TRIAL Nn-Discriminatin Statement and Multi-Language Interpreter Services infrmatin are lcated at the end f this dcument. Cverage fr services, prcedures, medical devices and drugs are dependent upn benefit eligibility as utlined in the member's specific benefit plan. This Medical Cverage Guideline must be read in its entirety t determine cverage eligibility, if any. This Medical Cverage Guideline prvides infrmatin related t cverage determinatins nly and des nt imply that a service r treatment is clinically apprpriate r inapprpriate. The prvider and the member are respnsible fr all decisins regarding the apprpriateness f care. Prviders shuld prvide BCBSAZ cmplete medical ratinale when requesting any exceptins t these guidelines. The sectin identified as Descriptin defines r describes a service, prcedure, medical device r drug and is in n way intended as a statement f medical necessity and/r cverage. The sectin identified as Criteria defines criteria t determine whether a service, prcedure, medical device r drug is cnsidered medically necessary r experimental r investigatinal. State r federal mandates, e.g., FEP prgram, may dictate that any drug, device r bilgical prduct apprved by the U.S. Fd and Drug Administratin (FDA) may nt be cnsidered experimental r investigatinal and thus the drug, device r bilgical prduct may be assessed nly n the basis f medical necessity. Medical Cverage Guidelines are subject t change as new infrmatin becmes available. Fr purpses f this Medical Cverage Guideline, the terms "experimental" and "investigatinal" are cnsidered t be interchangeable. BLUE CROSS, BLUE SHIELD and the Crss and Shield Symbls are registered service marks f the Blue Crss and Blue Shield Assciatin, an assciatin f independent Blue Crss and Blue Shield Plans. All ther trademarks and service marks cntained in this guideline are the prperty f their respective wners, which are nt affiliated with BCBSAZ. O801.5.dcx Page 1 f 13
TRIAL (cnt.) Descriptin: Blue Crss Blue Shield Arizna (BCBSAZ) prvides cverage fr services described as eligible in the benefit plan bklets and which meet all requirements specified therein. With the exceptin f cancer clinical trials, n benefits are paid fr treatments, prcedures, equipment, drugs, devices r supplies assciated with a clinical trial. See Appendix fr additinal infrmatin. Cancer Clinical Trials: In cmpliance with Arizna Revised Statutes 20-826.01, 20-1057.07 and 20-2328, benefits are available fr cvered member csts directly assciated with an eligible cancer clinical trial within the state f Arizna. The clinical trial must meet all f the requirements f Arizna law. Cvered member csts are thse charges fr services that BCBSAZ nrmally cvers when a member underges usual and custmary (standard, nn-investigatinal) medical treatment. These services may include labratry and radilgy services, physician services and medical diagnstic and/r surgical prcedures. Definitins: Clinical Trials/Studies: Research studies that test whether new medical technlgies are safe and effective fr use in humans. Each study answers scientific questins in an effrt t find new r imprved ways t prevent, diagnse r treat medical diseases and cnditins. Clinical trials may als be perfrmed t determine if new ways f using knwn therapies are safe and effective. Clinical trials are cnducted in phases: Phase I: Initial testing f experimental drugs r treatments t evaluate safety, safe dse range and identify side effects. The experimental drug r treatment is given t a small grup f peple; usually 20 t 80. Phase II: The experimental drug r treatment is given t a grup f 100 t 300 peple in rder t determine if it is effective and t cntinue its safety evaluatin. O801.5.dcx Page 2 f 13
TRIAL (cnt.) Definitins: (cnt.) Phase III: This phase cmpares the experimental drug r treatment, r the new use f a knwn therapy, t current standard therapy. It als cnfirms the effectiveness f the drug r treatment, mnitrs its side effects and cllects infrmatin t enable the experimental drug r treatment t be used safely. A grup f 1000 t 3000 peple participate in this phase. Phase IV: This phase studies the FDA-apprved drug r treatment t delineate additinal infrmatin including the drug's risks, benefits, and ptimal use. FDA: One f the criteria BCBSAZ uses t determine if treatments, prcedures, equipment, drugs, devices r supplies are eligible fr cverage is that the technlgy under cnsideratin must have final apprval frm the apprpriate gvernment regulatry bdies. The United States Fd and Drug Administratin (FDA) is ne such regulatry bdy. The FDA is respnsible fr ensuring that drugs and medical devices are safe and effective fr use by humans befre cmpanies and manufacturers can put them n the market. The FDA has different prcesses by which it can clear r apprve a device r drug fr marketing as well as a prcess allwing nn-apprved devices t be used in clinical studies t btain safety and effectiveness data. FDA 510K Premarket Ntificatin (510K): A befre market submissin t demnstrate a device is at least as safe and effective (substantially equivalent) t a similar, legally U.S. marketed device that is nt subject t Premarket apprval (PMA). Once the technlgy passes thrugh this prcess, the FDA cnsiders it cleared fr marketing. This clearance is identified in a letter frm the FDA stating the technlgy is substantially equivalent and that it can be marketed. FDA Premarket Apprval (PMA): A befre market review prcess t evaluate the safety and effectiveness f medical devices that sustain human life, prevent impairment f human health r which present a ptential, unreasnable risk f illness r injury. In this prcess, the manufacturer prvides the FDA with clinical data regarding the safety and effectiveness f the device. The data is usually gathered thrugh an Investigatinal Device Exemptin trial. The apprval is based n the FDA s determinatin that the device cntains enugh valid scientific evidence t assure it is safe and effective fr its intended use(s). An apprved PMA grants permissin t market the device. O801.5.dcx Page 3 f 13
TRIAL (cnt.) Definitins: (cnt.) FDA Humanitarian Device Exemptin (HDE): Similar t a PMA but exempt frm certain requirements. HDEs apply t Humanitarian Use Devices (HUDs) which are medical devices intended t treat rare diseases r cnditins; thse affecting less than 4000 peple per year. In this prcess, the manufacturer submits data n the safety and prbable benefit f the device. FDA HDE apprval authrizes marketing f HUDs. FDA Investigatinal Device Exemptin (IDE): A prcess that allws an investigatinal device t be used in a clinical study s that safety and effectiveness data can be cllected t supprt a PMA r a 510K Premarket Ntificatin submissin t the FDA. IDE devices are nt FDA apprved fr marketing. FDA Drug Review and Apprval Prcess: A several-step prcess invlving animal and human testing, study phases f increasing numbers f humans, applicatin submissins, reviews, facility inspectins and final decisin by the FDA. If the FDA determines the benefits f the drug utweigh the risks, apprval is given and the drug can be marketed. O801.5.dcx Page 4 f 13
TRIAL (cnt.) Criteria: This Medical Cverage Guideline is nt applicable fr nn-grandfathered grup and nngrandfathered individual n and ff exchange plans effective r renewed n r after January 1, 2014. Fr clinical trial cverage fr nn-grandfathered grup and nn-grandfathered individual n and ff exchange plans effective r renewed n r after January 1, 2014, see BCBSAZ Medical Cverage Guideline #O855, Cverage Eligibility f Services Assciated With a Clinical Trial fr Nn-Grandfathered Plans. Cancer Clinical Trials: The fllwing usual and custmary (standard, nn-investigatinal) services assciated with an eligible cancer clinical trial are eligible fr cverage with dcumentatin f ALL f the fllwing: 1. Cancer clinical trial is being cnducted within the state f Arizna 2. Individual r prvider has ntified BCBSAZ that the individual is enrlled in a cancer clinical trial determined t meet the requirements f Arizna law and that the services t be rendered are directly assciated with the trial 1 3. Participatin in any phase f the cancer clinical trial is vluntary 4. Any ut-f-netwrk prvider(s), has agreed, via Letter f Agreement (LOA) t accept BCBSAZ reimbursement as payment in full These services include: Labratry and radilgy services Physician services fr cnsultatins, medical assessments and fllw-up visits Medical diagnstic and/r surgical prcedures 1 Lack f ntificatin will result in administratin f benefits in accrdance with the ther terms f the benefit plan which may cause a denial f benefits. O801.5.dcx Page 5 f 13
TRIAL (cnt.) Criteria: (cnt.) Cancer Clinical Trials: (cnt.) The fllwing services that may be required fr an individual t receive treatment r interventin are a benefit plan exclusin and nt eligible fr cverage: 1. Any investigatinal medicatin (except as stated in Prescriptin Medicatins fr the Treatment f Cancer ) r device 2. Nn-health services that might be required fr a persn t receive treatment r interventin, such as travel/transprtatin and/r ldging expenses 3. Csts f managing the research f the trial, e.g., data cllectin and analysis 4. Treatment r services prvided utside f Arizna 5. Csts and services custmarily paid fr by the research spnsrs, gvernment, bitechnical, pharmaceutical r medical device industry surces, r which are free f charge fr any trial enrllee 6. Items and services fr which cverage is nt available under the member s specific benefit plan due t exclusin r limitatin, ther than thse services directly related t the fcus f the trial Other Clinical Trials: Except as indicated in cancer clinical trials abve, treatments, prcedures, equipment, devices, drugs, supplies and facility and prvider services assciated with a clinical trial are cnsidered experimental r investigatinal. This includes devices with and withut 510K, PMA, HDE and IDE status and drugs with and withut FDA apprval. This applies even if the prcedure and services are therwise cnsidered medically necessary. This experimental r investigatinal status is based upn the assciatin with the clinical trial. Therefre it is cnsidered experimental r investigatinal based upn: 1. Insufficient scientific evidence t permit cnclusins cncerning the effect n health utcmes, and 2. Insufficient evidence t supprt imprvement f the net health utcme, and 3. Insufficient evidence t supprt imprvement f the net health utcme as much as, r mre than, established alternatives, and 4. Insufficient evidence t supprt imprvement utside the investigatinal setting. O801.5.dcx Page 6 f 13
TRIAL (cnt.) Resurces: Literature reviewed 12/19/17. We d nt include marketing materials, pster bards and nnpublished literature in ur review. 1. Blue Crss Blue Shield f Arizna Benefit Plan Bklet. 2. Arizna Revised Statutes 20-826.01. Hspital r medical service crpratins; clinical trials; cancer definitins. Accessed 11/15/2013. 3. Arizna Revised Statutes 20-1057-07. Health care services rganizatins; clinical trials; cancer, definitins. Accessed 11/15/2013. 4. Arizna Revised Statutes 20-2328. Accuntable health plans; clinical trials; cancer; definitins. Accessed 11/15/2013. 5. FDA. Investigatinal Device Excemptin (IDE) Overview. 6. FDA. Premarket Ntificatin 510(k) Overview. 7. FDA. Understanding Clinical Trials. 8. FDA. Premarket Apprval (PMA) Overview. 9. FDA. Humanitarian Device Exemptin (HDE) Overview. O801.5.dcx Page 7 f 13
TRIAL (cnt.) Nn-Discriminatin Statement: Blue Crss Blue Shield f Arizna (BCBSAZ) cmplies with applicable Federal civil rights laws and des nt discriminate n the basis f race, clr, natinal rigin, age, disability r sex. BCBSAZ prvides apprpriate free aids and services, such as qualified interpreters and written infrmatin in ther frmats, t peple with disabilities t cmmunicate effectively with us. BCBSAZ als prvides free language services t peple whse primary language is nt English, such as qualified interpreters and infrmatin written in ther languages. If yu need these services, call (602) 864-4884 fr Spanish and (877) 475-4799 fr all ther languages and ther aids and services. If yu believe that BCBSAZ has failed t prvide these services r discriminated in anther way n the basis f race, clr, natinal rigin, age, disability r sex, yu can file a grievance with: BCBSAZ s Civil Rights Crdinatr, Attn: Civil Rights Crdinatr, Blue Crss Blue Shield f Arizna, P.O. Bx 13466, Phenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.cm. Yu can file a grievance in persn r by mail r email. If yu need help filing a grievance BCBSAZ s Civil Rights Crdinatr is available t help yu. Yu can als file a civil rights cmplaint with the U.S. Department f Health and Human Services, Office fr Civil Rights electrnically thrugh the Office fr Civil Rights Cmplaint Prtal, available at https://crprtal.hhs.gv/cr/prtal/lbby.jsf, r by mail r phne at: U.S. Department f Health and Human Services, 200 Independence Avenue SW., Rm 509F, HHH Building, Washingtn, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Cmplaint frms are available at http://www.hhs.gv/cr/ffice/file/index.html Multi-Language Interpreter Services: O801.5.dcx Page 8 f 13
TRIAL (cnt.) Multi-Language Interpreter Services: (cnt.) O801.5.dcx Page 9 f 13
APPENDIX CANCER CLINICAL TRIAL REQUIREMENTS AS SET FORTH BY ARIZONA LAW These requirements apply t cancer clinical trial benefits in the fllwing health plans: All fully insured, grandfathered individual plans All fully insured, grandfathered small grup plans All fully insured, grandfathered large grup plans Any self-funded (ASC), grandfathered grup plans that elect this benefit Fr all nn-grandfathered grup and individual plans, please refer t the dcument Clinical Trial Requirements As Set Frth by the Affrdable Care Act. A. T be eligible fr benefits fr cvered services directly related t an eligible cancer clinical trial, the trial must first meet all requirements as set frth by Arizna law (e.g., A.R.S. 20-826.01 and 20-1057.07), as determined by yur prvider(s). These requirements are as fllws: BCBSAZ is nt bligated t pay any csts, ther than cvered patient csts, that are directly assciated with a cancer clinical trial ffered in Arizna in which the insured participates vluntarily. A cancer clinical trial is a curse f treatment in which all f the fllwing apply: The treatment is part f a scientific study f a new therapy r interventin that is being cnducted at an institutin in this state, that is fr the treatment, palliatin r preventin f cancer in humans and in which the scientific study includes all f the fllwing: Specific gals. A ratinale and backgrund fr the study. Criteria fr patient selectin. Specific directins fr administering the therapy and mnitring patients. A definitin f quantitative measures fr determining treatment respnse. Methds fr dcumenting and treating adverse reactins. The treatment is being prvided as part f a study being cnducted in a phase I, phase II, phase III r phase IV cancer clinical trial. O801.5.dcx Page 10 f 13
The treatment is being prvided as part f a study being cnducted in accrdance with a clinical trial apprved by at least ne f the fllwing: One f the natinal institutes f health. A natinal institute f health cperative grup r center. The United States Fd and Drug Administratin in the frm f an investigatinal new drug applicatin. The United States Department f Defense. The United States Department f Veterans Affairs. A qualified research entity that meets the criteria established by the natinal institutes f health fr grant eligibility. A panel f qualified recgnized experts in clinical research within academic health institutins in this state. The prpsed treatment r study has been reviewed and apprved by an institutinal review bard f an institutin in this state. The persnnel prviding the treatment r cnducting the study: Are prviding the treatment r cnducting the study within their scpe f practice, experience and training and are capable f prviding the treatment because f their experience, training and vlume f patients treated t maintain expertise. Agree t accept reimbursement as payment in full frm the insurer at the rates that are established by the insurer and that are nt mre than the level f reimbursement applicable t ther similar services prvided by health care prviders with the insurer's prvider netwrk. There is n clearly superir, nninvestigatinal treatment alternative. The available clinical r preclinical data prvide a reasnable expectatin that the treatment will be at least as efficacius as any nninvestigatinal alternative. B. Pursuant t the patient infrmed cnsent dcument, n party is liable fr damages assciated with the treatment prvided during any phase f a cancer clinical trial. C. Benefits are available as set frth in the subscriber s benefit bklet. BCBSAZ is nt respnsible fr any prtin f the clinical trial that is custmarily paid fr by gvernment, bitechnical, pharmaceutical r medical device industry surces. O801.5.dcx Page 11 f 13
D. Neither A.R.S. 20-826.01 and 20-1057.01 requiring BCBSAZ and ther insurers t prvide benefits fr cvered services related t a cancer clinical trial meeting all f the requirements set frth by law creates any private right r cause f actin fr r n behalf f any patient/subscriber against BCBSAZ. Instead, this law prvides slely an administrative remedy t the directr f the Arizna Department f Insurance fr any vilatin f this law r any related rule. E. Nthing in A.R.S. 20-826.01 and 20-1057.01 prhibits BCBSAZ frm impsing deductibles, cinsurance r ther cst sharing measures in relatin t benefits prvided pursuant t these laws. F. Definitins as set frth in A.R.S. 20-826.01 and 20-1057.01: "Cperative grup" means a frmal netwrk f facilities that cllabrates n research prjects and that has an established natinal institutes f health apprved peer review prgram perating within the grup, including the natinal cancer institute clinical cperative grup and the natinal cancer institute cmmunity clinical nclgy prgram. "Institutinal review bard" means any bard, cmmittee r ther grup that is bth: Frmally designated by an institutin t apprve the initiatin f and t cnduct peridic review f bimedical research invlving human subjects and in which the primary purpse f such review is t assure the prtectin f the rights and welfare f the human subjects and nt t review a clinical trial fr scientific merit. Apprved by the natinal institutes f health ffice fr prtectin frm research risks. "Multiple prject assurance cntract" means a cntract between an institutin and the united states department f health and human services that defines the relatinship f the institutin t the united states department f health and human services and that sets ut the respnsibilities f the institutin and the prcedures that will be used by the institutin t prtect human subjects. "Patient" means the insured r the insured's cvered dependent. O801.5.dcx Page 12 f 13
"Patient cst" means any fee r expense that is cvered under the cntract and that is fr a service r treatment that wuld be required if the patient were receiving usual and custmary care. Patient cst des nt include the cst: f any drug r device prvided in a phase I cancer clinical trial. f any investigatinal drug r device. f nnhealth services that might be required fr a persn t receive treatment r interventin. f managing the research f the clinical trial. that wuld nt be cvered under the patient's cntract. f treatment r services prvided utside this state. Disclaimer Please read carefully: In administering claims fr cvered services directly assciated with an eligible cancer clinical trial, BCBSAZ des nt represent r warrant that the cancer clinical trial meets all f the requirements set frth by Arizna Law. BCBSAZ als des nt represent r warrant that the treatment, device, drug, service r ther item prvided thrugh the cancer clinical trial is safe, effective r apprpriate fr any subscriber. Decisins regarding whether the cancer clinical trial meets the criteria set frth by Arizna law and whether the cancer clinical trial is safe, effective and apprpriate fr yu, are decisins t be made by yu and yur prvider and/r the trial investigatr, using his/her independent medical judgment. If yu have any questins cncerning whether the cancer clinical trial is safe and effective and/r meets the criteria established by Arizna law, BCBSAZ encurages yu t speak with yur treating prvider and prvide him/her with a cpy f this disclaimer fr discussin. Shuld yu have any questins cncerning available benefits pursuant t Arizna law fr cvered services related t a cancer clinical trial, please cntact the custmer service department at the telephne number listed in the frnt f yur benefit bklet. O801.5.dcx Page 13 f 13