What is infusion therapy

Infusion therapy involves medicines and fluids given through a needle or catheter into your bloodstream. Infusion therapy commonly used include antibiotics, antifungal, antiviral, chemotherapy drugs, pain medicines, hydration 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.

Infusion therapy 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). Every person’s condition is different; it is not easy to say what infusion treatment means to you. Always follow your home healthcare provider’s directions. Always call your home healthcare provider if you have questions.

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—called a home infusion therapy pharmacy. The infusion therapy always originates with a prescription order from a qualified physician who is overseeing the care of the patient.

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.

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.

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. Many home infusion therapy providers operate one or more ambulatory infusion suites which are ideally suited for certain patient-therapy situations.

What diseases are treated with infusion therapy?

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 major 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.

What is specialty infusion therapy?

“Specialty infusion therapy” is a term in use when “specialty” infusion medications are administered. However, it also is used to reflect the highly specialized services and level of care that an infusion pharmacy provides to its infusion therapy patients. While there are some infusion pharmacy organizations that focus on providing a limited set of specialty infusion therapies, others provide the wide spectrum of traditional and specialty infusion therapies. The distinction, if any, between the meaning of “specialty infusion therapy” and “infusion therapy” is related to the context of their use.

What is a home infusion therapy provider?

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 pharmacy boards 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.

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:

• The Joint Commission (https://www.jointcommission.org/)
• Accreditation Commission for Health Care (https://www.achc.org/)
• Community Health Accreditation Program (https://chapinc.org/)
• Healthcare Quality Association on Accreditation (https://info.hqaa.org/home)
• National Association of Boards of Pharmacy (https://nabp.pharmacy/)
• The Compliance Team (https://thecomplianceteam.org/)

What alternate-site care settings are appropriate for infusion therapy in addition a patient’s home?

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 Ambulatory Infusion Suite is a setting where the clinical care provided pursuant to physician orders is managed and performed by RNs and registered 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 Ambulatory Infusion Suite facilities.

The Ambulatory Infusion Suite is one of three types of Ambulatory Infusion Centers (AICs):

• Ambulatory Infusion Suite of the home infusion therapy provider (AIS).
• Physician-based infusion clinic.
• Hospital-based infusion clinic.

What are the highly specialized services, supplies and equipment obtained from an infusion pharmacy that are necessary to ensure quality practices and outcomes?

Pertaining directly to the medications used, the infusion pharmacy ensures that infusion drugs are:

• Compounded in a sterile environment.
• Maintained in appropriate conditions to ensure sterility and stability.
• Administered at exactly the right dose and on the right schedule.
• Administered using the appropriate vascular access device (often a long-term device) which is placed in the correct anatomical location based on the expected duration of therapy, the pH, osmolarity, and osmolality of the medication.
• Administered using an appropriate drug delivery device.
• Flushed with the proper flushing solution between doses.
• Monitored for adverse reactions and therapeutic efficacy.

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.

What is the extensive array of professional services performed by infusion pharmacies?

To ensure safe and proper administration of infusion drugs, infusion pharmacies provide the following services:

• Comprehensive assessment that considers patient history, current physical and mental status, lab reports, cognitive and psychosocial status, family/care partner support, prescribed treatment, concurrent oral prescriptions, and over-the-counter medications.
• Maintenance of appropriate procedures for the compounding and distribution of sterile infusion products as outlined in the national standards and state and federal regulations.
• Drug interaction monitoring and identification of potential drug, dose or drug catheter incompatibilities.
• Comprehensive admission procedures that include patient education of medical and disposable equipment use, medication storage and handling, emergency procedures, vascular access device management, recognition and reporting of adverse drug reactions.
• Comprehensive care planning that considers actual or potential drug or equipment-related problems, therapy monitoring with specific patient goals, and coordination of activities with other providers such as home health agencies and physicians.
• Ongoing patient monitoring and reassessment activities to continually assess for response to treatment, drug complications, adverse reactions, and patient compliance.
• Laboratory report reviews, as applicable, and subsequent consults with care professionals to adjust medication orders if necessary.
• Maintenance of appropriate physical facilities for storage, preparation, dispensing, and quality control of all infusion medications and equipment.
• Ongoing employee education and competence validation activities.
• Performance improvement programs that include collection of clinical outcomes data, patient perception data, trending and analysis of these and other performance measurement data, and root cause evaluations of all sentinel events.

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 term “per diem” represents each day that a given patient is provided access to a prescribed therapy, beginning with the day the therapy is initiated and ending with the day the therapy is permanently discontinued. The term “permanently” shall not be construed to infer that a therapy shall never again be initiated, but rather that continuation of the therapy is simply not predicted or anticipated at the time of cessation. The expected course and duration of the treatment shall be determined by the plan of care as prescribed by the ordering physician.

It shall not be necessary for the patient to receive an actual drug infusion each and every day in order to be considered covered under an existing per diem, so long as additional infusions are anticipated in the near future as prescribed in the physician plan of care. The fact that the health care provider anticipates continued responsibility for the patient and incurs costs related to such responsibilities, remains accountable for the provision of such anticipated care, and is responsible for the acquisition and allocation of resources that will be necessary to meet these obligations, shall deem the existing per diem to be current, valid, and in force.

This definition is valid for per diem therapies of duration of up to and including every 72 hours. Therapies provided beyond this range (weekly, monthly, etc.) fall outside of the per diem structure, and should have separate reimbursement rates that are specified on a contractual or other basis.

Who provides the infusion nursing and what specializations do such nurses have?

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.

Do government and private insurance plans cover infusion therapy in the home and other alternate-sites?

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 Ambulatory Infusion Suite 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.

Does Medicare cover home infusion therapy?

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.

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.

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.

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.

What you need to do before using your infusion pump

• Read your infusion pump’s Instructions manual for Use and keep it handy.
  • Make sure you understand when to use the infusion pump.
  • Know what the infusion pump display screen should say while you are using it.
  • Understand the alarms and error messages.
  • Ask for a hands-on demonstration from your home healthcare provider (doctor, nurse or pharmacist) and invite your family to observe and practice with you.
• Ask questions and take notes.
  • Review your home healthcare provider’s guidelines for your pump.
  • Make sure you fully understand how to use your pump before beginning therapy.
• Call your home healthcare provider whenever you have questions or problems.

What is your role in maintaining your infusion pump?

• Always place the infusion pump and supplies on a clean surface.
• Keep food and drinks away from the area around your pump.
• Monitor children and animals when in the pump area.
• Before touching the pump
  • wash your hands thoroughly for 15 seconds
  • use liquid soap (not bar soap) and rinse
  • dry with a clean paper towel
• Change tubing according to your pump’s Instructions for Use.
• Change batteries or recharge your pump as directed by your home healthcare provider.
• Compare your doctor’s orders with your take-home instructions.
• Radio transmitters (such as cell phones, wireless hand-held computers, two-way radios) and other sources of strong electric and magnetic interference, such as large electric motors, could affect your pump.
  • Pump users, caregivers, and others should use caution and keep electromagnetic sources away from the pump.
  • Consult your pump manufacturer for more information and recommendations, if needed.

What is the role of your home healthcare provider and supplier in your infusion therapy?

Your home healthcare provider will:

• assess your health status
• discuss allergies and possible reactions
• check for correct prescription therapy (drug container label matches prescription)
• check all expiration dates before using medicine
• discuss proper storage of medicine
• teach self-care and provide directions for example, how to care for your pump and test it for accuracy
• discuss the proper use of needles and safe disposal in a sharps container (thick plastic, leak-proof, capped container).
• place all other used infusion items in leak-proof containers and safely discard.
• assure that your pump is programmed to deliver the correct dose of medicine
• supply emergency contact phone numbers (24 hours a day)

Your infusion pump supplier will:

• handle all pump repairs
• supply batteries, equipment and accessories
• schedule routine maintenance

What are the most common problems with an infusion pump and how do you manage them?

Over- or under-infusion – where infusion pump does not deliver the correct dose at the proper rate:

• Check tubing for leaks, kinks, twists and disconnects.
• Check for visible particles in the solution, tubing and filter area that might block the flow.
• Monitor pump to assure it is pumping.
• Check clamps to make sure they are open.
• Note infusion begin and end time to help monitor your pump’s accuracy.
• Change tubing according to instructions.

Wrong programming

• Check pump screen to be sure programmed rates and dosages match your medicine’s label.

Wrong prescription

• Call your home healthcare provider immediately if you think your medicine’s label is not correct.

Batteries

• In some cases, batteries should be used for back-up only.
• When you have to use batteries
  • change batteries according to your home healthcare provider’s directions.
  • an alarm will occur when the batteries are low
  • keep an extra supply of new batteries with you at all times
  • ask your suppliers about the life of your batteries

What do you need to know about traveling with your infusion pump?

• Before going out of town, contact the Transportation Security Administration (TSA) Consumer Response Center toll-free at 1-866-289-9673 or go to http://www.tsa.gov with questions about traveling with your pump.
  • Ask your supplier about additional needs when traveling.
  • Before going through a security screening station, inform the staff that you have an infusion pump and ask to be searched manually.
  • Going through the screening process may set off your pump’s alarm.
  • Security screening systems may cause your pump not to work properly.
  • After going through security, check the status of your pump.
  • For travel to another country, make sure your pump will work with that country’s power system. If it does not, you will need an adapter for the power source (voltage and frequency) and for the plug so that your pump will work.
• When traveling locally, pass through anti-theft systems and security systems (found in stores and in public places), quickly without stopping or touching the system.

Caregiver tips for children on infusion therapy

Your role as a caregiver:

• Explain the reasons for using the pump and infusion therapy.
  • Use language your child will understand.
  • Encourage your child to ask questions.
  • Be honest and try to use positive words and pictures.
• Show your child how he or she can help.
  • Allow children to help with their own care.
  • For a small child, try play-acting with a doll.
• Check on your child as often as your home healthcare provider recommends.
  • A younger child may need to be checked more often than an older child.
• Report any change in your child’s physical or mental condition to your home healthcare provider.
• Encourage children to play in a manner that is safe while they are receiving therapy.
• If you have any concerns, speak with your home healthcare provider.