www.infusioncenter.net 

 

May 26, 2011 

 

Re: IVIG Administration Codes, RAC Audits 

 

Arnold Balanoff, MD  

Chief Medical Officer 

Office of the Regional Administrator 

601 E. 12th Street, Suite 235 

Kansas City, MO 64106 

 In order  to provide clarity  to providers,  reduce cost  to CMS and  increase patient access  to  IVIG, CMS 

should publish a notice that chemotherapeutic administration codes for IVIG should be allowed, and the 

current RAC audits regarding the use of chemotherapy admin codes with IVIG should be dismissed.  

 

Beginning  in  November  2010,  the  NICA  received  notice  from  our  partners  that  certain  Medicare 

Contractors, were denying and/or down‐coding high‐level chemotherapy administration codes on  IVIG 

(Intravenous  Immune globulin)  claims  to  lower‐level  therapeutic administration  codes.    In May 2011, 

certain  Recovery  Audit  Contractors  (RACs)  such  as  Connolly  Healthcare  began  conducting  audits  in 

attempts to recover suspected “overpayments” on certain providers who billed the chemotherapeutic 

code (complex‐chemo admin codes) rather than the therapeutic code when administering IVIG. 

 

Chemotherapeutic Codes (IVIG administration codes being denied or down‐coded): 

96413 ‐ Chemotherapy and Complex drugs; Biologicals: Intravenous Infusion up to one hour 96415 ‐ Chemotherapy and Complex drugs; Biologicals: Intravenous Infusion each additional hour  Therapeutic Administration Codes:  96365 ‐ Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour  96366 ‐ Intravenous infusion, for therapy, prophylaxis, or diagnosis; each additional hour   History: 

The allowed use of  the chemotherapy administration codes  for non‐chemotherapeutic medications  is 

common place among all payers, including CMS and its Medicare Contractors.  For intravenous therapies 

that  are  deemed  complex,  including  some  specialty  biological  and  monoclonal  antibody  drugs, 

contractors have allowed providers to bill the higher  level chemotherapy administration codes.   Many 

MACs  have  published  specific  instructions  regarding medications  that may  be  billed  with  complex‐

chemo admin codes.  To view a specific example, please see the Trailblazer notice titled, “Chemotherapy 

Administration  Coding”  issued  on  July  21,  2010.    The  notice  specifically  outlines  many  non‐

chemotherapeutic drugs  that may be billed with complex‐chemo admin codes. The notice  specifically 

states that the  list of drugs that may be billed with complex‐chemo admin codes  is not  intended to be 

complete, and  it allows complex‐chemo admin codes to be billed when medications require “physician 

work or clinical staff monitoring well beyond that of therapeutic drug agents (CPT codes 96360–96379).” 

       

www.infusioncenter.net 

 

A copy of the notice can be found at the following link: 

http://www.trailblazerhealth.com/Tools/Notices.aspx?DomainID=1&ID=13802 

 

Immediate Dismissal of RAC Audits: 

The  current  RAC  audits  should  be  dismissed  based  on  the  fact  that  no  policy  prohibiting  billing  the 

complex‐chemo  admin  code  for  IVIG  or  any  other  complex  intravenous  medication  is  readily 

ascertainable. 

 

After speaking with our partners and researching this issue thoroughly, we have found no evidence of a 

CMS, local Medicare contractor (MAC), or any other regulating body policy stating that IVIG could not or 

should not be billed with complex‐chemo admin codes (96413‐96415).   

 

Our  research  did  find  an  Office  of  the  Inspector  General  (OIG)  report  dated  June  2009,  titled “Chemotherapy Administration: Payment and Policy” that states in their findings,  

“Carriers  have  implemented  inconsistent  chemotherapy  administration  coding  polices  and review procedures"  

The same OIG report recommends that CMS:   

“Establish  a  process  to  determine  which  specific  drugs  qualify  for  the  chemotherapy administration rate.” 

 Because  (i) no policy prohibiting billing complex‐chemo admin codes with  IVIG  is available and  (ii)  the OIG Report’s recommendation, the RAC audits should be dismissed.  IVIG warrants coverage using chemotherapeutic administration code:  IVIG  at  least  warrants  the  same  administration  coverage  as  other monoclonal  class  drugs  such  as 

Remicade, Orencia, and Rituxan due  to  the  increased patient monitoring and administration burdens 

associated with administering IVIG (see Trailblazer LCD below). Clinically, it is well understood that that 

IVIG  is at  least as complex as  the chemotherapeutic and non‐chemotherapeutic medications currently 

covered  under  the  complex‐chemo  admin  codes.    (Please  see  attached  chart  titled  –  “Medication 

Comparison”).  Therefore,  the  administration  of  IVIG  should  be  paid  at  a  higher  level  than  the 

administration of Ceftriaxone (Rocephin), Cipro, and other non‐complex therapies. 

 

Trailblazer  Health’s  LCD  (local  coverage  determination)  for  IVIG  acknowledges  that  IVIG  is  clinically 

difficult to administer:  

“Sensitivity  to  these  (IVIG)  reactions  is usually  related  to  the  infusion  rate. Caution  should be 

exercised in the administration of intravenous immune globulin; reactions may cause a rapid fall 

in blood pressure and clinical anaphylaxis.” 

 

 

       

www.infusioncenter.net 

 

Solution: Increase Patient Access and reduce CMS costs: 

The  issue of clarifying appropriate administration codes for specialty medications  is a core objective of 

the NICA. We believe it is in the favor of all parties to establish a set criterion for providers that define all 

specialty  injectable/infusible medications  and  their  appropriate  administration  codes.   Providers who 

remain uncertain about CMS or Medicare contractor policies for administration codes are more likely to 

not offer  these medications  in  their practice out of  concern  for possible  future auditing and medical 

review. This uncertainty means more patients will have to receive these specialty medications at a non‐

preferred, high‐cost facility such as a hospital where costs  for the patient and payer can easily double 

and increase by as much as 100%.  It is proven that infusion therapy administered in a provider’s office is 

significantly less expensive than the hospital.  

 

Conclusion and Recommendations:  

The  NICA  is  asking  CMS  Medical  Directors  and  appropriate  staff  to  consider  the  benefits  of  the 

discussion  on  this  topic.  Clarity  on  this  issue will  insure  that  chronically  ill  patients  can  continue  to 

receive their treatments in a lower cost, non‐hospital setting.  Accordingly, the NICA is asking CMS to: 

 

Publish  a  notice  clarifying  the  allowed  use  of  the  higher‐level  complex‐chemo  codes  when 

administering biologic, specialty drugs like IVIG, and 

Remove the RAC audit approved  issue “Chemotherapy Administration Codes” and rescind the 

corresponding RAC audits on the issue  

 

If you have comments on this letter, you may email them to bryan.johnson@infusioncenter.net 

 

Thank you,  

 

 

 

Bryan Johnson, President National Infusion Center Association  

 

Enclosures:  

1. Administration Code Comparison Chart 

2. OIG Report, Medicare Part B Chemotherapy Administration Payment and Policy,  June 2009 

3. Trailblazer Chemotherapy Administration Code Policy dated July 21, 2010 

*Some specialized therapeutic medications will require these conditions **IVIG preparation varies from Lyophilized & Liquid products/brands  

 

Administration Code Comparison Chart Current Covered (96413, 96415) Medications vs. IVIG 

 

  From Trailblazer Health Enterprises LCD L26774:  “Sensitivity to these reactions is usually related to the infusion rate. Caution should be exercised in the administration of intravenous immune globulin; reactions may cause a rapid fall in blood pressure and clinical anaphylaxis.”  

MEDICATION

ADMINISTR

ATION REQ

UIREM

ENTS 

Direct Physician/N

urse Supervision 

Specialized

 Preparation 

Infusion Pump Recommen

ded

 

Pre‐Treatment Screening 

Dosage Adjustmen

ts at Time of Treatm

ent 

(weight‐based dosing) 

Infusion Rate Change Required

 During 

Treatm

ent 

PATIEN

T MONITORING 

Freq

uent Vitals During Infusion 

Freq

uent Assessm

ents During Treatm

ent 

Post Infusion Instruction Recommen

ded 

ADVER

SE EVEN

TS PROFILE 

Higher Incidence of Infusion related 

reactions 

Higher Risk of Infusion Anaphylaxis  

Increases/Decreases in

 Blood Pressure 

Avg. Treatment Inventory Cost 

(Per Day) 

Remicade X X X X X X X X X X X X $2,800-4,000 Actemra  X X X X X X X X X $1,000-1,500 Rituximab  X X X X X X X X X X X $3,000-7,500 Tysabri  X X X X X X X X X X X $2,500 Xolair  X X X X X X X X $600-2,400 Orencia  X X X X X X X $600-1,200 Avg. Therapeutic  Drug  * * * * $5-150 IVIG (all brands)  X X* X X X X X X X X X X $2,500-7,500

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Chemotherapy Administration Coding(7/21/2010)

TrailBlazer’s Medical Review staff recently performed a number of audits on several drugs and associated drug administration codes. Findings of the audit indicate the need for review of the proper use of chemotherapy administration CPT codes 96401–96549. The full instructions for the use of these codes are located in two separate documents. The chemotherapy administration CPT codes (96401–96549):

Are used to report the administration of certain non-radionuclide drugs when the infusion requires physician work or clinical staff monitoring well beyond that of therapeutic drug agents (CPT codes 96360–96379).

•

Apply to parenteral administration of non-radionuclide antineoplastic drugs, antineoplastic agents provided for the treatment of non-cancer diagnoses (e.g., cyclophosphamide for autoimmune conditions), substances such as monoclonal antibody agents and other biologic response modifiers.

•

Drugs commonly falling in the category of monoclonal antibodies include infliximab, rituximab, alemtuzumb, gemtuzumab and trastuzumab. Drugs commonly falling in the category of hormonal antineoplastics include leuprolide acetate and goserelin acetate. The drugs listed above are not intended to be a complete list of drugs that may be administered using the chemotherapy administration codes. The chemotherapy administration CPT codes (96401–96549) may not be used to report administration of:

Substances used as diagnostic agents such as radio-opaque dyes. •Therapeutic radionuclides (use CPT codes 79101, 79403 or 79999). •Anti-anemia drugs. •Anti-emetic drugs. •Hydration fluids. •Drugs that appear on the “usually self-administered” drug exclusion list. •

If performed to facilitate the chemotherapy infusion or injection, the following services and items are included in the payment for CPT codes 96401–96549 and are not separately billable/payable:

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

If a significant, separately identifiable Evaluation and Management (E/M) service is performed, the appropriate E/M code should be reported utilizing modifier 25 in addition to the chemotherapy code. For an E/M service provided on the same day, a different diagnosis is not required. Additional detailed information is available in the preamble of the CPT codebook and in the Internet-Only Manual (IOM) Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.5.D. (Reference: From the Desk of the Medical Director)

Programs: Part A,Part BTopics: Policies, Specialty ServicesSubtopics: Chemotherapy, Contractor Medical Directors, Drugs and Biologicals

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2010 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

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