VIRGINIA MEDICAID s SYNAGIS SERVICE AUTHORIZATION Season: October 1 through March 31

Transcription

1 VIRGINIA MEDICAID s SYNAGIS SERVICE AUTHORIZATION Season: October 1 through March 31 COMMONWEALTH of VIRGINIA Department of Medical Assistance Services Patient s Name: Patient s Medicaid ID#: (12 digits) Patient s Date of Birth/Current Age (months): Drug Name & Strength: PATIENT INFORMATION Patient s Diagnosis/ICD-9 code: Patient s Weight (kg) Patient s Gestational Age: wks days DRUG/CLINICAL INFORMATION Quantity Per Month/# of Doses requested: Gestational age < 28 wks, 6 days and patient s CA < 12 months Gestational age 29 wks, 0 days-31 wks, 6 days and patient s CA < 6 months Chronic lung disease of prematurity (gestational age 32 wks, 0 days) and patient s CA <12 months old at start of RSV season and required >21% oxygen for at least 28 days after birth Patient s CA < 12 months with congenital abnormalities of the airway or neuromuscular disease that compromises handling of respiratory secretions* CHECK APPLICABLE AGE, CONDITION AND RISK FACTORS Patient s CA < 24 months old with Chronic Lung Disease* of prematurity (gestational age < 32 wks) Patient s CA < 12 months old with hemodynamically Congenital Heart Disease* (without surgical correction) Patient s CA <24 months old and severely immunocompromised Chronological age (CA) at start of RSV season Include ICD-9codes for the indicated disease states. For CLD/CHD, attach supporting documentation (i.e., progress notes, discharge notes, and/or chart notes). AND Is the patient currently outpatient without an inpatient hospitalization within the last 2 weeks? Yes No If no, document the discharge date Has the patient received any Synagis doses during the current RSV season? Yes No If yes, document the administration date(s) Medical justification/ Documentation for diagnoses not listed above (attach supporting documentation). PRESCRIBER INFORMATION Name (print):_ NPI Number: Phone Number: (_ ) - Fax Number: ( ) - Signature of Prescribing Provider: PLEASE INCLUDE ALL REQUESTED INFORMATION INCOMPLETE FORMS WILL DELAY THE SERVICE AUTHORIZATION PROCESS FAX FORM TO SERVICE AUTHORIZATION CRITERIA ARE SUBJECT TO CHANGE AND THUS DRUG COVERAGE. SUBMISSION OF DOCUMENTATION DOES NOT GUARANTEE COVERAGE BY THE DEPARTMENT OF MEDICAL ASSISTANCE SERVICES. FINAL COVERAGE DECISIONS MAY BE AFFECTED BY SPECIFIC MEDICAID LIMITATIONS. DMAS-172A 08/2017 1

2 Virginia Department of Medical Assistance Services Synagis Service Authorization Criteria 1. Is the infant s gestational age < 28 wks, 6 days and chronological age 1 less than 12 months old? No (If no, go to #2) 2. Is the infant s gestational age 29 wks up to 31 wks, 6 days and chronological age 1 less than 6 months old? No (If no, go to #3) 3. Chronic lung disease of prematurity (gestational age <32 wks, 0 days) AND patient s CA <12 months old at start of RSV season AND required >21% oxygen for at least 28 days after birth. No (If no, go to #4) 4. Is the infant s chronological age 1 < 12 months with a diagnosis 2 of congenital abnormalities of the airway or neuromuscular disease that compromises handling of respiratory secretions? Supporting documentation*of diagnosis/icd-9 code must be included. No (If no, go to #5) 5. Is the patient less than 24 months of age with a diagnosis of Chronic Lung Disease 2 (CLD) of prematurity (defined as gestational age less than 32 weeks) and has received medical therapy (supplemental oxygen [>21% for at least 28 days, vent not required], diuretic, or chronic corticosteroid therapy) within 6 months before the start of the RSV season or who continue to require medical therapy (as defined above). Supporting documentation* of diagnosis/icd9 code and medical therapy must be included. Yes (If yes, indicate treatment below and go to #8) No (If no, go to #6) 6. Is the patient 12 months of age or younger with a diagnosis of hemodynamically significant Congenital Heart Disease(CHD) with one of the following: (a) Congenital heart disease 2 patient who is receiving medication to control congestive heart failure (CHF), or (b) Moderate to severe pulmonary hypertension 2, or (c) Cyanotic heart disease with no or incomplete surgical correction of defect 2? Supporting documentation* of diagnosis/icd9 code as well as medications (if applicable) must be included. Yes (If yes for 6a, 6b or 6c, go to #8) No (If no, go to #7) 7. Is the patient less than 24 months of age and severely immunocompromised? No (If no, must be reviewed by Pharmacist or Medical Director) 8. Is the patient currently an outpatient and has not been enrolled as an inpatient within 2-weeks of the date the Synagis is requested? Enter discharge date (if applicable) Yes (If yes, approve request) No (If no, SA must be given to be effective 2 weeks post hospital discharge) One of the first 6 criteria and the final criterion must be met before approval can be granted. Docu mentation of the hospital discharge summary from birth or documentation of the first office visit with pertinent information (gestational age, diagnosis, etc.) is required on all Synagis PA requests. RSV prophylaxis approval will terminate March 31. RSV season is defined by the Virginia Medicaid Agency as October 1 through March 31. NOTE: Approval authorizes up to a five (5) dose maximum or through March 31. A dose is defined as the calculated dosage [patient weight (kg) X 15mg/kg divided by 100 mg/ml of Synagis ]. The results of the calculation will be the number of mls the patient needs. Use the appropriate combination of vials to get the correct dose. No dose may be given after March 31. Requests for more than one dose in a 28 day period cannot be approved. If the patient received a dose in an inpatient setting, approval will only be given for 4 doses, with the exception of infants identified in item number 3. Letters will be faxed to both prescriber and dispensing pharmacy notating approval or denial. *Supporting documentation is supplemental information submitted to support the patient meeting the criteria. Supporting documentation may include copies of hospital discharge notes, progress notes, pharmacy profiles, etc., and must include all medications, frequency of medication dosing, and diagnosis(es) with indications of severity of illness. 1 Chronological age at the start of the RSV Season 2 Please refer to Appendix A of the Synagis Service Authorization Instruction Worksheet for acceptable diagnosis/icd-9 codes for all applicable diagnoses as well as acceptable medications used in CHD. 3 A maximum of three doses will be approved for this group. Administration of Synagis is not recommended for children greater than 3 months of age in this population. 2

3 Virginia Department of Medical Assistance Services Synagis Service Authorization Instruction Worksheet Palivizumab (hereby called by its trade name Synagis ) is FDA approved for the prevention of respiratory syncytial virus (RSV) in selected infants and children. Synagis requires service authorization (SA) for reimbursement through the Virginia Medicaid Agency. The approval time frame for Synagis will begin October 1 and will be effective through March 31 of the following year. Synagis should be administered monthly; a total of up to five doses will be allowed per recipient from October 1 through March 31. There are no circumstances that will allow for approval of a sixth dose. For approval of requests, the recipient must meet gestational and chronological age requirements. In order to meet chronological age requirements, the recipient must be the required age at the start of the RSV season. Prescribers - not the pharmacy, manufacturer, or any other third party entity - are to submit requests for Synagis on a separate SA form (DMAS-172A) or by phone directly to Magellan and may be accepted beginning September 1 (for an October 1 effective date). Letters will be faxed to the prescriber notating approval or denial. The following outlines the instructions and additional information for completing the Synagis SA form (DMAS-172A). Questions regarding the Synagis SA process can be directed to Magellan at Patient Information Complete Patient Information Section to include Patient Name, Medicaid Recipient ID #, date of birth, and phone number with area code. Prescriber Information Complete Prescriber Information Section to include Prescriber name, NPI, License #, phone and fax number, and address (optional). The prescriber MUST sign and date the SA form attesting the information on the submitted form and supplemental information is accurate information. Stamped signatures will not be accepted. Drug/Clinical Information Synagis has been approved by Virginia Medicaid for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) as outlined by the American Academy of Pediatrics (AAP) recommendations 1 for the prevention of RSV. The patient must meet the most current AAP guidelines 1, the gestational age, chronological age, and must be an outpatient with no in-patient stay for at least two weeks prior to the date of the medication request. In order to meet chronological age requirements, the recipient must be the required age at the start of the RSV season. See Appendix A of the Synagis SA Instruction Worksheet for a list of diagnosis/icd-9 codes and acceptable medications for use with the Synagis SA form. If a dose was administered in an inpatient setting, the date the dose was administered must be included on the SA request form. See Synagis Service Authorization Criteria for specific requirements for approval. Required fields within this section of the SA form include: Drug requested Strength Qty per month Current weight of recipient (in kg) Gestational age (in weeks and days) Number of doses requested ICD-9 Code Other fields within this section of the SA form are to be completed/marked if applicable. SA Approval Timeframes Approval may be given for up to 5 doses or through the end of RSV season (March 31), whichever comes first. Infants eligible for a maximum of three doses are those with a GA of 32 weeks, 0 days to 34 weeks, 6 days with at least one risk factor and born 3 months before or during the RSV season. 3

4 Prior Treatment Trials Prior treatment trials do not apply to Synagis. Stable Therapy Stable therapy does not apply to Synagis. A new SA must be submitted for each defined Synagis season. Electronic Service Authorizations Not Applicable Verbal SA Requests Providers may submit verbal SA requests to Magellan at Glossary: Chronic Lung Disease (CLD): also known as bronchopulmonary dysplasia (BPD): an infant less than 32 weeks gestation evaluated at 36 weeks postmenstrual age or an infant of more than 32 weeks gestation evaluated at more than 28 days but less than 56 days of age who has been receiving supplemental oxygen for more than 28 days. 1 CLD of prematurity is defined as CLD with gestational age less than 35 weeks. 1 Note: CLD does not include croup, URI, bronchitis, bronchiolitis, asthma, or wheezing. Hemodynamically significant Congenital Heart Disease (CHD): children with congenital heart disease who are receiving medication to control congestive heart failure, have moderate to severe pulmonary hypertension, or have cyanotic heart disease. 1 Decisions regarding prophylaxis with Synagis in children with CHD should be made on the basis of the degree of physiologic cardiovascular compromise. 1 Medical Justification: an explanation of the reason the drug is required in a particular patient and any additional information needed. Medical justification may include supporting documentation from the patient chart or peer-reviewed literature to support the physician s request for the drug. Supporting Documentation: supplemental information submitted to support the patient meeting the criteria. Supporting documentation may include copies of hospital discharge notes, progress notes, pharmacy profiles, etc. References 1 Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014 Aug 1; 134: ²RSV Policy Statement Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics 2014 December; 134:1221. Please see pages below for ICD-9 CODE and MEDICATION LIST FOR USE WITH SYNAGIS CRITERIA 4

5 VIRGINIA DEPARTMENT of MEDICAL ASSISTANCE SERIVCES SYNAGIS SA INSTRUCTION WORKSHEET ICD-9 CODE and MEDICATION LIST FOR USE WITH SYNAGIS CRITERIA Note: ANY accepted diagnosis/icd-9 Code listed on the service authorization form MUST have supporting documentation attached. Supporting Documentation is supplemental information submitted to support the patient meeting the criteria and may include copies of hospital discharge notes, progress notes, pharmacy profiles, etc. I. Neuromuscular Disorders Acceptable ICD-9 codes include: Infantile paralysis Cerebral degenerations Myoclonus Spinocerebellar disease Werdning-Hoffman disease (Infantile spinal muscular atrophy) Spinal muscular atrophy Motor neuron disease Exclude (but not limited to) the following (ie the following are NOT accepted): Cerebral Palsy Generalized Convulsive epilepsy Grand mal seizures Epilepsy Spina bifida Newborn seizures Infantile seizures II. Congenital Abnormalities of the Airways Acceptable ICD-9 codes include: Other diseases of the trachea and bronchus,not elsewhere classified (Must specify Tracheomalacia or tracheal stenosis) Other anomalies of larynx, trachea, and bronchus (Must specify congenital tracheal atenosis, atresia of trachea, laryngomalacia, or absence or agenesis of bronchus, trachea) Congenital cystic lung Agenesis, hypoplasia, and dysplasia of the lung Congenital bronchiectasis Macroglossia Uvula anomaly Beckwith (-Wiedemann) Syndrome Exclude (but not limited to) the following (ie the following are NOT accepted): Anomaly of lung, unspecified Other anomaly of the lung III. Chronic Lung Disease Acceptable ICD-9 code: Chronic respiratory disease arising in the perinatal period (CLD/BPD/Interstitial pulmonary fibrosis of prematurity/wilson-mikity syndrome) Exclude (but not limited to) the following (ie the following are NOT accepted): Croup URI Bronchitis Bronchiolitis 493 Asthma Wheezing Continued below 5

6 IV. Congential Heart Diseases (CHD) Acceptable ICD-9 codes: A. Acyanotic CHD: Must currently be receiving medication to control CHF (see below) Aortic stenosis* 425 Cardiomyopathy (must be moderate to severe) Ventricular septal defect* Atrial septal defect* Atrioventricular canal (endocardial cushion defect) Pulmonic stenosis* Patent ductus arteriosus* / Coarctation of the aorta* B. Cyanotic CHD: Does not require use of medication/must not have had or completed surgical correction Truncus arteriosus Transpostion of the great vessels Tetralogy of Fallot Atresia, congenital Tricuspid atresia and stenosis, congenital Ebstein s anomaly Hypoplastic left heart Hypoplastic right heart Total anomalous pulmonary venous return C. Pulmonary Hypertension: Acute cor pulmonale Primary pulmonary hypertension Other chronic pulmonary heart disease (pulmonary hypertension, secondary) Persistent fetal circulation (persistent pulmonary hypertension/primary pulmonary hypertension of newborn) *Per AAP guidelines, decisions on prophylaxis with Synagis in children with CHD should be made on the degree of cardiovascular compromise. CHD that is deemed hemodynamically insignificant will not meet criteria. Documentation must specifically support CHD being hemodynamically significant (e.g. medications, etc.). 6