Coding Guidelines

The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This information does not take precedence over CCI edits. Please refer to CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.

If 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. 

NOC codes should only be reported for those drugs that do not have a valid HCPCS code which describes the drug being administered.

When appropriate, the NOC code is selected based upon the therapeutic value of the drug (e.g., J8999 Prescription drug, oral, chemotherapeutic, NOS; J3490 Unclassified drugs, etc.)

When billing with an NOC code, include on the claim, the narrative description reflective of the agent and the dose administered.

Where the sole purpose of an office visit was for the patient to receive an injection, (90772, 90773, 90774, and 90779) payment may be made only for the injection service (if it is covered).

Conversely, injection services (codes 90772, 90773, 90774, and 90779) included in the Medicare Physician Fee Schedule (MPFS) are not paid for separately, if the physician is paid for any other physician fee schedule service furnished at the same time.

The injection or infusion of certain cancer drugs not used to treat cancer, monoclonal antibodies and cancer chemotherapy injections (CPT codes 96401-96549) will be paid in addition to a significant separately identifiable Evaluation and Management service performed on the same day, when billed.

The drug is separately payable. All injection claims must include the specific name of the drug and dosage. Identification of the drug enables proper payment for the services.

Off-label Usage of an FDA-Approved Drug 

An unlabeled use of a drug is a use that is not included as an indication on the drug's label as approved by the FDA. FDA-approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the criteria below are met.

An off-label usage of an FDA-approved drug will be considered for coverage when there are no specific contraindications and one of the following criteria is met.

1. Its usage is supported by one or more citations in at least one of the drug compendia listed below, and the usage is not listed as "not indicated" in any of the compendia listed below:
   • American Hospital Formulary Service Drug Information
   • American Medical Association Drug Evaluations
   • United States Pharmacopoeia Drug Information (USPDI)

2. The use is supported by clinical research that appears in peer-reviewed medical literature. This applies only when an unlabeled use does not appear in any of the compendia or is listed as insufficient data or investigational. Peer-reviewed medical literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts). Furthermore, the level of evidence in each article must be determined.

Levels of evidence, as defined below, will be used use to assess research and to determine a grade of recommendation for a particular medical treatment.

	Level 1: Randomized controlled trials/meta analyses
	Level 2: Cohort studies
	Level 3: Case controlled studies
	Level 4: Cross sectional surveys, case reports, or case series
	Level 5: Expert opinion

If the peer-reviewed literature is a Level 1 study, the use of that specific therapeutic agent is considered to be the community standard and the agent is covered. However, if the peer-reviewed literature is a Level 2, 3, or 4 study two or more articles by different authoring groups are required to establish the use of the therapeutic agent as the community standard before the agent will be covered. If the literature is only Level 5 then the agent has not been established as a community standard and will not be covered. The design, conduct and analysis of trials are important factors as well. For example, a well designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size.

In determining whether there is supportive clinical evidence for a particular use of a drug, the quality of the published evidence must be considered. Such consideration involves the assessment of the following study characteristics:

• The adequacy of the number of subjects;
• The response rate;
• The effect on key status and survival indications. That is, the effect on the patient's well-being and other responses to therapy that indicate effectiveness (e.g., reduction in mortality, morbidity, signs and symptoms);
• The appropriateness of the study design, that is, 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.); and
• The prevalence and life history of the disease when evaluating the adequacy of the number of subjects and the response rate.

Regardless of the evidence supporting coverage for a particular off-label use, payment may only be made if the use is reasonable and necessary for the treatment of illness or injury of the specific patient receiving the drug.

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.

If the provider decides to use a therapeutic agent that does not have FDA-approved labeling, the evidence used to make that decision (information in the compendia, established guidelines, research studies in approved peer-reviewed medical journals, etc.) must be retained. This information must be retained in the patient’s record either as a hard copy of the reference material itself or citations of the reference material. Retention of this specifically required documentation on file is indicated by use of the KX modifier on the submitted claim. This material must be submitted whenever requested.

Specific Coding Guidelines 

Administration of Drugs (90765-90779) and Administration of Certain Monoclonal Antibody Agents, Anti-Neoplastic Agents for Treatment of Noncancer Diagnoses and Chemotherapy Administration (96401, 96402, 96409, 96411, 96413, 96415-96417)

The chemotherapy administration codes apply to parenteral administration of non-radionuclide antineoplastic drugs and antineoplastic agents provided for the treatment of noncancer diagnoses (e.g. cyclophosphamide for autoimmune conditions), or to substances such as monoclonal antibody agents and other biologic response modifiers. Administration of anti-anemia drugs and anti-emetic drugs by injection or infusion for cancer patients is not considered chemotherapy administration. Such services are reported using the following codes as appropriate: 90765-90768 and 90772, 90774-90776.

The chemotherapy administration codes may be reported when the clinical indication for the drug being administered satisfies the definition above.

Chemotherapy administration codes include confirmation or recalculation of doses based upon the condition of the patient on the day of chemotherapy administration.

When 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).

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 96411 for IV push administration of additional drugs/substances at the same session and 96417 for IV infusion administration of additional drugs/substances at the same session.

When 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.

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 1 hour.

Report 96415 for infusion intervals of greater than 30 minutes beyond 1 hour increments. Report 96415 in conjunction with 96413.

Do not report 90760 if performed as a concurrent infusion service. Report 90761 to identify hydration furnished as a secondary or subsequent service after a different initial service is administered through the same IV access. Report 90766, 90767, 90775 or 90776, to identify therapeutic, prophylactic or diagnostic drug infusion or injection when provided as a secondary or subsequent service in association with 96413. 

Report 96417 in conjunction with 96413. Report 96417 only once per sequential infusion. 

The appropriate E&M CPT code (other than 99211) should be reported utilizing modifier 25 in addition to chemotherapy adiministration if a significant separately identifiable E & M service is performed. For an E&M service provided on the same day, a different diagnosis is not required.

Report 96523 if it is the only service provided that day. If there is a visit or other drug administration service provided on the same day, payment for 96523 is included in the payment for the other service.

If performed to facilitate an infusion or injection, the following are included and are not reported separately:

• Use of local anesthesia
• IV start
• Access to indwelling IV, subcutaneous catheter or port
• Flush at conclusion of infusion
• Standard tubing, syringes and supplies
• Preparation of chemotherapy agent(s)

Report CPT code 36550 for declotting a catheter or port.

Report separate codes for each parenteral method of administration employed when therapy is administered by different techniques. Medications (e.g., antibiotics, steroidal agents, antiemetics, narcotics analgesics) administered independently or sequentially as supportive management of chemotherapy or certain monoclonal antibody administration should be separately reported using 90760, 90761, 90765 or 90779 as appropriate. Report the specific service as well as code(s) for the specific substance or drug(s) provided.

The fluid used to administer the drug(s) is considered 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.

Chemotherapy Intravenous Infusion:

96413	CHEMOTHERAPY ADMINISTRATION, INTRAVENOUS INFUSION TECHNIQUE; UP TO 1 HOUR, SINGLE OR INITIAL SUBSTANCE/DRUG
96415	CHEMOTHERAPY ADMINISTRATION, INTRAVENOUS INFUSION TECHNIQUE; EACH ADDITIONAL HOUR (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
96417	CHEMOTHERAPY ADMINISTRATION, INTRAVENOUS INFUSION TECHNIQUE; EACH ADDITIONAL SEQUENTIAL INFUSION (DIFFERENT SUBSTANCE/DRUG), UP TO 1 HOUR (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Chemotherapy IV Push: 

96409	CHEMOTHERAPY ADMINISTRATION; INTRAVENOUS, PUSH TECHNIQUE, SINGLE OR INITIAL SUBSTANCE/DRUG
96411	CHEMOTHERAPY ADMINISTRATION; INTRAVENOUS, PUSH TECHNIQUE, EACH ADDITIONAL SUBSTANCE/DRUG (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Note: An Intravenous/Intra-Arterial push is defined as an injection in which the healthcare professional who administers the substance/drug is continuously present to administer the injection and observe the patient, or an infusion of 15 minutes or less.

Chemotherapy Subcutaneous (SQ) or Intramuscular (IM):

96401	CHEMOTHERAPY ADMINISTRATION, SUBCUTANEOUS OR INTRAMUSCULAR; NON-HORMONAL ANTI-NEOPLASTIC
96402	CHEMOTHERAPY ADMINISTRATION, SUBCUTANEOUS OR INTRAMUSCULAR; HORMONAL ANTI-NEOPLASTIC

Chemotherapy Infusion via portable or implantable pump: 

96416

CHEMOTHERAPY ADMINISTRATION, INTRAVENOUS INFUSION TECHNIQUE; INITIATION OF PROLONGED CHEMOTHERAPY INFUSION (MORE THAN 8 HOURS), REQUIRING USE OF A PORTABLE OR IMPLANTABLE PUMP

Note: for refilling and maintenance of a pump/reservoir for drug delivery refer to codes 96521-96523.

Hydration Administration (90760, 90761)

Medicare currently permits separate payment of hydration therapy provided sequentially (but not concurrently) to chemotherapy infusion.

Codes 90760 and 90761 are intended to report a hydration IV infusion consisting of a prepackaged fluid and/or electrolyte solutions (e.g., normal saline, D5-1/2 normal saline +30mEq 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.

Discarded Drugs and Biologicals 

The CMS encourages physicians, hospitals and other providers to schedule patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner. However, if a physician, hospital or other provider must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded along with the amount administered, up to the amount of the drug or biological as indicated on the vial or package label.

When processing all drugs except those provided under the Competitive Acquisition Program for Part B drugs and biologicals (CAP), local contractors may require the use of the modifier JW to identify unused drug or biologicals from single use vials or single use packages that are appropriately discarded. This modifier will provide payment for the discarded drug or biological.

The JW modifier must not be used on Medicare Part B Drug CAP claims; providers shall not code for wastage for drugs furnished under the CAP. Claims for drugs provided under CAP submitted with the JW modifier will be treated as unprocessable.

NOTE: Multi-use vials are not subject to payment for discarded amounts of drug or biological.

Bill Type Codes

11x	Hospital-inpatient (including Part A)
12x	Hospital-inpatient or home health visits (Part B only)
13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
83x	Special facility or ASC surgery-ambulatory surgical center (Discontinued for Hospitals Subject to Outpatient PPS; hospitals must use 13X for ASC claims submitted for OPPS payment -- eff. 7/00)
85x	Special facility or ASC surgery-rural primary care hospital (eff 10/94)

Revenue Codes 

0636	Drugs requiring specific identification-detailed coding (eff 3/92)