(Medicare Benefit Policy Manual)

Medicare Benefit Policy Manual  Chapter 11 - End Stage Renal Disease (ESRD)   Table of Contents  (Rev. 2 57, 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 Trainin g 40 - Other Services  50 - ESRD Prospective Payment System (PPS) Base Rat e 60 - ESRD PPS Case -Mix Adjustment s 70 - ESRD PPS Transition Period  80 - Bad Debt s 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 B iologicals  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 Trainin g 40 - Other Services  50 - ESRD Prospective Payment System (PPS) Base Rat e 60 - ESRD PPS Case -Mix Adjustment s 70 - ESRD PPS Transition Period  80 - Bad Debt s 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 Ra te 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 Ra tes 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 Preentitlemen t Period  140.6 -  Kidney Recipient Admitted for Transplant Evaluation 140.7 -  Kidney Recipient Evaluated for Transplant During Inpatient Stay  140.8 -  Kidney Reci pient 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   10 - Definitions Relating to ESRD  (Rev. 224, Issued: 06- 03-16, Effective: 01- 01-16, Implementation: 09- 06-16)  End Stage Renal Disease (ESRD) occurs from the destruction of normal kidney tissues over a long period of time.  Often there are no symptoms until the kidney has lost more than half its function.  The loss of kidney function in ESRD is usually irreversible and permanent.   Dialysis services furnished to  hospital in -patients are covered under Medicare Part A and paid in accordance with applicable payment rules.   ESRD facilities must be certified by Medicare and are required to comply with the Conditions for Coverage set forth in 42 CFR Part 494.  Survey a nd certification information for ESRD facilities can be found at the following Centers for Medicare and Medicaid Services website: http://www.cms.gov/Medicare/Provider -Enrollment -and-Certification/GuidanceforLawsAndRegulations/Dialysis.html .  ESRD PPS is covered under Medicare Part B.   Medicare Part B covers the services listed below unless otherwise noted.   A.  Dialysis   Dialysis is  the process of removing waste products from the body by diffusion from one fluid compartment to another across a semi -permeable membrane.  Dialysis procedures can include hemodialysis, peritoneal dialysis, hemofiltration and ultrafiltration.  Of these typ es of dialysis procedures, two are commonly used for the treatment of ESRD: hemodialysis and peritoneal dialysis.   1.  Hemodialysis -  Blood passes through an artificial kidney machine and the waste products diffuse across a manmade membrane into a bath sol ution known as dialysate after which the cleansed blood is returned to the patients body.  Hemodialysis is accomplished usually in 3 to 5 hour sessions, 3 times a week.  See 50.A.1 of this chapter for payment information.   2.  Peritoneal -  Waste products  pass from the patients body through the peritoneal membrane into the peritoneal (abdominal) cavity where the bath solution (dialysate) is introduced and removed periodically.  See 50.A.4 of this chapter for payment information.  Peritoneal dialysis is p articularly suited for:    Patients without caregivers to assist in self -dialysis;    Children;    Patients with no peripheral sites available for fistula or cannula placement;    Patients who have difficulty learning the more complex hemodialysis technique; and    Elderly patients with cardiovascular disease who are unable to tolerate intravascular fluid shifts associated with hemodialysis.   The three types of peritoneal dialysis are listed below:   a. Continuous Ambulatory Peritoneal Dialysis (CAPD)  - In CAPD, the patients peritoneal membrane is used as a dialyzer.  The patient connects a 2 -liter plastic bag of dialysate to a surgically implanted indwelling catheter that allows the dialysate to pour into the beneficiarys peritoneal cavity.  Every 4 to 6 hours the patient drains the fluid out into the same bag and replaces the empty bag with a new bag of fresh dialysate.  This is done several times a day.   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 patie nt 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 patients body through the peritoneal membrane into th e 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 a cross 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 occ ur 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 simi lar management functions;    The ESRD facilitys director or administrator is under the supervision of the hospitals chief executive officer and reports through that officer to the governing board;    The ESRD facilitys personnel policies and practices conf orm 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 integrat ed, 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 referra l 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 do es 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 a rrangement).  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.