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Certificate of Medical Necessity: Solid Organ Transplants Fax or email this completed form to: and other required documentation including letter of medical necessity from physician, patient history of illness, all pertinent laboratory findings, diagnostic testing including radiology reports, and other pertinent documentation Fax: (904) 357-6331 Email: [email protected] Phone: 1 (800) 955-5692 Extension: 19001 Section A Physician Information/ Requesting Provider Name: BCBSF No: National Provider Identifier (NPI): Contact Name: Phone: Facility Information/ Location where services will be rendered Name: Transplant Coordinator Name: Phone: Fax: Financial Coordinator Name: Phone: Fax: Last Name: First Name: Member Information BCBSF No: National Provider Identifier (NPI): Contact Name: Phone: Male Member/Contract Number (alpha and numeric): Procedure Information Female Date of Birth: Procedure Code(s): Procedure Description: Diagnosis code(s): Diagnosis Description: Date of Service/Tentative Date: Member Status Coding This is an urgent request Member is currently in-member ICD-9 codes: Diagnosis codes description (Including co-morbidities): Section B – General Information Check all boxes and complete all entries that apply: What type of end-stage organ disease does the member have? Check all the apply: Heart Pancreas Multiple Visceral (specify organs) Heart/Lung Kidney Small Bowel Lung Liver Pancreatic Islet Cell The member will receive: Living organ Cadaveric organ Certificate of Medical Necessity: Solid Organ Transplants CMN 09-J0000-48_072515 1 Section C – Current Medical Information Check all boxes and complete all entries that apply: Yes No Does the member have any psychosocial conditions or chemical dependency affecting ability to adhere to therapy? Yes No Is the member actively involved in alcohol or drug abuse treatment? If Yes, 1. provide date treatment began: 2. Attach a copy of the most recent drug screen including date collected. Yes No Does the member have an untreated systemic infection making immunosuppression unsafe, including chronic infection? Yes No Does the member have systemic disease that could be exacerbated by immunosuppression? Yes No Does the member have any serious health conditions that create an inability to tolerate surgery or post-transplant care? Yes No Does the member have an untreatable end-stage disease of another organ? If Yes, explain: Yes No Does member have adequate support system in place? Yes No Does the member have a known, current malignancy? If Yes, attach documentation of type, location, and treatment. Yes No Does the member have a recent malignancy with a high rate of recurrence? Yes No Has the entire transplant evaluation workup been completed? Section D – Organ Specific Information Check all boxes and complete all entries that apply: Heart - Adult Which of the following indications is applicable for the member? Heart failure with evidence of maximal VO2 <10 ml/kg/min with achievement of anaerobic metabolism Heart failure with evidence of refractory cardiogenic shock Heart failure with evidence of documented dependence on intravenous inotropic support to maintain adequate organ perfusion Recurrent unstable ischemia not amenable to bypass surgery or angioplasty Maximal VO2<14 ml/kg/min and major limitation of the member’s activities Recurrent symptomatic ventricular arrhythmias refractory to ALL accepted therapeutic modalities Instability of fluid balance/renal function not due to member non-compliance with regimen of weight monitoring, flexible use of diuretic drugs and salt restriction Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty Heart – Pediatric Which of the following indications is applicable for the member? Heart failure with persistent symptoms at rest that requires continuous infusion of intravenous inotropic agents. Heart failure with persistent symptoms at rest that requires mechanical circulatory or ventilator support. Severe limitation of exercise and activity (if measurable, such members would have a peak maximum oxygen consumption <50% predicted for age and sex.) Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease. Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator. Restrictive cardiomyopathy with reactive pulmonary hypertension. Reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotropic heart transplantation in the future. Certificate of Medical Necessity: Solid Organ Transplants 2 Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle. Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction. Intestinal/Multivisceral Yes No Is the member TPN dependent? If Yes, for how long? Yes No Does the member have intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance)? Yes No Does the member have evidence of impending end-stage liver failure? If Yes, explain: Yes No Does the member have adequate cardiopulmonary status? Yes No Is the member compliant with medical management? Yes No Does the member have evidence of intolerance of total parenteral nutrition (TPN), including but is not limited to, multiple and prolonged hospitalizations to treat TPN-related complications, or the development of progressive but reversible liver failure? Yes No Is the member HIV positive? If Yes, continue to the next section. Intestinal/Multivisceral Transplant Candidate in HIV Positive Member Yes No Is the CD4 count greater than 200 cells per cubic millimeter for greater than 6 months? If Yes, what is the level? Yes No Is HIV-1 RNA undetectable? Yes No Is the member stable on anti-retroviral therapy for more than 3 months? Yes No Does the member have any other complications from AIDS [acquired immune deficiency syndrome] (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidiosis mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm? If Yes, explain: Isolated Small Bowel Yes No Is the member TPN dependent? If Yes, for how long? Which of the following conditions is applicable for the member? Multiple prolonged hospitalizations to treat TPN-related complications (e.g., repeated episodes of catheter-related sepsis) Development of progressive liver failure If Yes, explain: Inability to maintain venous access Kidney Yes No Does the member have end-stage renal disease? If Yes, what is the etiology/condition causing end state renal disease? Yes No Is the member HIV positive? If yes, continue to the next section. Certificate of Medical Necessity: Solid Organ Transplants 3 Kidney Transplant Candidate in HIV Positive Member Yes No Is the CD4 count greater than 200 cells per cubic millimeter for greater than 6 months? If Yes, what is the level? Yes No Is HIV-1 RNA undetectable? Yes No Is the member stable on anti-retroviral therapy for more than 3 months? Yes No Does the member have any other complications from AIDS [acquired immune deficiency syndrome] (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidiosis mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm? If Yes, explain: Liver What is the member’s MELD/PELD score? Yes No Does the patient have or had hepatocellular carcinoma beyond the liver? Lung Which procedure will the member receive? Single Bilateral Living Lobar Yes No Does the member have colonization with highly resistant or highly virulent bacteria, fungi or mycobacteria? Yes No Does the member have irreversible, progressively disabling, end-stage pulmonary disease? Heart-Lung Which of the following conditions is applicable for the member? Irreversible primary pulmonary hypertension with heart failure Non-specific severe pulmonary fibrosis, with severe heart failure Eisenmenger complex with irreversible pulmonary hypertension and heart failure Cystic fibrosis with severe heart failure Chronic obstructive pulmonary disease with heart failure Emphysema with severe heart failure Pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure Pancreas and Pancreatic Islet Cells Which procedure will the member receive? Autologous pancreas islet cell Simultaneous pancreas-kidney transplant (SPK) Pancreas after kidney transplant Pancreas transplant alone Which of the following conditions is applicable for the member? End stage renal disease (ESRD) and insulin-dependent diabetes for SPK IDDM patient for pancreas transplant after prior kidney transplant (PAK) Severely disabling and potentially life-threatening complications due to hypoglycemia unawareness or labile diabetes that persists in spite of optimal medical management for PTA (include documentation of hospitalizations, progress notes, and emergency room visits) Yes No Does the patient have a consistent failure of insulin based management to prevent acute complications? Yes No Does the patient have a history of frequent, acute and severe metabolic complications requiring recurrent hospitalizations? Certificate of Medical Necessity: Solid Organ Transplants 4 Section E – Required Documentation Check all boxes and complete all entries that apply: The letter of medical necessity includes the following: Summary of course of illness Current medications Current smoking/alcohol/drug abuse or history The medical records include the following: History and physical with complete medical history Pulmonary and cardiac clearances Psychosocial assessment Patient intake sheet with demographics All radiology results All diagnostic testing Consultations All laboratory results (chemistry, serology, recent toxicology screen, CD4 levels, infectious disease) Additional Comments: I hereby certify that (i) I am the treating physician for above member, (ii) the information contained in and included with this Certificate of Medical Necessity is true, accurate and complete to the best of my knowledge and belief, (iii) the member’s medical records contain all appropriate documentation necessary to substantiate this information. I acknowledge that a determination made based upon this Certificate of Medical Necessity is not necessarily a guarantee of payment and that payment remains subject to application of the provisions of the member’s health benefit plan, including eligibility and plan benefits. Additionally, I further acknowledge and agree that Florida Blue may audit or review the underlying medical records at any time and that failure to comply with such request may be a basis for the denial of a claim associated with such services. Ordering Physician’s Signature: Certificate of Medical Necessity: Solid Organ Transplants Date: 5