscular injections and epidural routes (into the membranes surrounding the spinal cord). “Traditional” prescription drug therapies commonly administered via infusion include antibiotic, antifungal, antiviral, chemotherapy, hydration, pain management, and parenteral nutrition. Infusion therapy is also provided to patients for treating a wide assortment of often chronic and sometimes rare diseases for which “specialty” infusion medications are effective. While some have been available for many years, others are newer drugs and biologics. Examples include blood factors, corticosteroids, erythropoietin, infliximab, inotropic heart medications, growth hormones, immunoglobulin, natalizumab and many others.
Diseases commonly requiring infusion therapy include infections that are unresponsive to oral antibiotics, cancer and cancer-related pain, dehydration, gastrointestinal diseases or disorders which prevent normal functioning of the gastrointestinal system, and more. Other conditions treated with specialty infusion therapies may include cancers, congestive heart failure, Crohn’s Disease, hemophilia, immune deficiencies, multiple sclerosis, rheumatoid arthritis, and more.
By far, the majority of home infusion therapies are IV antibiotics, prescribed primarily for such diagnoses as cellulitis, sepsis, and osteomyelitis; other diagnoses include urinary tract infections, pneumonia, sinusitis and more.
Until the 1980s, patients receiving infusion therapy had to remain in the inpatient setting for the duration of their therapy. Heightened emphasis on cost-containment in health care, as well as developments in the clinical administration of the therapy, led to strategies to administer infusion therapy in alternate settings. For individuals requiring long-term therapy, inpatient care is not only tremendously expensive but also prevents the individual from resuming normal lifestyle and work activities.
The technological advances that enabled safe and effective administration of infusion therapies in the home, the desire of patients to resume normal lifestyles and work activities while recovering from illness, and the cost-effectiveness of home care are important. Consequently, home infusion therapy has evolved into a comprehensive medical therapy that is a much less costly alternative to inpatient treatment in a hospital or skilled nursing facility.
Home infusion has been proven to be a safe and effective alternative to inpatient care for many disease states and therapies. For many patients, receiving treatment at home or in an outpatient infusion suite setting is preferable to inpatient care. A thorough patient assessment and home assessment are performed before initiating infusion therapy at home to ensure that the patient is an appropriate candidate for home care.
An infusion therapy provider is most normally a “closed-door,” state-licensed pharmacy that specializes in provision of infusion therapies to patients in their homes or other alternate-sites. The infusion therapy always originates with a prescription order from a qualified physician who is overseeing the care of the patient.
A nationally accepted, technical definition of a home infusion therapy pharmacy is a:
Pharmacy-based, decentralized patient care organization with expertise in USP 797-compliant sterile drug compounding that provides care to patients with acute or chronic conditions generally pertaining to parenteral administration of drugs, biologics and nutritional formulae administered through catheters and/or needles in home and alternate sites. Extensive professional pharmacy services, care coordination, infusion nursing services, supplies and equipment are provided to optimize efficacy and compliance.
Qualified infusion pharmacies must satisfy licensing and other regulatory requirements imposed by state boards of pharmacy as well as accreditation standards required by most third-party payers. Home infusion pharmacies may also provide additional professional therapies and services, including enteral nutrition therapy, inhalation therapies using nebulizers, and disease state and care management services.
Pharmacy organizations providing infusion therapy include local, regional, and national organizations. Some are independent pharmacies. Others are affiliated with hospitals, home nursing agencies, traditional retail pharmacies, respiratory therapy suppliers, or other health care providers.
Patients may shorten or avoid stays in institutions such as hospitals and nursing homes when their infusion therapy can be provided in alternate-site settings including their homes and ambulatory infusion centers.
Many home infusion therapy providers operate a health care facility called the Ambulatory Infusion Suite of the home infusion therapy provider, or AIS. The AIS is a setting where the clinical care provided pursuant to physician orders is managed and performed by registered nurses and pharmacists that are highly skilled in provision of infusion/specialty drug administration. Due to the cost-effectiveness of this care and its appropriateness for use with certain patient-therapy situations, there is significant growth in openings of new AIS facilities.
The AIS is one of three types of Ambulatory Infusion Centers (AICs):
Pertaining directly to the medications used, the infusion pharmacy ensures that infusion drugs are:
No less important, infusion pharmacies provide an extensive array of professional services—patient assessment and admission, education and training, care planning and coordination, care management by clinical infusion pharmacists, trouble-shooting and treatment plan oversight, and much more—all essential to achieving high-quality outcomes for patients receiving infusion therapy.
Also essential are the specialized equipment (infusion pumps and poles) and many administration supplies (such as IV sets, syringes, and more) required for infusion therapy. The infusion pharmacy also supplies these to the patient and services the equipment when necessary.
To ensure safe and proper administration of infusion drugs, infusion pharmacies provide the following services:
These essential specialized services listed above, as well as many other services, equipment and supplies needed for infusion therapy, are paid for by the majority of health insurance plans under a per diem payment system. The NHIA National Definition of Per Diem provides a complete list of everything included in per diem payment.
Depending on local practices, regulation and availability of skilled infusion nurses, infusion nurses are provided directly by the infusion pharmacy or by an affiliated or separate nursing agency. Along with the infusion pharmacy staff, infusion nurses are key members of the patient’s infusion care team and work closely in coordination of care plans and other activities with the infusion pharmacy. When infusion therapy is provided in a patient’s home, the infusion nurse will ensure proper patient education and training and monitor the care of the patient in the home.
Infusion nurses will have special education, training, and expertise in home or other alternate-site administration of drugs and biologics via infusion. Services they typically provide include evaluation and assessment, education and training for the patient or caregiver, inspection and consultation of aseptic home environment, catheter insertion, and patient assessment. Using the education and training provided, many caregivers or patients are successfully able to administer their infusion therapies without the infusion nurse normally being present in the home.
While accreditation is voluntary, most commercial insurers require infusion pharmacies to be accredited to serve their patients. Home infusion pharmacies are often accredited by organizations such as:
Home and alternate-site infusion therapy is much more than just the dispensing of drugs. Managing infusion drug therapies requires specialized expertise, clinical and supportive services, and specialized facilities.
Most third-party payers require infusion therapy pharmacies to undergo a process of voluntary accreditation as a means of validating the organization’s compliance with state and federal regulations and professional standards of practice, and that it is providing clinical and supportive services in a manner designed to ensure patient safety and quality of care.
The range of variables that must be managed by the infusion pharmacy to ensure safe and appropriate administration has led nearly all commercial health plans to treat home infusion therapy as a medical service, reimbursed under their medical benefit (rather than the prescription drug benefit) and paid for using a per diem for clinical services, supplies, and equipment with separate payments for the drugs and nursing visits. It also has led most commercial plans to require that infusion pharmacies be accredited by nationally recognized accreditation organizations. Commercial plans have used this model aggressively to reduce overall health care costs while achieving high levels of patient satisfaction.
Government health plans such as Medicaid, TRICARE, and the Federal Employees Health Benefits Program also reimburse for home infusion therapy, although for Medicaid in a few states the extent of coverage can have gaps. A major exception in completeness of coverage is, unfortunately, the Medicare program.
For infusion therapy provided in Ambulatory Infusion Suites, commercial insurers are fast recognizing the appropriateness of this infusion setting and its cost-competitiveness with other Ambulatory Infusion Center settings. Medicaid coverage varies by state. Medicare’s prescription drug plan (Part D) may cover the cost of the infusion drugs, but the costs of AIS services, supplies, equipment and nursing are not covered. The infusion therapy provider will ascertain coverage for patients and advise on the extent of coverage and patient obligations prior to start of service.
Unfortunately, Medicare’s fee-for-service program (Parts A, B and D) is the only major health plan in the country that has not recognized the clear benefits of adequately covering provision of infusion therapies in a patient’s home. Because most Medicare beneficiaries are enrolled in the fee-for-service program, when seniors and the disabled find they may need infusion therapy they often find it unaffordable to receive this care in the comfort of their home. NHIA estimates that 17-24 million Medicare beneficiaries do not have access to a comprehensive home infusion benefit.
Providing home infusion therapy involves not only the delivery of medication, but also requires professional services, specialized equipment and supplies to ensure safe and effective administration of the therapy. While most infusion drugs may be covered by the Medicare Part D prescription drug benefit, the Centers for Medicare & Medicaid Services (CMS) has determined that it does not have the authority to cover the infusion-related services, equipment and supplies under Part D. As a result, many Medicare beneficiaries are effectively denied access to home infusion therapy and are being forced into receiving infusion therapy in hospitals and skilled nursing facilities at a significantly higher cost to Medicare and at great inconvenience to the patients. NHIA is underway with a critical legislation initiative to rectify this situation.
In Medicare Part B, there is some coverage for certain therapies administered using durable medical equipment (a mechanical or electronic external infusion pump). Unfortunately, only a select few therapies are covered and only under very specific conditions. These include some anti-infective, some chemotherapy drug, some inotropic therapies (e.g., dobutamine), some pain management, immune globulin administered subcutaneously, and a few other therapies. For parenteral and enteral nutrition therapies, there can be coverage in Part B only if the need for the therapy is documented to be for at least 90 days and other coverage criteria are met. There may be coverage for intravenous immune globulin (IVIG) for primary immune deficiency patients but the supplies and equipment are not paid for. More specific information can be obtained by contacting the Medicare entities called Durable Medical Equipment Medicare Administrative Contractors (DME MACs). The coverage criteria for home infusion that all contractors follow are found from a DME MAC.
For home nursing visits needed for beneficiaries receiving infusion therapy, there can be Medicare Part A coverage under Medicare’s home health benefit only if the patients are serviced by a Medicare-certified home health agency, as well as considered to be homebound and in need of intermittent (not 24 hour) home nursing. NHIA’s Medicare legislation initiative is intended to broaden this gap in coverage too.
Some Medicare fee-for-service plan patients may have other insurance that will pick up some of the home infusion costs not covered by Medicare. A minority of the Medicare population is enrolled in the Medicare Advantage (Part C) program. Similar to most commercial health plans, many Medicare Advantage health plans cover home infusion because they recognize it will reduce their overall health care costs and achieve high levels of patient satisfaction.
Most home infusion therapy providers are familiar with Medicare’s coverage details and will advise prospective patients of their specific coverage and anticipated out-of-pocket obligations should they undertake home infusion therapy.
Driven by heightened emphasis on cost-effectiveness and cost-containment, and the desire of patients to resume normal lifestyles and work activities while recovering from illness, the alternate-site infusion therapy sector continues to expand. In 2020, NHIA estimates that home and specialty infusion is a $19 billion industry made up of over 900 providers serving 3.2 million patients annually.
However, the overall contribution of home infusion therapy to the health care system is certainly much more significant. The cost of infusion therapy administered in the home or alternate-site care setting is far less than the cost of inpatient treatment.
For an overview of the industry’s size and scope as well as an in-depth analysis of how the
home and specialty infusion industry has evolved over the last decade, consider purchasing Infusion Industry Trends, the most comprehensive set of insights about the industry.
There’s no excuse for not doing your own local research. Utilization of home care and home infusion, coverage policies, and reimbursement rates vary tremendously from one region of the country to the next.
To make an informed decision regarding expanding into infusion therapy in a given market or expanding into a new infusion therapy specialty area, it’s important to understand your current revenue base and historic revenue trends, your competition, and your referral sources.
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