Article - Billing and Coding: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A59576)

In determining whether an off-label use is supported, the contractor will consider (among other things) the following:Whether the clinical characteristics of the beneficiary and the cancer are adequately represented in the published evidence.Whether the administered chemotherapy regimen is adequately represented in the published evidence.Whether the reported study outcomes represent clinically meaningful outcomes experienced by patients.Whether the study is appropriate to address the clinical question.The contractor will consider:Whether the experimental design, in light of the drugs and conditions under investigation, is appropriate to address the investigative question. (For example, in some clinical studies, it may be unnecessary or not feasible to use randomization, double blind trials, placebos, or crossover);that non-randomized clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs; andthat case reports are generally considered uncontrolled and anecdotal information and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.Coverage will be determined based on the results of peer reviewed medical literature published in the regular editions of the following publications, not to include supplement editions privately funded by parties with a vested interest in the recommendations of the authors:American Journal of MedicineAnnals of Internal MedicineAnnals of OncologyAnnals of Surgical OncologyBiology of Blood and Marrow TransplantationBloodBone Marrow TransplantationBritish Journal of CancerBritish Journal of HematologyBritish Medical JournalCancerClinical Cancer ResearchDrugsEuropean Journal of Cancer (formerly The European Journal of Cancer and Clinical Oncology)Gynecologic OncologyInternational Journal of Radiation, Oncology Biology, and PhysicsThe Journal of the American Medical AssociationJournal of Clinical OncologyJournal of the National Cancer InstituteJournal of the National Comprehensive Cancer Network (NCCN)Journal of UrologyLancetLancet OncologyLeukemiaThe New England Journal of MedicineRadiation OncologyWhen the provider decides to use an FDA approved chemotherapeutic agent off-label, the evidence used to make that decision (information in the compendia, established guidelines [for example, guidelines developed by the NCCN], research studies in approved peer-reviewed medical journals, etc.) must be available upon request. Physicians or suppliers are expected to be able to produce copies of relevant supporting full-text articles, guidelines, and/or supporting literature when an unlabeled use does not appear in at least one of the approved compendia, or the unlabeled use is listed in the compendia as having insufficient data or as investigational. Abstracts, opinions, or book chapters are not acceptable.If a use is identified as not indicated by the CMS or the FDA, specifically identified as not indicated in one or more compendia listed, or the contractor determines, based on peer-reviewed medical literature, that a particular use of a drug is not safe and effective, the off-label usage is not supported. Therefore, the drug is not covered.Hydration Administration (CPT codes 96360 and 96361)Medicare currently allows separate payment of hydration therapy provided sequentially (but not concurrently) to chemotherapy infusion.CPT codes 96360 and 96361 are intended to report a hydration intravenous (IV) infusion consisting of a prepackaged fluid and/or electrolyte solutions (e.g., normal saline, D5-1/2 normal saline +30 mEq KC1/liter) but are not used to report infusion of drugs or other substances. Hydration IV infusion typically requires direct physician supervision for purposes of consent, safety oversight or intra-service supervision of staff. Typically, such infusions require little special handling to prepare or dispose of, and staff which administer these do not typically require advanced training. After initial set up, infusion typically entails little patient risk and thus little monitoring. Further instructions regarding hydration and its use may be found in the CPT Manual, particularly with regard to facilities. In addition, certain coding combinations are not permissible by the National Correct Coding Initiative (NCCI) edits.JW Modifier RequirementThe CMS encourages physicians, hospitals and other providers and suppliers to care for and administer drugs and biologicals to patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner. According to the Social Security Act (SSA) Section 1861(v)(1)(A), the reasonable cost of any service is the cost actually incurred, excluding any part of an incurred cost found to be unnecessary in the efficient delivery of needed health services. On this basis, the definition of a reasonable cost for a drug or biological is met when the beneficiary is administered the required dose of the drug or biological in an efficient manner.Effective January 1, 2017, when billing for drugs and biologicals (except those provided under the Competitive Acquisition Program for Part B drugs and biologicals [CAP]),the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required.The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded amounts of drugs or biologicals in the patients medical record.The following elements must be followed in order for the discarded amount to be covered.The vial/package must be a single-use vial/package.The units billed must correspond with the smallest dose (vial) available for purchase from the manufacturer/supplier that could provide the appropriate dose for the patient.The left-over amount must actually be discarded and may not be used for another patient regardless of whether or not that other patient has Medicare.A situation in which the JW modifier is not permitted is when the actual dose of the drug or biological administered is less than the billing unit. For example, one billing unit for a drug is equal to 10mg of the drug in a single use vial. A 7mg dose is administered to a patient while 3mg of the remaining drug is discarded. The 7mg dose is billed using one billing unit that represents 10mg on a single line item. The single line item of 1 unit would be processed for payment of the total 10mg of drug administered and discarded. Billing another unit on a separate line item with the JW modifier for the discarded 3mg of drug is not permitted because it would result in overpayment. Therefore, when the billing unit is equal to or greater than the total actual dose and the amount discarded, the use of the JW modifier is not permitted.JZ Modifier RequirementEffective 07/01/2023, providers must report the JZ modifier (Zero drug amount discarded/not administered to any patient) when there is no wastage to report. This must be reported on all claims that bill for drugs separately payable under Part B when there is no discarded amount from single-dose containers or single-use packages. For the amount administered, the claim line must include the billing and payment code, the JZ modifier showing no discarded amounts, and the number of units administered in the units field.The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting or to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator N1 (ASC).Coding GuidanceThe HCPCS/CPT code(s) may be subject to NCCI edits. This information does not take precedence over NCCI edits. Please refer to the NCCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.All injection claims must include the specific name of the drug and dosage. Identification of the drug enables proper payment for the services.Services related to non-covered services or drugs are also not covered (e.g., administration services).When the drug is purchased by the beneficiary, or when the drug was supplied without charge by the manufacturer, it should NOT be billed to Medicare by the provider, even with a submitted charge of $0.00.Reporting the Appropriate Number of UnitsIf the "J" code descriptor can be multiplied to reflect the dosage being administered, use the J-code, with the appropriate number of units which reflect the dosage given.It is not appropriate to use the "J" code with a multiplier in the units field when there is another "J" code which more closely describes the amount given.It is not appropriate to bill for the full amount of a drug when it has been split between two or more patients. Bill only for the amount given to each beneficiary.Reporting Not Otherwise Classified (NOC) Code(s)Please refer to Billing and Coding Articles A59074, Complex Drug Administration Coding for information regarding billing NOC codes.Reporting Evaluation and Management (E/M) Visit on the Same Day as Drug Administration ServicesThe E/M service for CPT code 99211 cannot be paid if it is billed with a drug administration service. This includes a chemotherapy or nonchemotherapy drug infusion service, as well as a therapeutic or diagnostic injection code.When a medically necessary, significant and separately identifiable E/M service (which meets a higher complexity level than CPT code 99211) is performed, in addition to drug administration service(s), the appropriate E/M CPT code should be reported with modifier -25. Documentation should support the level of E/M service billed. For an E/M service provided on the same day, a different diagnosis is not required.Please refer to the CMS IOM Publication 100-04, Chapter 12, Sections 20.3.B, 30.5.C, D, F, 30.6.6 and 30.6.7.D for additional information on E/M services furnished on the same day as drug administration services.Please refer to Billing and Coding Articles A59074, Complex Drug Administration Coding for information regarding chemotherapy and nonchemotherapy drug administration codes.Reporting Multiple Infusions or InjectionsWhen administering multiple infusions, injections, or combinations, only one "initial" drug administration service code should be reported per patient per day, unless protocol requires that two separate IV sites must be used. The initial code is the code that best describes the key or the primary reason for the encounter and is reported irrespective of the order in which the infusions or injections occur.If an injection or infusion is of a subsequent or concurrent nature, even if it is the first such service within that group of services, the subsequent or concurrent code from the appropriate section should be reported (e.g., the first IV push given subsequent to an initial one-hour infusion is reported using a subsequent IV push code).Report separate codes for each parenteral method of administration employed when therapy is administered by different techniques. Medications (e.g., antibiotics, steroidal agents, antiemetics, narcotic analgesics) administered independently or sequentially as supportive management of chemotherapy or certain monoclonal antibody administration should be separately reported using CPT codes 96360, 96361, 96365 or 96379 as appropriate. Report the specific service as well as the code(s) for the specific substance or drug(s) provided.There is no code for concurrent administration of chemotherapeutic drugs. Multiple drugs given at the same session are considered to be sequential, rather than concurrent. The services are reported with CPT code 96411 for IV push administration of additional drugs/substances at the same session and CPT code 96417 for IV infusion administration of additional drugs/substances at the same session.Modifier EJ  Subsequent Dose in a SeriesTo distinguish between the initial dose of a drug and subsequent doses of that same drug used in a sequential series in the treatment of a condition, the modifier EJ should be used to identify the subsequent doses. Do not report an initial dose of a drug with the EJ modifier.Reporting Infusion Time(s) and FluidWhen reporting codes for which infusion time is a factor, use the actual time over which the infusion is administered. Services leading up to the infusion and to conclude the infusion are included in the infusion service and not separately reported. The services include starting the IV and monitoring the patient post-infusion. Standard clinical practice is to document the actual start and stop times in the patients medical records. This would ensure that the times are accurate in the event there are interruptions or delays during the infusion process. Flow sheets kept by personnel during infusion services help to identify proper infusion times. Time may be documented with start and stop times or with total time.The first hour initial codes are defined as "up to one hour". This eliminates the need to report the 52 modifier to inform Medicare of durations of less than one hour.Report the additional hour of chemotherapy administration with CPT code 96415 for infusion intervals of greater than 30 minutes beyond one hour increments. Report CPT code 96415 in conjunction with the initial chemotherapy administration CPT code 96413.The fluid used to administer the drug(s) is considered incidental hydration and is not separately reportable. An infusion consisting of three substances in a single bag is not intended to be reported as three separate infusion services.Do not report the initial hydration CPT code 96360 if performed as a concurrent infusion service. Report the additional hour of hydration with CPT code 96361 to identify hydration furnished as a secondary or subsequent service after a different initial service is administered through the same IV access.Report the additional hour or additional sequential CPT code 96366, 96367, 96375 or 96376 (as applicable) to identify therapeutic, prophylactic or diagnostic nonchemotherapy drug infusion or injection when provided as a secondary or subsequent service in association with chemotherapy administration CPT code 96413.Report the additional sequential infusion chemotherapy administration CPT code 96417 in conjunction with the initial chemotherapy administration CPT code 96413. Report CPT code 96417 only once per sequential infusion.Report irrigation CPT code 96523 if it is the only service provided that day. If there is an E/M visit or other drug administration service provided on the same day, payment for CPT code 96523 is included in the payment for the other service.Report CPT code 36593 for declotting a catheter or port.Please refer to Billing and Coding Articles A59074, Complex Drug Administration Coding for additional information regarding chemotherapy and nonchemotherapy drug administration codes.