evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
a. In-facility Dialysis  - Dialysis furnished on an outpatient basis in a Medicare certified ESRD f acility.   b. Home Dialysis -  Dialysis performed at home, including a nursing home, by an ESRD patient or caregiver who has completed an appropriate course of training as specified at 42 CFR 494.100(a).   c. Staff -Assisted Dialysis -  Dialysis performed by t he staff of the ESRD facility in the ESRD facility.   d. Self-Dialysis  - Dialysis performed by an ESRD patient in -facility with the expectation that the patient performs their dialysis treatment with little or no professional assistance.  The patient must have completed an appropriate course of training as specified at 42 CFR 494.100(a).   NOTE:  Self-dialysis and home dialysis include training programs that educate ESRD patients and/or other individuals to assist the patient in performing self -dialysis or home dialysis with little or no professional assistance.   2.  Back -Up Dialysis -  Dialysis given to patients under special circumstances.  Examples are: dialysis of a home dialysis patient in an ESRD facility when the patients equipment fails, inpatient dialysis when a patients illness requires more comprehensive care, and preoperati ve and postoperative dialysis provided to transplant patients.   E.  Home Dialysis -  Supplies, Equipment, and Support Services   ESRD facilities are responsible for furnishing supplies, equipment, and support services for home dialysis.  ESRD facilities are financially responsible and may not bill Medicare or the patient for separate payment.  If an ESRD facility arranges for a supplier to furnish renal dialysis supplies and equipment, the supplier may seek payment only from the ESRD facility and may not bill  Medicare or the patient for separate payment.
(Medicare Benefit Policy Manual)
Method Selection   For home dialysis services furnished prior to January 1, 2011, a beneficiary selected one of two methods to secure home dialysis items and services.  Under Method I, the ESRD facility with which the patient is associated, assumes total responsibility for furnishing all home dialysis items or services.  Under Method II, the beneficiary dealt directly with a dialysis supplier to secure home dialysis items and services.  Beginning January 1, 2011, Method II is no longer an option for home dialysis items and services under Medicare.  Therefore, beginning January 1, 2011, all home dialysis patients are Method I.   Under Method I, Medicare payment for all modalities of home dialysis is made to the E SRD facility under the ESRD PPS.  Renal dialysis items and services may be furnished directly by the facility or under arrangement with a supplier.   The ESRD facility or home dialysis supplier may not bill the beneficiary directly for renal dialysis supplies, services, or equipment.  For further discussion on Method I payment refer to 20.1 of this chapter.   1.  Home Dialysis Equipment - Home dialysis equipment includes all of the medically necessary equipment ordered by the attending physician, including ( but not limited to) artificial kidneys, automated peritoneal dialysis machines, and support equipment.  Home dialysis supplies and equipment may be covered if used by an ESRD beneficiary in a nursing home or a SNF.  See 40.C and 40.D of this chapter for more information.   2.  Installation -  Installation includes (but is not limited to) the identification of any minor plumbing and electrical changes required to accommodate the equipment, the ordering and performing of these changes, delivery of the equipme nt and its actual installation (i.e., hookup), as well as any necessary testing to assure proper installation and function.  Minor plumbing and electrical changes include those parts and labor required to connect the dialysis equipment to plumbing and elec trical lines that already exist in the room where the patient will dialyze.  Medicare does not cover wiring or rewiring of the patients home or installing any plumbing to the patients home or to the room of the home where the patient will dialyze.
(Medicare Benefit Policy Manual)
3.  M aintenance -  Maintenance includes (but is not limited to) travel to the patients home, transportation of the equipment to a repair site, the actual performance of the maintenance or repair, and necessary parts.  Water purification equipment maintenance in cludes replacing the filter on a reverse osmosis device, regenerating the resin tanks on a deionization device, using chemicals in a water softener, and periodic water testing to assure proper performance.   Routine maintenance customarily performed by a pa tient is not a covered service except for the cost of parts involved in the maintenance furnished by the ESRD facility to the patient.   4.  Supplies -  Supplies include all durable and disposable items and medical supplies necessary for the effective performance of a patients dialysis.  Supplies include (but are not limited to): dialyzers, forceps, sphygmomanometer with cuff and stethoscope, scales, scissors, syringes, alcohol wipes, sterile drapes, needles, topical anesthetics, and gloves.   5.  Suppo rt Services  See 30.1.A of this chapter.  6.  Support Equipment -  Support equipment is equipment used in conjunction with the basic dialysate delivery system.  Such equipment includes (but is not limited to) pumps, such as blood and heparin pumps, alarms , such as bubble detectors, water purification equipment used to improve the quality of the water used for dialysis, and adjustable dialysis chairs.    F.  Overview of Medicares ESRD Payment Policy   1.  ESRD Prospective Payment System (ESRD PPS)  Section 153(b) of Pub. L. 110- 275, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) amended section 1881(b) of the Social Security Act to require the implementation of an ESRD bundled payment system effective January 1, 2011.  Under MIPPA, the ESRD PPS replaced the basic case- mix adjusted composite rate payment system and the methodologies for the reimbursement of separately billable outpatient renal dialysis items and services.   The ESRD PPS provides a case -mix and facility -level adjusted s ingle payment to ESRD facilities for renal dialysis services provided in an ESRD facility or in a beneficiarys home.  (See 10.C of this chapter for the items and services considered to be renal dialysis services.)
(Medicare Benefit Policy Manual)
To account for higher resource utilizat ion, the ESRD PPS applies case -mix adjusters to the base rate and, when applicable, also includes an add- on for home and self -dialysis training and an outlier payment.   The ESRD PPS provided for a 4 year transition period under which facilities may have re ceived a blend of the payment methodology prior to January 1, 2011 (that is, the basic case -mix adjusted composite rate payment system) and the ESRD PPS.  In 2014, all ESRD facilities that receive Medicare payment are paid 100 percent under the ESRD PPS.   The ESRD PPS combines payment for what had previously been composite rate and separately billable outpatient renal dialysis items and services into a single base rate for both adult and pediatric patients.  The per dialysis treatment base rate is subsequen tly adjusted to reflect:    Patient -level adjustments for: o case- mix, (see 60.A.1 of this chapter for adult patient adjustments and 60.A.6 of this chapter for pediatric patient adjustments)   o An onset of dialysis adjustment for adult patients that have Medicare ESRD coverage during their initial 4 months of dialysis, (see 60.A.4 of this chapter)    Facility -level adjustments for: o A low- volume facility adjustment for ESRD facilities that meet certain criteria, (see 60.B.1 of this chapter)   o A wage index ad justment to reflect differences in wage levels among the urban and rural areas in which ESRD facilities are located, (see 60.B.2 of this chapter)   o A rural adjustment, effective January 1, 2016    Other adjustments: o A home or self -dialysis training add -on, (see 60.C of this chapter)  o An outlier payment , (see 60.D of this chapter)
(Medicare Benefit Policy Manual)
 Other adjustments: o A home or self -dialysis training add -on, (see 60.C of this chapter)  o An outlier payment , (see 60.D of this chapter)   The ESRD PPS implemented consolidated billing edits for certain renal dialysis laboratory services, drugs and biologicals, equipment, and supplies to ensure that payment for renal dialysis services is not made to providers other than the ESRD facility.  A service furnished by an ESRD facility that is not for the treatment of ESRD must be submitted with an AY modifier to allow for separate payment outside of the ESRD PPS.  The list of renal dialysis services identified for the ESRD PPS consolidated billing may be viewed at http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/ESRDpayment/Consolidated_Billing.html .  Note that this list is n ot an all -inclusive list, and ESRD facilities are responsible and reimbursed for furnishing all renal dialysis services under the ESRD PPS.   2.  Basic Case -Mix Adjusted Composite Rate Payment System   The basic case- mix adjusted composite rate payment syst em was implemented in CY 2005 and maintained until 2014 for purposes of the blended payment during the ESRD PPS transition period.  It applied patient -level case- mix adjusters, additional payment for home and self -dialysis training, and a drug add- on to the composite rate.   The drug add- on accounted for the difference between the methodologies of payment for separately billed drugs and biologicals prior to the enactment of the revised drug pricing specified in the Medicare Modernization Act of 2003 (MMA).  For more information on the history of the composite rate see Appendix C and for more information regarding the transition period see 70 of this chapter.
(Medicare Benefit Policy Manual)
3.  Composite Rate  The composite rate was the first step Medicare made toward creating a bundled payment for renal dialysis items and services.  It covered routine laboratory testing, certain drugs, equipment and supplies, and support services furnished for outpatient maintenance dialysis in Medicare -certified ESRD facilities.  Under the composite rate methodology, separate payment was made to ESRD facilities for most drugs and biologicals furnished to ESRD patients.  For more information regarding composite rate items and services, see 20.1, for composite rate laboratory services, see 20.2.E, and for composite rate drugs, see 20.3.F of this chapter.   20 - Renal Dialysis Items and Services  (Rev. 200, Issued: 12- 02-14, Effective: 01- 01-15, Implementation: 01- 05-15)  Medicare provides payment under the ESRD PPS for all renal dialysis services for outpati ent maintenance dialysis when they are furnished to Medicare ESRD patients for the treatment of ESRD by a Medicare certified ESRD facility or a special purpose dialysis facility.  Renal dialysis services are the items and services included under the compos ite rate and the items and services that were separately paid as of December 31, 2010 that were used for the treatment of ESRD.  Renal dialysis services are furnished in various settings including hospital outpatient ESRD facilities, independent ESRD facil ities, or in the patients home.  Renal dialysis items and services furnished at ESRD facilities differ according to the types of patients being treated, the types of equipment and supplies used, the preferences of the treating physician, and the capabilit y and makeup of the staff.  Although not all facilities provide an identical range of services, the most common elements of dialysis treatment include:    Laboratory Tests;   Drugs and Biologicals;   Equipment and supplies -  dialysis machine use and maintenance;   Personnel services;   Administrative services;   Overhead costs;   Monitoring access and related declotting or referring the patient, and   Direct nursing services include registered nurses, licensed practical nurses, technicians, social workers, and dietitians.  20.1 - Composite Rate Items and Services  (Rev. 171, Issued: 06 -07-13, Effective: 01- 01-11, Implementation: 09- 09-13)
(Medicare Benefit Policy Manual)
20.1 - Composite Rate Items and Services  (Rev. 171, Issued: 06 -07-13, Effective: 01- 01-11, Implementation: 09- 09-13)  Beginning January 1, 2011, all renal dialysis services (defined at 10.C of this chapter) are included in the ESRD PPS.  Renal dialysis services include, but are not limited to, the items and services included under the composite rate as of December 31. 2010.   The composite payment rate (defined at 10.F.3 of this chapter) was a comprehensive payment for all modes of in-facility and Method  I home dialysis.  Most items and services related to the treatment of the patients end-stage renal disease were covered under the composite rate payment with the exception of physicians professional services, separately billable laboratory services, and  separately billable drugs.  If a facility failed to furnish, either directly or under an arrangement, any part of the items and services covered under the composite rate, then the ESRD facility could not be paid any amount for the service.  This payment w as subject to the normal Part B deductible and coinsurance requirements.   Below are examples of items and services included under the composite rate and furnished by the ESRD facility, either directly or under arrangement.    Dialysate;   Cardiac monitoring;   Catheter changes;   Suture removal;   Dressing changes;   Crash cart usage for cardiac arrest;   Declotting of shunt performed by ESRD facility staff in the dialysis unit;  All oxygen and its administration furnished in the dialysis unit;   Staff time to administer blood;   Staff time used to administer separately billable parenteral items; and   Staff time used to collect specimens for laboratory tests.   20.2 - Laboratory Services  (Rev. 224, Issued: 06- 03-16, Effective: 01- 01-16, Implementation: 09- 06-16)  All laboratory services furnished to individuals for the treatment of ESRD are included in the ESRD PPS as Part B services and are not paid separately as of January 1, 2011.  The laboratory services include but are not limited to:    Laboratory tests included under the composite rate as of December 31, 2010 (discussed below); and    Former separately billable Part B laboratory tests that were billed by ESRD facilities and independent laboratories for ESRD patients.
(Medicare Benefit Policy Manual)
 Laboratory tests included under the composite rate as of December 31, 2010 (discussed below); and    Former separately billable Part B laboratory tests that were billed by ESRD facilities and independent laboratories for ESRD patients.  Composite rate laboratory tests are listed in 20.2.E of this chapter.  More information regarding composite rate laboratory tests can be found in Pub. 100- 04, Medicare Claims Processing Manual, chapter 8, 50.1, 60.1, and 80.  As discussed below, composite rate laboratory services should not be reported on cl aims.   To the extent a laboratory test is performed to monitor the levels or effects of any of the drugs that were specifically excluded from the ESRD PPS, these tests would be separately billable.  The following table lists the drug categories that were excluded from the ESRD PPS and the rationale for their exclusion.  Laboratory services furnished to monitor the medication levels or effects of drugs and biologicals that fall in those categories would not be considered to be furnished for the treatment of ESRD.     DRUG CATEGORIES EXCL UDED FROM THE ESRD P PS BASE RATE FOR THE PURPOSE OF R EPORTING LABS
(Medicare Benefit Policy Manual)
DRUG CATEGORIES EXCL UDED FROM THE ESRD P PS BASE RATE FOR THE PURPOSE OF R EPORTING LABS   Drug Category  Rationale for Exclusion  Anticoagulant  Drugs labeled for non -renal dialysis conditions and not for vascular access.  Antidiuretic  Used to prevent fluid loss.  Antiepileptic  Used to prevent seizures.  Drug Category  Rationale for Exclusion  Anti-inflammatory  May be used to treat kidney disease (glomerulonephritis) and other inflammatory conditions.  Antipsychotic  Used to treat psychosis.  Antiviral  Used to treat viral conditions such as shingles.  Cancer management  Includes oral, parenteral and infusions. Cancer drugs are covered under a separate benefit category.  Cardiac management  Drugs that manage blood pressure and cardiac conditions.  Cartilage  Used to replace synovial fluid  in a joint space.  Coagulants  Drugs that cause blood to clot after anti -coagulant overdose or factor VII deficiency.  Cytoprotective agents  Used after chemotherapy treatment.  Endocrine/metabolic management  Used for endocrine/metabolic disorders such as thyroid or endocrine deficiency, hypoglycemia, and hyperglycemia.  Erectile dysfunction management  Androgens were used prior to the development of ESAs for anemia management and currently are not recommended practice.  Also used for hypogonadism and erectile dysfunction.  Gastrointestinal management  Used to treat gastrointestinal conditions such as ulcers and gallbladder disease.  Immune system management  Anti-rejection drugs covered under a separate benefit category.  Migraine management  Used to treat migraine headaches and symptoms.  Musculoskeletal management  Used to treat muscular disorders such as prevent muscle spasms, relax muscles, improve muscle tone as in myasthenia gravis, relax muscles for intubation and induce uterine contractions.  Pharmacy handling for oral anti -cancer, anti -emetics and immunosuppressant drugs  Not a function performed by an ESRD facility.  Pulmonary system management  Used for respiratory/lung conditions such as opening airways and newborn apnea.  Radiopharmaceutical  procedures  Includes contrasts and procedure preparation.  Unclassified drugs  Should only be used for drugs that do not have a HCPCS code and therefore cannot be identified.  Vaccines  Covered under a separate benefit category.
(Medicare Benefit Policy Manual)
The distinction of what is considered to be a renal dialysis laboratory test is a clinical decision determined by the ESRD patients ordering practitioner.  If a laboratory test is ordered for the treatment of ESRD, then the laboratory test is not paid separately.   Payment for all r enal dialysis laboratory tests furnished under the ESRD PPS is made directly to the ESRD facility responsible for the patients care.  The ESRD facility must furnish the laboratory tests directly or under arrangement and report renal dialysis laboratory tests on the ESRD facility claim (with the exception of composite rate laboratory services).   An ESRD facility must report renal dialysis laboratory services on its claims in order for the laboratory tests to be included in the outlier payment calculation.  Renal dialysis laboratory services that were or would have been paid separately under Medicare Part B prior to January 1, 2011, are priced for the outlier payment calculation using the Clinical Laboratory Fee Schedule.  Further information regarding the outlier policy can be found in 60.D of this chapter.   Certain laboratory services will be subject to Part B consolidated billing requirements and will no longer be separately payable when provided to ESRD beneficiaries by providers other than the ESRD facil ity.  The list below includes the renal dialysis laboratory tests that are routinely performed for the treatment of ESRD.  Payment for the laboratory tests identified on this list is included in the ESRD PPS.  The laboratory tests listed in the table are u sed to enforce consolidated billing edits to ensure that payment is not made for renal dialysis laboratory tests outside of the ESRD PPS.  The list of renal dialysis laboratory tests is not an all-inclusive list.  If any laboratory test is ordered for the treatment of ESRD, then the laboratory test is considered to be included in the ESRD PPS and is the responsibility of the ESRD facility.  Additional renal dialysis laboratory tests may be added through administrative issuances in the future.
(Medicare Benefit Policy Manual)
LABS SUBJECT TO ESRD CONSOLIDATED BILLING  CPT/ HCPCS  Short Description  80047  Basic Metabolic Panel (Calcium, ionized)  80048  Basic Metabolic Panel (Calcium, total)  80051  Electrolyte Panel  80053  Comprehensive Metabolic Panel  80061*  Lipid Panel*  80069  Renal Function  Panel  80076  Hepatic Function Panel  82040  Assay of serum albumin  82108  Assay of aluminum  82306  Vitamin d, 25 hydroxy  82310  Assay of calcium  82330  Assay of calcium, Ionized  82374  Assay, blood carbon dioxide  82379  Assay of carnitine  82435  Assay of blood chloride  82565  Assay of creatinine  82570  Assay of urine creatinine  82575  Creatinine clearance test  82607  Vitamin B -12 82652  Vit d 1, 25 -dihydroxy  82668  Assay of erythropoietin  82728  Assay of ferritin  82746  Blood folic acid serum  83540  Assay of iron  83550  Iron binding test  83735  Assay of magnesium  83970  Assay of parathormone  84075  Assay alkaline phosphatase  84100  Assay of phosphorus  84132  Assay of serum potassium  84134  Assay of prealbumin  84155  Assay of protein, serum  84157  Assay of protein by other source  84295  Assay of serum sodium  84466  Assay of transferrin  84520  Assay of urea nitrogen  84540  Assay of urine/urea -n 84545  Urea -N clearance test  85014  Hematocrit  85018  Hemoglobin  85025  Complete (cbc), automated (HgB, Hct, RBC, WBC, and Platelet count) and automated differential WBC count.  85027  Complete (cbc), automated (HgB, Hct, RBC, WBC, and Platelet count)  85041  Automated rbc count  85044  Manual reticulocyte count  85045  Automated reticulocyte count  85046  Reticyte/hgb concentrate  85048  Automated leukocyte count  86704  Hep b core antibody, total  86705  Hep b core antibody, igm  86706  Hep b surface antibody  87040  Blood culture for bacteria  87070  Culture, bacteria,
(Medicare Benefit Policy Manual)
concentrate  85048  Automated leukocyte count  86704  Hep b core antibody, total  86705  Hep b core antibody, igm  86706  Hep b surface antibody  87040  Blood culture for bacteria  87070  Culture, bacteria, other  87071  Culture bacteri aerobic othr  87073  Culture bacteria anaerobic  87075  Cultr bacteria, except blood  87076  Culture anaerobe ident, each  87077  Culture aerobic identify  87081  Culture screen only  87340  Hepatitis b surface ag, eia  G0306  CBC/diff wbc w/o platelet  G0307  CBC without platelet