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 complexchemo 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 nonchemotherapeutic 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 nonpreferred, 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 www.infusioncenter.net
Administration Code Comparison Chart Current Covered (96413, 96415) Medications vs. IVIG ADMINISTRATION REQUIREMENTS Direct Physician/Nurse Supervision Specialized Preparation Infusion Pump Recommended Pre Treatment Screening Dosage Adjustments at Time of Treatment (weight based dosing) Infusion Rate Change Required During Treatment PATIENT MONITORING Frequent Vitals During Infusion Frequent Assessments During Treatment Post Infusion Instruction Recommended ADVERSE EVENTS PROFILE Higher Incidence of Infusion related reactions Higher Risk of Infusion Anaphylaxis Increases/Decreases in Blood Pressure Avg. Treatment Inventory Cost (Per Day) MEDICATION 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 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. *Some specialized therapeutic medications will require these conditions **IVIG preparation varies from Lyophilized & Liquid products/brands
Notices Tools TrailBlazerHealth.com - Chemotherapy Administration Coding http://www.trailblazerhealth.com/tools/notices.aspx?domainid=1&id=13802 Page 1 of 2 4/11/2011 HOW DO I? CALENDAR OF EVENTS NOTICES LISTSERVS FAQS SELF-SERVICE TOOLS CONTACT US Welcome. LOGIN REGISTER Search Quick Links FEE SCHEDULES FORMS LOCAL COVERAGE DETERMINATIONS EVALUATION AND MANAGEMENT APPEALS AUDIT & REIMBURSEMENT BENEFICIARY CERT CLAIMS CUSTOMER SERVICE EDUCATION EDI FACILITY TYPES MSP PAYMENT POLICIES PROVIDER ENROLLMENT PUBLICATIONS QUALITY INITIATIVES SPECIALTY SERVICES Printable View RSS Feed Site Tutorial Download Adobe Reader TrailBlazer Sites Medicare Home Page Corporate We Are Listening! Send us your Web site feedback. Visit the Program Safeguard Contractor for the J4 MAC areas. Notices Medicare Home Page Notices CMS and TrailBlazer Are Official Sources for Medicare Information All TrailBlazer Part A and Part B notices will be posted to this site. Users are able to view the latest information from TrailBlazer and CMS, such as CR or JSM instructions, or easily retrieve the most up-to-date information without searching the entire site. The CMS mandated notices will include a link to the CMS Web site where providers may view the transmittals in their entirety. For your convenience, notices are listed in date order with the most current being shown first. This page is updated daily. Search other Notices 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) This content pertains to... Programs: Part A,Part B Topics: Policies, Specialty Services Subtopics: 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.