evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.    The plan of care would indicate the need for routine monitoring and specify the interval for evaluation and documentation of patient -reported response to therapy, any adverse effects or infusion complications, verify pump rate, obtain blood work, and obtai n any necessary vital signs.  Direct communication and coordination with the patient, caregivers, and clinicians regarding any change in the patients condition is on- going so that any adjustment to treatment is made as needed and in a timely fashion. This  can be done remotely or directly during in- home patient visits at specified intervals.
(Medicare Benefit Policy Manual)
Remote monitoring may be performed through telephone or other electronic communication, based on the plan of care and the patients preference of communication.  Remote monitoring may include the use of a telecommunications system through which patients ar e monitored by electronic submission of self -obtained vital signs, such as weight, blood pressure, and heart rate.  The patient must be instructed on obtaining vital signs and on self -monitoring equipment use.  An off -site monitoring service may also be utilized to communicate any abnormal results to the clinician for adjustments to the plan of care as needed.   Qualified home infusion therapy suppliers may use all available remote monitoring methods that are safe and appropriate for their patients and clinicians and as specified in the plan of care as long as adequate security and privacy protections are utilized.     320.7 - Home Infusion Therapy Drugs (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Home infusion drugs are defined as parenteral drugs and biologicals administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of DME covered under the Medicare Part B DME benefit, pursuant to and the regulatory definition set out at 42 CFR 486 Subpart I and the statutory definition set out in section 1861(iii)(3)(C) of the Act, and incorporated by cross reference at section 1834(u)(7)(A)(iii) of the Act.    Section 1861(iii)(3)(C) of the Act also states that such term home infusion drugs  does not include insulin pump systems or self -administered drugs or biologicals on a self -administered drug exclusion list.  See section 50.2 of this chapter for instructions regarding the determination of self -administered drugs or biologicals.  See the Medicare Claims Processing Manual, Chapter 32, Section 411 for a list of drugs and biologicals that meet the criteria of a home infusion drug.  It is important to note that this list is not static.
(Medicare Benefit Policy Manual)
See the Medicare Claims Processing Manual, Chapter 32, Section 411 for a list of drugs and biologicals that meet the criteria of a home infusion drug.  It is important to note that this list is not static.   The home infusion drugs identified for coverage of home infusion therapy services are paid under the DME benefit. The related pharmacy services, furnished by a Medicare enrolled DMEPOS supplier, including the preparation and dispensing of home infusion drugs, are also paid under the DME benefit and are not part of this specific home infusion therapy services benefit.   320.7.1  - Determining Qualifying Home Infusion Drugs  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  In general, Medicare Part B covers a limited number of home infusion drugs through the DME benefit if:  1. the drug is necessary for the effective use of an infusion pump classified as DME and determined to be reasonable and necessary for administration of the drug; and  2. the drug being used with the pump is itself reasonable and necessary for the treatment of an illness or injury.   Specifically, under this home infusion therapy services benefit, a home infusion drug must require infusion through an external infusion pump that is covered under the DME benefit.  If the drug or biological can be infused through a disposable pump or by a  gravity drip, it does not meet this criterion.
(Medicare Benefit Policy Manual)
Only certain types of infusion pumps are covered under the DME benefit. The Medicare National Coverage Determinations Manual, Publication 100- 03, Chapter 1, Section 280.1 describes the types of infusion pumps that are covered under the DME benefit.  The DM E MACs then specify the details of which infusion drugs are covered with these pumps.   The drugs and biologicals identified in the DME Local Coverage Determination (LCD) for External Infusion Pumps (L33794) qualify as home infusion drugs as long as they are infused intravenously or subcutaneously over a period of 15 minutes or more, are not classified as insulin for insulin pump use, and are not on a self -administered drug exclusion list.  These drugs continue to be paid for under the DME benefit as supply drugs to the covered infusion pump.  Any additional training and education services needed for the patient to administer these drugs at home would be covered under this home infusion therapy services benefit.  There are other infusion drugs covered under Part B that could potentially be added to the DME LCD for External Infusion Pumps (L33794) and thus qualify for services under the home infusion therapy services benefit.  Allowing the DME MACs to maintain the l ist of infusion drugs and biologicals ensures quarterly review of any and all medications that meet the criteria for external infusion pumps, thus ensuring an up to date, inclusive benefit.   320.8 - Payment for Home Infusion Therapy Services                             (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  A unit of single payment is made for items and services furnished by a qualified home infusion therapy supplier per payment category for each infusion drug administration calendar day.  The single payment amount represents payment in full for all costs associated with the furnishing of home i nfusion therapy services.   320.8.1 - Home Infusion Drug Payment Categories  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Payment for home infusion therapy services is contingent upon a corresponding home infusion drug being covered and paid for under the DME benefit.  Therefore, home infusion therapy suppliers must ensure that the appropriate drug is billed by the DME suppli er no more than 30 days prior to the home infusion therapy service visit.
(Medicare Benefit Policy Manual)
Home infusion drugs are assigned to three payment categories, as determined by the HCPCS J -code:   - Payment category 1 includes certain intravenous infusion drugs for therapy, prophylaxis, or diagnosis, such as antifungals and antivirals, inotropic and pulmonary hypertension drugs, pain management drugs, chelation drugs; but excludes chemotherapy and other highly complex drugs or biologicals.  - Payment category 2 includes subcutaneous infusions for therapy or prophylaxis, such as certain subcutaneous immunotherapy infusions.   - Payment category 3 includes intravenous chemotherapy infusions, including certain chemotherapy drugs, and other highly complex drugs and biologicals.   Specific billing codes are associated with each of the three payment categories in order for qualified home infusion therapy suppliers to bill Medicare for home infusion therapy services on an infusion drug administration calendar day.    A unit of single payment is made for items and services furnished by a qualified home infusion therapy supplier per payment category for each infusion drug administration calendar day.   The J -codes for eligible home infusion drugs, the G -codes for the home infusion therapy services, and billing instructions for home infusion therapy payments are found in the Medicare Claims Processing Manual Chapter 32, Section 411.   320.8.2 - Infusion Drug Administration Calendar Day and Unit of Single Payment  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)
(Medicare Benefit Policy Manual)
320.8.2 - Infusion Drug Administration Calendar Day and Unit of Single Payment  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Section 1834(u)(7)(E)(i) of the Act states that payment to a qualified home infusion therapy supplier for an infusion drug administration calendar day in the individuals home refers to payment only for the date on which professional services, as described in section 1861(iii)(2)(A) of the Act, were furnished to administer such drugs to such individual. This means the day on which home infusion therapy services are furnished by a skilled professional in the individual's home on the day of infusion drug administration.  This includes all such drugs administered to such individual on such day.    A single payment amount for an infusion drug administration calendar day means that all home infusion therapy services, which include professional services, including nursing; training and education; remote monitoring; and monitoring, are built into the day on which the services are furnished in the home and the drug is being administered. There may be professional services furnished in the patients home that do not occur on a day the drug is being administered, however, the home infusion therapy service s payment is a unit of single payment.  In other words, payment for an infusion drug administration calendar day is a bundled payment amount per visit in the patients home furnishing services specifically related to the physical process by which the drug enters the patients body. The home infusion therapy payment rates reflect the increased complexity of the skilled professional services provided per payment category.  The skilled services provided on such 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.   A unit of single payment is made for items and services furnished by a qualified home infusion therapy supplier per payment category for each infusion drug administration calendar day.  Although the single payment covers both professional services under section 1861(iii)(2)(A) and training and education, remote monitoring, and other monitoring services under section 1861(iii)(2)(B), payment is only issued on days on which professional services are provided in the patients home, by the qualified home infusi on therapy supplier.