CLINICAL MEDICAL POLICY

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1 Plicy Name: Plicy Number: Respnsible Department(s): CLINICAL MEDICAL POLICY Supervised Exercise Therapy fr Peripheral Artery Disease (PAD) MP-077-MD-DE Medical Management Prvider Ntice Date: 01/15/2019 Issue Date: 02/18/2019 Effective Date: 02/18/2019 Annual Apprval Date: 12/11/2019 Revisin Date: Prducts: Applicatin: N/A Page Number(s): 1 f 6 Highmark Health Optins Medicaid All participating hspitals and prviders DISCLAIMER Highmark Health Optins medical plicy is intended t serve nly as a general reference resurce regarding cverage fr the services described. This plicy des nt cnstitute medical advice and is nt intended t gvern r therwise influence medical decisins. POLICY STATEMENT Highmark Health Optins may prvide cverage under the therapy benefits f the Cmpany s Medicaid prducts fr medically necessary supervised exercise therapy (SET) fr the treatment f patients with symptmatic peripheral artery disease (PAD). This plicy is designed t address medical necessity guidelines that are apprpriate fr the majrity f individuals with a particular disease, illness r cnditin. Each persn s unique clinical circumstances warrant individual cnsideratin, based upn review f applicable medical recrds. The qualificatins f the plicy will meet the standards f the Natinal Cmmittee fr Quality Assurance (NCQA) and the Delaware Department f Health and Scial Services (DHSS) and all applicable state and federal regulatins. Plicy N. MP-077-MD-DE Page 1 f 6

2 DEFINITIONS Intermittent claudicatin (vascular claudicatin) A symptm that describes muscle pain r mild exertin, classically in the calf muscle, which ccurs during exercise, such as walking, and is relieved by a shrt perid f rest. PROCEDURES 1. Medical Necessity Guidelines Highmark Health Optins may prvide cverage fr up t 36 sessins ver a 12-week perid if all f the fllwing cmpnents f a SET prgram are met: A. The prgram must cnsist f sessins lasting minutes cmprising a therapeutic exercise-training prgram fr PAD in members with claudicatin; AND B. The prgram must be cnducted in a hspital utpatient setting, ambulatry utpatient r a physician s ffice; AND C. The prgram must be delivered by qualified auxiliary persnnel t ensure benefits exceed harms, and wh are trained in exercise therapy fr PAD; AND D. The member must be under the supervisin f a physician, physician assistant, r nurse practitiner/clinical nurse specialist trained in bth basic and advanced life supprt techniques; AND E. The member must have a face-t-face visit with the physician respnsible fr PAD treatment t btain the referral fr SET prgram. 1) At the visit, the member must receive infrmatin regarding cardivascular disease and PAD risk factr reductin, which culd include educatin, cunseling, behaviral interventins, and utcme assessments. 2. Cntraindicatins Highmark Health Optins cnsiders SET prgrams f peripheral vascular disease (PAD) t be experimental and investigatinal fr members with abslute cntraindicatins t exercise and fr all ther indicatins because the value fr ther indicatins is nt well dcumented by the available peerreviewed literature. 3. When the SET prgram is nt cvered Supervised Exercise Therapy (SET) services are nt cvered fr cnditins ther than thse listed abve because the scientific evidence has nt been established. Highmark Health Optins cnsiders the PADnet System and testing prgram experimental and investigatinal fr evaluatin f peripheral artery disease and ther indicatins because f insufficient evidence f its effectiveness. 4. Pst-payment Audit Statement The medical recrd must include dcumentatin that reflects the medical necessity criteria and is subject t audit by Highmark Health Optins at any time pursuant t the terms f yur prvider agreement. 5. Place f Service The place f service fr SET is ambulatry utpatient, physician ffice, r hspital utpatient setting. Plicy N. MP-077-MD-DE Page 2 f 6

3 6. Length f Cverage Highmark Health Optins may cver SET beynd 36 sessins ver 12 weeks and may cver an additinal 36 sessins ver an extended perid f time. A secnd physician referral is required fr additinal sessins. CODING REQUIREMENTS Prcedure Cdes CPT Cde Descriptin Peripheral arterial disease (PAD) rehabilitatin, per sessin Diagnsis Cdes ICD-10 Descriptin Cdes I Athersclersis f native arteries f extremities with intermittent claudicatin, right leg I Athersclersis f native arteries f extremities with intermittent claudicatin, left leg I Athersclersis f native arteries f extremities with intermittent claudicatin, bilateral legs I Athersclersis f native arteries f extremities with intermittent claudicatin, ther extremity I Athersclersis f unspecified type f bypass graft(s) f the extremities with intermittent claudicatin, right leg I Athersclersis f unspecified type f bypass graft(s) f the extremities with intermittent claudicatin, left leg I Athersclersis f unspecified type f bypass graft(s) f the extremities with intermittent claudicatin, bilateral legs I Athersclersis f unspecified type f bypass graft(s) f the extremities with intermittent claudicatin, ther extremity I Athersclersis f nnbilgical bypass graft(s) f the extremities with intermittent claudicatin, right leg I Athersclersis f nnbilgical bypass graft(s) f the extremities with intermittent claudicatin, left leg I Athersclersis f nnbilgical bypass graft(s) f the extremities with intermittent claudicatin, bilateral legs I Athersclersis f nnbilgical bypass graft(s) f the extremities with intermittent claudicatin, ther extremity I Athersclersis f ther type f bypass graft(s) f the extremities with intermittent claudicatin, right leg I Athersclersis f ther type f bypass graft(s) f the extremities with intermittent claudicatin, left leg I Athersclersis f ther type f bypass graft(s) f the extremities with intermittent claudicatin, bilateral legs I Athersclersis f ther type f bypass graft(s) f the extremities with intermittent claudicatin, ther extremity REIMBURSEMENT Participating facilities will be reimbursed per their Highmark Health Optins cntract. Plicy N. MP-077-MD-DE Page 3 f 6

4 SUMMARY OF LITERATURE Peripheral artery disease (PAD) is a cmmn chrnic cardivascular cnditin that affects the lwer extremities and can substantially limit daily activities and quality f life (Heschis, 2018). Arterial bstructin and symptms f arterial insufficiency are caused by reduced bld flw (Heschis, 2018). Many PAD patients d nt have symptms but sme PAD patients develp intermittent claudicatin. Physical activity and medicatins are tw frms f treatment fr patients with PAD. Exercise therapy prvides significant benefits fr patients with PAD and symptms f intermittent claudicatin (Hageman, 2018). Supervised Exercise Therapy (SET) fr PAD is a physician referred exercise and educatin based prgram that is designed t help peple walk lnger withut pain in the hpe f imprving their verall quality f life. Accrding t the Center fr Medicare and Medicaid (2017), Research has shwn that SET is an effective, minimally invasive methd t alleviate claudicatin (the mst cmmn symptm f PAD) and may als prevent the prgressin f PAD and lwer the risk f ther cardivascular events in these patients. A Cchrane study was perfrmed n SET and included 21 trials in which a ttal f 1400 participants with intermittent claudicatin (65% male, mean age 66 years) had been assigned t either SET, hme-based exercise, r walking advice (Hageman, 2018). SET demnstrated imprvement in patients walking ability t a greater extent than the patients wh cmpleted hme-based exercise r walking advice (Hageman, 2018). Befre SET, the patients maximal pain-free walking distance was 140 meters. After three mnths f SET, patients culd walk 120 and 210 meters farther than the maximal walking distance fr thse wh fllwed a hme-based exercise prgram r received walking advice (Hageman, 2018). In May 2017, CMS annunced extended cverage fr supervised exercise therapy (SET) t treat peripheral artery disease (PAD). Accrding t CMS (2017), ther studies and trials have shwed decreases in mrtality, reduced cardivascular risk factrs, increases in capacity, and increases in quality f life in lder adults (APTA, 2017). In 2014, the Natinal Institute fr Health and Care Excellence (NICE) created guidelines and recmmendatins fr supervised exercise prgrams. The guideline des nt recmmend any hmebased exercise prgrams (NICE, 2014). Key pints in the NICE 2014 clinical evidence update include: Management f intermittent claudicatin - Exercise prgrams Supervised exercise is assciated with increases in maximal walking distance (MWD) cmpared with hme-based r ther unsupervised exercise prgrams. Supervised exercise is assciated with greater increases in walking distance in peple with art-iliac disease than either stenting r ptimum medical care. Supervised exercise appears t be mre cst effective than either angiplasty alne r supervised exercise plus angiplasty in peple with IC due t femra-ppliteal cclusin. The American Cllege f Cardilgy (ACC)/American Heart Assciatin (AHA) recmmended the SET prgrams and develped guidelines (2016): In patients with claudicatin, a supervised exercise prgram is recmmended t imprve functinal status and QL and t reduce leg symptms. (COR I) (LOE A) A supervised exercise prgram shuld be discussed as a treatment ptin fr claudicatin befre pssible revascularizatin. (COR I) (LOE B-R) Supervised exercise prgram definitins (COR I) (LOE A) Plicy N. MP-077-MD-DE Page 4 f 6

5 Prgram takes place in a hspital r utpatient facility Prgram uses intermittent walking exercise as the treatment mdality Prgram can be standalne r within a cardiac rehabilitatin prgram Prgram is directly supervised by qualified healthcare prvider(s) Training is perfrmed fr a minimum f minute/sessin; sessins are perfrmed at least 3 times/week fr a minimum f 12 weeks Training invlves intermittent buts f walking t mderate-t-maximum claudicatin, alternating with perids f rest Warm-up and cl-dwn perids precede and fllw each sessin f walking POLICY SOURCE(S) Centers fr Medicare and Medicaid Services: Medicare Natinal Cverage Determinatin fr Supervised Exercise Therapy fr Symptmatic Peripheral Artery Disease (PAD) (NCD 20.35) Publicatin N , Versin 1. Effective Date 5/25/2017. Accessed n Octber 5, Centers fr Medicare and Medicaid Services: Decisin mem fr Supervised Exercise Therapy (SET) fr Symptmatic Peripheral Artery Disease (PAD) (CAG-00449N).May 25, Accessed n Octber 5, Hayes, Inc. Supervised Exercise Therapy (SET) fr the Treatment f Symptmatic Peripheral Artery Disease (PAD). Publicatin Date: July 13, Accessed n Octber 5, Natinal Institute fr Health and Care Excellence (NICE). Lwer limb peripheral arterial disease. Evidence update Nvember Evidence Update 69. Lndn, UK: NICE; Nvember Accessed n Octber 5, Hirsch AT, Haskal ZJ, Hertzer NR, et al; American Assciatin fr Vascular Surgery; Sciety fr Vascular Surgery; Sciety fr Cardivascular Angigraphy and Interventins; Sciety fr Vascular Medicine and Bilgy; Sciety f Interventinal Radilgy; ACC/AHA Task Frce n Practice Guidelines Writing Cmmittee t Develp Guidelines fr the Management f Patients With Peripheral Arterial Disease; American Assciatin f Cardivascular and Pulmnary Rehabilitatin; Natinal Heart, Lung, and Bld Institute; Sciety fr Vascular Nursing; TransAtlantic Inter-Sciety Cnsensus; Vascular Disease Fundatin. ACC/AHA 2005 Practice Guidelines fr the management f patients with peripheral arterial disease (lwer extremity, renal, mesenteric, and abdminal artic): A cllabrative reprt frm the American Assciatin fr Vascular Surgery/Sciety fr Vascular Surgery, Sciety fr Cardivascular Angigraphy and Interventins, Sciety fr Vascular Medicine and Bilgy, Sciety f Interventinal Radilgy, and the ACC/AHA Task Frce n Practice Guidelines (Writing Cmmittee t Develp Guidelines fr the Management f Patients With Peripheral Arterial Disease): Endrsed by the American Assciatin f Cardivascular and Pulmnary Rehabilitatin; Natinal Heart, Lung, and Bld Institute; Sciety fr Vascular Nursing; TransAtlantic Inter-Sciety Cnsensus; and Vascular Disease Fundatin. J Am Cll Cardil. 2006;47(6): Accessed n Octber 5, Heschis, D.G., Glden, M.A. Clinical features and diagnsis f lwer extremity peripheral artery disease. UpTDate, June 11, Accessed n Octber 5, Plicy N. MP-077-MD-DE Page 5 f 6

6 Hageman, D., Fkkenrd, HJP. Supervised exercise therapy vs hme-based exercise therapy vs walking advice fr patients with leg pain while walking (intermittent claudicatin). April 8, Accessed n Octber 5, Plicy Histry: Date Activity 10/03/2018 Initial plicy develped 12/11/2018 QI/UM Cmmittee apprval 02/18/2019 Prvider effective date Plicy N. MP-077-MD-DE Page 6 f 6