evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
By definition, chronic kidney disease (CKD) is kidney damage for 3 months or longer, regardless of the cause of kidney damage.  CKD typically evolves over a long period of time and patients may not have symptoms until significant, possibly irreversible, da mage has been done.  Complications can develop from kidneys that do not function properly, such as high blood pressure, anemia, and weak bones.  When CKD progresses, it may lead to kidney failure, which requires artificial means to perform kidney functions  (dialysis) or a kidney transplant to maintain life.   Patients can be classified into 5 stages based on their glomerular filtration rate (GFR, how quickly blood is filtered through the kidneys), with stage I having kidney damage with normal or increased GFR to stage V with kidney failure, also called end- stage renal disease (ESRD).  Once patients with CKD are identified, treatment is available to help prevent complications of decreased kidney function, slow the progression of kidney disease, and reduce the risk of other diseases such as heart disease.   Beneficiaries with CKD may benefit from kidney disease education (KDE) interventions due to the large amount of medical information that could affect patient outcomes, including the increasing emphasis on self -care and patients desire for informed, autonomous decision- making.  Pre -dialysis education can help patients achieve better understanding of their illness, dialysis modality options, and may help delay the need for dialysis.  Education interventions should be patient -centered, encourage collaboration , offer support to the patient, and be delivered consistently.   Effective for claims with dates of service on and after January 1, 2010, Section 152(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) covers KDE services under Medicare Part B.  KDE services are designed to provide beneficiari es with Stage IV CKD comprehensive information regarding: the management of comorbidities, including delaying the need for dialysis; prevention of uremic complications; all therapeutic options (each option for renal replacement therapy, dialysis access opt ions, and transplantation); ensuring that the beneficiary has opportunities to actively participate in his/her choice of therapy; and that the services be tailored to meet the beneficiarys needs.
(Medicare Benefit Policy Manual)
Regulations for KDE services were established at 42 CFR 410.48.  Claims processing instructions and billing requirements can be found in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 32  Billing Requirements for Special Services, Section 20.  310.1 - Beneficiaries Eligible for Coverage  (Rev. 117; Issued:  12- 18-09; Effective Date:  01 -01-10; Implementation Date:  04-05-10)  Medicare Part B covers outpatient, face -to-face KDE services for a beneficiary that:    is diagnosed with Stage IV CKD, using the Modification of Diet in Renal Disease (MDRD) Study formula (severe decrease in GFR, GFR value of 15 -29 mL/min/1.73 m2), and    obtains a referral from the physician managing the beneficiarys kidney condition. The referral should be documented in the beneficiarys medical records.   310.2 - Qualified Person  (Rev. 117; Issued:  12- 18-09; Effective Date:  01 -01-10; Implementation Date:  04 -05-10)  Medicare Part B covers KDE services provided by a qualified person, meaning a:    physician (as defined in section 30 of this chapter),   physician assistant, nurse practitioner, or clinical nurse specialist (as defined in sections 190, 200, and 210 of this chapter),    hospital, critical access hospital (CAH), skilled nursing facility (SNF), comprehensive outpatient rehabilitation facility (CORF), home health agency (HHA), or hospice, if the KDE services are provided in a rural area (using the actual geographic location core based statistical area (CBSA) to identify facilities located in  rural areas), or    hospital or CAH that is treated as being rural (was reclassified from urban to rural status per 42 CFR 412.103).  NOTE:   The incident to requirements at section 1861(s)(2)(A) of the Social Security Act (the Act) do not apply to KDE services.  The following providers are not qualified persons and are excluded from furnishing KDE services:
(Medicare Benefit Policy Manual)
 A hospital, CAH, SNF, CORF, HHA, or hospice located outside of a rural area (using the actual geographic location CBSA to identify facilities located outside of a rural area), unless the services are furnished by a hospital or CAH that is treated as being in a rural area; and    Renal dialysis facilities.   310.3 - Limitations for Coverage  (Rev. 194, Issued: 09- 03-14, Effective: Upon Implementation of ICD -10, Implementation: Upon Implementation of ICD -10)  Medicare Part B covers KDE services:    Up to six (6) sessions as a beneficiary lifetime maximum.  A session is 1 hour.  In order to bill for a session, a session must be at least 31 minutes in duration.  A session that lasts at least 31 minutes, but less than 1 hour still constitutes 1 session.    On an individual basis or in group settings; if the services are provided in a group setting, a group consists of 2 to 20 individuals who need not all be Medicare beneficiaries .  NOTE:   Two HCPCS codes were created for this benefit and one or the other must be present, along with the appropriate ICD diagnosis codes.   The diagnosis codes are:    ICD-9-CM -  code 585.4 (chronic kidney disease, Stage IV (severe)), or    ICD-10-CM -  code N18.4 (chronic kidney disease, Stage IV).   The HCPCS  codes are:    G0420:  Face -to-face educational services related to the care of chronic kidney disease; individual, per session, per one hour    G0421:   Face -to-face educational services related to the care of chronic kidney disease; group, per session, per one hour   310.4  Standards for Content  (Rev. 117; Issued:  12- 18-09; Effective Date:  01 -01-10; Implementation Date:  04-05-10)  Medicare Part B covers KDE services, provided by a qualified person, which provide comprehensive information regarding:   A. The management of comorbidities, including delaying the need for dialysis, which includes, but is not limited to, the following topics:
(Medicare Benefit Policy Manual)
A. The management of comorbidities, including delaying the need for dialysis, which includes, but is not limited to, the following topics:    Prevention and treatment of cardiovascular disease,   Prevention and treatment of diabetes,   Hypertension management,  Anemia management,   Bone disease and disorders of calcium and phosphorus metabolism management,  Symptomatic neuropathy management, and   Impairments in functioning and well -being.   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)
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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)
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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)
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.