evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
*  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 facilitys 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 dial ysis 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 Furn ished for Reasons Other Than for the Treatment of ESRD   1.  Independent Laboratory   A patients 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 patients 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
(Medicare Benefit Policy Manual)
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 subm it 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, emergen cy 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. Append ing 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 treati ng the patients 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 ass uming 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.  Hepatit is 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.
(Medicare Benefit Policy Manual)
D.  Hepatit is 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 Conditi ons 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 patients home ESR D facility should have systems in place for communicating hepatitis B test results to the destination ESRD facility.   E.  Laboratory Services Included Under Composite Rate   Prior to the implementation of the ESRD PPS, the costs of certain ESRD laboratory services furnished for outpatient maintenance dialysis by either the ESRD facilitys staff or an independent laboratory, were included in the composite rate calculations.  Therefore, payment for all of these laboratory tests was included in the ESRD facili tys composite rate and the tests could not have been billed separately to the Medicare program.   All laboratory services that were included under the composite rate are included under the ESRD PPS unless otherwise specified.  Payments for these laboratory  tests are included in the ESRD PPS and are not paid separately under the composite rate portion of the blended payment and are not eligible for outlier payments.  Therefore, composite rate laboratory services should not be reported on the claim.  Laboratory tests included in the composite payment rate are identified below.   1.  Routinely Covered Tests Paid Under Composite Rate   The tests listed below are usually performed for dialysis patients and were routinely covered at the frequency specified in the ab sence of indications to the contrary, (i.e., no documentation of medical necessity was required other than knowledge of the patients status as an ESRD beneficiary).  When any of these tests were performed at a frequency greater than that specified, the ad ditional tests were separately billable and were covered only if they were medically justified by accompanying documentation.  A diagnosis of ESRD alone was not sufficient medical evidence to warrant coverage of the additional tests.  The nature of the ill ness or injury (diagnosis, complaint, or symptom) requiring the performance of the test(s) must have been present, along with ICD diagnosis coding, on the claim for payment.
(Medicare Benefit Policy Manual)
a. Hemodialysis, IPD, CCPD, and Hemofiltration    Per Treatment  - All hematocrit, h emoglobin, and clotting time tests furnished incident to dialysis treatments;   Weekly -  Prothrombin time for patients on anticoagulant therapy and Serum Creatinine;    Weekly or Thirteen Per Quarter - BUN;    Monthly  - Serum Calcium, Serum Potassium, Serum Chloride, CBC, Serum Bicarbonate, Serum Phosphorous, Total Protein, Serum Albumin, Alkaline Phosphatase, aspartate amino transferase (AST) (SGOT) and LDH; and    Automated Multi- Channel Chemistry (AMCC)  - If an automated battery of tests, such as the SMA -12, is performed and contains most of the tests listed in one of the weekly or monthly categories, it is not necessary to separately  identify any tests in the battery that are not listed.  Further informat ion concerning automated tests and the 50 percent rule can be found below and in Pub. 100- 04, Medicare Claims Processing Manual, chapter 16, 40.6.1.  b. CAPD   Monthly  BUN, Creatinine, Sodium, Potassium, CO2, Calcium, Magnesium, Phosphate, Total Protei n, Albumin, Alkaline Phosphatase, LDH, AST, SGOT, HCT, Hbg, and Dialysate Protein.   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.
(Medicare Benefit Policy Manual)
 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.
(Medicare Benefit Policy Manual)
 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)
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
 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   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 categ ory 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 ele ctrolyte 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 Par t 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 fa cilities 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.