AJRR Webinar ICD10-PCS guidance Unique Device Identifiers 2015

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1 AJRR Webinar ICD10-PCS guidance Unique Device Identifiers 2015 AJRR Team Terra Miller Marketing Communications Kristine Baldwin Data Submission Analyst Randolph Meinzer - IT Director / Privacy Security Officer

2 Agenda Hip and knee ICD-10-PCS overview Triggering code definitions Unique Device Identifier (UDI) format Specification and file submission format Brief Level II and Level III update Question and Answer session

3 AJRR Mission & Vision AJRR is a multi-stakeholder, independent, not-forprofit with diverse national constituents We optimize patient outcomes through collection of data on all primary and revision total joint replacement procedures in the U.S. Our mission is to enhance patient safety, improve quality of care, and reduce the cost of care Our goal is to capture 90% of all total joint replacement procedures in the U.S.

4 Thank You, AJRR Participants! AJRR has grown to over 525 participants and currently has approximately 316,000 orthopaedic procedures representing over 285,000 patients AJRR growth is largely a product of your efforts and for that, the AJRR IT and Analytics team would like to say Thank You!

Background ICD-10-PCS Conversion required per the regulations beginning October 1, 2015 Unique Device Identifier (UDI) labeling required by September 27, 2015 for all manufacturers of Orthopaedic

5 Background ICD-10-PCS Conversion required per the regulations beginning October 1, 2015 Unique Device Identifier (UDI) labeling required by September 27, 2015 for all manufacturers of Orthopaedic Implants AJRR Progress ICD9-CM->ICD-10-PCS guidance document created by AJRR Cross walk 9->10 ICD-10-PCS triggering codes Explanations of the procedure types (replacement, removal, revision, supplement) Changes to the method for submitting procedures previously classified as revisions Level I specifications and submission file format drafted

6 Procedure Types - Hip & Knee Replacement [R]: Putting in or on biological or synthetic material that physically takes the place and/or function of all or a portion of a body part Example: 0SR90J5 Replacement of right hip joint with synthetic substitute, metal on polyethylene, open apprach Supplement [U]: Putting in or on biological or synthetic material that physically reinforces and/or augments the function of a portion of a body part Example: 0SU90BZ Supplement right hip joint with resurfacing device, open approach Removal [P]: Taking out or off a device from a body part Example: 0SP90JZ Removal of synthetic substitute, right hip joint, open approach Revision [W]: Correcting, to the extent possible, a portion of a malfunctioning device or the position of a displaced device. Example: 0SWC0JZ Revision of liner in right knee joint, open approach Old ICD9-CM Revision procedures now require a dual Removal Replacement set to be submitted through administrative claims ICD-10-PCS requires that the singular ICD9-CM codes for revisions be reported as a removal and replacement procedures.

7 Example Replacement Code ICD-10-PCS Code: 0SR904A Section Body System Operation Body Part Approach Device Qualifier Character 1 Character 2 Character 3 Character 4 Character 5 Character 6 Character 7 0 S R A MedSurg Lower Joints Replacement Hip Joint, Open Synthetic Uncemented Right Substitute Ceramic, on poly Challenges Reporting Revisions (now removal replacement dual codes) Separate Removal code procedure with associated diagnosis Followed by a replacement procedure code and associated diagnosis

8 Example of Removal Replacement Old ICD-9-CM Code Description ICD10-PCS Codes CPT Code Legal Combinations Revision of hip replacement, femoral component 0SRR0JG (Replacement Right Hip Joint Femoral Surface), with 0SP90JZ Removal of synthetic substitute from right Hip Joint, open approach SRR0JG With 0SP90JZ

9 Additions to reporting file template PPXDate pdx ppx PPX10Removal Date PPX10Removal Procedure PDX10Removal Diagnosis PPXReplacement Procedure PDX10Replacement Diagnosis CPT Date for either ICD- 9-CM or ICD-10-PCS Procedure ICD-9CM Procedure Diagnosis Backward Compatibility PPXDate PDX PPX PPX10RemovalDa te New fields to support replacement removal and CPT codes. The CPT codes will be mapped to the appropriate ICD-10-PCS codes for normalization when placed in the AJRR database Additions and population of the AJRR File submission template PPX10Rem ovalproced ure PPX10Rem oval Diagnosis PDX10Repl acement Procedure PPX10Repl acement Diagnosis 11/11/ /11/2015 0SP90JZ T SRR0JG T CPT Private Practice Physician Participants Mechanical loosening of internal right hip prosthetic joint

10 Unique Device Identifiers (UDI) All implant manufacturers are required to replace old product labeling (catalog code numbers and lot numbers) with a singular UDI label in October 2015 The UDI label is provided by issuing agencies Industry Business Communications Council (HIBCC) Issuing Agency GS1 All indications are the orthopaedic manufacturers will use GS1 Others

11 Unique Device Identifiers (UDI) Device Identifier (DI) + Production Identifier(s)(PI) DI= field (01) mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device PI= field (10) a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: Lot or batch number Serial number Expiration date Manufacturing date For an HCT/P regulated as a device, the distinct identification code

12 Global Unique Device Identification Database (GUDID) Repository of key device identification information Contains ONLY the DI; PIs are not submitted to or stored in the GUDID Contains only PI flags to indicate which PI attribute(s) are on the device label

13 UDI Record 13

14 GS1 Issuing Agency Label Format Replaces Catalog Number AJRR has added a specific UDI field to the file specification: UDIDeviceIdentifier Issuing Agency Data Delimiters Identifier Data type Human Readable Field Size Database Field Size GS1 (01) DI Numeric GS1 (11) Manufacturing/ Production Date numeric [YYMMDD] 8 6 GS1 (17) Expiration Date numeric [YYMMDD] 8 6 GS1 (10) Batch/Lot Number alphanumeric GS1 (21) Serial Number alphanumeric GS1 Maximum Base UDI alphanumeric ex: (01) (11)141231(17)150707(10)A213B1(21)1234 Replaces Lot Number; This value should be placed in the existing lot number fields

15 UDI Additions to the File Template Maintained for backward compatibility with old labeling Entire UDI Manufacturer UDIDeviceIdentifier CatalogNumber ComponentName LotNumber CompleteUDI Depuy Uber Straight Femoral Stem Device Identifier Field (01) Production Identifier Field (10)

16 Recommended actions Review documentation and adjust AJRR report Send test file to the AJRR include Place TESTICD10 somewhere in the filename Send the file to your normal account on our SFTP site AJRR Contact Kristine Baldwin AJRR will review and provide feedback within 1 week worst case If necessary adjust report Begin regular submission of ICD10 data Documentation available at AJRR_Level 1_Data_Element_Definition_V3_4Draft_8_11_2015.xlsx AJRR_ICD10_Submission_Instructions_7_1_2015_DRAFT.doc

17 AJRR Level 3 and Level 2 Update AJRR Development Program Release October 2015 ICD10 support and normalization for reporting Add PROMIS-10, VR-12, Short form HOOS and KOOS, and a one question pain scale to the AJRR PROMS Portfolio Patient reported outcome dashboards UDI support Network hospital reporting Component reference library attribute expansion Material, lengths, systems, plus many more AJRR Level 2 system update System prepared for accepting level 2 data Goal end of 2015/early 2016 Why? Total review of Level 2 data elements (in progress) minimizing reporting requirements and alignment with risk adjustment Adjustment of forms, specifications, dashboards and reporting It made sense to wait for the ICD10 conversion Risk adjustment metrics available 2016 Risk Adjustment using AJRR Level 2 data (Average patient, predicted versus observed) AJRR will be required to collect a minimum set of statistically relevant data to provide meaningful risk adjustment at the national level for comparison by hospitals Private practice group support

18 Thank You! Questions? For starters, AJRR has a question for the experts. Will the diagnosis codes for a removal / replacement procedure pair be the same??? If you have general questions please contact your AJRR program coordinator Phil, Kate or Savana If you have technical questions on the codes or file specifications contact Randy or Kristine

Incorporating the Unique Device Identifier (UDI) into Health Care Delivery. Margaret Weiker, President, The Weiker Group

Incorporating the Unique Device Identifier (UDI) into Health Care Delivery Margaret Weiker, President, The Weiker Group Unique Device Identifier (UDI) Unique Device Identifier (UDI) an identifier that