Chemotherapy Administration (A52953)
“Chemotherapy administration codes 96401-96549 apply to parenteral administration of non-radionuclide anti-neoplastic drugs; and also to anti-neoplastic agents provided for treatment of non-cancer diagnoses (e.g., cyclophosphamide for auto-immune conditions) or to substances such as certain monoclonal antibody agents, and other biologic response modifiers. The highly complex infusion of chemotherapy or other drug or biologic agents requires physician or other qualified health care professional work and/or clinical staff monitoring well beyond that of therapeutic drug agents (96360-96379) because the incidence of severe adverse patient reactions are typically greater. These services can be provided by any physician or other qualified health care professional. Chemotherapy services are typically highly complex and require direct supervision for any or all purposes of patient assessment, provision of consent, safety oversight, and intra-service supervision of staff. Typically, such chemotherapy services require advanced practice training and competency for staff who provide these services; special considerations for preparation, dosage, or disposal; and commonly, these services entail significant patient risk and frequent monitoring. Examples are frequent changes in the infusion rate, prolonged presence of the nurse administering the solution for patient monitoring and infusion adjustments, and frequent conferring with the physician or other qualified health care professional about these issues. When performed to facilitate the infusion or injection, preparation of chemotherapy agent(s), highly complex agent(s), or other highly complex drugs is included in the administration service and is not reported separately. To report infusions that do not require this level of complexity, see 96360-96379. Codes 96401-96402, 96409-96425, 96521-96523 are not intended to be reported by the individual physician or other qualified health care professional in the facility setting.
“The term ‘chemotherapy’ in 96401-96549 includes other highly complex drugs or highly complex biologic agents.” (End quotation from CPT®.)
Medicare has determined under Section 1861(t) that these drugs may be paid when they are administered incident to a physician’s service and determined to be medically reasonable and necessary. Such determination of reasonable and necessary is determined by the Medicare Administrative Contractor. The documentation in the patient’s medical record must support that the drug is medically reasonable and necessary for the specific clinical circumstances.
As stated in the Internet Only Manual, CMS Pub 100-04-Medicare Claims Processing Manual, Chapter 12-Physicians/Non-physician Practitioners, MCPM . Section 30.5 -Payment for Codes for Chemotherapy Administration and Non-chemotherapy Injections and Infusions, Part D-Chemotherapy Administration: “...Local carriers may provide additional guidance as to which drugs may be considered to be chemotherapy drugs under Medicare.”
The lists below are not all-inclusive and will continue to be revised as new information becomes available.
Intramuscular and subcutaneous injections
The administration of the following drugs in their subcutaneous or intramuscular forms should not be billed using a chemotherapy administration code. Instead, these should be billed using CPT® code 96372 [therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular].
|Generic Name||Trade Name||HCPCS Code|
|denosumab||Prolia® / Xgeva®||J0897|
|golimumab||Simponi®||J3590 (OPPS: C9399)|
|mepolizumab||Nucala®||J3590 (OPPS: C9399) J2182 Effective 01/01/2017|
|octreotide acetate Depot||Sandtstatin LAR depot®||J2353|
The intralesional administration of talimogene laherparepvec (Imlygic™) should be billed using HCPCS code J9999 (OPPS: C9472) through 12/31/2016. For dates of service (DOS) on or after 01/01/2017 use HCPCS J9325 with intralesional CPT® code 96405 or 96406, as appropriate.
When gonadotropin releasing hormone (GnRH) and analogs (including but not limited to J9217) are used in the treatment of cancer, the drugs may be billed only with CPT® 96402 – Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic.
This article notifies providers that the use of only one chemotherapy drug administration code is appropriate for these compounds: CPT® 96402. This code, and no other chemotherapy administration code, should be used for the administration of GnRH and its analogs and only when used for anticancer treatments.
Noridian has been questioned about the use of a chemotherapy administration code for an infusion (or push) of the following drugs. The below should not be billed using a chemotherapy administration code. Instead, these should be billed with CPT® codes in the series 96365-96379 (Therapeutic Prophylactic, and Diagnostic Injections and Infusions).
|Generic Name||Trade Name||HCPCS Code|
|atezolizumab||TecentriqTM||J3590 (OPPS C9399)|
|reslizumab||Cinqair®||J3590 (OPPS: C9399) J2786 Effective 01/01/2017|
The HCPCS Level II establishes “Chemotherapy Drugs” as those in the range of codes J9000-J9999. Infusions of drugs with assigned HCPCS codes in this range are accepted as appropriately billed using the chemotherapy administration codes.
Note: bendamustine hcl (Bendeka™), 1 mg, should be billed with HCPCS J9034 effective on or after DOS of 01/01/2017.
Additionally, because of the documented increased infusion reactions and/or other reasons necessitating increased administration practice expense, Noridian agrees with the use of an appropriate chemotherapy administration code for an infusion (or push) of the following drugs.
|Generic Name||Trade Name||HCPCS Code|
|alemtuzumab 1 mg||Lemtrada™||J0202|
|daratumumab||Darzalex™||J3590 (OPPS: C9476) J9145 effective 01/01/2017|
|elotuzumab||Empliciti™||J3590 (OPPS: C9477) J9176 Effective 01/01/2017|
|irinotecan liposome||Onivyde™||J3590 (OPPS: C9474) J9205 Effective 01/01/2017|
|olaratumab||Lartruvo™||J3490 (OPPS: C9399)|
|necitumumab||Portrazza™||J9999 (OPPS: C9475) J9295 Effective 01/01/2017|
|trabectedin*||Yondelis®*||J3490 (OPPS: C9480) J9352 Effective 01/01/2017|
|infliximab, biosimilar 10 mg**||Inflectra**||Q5102-ZB**|
|doxorubicin hydrochloride, liposomal, imported Lipodox, 10mg||Lipodox®Lipodox 50®||Q2049|
|doxorubicin hydrochloride, liposomal, NOS||Doxil®||Q2050|
*Note that the infusion of trabectedin (Yondelis®, J3490 (OPPS: C9480, which becomes J9352 effective January 1, 2017) is billed using HCPCS G0498 - Chemotherapy administration, intravenous infusion technique; initiation of infusion in the office/other outpatient setting using office/other outpatient setting pump/supplies, with continuation of the infusion in the community setting (e.g., home, domiciliary, rest home or assisted living) using a portable pump provided by the office/other outpatient setting, includes follow up office/other outpatient visit at the conclusion of the infusion as described below in this article.
**Note that infliximab-dyyb (infliximab biosimilar, Inflectra, Q5102-ZB effective on or after DOS 4/05/16 but processed 7/01/16 and after) must be billed with the ZB modifier which distinguishes it from Remicade®.
Noridian also reminds providers that when a patient has to return for a significant, separately identifiable infusion or injection on the same day or requires two IV lines per protocol, these circumstances are to be billed using the -59 modifier per Internet Only Manual (IOM) instruction.
Prolonged Drug and Biological Infusions Using an External Pump
Medicare pays for drugs and biologicals, which are not usually self-administered by the patient and are furnished “incident to” physicians’ services rendered to patients while in the physician’s office or the hospital outpatient department. In some situations, a hospital outpatient department or physician office may:
- purchase a drug for a medically reasonable and necessary prolonged drug infusion,
- begin the drug infusion in the care setting using an external pump,
- send the patient home for a portion of the infusion, and
- have the patient return at the end of the infusion period.
In this case, bill your A/B MAC for the drug or biological, the administration, and the external non-disposable infusion pump. Additional information is available in MLN Matters® Special Edition (SE)1609, in the “Downloads” section of the Medicare Part B Drug Average Sales Price webpage (ASP) .
One CPT® code that is intended for this purpose is:
- 96416 Initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump.
However the practice expense for 96416, though inclusive of all other expenses for provision of a prolonged chemotherapy infusion (other than the drug itself), does not include the expense specific for the pump (since 96416 was prepared for the situation where the pump has previously been implanted or is otherwise provided). Therefore, for billing the service to include the expense of the provision of the non-disposable pump, providers SHOULD NOT SUBMIT THE CODE 96416, 96379 OR ANOTHER PUMP CODE, but, per CR9749, should instead submit this service using the code:
- G0498 - Chemotherapy administration, intravenous infusion technique; initiation of infusion in the office/other outpatient setting using office/other outpatient setting pump/supplies, with continuation of the infusion in the community setting (e.g., home, domiciliary, rest home or assisted living) using a portable pump provided by the office/other outpatient setting, includes follow up office/other outpatient visit at the conclusion of the infusion.
This submission of G0498 will be paid by this contractor at a rate equal to the 96416 plus an additional amount for the non-disposable pump expense. G0498 must only be billed for the use of an external non-disposable pump where the chemotherapy infusion was initiated in the office/other outpatient setting using office/other outpatient setting pump/supplies, with continuation of the infusion in the community setting. This also includes follow up office/other outpatient visit at the conclusion of the infusion.
CPT® 96416 should not be billed with G0498 as it is included in the fee for the pump. On the occasion a separate service is performed for procedure code 96416 (or other appropriate chemotherapy administration), this service and the drug should be billed on a separate claim.
Patients supplying their own drugs
The Medicare Program provides limited benefits for outpatient drugs. The program covers drugs that are furnished under the “incident to” benefit (section 1861(s)(2)(A) or (B) of the Social Security Act), for an FDA approved drug or biological which is furnished by a physician’s practice or hospital (respectively), provided that the drug is not usually self-administered by the patient, and is reasonable and necessary for the diagnosis or treatment of the illness or injury according to accepted standards of medical practice. The physician practice or hospital must incur a cost for the drug or biological which is then administered by the physician or by auxiliary personnel employed by the practice or hospital and under the physician's personal supervision.
Per the "incident to" guidelines explained above and in the Medicare Benefit Policy Manual, CMS Internet-Only Manual (IOM) Publication 100-02, Chapter 15, Sections 50 and 50.3 MBPM , providers are not allowed to instruct patients to purchase a drug themselves and bring it to the provider's office for administration. Claims that are billed with the chemotherapy administration codes 96401-96549 that do not have an associated drug in claim history, will deny. When the administration claim is processing, an allowed claim for the drug must be present, either on a prior claim or on the same claim as the administration. For further information on the rare circumstances where it may be appropriate to submit a claim for a drug administration where the provider has not incurred the expense for the drug, see the separate Noridian article “Patients Supplying Their Own Drugs” link under the Related Local Coverage Document below.
For other regulations related to the billing of chemotherapy administration, refer to the IOM Medicare Claims Processing Manual Publication 100-04, Chapter 12, Section 30.5 at MCPM .
|Bill Type Codes||Description|
|085X||Critical Access Hospital|
|Revision History Number||Revision History Date||Revision History Explanation|
|6||01/01/2017||Article revised to move atezolizumab TecentriqTM from under the Intramuscular and subcutaneous injections section to the Infusions Non-Chemotherapy section of this article per labeled indications.|
|5||01/01/2017||LCD revised to correct typographical error in the Revision History #4 to say Per CR9749 and for DOS on or after 01/01/16, G0498 replaces CPT® 96549 for the use of the non-disposable external infusion pump for continuation of chemotherapy in the community setting and that TOB 13X and 85X were added in Revision #4.|
|4||01/01/2017||Article revised for editorial changes. Also, Tecentriq™ was added and has been processed as an Intramuscular and subcutaneous injections using J3590 (C9399 for OPPS) since 07/01/2016 per labeled indications. Cinqair® was added and has been processed as a Non-Chemotherapy Infusion using J3590 (C9399 for OPPS) since 07/01/2016 per labeled indications. Per CR9749 and for claims processed on or after 10/03/16 G0498 replaces CPT® 96549 for the use of the non-disposable external infusion pump for continuation of chemotherapy in the community setting. |
Effective 01/01/2017: J2182 replaced J3590 (OPPS:C9399) for Nucala®, J9325 replaces J9999 (OPPS: C9472) for Imlygic™, J2786 replaced J3590 (OPPS: C9399) for Cinqair® J9145 replaces J3590 (OPPS: C9477) for Darzalex™, J9176 replaces J3590 (OPPS: C9477) for Empliciti™, J9205 replaces J3590 (OPPS: C9474) for Onivyde™, J9295 replaces J9999 (OPPS: C9475) for Portrazza™, J9352 replaces J3490 (OPPS:C9480) Yondelis®, J9034 for Bendeka™, and J3490 (OPPS: C9399) for Lartruvo™, were added.
|3||07/01/2016||R3 editorial change to "When performed to facilitate the infusion or injection, preparation of chemotherapy agent(s), highly complex agent(s), or other highly |
complex drugs is included in the administration service and is not reported separately", HTLM format change so link to Medicare Claims Processing Manual (MCPM) would work and corrected abbreviation MCMP to MCPM in the article text.
|2||07/01/2016||R2 Revised to add editorial changes to daratumumab, elotuzumab, trabectedin and infliximab, biosimilar. Also corrected CPT code 95659 to 96549.|
|1||07/01/2016||R1 Article number A52952 for JEA will be retired on 6/30/16. This article will be the same as Article number A52953 for JEB and combines both contract numbers for both JEA & JEB.|
Related Articles: A55044 - Patients Supplying Their Own Drugs
Last Updated Jan 30, 2017