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January 2015 medical policy update bulletin Medical Policy, Drug Policy & Coverage Determination Guideline Updates UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice staff with a simple and predictable administrative experience. The Medical Policy Update Bulletin was developed to share important information regarding UnitedHealthcare Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) updates.* *Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates Overview This bulletin provides complete details on UnitedHealthcare Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) updates. The appearance of a service or procedure in this bulletin indicates only that UnitedHealthcare has recently adopted a new policy and/or updated, revised, replaced or retired an existing policy; it does not imply that UnitedHealthcare provides coverage for the service or procedure. In the event of an inconsistency or conflict between the information provided in this bulletin and the posted policy, the provisions of the posted policy will prevail. Note that most benefit plan documents exclude from benefit coverage health services identified as investigational or unproven/not medically necessary. Physicians and other health care professionals may not seek or collect payment from an enrollee for services not covered by the applicable benefit plan unless first obtaining the enrollee’s written consent, acknowledging that the service is not covered by the benefit plan and that they will be billed directly for the service. A complete library of Medical Policies, Drug Policies, and Coverage Determination Guidelines (CDGs) is available at UnitedHealthcareOnline.com > Tools & Resources > Policies, Protocols and Guides > Medical & Drug Policies and Coverage Determination Guidelines. Tips for using the Medical Policy Update Bulletin: 2 From the table of contents, click the policy title to be directed to the corresponding policy update summary. From the policy updates table, click the policy title to view a complete copy of a new, updated, or revised policy. Medical Policy Update Bulletin: January 2015 Policy Update Classifications New New clinical coverage criteria and/or documentation review requirements have been adopted for a service, procedure, test, or device Updated An existing policy has been reviewed and changes have not been made to the clinical coverage criteria or documentation review requirements; however, items such as the clinical evidence, FDA information, and/or list(s) of applicable codes may have been updated Revised An existing policy has been reviewed and revisions have been made to the clinical coverage criteria and/or documentation review requirements Replaced An existing policy has been replaced with a new or different policy Retired The procedural codes and/or services previously outlined in the policy are no longer being managed or are considered to be proven/medically necessary and are therefore not excluded as unproven/not medically necessary services, unless coverage guidelines or criteria are otherwise documented in another policy Note: The absence of a policy does not automatically indicate or imply coverage. As always, coverage for a service or procedure must be determined in accordance with the member’s benefit plan and any applicable federal or state regulatory requirements. Additionally, UnitedHealthcare reserves the right to review the clinical evidence supporting the safety and effectiveness of a medical technology prior to rendering a coverage determination. Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates In This Issue Take Note Page Annual CPT® and HCPCS Code Updates - Effective Jan. 1, 2015 ............................................................................................................................. 5 Reminder: Availability of the UnitedHealthcare Medical Policy Update Bulletin .......................................................................................................... 6 Medical Policy Updates NEW Balloon Sinus Ostial Dilation - Effective Apr. 1, 2015 ............................................................................................................................................. 7 Hysterectomy for Benign Conditions - Effective Apr. 1, 2015 .................................................................................................................................. 7 UPDATED Deep Brain Stimulation - Effective Feb. 1, 2015.................................................................................................................................................... 7 Electrical Stimulation and Electromagnetic Therapy for Wounds - Effective Feb. 1, 2015 ............................................................................................ 9 Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography - Effective Feb. 1, 2015 ................................................................ 10 Hip Resurfacing Arthroplasty - Effective Feb. 1, 2015 .......................................................................................................................................... 11 Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors - Effective Feb. 1, 2015 ........................................................................ 12 Mechanical Stretching and Continuous Passive Motion Devices - Effective Feb. 1, 2015 ........................................................................................... 14 Nerve Graft to Restore Erectile Function during Radical Prostatectomy - Effective Feb. 1, 2015 ................................................................................ 15 Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders - Effective Feb. 1, 2015 ......................................................................... 16 Sensory Integration Therapy and Auditory Integration Training - Effective Feb. 1, 2015 .......................................................................................... 17 Temporomandibular Joint Disorders - Effective Jan. 1, 2015 ................................................................................................................................ 18 REVISED Infertility Diagnosis and Treatment - Effective Feb. 1, 2015 ................................................................................................................................. 20 Obstructive Sleep Apnea Treatment - Effective Feb. 1, 2015 ................................................................................................................................ 23 Omnibus Codes - Effective Feb. 1, 2015 ............................................................................................................................................................ 27 Surgical Treatment for Spine Pain - Effective Feb. 1, 2015 ................................................................................................................................... 27 Transcranial Magnetic Stimulation - Effective Feb. 1, 2015................................................................................................................................... 31 RETIRED Intrastromal Corneal Ring Segments - Effective Jan. 1, 2015 ............................................................................................................................... 33 Drug and Biologics Policy Updates NEW 3 Entyvio (Vedolizumab) - Effective Mar. 1, 2015.. ................................................................................................................................................ 34 Medical Policy Update Bulletin: January 2015 Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates In This Issue Simponi Aria (Golimumab) - Effective Mar. 1, 2015 ............................................................................................................................................ 35 Coverage Determination Guideline (CDG) Updates REVISED Preventive Care Services - Effective Feb. 15, 2015 ............................................................................................................................................. 36 Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs - Effective Feb. 1, 2015 .......................................................................... 37 Utilization Review Guideline (URG) Updates NEW Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion - Effective Feb. 1, 2015 ......................... 44 RETIRED 4 Autism Spectrum Disorder - Effective Jan. 1, 2015 ............................................................................................................................................. 45 Medical Policy Update Bulletin: January 2015 Take Note Annual CPT® and HCPCS Code Updates Effective Jan. 1, 2015, the following Medical Policies, Drug Policies and Coverage Determination Guidelines (CDGs) have been modified to reflect the 2015 Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) code additions, revisions, and deletions. Refer to the sources below for information on the 2015 code updates: 5 American Medical Association. Current Procedural Terminology: CPT® 2015 Centers for Medicare & Medicaid Services. Healthcare Common Procedure Coding System: HCPCS Level II Policy Title Attended Polysomnography for Evaluation of Sleep Disorders Policy Type Medical Policy Summary of CPT®/HCPCS Code Edits Added 0381T, 0382T, 0383T, 0384T, 0385T and 0386T Blepharoplasty, Blepharoptosis and Brow Ptosis Repair CDG Revised description for 67961 and 67966 Breast Imaging for Screening and Diagnosing Cancer Medical Policy Added 76641, 76642, 77061, 77062, 77063 and G0279 Removed 76645 Cardiovascular Disease Risk Tests Medical Policy Added 93895 Clinical Trials CDG Added G0276 Clotting Factors and Coagulant Blood Products Drug Policy Added J7181, J7182, J7200 and J7201 Corneal Hysteresis and Intraocular Pressure Measurement Medical Policy Added 92145 Removed 0181T Cosmetic and Reconstructive Procedures CDG Removed 36469 Revised description for 36468 Emergency Health Services and Urgent Care CDG Revised description for 99284 Fecal DNA Testing Medical Policy Added G0464 Glaucoma Surgical Treatments Medical Policy Added 0376T, 66179 and 66184 Revised description for 0191T and 0253T Home Traction Therapy Revised description for E0856 Infertility Diagnosis and Treatment Medical Policy Medical Policy Added 89337 Removed 0059T Intensity-Modulated Radiation Therapy Medical Policy Added 77385, 77386, 77387, G6015, G6016 and G6017 Removed 0073T, 0197T and 77418 Neurophysiologic Testing Medical Policy Removed 0199T Medical Policy Update Bulletin: January 2015 Take Note Annual CPT® and HCPCS Code Updates Noninvasive Prenatal Diagnosis of Fetal Medical Policy Aneuploidy Using Cell-Free Fetal Nucleic Acids in Maternal Blood Added 81420 Occipital Neuralgia and Headache Treatment Medical Policy Revised description for 95972 Omnibus Codes Revised description for Q4147 Proton Beam Radiation Therapy Medical Policy Medical Policy Added 77385, 77386, 77387, G6015, G6016 and G6017 Removed 0073T, 0197T and 77418 Preventive Care Services CDG Added 87624, 87625, 90630, 99188, G0473, G9458, G9459 and G9460 Removed 44393, 45339, 45383, 87620, 87621 and 87622 Sodium Hyaluronate Medical Policy Added 20606, 20611 and J7327 Revised description for 20605 and 20610 Temporomandibular Joint Disorders Medical Policy Added 20606 Revised description for 20605 Total Artificial Disc Replacement for the Spine Medical Policy Added 0375T and 22858 Removed 0092T Revised description for 22856 Transcatheter Heart Valve Procedures Medical Policy Added 33418 and 33419 Removed 0343T and 0344T Reminder: Availability of the UnitedHealthcare Medical Policy Update Bulletin The monthly Medical Policy Update Bulletin provides online notice of UnitedHealthcare Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) updates. It will continue to be available for your reference on UnitedHealthcareOnline.com throughout 2015. 6 A new Medical Policy Update Bulletin is published on the first calendar day of every month at UnitedHealthcareOnline.com > Tools & Resources > Policies, Protocols and Guides > Medical & Drug Policies and Coverage Determination Guidelines > Medical Policy Update Bulletin. As a supplemental reminder to the detailed policy update summaries announced in the Medical Policy Update Bulletin, a list of recently approved, revised and/or retired Medical Policies, Drug Policies and CDGs is also provided in the Network Bulletin available at UnitedHealthcareOnline.com > Tools & Resources > News & Network Bulletin. For each policy update appearing in the Medical Policy Update Bulletin, the corresponding reminder notice will be included in the following month’s edition of the Network Bulletin. Medical Policy Update Bulletin: January 2015 Medical Policy Updates NEW Policy Title Balloon Sinus Ostial Dilation Effective Date Apr. 1, 2015 Coverage Rationale Balloon sinus ostial dilation is proven and medically necessary for treating chronic rhinosinusitis (defined as rhinosinusitis lasting longer than 12 weeks) when all of the following are met: Balloon sinus ostial dilation is limited to the frontal, maxillary or sphenoid sinuses There are no polyps or tumors Balloon sinus ostial dilation is performed either as a stand-alone procedure or as part of functional endoscopic sinus surgery (FESS) Balloon sinus ostial dilation is performed in persons older than 12 years of age whose symptoms persist despite medical therapy with one or more of the following: o Nasal lavage o Antibiotic therapy, if bacterial infection is suspected o Intranasal corticosteroids Balloon sinus ostial dilation is unproven and not medically necessary in children 12 years of age or younger. There is insufficient evidence to support the use of balloon sinus ostial dilation in the management of rhinosinusitis in children. Long-term, well-designed studies using appropriate controls are needed to determine the effectiveness of balloon sinus ostial dilation in this population. Hysterectomy for Benign Conditions Apr. 1, 2015 For information regarding medical necessity review, when applicable, see the following MCG™ Care Guidelines, 18th edition, 2014: Hysterectomy, Abdominal, ORG: S-650 (ISC) Hysterectomy, Vaginal, ORG: S-660 (ISC) Hysterectomy, Laparoscopic, ORG: S-665 (ISC) Effective Date Feb. 1, 2015 Summary of Changes Reorganized policy content Updated benefit considerations: o Added language pertaining to the 2011 Certificate of Coverage (COC) to indicate humanitarian use devices (HUDs) are not considered investigational and are covered when used for proven indication(s) o Added language pertaining to Essential Health Benefits for UPDATED Policy Title Deep Brain Stimulation 7 Medical Policy Update Bulletin: January 2015 Coverage Rationale Deep brain stimulation is proven and medically necessary for treating the following: Idiopathic Parkinson's disease when used according to U.S. Food and Drug Administration (FDA) indications Essential tremor when used according to U.S. Food and Drug Administration (FDA) indications Primary dystonia* (occurs apart from any other identifiable illness) including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis) when used according to the U.S. Food and Drug Administration (FDA) indications *Primary dystonia may include genetic torsion dystonia, acquired Medical Policy Updates UPDATED Policy Title Deep Brain Stimulation (continued) 8 Effective Date Feb. 1, 2015 Summary of Changes Individual and Small Group plans to indicate: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and NonGrandfathered plans The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage o Added language specific to the 2011 Certificate of Coverage (COC) to indicate humanitarian use devices (HUDs) are not considered investigational and are Medical Policy Update Bulletin: January 2015 Coverage Rationale torsion dystonia (not due to drugs), spasmodic torticollis, fragments of torsion dystonia, and unspecified torticollis. Deep brain stimulation is unproven and not medically necessary for treating secondary Parkinsonism (result of head trauma, metabolic conditions, toxicity, drugs, or other medical disorders). Well-designed studies demonstrating the efficacy of deep brain stimulation for treating secondary Parkinsonism are not available. Clinical trials are needed to demonstrate the benefit of deep brain stimulation for this patient population. Deep brain stimulation is unproven and not medically necessary for treating secondary dystonia (occurs with illness, after trauma or following exposure to certain medications or toxins). There is inadequate evidence of the safety and efficacy of deep brain stimulation for treating secondary dystonia. Questions remain with regard to patient selection criteria and long-term benefits and safety compared with standard treatments. Formal comparisons, with large randomized controlled or comparative trials of pallidotomy, thalamotomy, and deep brain stimulation, are required before conclusions can be drawn regarding the use of deep brain stimulation for patients with secondary dystonia. Deep brain stimulation is unproven and not medically necessary for treating conditions other than those listed as proven. This includes but is not limited to the following diagnoses: Depression Obsessive-compulsive disorder (OCD) Epilepsy Tourette syndrome Cluster headache Impulsive or violent behavior Chronic pain Trigeminal neuralgia Movement disorders caused by multiple sclerosis (MS) Some studies have examined the use of deep brain stimulation for treating major depression, obsessive-compulsive disorder (OCD), Medical Policy Updates UPDATED 9 Policy Title Deep Brain Stimulation (continued) Effective Date Feb. 1, 2015 Summary of Changes covered when used for proven indication(s) Updated coverage rationale: o Reformatted and relocated information pertaining to medical necessity review; added language to indicate if service is “medically necessary” or “not medically necessary” to applicable proven/unproven statement Updated supporting information to reflect the most current clinical evidence, CMS information and references Coverage Rationale epilepsy, Tourette syndrome, cluster headache, impulsive or violent behavior, stroke pain, chronic pain, phantom limb pain, trigeminal neuralgia and movement disorders of multiple sclerosis (MS). However, because of limited studies, small sample sizes, weak study designs and heterogenous patient characteristics, there is insufficient data to conclude that deep brain stimulation is safe and/or effective for treating these indications. Electrical Stimulation and Electromagnetic Therapy for Wounds Feb. 1, 2015 Electrical stimulation is unproven and not medically necessary for the treatment of wounds including venous stasis ulcers, arterial ulcers, diabetic foot ulcers and chronic pressure sores. There is insufficient evidence from randomized, controlled trials that electrical stimulation, as an adjunct to standard wound care, can increase the healing rate of chronic dermal or cutaneous wounds. There were substantial methodological flaws in the available studies, which make it difficult to define the magnitude of treatment effects and to determine what types of wounds are most likely to benefit from electrical stimulation. There is also insufficient evidence to determine the type of device or form of electrical current for use in wound healing. Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered Medical Policy Update Bulletin: January 2015 Electromagnetic therapy is unproven and not medically necessary for the treatment of wounds including venous stasis ulcers, arterial ulcers, diabetic foot ulcers, chronic pressure sores and soft tissue injuries. The available evidence regarding the use of pulsed high-frequency electromagnetic energy for the treatment of chronic wounds and soft tissue injuries is insufficient to support conclusions regarding the efficacy of this technology. The data from clinical trials are insufficient to prove efficacy, to define optimal treatment protocols, to establish patient selection criteria, or to evaluate the relative efficacy of this therapy compared with other treatment options. The available studies involved small numbers of subjects and because significant differences Medical Policy Updates UPDATED 10 Policy Title Electrical Stimulation and Electromagnetic Therapy for Wounds (continued) Effective Date Feb. 1, 2015 Summary of Changes and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Updated coverage rationale; added language to indicate the unproven services are “not medically necessary” Updated supporting information to reflect the most current clinical evidence, CMS information and references Coverage Rationale were noted between intervention and control groups, it is not possible to draw valid conclusions about the efficacy of this technology. Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography Feb. 1, 2015 Epiduroscopy (including spinal myeloscopy) is unproven and not medically necessary for the diagnosis of back pain. There is insufficient evidence to conclude that epiduroscopy can improve patient management or disease outcomes. The available studies primarily evaluated the feasibility of the procedure and the ability to visualize normal and pathological structures with an epiduroscope. None of the studies systematically evaluated the accuracy of epiduroscopy for diagnosis of causes of back pain and neurological signs. Reorganized policy content Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all Medical Policy Update Bulletin: January 2015 Percutaneous and endoscopic epidural lysis of adhesions is unproven and not medically necessary for the treatment of back pain. There is insufficient evidence to conclude that epidural lysis of adhesions can provide sustained reduction in chronic back pain in patients with a presumptive diagnosis of epidural adhesions. No published studies have evaluated this procedure relative to open surgical procedures for chronic back pain. Further validation with larger study populations and long term follow up is needed to verify the effectiveness of epidural adhesiolysis in the treatment of back pain. Functional anesthetic discography (FAD) is unproven and not medically necessary for the diagnosis of back pain. Although researchers are presently investigating the use of FAD for Medical Policy Updates UPDATED 11 Policy Title Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography (continued) Effective Date Feb. 1, 2015 Summary of Changes dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Updated coverage rationale; added language to indicate the unproven services are “not medically necessary” Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS information, and references Coverage Rationale diagnosing discogenic pain, there is insufficient evidence at this time to draw conclusions. Hip Resurfacing Arthroplasty Feb. 1, 2015 Hip resurfacing arthroplasty (HRA) with U.S. Food and Drug Administration (FDA) approved devices is proven and medically necessary for the treatment of hip disease in patients who are younger than age 65 and who meet ALL of the following criteria: have chronic, persistent pain and/or disability, are otherwise fit and active, have normal proximal femoral bone geometry and bone quality, and would otherwise receive a conventional primary total hip replacement (THR), but are likely to live longer than a conventional THR is expected to last. Reorganized policy content Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are Medical Policy Update Bulletin: January 2015 Hip resurfacing arthroplasty (HRA) is unproven and not medically necessary for devices not approved by the FDA or for treatment of patients who do not meet the above criteria. There is a lack of evidence that outcomes after HRA are equivalent or superior to those of THR in other patient populations. Medical Policy Updates UPDATED 12 Policy Title Hip Resurfacing Arthroplasty (continued) Effective Date Feb. 1, 2015 Summary of Changes deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Updated coverage rationale; added language to indicate if service is “medically necessary” or “not medically necessary” to applicable proven/unproven statement Updated supporting information to reflect the most current clinical evidence, CMS information and references Coverage Rationale Implantable BetaEmitting Microspheres for Treatment of Malignant Tumors Feb. 1, 2015 Yttrium-90 (90Y) microsphere radioembolization is proven and medically necessary for the following indications: unresectable metastatic liver tumors from primary colorectal cancer (CRC) unresectable metastatic liver tumors from neuroendocrine tumors unresectable primary hepatocellular carcinoma (HCC) Reorganized policy content Updated benefit considerations to indicate: o Essential Health Benefits for Individual and Small Group plans: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) Large group plans (both selffunded and fully insured), and Medical Policy Update Bulletin: January 2015 Yttrium-90 (90Y) microsphere radioembolization is unproven and not medically necessary for all other indications. Limited evidence suggests that treatment with intrahepatic microsphere radiation (IMR) might shrink tumors and relieve symptoms in some patients, sometimes enough to render some inoperable tumors operable. However, limited available evidence has not shown improved survival. In addition, the treatment's potential impact on quality of life has not been studied. No studies have yet compared the effects of IMR therapy with alternative treatments, such as chemoembolization. Randomized controlled trials are needed to determine the clinical utility Medical Policy Updates UPDATED Policy Title Implantable BetaEmitting Microspheres for Treatment of Malignant Tumors (continued) 13 Effective Date Feb. 1, 2015 Summary of Changes small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and NonGrandfathered plans The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage o Some benefit documents allow coverage of experimental/investigational/unpr oven treatments for lifethreatening illnesses when certain conditions are met; the enrolleespecific benefit document must be consulted to make coverage decisions for this service Updated coverage rationale: o Removed references to specific device/product names (“SIRSpheres® and TheraSphere®”) used in microsphere radioembolization o Reformatted and relocated information pertaining to medical necessity review; added language to indicate if service is “medically Medical Policy Update Bulletin: January 2015 Coverage Rationale of this treatment. Medical Policy Updates UPDATED 14 Policy Title Implantable BetaEmitting Microspheres for Treatment of Malignant Tumors (continued) Effective Date Mechanical Stretching and Continuous Passive Motion Devices Feb. 1, 2015 Feb. 1, 2015 Summary of Changes necessary” or “not medically necessary” to applicable proven/unproven statement Updated supporting information to reflect the most current description of services, clinical evidence and references Coverage Rationale The use of continuous passive motion (CPM) devices is proven for the prevention of joint contractures of the upper and lower extremities. Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to Medical Policy Update Bulletin: January 2015 Continuous passive motion devices are medically necessary for patients in the immediate post-operative phase of joint surgery as an adjunct to (and not replacement of) physical therapy to prevent contractures of the joints of the upper and/or lower extremities. The lumbar continuous passive motion device is unproven and not medically necessary. Clinical evidence is limited to manufacturer data. There is no scientific evidence in the published peer-reviewed medical literature that these devices for patient controlled therapy are safe or effective. The use of low-load prolonged-duration stretch devices is proven and medically necessary for the treatment of existing joint contractures of the upper and lower extremities. Static progressive (SP) stretch splint devices and patient actuated serial stretch (PASS) devices, for the treatment of joint contractures of the extremities alone or combined with standard physical therapy are unproven and not medically necessary. Clinical evidence is not sufficient to demonstrate that use of static progressive or patient actuated devices is a safe or effective treatment option. Studies are limited to small sample sizes. Medical Policy Updates UPDATED 15 Policy Title Mechanical Stretching and Continuous Passive Motion Devices (continued) Effective Date Nerve Graft to Restore Erectile Function during Radical Prostatectomy Feb. 1, 2015 Feb. 1, 2015 Summary of Changes determine benefit coverage Updated coverage rationale: o Reformatted and relocated information pertaining to medical necessity review; added language to indicate if service is “medically necessary” or “not medically necessary” to applicable proven/unproven statement o Removed reference to specific actuated serial stretch device/product names (“ERMI Extensionater” and “Flexionater”) Updated supporting information to reflect the most current clinical evidence and references Coverage Rationale Sural or other nerve grafts to restore erectile function during radical prostatectomy are unproven and not medically necessary. No comparative studies between nerve grafts and standard medical therapy (e.g., intracorporal injection, or vacuum erection devices) have been completed. The evidence for nerve grafts for restoration of erectile function is derived mainly from non-randomized studies limited by small sample sizes. A randomized controlled trial was discontinued when it was determined that unilateral nerve-sparing radical prostatectomy was not effective. Reorganized policy content Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity Medical Policy Update Bulletin: January 2015 Medical Policy Updates UPDATED 16 Policy Title Nerve Graft to Restore Erectile Function during Radical Prostatectomy (continued) Effective Date Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders Feb. 1, 2015 Feb. 1, 2015 Summary of Changes benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Updated coverage rationale; added language to indicate the unproven service is “not medically necessary” Updated supporting information to reflect the most current clinical evidence, CMS information and references Coverage Rationale Percutaneous tibial nerve stimulation is proven and medically necessary for the treatment of overactive bladder syndrome (OAB) including urinary frequency, urgency and urge incontinence. Percutaneous tibial nerve stimulation is proven and medically necessary for the treatment of urinary frequency, urgency, and urge incontinence in adult patients refractory to standard first-line treatment with pharmacotherapy, when anatomical abnormalities of the lower urinary tract and active urinary tract infections are excluded. Reorganized policy content Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide Medical Policy Update Bulletin: January 2015 Transurethral radiofrequency energy therapy (Renessa® System) is unproven and not medically necessary for the treatment of urinary incontinence. There is insufficient evidence to conclude that transurethral radiofrequency therapy is effective for treating urinary incontinence. Analysis and interpretation of published study results are complicated by a high placebo response rate and by the single-blind design of the trials. Further studies incorporating blinded assessment of objective outcomes and longer follow-up are needed, both to confirm the efficacy and safety of this procedure, and to define the patients who are likely to Medical Policy Updates UPDATED 17 Policy Title Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders (continued) Effective Date Sensory Integration Therapy and Auditory Integration Training Feb. 1, 2015 Feb. 1, 2015 Summary of Changes coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Updated coverage rationale: o Reformatted and relocated information pertaining to medical necessity review; added language to indicate if service is “medically necessary” or “not medically necessary” to applicable proven/unproven statement Coverage Rationale benefit from this procedure. Sensory integration therapy is unproven and not medically necessary for the treatment of any condition including the following: Learning disabilities Developmental delay Sensory integration disorder Autism spectrum disorder Cerebrovascular accident Speech disturbances Lack of coordination Abnormality of gait Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer Medical Policy Update Bulletin: January 2015 Transvaginal radiofrequency energy therapy is unproven and not medically necessary for the treatment of urinary incontinence. There is insufficient evidence to conclude that transvaginal radiofrequency therapy is effective for treating urinary incontinence. Studies report low cure rates and high rates of additional corrective treatment. The available studies of sensory integration therapy are weak and inconclusive and derived primarily from poorly controlled trials with methodological flaws. These trials fail to demonstrate that sensory integration therapy provides long-term improvement in neurological development and behavioral development. There is no reliable data Medical Policy Updates UPDATED Policy Title Sensory Integration Therapy and Auditory Integration Training (continued) Temporomandibular Joint Disorders 18 Effective Date Feb. 1, 2015 Jan. 1, 2015 Summary of Changes coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Updated coverage rationale; added language to indicate the unproven services are “not medically necessary” Updated supporting information to reflect the most current CMS information and references Coverage Rationale from well-designed clinical studies that indicate that sensory integration therapy improves clinical outcomes in patient with cerebrovascular accidents, speech disturbances, gait abnormalities, or other medical conditions. Further and better designed clinical trials of sensory integration therapy are necessary in order to establish their clinical usefulness. The following services are proven and medically necessary for treating disorders of the temporomandibular joint (TMJ): Arthrocentesis Arthroplasty [For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines®, 18th edition, 2014, Temporomandibular Joint Arthroplasty, ACG: A-0523 (AC)] Arthroscopy (with or without FDA approved bone anchor devices) Arthrotomy/open joint surgery (with or without FDA approved bone anchor devices) Injections of corticosteroids for rheumatoid arthritis-related TMJ disorders Physical therapy Stabilization and repositioning splint therapy (Does not include lowload prolonged-duration stretch (LLPS) devices discussed below) Updated benefit considerations: o Added language pertaining to Essential Health Benefits for Individual and Small Group plans to indicate: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) Large group plans (both selffunded and fully insured), and Medical Policy Update Bulletin: January 2015 Auditory integration training (AIT) is unproven and not medically necessary. There is insufficient reliable data indicating that AIT devices significantly improve behavior, language, listening ability, or learning ability. AIT is based on the unproven theory that some disorders are caused by hearing or listening deficiencies. It is unknown if the sound levels used for AIT are harmful to hearing. Partial or total joint replacement with an artificial prosthesis is proven and medically necessary for treating disorders of the Medical Policy Updates UPDATED Policy Title Temporomandibular Joint Disorders (continued) 19 Effective Date Jan. 1, 2015 Summary of Changes small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and NonGrandfathered plans The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Replaced reference to “Certificates of Coverage and Summary Plan Descriptions” with “benefit documents” o Updated coverage rationale; removed references to specific low-load prolonged-duration stretch (LLPS) device/product name (“Dynasplint system”) Updated list of applicable CPT codes to reflect annual code edits (effective 01/01/2015): o Added 20606 o Revised description for 20605 Updated supporting information to reflect the most current clinical evidence and references Medical Policy Update Bulletin: January 2015 Coverage Rationale temporomandibular joint (TMJ) when all other treatments have failed. Not all services treat all TMJ disorders; specific treatments are based upon the specific diagnosis. The following services are unproven and not medically necessary for treating disorders of the temporomandibular joint (TMJ): Biofeedback Craniosacral manipulation Passive rehabilitation therapy Low-load prolonged-duration stretch (LLPS) devices There are limited studies evaluating biofeedback for the treatment of musculoskeletal pain, including TMJ pain. One small uncontrolled study reported positive effects, while a larger randomized controlled study failed to demonstrate any treatment effect. Well-designed randomized, blinded and placebo-controlled outcome studies published on craniosacral manipulation for TMJ are not available. For additional information regarding manipulation under anesthesia for TMJ disorders, see the Medical Policy titled Manipulation Under Anesthesia. While there are some data from several randomized trials and case series studies that certain types of passive rehabilitation techniques may improve jaw mobility early in recovery in patients who have undergone TMJ surgery, or have lost jaw mobility due to TMJ derangement or to contracture following radiation therapy, these studies all included very small numbers of patients, and did not provide blinded assessment of outcomes, long-term follow-up, or information on optimal treatment protocols. Further prospective controlled clinical trials that directly compare LLPS devices to other treatment modalities are needed. Medical Policy Updates REVISED Policy Title Infertility Diagnosis and Treatment Effective Date Feb. 1, 2015 Summary of Changes Clarified benefits considerations language; replaced references to; o “Gestational carrier” with “surrogate/gestational carrier” o “In vitro fertilization (IVF)” with “assisted reproductive technologies (ART)” Clarified coverage rationale for proven/medically necessary therapeutic procedures; replaced reference to “procedures to correct underlying disorders” with “procedures to correct underlying conditions that contribute to infertility” Updated list of applicable codes; removed “coding clarification” statement Coverage Rationale Diagnostic Procedures Females The following tests or procedures are proven and medically necessary for diagnosing infertility in female patients: Antral follicle count Clomiphene citrate challenge test The following hormone level tests: o antimüllerian hormone (AMH) o estradiol o follicle-stimulating hormone (FSH) o luteinizing hormone (LH) o progesterone o prolactin o thyroid-stimulating hormone (TSH) Hysterosalpingogram (HSG) Diagnostic hysteroscopy Diagnostic laparoscopy with or without chromotubation Pelvic ultrasound (transabdominal or transvaginal) Sonohysterogram or saline infusion ultrasound The following tests are unproven and not medically necessary for diagnosing infertility in female patients: Inhibin B Uterine/endometrial receptivity testing (e.g., E-tegrity® and Endometrial Function Test® (EFT®)) There is insufficient evidence to permit conclusions regarding the use of these tests. More studies are needed to support improved outcomes (i.e., increased successful pregnancies with delivery of liveborn children) with use of these diagnostic tests. Males The following tests or procedures are proven and medically necessary for diagnosing infertility in male patients: Antisperm antibodies The following genetic screening tests: o cystic fibrosis gene mutations o karyotyping for chromosomal abnormalities o Y-chromosome microdeletions testing 20 Medical Policy Update Bulletin: January 2015 Medical Policy Updates REVISED Policy Title Infertility Diagnosis and Treatment (continued) Effective Date Summary of Changes Feb. 1, 2015 Coverage Rationale The following hormone level tests: o LH o FSH o prolactin o testosterone (total and free) Leukocyte count in semen Post-ejaculatory urinalysis Scrotal, testicular or transrectal ultrasound Semen analysis Testicular biopsy Vasography The following tests are unproven and not medically necessary for diagnosing infertility in male patients: Computer-assisted sperm analysis (CASA) Hyaluronan binding assay (HBA) Postcoital cervical mucus penetration test Reactive oxygen species (ROS) test Sperm acrosome reaction test Sperm DNA integrity/fragmentation tests (e.g. sperm chromatin structure assay (SCSA), single-cell gel electrophoresis assay (Comet), deoxynucleotidyl transferase-mediated dUTP nick end labeling assay (TUNEL), sperm chromatin dispersion (SCD) or Sperm DNA Decondensation™ Test (SDD)) Sperm penetration assays There is insufficient evidence to permit conclusions regarding the use of these tests. More studies are needed to support improved outcomes (i.e., increased successful pregnancies with delivery of liveborn children) with use of these diagnostic tests. Therapeutic Procedures The following procedures are proven and medically necessary for the treatment of infertility: Assisted reproductive technologies (e.g., in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT) and elective single-embryo transfer (eSET)) Ovulation induction or controlled ovarian stimulation Insemination procedures 21 Medical Policy Update Bulletin: January 2015 Medical Policy Updates REVISED Policy Title Infertility Diagnosis and Treatment (continued) Effective Date Summary of Changes Feb. 1, 2015 Coverage Rationale Assisted embryo hatching Intracytoplasmic sperm injection (ICSI) for treating male factor infertility Sperm retrieval techniques (e.g., microsurgical epididymal sperm aspiration (MESA), percutaneous epididymal sperm aspiration (PESA), testicular sperm extraction (TESE), testicular sperm aspiration (TESA) and electroejaculation) The following procedures to correct underlying conditions that contribute to infertility are proven and medically necessary: Lysis of adhesions Drainage of ovarian cyst Surgery (laparoscopic or open) for endometriosis Surgery (laparoscopic or open) to repair diseased, damaged or blocked fallopian tubes (e.g., fimbrioplasty, salpingostomy, neosalpingostomy) Transurethral resection of ejaculatory ducts for treating ejaculatory duct obstruction Varicocele repair Wedge resection of ovary or ovarian drilling in women with polycystic ovary syndrome. (NOTE: Ovarian drilling is a measure of last resort due to the increased risk of pelvic adhesions.) The following procedures are unproven and not medically necessary for treating infertility: Co-culture of embryos EmbryoGlue® In vitro maturation (IVM) of oocytes Studies describe different techniques of co-culture of embryos, but no standardized method of co-culturing has been defined. The use of cocultures may improve blastocyst development but may not result in an improved pregnancy or delivery rate. There is inadequate published scientific data to permit conclusions regarding the use of EmbryoGlue. Although preliminary results with IVM are promising, studies to date show that implantation and pregnancy rates are significantly lower than those achieved with standard IVF. Further evidence from well-designed 22 Medical Policy Update Bulletin: January 2015 Medical Policy Updates REVISED Policy Title Infertility Diagnosis and Treatment (continued) Effective Date Summary of Changes Feb. 1, 2015 Coverage Rationale trials is needed to determine the long-term safety and efficacy of the procedure. Cryopreservation Cryopreservation of sperm, semen or embryos is proven and medically necessary for individuals who are undergoing treatment with assisted reproductive technologies or are planning to undergo therapies that threaten their reproductive health, such as cancer chemotherapy. Cryopreservation of mature oocytes (eggs) is proven and medically necessary for women, under the age of 42, who are undergoing treatment with assisted reproductive technologies or are planning to undergo therapies that threaten their reproductive health, such as cancer chemotherapy. Cryopreservation of immature oocytes (eggs) is unproven and not medically necessary. Further evidence from well-designed trials is needed to determine the long-term safety and efficacy of cryopreserving immature oocytes for future in vitro maturation. Cryopreservation of ovarian or testicular tissue is unproven and not medically necessary. Ovarian tissue banking remains a promising clinical technique because it avoids ovarian stimulation and provides the opportunity for preserving gonadal function in prepubertal, as well as adult patients. However, this procedure has produced very few live births. Testicular tissue or testis xenografting are in the early phases of experimentation and have not yet been successfully tested in humans. Obstructive Sleep Apnea Treatment 23 Feb. 1, 2015 Updated reference links to reflect name change for policy titled Attended Polysomnography for Evaluation of Sleep Disorders (previously titled Polysomnography and Portable Monitoring for Sleep Related Breathing Disorders) Medical Policy Update Bulletin: January 2015 Nonsurgical Treatment Removable oral appliances are proven and medically necessary for treating obstructive sleep apnea (OSA) as documented by polysomnography. Refer to the Medical Policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. For information regarding medical necessity review, when Medical Policy Updates REVISED Policy Title Obstructive Sleep Apnea Treatment (continued) 24 Effective Date Feb. 1, 2015 Summary of Changes Revised coverage rationale; added language to indicate implantable hypoglossal nerve stimulation is unproven and not medically necessary for treating obstructive sleep apnea Updated list of applicable CPT codes; added 64553, 64568, 64569, 64570 Updated list of applicable HCPCS codes; added L8679, L8680, L8681 and L8686 Added list of applicable ICD-9 procedure codes:04.92, 04.93, 04.99, 86.96 and 86.97 Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS information, and references Medical Policy Update Bulletin: January 2015 Coverage Rationale applicable, see MCG™ Care Guidelines, 18th edition, 2014, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG). Removable oral appliances are unproven and not medically necessary for treating central sleep apnea. This type of sleep apnea is caused by impaired neurological function, and these devices are designed to manage physical obstructions. Nasal dilator devices are unproven and not medically necessary for treating obstructive sleep apnea (OSA). There is insufficient clinical evidence supporting the safety and efficacy of nasal dilators for treating OSA. Results from available studies indicate that therapeutic response is variable among the participants. Further research from larger, well-designed studies is needed to evaluate the effectiveness of the device compared with established treatments for OSA, to determine its long-term effectiveness and to determine which patients would benefit from this therapy. Surgical Treatment The following surgical procedures are proven and medically necessary for treating obstructive sleep apnea as documented by polysomnography. Refer to the medical policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. Uvulopalatopharyngoplasty (UPPP) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 18th edition, 2014, Uvulopalatopharyngoplasty (UPPP), A-0245 (ACG). Maxillomandibular advancement surgery (MMA) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 18th edition, 2014, Maxillomandibular Osteotomy and Advancement, A-0248 (ACG). Multilevel procedures whether done in a single surgery or phased multiple surgeries. There are a variety of procedure combinations, including mandibular Medical Policy Updates REVISED Policy Title Obstructive Sleep Apnea Treatment (continued) Effective Date Summary of Changes Feb. 1, 2015 Coverage Rationale osteotomy and genioglossal advancement with hyoid myotomy (GAHM). For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 18th edition, 2014, Mandibular Osteotomy, A-0247 (ACG). Radiofrequency ablation of the soft palate and/or tongue base is proven and medically necessary for treating mild to moderate obstructive sleep apnea as documented by polysomnography. Refer to the medical policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. In addition to the criteria listed above, radiofrequency ablation of the soft palate and/or tongue base is medically necessary for patients who fail to improve with or cannot tolerate an adequate trial of continuous positive airway pressure (CPAP) or another device, including bi-level positive airway pressure (BiPAP), auto-titrating positive airway pressure (APAP) and/or oral appliances. According to the American Academy of Sleep Medicine (AASM) the diagnosis of OSA is confirmed if the number of obstructive events† (apneas, hypopneas + respiratory event related arousals) on polysomnography (PSG) is greater than 15 events/hour or greater than 5/hour in a patient who reports any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping or choking; or the bed partner describing loud snoring, breathing interruptions or both during the patient’s sleep (Epstein et al., 2009). † The frequency of obstructive events is reported as an apnea + hypopnea index (AHI) or respiratory disturbance index (RDI). RDI has at times been used synonymously with AHI, but at other times has included the total of apneas, hypopneas and respiratory effort related arousals (RERAs) per hour of sleep. When a portable monitor is used that does not measure sleep, the RDI refers to the number of apneas plus hypopneas per hour of recording. OSA severity is defined as; mild for AHI or RDI ≥ 5 and < 15 moderate for AHI or RDI ≥ 15 and ≤ 30 25 Medical Policy Update Bulletin: January 2015 Medical Policy Updates REVISED Policy Title Obstructive Sleep Apnea Treatment (continued) Effective Date Summary of Changes Feb. 1, 2015 Coverage Rationale severe for AHI or RDI > 30/hr The following surgical procedures are unproven and not medically necessary for treating obstructive sleep apnea: Laser-assisted uvulopalatoplasty (LAUP) Palatal implants Lingual suspension - also referred to as tongue stabilization, tongue stitch or tongue fixation Transoral robotic surgery (TORS) Implantable hypoglossal nerve stimulation There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved AHI or secondary outcomes. Some studies saw a worsening of symptoms as well as increased complications. Results of studies provide preliminary but inconsistent evidence that palatal implants benefit patients with mild to moderate OSA. However, the magnitude of the benefits has been small; the largest randomized controlled trial (RCT) found that average OSA worsened in spite of treatment; and the available studies involved ≤ 1 year of patient monitoring after treatment. Additional studies are needed to determine the role of palatal implants in the management of OSA There is insufficient evidence to support the safety, efficacy and longterm outcomes of lingual suspension in the treatment of OSA. The published peer-reviewed medical literature includes a few small, uncontrolled studies with short-term follow-up. Large, controlled studies, with long-term follow-up, comparing lingual suspension to established procedures are necessary. There is insufficient evidence to support the safety, efficacy and longterm outcomes of transoral robotic surgery (TORS) in the treatment of OSA. Large, controlled studies, with long-term follow-up, comparing TORS to established procedures are necessary. There is insufficient evidence to support the safety, efficacy and longterm outcomes of hypoglossal nerve stimulation in the treatment of OSA. The optimal patient selection criteria for the use of hypoglossal 26 Medical Policy Update Bulletin: January 2015 Medical Policy Updates REVISED 27 Policy Title Obstructive Sleep Apnea Treatment (continued) Effective Date Summary of Changes Coverage Rationale nerve stimulation have not been defined. Randomized controlled trials or comparative effectiveness trials with long-term follow-up, comparing hypoglossal nerve stimulation to established procedures are necessary to evaluate the effectiveness of this technology. Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida et al., 2006; Ferguson et al., 2006). Refer to the medical policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. Omnibus Codes Feb. 1, 2015 Revised coverage rationale: o Pillcam Colon 2 gastrointestinal tract imaging device (CPT code 0355T): Added language to indicate Pillcam Colon 2 gastrointestinal tract imaging device is unproven due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical literature o MyoPro™ myoelectric limb orthosis (HCPCS code L3999): Updated coverage statement; replaced reference to “MyoPro™ artificial limb” with “MyoPro™ upper limb orthotic” o Skin allografts (HCPCS codes Q4115, Q4123, Q4131 Q4143 and Q4145 - Q4149): Updated list of applicable HCPCS codes to reflect annual code edits; revised description for Q4147 Refer to the policy for complete details on the coverage guidelines for Omnibus Codes. Surgical Treatment for Spine Pain Feb. 1, 2015 Reorganized policy content o Added benefit considerations language for Essential Health Spinal fusion using extreme lateral interbody fusion (XLIF®) or direct lateral interbody fusion (DLIF) is proven. Feb. 1, 2015 Medical Policy Update Bulletin: January 2015 Medical Policy Updates REVISED Policy Title Surgical Treatment for Spine Pain (continued) 28 Effective Date Feb. 1, 2015 Summary of Changes Benefits for Individual and Small Group plans to indicate: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and NonGrandfathered plans The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Revised coverage rationale; updated content/language pertaining to unproven indications: o Spinal Fusion Medical Policy Update Bulletin: January 2015 Coverage Rationale Coding Clarification The North American Spine Society (NASS) recommends that anterior or anterolateral approach techniques performed via an open approach should be billed with CPT codes 22554 – 22585. These codes should be used to report the use of extreme lateral interbody fusion (XLIF) and direct lateral interbody fusion (DLIF) procedures (NASS, 2010). Laparoscopic approaches should be billed with an unlisted procedure code. For information regarding medical necessity review, when applicable, see the following MCG™ Care Guidelines, 18th edition, 2014: Cervical Diskectomy or Microdiskectomy, Foraminotomy, Laminotomy, S-310 (ISC) Lumbar Diskectomy, Foraminotomy, or Laminotomy S-810 (ISC) Cervical Laminectomy S-340 (ISC) Lumbar Laminectomy S-830 (ISC) Cervical Fusion, Anterior S-320 (ISC) Cervical Fusion, Posterior S-330 (ISC) Lumbar Fusion S-820 (ISC) The following spinal procedures are unproven: A. Spinal fusion, when performed via the following methods: 1. Laparoscopic anterior lumbar interbody fusion (LALIF) 2. Transforaminal lumbar interbody fusion (TLIF) which utilizes only endoscopy visualization (such as a percutaneous incision with video visualization) 3. Axial lumbar interbody fusion (AxiaLIF) 4. Interlaminar lumbar instrumented fusion (ILIF) This includes interbody cages, screws, and pedicle screw fixation devices with any of the above procedures. Clinical evidence is limited primarily to retrospective studies and case series. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy. Medical Policy Updates REVISED Policy Title Surgical Treatment for Spine Pain (continued) 29 Effective Date Feb. 1, 2015 Summary of Changes Added “pedicle screw fixation” to list of unproven procedures/devices Removed reference to specific interbody cage device/product name (“PEEK”) o Spinal Decompression Removed reference to specific interspinous process decompression (IPD) system device/product name (“XSTOP”) Updated clinical evidence for minimally invasive lumbar decompression (MILD®) to indicate: - Clinical evidence is limited to small, uncontrolled studies; additional randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy o Spinal Stabilization Removed reference to specific stabilization system device/product names (“Dynesys®”, “Dynamic Stabilization System” and “DSS Stabilization System”) Added clinical evidence for total facet joint arthroplasty, including facetectomy, laminectomy, foraminotomy, Medical Policy Update Bulletin: January 2015 Coverage Rationale B. Spinal Decompression 1. Interspinous process decompression (IPD) systems, for the treatment of spinal stenosis 2. Minimally invasive lumbar decompression (MILD®) Clinical evidence is limited to small, uncontrolled studies. Additional randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy. C. Spinal Stabilization 1. Stabilization systems for the treatment of degenerative spondylolisthesis 2. Total facet joint arthroplasty, including facetectomy, laminectomy, foraminotomy, vertebral column fixation The current published evidence is insufficient to determine whether facet arthroplasty is as effective or as safe as spinal fusion, the current standard for surgical treatment of degenerative disc disease. In addition, no devices have received approval from the U.S. Food and Drug Administration for use outside the clinical trial setting. 3. Percutaneous sacral augmentation (sacroplasty) with or without a balloon or bone cement for the treatment of back pain The available clinical evidence shows that percutaneous sacroplasty, may alleviate the pain and functional impairment of sacral insufficiency fractures (SIF) in most patients with few and predominantly minor adverse effects, suggesting that this procedure may be relatively safe and efficacious for treatment of SIF. Despite these promising findings, the overall quality of the body of evidence is low given that the available studies were limited by methodological flaws (e.g., retrospective design, small sample size, subjective outcome measures, lack of a control group, and inadequate follow-up). Before reliable recommendations may be made, higher-quality studies are required that entail large populations with sufficient statistical power. D. Stand-alone facet fusion without an accompanying Medical Policy Updates REVISED Policy Title Surgical Treatment for Spine Pain (continued) 30 Effective Date Feb. 1, 2015 Summary of Changes vertebral column fixation to indicate: - The current published evidence is insufficient to determine whether facet arthroplasty is as effective or as safe as spinal fusion, the current standard for surgical treatment of degenerative disc disease - In addition, no devices have received approval from the U.S. Food and Drug Administration for use outside the clinical trial setting Updated clinical evidence for percutaneous sacral augmentation (sacroplasty) to indicate: - The available clinical evidence shows that percutaneous sacroplasty, may alleviate the pain and functional impairment of sacral insufficiency fractures (SIF) in most patients with few and predominantly minor adverse effects, suggesting that this procedure may be relatively safe and efficacious for treatment of SIF - Despite these promising findings, the overall Medical Policy Update Bulletin: January 2015 Coverage Rationale decompressive procedure. This includes procedures performed with or without bone grafting and/or the use of posterior intrafacet implants such as fixation systems, facet screw systems or antimigration dowels. Clinical evidence is limited primarily to case series and nonrandomized studies. Randomized, controlled trials comparing facet fusion to standard procedures are needed to determine impact on health outcomes and long-term efficacy. Medical Policy Updates REVISED 31 Policy Title Surgical Treatment for Spine Pain (continued) Effective Date Transcranial Magnetic Stimulation Feb. 1, 2015 Feb. 1, 2015 Summary of Changes quality of the body of evidence is low given that the available studies were limited by methodological flaws (e.g., retrospective design, small sample size, subjective outcome measures, lack of a control group, and inadequate follow-up) - Before reliable recommendations may be made, higher-quality studies are required that entail large populations with sufficient statistical power Updated list of applicable (unproven) CPT codes to reflect annual code edits; revised description for 0200T and 0201T Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS information, and references Coverage Rationale Transcranial magnetic stimulation is unproven and not medically necessary for treating all medical (i.e., non-behavioral) conditions including the following: Chronic neuropathic pain Dystonia Epilepsy Headaches Parkinson’s disease Stroke Tinnitus Reorganized policy content Added benefit considerations language for Essential Health Benefits for Individual and Small Group plans to indicate: o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured nongrandfathered individual and small group plans (inside and outside of Exchanges) to provide Medical Policy Update Bulletin: January 2015 For behavioral disorders, refer to the following Optum Behavioral Medical Policy Updates REVISED Policy Title Transcranial Magnetic Stimulation (continued) 32 Effective Date Feb. 1, 2015 Summary of Changes coverage for ten categories of Essential Health Benefits (“EHBs”) o Large group plans (both selffunded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and NonGrandfathered plans o The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage Revised coverage rationale: o Added language to indicate the unproven services are “not medically necessary” o Added language to clarify transcranial magnetic stimulation is unproven and not medically necessary for treating all medical (i.e., non-behavioral) conditions o Removed “depression and other psychiatric disorders” from list of unproven indications; added reference to the following Optum Behavioral Solutions Technology Assessments for guidelines Medical Policy Update Bulletin: January 2015 Coverage Rationale Solutions Technology Assessments: NeuroStar Transcranial Magnetic Stimulation Therapy for Major Depression Brainsway Deep TMS for Major Depression. Some studies have examined the use of transcranial magnetic stimulation for treating disorders such as pain, dystonia, epilepsy, headaches, Parkinson’s disease, stroke, and tinnitus. However, because of limited studies and small sample size there is insufficient data to conclude that transcranial magnetic stimulation is beneficial for treating these conditions. Navigated transcranial magnetic stimulation (nTMS) is unproven and not medically necessary for treatment planning or for diagnosing motor neuron diseases or neurological disorders. There is limited information from the peer-reviewed published medical literature to conclude that navigated transcranial magnetic stimulation is an effective clinical diagnostic test. Most published studies involve a small number of patients. Randomized controlled trials with large populations are needed to evaluate how this test can reduce clinical diagnostic uncertainty or impact treatment planning. Medical Policy Updates REVISED Policy Title Transcranial Magnetic Stimulation (continued) Effective Date Feb. 1, 2015 Summary of Changes pertaining to the treatment of behavioral disorders: NeuroStar Transcranial Magnetic Stimulation Therapy for Major Depression Brainsway Deep TMS for Major Depression Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS information, and references Coverage Rationale RETIRED Policy Title Intrastromal Corneal Ring Segments 33 Effective Date Jan. 1 2015 Summary of Changes Policy retired; intrastromal corneal ring segments (ICRS) implantation is now covered without need for clinical review Medical Policy Update Bulletin: January 2015 Drug and Biologics Policy Updates NEW Policy Title Entyvio (Vedolizumab) Effective Date Mar. 1, 2015 Coverage Rationale 1. Vedolizumab is proven and medically necessary for the treatment of ulcerative colitis (UC) when all of the following criteria are met: A. Moderate to severe disease activity ulcerative colitis AND B. One of the following: 1) History of failure, contraindication, or intolerance to at least one of the following conventional therapies: Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)] Immunomodulator (e.g., azathioprine, 6-mercaptopurine) Corticosteroid 2) Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of UC) AND C. Patient is not receiving vedolizumab in combination with either of the following: 1) Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)] 2) Tysabri (natalizumab) 2. Vedolizumab is proven and medically necessary for the treatment of active Crohn's disease (CD) when all of the following criteria are met: A. Moderate to severe disease activity Crohn’s disease (e.g., esophageal, gastroduodenal, perianal, or rectal disease; history of colonic or small-bowel resection) AND B. One of the following: 1) History of failure, contraindication, or intolerance to at least one of the following conventional therapies: Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Simponi (golimumab)] Immunomodulator (e.g., azathioprine, 6-mercaptopurine) Corticosteroid 2) Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of UC) AND C. Patient is not receiving vedolizumab in combination with either of the following: 1) Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Simponi (golimumab)] 2) Tysabri (natalizumab) Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for vedolizumab (Entyvio™). Local Coverage Determinations (LCDs) do not exist at this time. Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf. 34 Medical Policy Update Bulletin: January 2015 Drug and Biologics Policy Updates NEW Policy Title Simponi Aria (Golimumab) Effective Date Mar. 1, 2015 Coverage Rationale Golimumab is proven and medically necessary for the treatment of rheumatoid arthritis. Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf. Medicare does not have a National Coverage Determination (NCD) for Simponi® ARIA™ (golimumab). Local Coverage Determinations (LCDs) do not exist at this time. 35 Medical Policy Update Bulletin: January 2015 Coverage Determination Guideline (CDG) Updates REVISED Policy Title Preventive Care Services 36 Effective Date Feb. 15, 2015 Summary of Changes Revised list of applicable procedure and diagnosis codes for Preventive Care Services: o Abdominal Aortic Aneurysm Screening Updated claims edit criteria to clarify benefit age limit of 65 to 75 years “ends on the enrollee’s 76 birthday” (no change to coverage guidelines) o Hepatitis C Virus Infection Screening Updated/clarified claims edit criteria to indicate the following (no change to coverage guidelines): Hepatitis C Virus Infection Screening: - Screening is preventive when billed with a listed Hepatitis C Virus Infection Screening Diagnosis Code (refer to the policy for list of applicable codes) Blood Draw: - Service is preventive when billed with a listed Hepatitis C Virus Infection Screening Procedure Code and a listed Hepatitis C Virus Infection Screening Diagnosis Code (refer to the policy for lists of applicable codes) o Prostate Cancer Screening Medical Policy Update Bulletin: January 2015 Coverage Rationale Refer to the policy for complete details on the coverage guidelines for Preventive Care Services. Coverage Determination Guideline (CDG) Updates REVISED Policy Title Preventive Care Services (continued) Effective Date Feb. 15, 2015 Summary of Changes Updated applicable diagnosis code instructions for Code Group 1 to clarify screening “does not have diagnosis code requirements for preventive benefits to apply” (no change to coverage guidelines) o Behavioral Counseling in Primary Care to Promote a Healthy Diet Updated list of applicable HCPCS codes; added G0473 Updated claims edit criteria to indicate a listed diagnosis code is not required for HCPCS code G0473 o Pregnancy Diagnosis Code List Corrected typographical errors in list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/2015); added missing decimals to code listings (no change to code list) Coverage Rationale Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs Feb. 1, 2015 Benefit Document Language Before using this guideline, please check enrollee’s specific benefit document and any federal or state mandates, if applicable. 37 Reorganized and renamed policy; combined content previously outlined in the CDGs titled: o Prosthetic Devices and Wigs o Specialized, Microprocessor or Myoelectric Limbs Revised coverage rationale/ indications for coverage for prosthetic devices and wigs; added language to indicate: o A determination of coverage for the prosthesis is based on the Medical Policy Update Bulletin: January 2015 Essential Health Benefits for Individual and Small Group: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer Coverage Determination Guideline (CDG) Updates REVISED Policy Title Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued) Effective Date Feb. 1, 2015 Summary of Changes Coverage Rationale enrollee’s potential functional coverage for EHBs. However, if such plans choose to provide coverage abilities for benefits which are deemed EHBs (such as maternity benefits), the o Potential functional ability is ACA requires all dollar limits on those benefits to be removed on all based on the reasonable Grandfathered and Non-Grandfathered plans. The determination of expectations of the prosthetist which benefits constitute EHBs is made on a state by state basis. As and treating physician, such, when using this guideline, it is important to refer to the enrollee considering factors including, but specific benefit document to determine benefit coverage. not limited to: The enrollee’s past history Indications for Coverage (including prior prosthetic use I. Prosthetic Devices and Wigs if applicable); and A determination of coverage for the prosthesis is based on the The enrollee’s current enrollee’s potential functional abilities. Potential functional ability is condition including the status based on the reasonable expectations of the prosthetist, and of the residual limb and the treating physician, considering factors including, but not limited to: nature of other medical The enrollee’s past history (including prior prosthetic use if problems applicable); and Revised definitions; updated “Lower The enrollee’s current condition including the status of the Limb Rehabilitation Classification residual limb and the nature of other medical problems. Levels” 1. Prosthetic device coverage is limited to those prosthetic devices o Added applicable “K-Level” that replace a limb or external body part that are listed below: headers/descriptors o Updated description for “K-Level Artificial arms, legs, feet and hands 0” Artificial eyes, ears and nose o Removed “VA requirements for Breast prosthesis as required by the Women’s Health and computerized limbs” Cancer Rights Act of 1998. Benefits include mastectomy Updated list of applicable HCPCS bras and lymphedema stockings for the arm. codes to reflect annual code edits Speech aid prosthetics and tracheo-esophageal voice (effective 01/01/2015): prosthesis. Although these are typically external devices o Upper Limb Prosthetics: replacing the vocal cords, there may be an intra-oral Added L6026 component. These devices are covered as either DME or Removed L6025 Prosthetics. Please check enrollee specific benefit o External Power Upper Limb document for coverage. Prosthetics: 2. Prosthetic devices when covered, regardless of the setting or Added L7259 vendor from whom the prosthetic device is dispensed, are Removed L7260 and L7261 covered under the Prosthetic Devices section of the benefit document. 3. Prosthetic devices must be ordered by or under the direction of a physician. 38 Medical Policy Update Bulletin: January 2015 Coverage Determination Guideline (CDG) Updates REVISED Policy Title Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued) Effective Date Feb. 1, 2015 Summary of Changes Coverage Rationale 4. The prosthetic device must be approved by the Food and Drug Administration (FDA) and otherwise generally considered to be safe and effective for the purposes intended and the item must be reasonable and necessary for the individual patient. 5. Breast prosthetics which include the breast prosthesis, mastectomy bra, and lymphedema arm stockings, are always covered on an unlimited basis as to number of items and dollar amounts covered as required by the Women’s Health and Cancer Act of 1998. 6. Implantable devices/prostheses, such as artificial heart valves, are not prosthetics. If covered, these devices would be covered as a surgical service. 7. Coverage is available for repair and replacement, when it is not due to misuse, malicious damage or gross neglect. 8. Several states mandate coverage for prosthetics. Please check the enrollee specific benefit document for coverage. II. Specialized, Microprocessor or Myoelectic Limbs Computerized, bionic, microprocessor or myoelectric terms are considered the same for the purpose of this policy. Some states may require coverage of prosthetics that UnitedHealthcare may not otherwise consider covered. Computerized or microprocessor limbs are based on a patient’s current functional capabilities and his/her expected functional rehabilitation potential. If more than one prosthetic limb meets a patient’s prosthetic rehabilitation needs, the least costly prosthetic will be approved. Evidence is insufficient to permit conclusions regarding the effect of a microprocessor-controlled prosthesis on health outcomes in limited community ambulators. Evidence is also insufficient to permit conclusions regarding the effect of a next-generation microprocessor-controlled prosthesis on health outcomes. Therefore, these are considered investigational. 1. Computerized Prosthetic limbs are a covered health service when criteria are met: 39 Medical Policy Update Bulletin: January 2015 Coverage Determination Guideline (CDG) Updates REVISED Policy Title Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued) Effective Date Feb. 1, 2015 Summary of Changes Coverage Rationale a) Ordered by a physician; and b) Patient is evaluated for his/her individual needs by a healthcare professional with the qualifications and training and under the supervision of the ordering physician to make an evaluation (documentation should accompany the order); and c) Ordering physician signs the final prosthetic proposal; and d) The records must document the patient’s current functional capabilities and his/her expected functional rehabilitation potential, including an explanation for the difference, if that is the case. (It is recognized within the functional classification hierarchy that bilateral amputees often cannot be strictly bound by functional level classifications); and e) Prosthetic replaces all or part of a missing limb; and f) Prosthetic will help patient regain or maintain function; and g) Patient is willing and able to participate in the training for the use of the prosthetic (especially important in use of a computerized upper limb); and h) Patient is able to physically function at a level necessary for a computerized prosthetic or microprocessor, e.g. hand, leg or foot 2. Coverage of computerized and specialized lower limb prostheses is based on maximum prosthetic function level of the patient (see Lower Limb Rehabilitation Classification Levels 1-4 under Definition section below.) a) Patient meets criteria in #1 (one) above; and b) Patient has or is able to gain Lower Limb Rehabilitation Classification Levels 3 or 4 for prosthetic ambulation (see Definition section below) A. Microprocessor or specialized foot or feet; i. Microprocessor controlled ankle foot system (L5973), energy storing foot (L5976), multi-axial ankle/foot (L5978), dynamic response foot with multi-axial ankle (L5979), flex foot system (L5980), flex-walk system or equal (L5981), or shank foot system with vertical loading pylon (L5987) is indicated for 40 Medical Policy Update Bulletin: January 2015 Coverage Determination Guideline (CDG) Updates REVISED Policy Title Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued) Effective Date Feb. 1, 2015 Summary of Changes Coverage Rationale patients whose functional level is 3 or above. (A user adjustable heel height feature (L5990) will be denied as not meeting criteria for coverage. B. Knees: Basic lower extremity prostheses include a single axis, constant friction knee. Other prosthetic knees are indicated based upon functional classification. i. A high activity knee control frame (L5930) (e.g. i Ottobock C-Leg® Microprocessor Knee System) is covered for patients whose function level is 4. ii. A fluid, pneumatic, or electronic knee (L5610, L5613, L5614, L5722-L5780, L5814, L5822-L5840, L5848, L5856, L5857, and L5858) is indicated for patients whose functional level is 3 or above. iii. L5859 is only covered when the enrollee meets all of the criteria below: Has a microprocessor (swing and stance phase type (L5856)) controlled (electronic) knee K3 functional level only Weight greater than 110 lbs and less than 275 lbs Has a documented comorbity of the spine and/or sound limb affecting hip extention and/or quadriceps function that impairs K-3 level function with the use of a microprocessor-controlled knee alone Is able to make use of a product that requires daily charging Is able to understand and respond to error alerts and alarms indicating problems with the function of the unit C. Ankles: i. An axial rotation unit (L5982-L5986) is indicated for patients whose Lower Limb Rehabilitation Classification is 2 or above. ii. A microprocessor controlled ankle foot system (L5973), energy storing foot (L5976), dynamic response foot with multi-axial ankle (L5979), flex foot system (L5980), flex-walk system or equal 41 Medical Policy Update Bulletin: January 2015 Coverage Determination Guideline (CDG) Updates REVISED Policy Title Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued) Effective Date Feb. 1, 2015 Summary of Changes Coverage Rationale (L5981), or shank foot system with vertical loading pylon (L5987) is covered for beneficiaries whose functional level is 3 or above. D. Sockets: i. More than 2 test (diagnostic) sockets (L5618-L5628) for an individual prosthesis are not indicated unless there is documentation in the medical record which justifies the need. Exception: a test socket is not indicated for an immediate prosthesis (L5400-L5460) ii. No more than two of the same socket inserts (L5654-L5665, L5673, L5679, L5681, and L5683) are allowed per individual prosthesis at the same time. iii. Socket replacements are indicated if there is adequate documentation of functional and/or physiological need. It is recognized that there are situations where the explanation includes but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive patient weight or prosthetic demands of very active amputees. 3. Myoelectric Upper Limbs (arms, joints and hands) are covered when criteria are met: a) Patient meets all the criteria in #1 (one) above; and b) Patient has a congenital missing or dysfunctional arm and/or hand; or c) Patient has a traumatic or surgical amputation of the arm (above or below the elbow); and d) The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device (usually 3-5 muscle groups must be activated to use a computerized arm/hand); and e) A standard body-powered prosthetic device cannot be used or is insufficient to meet the functional needs of the individual in performing activities of daily living. Coverage Limitations and Exclusions 42 Medical Policy Update Bulletin: January 2015 Coverage Determination Guideline (CDG) Updates REVISED Policy Title Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued) 43 Effective Date Feb. 1, 2015 Summary of Changes Medical Policy Update Bulletin: January 2015 Coverage Rationale 1. Coverage for wigs/scalp hair prosthesis is excluded unless specifically listed as a covered health service. Some states mandate coverage. Check the enrollee specific benefit document for coverage. When wigs are covered, the benefit does not include coverage for hair implants or hair plugs. 2. Coverage is not available for prosthetics if the patient is eligible through a governmental program for a prosthetic due to military service related injuries and/or primary insurance coverage, e.g., VA, Medicare or TriCare. 3. Replacement of prosthetic devices due to misuse, malicious damage or gross neglect or to replace lost or stolen items. (Check enrollee specific benefit document) 4. Repairs to prosthetic devices due to misuse, malicious damage or gross neglect (Check enrollee specific benefit document) 5. If more than one prosthetic device can meet the enrollees functional needs, benefits are only available for the prosthetic device that meets the minimum specifications for the enrollees needs. 6. Coverage beyond any dollar or frequency limits specified in the enrollees specific benefit documents. Utilization Review Guideline (URG) Updates NEW Policy Title Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion Effective Date Feb. 1, 2015 Coverage Rationale Essential Health Benefits for Individual and Small Group: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage. Introduction This guideline addresses the criteria for consideration of allowing hospital outpatient facility infusion service and billing hospital based services with CMS/AMA Place of Service code 22 for immune globulin (IVIG and SCIG) therapy. Criteria and Clinical Indications for Hospital Outpatient Site of Care Selection Criteria: When requested, hospital outpatient site of care may be approved when: Any of the clinical indications questions 1-8 below can be answered ‘yes’; and The provider has submitted the appropriate supporting documentation. Clinical Indications: See the above criteria for the following questions. Note: If more than one of the criteria addressed in the questions below are met, then the greatest of the applicable approval time periods will be allowed. 1. Is this the patient’s initial infusion of immune globulin or re-initiation after more than 6 months off of immune globulin? 2. Is the patient changing immune globulin products? 3. Has the patient previously experienced a severe adverse event to immune globulin (examples might include, but are not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, and renal failure, other – provide reaction)? 4. Is the patient clinically unstable? 5. Is the patient continually experiencing moderate or severe adverse events not able to be mitigated by use of acetaminophen, steroids, diphenhydramine, fluids or other pre-medications on therapy? 6. Has the patient had an adverse event not able to be mitigated by use of acetaminophen, steroids, diphenhydramine, fluids or other pre-medications to immune globulin therapy documented for which the physician is uncomfortable administering immune globulin in a home or ambulatory setting? 7. Is the patient physically or cognitively disabled to the point where receiving treatment in at home or in a physician office would present a risk to their health? 8. Does the patient have immunoglobulin A (IgA) deficiency with anti-IgA antibodies? 44 Medical Policy Update Bulletin: January 2015 Utilization Review Guideline (URG) Updates NEW Policy Title Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion (continued) Effective Date Feb. 1, 2015 Coverage Rationale Benefit Considerations This guideline applies to: Members with 2011 COC or Summary Plan Document with benefits available for healthcare services if medically necessary. UHC Commercial and Medicaid plans. This guideline does not apply to Medicare plans. Supporting Information and Clinical Evidence 1. Clinical use of Immune globulin use is proven according to the UnitedHealthcare Drug Policy for Immune Globulin (IVIG and SCIG). See policy: Immune Globulin (IVIG and SCIG) 2. With respect to the site of care there are several options for administering immune globulin and should be based on patient clinical characteristics a. Hospital inpatient physician/nurse supervised infusion b. Hospital outpatient physician/nurse supervised infusion c. Physician office based physician/nurse supervised infusion d. Home based infusion with nurse supervision e. Home based infusion without nurse supervision 3. Immune Globulin infusion is widely used throughout the various sites of care 5. According to a 2008 survey by the Immune Deficiency Foundation of 1,030 patients being treated with immune globulin, two out of five (42%) IVIG users reported that they usually received their infusion at home. Of those, 7% were able to self-infuse, while the other 35% had a nurse perform the infusion. Twentysix percent of IVIG users usually got their infusion at a hospital outpatient department (21%), or at a hospital clinic (5%). Most of the remainder said that they usually got their infusion in a doctor’s private office (9%) or an infusion suite (16%). 4. Home infusion as a place of service is well established and accepted by physicians6 A 2010 home infusion provider survey by the National Home Infusion Association reported providing 1.24 million therapies to approximately 829,000 patients, including 129,071 infusion therapies of specialty medications, which includes immune globulin. RETIRED Policy Title Autism Spectrum Disorder 45 Effective Date Jan. 1, 2015 Summary of Changes Policy retired; refer to the enrollee-specific benefit document for applicable coverage guidelines and/or exclusions Medical Policy Update Bulletin: January 2015
