Local Coverage Article Billing and Coding

Billing and Coding: Complex Drug Administration Coding

A58527

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Article ID
A58527
Article Title
Billing and Coding: Complex Drug Administration Coding
Article Type
Billing and Coding
Original Effective Date
11/26/2020
Revision Effective Date
04/01/2022
Revision Ending Date
N/A
Retirement Date
N/A
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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1861(t) states that these drugs may be paid when they are administered incident to a physician’s service and determined to be medically reasonable and necessary

Title XVIII of the Social Security Act, §1861(s)(2)(A) or (B) definition of medical and other health services

Title XVIII of the Social Security Act, §1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

CMS Internet Only-Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals and §50.3 Incident To Requirements

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

CMS Internet Only-Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, §40 Discarded Drugs and Biologicals

Article Guidance

Article Text

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 one 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

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, 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.

(See MLN Matters Number: MM9603)

Route of Administration Modifier

The use of the JA and JB modifiers is required for drugs which have one 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 Nyvepria Q5122
rilonacept Arcalyst® J2793
tildrakizumab-asmn Ilumya™ 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 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 Saphnelo J0491
belatacept Nulojix® J0485
bezlotoxumab Zinplava™ J0565
eculizumab Soliris® J1300
edaravone Radicava™ 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 subcutaneous (SQ) form is on the Self-Administered Drug Exclustion List (SAD List).

Coding Information

CPT/HCPCS Codes

Group 1

(21 Codes)
Group 1 Paragraph

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. For the administration of a drug using an On-Body Injector bill with CPT® code 96377.

J1442, Q5101 or Q5110: The subcutaneous and intravenous formulations of filgrastim need to be billed with the corresponding modifier - JA if intravenous or JB if subcutaneous.

Group 1 Codes
CodeDescription
96372 Ther/proph/diag inj sc/im
96377 Applicaton on-body injector
J0517 Inj., benralizumab, 1 mg
J0638 Canakinumab injection
J0717 Certolizumab pegol inj 1mg
J0896 Inj luspatercept-aamt 0.25mg
J0897 Denosumab injection
J1442 Inj filgrastim excl biosimil
J1447 Inj tbo filgrastim 1 microg
J2182 Injection, mepolizumab, 1mg
J2353 Octreotide injection, depot
J2357 Omalizumab injection
J2506 Inj pegfilgrast ex bio 0.5mg
J2793 Rilonacept injection
J3245 Inj., tildrakizumab, 1 mg
Q5101 Injection, zarxio
Q5108 Injection, fulphila
Q5110 Nivestym
Q5111 Injection, udenyca 0.5 mg
Q5120 Inj pegfilgrastim-bmez 0.5mg
Q5122 Inj, nyvepria

Group 2

(26 Codes)
Group 2 Paragraph

The administration of the following drugs should not be billed using a chemotherapy administration code. Instead, the IV administration of the drugs should be billed with the following CPT® codes for IV injection/infusion.

J3358: 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.

J2354: The subcutaneous and intravenous formulations of octreotide acetate need to be billed with the corresponding modifier - JA if intravenous or JB if subcutaneous. The subcutaneous (SQ) form is on the Self-Administered Drug Exclusion List (SAD List).

J1442, Q5101, Q5110: The subcutaneous or intravenous formulations of filgrastim needs to be billed with the corresponding modifier - JA if intravenous or JB if subcutaneous.

J0129: The subcutaneous and intravenous formulations of abatacept need to be billed with the corresponding modifier - JA if intravenous or JB if subcutaneous. The subcutaneous (SQ) form is on the Self-Administered Drug Exclusion List (SAD List).

Group 2 Codes
CodeDescription
96365 Ther/proph/diag iv inf init
96366 Ther/proph/diag iv inf addon
96367 Tx/proph/dg addl seq iv inf
96368 Ther/diag concurrent inf
96374 Ther/proph/diag inj iv push
96375 Tx/pro/dx inj new drug addon
96376 Tx/pro/dx inj same drug adon
96379 Ther/prop/diag inj/inf proc
J0129 Abatacept injection
J0222 Inj., patisiran, 0.1 mg
J0248 Inj, remdesivir, 1 mg
J0485 Belatacept injection
J0491 Inj anifrolumab-fnia 1mg
J0565 Inj, bezlotoxumab, 10 mg
J1300 Eculizumab injection
J1301 Injection, edaravone, 1 mg
J1442 Inj filgrastim excl biosimil
J1602 Golimumab for iv use 1mg
J2323 Natalizumab injection
J2354 Octreotide inj, non-depot
J2786 Injection, reslizumab, 1mg
J3358 Ustekinumab, iv inject, 1 mg
J3380 Injection, vedolizumab
J3590 Unclassified biologics
Q5101 Injection, zarxio
Q5110 Nivestym

CPT/HCPCS Modifiers

Group 1

(4 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
GY ITEM OR SERVICE STATUTORILY EXCLUDED, DOES NOT MEET THE DEFINITION OF ANY MEDICARE BENEFIT OR, FOR NON-MEDICARE INSURERS, IS NOT A CONTRACT BENEFIT
JA ADMINISTERED INTRAVENOUSLY
JB ADMINISTERED SUBCUTANEOUSLY
JW DRUG AMOUNT DISCARDED/NOT ADMINISTERED TO ANY PATIENT

ICD-10-CM Codes that Support Medical Necessity

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

N/A

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
04/01/2022 R4

Under Article Text – Infusions Non-Chemotherapy Table added code J0248 for remdesivir. The code for Anifrolumab-fnia was changed from J3590 to J0491. Under CPT/HCPCS Codes Group 2: Codes added codes J0248 and J0491.

01/01/2022 R3

Under Article Text – Subcutaneous and Intramuscular Injection Non-Chemotherapy added code J2506 and deleted code J2505 from the table. Under Infusions Non-Chemotherapy added code J3590 to the table. Formatting, punctuation and typographical errors were corrected, and statements with asterisks were revised where appropriate throughout the Article Text section. Under CPT/HCPCS Codes Group 1: Paragraph and Group 2: Paragraph revisions were made to the verbiage to reflect the changes made in the Article Text section. Under CPT/HCPCS Codes Group 1: Codes added code J2506 and deleted code J2505. Under CPT/HCPCS Codes Group 2 Codes added code J3590. This revision is due to the Annual CPT/HCPCS update and is effective on 1/1/22.

07/01/2021 R2

Under Article Text - Route of Administration Modifier revised the first sentence to read, “The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration”. Under Infusions Non-Chemotherapy Generic/Trade Names the first asterisk (*) was revised to add Ulcerative Colitis. Under CPT/HCPCS Codes Group 2: Paragraph J3358 revised the language to add Ulcerative Colitis. Formatting, punctuation and typographical errors were corrected throughout the article.

01/01/2021 R1

Under Article Text – Route of Administration Modifier verbiage in this section was replaced with “The use of the JA and JB modifiers would apply to medications that have one J Code for 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.” Under Subcutaneous and Intramuscular Injection Non-Chemotherapy added the sentence that reads “***The subcutaneous or intravenous formulation of filgrastim is billed using HCPCS code J1442, Q5101 or Q5110 with the JA (intravenous) or JB (subcutaneous) modifier” and identified medications that apply in the table above. Under Infusions Non-Chemotherapy removed medications decitabine-Dacogen®-J0894 and tbo-filgrastim-Granix®-J1447 from the table. The code J1447 was removed from the next to last sentence in this section. Under CPT/HCPCS Codes Groups 1 and 2: Paragraph removed code J1447 from the text. Revisions were made to these entire sections to improve formatting and layout of the information. Under CPT/HCPCS Codes Group 1: Codes added code Q5122 due to the Q1 2021 CPT/HCPCS code update. Under CPT/HCPCS Codes Group 2: Codes deleted codes J0894 and J1447.

Keywords

  • Drug
  • Biological