(Medicare Benefit Policy Manual)

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.   2.  Separately Billable Tests Under the Composite Rate   The following list identifies certain separately billable laboratory tests that were covered routinely and without documentation of medical necessity other than knowledge  of the patients status as an ESRD beneficiary, when furnished at specified frequencies.  If they were performed at a frequency greater than that 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 fo llowing 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 pe rcent 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 modif ier 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 a re 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, Medica re 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://ww w.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 Process ing 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.   NOTE:   Effective January 1, 2012, ESRD facilities and other providers may receive separate payment for vancomycin by placing the AY modifier on the claim when vancomycin is furnished for reasons other than for the treatment of ESRD.  The ESRD facility must indicate the appropriate ICD diag nosis code for which the vancomycin is indicated.  NOTE:   Effective January 1, 2013, ESRD facilities and other providers may receive separate payment for daptomycin by placing the AY modifier on the claim when daptomycin is furnished for reasons other than for the treatment of ESRD.  The ESRD facility must indicate the appropriate ICD diagnosis code for which the daptomycin is indicated.  See Pub.100- 04, Medicare Claims Processing Manual, chapter 8, 60.2.1.1 for additional information.  A.  ESRD PPS Functional Categories   The ESRD PPS functional category is a distinct grouping of drugs and biologicals, as determined by CMS, whose end action effect is the treatment or management of a condition or conditions associated with ESRD.  The Drug Designation P rocess is dependent on the functional categories, as discussed in section 20.3.1.  Drugs and biologicals always considered to be renal dialysis services are those used for access management, anemia management, bone and mineral metabolism management, and cellular management.  ESRD facilities are responsible for furnishing these drugs directly or under arrangement.  This includes any drug or biological that is furnished in the ESRD facility or taken by the patient outside of the ESRD facility.   Erythropoiesis  stimulating agents (ESAs), such as epoetin alfa (EPOGEN) and darbepoetin alfa (ARANESP) when furnished to Medicare ESRD patients are always considered to be renal dialysis services and included in the ESRD PPS.  Monthly dosages of these ESAs are subject  to Medicares ESA claims monitoring policy.  See Pub. 100- 04, Medicare Claims Processing Manual, chapter 8, 60.4.1 for more information on the ESA monitoring policy.   NOTE:   ESA dose edits are applied prior to pricing so that ESAs are not overvalued in determining eligibility for outlier payments.   Functional Categories Included in the ESRD PPS Base Rate, Always Considered to be Renal Dialysis Services, and Not Separately Payable   Category  Rationale for Association  Access Management  Drugs used to ensure  access by removing clots from grafts, reverse anticoagulation if too much medication is given, and provide anesthetic for access placement.  Anemia Management  Drugs used to stimulate red blood cell production and/or treat or prevent anemia.  This category includes ESAs as well as iron.  Bone and Mineral Metabolism  Drugs used to prevent/treat bone disease secondary to dialysis.  This category includes phosphate binders and calcimimetics.  Cellular Management  Drugs used for deficiencies of naturally occurring substances needed for cellular management.  This category includes levocarnitine.   Drugs and biologicals included in the ESRD PPS base rate that may be used for both the treatment of ESRD and for reasons other than the treatment of ESRD are thos e used as antiemetics, anti -infectives, antipruritics, anxiolytics, excess fluid management, fluid and electrolyte management including volume expanders, and pain management.  ESRD facilities are responsible for furnishing these drugs directly or under arr angement when they are prescribed for the treatment of ESRD.  This includes any drug or biological that is furnished in the ESRD facility or taken by the patient outside of the ESRD facility.   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 patients 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 Includ ed in the ESRD Base Rate but May be Used for Dialysis and Non -Dialysis Purposes