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Medicare Benefit Policy Manual
Chapter 11 - End Stage Renal Disease (ESRD)
Table of Contents (Rev. 257, 03-01-19)
Transmittals for Chapter 11
10 - Definitions Relating to ESRD
20 - Renal Dialysis Items and Services
20.1 - Composite Rate Items and Services 20.2 - Laboratory Services 20.3 - Drugs and Biologicals 20.3.1 - Drug Designation Process 20.4 - Equipment and Supplies
30 - Home Dialysis
30.1 - Home Dialysis Items and Services 30.2 - Home Dialysis Training
40 - Other Services
50 - ESRD Prospective Payment System (PPS) Base Rate
60 - ESRD PPS Case-Mix Adjustments
70 - ESRD PPS Transition Period
80 - Bad Debts
90 - Medicare as a Secondary Payer
10 - Definitions Relating to ESRD
20 - Renal Dialysis Items and Services
20.1 - Composite Rate Items and Services 20.2 - Laboratory Services 20.3 - Drugs and Biologicals 20.3.1 - Drug Designation Process 20.4 - Equipment and Supplies
30 - Home Dialysis
30.1 - Home Dialysis Items and Services 30.2 - Home Dialysis Training
40 - Other Services
50 - ESRD Prospective Payment System (PPS) Base Rate
60 - ESRD PPS Case-Mix Adjustments
70 - ESRD PPS Transition Period
80 - Bad Debts
90 - Medicare as a Secondary Payer
100 - Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury
(AKI)
100.1 - Definition of AKI 100.2 - Payment Rate for AKI Dialysis 100.3 - Geographic Adjustment Factor 100.4 - Other Adjustments to the AKI Payment Rate 100.5 - Renal Dialysis Services Included in the AKI Payment Rate 100.6 - Applicability of Specific ESRD PPS Policies to AKI Dialysis 100.6.1 - Dialysis Modality 100.6.2 - Uncompleted Dialysis Treatment 100.6.3 - Home and Self-Dialysis 100.6.4 - Vaccines and Their Administration 100.6.5 – Telehealth
110 - Reserved
120 - Reserved
130 - Reserved
Appendix A - Composite Rate Tests for Hemodialysis, IPD, CCPD, and Hemofiltration
Appendix B - Appendix B/Composite Rate Tests for CAPD
Appendix C - Appendix C/Brief History of ESRD Composite Payment Rates for Outpatient Maintenance Dialysis
140 - Transplantation
140.1 - Identifying Candidates for Transplantation 140.2 - Identifying Suitable Live Donors 140.3 - Pretransplant Outpatient Services 140.4 - Pretransplant Inpatient Services 140.5 - Living Donor Evaluation, Patient Has Entitlement or is in Preentitlement Period 140.6 - Kidney Recipient Admitted for Transplant Evaluation 140.7 - Kidney Recipient Evaluated for Transplant During Inpatient Stay 140.8 - Kidney Recipient Admitted for Transplantation and Evaluation 140.9 - Posttransplant Services Provided to Live Donor 140.10 - Coverage After Recipient Has Exhausted Part A 140.11 - Cadaver Kidneys 140.12 - Services Involved 140.13 - Tissue Typing Services for Cadaver Kidney 140.14 - Cadaver Excision Yielding Two Kidneys 140.15 - Provider Costs Related to Cadaver Kidney Excisions 140.16 - Noncovered Transplant Related Items and Services 140.17 - Other Covered Services 140.18 - Hospitals that Excise but Do Not Transplant Kidneys
b. Continuous Cycling Peritoneal Dialysis (CCPD) - CCPD is a treatment modality that combines the advantages of the long dwell, continuous steady-state dialysis of CAPD, with the advantages of automation inherent in intermittent peritoneal dialysis. The major difference between CCPD and CAPD is that the solution exchanges, which are performed manually during the day by the patient on CAPD, are moved to nighttime with CCPD and are performed automatically with a peritoneal dialysis cycler. Generally, there are three nocturnal exchanges occurring at intervals of 2 1/2 to 3 hours. Upon awakening, the patient disconnects from the cycler and leaves the last 2-liter fill inside the peritoneum to continue the daytime long dwell dialysis.
c. Intermittent Peritoneal Dialysis (IPD) - Waste products pass from the patient’s body through the peritoneal membrane into the peritoneal cavity where the dialysate is introduced and removed periodically by machine. Peritoneal dialysis generally is required for approximately 30 hours a week, either as three 10-hour sessions or less frequent, but longer, sessions. See §50.A.5 of this chapter for payment information.
3. Hemofiltration - Hemofiltration is an alternative to peritoneal dialysis and hemodialysis. Hemofiltration (which is also known as diafiltration) removes fluid, electrolytes, and other low molecular weight toxic substances from the blood by filtration through hollow artificial membranes and may be routinely performed in three weekly sessions. In contrast to both hemodialysis and peritoneal dialysis treatments, which eliminate dissolved substances via diffusion across semi permeable membranes, hemofiltration mimics the filtration process of the normal kidney. The technique requires an arteriovenous access. Hemofiltration may be performed either in an ESRD facility or at home. For payment information see §50 A.2 of this chapter. 4. Ultrafiltration – Ultrafiltration is the process of removing excess fluid from the blood through a dialysis membrane by exerting pressure. This is not a substitute for dialysis. Ultrafiltration is used in cases where excess fluid cannot be removed easily during the regular course of hemodialysis. It is commonly done during the first hour or two of hemodialysis on patients who have refractory edema. Occasionally, medical complications may occur which require that ultrafiltration be performed separately from the dialysis treatment. See §50.A.3 of this chapter for payment information.
B. ESRD Facility
An ESRD facility is an entity that provides outpatient maintenance dialysis services, or home dialysis training and support services, or both. ESRD facilities are classified in Section 1881 of the Act and codified in 42 CFR 413.174 as being either hospital-based or independent facilities. There is no distinction between the two facility types for the purposes of payment under the ESRD Prospective Payment System (PPS).
1. Hospital-Based ESRD Facilities
As defined in 42 CFR 413.65(a) hospital-based or independent ESRD facilities are not considered part of the hospital and do not qualify as provider-based departments of a hospital. Hospital-based ESRD facilities may be located on a hospital campus and may share certain overhead costs and administrative functions with the hospital. However, hospital-based ESRD facilities have separate provider numbers under which they bill Medicare and are subject to unique Conditions for Coverage that differ from hospital Conditions of Participation. Information regarding the survey and certification of ESRD facilities may be found at the following link: http://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/GuidanceforLawsAndRegulations/Dialysis.html.
CMS determines that an ESRD facility is hospital-based if:
- The ESRD facility and hospital are subject to the bylaws and operating decisions of a common governing board. This governing board, which has final administrative responsibility, approves all personnel actions, appoints medical staff, and carries out similar management functions;
- The ESRD facility’s director or administrator is under the supervision of the hospital’s chief executive officer and reports through that officer to the governing board;
- The ESRD facility’s personnel policies and practices conform to those of the hospital;
- The administrative functions of the ESRD facility (for example, records, billing, laundry, housekeeping, and purchasing) are integrated with those of the hospital; and
- The ESRD facility and hospital are financially integrated, as evidenced by the cost report, which must reflect allocation of hospital overhead to the facility through the required step-down methodology.
CMS does not consider the existence of an agreement between an ESRD facility and a hospital for the referral of patients, a shared service arrangement between a facility and a hospital, or the physical location of a dialysis unit on the premises of a hospital, to mean that an ESRD facility is hospital-based.
2. Independent ESRD Facility – Any facility that does not meet the criteria of a hospital-based ESRD facility.
There are several terms used to describe independent dialysis facilities which include the following:
a. Renal Dialysis Center - A hospital-based unit, which is approved to furnish the full spectrum of diagnostic, therapeutic, and rehabilitative services required for the care of ESRD dialysis patients (including inpatient dialysis furnished directly or under arrangement). A hospital need not provide renal transplantation to qualify as a renal dialysis center. Under the ESRD PPS CMS refers to renal dialysis centers as ESRD facilities.
b. Renal Dialysis Facility - An independent unit that is approved to furnish outpatient maintenance dialysis services directly to ESRD patients. Under the ESRD PPS CMS refers to renal dialysis facilities as ESRD facilities.
c. Self-Dialysis Unit - A dialysis unit that furnishes self-dialysis services and is part of a Medicare certified ESRD facility.
d. Home Dialysis Training and Support ESRD Facility – A Medicare certified ESRD facility that furnishes home dialysis training and support services. See 42 CFR 494.100 for more information regarding Medicare certification requirements.
e. Special Purpose Renal Dialysis Facility – An ESRD facility that is approved to furnish dialysis at special locations, on a short-term basis, to a group of dialysis patients otherwise unable to obtain treatment in their geographical area. The special locations must be either special rehabilitative (including vacation) locations serving ESRD patients temporarily residing there, or locations in need of ESRD facilities under emergency circumstances.
C. Renal Dialysis Services
Renal dialysis services are all items and services used to furnish outpatient maintenance dialysis to individuals for the treatment of ESRD in the ESRD facility or in a patient’s home.
Renal dialysis services include but are not limited to:
- All items and services included under the composite rate as of December 31, 2010 (see §20.2.E, §20.3.F, and §70.B of this chapter for more information);
patient’s illness requires more comprehensive care, and preoperative 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.
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 ESRD 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 equipment 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 electrical lines that already exist in the room where the patient will dialyze. Medicare does not cover wiring or rewiring of the patient’s home or installing any plumbing to the patient’s home or to the room of the home where the patient will dialyze.
3. Maintenance - Maintenance includes (but is not limited to) travel to the patient’s home, transportation of the equipment to a repair site, the actual performance of the maintenance or repair, and necessary parts. Water purification equipment maintenance includes 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 patient 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 patient’s 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. Support 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 Medicare’s 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 single payment to ESRD facilities for renal dialysis services provided in an ESRD facility or in a beneficiary’s home. (See §10.C of this chapter for the items and services considered to be renal dialysis services.)
To account for higher resource utilization, 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 received 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 subsequently 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 adjustment 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)
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 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 patient’s 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 was 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.
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 claims.
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 EXCLUDED FROM THE ESRD PPS BASE RATE FOR THE PURPOSE OF REPORTING 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.
The distinction of what is considered to be a renal dialysis laboratory test is a clinical decision determined by the ESRD patient’s ordering practitioner. If a laboratory test is ordered for the treatment of ESRD, then the laboratory test is not paid separately.
Payment for all renal dialysis laboratory tests furnished under the ESRD PPS is made directly to the ESRD facility responsible for the patient’s 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
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, 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
***** Effective January 1, 2016, the lipid panel is no longer considered to be a renal dialysis service. However, if the panel is furnished for the treatment of ESRD it is the responsibility of the ESRD facility and should be reported on the facility’s claim.
A. Automated Multi-Channel Chemistry (AMCC) Tests
During the ESRD PPS transition period (see §70 of this chapter) ESRD facilities were required to report the renal dialysis AMCC tests with the appropriate modifiers (CD, CE, or CF) on their claims for purposes of applying the 50/50 rule under the composite rate portion of the blended payment. Refer to §70.B of this chapter for additional information regarding the composite rate portion of the blended payment during the transition.
The 50/50 rule is necessary for those ESRD facilities that chose to go through the transition period. If the 50/50 rule allows for separate payment, then the laboratory tests are priced using the clinical laboratory fee schedule. Information regarding the 50/50 rule can be found in §20.2.E of this chapter and in Pub. 100-04, Medicare Claims Processing Manual, chapter 16, §40.6.
NOTE: An ESRD facility billing a renal dialysis AMCC test must use the CF modifier when the AMCC is not in the composite rate but is a renal dialysis service. AMCC tests that are furnished to individuals for
reasons other than for the treatment of ESRD should be billed with the AY modifier to Medicare directly by the entity furnishing the service with the AY modifier.
B. Laboratory Services Furnished for Reasons Other Than for the Treatment of ESRD
1. Independent Laboratory
A patient’s physician or practitioner may order a laboratory test that is included on the list of items and services subject to consolidated billing edits for reasons other than for the treatment of ESRD. When this occurs, the patient’s physician or practitioner should notify the independent laboratory or the ESRD facility (with the appropriate clinical laboratory certification in accordance with the Clinical Laboratory Improvement Act) that furnished the laboratory service that the test is not a renal dialysis service and that entity may bill Medicare separately using the AY modifier. The AY modifier serves as an attestation that the item or service is medically necessary for the patient but is not being used for the treatment of ESRD.
2. Hospital-Based Laboratory
Hospital outpatient clinical laboratories furnishing renal dialysis laboratory tests to ESRD patients for reasons other than for the treatment of ESRD may submit a claim for separate payment using the AY modifier. The AY modifier serves as an attestation that the item or service is medically necessary for the patient but is not being used for the treatment of ESRD.
C. Laboratory Services Performed in Emergency Rooms or Emergency Departments
In an emergency room or emergency department, the ordering physician or practitioner may not know at the time the laboratory test is being ordered, if it is being ordered as a renal dialysis service. Consequently, emergency rooms or emergency departments are not required to append an AY modifier to these laboratory tests when submitting claims with dates of service on or after January 1, 2012.
When a renal dialysis laboratory service is furnished to an ESRD patient in an emergency room or emergency department on a different date of service, hospitals can append an ET modifier to the laboratory tests furnished to ESRD patients to indicate that the laboratory test was furnished in conjunction with the emergency visit. Appending the ET modifier indicates that the laboratory service being furnished on a day other than the emergency visit is related to the emergency visit and at the time the ordering physician was unable to determine if the test was ordered for reasons of treating the patient’s ESRD.
Allowing laboratory testing to bypass consolidated billing edits in the emergency room or department does not mean that ESRD facilities should send patients to other settings for routine laboratory testing for the purpose of not assuming financial responsibility of renal dialysis items and services. For additional information regarding laboratory services furnished in a variety of settings, see Pub. 100-04, Medicare Claims Processing Manual, chapter 16, §30.3 and §40.6.
D. Hepatitis B Laboratory Services for Transient Patients
Laboratory testing for hepatitis B is a renal dialysis service. Effective January 1, 2011, hepatitis B testing is included in the ESRD PPS and therefore cannot be billed separately to Medicare.
The Conditions for Coverage for ESRD facilities require routine hepatitis B testing (42 CFR §494.30(a)(1)). The ESRD facility is responsible for the payment of the laboratory test, regardless of frequency. If an ESRD patient wishes to travel, the patient’s home ESRD facility should have systems in place for communicating hepatitis B test results to the destination ESRD facility.
E. Laboratory Services Included Under Composite Rate
specified, they were covered only if accompanied by medical documentation. A diagnosis of ESRD alone was not sufficient documentation. The medical necessity of the test(s), the nature of the illness or injury (diagnosis, complaint or symptom) requiring the performance of the test(s) must have been furnished on claims using the ICD diagnosis coding system.
- Separately Billable Tests for Hemodialysis, IPD, CCPD, and Hemofiltration
Serum Aluminum - one every 3 months Serum Ferritin - one every 3 months
- Separately Billable Tests for CAPD
WBC, RBC, and Platelet count – One every 3 months Residual renal function and 24 hour urine volume – One every 6 months
Under the ESRD PPS frequency requirements do not apply for the purpose of payment. However, laboratory tests should be ordered as necessary and should not be restricted because of financial reasons.
3. Automated Multi-Channel Chemistry (AMCC) Tests Under the Composite Rate
Clinical diagnostic laboratory tests that comprise the AMCC (listed in Appendix A and B) could be considered to be composite rate and non-composite rate laboratory services. Composite rate payment was paid by the A/B MAC (A). To determine if separate payment was allowed for non-composite rate tests for a particular date of service, 50 percent or more of the covered tests must be non-composite rate tests. This policy also applies to the composite rate portion of the blended payment during the transition. Beginning January 1, 2014, the 50 percent rule will no longer apply and no separate payment will be made under the composite rate portion of the blended payment.
Medicare applied the following to AMCC tests for ESRD beneficiaries:
- Payment was the lowest rate for services performed by the same provider, for the same beneficiary, for the same date of service.
- The A/B MAC identified, for a particular date of service, the AMCC tests ordered that were included in the composite rate and those that were not included. The composite rate tests were defined for Hemodialysis, IPD, CCPD, and Hemofiltration (see Appendix A) and for CAPD (see Appendix B).
- If 50 percent or more of the covered tests were included under the composite rate payment, then all submitted tests were included within the composite payment. In this case, no separate payment in addition to the composite rate was made for any of the separately billable tests.
- If less than 50 percent of the covered tests were composite rate tests, all AMCC tests submitted for that Date of Service (DOS) were separately payable.
- A non-composite rate test was defined as any test separately payable outside of the composite rate or beyond the normal frequency covered under the composite rate that was reasonable and necessary.
Three pricing modifiers identify the different payment situations for ESRD AMCC tests. The physician who ordered the tests was responsible for identifying the appropriate modifier when ordering the tests.
- CD - AMCC test had been ordered by an ESRD facility or Medicare capitation payment (MCP) physician that was part of the composite rate and was not separately billable
- CE - AMCC test had been ordered by an ESRD facility or MCP physician that was a composite rate test but was beyond the normal frequency covered under the rate and was separately reimbursable based on medical necessity
- CF - AMCC test had been ordered by an ESRD facility or MCP physician that was not part of the composite rate and was separately billable
The ESRD clinical diagnostic laboratory tests identified with modifiers “CD”, “CE” or “CF” may not have been billed as organ or disease panels. Effective October 1, 2003, all ESRD clinical diagnostic laboratory tests must be billed individually. See Pub. 100-04, Medicare Claims Processing Manual, chapter 16, §40.6.1, for additional billing and payment instructions as well as examples of the 50/50 rule.
For ESRD dialysis patients, CPT code 82330 Calcium; ionized shall be included in the calculation for the 50/50 rule (Pub. 100-04, Medicare Claims Processing Manual, chapter 16, §40.6.1). When CPT code 82330 is billed as a substitute for CPT code 82310, Calcium; total, it shall be billed with modifier CD or CE. When CPT code 82330 is billed in addition to CPT 82310, it shall be billed with CF modifier.
20.3 - Drugs and Biologicals
(Rev. 224, Issued: 06-03-16, Effective: 01-01-16, Implementation: 09-06-16)
All drugs and biologicals used for the treatment of ESRD are included in the ESRD PPS and are not separately paid as of January 1, 2011. The drugs and biologicals include but are not limited to:
- Drugs and biologicals included under the composite rate as of December 31, 2010 (discussed below);
- Former separately billable Part B injectable drugs;
- Oral or other forms of injectable drugs used for the treatment of ESRD formerly billed under Part D; and
- Oral or other forms of drugs and biologicals without an injectable form. (Implementation delayed until January 1, 2025.)
See §60.D of this chapter for details on drug eligibility under the outlier payment policy.
Drugs and biologicals furnished to ESRD beneficiaries that are not used for the treatment of ESRD, may be paid separately. When drugs or biologicals are furnished to an ESRD beneficiary and are not a renal dialysis service, the ESRD facility or other provider shall append the claim with the AY modifier to receive separate payment. For more information regarding the AY modifier refer to Pub. 100-04, Medicare Claims Processing Manual, chapter 8, §60.2.1.1.
Drugs and biologicals identified for consolidated billing are designated as always renal dialysis services and therefore no separate payment is made to ESRD facilities or other providers when these drugs are furnished to ESRD beneficiaries. The list of drugs and biologicals used for the ESRD PPS consolidated billing may be viewed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/ESRDpayment/Consolidated_Billing.html. Information regarding consolidated billing requirements for drugs and biologicals can be found in §10.F. of this chapter and in Pub. 100-04, Medicare Claims Processing Manual, chapter 8, §60.2.1.1.
This list is used to enforce consolidated billing edits which ensure that payment is not made for renal dialysis drugs and biologicals outside of the ESRD PPS. This is not an all-inclusive list and any drug or biological that is used for the same purpose as those drugs and biologicals on the list are also included under the ESRD PPS. Providers other than ESRD facilities furnishing those drugs must look to the ESRD facility for payment.
ESRD facilities are responsible for furnishing antibiotics for access site infections directly or under arrangement. When antibiotics are used at home by a patient to treat an infection of the catheter site or peritonitis associated with peritoneal dialysis, the antibiotics are included in the ESRD PPS and may not be paid separately. This includes antibiotics that may be added to a patient’s dialysate solution for the purposes of vascular access-related and peritonitis infections.
Any other drugs (other than those categories described above and below) when used for the treatment of ESRD are also included in the ESRD PPS. For example,
- Patient A experiences nausea or pain during a hemodialysis dialysis treatment and requires medications. Any medication furnished during the dialysis treatment or after the treatment is considered a renal dialysis service and may not be billed separately.
- Patient B experiences anxiety with dialysis treatments and is prescribed anti-anxiety medication during and between the dialysis treatments. Any medications furnished in preparation for the dialysis treatment, during the dialysis treatment or after the dialysis treatment, is considered a renal dialysis service and may not be billed separately.
- Any drug or biological added to patient dialysate solutions.
Functional Categories Included in the ESRD Base Rate but May be Used for Dialysis and Non- Dialysis Purposes
Category Rationale for Association Antiemetic Used to prevent or treat nausea and vomiting related to dialysis. Excludes antiemetics used for purposes unrelated to dialysis, such as those used in conjunction with chemotherapy as these are covered under a separate benefit category. Anti-infectives Used to treat vascular access-related and peritonitis infections. May include antibacterial and antifungal drugs. Antipruritic Drugs in this classification have multiple clinical indications. Use within an ESRD functional category includes treatment for itching related to dialysis. Anxiolytic Drugs in this classification have multiple actions. Use within an ESRD functional category includes treatment of restless leg syndrome related to dialysis. Excess Fluid Management
Drug/fluids used to treat fluid excess/overload.
Fluid and Electrolyte Management Including Volume Expanders
Intravenous drugs/fluids used to treat fluid and electrolyte needs.
Pain Management Drugs used to treat vascular access site pain and to treat pain medication overdose, when the overdose is related to medication provided to treat vascular access site pain.
B. Injectable Drugs and Biologicals
All injectable drugs or biologicals used for the treatment of ESRD are included in the ESRD PPS and are not separately paid. This includes renal dialysis drugs and biologicals that prior to the implementation of the ESRD PPS were separately billable under Part B. During the transition period, ESRD facilities receiving a blended payment were permitted to receive a separate payment for these drugs and biologicals under the composite rate portion of the blend during the transition. Since January 1, 2014, all facilities are paid 100 percent under the ESRD PPS and no separate payment is permitted for drugs and biologicals used for the treatment of ESRD. For more information on the transition, see §70 of this chapter.
Injectable drugs and biologicals furnished to Medicare ESRD patients that are not used for the treatment of ESRD may continue to be paid separately, when reported on the claim with an AY modifier. See §20.4.C of this chapter for more information on the AY modifier.
NOTE: ESRD patients should not be sent to other settings for the purpose of receiving separate payment for renal dialysis injectable drugs and biologicals or for the purpose of not assuming financial responsibility for renal dialysis items and services.
ESRD facilities must report the appropriate Healthcare Common Procedure Coding System (HCPCS) codes used for the administration and furnishing of renal dialysis drugs and biologicals. This includes drugs and biologicals that are furnished in the beneficiary’s home. These supplies include:
- A4657: Injection administration-supply charge (includes the cost of alcohol swab, syringe, and gloves) and
- A4913: IV administration-supply charge (includes the cost of IV solution administration set, alcohol swab, syringe, and gloves). A4913 should only be used when an IV solution set is required for a drug to be given.
See Pub. 100-04, Medicare Claims Processing Manual, chapter 8, §60.2.1 for billing procedures. These supplies are eligible for payment as outlier services in accordance with §60.D of this chapter.
C. Oral or Other Forms of Injectable Drugs and Biologicals
The ESRD PPS includes certain drugs and biologicals that were previously paid under Part D. Oral or other forms of injectable renal dialysis drugs and biologicals, for example, Vitamin D analogs, Levocarnitine, antibiotics or any other oral or other form of injectable drug or biological furnished as renal dialysis services are also included in the ESRD PPS and may not be separately paid.
The ESRD facility should report any drug or biological furnished on the ESRD claim with the line item date of service and the quantity of the drug or biological furnished at the time of the visit. For claims processing instructions see Pub. 100-04, Medicare Claims Processing Manual, chapter 8, §60.2.1.2.
For oral or other forms of renal dialysis drugs that are filled at the pharmacy for home use, ESRD facilities should report one line item per prescription, but only for the quantity of the drug expected to be taken during the claim billing period.
Example: A prescription for oral vitamin D was ordered for one pill to be taken 3 times daily for a period of 45 days. The patient began taking the medication on April 15, 2011. On the April claim, the ESRD facility would report the appropriate National Drug Code (NDC) code for the drug with the quantity 45 (15 days x 3 pills per day). The remaining pills which would be taken in May would appear on the May claim for a quantity of 90 (30 days x 3 pills per day). Prescriptions for a 3 month supply of the drug would never be reported on a single claim. Only the amount expected to be taken during the month would be reported on that month’s claim.
Oral and other forms of injectable renal dialysis drugs are eligible for consideration as outlier services. See the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/ESRDpayment/Outlier_Services.htmlfor a list of these drugs. CMS prices these drugs using national average drug prices based on the Medicare Prescription Drug Plan Finder. Payment also includes a mean dispensing fee that is applied to each NDC included on the monthly claim, in accordance with Pub. 100-04, Medicare Claims Processing Manual, chapter 8, §60.2.1.2.
Payments for oral or other forms of renal dialysis injectable drugs or biologicals are included in the ESRD PPS and are only made to the ESRD facility. ESRD facilities should report all oral or other forms of renal dialysis injectable drugs and biologicals furnished to their patients on the claim.
