Page New: Ophthalmologic Policy - Vascular Endothelial Growth Factor (VEGF) - Effective May 1,

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1 March 2014 Page New: Ophthalmlgic Plicy - Vascular Endthelial Grwth Factr (VEGF) - Effective May 1, Updated: Fecal DNA Testing - Effective Apr. 1, Platelet Derived Grwth Factrs fr Treatment f Wunds - Effective Apr. 1, Revised: Bne r Sft Tissue Healing and Fusin Enhancement Prducts - Effective Apr. 1, Cllagen Crsslinks and Bichemical Markers f Bne Turnver - Effective Apr. 1, Hme Hemdialysis - Effective May 1, Infertility Diagnsis and Treatment - Effective Apr. 1, Nninvasive Prenatal Diagnsis f Fetal Aneuplidy Using Cell-Free - Effective Apr. 1, Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) - Effective May 1, Omnibus Cdes - Effective Apr. 1, Outpatient Cardivascular Telemetry - Effective Apr. 1, Preventive Care Services - Effective Apr. 1, Thermal Capsulrrhaphy/Thermal Shrinkage Therapy - Effective Apr. 1, Retired: Enzyme Replacement Therapy - Effective Apr. 1, Hystersalpinggraphy - Effective Apr. 1, Hystersngraphy - Effective Apr. 1, UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

2 Cverage Plicy Updates The fllwing Cverage Plicies have been updated r revised. Cmplete details n the changes are prvided belw fr yur review. These plicy updates apply t UnitedHealthcare f the River Valley cmmercial and hawk-i plan membership nly; they d nt apply t members enrlled in a River Valley Ohi r Suth Carlina prduct. Nte: The appearance f a service r prcedure n this list des nt imply that UnitedHealthcare prvides cverage fr the service r prcedure. In the event f an incnsistency r cnflict between the infrmatin prvided in this bulletin and the psted plicy, the prvisins f the psted plicy will prevail. NEW Title Effective Date Cverage Ratinale Ophthalmlgic Plicy - Vascular Endthelial Grwth Factr (VEGF) Inhibitrs May 1, 2014 This plicy prvides infrmatin abut the use f certain specialty pharmacy medicatins administered by the intravitreal rute fr phthalmlgic cnditins. This plicy refers t the fllwing drug prducts, all f which are vascular endthelial grwth factr (VEGF) inhibitrs: aflibercept (Eylea ) bevacizumab (Avastin ) pegaptanib (Macugen ) ranibizumab (Lucentis ) Prven/Medically Necessary Uses: Aflibercept is prven/medically necessary fr the treatment f: 1. nevascular age-related macular degeneratin (AMD) 2. macular edema secndary t branch retinal vein cclusin (BRVO) r central retinal vein cclusin (CRVO) Bevacizumab is prven/medically necessary fr the treatment f: 1. nevascular age-related macular degeneratin (AMD) 2. diabetic macular edema 3. macular edema secndary t branch retinal vein cclusin (BRVO) r central retinal vein cclusin (CRVO) 4. prliferative diabetic retinpathy 5. nevascular glaucma 6. chridal nevascularizatin secndary t pathlgic mypia, angiid streaks/pseudxanthma elasticum, r cular histplasmsis syndrme (OHS) Pegaptanib is prven/medically necessary fr the treatment f: 1. nevascular age-related macular degeneratin (AMD) 2. diabetic macular edema Ranibizumab is prven/medically necessary fr the treatment f: 1. nevascular age-related macular degeneratin (AMD) 2. diabetic macular edema 3. macular edema secndary t branch retinal vein cclusin (BRVO) r central retinal vein cclusin (CRVO) 4. chridal nevascularizatin secndary t pathlgic mypia, angiid streaks/pseudxanthma elasticum, r cular histplasmsis syndrme (OHS) 2 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

3 Cverage Plicy Updates NEW Title Effective Date Cverage Ratinale Ophthalmlgic Plicy - Vascular Endthelial Grwth Factr (VEGF) Inhibitrs (cntinued) May 1, 2014 Unprven Use: Aflibercept, bevacizumab, pegaptanib, and ranibizumab are unprven/nt medically necessary fr the treatment f retinpathy f prematurity. Because VEGF is invlved in a wide variety f physilgic prcesses, the cular and systemic safety f anti-vegf agents is f prime cncern in nenates. Additinal Infrmatin: Bevacizumab is supplied in sterile vials cntaining a slutin f 25 mg/ml. Dses utilized in phthalmic cnditins generally range frm 6.2 mcg t 2.5 mg. Therefre, bevacizumab in vials is ften divided int single-dse, prefilled syringes fr intravitreal use by cmpunding pharmacies. Cmpunding pharmacies must cmply with United States Pharmacpeia (USP) Chapter 797, which sets standards fr the cmpunding, transprtatin, and strage f cmpunded sterile prducts (CSP). The Pharmacy Cmpunding Accreditatin Bard can verify that the pharmacy is adhering t these standards. Please refer t the US Fd and Drug Administratin (FDA) sectin f this plicy fr infrmatin related t cntaminatin f cmpunded bevacizumab. In an effrt t guard against cntaminatin during the cmpunding prcess, the United States Veterans Health Administratin (USVHA) requires that nly USVHA pharmacies may dispense bevacizumab fr intravitreal administratin t Veterans Administratin beneficiaries. The medicatin must be dispensed directly t the VA phthalmlgist, wh will then be respnsible fr preparing and administering the bevacizumab dse fr each patient. In additin t strict labeling and strage requirements, the phthalmlgists is required t prepare nly ne dse f medicatin frm each vial; if bth eyes are t be treated, a separate vial and syringe must be utilized. UPDATED Title Effective Date Summary f Changes Cverage Ratinale Fecal DNA Testing Apr. 1, 2014 Rerganized plicy cntent Updated cverage ratinale; added language t indicate the unprven services are nt medically necessary Remved benefit cnsideratins sectin Updated supprting infrmatin t reflect mst current clinical evidence and references Fecal DNA testing fr clrectal cancer screening and/r mnitring is unprven, investigatinal, and nt medically necessary due t lack f U.S. Fd and Drug Administratin (FDA) apprval. There is insufficient evidence in the clinical literature supprting the diagnstic accuracy f fecal DNA tests t screen fr clrectal cancer in asymptmatic, average-risk patients. The existing evidence has little r n applicability t currently available fecal DNA tests. Further studies are needed t determine the analytic and clinical validity f the test as cmpared t ther screening methds. At this time, n tests have received FDA apprval. Until the FDA cmpletes its 3 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

4 Cverage Plicy Updates UPDATED Title Effective Date Summary f Changes Cverage Ratinale Fecal DNA Apr. 1, 2014 review f fecal DNA tests, they are Testing investigatinal. The FDA has classified (cntinued) DNA testing as a device; therefre, it is subject t FDA review. Platelet Derived Grwth Factrs fr Treatment f Wunds Apr. 1, 2014 Rerganized plicy cntent Updated cverage ratinale; added language t indicate if service is medically necessary r nt medically necessary t applicable prven/unprven statement Updated supprting infrmatin t reflect the mst current clinical evidence and references Recmbinant-Human Platelet Derived Grwth Factrs When used accrding t U.S. Fd and Drug Administratin (FDA) apprved indicatins, becaplermin (Regranex Gel) is prven and medically necessary fr the treatment f lwer extremity diabetic neurpathic ulcers. In June 2008, the U.S. Fd and Drug Administratin (FDA) annunced the additin f a bxed warning t the labeling f becaplermin (Regranex Gel). Please see the Regulatry Requirements sectin and the Precautins sectin fr mre infrmatin. Platelet Rich Plasma Autlgus platelet rich plasma (e.g., Prcuren, AutlGel, r SafeBld ) is unprven and nt medically necessary fr the treatment f wunds. The better designed studies d nt demnstrate that autlgus platelet rich plasma such as Prcuren, AutlGel r SafeBld imprves health utcmes in patients with wunds. The remaining studies have design flaws that d nt allw cnfidence in analyzing final study results. The clinical utility f autlgus platelet rich plasma remains t be determined in larger well-designed cntrlled clinical trials cmparing their use with standard wund care. Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Apr. 1, 2014 Rerganized plicy cntent Tissue Healing Updated benefit and Fusin Enhancement Prducts cnsideratins; added language fr Essential Health Benefits fr Individual and Small Grup plans t indicate: Fr plan years beginning n r after Bne graft materials used in spinal fusin surgery can be categrized int the fllwing dmains: Autgrafts Allgrafts including (cadaver bne graft) Amnitic Tissue Membrane Demineralized Bne Matrix (DBM) Bne Mrphgenetic Prteins 4 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

5 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Tissue Healing and Fusin Enhancement Prducts (cntinued) Apr. 1, 2014 January 1, 2014, the Affrdable Care Act f 2010 (ACA) requires fully insured nngrandfathered individual and small grup plans (inside and utside f Exchanges) t prvide cverage fr ten categries f Essential Health Benefits ( EHBs ) Large grup plans (bth self-funded and fully insured), and small grup ASO plans, are nt subject t the requirement t ffer cverage fr EHBs; hwever, if such plans chse t prvide cverage fr benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dllar limits n thse benefits t be remved n all Grandfathered and Nn-Grandfathered plans The determinatin f which benefits cnstitute EHBs is made n a state by state basis; as such, when using this guideline, it is imprtant t refer t the enrllee s specific plan dcument t determine benefit cverage Revised cverage ratinale: Amnitic Tissue Membrane: Added language t indicate the use f amnitic membrane prducts in the treatment f spine disease r in spine surgery is unprven and nt medically necessary due t insufficient (BMP) Ceramic-based prducts Cell-based prducts Platelet-Rich Plasma Autgrafts Autgrafts are prven and medically necessary fr bne fusin enhancement: Autgrafts harvest bne fr grafting frm the persn underging surgery. The harvested bne is typically retrieved frm the patient s wn tibia, fibula r iliac crest and then placed at the surgery site. Allgrafts Demineralized bne matrix (DBM) is a type f allgraft and is prven and medically necessary fr bne fusin enhancement. Allgrafts are prven and medically necessary fr bne fusin enhancement. Allgrafts harvest bne fr grafting frm a persn ther than the surgical candidate. Cadaver bne is ne type f allgraft. Amnitic tissue membrane The use f amnitic membrane prducts in the treatment f spine disease r in spine surgery is unprven and nt medically necessary due t insufficient clinical evidence f safety and/r efficacy in published peer-reviewed medical literature. Evidence is limited t animal studies nly. N current clinical trials with humans were identified. There is limited evidence that amnitic tissue membrane imprves health utcmes when used in lumbar spine fusin. Lng term safety and efficacy have nt been established. Bne Mrphgenetic Prteins (BMP) Bne Mrphgenetic Prtein-2 (rhbmp-2) Nte: As indicated in the Clinical Evidence sectin belw, the use f bne mrphgenic prtein as an adjunct t spinal fusin surgery may be assciated with significant adverse events. Thus, 5 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

6 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Tissue Healing and Fusin Enhancement Prducts (cntinued) Apr. 1, 2014 clinical evidence f safety and/r efficacy in published peerreviewed medical literature (evidence is limited t animal studies nly; n current clinical trials with humans were identified) Bne Mrphgenetic Prteins (BMP): Added language t indicate the use f bne mrphgenic prtein as an adjunct t spinal fusin surgery may be assciated with significant adverse events. Thus, befre using bne mrphgenic prtein, the physician shuld engage in a shared decisin-making prcess with the patient, discussing the ptential advantages, harms and alternatives t the use f bne mrphgenic prtein as an adjunct t spinal fusin surgery Refrmatted and relcated infrmatin pertaining t medical necessity review (when applicable); added language t identify if service is medically necessary r nt medically necessary t applicable prven/unprven statement Revised definitins: Added definitin f amnitic tissue membrane and mesh grafting system Remved definitin f OptiMesh Remved prprietary names f specific mesenchymal stem cell befre using bne mrphgenic prtein, the physician shuld engage in a shared decisin-making prcess with the patient, discussing the ptential advantages, harms and alternatives t the use f bne mrphgenic prtein as an adjunct t spinal fusin surgery. When used accrding t U.S. Fd and Drug Administratin (FDA) labeled indicatins, INFUSE Bne Graft is prven and medically necessary fr the enhancement f bne healing and/r fusin f the lumbar spine in patients wh meet all f the fllwing criteria: Implanted via an anterir apprach and used in cnjunctin with an INFUSE Bne Graft fusin device INFUSE Bne Graft fusin devices include: InFUSE bne graft/lt-cage InFUSE bne graft/lumbar Tapered Fusin Device InFUSE bne graft/interfix threaded fusin device InFUSE bne graft/inter Fix RP threaded fusin device Skeletally mature patient (18 years f age r lder r radigraphic evidence f epiphyseal clsure) with degenerative disc disease at ne level frm L4 S1 N mre than Grade I spndyllisthesis at the invlved level Failure f at least 6 mnths f nnperative treatment INFUSE Bne Graft is unprven and nt medically necessary fr all ther indicatins including but nt limited t the fllwing: Enhancement f bne healing and/r fusin f the lumbar spine via a psterir apprach. Treatment f cervical spine r any ther area with r withut use f ther devices including the PEEK device. Knwn cntraindicatins including: 6 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

7 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Tissue Healing and Fusin Enhancement Prducts Apr. 1, 2014 (cntinued) Pregnancy prducts Revised list f unprven CPT cdes fr amnitic (tissue) membrane prducts; added Q4100, Q4131 and Q4149 Updated supprting infrmatin t reflect the mst current clinical evidence, FDA infrmatin, and references hypersensitivity t recmbinant human Bne Mrphgenetic Prtein-2, bvine Type I cllagen r t ther cmpnents f the frmulatin Active infectin at perative site r patient has an allergy t titanium r titanium ally Planned use f grafting in the vicinity f a resected r extant tumr Skeletally immature patient (yunger than 18 years f age r 18 years f age r lder with n radigraphic evidence f epiphyseal clsure) Psterlateral r psterir lumbar interbdy fusin utilizing INFUSE Bne Graft has nt received FDA apprval. Available studies have demnstrated increased adverse events with the psterir apprach. The safety and effectiveness f INFUSE Bne Graft in the cervical spine have nt been demnstrated. There is insufficient clinical evidence t supprt the use f INFUSE Bne Graft with devices made f PEEK r ther bicmpatible materials. In additin, INFUSE Bne Graft has nt been apprved by the FDA fr use with PEEK cages. When used accrding t U.S. Fd and Drug Administratin (FDA) indicatins, the INFUSE/MASTERGRAFT TM Psterlateral Revisin Device system is prven and medically necessary in patients wh meet all f the fllwing criteria: Implanted via a psterlateral apprach Presence f symptmatic psterlateral lumbar spine pseudarthrsis Skeletally mature patient (lder than 21 years f age r radigraphic evidence f epiphyseal clsure) Treatment f 2 r mre levels f the lumbar spine Autlgus bne and/r bne marrw harvest is nt feasible r is 7 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

8 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Tissue Healing and Fusin Enhancement Prducts (cntinued) Apr. 1, 2014 nt expected t prmte fusin. These patients are diabetics and smkers. The INFUSE/MASTERGRAFT TM Psterlateral Revisin Device system is unprven and nt medically necessary fr all ther indicatins including the fllwing: Knwn cntraindicatins including: hypersensitivity t recmbinant human Bne Mrphgenetic Prtein-2, bvine Type I cllagen r t ther cmpnents f the frmulatin Knwn active malignancy r patients underging treatment fr a malignancy Pregnancy Active infectin at perative site Planned use f grafting in the vicinity f a resected r extant tumr Skeletally immature patient (lder than 21 years f age r radigraphic evidence f epiphyseal clsure) INFUSE/MASTERGRAFT TM Psterlateral Revisin Device system has nt received FDA apprval fr any ther indicatins except thse indicated as prven. The safety and effectiveness f INFUSE/MASTERGRAFT TM Psterlateral Revisin Device system has nt been demnstrated fr ther cnditins in studies published in peer-reviewed literature. Bne Mrphgenetic Prtein-7 (BMP- 7) OP-1 Implant and OP-1 Putty are unprven and nt medically necessary fr the enhancement f bne healing and/r fusin with r withut use f ther devices (including the PEEK device). Use f BMP7 has nt demnstrated accelerated healing. In ne study better results were achieved in patients receiving traditinal autgraft. Additinally, available studies have been limited by substantial lss f study 8 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

9 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Tissue Healing and Fusin Enhancement Prducts (cntinued) Apr. 1, 2014 participants at fllw-up as well as by shrt fllw-up times. Bne graft substitutes have verlapping prperties and are made f a variety f materials such as plymers (degradable and nndegradable), ceramics and cmpsites (calcium phsphate, calcium sulfate, and biactive glass), factrbased techniques (recmbinant grwth factrs) and cell-based techniques (mesenchymal stem cells). Ceramic-based prducts: Ceramic-based prducts such as beta tricalcium phsphate (b-tcp) when used alne r with bne marrw aspirate are unprven and nt medically necessary fr the enhancement f bne healing and/r fusin. Only very weak cnclusins abut effectiveness f ceramic-based prducts may be drawn frm studies because f small sample size, lack f cntrl r cmparisn grups in mst studies. The absence f a frmal assessment f clinical utcmes in mst studies limits the cnclusins that can be drawn abut the place f b-tcp in bne healing and fusin. Furthermre, definitive patient selectin criteria have nt been established fr the use f b-tcp bne vid fillers. Cell-based prducts: Cell-based prducts such as mesenchymal stem cells, Ostecel, r Trinity Evlutin are unprven and nt medically necessary fr the enhancement f bne healing. The lack f adequate cntrls, randmizatin and blinding and the small sample sizes in available published clinical evidence precludes definitive cnclusins regarding the net health benefit f MSC therapy. Platelet-Rich Plasma Platelet-rich plasma (e.g., autlgus platelet derived grwth factr) is unprven and nt medically necessary when used t enhance bne r sft tissue healing. Evidence in the published scientific literature is incnsistent and des nt 9 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

10 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Bne r Sft Tissue Healing and Fusin Enhancement Prducts (cntinued) Apr. 1, 2014 lend strng supprt t the clinical utility f using PRP t augment bne r sft tissue healing. OptiMesh The OptiMesh deplyable grafting system is unprven and nt medically necessary. There is insufficient evidence that the use f OptiMesh will imprve structural supprt f the vertebrae. Further studies are needed t evaluate safety and efficacy f this grafting system. Cllagen Crsslinks and Bichemical Markers f Bne Turnver Apr. 1, 2014 Rerganized plicy cntent Added benefit cnsideratins language fr Essential Health Benefits fr Individual and Small Grup plans t indicate: Fr plan years beginning n r after January 1, 2014, the Affrdable Care Act f 2010 (ACA) requires fully insured nngrandfathered individual and small grup plans (inside and utside f Exchanges) t prvide cverage fr ten categries f Essential Health Benefits ( EHBs ) Large grup plans (bth self-funded and fully insured), and small grup ASO plans, are nt subject t the requirement t ffer cverage fr EHBs; hwever, if such plans chse t prvide cverage fr benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dllar limits n thse benefits t be remved n all Grandfathered and Nn-Grandfathered plans Serum r urine cllagen crsslinks r bichemical markers are unprven and nt medically necessary t assess risk f fracture, predict bne lss r assess respnse t antiresrptive therapy. There is insufficient evidence in the clinical literature demnstrating the clinical utility f bne turnver markers and the impact n patient management. 10 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

11 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Cllagen Crsslinks and Bichemical Markers f Bne Turnver (cntinued) Apr. 1, 2014 The determinatin f which benefits cnstitute EHBs is made n a state by state basis; as such, when using this guideline, it is imprtant t refer t the member s specific plan dcument t determine benefit cverage Updated cverage ratinale; added language t indicate the unprven service is nt medically necessary Updated supprting infrmatin t reflect the mst current clinical evidence and references Hme Hemdialysis May 1, 2014 Revised cverage ratinale: Refrmatted and clarified medical necessity criteria Updated/expanded medical necessity criteria fr prfessinal staff-assisted hme hemdialysis; added language t indicate staff assisted hme hemdialysis prtcls generally match thse prvided in the hemdialysis center (i.e. at least 3 times per week, 3-4 hur treatments); the exact dialysis therapy emplyed is determined n an individual basis by the attending nephrlgist Revised list f applicable CPT/HCPCS cdes; changed cverage status fr and S9335 frm cvered t requires preauthrizatin in the hme setting Updated supprting infrmatin t reflect the mst current descriptin f Hme hemdialysis (HHD) is a prven therapy as an alternative t facilitybased hemdialysis fr patients with end-stage renal disease and medically necessary when the fllwing criteria are met: Patient is stable n dialysis with n evidence f cmplex skilled interventins being necessary during treatments Patient r nn-prfessinal caregiver has the ability t perfrm and maintain hme hemdialysis and has received cmprehensive training regarding prper prtcl. Absence f cmplicatins and significant cncmitant disease that wuld cause hme hemdialysis t be unsafe r unsuitable Presence f well-functining vascular access Prfessinal staff-assisted hme hemdialysis is medically necessary as an alternative t facility- based hemdialysis fr patients with end-stage renal disease wh meet all f the fllwing criteria: Patient is stable n dialysis and nt at increased risk as a result f having the prcedure perfrmed utside a dialysis center venue; and Patient has well-functining vascular access; and 11 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

12 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Hme May 1, 2014 services, clinical evidence, Patient has medical Hemdialysis (cntinued) and references cntraindicatins t leaving hme fr hemdialysis; and Patient r nn-prfessinal caregiver is nt capable f perfrming hme hemdialysis Staff assisted hme hemdialysis prtcls generally match thse prvided in the hemdialysis center (i.e. at least 3 times per week, 3-4 hur treatments). The exact dialysis therapy emplyed is determined n an individual basis by the attending nephrlgist. See the Medicare Benefit Plicy Manual Chapter 11, Sectin 30.2 Hemdialysis Training. Available at: ds/bp102c11.pdf Accessed December Infertility Diagnsis and Treatment Apr. 1, 2014 Updated descriptin f services t reflect mst current clinical evidence, FDA infrmatin and references Refrmatted and revised cverage ratinale: Expanded list f prven/medically necessary prcedures fr diagnsing infertility in females; added antral fllicle cunt and antimüllerian hrmne (AMH) Expanded list f unprven/nt medically necessary prcedures fr diagnsing infertility in females; added inhibin B Expanded list f prven/medically necessary prcedures fr diagnsing infertility in males; added cystic fibrsis gene mutatins, karytyping fr chrmsmal abnrmalities, Y- chrmsme Diagnstic Prcedures Females The fllwing tests r prcedures are prven/medically necessary fr diagnsing infertility in female patients: Antral fllicle cunt Clmiphene citrate challenge test The fllwing hrmne level tests: antimüllerian hrmne (AMH) estradil fllicle stimulating hrmne (FSH), luteinizing hrmne (LH) prgesterne prlactin, thyrid-stimulating hrmne (TSH) Hystersalpinggram (HSG) Diagnstic hysterscpy Diagnstic laparscpy with r withut chrmtubatin Pelvic ultrasund (ttransabdminal r transvaginal) Snhystergram r saline infusin ultrasund The fllwing tests are unprven/nt medically necessary fr diagnsing infertility in female patients: Inhibin B Uterine/endmetrial receptivity 12 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

13 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Infertility Diagnsis and Treatment (cntinued) Apr. 1, 2014 micrdeletin testing, pst-ejaculatry urinalysis, and testicular ultrasund Expanded list f unprven/nt medically necessary prcedures fr diagnsing infertility in males; added reactive xygen species (ROS) test Expanded list f prven/medically necessary prcedures fr treating infertility; added varian stimulatin Expanded list f unprven/nt medically necessary prcedures fr treating infertility; added in vitr maturatin f cytes Updated lists f prcedures fr diagnsing and treating infertility; remved cultures fr bth males and females, hemizna assay test, partial znal dissectin (PZD) and subznal sperm insertin (SUZI) Replaced language indicating crypreserva tin f cytes (eggs) is unprven with crypreservatin f cytes (eggs) is prven fr wmen (under the age f 42) wh are underging treatment with assisted reprductive technlgies r are planning t underg therapies that threaten their reprductive health, such as cancer chemtherapy Refrmatted and revised lists f applicable CPT and HCPCS cdes: testing (e.g., E-tegrity and Endmetrial Functin Test (EFT )) There is insufficient evidence t permit cnclusins regarding the use f these tests. Mre studies are needed t supprt imprved utcmes (i.e., increased successful pregnancies with delivery f livebrn children) with use f these diagnstic tests Males The fllwing tests r prcedures are prven/medically necessary fr diagnsing infertility in male patients: Antisperm antibdies The fllwing genetic screening tests: cystic fibrsis gene mutatins karytyping fr chrmsmal abnrmalities Y-chrmsme micrdeletins testing The fllwing hrmne level tests: LH FSH prlactin teststerne (ttal and free) Leukcyte cunt in semen Pst-ejaculatry urinalysis Scrtal, testicular r transrectal ultrasund Semen analysis Testicular bipsy Vasgraphy The fllwing tests are unprven/nt medically necessary fr diagnsing infertility in male patients: Cmputer-assisted sperm analysis (CASA) Hyalurnan binding assay (HBA) Pstcital cervical mucus penetratin test Reactive xygen species (ROS) test Sperm acrsme reactin test Sperm DNA integrity/fragmentatin tests (e.g. sperm chrmatin structure assay (SCSA), single-cell gel electrphresis assay (Cmet), dexynucletidyl transferasemediated dutp nick end labeling assay (TUNEL), sperm chrmatin 13 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

14 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Infertility Diagnsis and Treatment (cntinued) Apr. 1, 2014 Diagnstic Services - Prven/Medically Necessary: Cvered fr nninfertility indicatins; cvered nly when an infertility benefit/rider is available fr infertility indicatins: - Added 76830, 80426, 81224, 83520, 88248, 88261, 88262, 88263, 88273, 88280, and Remved and Cvered nly when an infertility benefit/rider is available: Added Cvered under general benefits package when billed with diagnsis cde V26.52 and V25.8 (pst-vasectmy sperm cunt) ; cvered fr all ther indicatins nly when infertility benefit/rider is available: Remved Changed cverage status fr: - CPT cde frm cvered fr bth infertility and nninfertility indicatins t cvered nly when an dispersin (SCD) r Sperm DNA Decndensatin Test (SDD) Sperm penetratin assays There is insufficient evidence t permit cnclusins regarding the use f these tests. Mre studies are needed t supprt imprved utcmes (i.e., increased successful pregnancies with delivery f livebrn children) with use f these diagnstic tests. Therapeutic Prcedures The fllwing prcedures are prven/medically necessary fr the treatment f infertility: Assisted reprductive technlgies (e.g., in vitr fertilizatin (IVF), gamete intrafallpian transfer (GIFT), and elective single-embry transfer (eset)) Ovulatin inductin r cntrlled varian stimulatin Inseminatin prcedures Assisted embry hatching Intracytplasmic sperm injectin (ICSI) fr treating male factr infertility Sperm retrieval techniques (e.g.,micrsurgical epididymal sperm aspiratin (MESA), percutaneus epididymal sperm aspiratin (PESA), testicular sperm extractin (TESE), testicular sperm aspiratin (TESA) and electrejaculatin) The fllwing prcedures t crrect underlying disrders are prven/medically necessary fr the treatment f infertility: Lysis f adhesins Drainage f varian cyst Surgery (laparscpic r pen) fr endmetrisis Surgery (laparscpic r pen) t repair diseased, damaged r blcked fallpian tubes (e.g, fimbriplasty, salpingstmy, nesalpingstmy) Transurethral resectin f ejaculatry ducts fr treating f ejaculatry duct bstructin 14 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

15 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Infertility Diagnsis and Treatment (cntinued) Apr. 1, 2014 infertility benefit/rider is available - CPT cdes 58350, and frm cvered fr infertility indicatins nly t cvered fr nn-infertility indicatins; cvered nly when an infertility benefit/rider is available fr infertility indicatins Treatment Services - Prven/Medically Necessary: Cvered nly when an infertility benefit/rider is available: - Added CPT cdes 0059T, and Added HCPCS cdes S4020, S4027, S4030 and S4031 Cvered fr nninfertility indicatins; cvered nly when an infertility benefit/rider is available fr infertility indicatins: Added Changed cverage status fr: - CPT cde 0059T frm nt cvered t cvered nly when an infertility benefit/rider is available - CPT cdes 58672, Variccele repair Wedge resectin f vary r varian drilling in wmen with plycystic vary syndrme. (NOTE: Ovarian drilling is a measure f last resrt due t the increased risk f pelvic adhesins.) The fllwing prcedures are unprven/nt medically necessary fr treating infertility: C-culture f embrys EmbryGlue In vitr maturatin (IVM) f cytes Studies describe different techniques f c-culture f embrys, but n standardized methd f c-culturing has been defined. The use f c-cultures may imprve blastcyst develpment but may nt result in an imprved pregnancy r delivery rate. There is inadequate published scientific data t permit cnclusins regarding the use f EmbryGlue. Althugh preliminary results with IVM are prmising, studies t date shw that implantatin and pregnancy rates are significantly lwer than thse achieved with standard IVF. Further evidence frm well-designed trials is needed t determine the lng-term safety and efficacy f the prcedure. Crypreservatin Crypreservatin f sperm, semen r embrys is prven fr individuals wh are underging treatment with assisted reprductive technlgies r are planning t underg therapies that threaten their reprductive health such as cancer chemtherapy. Crypreservatin f cytes (eggs) is prven/medically necessary fr wmen [under the age f 42] wh are underging treatment with assisted reprductive technlgies r are planning t underg therapies that threaten their reprductive health, such as cancer chemtherapy. 15 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

16 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Infertility Diagnsis and Treatment (cntinued) Apr. 1, and frm cvered t cvered nly when an infertility benefit/rider is available - CPT cde frm cvered fr bth infertility and nn-infertility indicatins t cvered nly when an infertility benefit/rider is available - HCPCS cde S4020, S4027, S4030 and S4031 frm nt cvered t cvered nly when an infertility benefit/rider is available - HCPCS cde S0132 frm infertility t cvered fr nninfertility indicatins; cvered nly when an infertility benefit/rider is available fr infertility indicatins. Diagnstic Services - Unprven/Nt Medically Necessary: Nt cvered: Added 82397, (when used t reprt inhibin B), and Treatment Services - Unprven/Nt Medically Necessary: Nt cvered: - Added Remved 0059T Changed cverage status fr frm cvered nly Crypreservatin f varian r testicular tissue is unprven/nt medically necessary. Ovarian tissue banking remains a prmising clinical technique because it avids varian stimulatin and prvides the pprtunity fr preserving gnadal functin in prepubertal, as well as adult patients. Hwever, this prcedure has prduced very few live births. Testicular tissue r testis xengrafting are in the early phases f experimentatin and have nt yet been successfully tested in humans. 16 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

17 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Infertility Diagnsis and Treatment (cntinued) Apr. 1, 2014 when an infertility benefit/rider is available t nt cvered Crypreservatin: Nt cvered: Remved Crypreservatin and Strage: Nt cvered: Remved S4027, S4030 and S4031 Added lists f applicable ICD-9 cdes fr Illinis plan members: ICD-9 prcedure cdes: and ICD-9 diagnsis cdes: , , V26.1, V26.8, V26.9 Added list f applicable ICD-10 diagnsis cdes fr Illinis plan members (preview draft effective 10/01/14) Remved CMS infrmatin Nninvasive Prenatal Diagnsis f Fetal Aneuplidy Using Cell-Free Fetal Nucleic Acids in Maternal Bld Apr. 1, 2014 Rerganized plicy cntent Added benefit cnsideratins language fr Essential Health Benefits fr Individual and Small Grup plans t indicate: Fr plan years beginning n r after January 1, 2014, the Affrdable Care Act f 2010 (ACA) requires fully insured nngrandfathered individual and small grup plans (inside and utside f Exchanges) t prvide cverage fr ten categries f Essential Health Benefits ( EHBs ) Large grup plans (bth self-funded and fully insured), and small grup ASO plans, are nt subject t the DNA-based nninvasive prenatal tests f fetal aneuplidy ( are prven and medically necessary as screening tls fr trismy 21 (Dwn syndrme), trismy 18 (Edwards syndrme) r trismy 13 (Patau syndrme) in ANY ONE f the fllwing circumstances: Maternal age f 35 years r lder at delivery Fetal ultrasund findings indicating an increased risk f aneuplidy Histry f a prir pregnancy with a trismy Psitive first- r secnd-trimester screening test results fr aneuplidy Parental balanced Rbertsnian translcatin with an increased risk f fetal trismy 13 r trismy 21. DNA-based nninvasive prenatal tests f fetal aneuplidy (e.g., MaterniT21 PLUS, verifi r Harmny Prenatal Test ) are unprven and nt medically necessary fr pregnant wmen wh d nt meet 17 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

18 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nninvasive Prenatal Diagnsis f Fetal Aneuplidy Using Cell-Free Fetal Nucleic Acids in Maternal Bld (cntinued) Apr. 1, 2014 requirement t ffer cverage fr EHBs; hwever, if such plans chse t prvide cverage fr benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dllar limits n thse benefits t be remved n all Grandfathered and Nn-Grandfathered plans The determinatin f which benefits cnstitute EHBs is made n a state by state basis; as such, when using this guideline, it is imprtant t refer t the member s specific plan dcument t determine benefit cverage Updated cverage ratinale; added language t indicate if service is medically necessary r nt medically necessary t applicable prven/unprven statement Updated supprting infrmatin t reflect the mst current descriptin f services, inical evidence, FDA infrmatin and references the abve criteria r wmen with multiple gestatins. Further studies are needed t evaluate the use f these tests in lw-risk ppulatins r wmen with multiple gestatins. Genetic Cunseling Genetic cunseling is strngly recmmended prir t this test in rder t infrm persns being tested abut the advantages and limitatins f the test as applied t a unique persn. Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) May 1, 2014 Changed plicy title; previusly titled Nutritin Added benefit cnsideratins language fr: Essential Health Benefits fr Individual and Small Grup plans hawk-i plans Revised cverage ratinale; added medical necessity criteria fr enteral nutritin, nutrients, and equipment and supplies fr members with cverage under the Nutritinal Cunseling Nutritinal cunseling services prvided by a dietician (a licensed health prfessinal) t develp a dietary treatment plan t treat and/r manage cnditins such as diabetes, heart failure, kidney failure, high chlesterl, anrexia, bulimia, etc. are Cvered Heath Services when bth f the fllwing are true: Nutritinal educatin is required fr a disease in which patient selfmanagement is an imprtant cmpnent f treatment. There exists a knwledge deficit 18 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

19 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nutritin (Including: May 1, 2014 COC r due t a state mandate Cunseling, Revised definitins; updated Therapy, Enteral the definitin f enteral nutritin Nutritin, Revised list f applicable Infant Frmula, Breast Milk, CPT/HCPCS cdes; Supplements and Fd) (cntinued) Added cverage status by cde listing: Nutritinal Cunseling - Nt cvered: S Cvered: 97802, 97803, 97804, 99078, G0270, G0271 and S9470 Enteral Nutritin - Preauthrizatin required: B4100, B4102, B4103, B4104, B4149, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161 and B4162 Infant Frmula and Dnr Breast Milk - Nt cvered: T2101 Nutritinal Therapy, Csmetic Nutritinal Therapy, and Fd Preauthrizatin required: S9433, S9434 and S9435 Added reference link t plicy titled Preventive Care Services fr additinal infrmatin n nutritinal cunseling cdes regarding the disease which requires the interventin f a trained health prfessinal. Fr additinal infrmatin n Nutritinal Cunseling please see the enrllee specific plan dcument and the Preventive Care Services plicy. Enteral Nutritin Enteral feedings (Enteral frmula) are excluded frm cverage. The nly exceptin t this exclusin is fr state mandates that require cverage fr Enteral frmula fr certain diagnses. Nte: The Enteral frmula exclusin des nt apply t eligible Durable Medical Equipment that is used t administer the frmula, such as Enteral pumps and tubing. Infant Frmula and Dnr Breast Milk Infant frmula and dnr breast milk and all assciated strage, delivery fees r prcurement fees are excluded frm cverage. Nte: The nly exceptin t this exclusin is fr state mandates that require cverage fr infant frmulas fr certain diagnses. There are n exceptins fr dnr breast milk. Nutritinal Therapy, Csmetic Nutritinal Therapy, and Fd Nutritinal r csmetic therapy using high-dse r mega quantities f vitamins, minerals r elements and ther nutritin based therapy are excluded frm cverage. Examples include supplements, electrlytes, and fds f any kind. This includes, but is nt limited t: high prtein fds, lw prtein fds, and lw carbhydrate fds. Nte: This exclusin des nt apply t medically indicated, prvideradministered, injectins such as vitamin K. Please refer t the Enrllee s Plan 19 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

20 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) (cntinued) May 1, 2014 Specific dcument t verify cverage fr enteral nutritin. Fr plans that cver enteral nutritin, if there is a difference between an Enrllee's plan dcuments and the infrmatin belw, the Enrllee's plan dcument shuld be used fr making benefit determinatins. Reminder: Check state mandate applicability befre prceeding with the fllwing. Additinal Cnsideratins: A. When the Plan Dcument includes Nutritinal cverage fr Sle Surce r Majrity f Nutritin check the plan specific dcuments fr definitin f Sle Surce r Majrity f Nutritin if the plan dcuments are silent n a definitin cnsider the fllwing: 1. Adequate nutritin can nt be pssible by dietary adjustment and/r ral supplements 2. The Enteral Feeding is the patient s sle surce f the patient s calric intake; when cnsidering sle surce, minr amunts f ral intake, t lw t be significant surce f nutritin shuld nt lead t denial f enteral feedings simply because there is sme ral intake. Sle surce can still be the cnclusin when we see sme fd used, fr example in swallwing therapy, r when small amunts f fd r drink are given fr taste 3. Calries frm Parenteral Nutritin shuld nt be cnsidered when assessing fr the sle surce f nutritin (e.g., transitining t enteral feedings) Frmula That Is Nt Specifically Made Fr Inbrn Errrs f 20 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

21 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) (cntinued) May 1, 2014 Metablism: Even when a frmula is the sle surce f nutritin, frmula that is nt specifically made fr persns with inbrn errrs f metablism is nt cvered. The nly exceptin is when the enrllee s plan-specific SPD says that these frmulas are cvered. Refer t the enrllee-specific plan dcuments t determine. Allergies r intlerance t cw milk, r cw milk frmula, are nt inbrn errrs f metablism. These cnditins can be treated with frmula that is readily available in fd stres and pharmacies, r by fd eliminatin. B. When the Plan Dcument includes Enteral Nutritinal cverage fr Inbrn Errrs f Metablism r Metablic Diseases: Check the plan dcuments fr definitin f the Errrs f Metablism r Metablic Diseases if the plan dcuments are silent cnsider the fllwing: The American Academy f Pediatric Cnsensus Statement 2002 reaffirmed 2006: Metablic diseases include inbrn errrs f amin acid metablism, such as phenylketnuria, maternal phenylketnuria, maple syrup urine disease, hmcystinuria, methylmalnicacidemia, prpinicacidemia, isvalericacidemia, and ther disrders f leucine metablism; glutaricaciduria type I and tyrsinemia types I and II; and urea cycle disrders. These are all disrders treatable by dietary mdificatins, which can prevent cmplicatins like severe mental retardatin and death. If the Plan Dcument includes frmula r fd fr a metablic disrders r 21 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

22 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) (cntinued) May 1, 2014 Inbrn Errr f Metablism: cnsider the fllwing: Examples (nt an all-inclusive list): Glutaric aciduria Glycgen strage diseases Hmcystinuria Maple syrup urine disease Methylmalnic aciduria Phenylketnuria (PKU) Tyrsinemias Urea cycle disrders Nte: See abve paragraph called Frmula That is Nt Specifically Made fr Inbrn Errrs f Metablism. Additinal Cnsideratins: If a plan limits an enteral frmula benefit t patients with inbrn errrs f metablism, then Nutritinal frmulas used fr cnditins ther than inbrn errrs f metablism are cnsidered fd and, therefre, are nt cvered in mst certificates f cverage and summary plan descriptins. Refer t enrllee s plan specific dcuments. MEDICAL NECESSITY PLANS The fllwing applies t plans that cver enteral frmula but als allw, r require, a medical necessity review. Enteral nutritin is cvered fr a patient wh has (a) permanent nn-functin r disease f the structures that nrmally permit fd t reach the small bwel r (b) disease f the small bwel which impairs digestin and absrptin f an ral diet, either f which requires tube feedings t prvide sufficient nutrients t maintain weight and strength cmmensurate with the patient's verall health status. The patient must have a permanent impairment. Permanence des nt require a determinatin that there is n pssibility that the patient's cnditin may imprve smetime in the future. If the judgment f the attending physician, substantiated in the medical recrd, is that the cnditin is f lng and 22 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

23 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) (cntinued) May 1, 2014 indefinite duratin (rdinarily at least 3 mnths), the test f permanence is cnsidered met. Enteral nutritin will be denied as nn-cvered in situatins invlving temprary impairments. The patient's cnditin culd be either anatmic (e.g., bstructin due t head and neck cancer r recnstructive surgery, etc.) r due t a mtility disrder (e.g., severe dysphagia fllwing a strke, etc.). Enteral nutritin is nn-cvered fr patients with a functining gastrintestinal tract whse need fr enteral nutritin is due t reasns such as anrexia r nausea assciated with md disrder, endstage disease, etc. (Please check enrllee plan specific dcument fr pssible cverage.) The patient must require tube feedings t maintain weight and strength cmmensurate with the patient's verall health status. Adequate nutritin must nt be pssible by dietary adjustment and/r ral supplements. Cverage is pssible fr patients with partial impairments - e.g., a patient with dysphagia wh can swallw small amunts f fd r a patient with Crhn's disease wh requires prlnged infusin f enteral nutrients t vercme a prblem with absrptin. Enteral nutritin prducts that are administered rally and related supplies are nt cvered. Check enrllee plan specific dcument fr pssible cverage. If the cverage requirements fr enteral nutritin are met, medically necessary nutrients, administratin supplies, and equipment are cvered. Nutrients Enteral frmulas cnsisting f semisynthetic intact prtein/prtein islates (B4150 r B4152) are apprpriate fr the majrity f patients requiring enteral nutritin. The medical necessity fr special enteral frmulas (B4149, B4153-B4157, B4161, and B4162) must be justified in each 23 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm

24 Cverage Plicy Updates Title Effective Date Summary f Changes Cverage Ratinale Nutritin (Including: Cunseling, Therapy, Enteral Nutritin, Infant Frmula, Breast Milk, Supplements and Fd) (cntinued) May 1, 2014 patient. If a special enteral nutritin frmula is prvided and if the medical recrd des nt dcument why that item is medically necessary, it will be denied as nt reasnable and necessary. Fd thickeners (B4100), baby fd, and ther grcery prducts that can be blenderized and used with the enteral system will be denied as nt cvered. Cdes B4102 and B4103 describe electrlyte-cntaining fluids that are nt cvered. Self-blenderized frmulas are nt cvered. Cde B4104 is an enteral frmula additive. The enteral frmula cdes include all nutrient cmpnents, including vitamins, mineral, and fiber. Therefre, cde B4104 will be denied as nt separately payable. Equipment and Supplies Enteral nutritin may be administered by syringe, gravity, r pump. Sme enteral patients may experience cmplicatins assciated with syringe r gravity methd f administratin. If a pump (B9000-B9002) is rdered, there must be dcumentatin in the patient s medical recrd t justify its use (e.g., gravity feeding is nt satisfactry due t reflux and/r aspiratin, severe diarrhea, dumping syndrme, administratin rate less than 100 ml/hr., bld glucse fluctuatins, circulatry verlad, gastrstmy/jejunstmy tube used fr feeding). If the medical necessity f the pump is nt dcumented, the pump will be cnsidered nt medically necessary. If a pump supply kit (B4035) is prvided and if the medical necessity f the pump is nt dcumented, it will be cnsidered nt medically necessary. The cdes fr feeding supply kits (B4034-B4036) are specific t the rute f administratin. Claims fr mre than ne type f kit cde delivered n the same date r prvided n an nging basis will be cnsidered nt medically 24 UnitedHealthcare f the River Valley Plicy Update Bulletin March 2014 Fr mre infrmatin, visit uhcrivervalley.cm