1. Chris Mancill Director, Global Government Affairs Amgen Inc. The Role of Appropriate Coding

2. 2 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

3. 3  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 Case Study: New Oncology Launch

4. 4 Background: Codes Used in Medical Settings CPT ® Current Procedural Terminology Healthcare Common Procedure Coding System HCPCS ICD-9-CM 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.

5. 5 Results of Our Coding Assessment CPT ® Codes currently exist to describe administration Miscellaneous code exists at launch; unique codes require application after launch HCPCS ICD-9-CM Codes currently exist to describe diagnoses NDCs Codes assigned upon product approval Revenue Codes Codes currently exist to describe facility cost centers CPT © 2005 American Medical Association. All rights reserved.

6. 6 Background: HCPCS Coding J-Codes Unique, Permanent Codes; All Settings; All Payers Unique, Temporary Codes; Medicare Only 1 ; OPPS Only C-Codes Q-Codes Unique, Temporary Codes; All Settings; Medicare Only NOC Codes Miscellaneous, Permanent Codes; Often Setting Specific; All Settings 1 Some other payers (e.g., some Blue Cross/Blue Shield plans) may accept HCPCS C-codes, but most do not.

7. 7 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

8. 8 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

9. 9 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.

10. 10 Questions? Chris Mancill Director Global Government Affairs Amgen Inc. cmancill@amgen.com (202) 585-9718