The Role of Appropriate Coding Chris Mancill Director, Global Government Affairs Amgen Inc. Case Study: Coding for a New Product This session focuses on the important role of coding in obtaining coverage and payment for new product launches We will review a relevant and recent case study from Amgen's experience 2 Case Study: New Oncology Launch In advance of launching our new oncology therapeutic for colorectal cancer (Vectibix™ (panitumumab)), Amgen performed a coding assessment to determine potential gaps in coding Vectibix™ is a novel therapeutic that is administered intravenously by a physician in her or his office or in the hospital outpatient setting The assessment was comprehensive in focus Coding across settings of care and payer types Coding for the product as well as the associated diagnoses and procedures In some cases, code sets take time to catch up with new products The goal of our assessment was to ensure that patient access was available once our product launched 3 Background: Codes Used in Medical Settings CPT® HCPCS ICD-9-CM Current Procedural Terminology Healthcare Common Procedure Coding System International Classification of Diseases, Ninth Revision, Clinical Modification NDCs National Drug Codes Revenue Codes Facility Cost Centers Current Procedural Terminology (CPT®) codes copyright 2005 American Medical Association (AMA). All Rights Reserved. CPT® is a trademark of the AMA. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. 4 Results of Our Coding Assessment CPT® HCPCS ICD-9-CM NDCs Revenue Codes CPT © 2005 American Medical Association. All rights reserved. 5 Codes currently exist to describe administration Miscellaneous code exists at launch; unique codes require application after launch Codes currently exist to describe diagnoses Codes assigned upon product approval Codes currently exist to describe facility cost centers Background: HCPCS Coding 1 6 J-Codes Unique, Permanent Codes; All Settings; All Payers C-Codes Unique, Temporary Codes; Medicare Only1; OPPS Only Q-Codes Unique, Temporary Codes; All Settings; Medicare Only NOC Codes Miscellaneous, Permanent Codes; Often Setting Specific; All Settings Some other payers (e.g., some Blue Cross/Blue Shield plans) may accept HCPCS C-codes, but most do not. Codes Available at Launch Two miscellaneous HCPCS codes available upon launch J9999 (NOC anti-neoplastic) for physician office C9399 (unclassified drugs or biologicals) for OPPS Specific HCPCS coding applications to be submitted upon launch Temporary HCPCS C-code for use under OPPS Permanent HCPCS J-code 7 Access is Available Immediately Upon Launch The two miscellaneous HCPCS codes permit access to be available immediately upon launch J9999 (NOC anti-neoplastic) for physician office C9399 (unclassified drugs or biologicals) for OPPS The specific HCPCS codes will facilitate access by permitting automating claims processing Amgen is educating oncologists and their office staff on the use of miscellaneous codes Using these codes for new products is commonplace Physicians are familiar with the codes and the process for new products 8 Issues to Consider for Other Products Does the product fall into a Medicare benefit category? If the product is not physician administered, a new HCPCS code may not be necessary. Does the product similar to others on the market currently? If so, is a new code warranted? Is the product’s method of administration novel? If the route of administration is novel, a new CPT® code for its administration may also be needed. Is there a diagnosis code for the condition the product treats? Is it sufficiently specific? If not, a new or revised ICD-9-CM code may be needed. 9 Questions? Chris Mancill Director Global Government Affairs Amgen Inc. cmancill@amgen.com (202) 585-9718 10