POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY
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1 Original Issue Date (Created): July 1, 2002 Mst Recent Review Date (Revised): Nvember 25, 2014 Effective Date: February 1, 2015 POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY I. POLICY External infusin pumps (EIP) may be cnsidered medically necessary when ALL f the fllwing criteria are met: Drug therapy is nging and a therapeutic advantage is expected by using cntinuus infusin rather than intermittent injectins. When used with ONE OR MORE f the fllwing FDA apprved drugs: Subcutaneus r intravenus Mrphine r ther parenteral analgesics fr treatment f severe, chrnic cancer pain that is resistant t cnventinal therapy. Subcutaneus r intravenus Heparin fr treatment f severe thrmbemblic disease that cannt be managed cnventinally (e.g. cmplicated pregnancy). Chemtherapeutics fr treatment f cancer. Acceptable rutes are stipulated in the drug label and might include either intravenus r intra-arterial. Drugs fr the treatment f irn verlad/irn pisning. Intravenus antibitics fr treatment f infectius cnditins. Additinal Infrmatin: Apprpriate candidates must meet ALL the fllwing: Patient is ambulatry Treatment can be apprpriately delivered n an utpatient basis with an expected imprvement in the quality f life Patients cnditin meets ONE OR MORE f the fllwing: Otherwise treatable nly by cnventinal infusin pump in a facility setting Cmpliance difficulties make intermittent injectins ineffective Patient educatin prtcls are dcumented Emergency supprt is available when unexpected adverse events ccur Favrable technical factrs exist, such as a cnvenient, safe, and reliable EIP delivery system alng with crrect placement f the needle and catheter. Page 1
2 Insulin infusin pumps fr treatment f diabetes mellitus may be cnsidered medically necessary in patients wh meet all f the fllwing set f criteria*: Supprting clinical dcumentatin frm either the patient s primary physician r a cnsulting endcrinlgist must be submitted fr review when requesting the insulin pump; and The patient/family has cmpleted a cmprehensive diabetes educatin prgram; and A cmplete assessment that prvides dcumented evidence f patient/family cmmitment t self-management f the insulin pump. including dcumentatin f very gd cmpliance with the current self-management prgram and demnstrated mastery f carbhydrate cunting; and The patient has been n a prgram f multiple daily injectins f insulin (i.e., tw [2] t three [3] injectins per day); and The patient/family has had frequent self-adjustments f insulin dse fr at least six (6) mnths prir t initiatin f the insulin pump; and The patient/family has dcumented glucse self-testing at least fur (4) times per day during the tw (2) mnths prir t initiatin f the insulin pump; and Meets ne r mre f the fllwing criteria while n the multiple daily injectin regimen: Glycsylated hemglbin level (HbA1c) greater than 7.0 percent; Histry f recurring hypglycemia; Wide fluctuatins in bld glucse befre mealtime; Dawn phenmenn with fasting bld sugars frequently exceeding 200 mg/dl; r Histry f severe glycemic excursins. *Nte: Individual cnsideratin is prvided fr diabetic wmen wh are pregnant. In additin, a patient with Type 2 diabetes may be cnsidered fr an insulin pump if he/she meets the abve criteria as well as the fllwing: Has been n a cmbinatin f at least tw ral agents used cncmitantly, prir t beginning insulin therapy (either alne r while cntinuing ral therapy). Page 2
3 External Infusin Pump Replacement: Requests fr replacement f an insulin pump that is ut f warranty must include ne f the fllwing; Clear and cnclusive dcumentatin frm either the treating physician s ffice ntes r the device supplier s custmer service ntes, that the pump is nn-peratinal; r Dcumentatin that the patient has reverted t use f multiple daily injectins f insulin r a laner pump because the pump is nn-peratinal. Replacement f insulin pumps fr reasns ther than thse stated abve is cnsidered nt medically necessary. Crss-reference: MP Implantable Infusin Pump MP Cntinuus r Intermittent Mnitring f Glucse in Interstitial Fluid II. PRODUCT VARIATIONS [N] = N prduct variatin, plicy applies as stated [Y] = Standard prduct cverage varies frm applicatin f this plicy, see belw [N] Capital Cares 4 Kids [N] PPO [N] HMO [Y] SenirBlue HMO* [Y] SenirBlue PPO* [N] Indemnity [N] SpecialCare [N] POS [Y] FEP PPO* * Refer t Durable Medical Equipment Reginal Carrier (DMERC) Regin A, Lcal Cverage Determinatin (LCD) L5044, External Infusin Pumps ** The FEP prgram dictates that all drugs, devices r bilgical prducts apprved by the U.S. Fd and Drug Administratin (FDA) may nt be cnsidered investigatinal. Therefre, FDA-apprved drugs, devices r bilgical prducts may be assessed n the basis f medical necessity. Page 3
4 III. DESCRIPTION/BACKGROUND External Infusin Pump (EIP) is a prtable battery perated device intended t prvide cntinuus ambulatry drug infusin therapy ver an extended time perid. The EIP is als knwn as an external pump, ambulatry pump, r a mini-infuser. Prpsed drug delivery rutes using the EIP include the intravenus, intra-arterial, subcutaneus, intraperitneal, epidural, intrathecal, and intraventricular rutes. A heparinized saline slutin may be used during an interruptin f drug therapy t maintain catheter patency. A catheter frm the pump is attached t the desired access rute fr drug delivery. The drug reservir refilling is nn-invasive. Sme external insulin infusin pumps (e.g., Paradigm Real-Time Insulin Pump and Cntinuus Glucse Mnitring System) are able t take results f the bld glucse reading, calculate the apprpriate insulin infusin rate, wirelessly transmit the results frm the bld glucse mnitr t the pump, and autmatically adjust the insulin infusin rate, saving the member sme extra steps. These insulin pump features, when present, are cnsidered integral t the external insulin infusin pump and bld glucse mnitr. There are ver 600 different mdels f pumps, mst f which have received clearance fr marketing by the Fd and Drug Administratin (FDA) thrugh a pre-ntificatin applicatin (510 (K)). IV. RATIONALE A search f the literature was cmpleted thrugh the MEDLINE database in develping this plicy. Review f the literature revealed n new infrmatin that wuld alter the cnclusins reached abve in the plicy. Therefre, the plicy statements are unchanged. V. DEFINITIONS NA VI. BENEFIT VARIATIONS The existence f this medical plicy des nt mean that this service is a cvered benefit under the member's cntract. Benefit determinatins shuld be based in all cases n the applicable cntract language. Medical plicies d nt cnstitute a descriptin f benefits. A member s individual r grup custmer benefits gvern which services are cvered, which are excluded, and which are subject t benefit limits and which require preauthrizatin. Members and prviders shuld cnsult the member s benefit infrmatin r cntact Capital fr benefit infrmatin. Page 4
5 VII. DISCLAIMER Capital s medical plicies are develped t assist in administering a member s benefits, d nt cnstitute medical advice and are subject t change. Treating prviders are slely respnsible fr medical advice and treatment f members. Members shuld discuss any medical plicy related t their cverage r cnditin with their prvider and cnsult their benefit infrmatin t determine if the service is cvered. If there is a discrepancy between this medical plicy and a member s benefit infrmatin, the benefit infrmatin will gvern. Capital cnsiders the infrmatin cntained in this medical plicy t be prprietary and it may nly be disseminated as permitted by law. VIII. CODING INFORMATION Nte: This list f cdes may nt be all-inclusive, and cdes are subject t change at any time. The identificatin f a cde in this sectin des nt dente cverage as cverage is determined by the terms f member benefit infrmatin. In additin, nt all cvered services are eligible fr separate reimbursement. Cvered when medically necessary: CPT Cdes Current Prcedural Terminlgy (CPT) cpyrighted by American Medical Assciatin. All Rights Reserved. HCPCS Cde E0779 E0780 E0781 E0782 E0783 E0784 Descriptin Ambulatry infusin pump, mechanical, reusable, fr infusin 8 hurs r greater Ambulatry infusin pump, mechanical, reusable, fr infusin less than 8 hurs Ambulatry infusin pump, single r multiple channels, electric r battery perated, with administrative equipment, wrn by patient Infusin pump, implantable, nnprgrammable (includes all cmpnents, e.g., pump, catheter, cnnectrs, etc.) Infusin pump system, implantable, prgrammable (includes all cmpnents, e.g., pump, catheter, cnnectrs, etc.) External ambulatry infusin pump, insulin *Specific ICD-9 Cdes d nt apply Page 5
6 IX. REFERENCES Adams SC, Rice R. The patient receiving hme infusin therapies. In: Rice R, editr. Hme Care Nursing Practice: Cncepts and Applicatin. 4th ed. St. Luis, MO: Msby Elsevier; 2006: Centers fr Medicare and Medicaid Services (CMS) Natinal Cverage Determinatin (NCD) Infusin Pumps. Effective 02/18/05. CMS [Website]: AAA%3d%3d& Durable Medical Equipment Reginal Carrier (DMREC) Regin A, Lcal Cverage Determinatin (LCD) L5044, External Infusin Pumps. Effective 02/27/14. [Website]: Eugster EA, Francis G, Lawsn-Wilkins Drug and Therapeutics Cmmittee. Psitin statement: cntinuus subcutaneus insulin infusin in very yung children with Type I diabetes. Pediatrics 2006; 118: [Website]: I.V. therapy. In: Nettina SM, editr. Lippinctt Manual f Nursing Practice. 9th ed. Philadelphia: Wlters Kluwer Lippinctt Williams & Wilkins; 2010: McCullach D. Insulin therapy in type 1 diabetes. In: UpTDate Online Jurnal [serial nline]. Waltham, MA: UpTDate; updated July 9, [Website]: X. POLICY HISTORY MP CAC 7/29/03 CAC 11/30/04 CAC 10/25/05 CAC 11/28/06 CAC 1/30/07 Milliman Criteria CAC 5/27/08 CAC 5/26/09 CAC 5/25/10 Cnsensus CAC 7/26/11 Minr Revisin. Deleted infrmatin related t cmbinatin pump (Paradigm). Added statement individual cnsideratin is prvided fr diabetic wmen wh are pregnant. Deleted statement indicating requests fr pump replacements will be reviewed n an individual cnsideratin basis. Deleted Page 6
7 statement An external infusin pump ut f warranty des nt cnstitute a reasn fr a new pump. List f criteria fr insulin pump replacement remains unchanged. 10/13/11 FEP variatin changed t refer t refer t FEP medical plicy. CAC 10/30/12 Cnsensus review. References updated; n changes t the plicy statements. CAC 11/26/13 Cnsensus. N change t plicy statement. References updated. Deleted FEP reference t plicy manual this FEP plicy was retired. Added standard FEP variatin. CAC 11/25/14. Cnsensus review. References updated. N changes t the plicy statements. Cdes reviewed, n changes. Tp Health care benefit prgrams issued r administered by Capital BlueCrss and/r its subsidiaries, Capital Advantage Insurance Cmpany, Capital Advantage Assurance Cmpany and Keystne Health Plan Central. Independent licensees f the BlueCrss BlueShield Assciatin. Cmmunicatins issued by Capital BlueCrss in its capacity as administratr f prgrams and prvider relatins fr all cmpanies. Page 7
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