Methylnaltrexone Bromide (Relistor)

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Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes) References: clinical publications and sources relevant to this clinical edit te: Click the hyperlink to navigate directly to that section. Revision tes Initial publication and posting to website August 23, 2013 Copyright 2013 Health Information Designs, LLC 1

Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN RELISTOR 8MG/0.4ML SYRINGE 31279 RELISTOR 12MG/0.6ML KIT 99719 RELISTOR 12MG/0.6ML SYRINGE 31278 RELISTOR 12MG/0.6ML VIAL 99722 August 23, 2013 Copyright 2013 Health Information Designs, LLC 2

Clinical Edit Criteria Logic 1. Does the client have a diagnosis of opioid induced constipation in the last 730 days? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a history of palliative care in the last 365 days? [ ] (Go to #3) [ ] (Deny) 3. Is the client greater than or equal to ( ) 18 years of age? [ ] (Go to #4) [ ] (Deny) 4. Does the client have a diagnosis of mechanical gastrointestinal obstruction in the last 730 days? [ ] (Deny) [ ] (Go to #5) 5. Does the client have a claim for a laxative in the last 90 days? [ ] (Approve 365 days) [ ] (Deny) August 23, 2013 Copyright 2013 Health Information Designs, LLC 3

Clinical Edit Criteria Logic Diagram Step 1 Step 2 Step 3 Does the client have a diagnosis of opioid induced constipation in the past 730 days? Does the client have a history of palliative care in the past 365 days? Is the client 18 years of age? Step 4 Does the client have a diagnosis of mechanical gastrointestinal obstruction in the last 730 days? Step 5 Does the client have a claim for a laxative in the last 90 days? Approve Request (365 days) August 23, 2013 Copyright 2013 Health Information Designs, LLC 4

Supporting Tables Step 1 (diagnosis of opioid induced constipation) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 56400 CONSTIPATION, UNSPECIFIED 56409 OTHER CONSTIPATION Step 2 (history of palliative care) Required diagnosis: 1 Look back timeframe: 365 days ICD-9 Code V667 Description ENCOUNTER FOR PALLIATIVE CARE Step 4 (diagnosis of mechanical gastrointestinal obstruction) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 552 OTHER HERNIA OF ABDOMINAL CAVITY WITH OBSTRUCTION BUT WITHOUT MENTION OF GANGRENE 5520 FEMORAL HERNIA WITH OBSTRUCTION 55200 FEMORAL HERNIA WITH OBSTRUCTION, UNILATERAL OR UNSPECIFIED (NOT SPECIFIED AS RECURRENT) 55201 FEMORAL HERNIA WITH OBSTRUCTION, UNILATERAL OR UNSPECIFIED, RECURRENT 55202 FEMORAL HERNIA WITH OBSTRUCTION, BILATERAL (NOT SPECIFIED AS RECURRENT) 55203 FEMORAL HERNIA WITH OBSTRUCTION, BILATERAL, RECURRENT 5521 UMBILICAL HERNIA WITH OBSTRUCTION 5522 VENTRAL HERNIA WITH OBSTRUCTION 55220 VENTRAL, UNSPECIFIED, HERNIA WITH OBSTRUCTION 55221 INCISIONAL VENTRAL HERNIA WITH OBSTRUCTION 55229 OTHER VENTRAL HERNIA WITH OBSTRUCTION 5523 DIAPHRAGMATIC HERNIA WITH OBSTRUCTION 5528 HERNIA OF OTHER SPECIFIED SITES, WITH OBSTRUCTION August 23, 2013 Copyright 2013 Health Information Designs, LLC 5

ICD-9 Code Step 4 (diagnosis of mechanical gastrointestinal obstruction) Description Required diagnosis: 1 Look back timeframe: 730 days 5529 HERNIA OF UNSPECIFIED SITE, WITH OBSTRUCTION 560 INTESTINAL OBSTRUCTION WITHOUT MENTION OF HERNIA 5600 INTUSSUSCEPTION 5601 PARALYTIC ILEUS 5602 VOLVULUS 5603 IMPACTION OF INTESTINE 56030 IMPACTION OF INTESTINE, UNSPECIFIED 56031 GALLSTONE ILEUS 56032 FECAL IMPACTION 56039 OTHER IMPACTION OF INTESTINE 5608 OTHER SPECIFIED INTESTINAL OBSTRUCTION 56081 INTESTINAL OR PERITONEAL ADHESIONS WITH OBSTRUCTION (POSTOPERATIVE) (POSTINFECTION) 56089 OTHER SPECIFIED INTESTINAL OBSTRUCTION 5609 UNSPECIFIED INTESTINAL OBSTRUCTION Step 5 (history of laxative) Number of claims: 1 Look back timeframe: 90 days Label Name GCN AMITIZA 8MCG CAPSULE 99658 AMITIZA 24MCG CAPSULE 26473 CONSTULOSE 10G/15ML SOLUTION 10167 ENULOSE 10 GM/15 ML SOLUTION 10160 GENERLAC 10 GM/15 ML SOLUTION 10160 KRISTALOSE 10GM PACKET 10162 KRISTALOSE 20GM PACKET 11118 LACTULOSE 10G/15ML SOLUTION 10167 August 23, 2013 Copyright 2013 Health Information Designs, LLC 6

Clinical Edit Criteria References 1. Relistor Package Insert, Salix Pharmaceuticals, Inc. Raleigh, NC. Available at http://www.relistor.com/assets/pdf/relistor-methylnaltrexone-bromide-pi.pdf. Accessed on March 6, 2013. 2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; August 2012. Available at http://cp.gsm.com. Accessed on March 6, 2013. 3. 2013 ICD-9-CM Diagnosis Codes, Volume 1, 2012. Available at http://www.icd9data.com/. Accessed on March 6, 2013. August 23, 2013 Copyright 2013 Health Information Designs, LLC 7

Publication History The Publication History records the publication iterations and revisions to this document. tes for the most current revision are also provided in the Revision tes on the first page of this document. Publication Date tes 08/23/2013 Initial publication and posting to website August 23, 2013 Copyright 2013 Health Information Designs, LLC 8