(Medicare Benefit Policy Manual)

B. Prevention of uremic complications, which includes, but is not limited to, the following topics:    Information on how the kidneys work and what happens when the kidneys fail,  Understanding if remaining kidney function can be protected, preventing disease progression, and realistic chances of survival,   Diet and fluid restrictions, and   Medication review, including how each medication works, possible side effects and minimization of side effects, the importance of compliance, and informed decision making if the patient decides not to take a specific drug.   C. Therapeutic options, treatment modalities and settings, advantages and disadvantages of each treatment option, and how the treatments replace the kidney, including, but not limited to, the following topics:    Hemodialysis, both at home and in- facility;  Peritoneal dialysis (PD), including intermittent PD, continuous ambulatory PD, and continuous cycling PD, both at home and in- facility;  All dialysis access options for hemodialysis and peritoneal dialysis; and   Transplantation.   D. Opportunities for beneficiaries to actively participate in the choice of therapy and be tailored to meet the needs of the individual beneficiary involved, which includes, but is not limited to, the following topics:    Physical symptoms,   Impact on family and social life,   Exercise,   The right to refuse treatment,   Impact on work and finances,   The meaning of test results, and  Psychological impact.  310.5 - Outcomes Assessment  (Rev. 117; Issued:  12- 18-09; Effective Date:  01 -01-10; Implementation Date:  04-05-10)  Qualified persons that provide KDE services must develop outcomes assessments that are designed to measure beneficiary knowledge about CKD and its treatment.  The assessment must be administered to the beneficiary during a KDE session, and be made availabl e to the Centers for Medicare & Medicaid Services (CMS) upon request.  The outcomes assessments serve to assist KDE educators and CMS in improving subsequent KDE programs, patient understanding, and assess program effectiveness of:    Preparing the beneficiary to make informed decisions about their healthcare options related to CKD, and    Meeting the communication needs of underserved populations, including persons with disabilities, persons with limited English proficiency, and persons with health literacy needs .  320 - Home Infusion Therapy Services  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Effective January 1, 2021, section 5012 of the 21st Century Cures Act (Pub. L. 114255), which added sections 1861(s)(2)( GG) and 1861(iii) of the Act, established a new Medicare home infusion therapy services benefit.  Section 1861(iii) of the Act establishes certain provisions related to home infusion therapy with respect to the requirements that must be met for Medicare payment to be made to qualified home infusion therapy suppliers. These provisions serve as the basis for determining the scope of the home infusion drugs eligible for coverage of home infusion therapy services; outline beneficiary qualifications and plan of care requirements; and establish who can bill for payment under the benefit.    The Medicare home infusion therapy services benefit covers the professional services, including nursing services, furnished in accordance with the plan of care, patient training and education (not otherwise covered under the durable medical equipment (DME)  benefit), remote monitoring, and monitoring services for the provision of home infusion drugs, furnished by a qualified home infusion therapy supplier in the individuals home. The home infusion therapy services are covered for the safe and effective admi nistration of certain 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. The infusion pump and supplies (including hom e infusion drugs) will continue to be covered under the DME benefit.   320.1 - General Requirements for Payment of Home Infusion Therapy Services                                                                                                                             (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)   The home infusion therapy services must be furnished to an eligible beneficiary by, or under arrangement with, a qualified home infusion therapy supplier that meets the health and safety standards for qualified home infusion therapy suppliers at 42 CFR 486 Subpart I, and all requirements set forth in 42 CFR 414 Subpart P.    As a condition for payment, qualified home infusion therapy suppliers must ensure that a beneficiary meets certain eligibility criteria for coverage of services, as well as ensure that certain plan of care requirements are met.   320.2 - Home Infusion Therapy Services Benefit is Separate from DME Benefit                                                                                                         (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  In order to  avoid making duplicative payment, the training and education furnished under the DME benefit is explicitly excluded from the home infusion therapy services payment. The home infusion therapy services benefit provides a separate payment in addition to the existing payment made under the DME benefit, thus explicitly and separately paying for the home infusion therapy services. Therefore, the professional services covered under the DME benefit are not covered under the home infusion therapy services benefit. While the two benefits exist in tandem, the services are unique to each benefit and billed and paid for under separate payment systems.  For DME infusion pumps, the DME benefit covers the infusion drugs and other supplies and services necessary for the effective use of the pump, but does not explicitly require or pay separately for any associated skilled professional services beyond what is necessary for teaching the patient and/or caregiver how to operate the equipment in order to administer the infusion safely and effectively in the patients home (42 CFR 424.57( c)(12)).   The home infusion therapy services benefit is a separate payment in addition to the existing payment for the DME external infusion pump, supplies (including the furnishing of the home infusion drug), and related services covered under the DME benefit. Furt her billing information can be found in Publication 100- 04, Chapter 32, Section 411.   320.3 - Qualified Home Infusion Therapy Suppliers                                (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  Section 1861(iii)(3)(D)(i) of the Act defines a qualified home infusion therapy supplier as a pharmacy, physician, or other provider of services or supplier licensed by the State in which the pharmacy, physician, or provider of services or supplier furnishes items or services.    The qualified home infusion therapy supplier must:  A. Furnish home infusion therapy services to individuals with acute or chronic conditions requiring administration of home infusion drugs;  B. Ensure the safe and effective provision and administration of home infusion therapy services on a 7 -day-a-week, 24 -hour a -day basis;  C. Be accredited by an organization designated by the Secretary; and meet such other requirements as the Secretary determines appropriate.   The supplier may subcontract with a pharmacy, physician, other qualified supplier or provider of medical services, in order to meet these requirements.  Additionally, section 1861(u) of the Act defines provider of services to mean a hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, or, for purposes of secti ons 1814(g) and 1835(e) of the Act, a fund. Therefore, any of the previously noted entities who meet the Medicare accreditation requirements for home infusion therapy suppliers is eligible to enroll as a qualified home infusion therapy supplier.   In the case that a home health agency also becomes accredited as a home infusion therapy supplier, the HHA would continue to meet the requirements under the Home Health Conditions of Participation (CoPs) as well as the home infusion therapy supplier requir ements as set out in 42 CFR 486 Subpart I, of which DME services, including pharmacy services associated with the preparation and dispensing of home infusion drugs are not included.   The qualified home infusion therapy supplier is not required to furnish the infusion pump, home infusion drug, or related pharmacy services. The infusion pump, drug, other supplies, and the services required to furnish these items (that is, the compounding and dispensing of the drug) remain covered under the DME benefit.  Pharmacy services, remote or otherwise, furnished by a Medicare enrolled DMEPOS supplier, associated with the preparation and dispensing of home infusion drugs are covered under the DME benefit and are not part of this specific home infusion therapy services benefit.  320.4 - Patient Eligibility for Home Infusion Therapy                             (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)   To be eligible to receive home infusion therapy services under the home infusion therapy benefit, a beneficiary must have Medicare Part B and meet each of the following requirements:  A. The beneficiary must be under the care of an applicable provider, as defined in section 1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or physician assistant.    B. The beneficiary must be under a physician -established plan of care that meets the requirements specified in 42 CFR 414.1515 and 42 CFR 486.520, as described in section 320.5 of this chapter.  Home infusion services must be furnished in the patients home, which means the place of residence as defined for purposes of section 1861(n) of the Act used as the home of an individual, including an institution that is used as a home (excluding hospitals , critical access hospitals, and skilled nursing facilities as defined in section 1819(a)(1) of the Act).    320.4.1 - Home Infusion Therapy Services for Homebound Patients  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  A beneficiary is not required to be homebound in order to receive home infusion therapy services.  However, there may be instances where a beneficiary under a home health plan of care also requires home infusion therapy services.  If a patient receiving home infusion therapy is also under a home health plan of care, and receives a visit that is unrelated to home infusion therapy, then payment for the home health visit would be covered under the Home Health Prospective Payment System  (HH PPS) and billed on the home health claim.   When the home health agency furnishing home health services is also enrolled as the qualified home infusion therapy supplier furnishing home infusion therapy services, and a home visit is exclusively for the purpose of furnishing items and services related to the administration of the home infusion drug, the home health agency would submit a home infusion therapy services claim under the home infusion therapy services benefit.    If the home visit includes the provision of other home health services in addition to, and separate from, home infusion therapy services, the home health agency would submit both a home health claim under the HH PPS and a home infusion therapy services cla im under the home infusion therapy services benefit.  However, the agency must separate the time spent furnishing services covered under the HH PPS from the time spent furnishing services covered under the home infusion therapy services benefit.   If the qualified home infusion therapy supplier is not the same entity as the home health agency furnishing the home health services, the home health agency would continue to bill under the HH PPS on the home health claim, and the qualified home infusion t herapy supplier would bill for the services related to the administration of the home infusion drugs on the home infusion therapy services claim.   320.5 - Plan of Care Requirements  (Rev. 10547, Issued: 12- 31-20, Effective: 01 -01-21, Implementation: 01- 04-21)  In accordance with section 1861(iii)(1)(B) of the Act, the beneficiary must be under a plan of care, established by a physician (defined at section 1861(r)(1) of the Act as a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or acti on), prescribing the type, amount, and duration of infusion therapy services that are to be furnished, and periodically reviewed, in coordination with the furnishing of home infusion drugs under Part B.   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.