(Medicare Benefit Policy Manual)

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.    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.   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.   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.   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)  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.  The qualified home infusion therapy supplier must submit, in line -item detail on the claim, an appropriate G -code for each infusion drug administration calendar day. The claim should include the length of time, in 15- minute increments, for which professional services were furnished.  Billing instructions for home infusion therapy services are found in the Medicare Claims Processing Manual Chapter 32 Section 411.   320.8.3 - Initial Visits and Subsequent Visits for Home Infusion Therapy Services  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  The first visit furnished by a qualified home infusion therapy supplier to furnish services in the patients home may be longer or more resource intensive than subsequent visits.  For each of the three payment categories listed in 320.8.1 of this chapter, the payment amounts are set higher for the first visit by the qualified home infusion therapy supplier to initiate the furnishing of home infusion therapy services in the patient's home and lower for subsequent visits in the patient's home.   If a patient receiving home infusion therapy services is discharged from such services, in order to bill a first visit again, the patients history must show a gap of more than 60 days between home infusion therapy service visits. This means that upon re -admission, there cannot be a G -code billed for this patient within the past 60 days, and the last G -code billed for this patient must show that the patient had been discharged. A qualified home infusion therapy supplier could bill the first visit payment am ount on day 61 for a patient who had previously been discharged from service.   The G -codes for the initial and subsequent home infusion therapy service visits, and instructions for billing for home infusion therapy services payments are found in the Medicare Claims Processing Manual Chapter 32 Section 411.   320.9 - Medical Review (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  All payments under this benefit may be subject to a medical review adjustment reflecting the following:  1. Beneficiary eligibility.  2. Plan of care requirements.  3. Medical necessity determinations.   330  Marriage and Family Therapist (MFT)  Services  (Rev.  12448; Issued:01- 11-24, Effective: 01- 01-24; Implementation: 02- 12-24)   See the Medicare Claims  Processing  Manual  Chapter  12, Physician/Nonphysician Practitioners,  240, Marriage and Family Therapist  Services,  for payment  requirements.   A. Marriage and Family Therapist Defined    410.53 defines a  marriage and family therapist  as an individual  who:    Possesses a master's or doctor's degree which qualifies for licensure or certification as a marriage and family therapist pursuant to State law of the State in which such individual furnishes the services defined as marriage and family therapist services;    After obtaining such degree, has performed at least 2 years or 3,000 hours of post masters degree clinical supervised experience in marriage and family therapy in an appropriate setting such as a hospital, SNF, private practice, or clinic; and   Is licensed or certified as a marriage and family therapist by the State in which the services are performed.