DePuy Orthopaedics ASR Recall Reference Guide for U.S. Healthcare Professionals

DePuy Orthopaedics ASR Recall Reference Guide for U.S. Healthcare Professionals DPYUS 46 (Version 2) 1 October 18, 2010

Contents 1. Available Resources... 3 Surgeon-to-Patient Communications Support... 3 Patient Forms... 3 Blood Testing/Cross-Sectional Testing and Treatment Information... 3 Surgeon/Hospital Handling of Explants... 4 Filing Claims on Behalf of a Patient with an ASR Hip System... 4 Additional Information about the Patient Medical Authorization Form... 4 2. Identifying ASR Patients... 5 3. Patient Testing... 5 Testing and Treatment Recommendations for ASR Hip Patients... 5 Metal Ion Testing... 6 Special Patient Instructions for Metal Ion Testing... 7 Locating an Alternative Testing Facility... 7 Metal Ion Testing for Non-ASR Patients... 7 MRI Protocol... 7 Alternatives to MRI Testing... 7 Blood Storage... 7 Ion Levels... 7 4. Reimbursement... 8 DePuy s ASR Reimbursement Policy... 8 Patient Out-of-Pocket Expenses... 8 Medical Treatment Expenses... 8 Timing... 8 Patient Eligibility for Reimbursement... 8 Surgeon Eligibility for Reimbursement of Administrative Costs... 8 Uninsured Patient Claims... 9 Public and Private Healthcare Reimbursement... 9 Exclusions... 9 5. Contacting Patients... 10 6. General Information... 10 ASR Hips Worldwide Implantations... 10 Metals Used in ASR... 10 Revision Instrumentation... 10 Payor Notification... 10 Group Purchasing Organization Notification... 10 Related MHRA Alerts... 10 7. Contact Us... 10 Patient Questions... 10 Hospital Questions... 10 Surgeon Questions... 11 DPYUS 46 (Version 2) 2 October 18, 2010

This ASR Recall Reference Guide is being provided to share the latest information about the ASR Recall and the recommendations for care and treatment of patients with an ASR System, along with the reimbursement process associated with these services. DePuy is committed to sharing new information as it becomes available, so please check www.depuy.com often for the latest information. 1. Available Resources Surgeon-to-Patient Communications Support Information for Patients Handout (DPY 10, version 3). This is a patient education piece that provides important information for patients with an ASR Hip System. Sample Patient Letter (DPY 9, version 2). This can be used by surgeons to notify patients that they have an ASR Hip System that has been recalled. Sample Letter to Patients without an ASR (DPY 13). Surgeons may choose to use this document to notify their patients that they do not have an ASR Hip System and do not need to be concerned about the recall. Suggested Talking Points for Office Managers at Surgeons Offices (DPYUS 24). This is a script template for office staff to use if patients call about the ASR recall. Do you have an ASR Hip System? DePuy would like to share important claims and reimbursement information with you. (DPYUS 33). This document provides patients with the toll-free number for the claims center and an overview of how to begin the ASR verification and claims process to reimburse their out-of-pocket expenses. Patient Forms Authorization to Use or Disclose Information (DPYUS 11, version 3). Please use this form in place of previous versions. Please do not continue to distribute the original medical release form to patients. DePuy has retained a third party claims processor, Broadspire, to manage the call center and claims process. Broadspire will provide this new Patient Medical Authorization Form directly to patients to fill out when a claim is initiated with the call center. Alternatively, the most current Patient Medical Authorization Form can be downloaded from www.depuy.com. Explanation of the U.S. Patient Authorization Form for Surgeons (DPYUS 15). This letter can be downloaded from www.depuy.com. Blood Testing/Cross-Sectional Testing and Treatment Information ASR System Patient Treatment Flow Chart per MHRA Alerts (DPYUS 25, version 1). A pictorial view of the testing and treatment process as recommend by the MHRA guidelines. Healthcare Professional s Guide to ASR Testing and Treatment Recommendations (DPY 14). This guide provides an overview of the MHRA guidelines for testing and treatment, along with instructions for using LabCorp for metal ion testing and a list of DePuy contacts for surgeons. ASR Recall Update: LabCorp Agreement for ASR Blood Testing (DPYUS 35). A September 27 update on the LabCorp agreement and instructions for using a new form (DPYUS 36) to help streamline the patients experience when having blood tested with LabCorp. LabCorp Phlebotomist Instructions (DPYUS 36). The form that should be filled out and sent with patients when having their blood tested at a LabCorp Service Center. Guidance for the ASR XL Acetabular System/DePuy ASR Hip Resurfacing System Recall Metal Ion, Radiological and Cross-Sectional Testing Protocols DPYUS 46 (Version 2) 3 October 18, 2010

(DPYUS 39). This document provides whole blood sample collection instructions, radiological protocol suggestions, and MRI and ultrasound suggestions. Surgeon/Hospital Handling of Explants ASR XL Acetabular System/DePuy ASR Hip Resurfacing System: Retention of Explanted Components (DPYUS 40). This document explains the need to retain implants and the procedure for explanting and retaining surrounding tissue, and the preservation, packing and tracking of the explant. Filing Claims on Behalf of a Patient with an ASR Hip System DePuy Orthopaedics ASR Hip System Recall Reporting Form Instructions (DPYUS 41). This document provides instructions for assisting patients with a DePuy ASR Hip System with the claims initiation and reimbursement process. DePuy Orthopaedics ASR Product Recall Reporting Form (DPYUS 42). This is the form that needs to be filled out and submitted if a claim is being initiated on behalf of a patient with a DePuy ASR Hip System. Additional Information about the Patient Medical Authorization Form The completion of a new Patient Medical Authorization Form will allow surgeons to share information about the patient s case with DePuy and Broadspire and will allow DePuy to provide information directly to patients regarding the ASR Hip System. Broadspire will also use this information to process claims efficiently. The access to data (blood testing results, results of imaging and revision data) will help DePuy to better understand the causes of the higher than expected revision rate with the ASR Hip System. DePuy needs this medical information for reasons that include: (1) to confirm whether the patient received an ASR hip implant, (2) to evaluate whether costs related to the patient s treatment are eligible for reimbursement, and (3) in the event a revision surgery is required, to confirm that the revision is related to the ASR recall. If the surgeon anticipates contacting the ASR Help Line to initiate a claim for a patient, the Patient Medical Authorization Form will need to be completed, signed by the patient, and faxed to Broadspire before the claim can be initiated. Broadspire cannot accept patient information from surgeon offices without a copy of the new Patient Medical Authorization Form with the patient s signature. The only exception is if the surgeon is providing a claim related to a past or planned revision surgery. In that case, there is preliminary information that may be shared by the surgeon. U.S. privacy laws do not permit surgeons to disclose patient identifiable information to DePuy, or to companies such as Broadspire, without written patient consent authorizing the surgeon to disclose the information. A patient can provide the information directly to DePuy without the need to sign a written patient consent. It is important to note that the patient does not waive his/her right to pursue legal action by signing the Patient Medical Authorization Form or by providing the medical information to DePuy. In fact, the Patient Medical Authorization Form now expressly notifies patients that they will not be waiving these rights. DPYUS 46 (Version 2) 4 October 18, 2010

No patient is required to sign the Patient Medical Authorization Form or to provide their medical information. If a patient does not wish to sign the Patient Medical Authorization Form or to provide their medical information to Broadspire or DePuy, we will still endeavor to investigate their claim for reimbursement. However, in this situation a surgeon cannot initiate a claim on the behalf of a patient, the patient will need to call the ASR Help Line directly. Without access to the appropriate medical information, it is unlikely that we will be able to consider the patient s claims for reimbursement and prompt resolution of their claim may not be possible because without access to the patient s medical records, we cannot confirm that the patient has or has had an ASR implant. The Patient Medical Authorization Form, along with an explanation of the Patient Medical Authorization Form, is available at www.depuy.com. 2. Identifying ASR Patients Information regarding the specific implant a patient received is typically part of the patient record at the surgeon s office. Alternatively, the hospital should have a copy of the patient s implant information on file in the Medical Records Department. Patients should understand that this information may take some time to locate, and the doctor s office or hospital may require patients to appear in person to validate their identity before the information can be released to protect patient privacy. DePuy is asking surgeons to contact their patients directly about the recall as DePuy does not have a procedure for maintaining information to identify patients who receive implants. The following sample letter is available on www.depuy.com to assist with patient notification: Sample Patient Letter (DPY 9, version 2). This can be used by surgeons to notify patients that they have an ASR Hip System that has been recalled. 3. Patient Testing Testing and Treatment Recommendations for ASR Hip Patients DePuy recommends following the guidelines provided in the April 22, 2010 and the May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts, which include the following: Patients who received the ASR System should be instructed to return to your office for a follow up visit including clinical assessment and radiographic evaluation. If any radiographic change is indicative of product failure, the patient should be treated as per your discretion. If you or your patient are concerned about the hip, blood testing for cobalt and chromium ion levels in whole blood may be performed as part of the follow up, and/or an MRI or ultrasound if necessary as per the guidelines and schedule below. 1. An initial blood test should be performed. Cobalt and chromium ion levels should be 7 parts per billion (ppb) or below. If the patient is having symptoms, an MRI or ultrasound should also be considered at this time. 2. If either metal ion concentration is above 7 parts per billion (ppb), a second blood metal ion test (both cobalt and chromium) should be performed three months after the first if no symptoms are present. 3. If the metal ion concentration is again above 7ppb, the surgeon should consider MRI or ultrasound, even if the patient does not have symptoms. DPYUS 46 (Version 2) 5 October 18, 2010

4. If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered. 5. If metal ions are less than 7ppb and/or MRI or ultrasound are within normal values, patients should be evaluated on an annual basis for the first five years. These evaluations should be conducted according to your normal procedures. 6. If you or your patient continues to be concerned about the hip, metal ion testing may be conducted on an annual basis at your discretion. Metal Ion Testing Metal ion testing requires specialized equipment that is not widely available. In North America, DePuy recommends working with LabCorp for this testing. If your office has an account with LabCorp, Panel Code 284418 should be ordered. If your office does not have an account with LabCorp, the patient should be provided with a prescription requesting Cobalt and Chromium in whole blood Panel Code 284418 and instructed to go to a LabCorp patient service center. Cobalt and Chromium in whole blood will need to be drawn at a LabCorp patient service center. When sending patients to LabCorp, please complete the LabCorp Phlebotomist Instructions Form (DPYUS 36), available on www.depuy.com or through your sales representative, and provide it to the patient to take to the LabCorp Service Center. If the blood is drawn at your practice/clinic, please include the form with the blood sample. Please note that there are specific directions for the LabCorp phlebotomist on the form regarding whom to call if there are any questions regarding the order. Your account number and/or fax number is required so LabCorp can send the metal ion test results to your office. You may order tests without having a LabCorp account number, but in that case, a fax number is required so that the results may be faxed to your office. Directing the patient to the LabCorp Service Center is the preferred method for collecting the blood samples for ion analysis. In some cases, you may choose to have the blood drawn locally within the practice which is not recommended due to the specialized nature of this test and then contact LabCorp to courier the samples for analysis. The order form should be included with the samples. The samples should be refrigerated prior to transportation. Metal ion testing will be billed directly to DePuy regardless of where the blood is drawn (LabCorp Service Center or surgeon office/clinic), provided the order form is attached. While your account number is required for the reporting process, there should be no charges billed to your account. If your office, the insurer or ASR patient is mistakenly charged for the metal ion testing for an ASR patient, these charges will be reimbursed by DePuy/Broadspire upon receipt of the charges. If the patient is charged, please have them contact the Broadspire claims center at 866-874-2865. If your office is charged, please contact Pam Plouhar at (574) 372-7340 or Tony Cutshall at (574) 372-7229. If you are located in an area that is not served by LabCorp and the closest center is more than 100 miles away, special shipping is required. We are working with LabCorp to address how and where samples should be shipped from your location. Please store any samples collected in the freezer pending further instructions and notify Rodrigo Diaz, M.D. by email at Rdiaz16@its.jnj.com that you have collected samples which require special shipping. DPYUS 46 (Version 2) 6 October 18, 2010

Locating a local LabCorp Office for the U.S. and Canada: Visit www.labcorp.com and click on find a lab. The ASR Claim Number is required for direct billing to DePuy. If the patient has not done so, please advise them to contact the Call Center to initiate the claim process to obtain the DePuy ASR claim number. Special Patient Instructions for Metal Ion Testing Patients should be advised to refrain from taking mineral supplements, vitamin B-12 or vitamin B complex at least three days prior to specimen collection. Locating an Alternative Testing Facility If there is no LabCorp Patient Service Center in the area, patients should be directed to Quest Diagnostics with a detailed prescription containing: Special Miscellaneous test: Cobalt and Chromium in whole blood. Website: www.questdiagnostics.com/hcp/psc/jsp/hcp_psc_index.jsp Instructions related to Metal Ion Testing are included in the document Surgeon Communication LabCorp Instructions (DPYUS 35), which is available on www.depuy.com. Metal Ion Testing for Non-ASR Patients Metal ion testing for patients without an ASR Hip should be done at your discretion based on standard protocol. Please note that the cost of ion testing is typically not reimbursed through insurance and would be an out-of-pocket expense for patients. DePuy will only reimburse this expense for patients who have an ASR Hip. MRI Protocol We suggest you order a MARS MRI. Guidance regarding this protocol is available on www.depuy.com. The MARS MRI requires special software to minimize interference from the metal implant. Not all facilities are equipped with the special software. If MARS MRI capabilities are not available locally, ultrasound is a suitable alternative. Alternatives to MRI Testing Ultrasound is an alternative option. Guidance regarding this protocol is available on www.depuy.com. Additional information about why DePuy does not recommend CT tests as an alternative to MRI or ultrasound will be provided in the future. Blood Storage There s no need to store blood in the U.S. Ion Levels According to the British Orthopaedic Association (BOA) posting titled, Metal on Metal Hip Replacement and Hip Resurfacing Arthroplasty: What does the MHRA Medical Device Alert Mean: It is likely that Cobalt and Chromium levels may be useful for screening but they are not well understood at present. High levels may start as low as 7ppb for either metal. High levels have a higher correlation with revision, pain and soft tissue reactions, but the correlation is not absolute in the short term. DPYUS 46 (Version 2) 7 October 18, 2010

4. Reimbursement DePuy s ASR Reimbursement Policy DePuy intends to cover reasonable and customary costs of testing and treatment if patients need services, including revision surgery if necessary, associated with the ASR recall, as well as other costs listed below. Bills for services should be submitted to payors (public or private) in the usual manner, and then DePuy s intended process is to reimburse payors (public or private) for reasonable and customary expenses. Negotiations around the specifics of this process are in progress. Detailed information about the reimbursement process will be available shortly. Patient Out-of-Pocket Expenses Patients will be covered for out-of-pocket costs for reasonable and documented expenses, which may include, but are not limited to, co-pays, lost work time, travel expenses and other reimbursable expenses. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis. DePuy is working closely with the labs that will handle the metal ion testing so charges are billed directly to DePuy. As patients contact the call center, a claim number will be assigned so other reasonable expenses can be reimbursed as quickly as possible. Medical Treatment Expenses DePuy will provide reimbursement for the reasonable and customary costs of tests and treatments related to the ASR recall pursuant to the eligibility criteria described in this document and subject to review. This may include but is not limited to, blood testing, ultrasound scans, MRI scans, x- rays, and revision surgery costs if surgery is necessary. These expenses should be submitted through Broadspire for review of eligibility. A claim number and claims processor will be assigned so the claims can be processed. ASR Revisions Performed Prior to the Recall ASR revisions associated with the ASR recall, whether or not they occurred before the recall, will be covered, subject to DePuy s review as well as certain limited exclusions such as defined below or other reasons unrelated to the recall. Timing DePuy will reimburse if the ASR revision occurs within 7 years after the initial implantation. DePuy will reimburse for blood ion tests/mri/ultrasound scans if the testing occurs within 5 years from the date of the recall. Patient Eligibility for Reimbursement Reimbursement is subject to the completion and submission of required documentation to Broadspire to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted, that the treatment is associated with the ASR recall, and the ASR patient has consented, if requested, to provide DePuy with x-rays, explants and other related medical information after the revision surgery. Surgeon Eligibility for Reimbursement of Administrative Costs DePuy previously communicated that a $50 per-patient fee would be provided for administrative costs associated with notifying ASR patients. However, on Friday, September 10, 2010, the U.S. Office of Inspector General for the Department of Health and Human Services (OIG) issued an DPYUS 46 (Version 2) 8 October 18, 2010

Advisory Opinion that raised significant questions about whether the OIG would approve these types of payments. The OIG Advisory Opinion resulted from another medical device company proposing to pay health care professionals a fee for assisting with a warranty program. The OIG indicated these payments could violate the Anti-Kickback Statutes and result in penalties. This means the OIG could also take action against physicians who accept these types of payments. As a result, DePuy will not be implementing the reimbursement program until appropriate approvals are received from the OIG. It s possible that the OIG may either reject DePuy s proposal or require documentation from physician offices to substantiate the payments. DePuy recommends tracking the time already spent in identifying and notifying patients so this information won t need to be reconstructed months later. While it could be several months before the OIG responds, we recommend that customers begin tracking this time so the documentation will be available if the OIG allows DePuy to make these payments. The information the OIG may require includes: Title/position of the person doing the work A detailed description of the work performed The date the work was performed and the amount of time spent The amount of reimbursable time will be determined at a later date pending discussions with the OIG. DePuy is also evaluating other ways to assist practices with identifying and notifying ASR patients. Any support provided by DePuy, however, will need to be approved by the OIG. The OIG considers time spent scheduling appointments and caring for patients as part of the health care claim submitted for the appointment, so this time is not eligible for reimbursement. DePuy has contacted the OIG, and while it s not clear how long this process may take, we will update you when we have additional information. Uninsured Patient Claims Patients should call the toll-free number at 888-627-2677 and initiate a claim whether or not they are insured. Public and Private Healthcare Reimbursement DePuy intends to reimburse both national healthcare providers and payors (public or private) for reasonable and customary expenses related to eligible ASR revisions. Exclusions The following revision surgeries may not be covered, subject to review by DePuy: Component mismatches Traumatic injury where there is no evidence of soft tissue reaction at the time of surgery Femoral neck fractures within three months of primary surgery and subject to review on a case-by-case basis Infection confirmed by positive culture DPYUS 46 (Version 2) 9 October 18, 2010

5. Contacting Patients DePuy is asking surgeons to contact their patients directly about the recall as DePuy does not have a procedure for maintaining information to identify patients who receive implants. Where this information is available in our records, we may provide this to surgeons to assist with patient care. 6. General Information ASR Hips Worldwide Implantations Approximately 93,000 Metals Used in ASR ASR XL Femoral Head = Cast CoCrMo ASR XL Acetabular Cup = Porous coated Cast CoCrMo ASR XL Sleeve = Wrought CoCrMo ASR Femoral Resurfacing Component = Cast CoCrMo ASR Resurfacing Acetabular Component = porous coated Cast CoCrMo (same component as used with the XL product) Note: The ASR Hip Resurfacing System was approved for use outside the U.S. and the ASR XL Acetabular System was available worldwide. Revision Instrumentation DePuy s Moreland Revision Instruments are available in the U.S. Payor Notification In the U.S.: DePuy is working directly with payors. Group Purchasing Organization Notification GPOs are being notified globally. Related MHRA Alerts 1. Medical Device Alert: All metal-on-metal (MoM) hip replacements. http://www.mhra.gov.uk/ Publications/ Safetywarnings/MedicalDeviceAlerts/CON079157 2. Medical Device Alert: DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty and total hip replacement. http://www.mhra.gov.uk/publications/safetywarnings/medicaldevicealerts/con082089 7. Contact Us Patient Questions: English-speaking Patients and Non-English speaking Patients in the U.S. and Canada: Dial the toll-free number, 888-627-2677. This call center will be active from 8 a.m. to 9 p.m. EST, Monday through Saturday. Hospital Questions: Questions regarding the hospital recall notification: North America: Katie Seppa, Manager of Customer Quality: 1-574-372-7333 DPYUS 46 (Version 2) 10 October 18, 2010

Surgeon Questions: U.S./Canada/Latin America Rodrigo Diaz, Scientific Information Officer, 1-574-372-7401 Mikhail Chkolnik, Project Leader, Clinical Research, 1-888-554-2482 DPYUS 46 (Version 2) 11 October 18, 2010