(Medicare Benefit Policy Manual)

The qualified home infusion therapy supplier must ensure that all patients are under the care of an applicable provider and have a physician -established plan of care that meets all of the following requirements:   A. Plan of Care Content -  The plan of care must prescribe the type, amount, and duration of the home infusion therapy services that are to be furnished.  The plan of care would also include the specific medication, the prescribed dosage and frequency as well as the professional services to be utilized for treatment.   B. Physician's Orders -  The physician's orders for services in the plan of care must specify at what frequency the services will be furnished, as well as the discipline that will furnish the ordered professional services. Orders for care may indicate a specif ic range in frequency of visits to ensure that the most appropriate level of services is furnished. The plan of care would specify the care and services necessary to meet the patient specific needs   C. Physicians Signature -  The plan of care must be signed and dated by the ordering physician prior to submitting a claim for payment. The ordering physician must sign and date the plan of care upon any changes to the plan of care.    D. Periodic Review -  The plan of care for each patient must be periodically reviewed by the physician. The expectation is that the physician is active in the patients care and can make appropriate decisions related to the course of therapy if changes are necessary in regards to the progress and goals of the patients infusion therapy.   320.5.1 - Notification of Available Infusion Therapy Options  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Section 1834(u)(6) of the Act requires that prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan of care shall provide notification of the options available (such as home, physicians office, hospital outpatient department) for the furnishing of infusion therapy.  Physicians are expected to routinely discuss these infusion therapy options with their patients and annotate these discussions in their patients medical records  prior to establishing a home infusion therapy plan of care.   320.5.2 - Plan of Care Periodic Review and Provider Coordination  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Depending on patient acuity or the complexity of the drug administration, certain infusions may require more training and education, especially those that require special handling or pre -or post -infusion protocols.  The home infusion process typically requires coordination among multiple entities, including patients, physicians, hospital discharge planners, health plans, home infusion pharmacies, and, if applicable, home health agencies.   For payment purposes, all services billed to Medicare by the qualified home infusion therapy supplier must be reflected in the plan of care, which is required to be established and reviewed by the physician.  Section 1861(iii)(1)(B) of the Act requires tha t the plan of care be established and periodically reviewed by a physician in coordination with the furnishing of home infusion drugs.  This means that the plan of care must be established and reviewed by a physician in consultation with the suppliers responsible for furnishing the home infusion drug and related services.  The statute does not specify that the home infusion plan of care must be established by the same physician who orders the DME and infusion drugs and signs the detailed written order.  It is expected that in most cases the physician ordering the home infus ion therapy services is the same physician ordering the DME and the infusion drug, however, this may not always be the case.  Furthermore, if a hospital -based physician initially orders t he infusion drug and/or the home infusion therapy services for a patient, they will likely not continue to follow the patient after discharge; however, in order for the patient to continue to receive home infusion therapy services, that patient must be under a physician -established plan of care that is reviewed periodically.  Any updates to this plan of care would not likely be made by the hospital -based physician, rather by whichever physician that takes over the patients care after hospital discharge.  In this case, a physician serving as the applicable provider as described in section 320.4 could also be the ordering physician as mentioned in section 320.5.  Regardless of whether the physician ordering the home infusion drug is the same physician ordering and updating the home infusion therapy services, there must be care coordination among all entities in order to meet the plan of care requirements.   The physician establishing the plan of care is required to consult with the DME supplier and the home infusion therapy supplier.  In order to ensure that home infusion therapy is safe and effective and stays current throughout the course of treatment, the phys ician who orders the home infusion therapy services must review the plan of care on a regular basis in coordination with the DME supplier.  The DME supplier is also required to consult with the physician prescribing the infusion drug as needed to confi rm the drug order and any necessary changes, refinements, or additional evaluation to the prescribed equipment item(s), and/or service(s).    The plan of care plays an integral part in care coordination between providers, particularly when the physician ordering the home infusion drug is not the same physician establishing the home infusion therapy services plan of care.  Coordination between th e physician ordering the home infusion drug, the physician establishing the plan of care for the home infusion therapy services, and the DME supplier furnishing the home infusion drug is imperative in providing safe and effective home infusion therapy. Coordination would likely include review of the patient assessment and evaluation, including interpretation of lab results as they pertain to changes in medication type, dose, or frequency.  A current home infusion therapy services plan of care is essential i n order to ensure that the qualified home infusion therapy supplier is providing the appropriate professional services, including patient monitoring, to ensure that medication administration is safe and effective.   As coordination is required between the DME supplier responsible for furnishing the infusion drug, and both the physician establishing the home infusion therapy services plan of care and the prescriber of the home infusion drug, all entities are expected to be involved in this care coordination process.   320.6 - Professional Services, Including Nursing Services, for Home Infusion Therapy  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  In order to ensure that patients have access to expert clinical knowledge and advice to safely and effectively manage all aspects of treatment, especially in the event of an urgent or emergent infusion- related situation, the qualified home infusion therapy supplier must provide the following services on a 7- day-a-week, 24- hour-a-day basis, in accordance with the plan of care:   A. Professional services, including nursing services.   B. Patient training and education not otherwise paid for as durable medical equipment as described in 42 CFR 424.57(c)(12).   C. Remote monitoring and monitoring services for the provision of home infusion therapy services and home infusion drugs.  D. All home infusion therapy suppliers must provide home infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable state and federal laws and regulations. This could include the applicable provisions in the Federal Food, Drug, and Cosmetic Act.  Professional services, including nursing services, are skilled services which may be necessary for an individual patient or particular therapy or course of treatment, as determined by the physician responsible for the plan of care.  The skilled services provided on an infusion drug administration calendar day must be so inherently complex that they can only be safely and effectively performed by, or under the supervision of, professional or technical personnel.  Additionally, the skilled professional must only furnish services within the scope of his/her practice.    No payment may be made under Medicare Part A or Part B for any expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.  The services provided under the home infusion therapy services benefit are distinct from those required and paid under the DME benefit and may include, but are not limited to, the following:   - Training and education on care and maintenance of vascular access devices:  o Hygiene education  o Instruction on what to do in the event of a dislodgement or occlusion  o Education on signs and symptoms of infection  o Teaching and training on flushing and locking the catheter  - Dressing changes and site care  - Patient assessment and evaluation:  o Review history and assess current physical and mental status, including obtaining vital signs  o Assess any adverse effects or infusion complications  o Evaluate family and caregiver support  o Review prescribed treatment and any concurrent oral and/or over -the-counter treatments  o Obtain blood for lab- work  - Medication and disease management education:  o Instruction on self -monitoring  o Education on lifestyle and nutritional modifications  o Education regarding drug mechanism of action, side effects, interactions with other medications, adverse and infusion- related reactions  o Education regarding therapy goals and progress  o Instruction on administering pre -medications and inspection of medication prior to use  o Education regarding household and contact precautions and/or spills  - Remote monitoring services  - Monitoring services:  o Communicate with patient regarding changes in condition and treatment plan  o Monitor patient response to therapy  o Assess compliance   Some of these services are further described in sections 320.6.1 and 320.6.2 of this chapter.  320.6.1 - Home Infusion Therapy Services Training and Education  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Consistent with section 1861(iii)(2)(B) of the Act, qualified home infusion suppliers are required to provide patient training and education, not otherwise paid for as durable medical equipment, and as described in 42 CFR 424.57(c)(12).  In addition, the patient training and education requirements are consistent with standards that are already in place, as established by the current accrediting organizations of home infusion therapy suppliers.  This is a best practice, as home infusion therapy may entail the use of equipment and supplies with which patients may not be comfortable or familiar.   Hygiene Training and Maintenance of Vascular Access Devices   Many beneficiaries receiving home infusion therapy may have a unique need for a central vascular access device (CVAD) that requires training and education regarding maintenance and hygiene. This may include education regarding properly disinfecting access points and connectors, dressing changes, and recommended actions in the event of a dislodgement, occlusion, and signs of infection. This also includes teaching the patient about flushing the CVAD after the infusion to ensure all of the medication has been flushed through the tubing and catheter, and locking the catheter to prevent blood from backing into the catheter and clotting.  Education regarding specific techniques and solutions (saline or heparin) may also be given to minimize catheter occlusion.  Medication and Disease Management   The qualified home infusion therapy supplier is responsible for ensuring the patient has been properly educated about his/her disease, medication therapy, and lifestyle changes. This could include self -monitoring instruction (nutrition, temperature, blood pressure, heart rate, daily weight, abdominal girth measurement, edema, urine output) and identification of complications or problems necessitating a patient call to the designated infusion clinician (nurse, pharmacist, or physician), or emergency protocol s if they arise. The qualified home infusion therapy supplier should ensure the patients proper understanding of the medication therapy including: drug, route of administration, prescription (dosage, how often to administer, and duration of therapy), side  effects and interactions with other medications, adverse reactions to therapy, goals of therapy and indications of progress. Lifestyle education regarding behavior and food/fluid modifications/restrictions, symptom management, and infection control are al so important aspects of patient education.   While the durable medical equipment supplier is responsible for training the patient and caregiver on the infusion pump operation, maintenance, and troubleshooting, the qualified home infusion therapy supplier would be responsible for all other aspects of medication administration. These services may include inspection of medications, containers, and supplies prior to use; proper drug storage and disposal; hand hygiene and aseptic technique; education on pre/post medication/hydration administration; and training on medication preparation. Household precautions for chemotherapy drugs including spills, handling body wastes, and physical contact precautions must also be addressed.   Patient Assessment and Evaluation   Comprehensive patient assessment is imperative when providing home infusion therapy. The home infusion therapy supplier may evaluate patient history, current physical and mental status, lab reports, cognitive and psychosocial status, family/care -partner su pport, prescribed treatment, concurrent oral prescriptions, and over -the-counter medications.  For patients receiving potentially life -long, continuous intravenous infusion therapy, home infusion therapy suppliers can provide extensive support and education and address necessary lifestyle changes and realistic expectations of life with an ambulatory pump.   320.6.2 - Remote Monitoring and Monitoring Services  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Qualified home infusion therapy suppliers are required to ensure the safe and effective provision and administration of home infusion therapy on a 7- day-a-week, 24 -hour-a-day basis.  Monitoring the patient receiving infusion therapy in their home is an important standard of practice that is an integral part of providing medical care to patients in their home.  The expectation is that home infusion therapy suppliers would provide ongoing patient monitoring and continual reassessment of the patient to evaluat e response to treatment, drug complications, adverse reactions, and patient compliance.