Billing and Coding: Complex Drug Administration Coding

This Medicare Administrative Contractor (MAC) has determined in review of
submitted claims that there is inappropriate use of CPT codes 96401-96549 for
chemotherapy and other highly complex drug or highly complex biologic agent
administration.

The Current Procedural Terminology (CPT) codebook contains the following
information and direction for the Chemotherapy and Other Highly Complex Drug
or Highly Complex Biological Agent Administration CPT codes: "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 intraservice 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 of injection, preparation of chemotherapy
agent(s), highly complex agent(s), or other highly complex drugs is included
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."

Medicare has determined under 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 currently left to the discretion of the MACs. The documentation
in the patient's medical record must support the drugs as being medically
reasonable and necessary.

As stated in the CMS Internet Only-Manual, Pub. 100-04, Medicare Claims
Processing Manual, Chapter 12, 30.5 Payment for Codes for Chemotherapy
Administration and Nonchemotherapy Injections and Infusions, Part D.
Chemotherapy Administration, _" A/B MACs (B) may provide additional guidance
as to which drugs may be considered to be chemotherapy drugs under Medicare."_

**Not Otherwise Classified (NOC) Drug Billing**

**Office/Clinic**

Providers submit NOC codes in the 2400/SV101-2 data element in the 5010
professional claim transaction (837P). When billing a NOC code, providers are
required to provide a description in the 2400/SV101-7 data element. The 5010
TR3 Implementation Guide instructs: "Use SV101-7 to describe non-specific
procedure codes." (Do not use the 2400 NTE segment to describe non-specific
procedure codes with 5010.) The SV101-7 data element allows for 80 bytes
(i.e., characters, including spaces) of information.

In order for this A/B MAC to correctly reimburse NOC drugs and biologicals,
providers must indicate the following in the 2400/SV101-7 data element, or
Item 19 of the CMS 1500 form:

  * The name of the drug,
  * The total dosage (plus strength of dosage, if appropriate), and;
  * The method of administration.

Important: List **1** unit of service in the 2400/SV1-04 data element or in
item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals
even if multiple units are provided. Medicare determines the proper payment of
NOC drugs and biologicals by the narrative information, not the number of
units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if
any of the information above is missing, or if the NOC code is billed with
more than one unit of service. (Note: The remittance notice will include
remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the
drug furnished," even if the rejection is due to the number of units billed.)

For further information, see Palmetto GBA's Website Topic Article:
[Unclassified or Not Otherwise Classified (NOC) Drug Codes: Rejected if Not
Submitted
Correctly](https://www.palmettogba.com/palmetto/providers.nsf/DocsR/Providers~JJ%20Part%20B~Browse%20by%20Topic~Drugs%20Biologicals~AW8MMP6652?open)

**ASC and Hospital Outpatient Departments**

HCPCS code C9399, Unclassified drug or biological, should be used for new
drugs and biologicals that are approved by the United States (U.S.) Food and
Drug Administration (FDA) on or after January 1, 2004, for which a specific
HCPCS code has not been assigned.

**JW Modifier**

JW Modifier effective January 1, 2017. Claims for discarded drugs or
biologicals amount not administered to any patient shall be submitted using
the JW modifier.

Unused drugs or biologicals from single use vials or single use packages that
are opened, and the entire dose/quantity is not administered, and the
remainder is discarded. (Except those provided under the Competitive
Acquisition Program (CAP) for Part B drugs and biologicals.)

Providers must document the discarded drugs or biologicals in the patient's
medical record.

This modifier, billed on a separate line, will provide payment for the amount
of discarded drugs or biologicals.

_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, 1 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 1 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_
_._

(See [CMS Internet Only-Manual, Pub. 100-04, Medicare Claims Processing
Manual, Chapter 17, 40 Discarded Drugs and
Biologicals](https://www.cms.gov/regulations-and-
guidance/guidance/manuals/downloads/clm104c17.pdf))

**Route of Administration Modifier**

The use of the JA and JB modifiers is required for drugs which have 1 HCPCS
Level II (J or Q) code but multiple routes of administration. Drugs that fall
under this category must be billed with JA Modifier for the intravenous
infusion of the drug or billed with JB Modifier for subcutaneous injection of
the drug.

The lists below are not an all-inclusive list and may be subject to further
revision.

**Subcutaneous and Intramuscular Injection Non-Chemotherapy**

The administration of the following drugs should not be billed using a
chemotherapy administration code. Instead, the administration of the following
drugs in their subcutaneous or intramuscular forms should be billed using CPT
code 96372, (therapeutic, prophylactic, or diagnostic injection (specify
substance or drug); subcutaneous or intramuscular).

To avoid unnecessary rejections, claims for these types of drugs and their
non-chemotherapy administration should be billed as a pair on a separate claim
from any chemotherapy.

**Generic/Trade Names**

**Generic Name** | **Trade Name** | **HCPCS Code**  
---|---|---  
benralizumab | Fasenra | J0517  
canakinumab | Ilaris | J0638  
certolizumab pegol | Cimzia | J0717  
denosumab | Prolia/Xgeva | J0897  
filgrastim (g-csf) excludes biosimilars** | Neupogen** | J1442**  
tbo-filgrastim | Granix | J1447  
filgrastim-sndz biosimilar** | Zarxio** | Q5101**  
filgrastim-aafi** | Nivestym** | Q5110**  
luspatercept-aamt | Reblozyl | J0896  
mepolizumab | Nucala | J2182  
octreotide acetate depot | Sandostatin LAR depot | J2353  
omalizumab | Xolair | J2357  
pegfilgrastim excludes biosimilar* | Neulasta* | J2506*  
pegfilgrastim-jmbd, biosimilar | Fulphila | Q5108  
pegfilgrastim-cbqv | Udenyca | Q5111  
pegfilgrastim-bmez | Ziextenzo | Q5120  
pegfilgrastim-apgf, biosimilar | NyvepriaTM | Q5122  
pegfilgrastim-fpgk  | Stimufend  | Q5127  
pegfilgrastim-pbbk  | Fylnetra | Q5130  
rilonacept | Arcalyst | J2793  
tildrakizumab-asmn | IlumyaTM | J3245  
  
*Note: Effective 01/01/2018 providers are instructed to use 96377 for the on body application injector for Neulasta Onpro Kit.

**When billing filgrastim (HCPCS codes J1442, Q5101, or Q5110), append the JA
modifier for the intravenous (IV) formulation or the JB modifier for the
subcutaneous formulation.

**Infusions Non-Chemotherapy**

The administration of the following drugs should not be billed using a
chemotherapy administration code. The IV administration of the drugs below
should be billed with the appropriate IV injection/infusion CPT code listed
under Therapeutic Prophylactic, and Diagnostic Injections and Infusions.

To avoid unnecessary rejections, claims for chemotherapy drugs and their
chemotherapy administration should be billed as a pair on a separate claim. In
this circumstance, the Medicare Claims Processing System will still allow the
add-on codes 96367 and 96368 if billed appropriately on a separate claim from
the initial claim for the chemotherapy drug and administration codes with the
same date of service.

**Generic/Trade Names**

**Generic Name** | **Trade Name** | **HCPCS Code**  
---|---|---  
abatacept**** | Orencia**** | J0129****  
Anifrolumab-fnia | SaphneloTM | J0491  
belatacept | Nulojix | J0485  
bezlotoxumab | ZinplavaTM | J0565  
eculizumab | Soliris | J1300  
edaravone | RadicavaTM | J1301  
filgrastim (g-csf) excludes biosimilars*** | Neupogen*** | J1442***  
filgrastim-sndz, biosimilar*** | Zarxio*** | Q5101***  
filgrastim-aafi*** | Nivestym*** | Q5110***  
golimumab | Simponi Aria | J1602  
natalizumab | Tysabri | J2323  
octreotide acetate non-depot** | Sandostatin** | J2354**  
patisiran | Onpattro | J0222  
remdesivir | Veklury | J0248  
reslizumab | Cinqair | J2786  
ustekinumab* | Stelara* | J3358*  
vedolizumab | Entyvio | J3380  
  
*Effective September 23, 2016, IV ustekinumab (Stelara) should be billed with HCPCS J3590 (OPPS: C9399 for dates of service (DOS) _before_ 04/01/2017; C9487 for DOS from 04/01/2017 to 06/30/17, Q9989 for DOS from 07/01/2017-12/31/17 and J3358 for DOS 01/01/2018 and after) for the initial IV dose of Stelara when used for Crohn's disease and Ulcerative Colitis. Each subsequent subcutaneous dose **must** be billed with J3357. This IV formulation is now FDA approved for Crohn's disease and Ulcerative Colitis. On and after July 31, 2017, both the drug and administration should be billed on the same claim with no other drugs or administration to prevent inappropriate claim rejection.

**When billing octreotide acetate (HCPCS code J2354), append the JA modifier
for the IV formulation or the JB modifier for the subcutaneous formulation.
The subcutaneous (SQ) form is on the Self-Administered Drug Exclusion List
(SAD List).

***When billing filgrastim (HCPCS codes J1442, Q5101, Q5110), append the JA
modifier for the IV formulation or the JB modifier for the subcutaneous
formulation.

****When billing abatacept (HCPCS code J0129), append the JA modifier for the
IV formulation or the JB modifier for the subcutaneous formulation. The SQ
form is on the SAD List.