MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 09/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Penile Implants in the Treatment of Erectile Dysfunction B. Background Erectile dysfunction (ED) is the consistent or recurrent inability to acquire or sustain an erection, and the most common sexual problem affecting males. Surveys suggest 5-10% of men between the age s of 20 to 30 are a ffected, and that number increas es to 35-40 % of men aged 70 or older . The National Institutes of Health (NIH) estimates that up to 30 million men experience erectile dysfunction. Various treatment modalities exist for ED. One treatment option is a surgical penile implant (also called a penile prosthesis) . A penile implant is indicated when there is a clear medical cause for ED and when the problem is unlikely to resolve or improve naturally or with other medical treatments. A basic penile prosthesis consists of a pair of bendable, silicone rods that are surgically implanted within the erection chambers of the penis. Identification of the underlying etiology is an important first step. This includes ruling out the adverse effects of medication(s), identifying, and treating risk factors. C. Definitions Erectile Dysfunction The consistent or recurrent inability to acquire or sustain an erection. Neurogenic Impotence Nervous system issues affecting the ability to maintain or have an erection . Vascular Impotence Restricted or d ecreased blood flow to the penis causing impotence . D. Policy I. Medication is the f irst line of treatment for ED , including A. oral phosphodiesterase type 5 inhibitors B. intra-urethral alprostadil C. intracavernous vasoactive drug injections Ohio Medicaid does not cover m edications including oral, injectable, and transdermal varieties for the treatment of erectile dysfunction. II. External penile pumps or vacuum constr iction devices (VCD) are the s econd line of treatment after first line therapy has failed. III. Ohio Medicaid does not cover e xternal penile pumps and vacuum constr iction d evices . Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3IV. Internal penile prosthetic implants are covered in extraordinary circumstances . They are consi dered medically necessary when ALL of the following conditions are met: A. First and second line therapy have been documented as ineffective , or there is a compelling, well documented reason to proceed with surgery without a failed trial of first and second-line therapies. B. Absence of active alcohol or substance use disorder as documented in the medical record. C. Absence of drug induced impotence related to ALL of the following: 1. anabolic steroid use 2. anticholinergics 3. antidepressants 4. antipsychotics or central nervous system depressants D. Neurogenic impotence due to ONE of the following: 1. diabetes 2. fractured pelvis 3. m ajor surgery of the pelvis, retroperitoneum, radical prostatectomy, or colorectal surgery 4. m ultiple sclerosis 5. spina bifida 6. spinal cord injury/disease 7. syringomy elia OR E. Vascular impotence due to ONE of the following: 1. hypertension 2. intrapenile arterial disease 3. penile fracture 4. Peyronies disease 5. smoking 6. status post cavernosal infection 7. impotence due to radiation therapy to the pelvis or retroperitoneum V. Internal penile prosthetic implant removal is considered medically necessary when ANY of the following occur: A. infection B. mechanical failure C. urinary obstruction D. intractable pain E. Conditions of Coverage N/A F. Related Polic ies/Rules N/A Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4G. Review/Revision History DATE ACTIONDate Issued 07/26/2016Date Revised 05/13/2020 05/11/2022 05/10/2023 05/08/2024 06/18/2025Updated References, Updated Background information, condensed medical criteria. Added penile implant information to Background; updated references. No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee.Date Effective 09/01/2025 Date Archived H. References1. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. JUrology. 2018;200:633-641. doi:10.1016/j.juro.2018.05.004 2. Khera M. Treatment of male sexual dysfunction. UpToDate. Updated October 24, 2023. Accessed June 3, 2025. www.uptodate.com 3. Lazarou S. Surgical treatment of erectile dysfunction. UpToDate. Updated November 14, 2023. Accessed June 3, 2025. www.uptodate.com 4. Pharmacy Services: Covered Drugs and Associated Limitations, O HIO ADMIN . CODE 5160-9- 03(B)(3) (2024). 5. Urologic Surgery or Procedure GRG: SG-US. MCG Health. 28th ed. Updated February 1, 2024. Accessed June 3, 2025. www.careweb.careguidelines.com Inde pendent med ica l rev iew 05/2020Approved by ODM on 6/23/2025 .
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 H. References ………………………….. ………………………….. ………………………….. ……………………. 3 Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPeripheral Nerve Stimulators for Treatment of Pain B. BackgroundThe role of peripheral nerves as sources of pain and avenues of treatment when conservative therapy has failed is being more extensively explored than in previous years. Neuromodulation of peripheral nerves to treat refractory pain is one such area of interest. The neuromodulation of peri pheral nerves to reduce pain, known as peripheral nerve stimulation (PNS), has been developed as a minimally invasive pain management modality intended to manage acute and chronic pain. The proposed mechanism of action, referred to as the gate control theory, involves a method by which stimulation of large-diameter sensory neurons reduces transmission ofpainful stimuli from small nociceptive fibers to the brain. The stimulation system is placed adjacent to the nerve, a process commonly known as remote selective targeting. The lead is connected to a small, wearable stimulator. Depending on the device, the wearer may be able to adjust the level of stimulation using Bluetooth technology. C. DefinitionsAcute Pain Pain lasting 4 weeks or less. Chronic Pain A distressing feeling often caused by intense or damaging stimuli (pain) lasting more than 3 months, which is considered beyond normal healing time. Conservative Therapy A multimodality plan of care for treating pain non – surgically, including active and inactive conservative therapies. o Active A type of action or activity to strengthen supporting muscle groups and target key spinal structures, including physical therapy, occupational therapy, a physician-supervised home exercise program (HEP), and/or chiropractic care. o Inactive Lack of activity on behalf of the patient that aids in treating symptoms associated with pain but not necessarily the underlying source, including rest, ice, heat, medical devices, acupuncture, and/or prescription medications. Minimally Invasive Procedures involving entry into the living body through a small incision to lessen recovery time, level of pain, and risk of infection . Sub-Acute Pain Pain lasting between 4 and 12 weeks. D. PolicyI. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. Peripheral nerve stimulators are considered experimental and investigational and are unproven for all indications for the reduction of acute, sub-acute, and chronic pain.Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 III. Peripheral nerve stimulators are not covered. This includes, but is not limited to:A. IB-Stim B. SPRINT PNS System C. Nalu Neurostimulation System D. StimRouter Neuromodulation System E. Moventis PNS F. StimQ PNS System E. Conditions of CoverageN/A F. Related Policies/RulesMedical Necessity Determinations Experimental and /or Investigational Item or Service G. Review/Revision HistoryDATE ACTIONDate Issued 10/01/2022Date Revised 07/29/2022 02/15/202301/17/202406/05/2024 05/07/2025 Converted from administrative policy (AD-1201) to medical policy. Annual review. Updated definitions. Annual review : references updated ; approved at Committee. Revised Background, added D. III. A. Approved at Committee Annual review-references updated , approved at Committee. Date Effective 08/01/2025 Date Archived H. References1. Abd-Elsayed A, Keith MK, Cao NN, Fiala KJ, Martens JM. Temporary peripheral nerve stimulation as treatment for chronic pain. Pain Ther . 2023;12(6):1415-1426. doi:10.1007/s40122-023-00557-3 2. Albright-Trainer B, Phan T, Trainer RJ, et al. Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial. Pain Manage . 2022;12(3):357-369. doi:10.2217/pmt-2021-0087 3. Char S, Jin MY, Francio VT, et al. Implantable peripheral nerve stimulation for peripheral neuropathic pain: a systematic review of prospective studies. Biomed . 2022;10(10)2606. doi:10.3390/biomedicines10102606 4. DSouza RS, Jin MY, Abd-Elsayed A. Peripheral nerve stimulation for low back pain: a systematic review. Curr Pain Headache Rep . 2023;27:117-128. doi:10.1007/s11916-023-01109-2 5. Evidence Analysis Research Brief: Peripheral Nerve Stimulation for the Treatment of Superior Cluneal Neuralgia. Hayes; 2024. Accessed April 10, 2024. www.evidence.hayesinc.com Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 6. Evolving Evidence Review: IB-Stim (NeurAxis) for Treatment of Pain Associated withIrritable Bowel Syndrome in Adolescents. Hayes; 2022. Reviewed July 17 , 202 4. Accessed April 10 , 202 5. www.evidence.hayesinc.com 7. Evolving Evidence Review: SPRINT PNS System (SPR Therapeutics) for Chronic Pain. Hayes; 2021. Updated February 27, 2025 . Accessed April 10, 2025 . www.evidence.hayesinc.com 8. Hatheway J, Hersel A, Song J, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial. Reg Anesth Pain Med . 2024 ;0:1-7. doi:10.1136/rapm-2023-105264 9. Health Technology Assessment: Percutaneous Peripheral Nerve Stimulation for Treatment of Chronic Pain. Hayes; 2022. Reviewed May 8, 2024 . Accessed April 10, 2025 . www.evidence.hayesinc.com 10. Health Technology Assessment: Peripheral Nerve Field Stimulation for Treatment of Chronic Low Back Pain. Hayes; 2021. Reviewed April 17, 2024. Accessed April 10, 2025. www.evidence.hayesinc.com 11. Helm S, Shirsat N, Calodney A, et al. Peripheral nerve stimulation for chronic pain: a systematic review of effectiveness and safety. Pain Ther . 2021;10(2):985-1002. doi:10.1007/s40122-021-00306-4 12. Huntoon MA, Slavin KV, Hagedorn JM, et al. A retrospective review of real-world outcomes following 60-day peripheral nerve stimulation for the treatment of chronic pain. Pain Physician . 2023;26(3):273-281. Accessed April 10, 2025. www.painphysicianjournal.com 13. Kaye AD, Ridgell S, Alpaugh ES, et al. Peripheral nerve stimulation: a review of techniques and clinical efficacy. Pain Ther . 2021;10(2):961-972. doi:10.1007/s40122 – 021-00298-1 14. Li AH, Gulati A, Leong MS, et al. Considerations in permanent implantation of peripheral nerve stimulation (PNS) for chronic neuropathic pain. an international cross-sectional survey of implanters. Pain Pract . 2022;22(5):508-515. doi:10.1111/papr.13105 15. Luna D, Hettie G, Pirrotta L, et al. Real-world long-term outcomes of peripheral nerve stimulation: a prospective observational study. Pain Manag . 2025 ;15(1):37-44. doi: 10.1080/17581869.2025.2451605 16. McCullough M, Kenney D, Curtin C, et al. Peripheral nerve stimulation for saphenous neuralgia. Reg Anesth Pain Med . 2024;49(6):455-460. doi:10.1136/rapm-2023 – 104538 17. Smith BJ, Twohey EE, Dean KP, DSouza RS. Peripheral nerve stimulation for the treatment of postamputation pain: a systematic review. Am JPhys Med Rehabil . 2023;102(9):846-854. doi:10.1097/PHM.0000000000002237 18. Strand N, DSouza RS, Hagedorn JM. Evidence-based clinical guidelines from the American Society of Pain and Neuroscience for the use of implantable peripheral nerve stimulation in the treatment of chronic pain. JPain Res . 2022;15:2483-2504. doi:10.2147/JPR.S362204 Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 19. Vangeison CT, Bintrim DJ, Saha AK, et al. The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. Pain Manag . 2023;13(4):213-218. doi:10.2217/pmt-2023-0025 20. West T, Hussain N, Bhatia A, et al. Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: a 2-year multicenter analysis. Reg Anesth Pain Med . 2024. doi:10.1136/rapm-2024-105704 21. Xu J, Sun Z, Wu J, et al. Peripheral nerve stimulation in pain management: a systematic review. Pain Physician . 2021;24(2):E131-E152. Accessed April 10, 2025 . www.painphysicianjournal.com Approved by ODM on 05/13/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Genetic Testing and Counseling-OH MCD-MM-0003 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Polices/Rules ………………………….. ………………………….. ………………………….. ……… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectGenetic Testing and Counseling B. BackgroundAdvancements in technology have contributed to the rapid expansion of identified genetic variations . Some of these variations have been identified as disease-causing, while others are considered common variants with no clinical impact . With the ev er- expanding number of genetic tests available , it can be clinically difficult to determine the most appropriate tests for a particular patient. When clinically appropriate, genetic testing may provide diagnostic and/or actionable therapeutic results which can impact a patients outcome. Due to the complexity of genetic tests and th eir results , consultation with m edical genetics professionals and counselors may be required to assist members. According to the National Society of Genetic Counselors of the United States, genetic counseling is meant to integrate the following goals: 1) interpretation of family and medical histories to assess the chance of disease occurrence or recurrence; 2) education about the natural history of the condition, inheritance pattern, testing,management, prevention, support resources, and research; 3) counseling to promote informed choices in view of risk assessment, family goals, ethical and religious values; and 4) support to encourage the best possible adjustment to the disorder in an affected family member and/or to the risk of recurrence of that disorder. Genetic counselors are healthcare professionals trained to provide this care ; however , access issues may require other healthcare professionals to assume this role. Genetic counseling , whether provided by a certified genetic counselor or other qualified healthcare professional, is an integral component of genetic testing that is informative and supportive to memb ers, both before and after they undergo testing. C. Definitions Genetic Screening Th e process of testing a population for a genetic disease to identify a subgroup of people who either have the disease or the potential to pass it to offspring. Genetic Testing A medical test that identifies changes in genes, chromosomes, or proteins to confirm or rule out a suspected genetic condition , either hereditary or acquired. Human Leukocyte Antigen (HLA) Typing A test used to match patients and donors for bone marrow or cord blood transplants. Inherited Genetic Variant A type of DNA sequence change passed from parent to offspring (ie, germline). Precision Medicine A field of medicine that selects pharmacotherapies based on the patients genetics. Somatic Gene Variant A type of DNA sequence change that is not inherited from a parent but acquired during a persons life. Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. Prior authorization may be required for genetic testing . This includes both somatic and germline genetic testing. II. CareSource will review for medical neces sity using published MCG criteria whenavailable and the Medical Necessity Determinations administrative policy . This policy does not apply to requests that have MCG guidelines with clear genetic counseling requirements/recommendations. III. Proprietary panel testing requires evidence-based documentation per the MedicalNecessity Determinations administrative policy. Individual genetic tests may be requested separately based on the Medical Necessity Determinations administrati ve policy for panels not meeting medical necessity requirements. IV. Genetic counseling is required for all germline genetic testing , as indicated by ALLthe following: A. Counseling is provided by a healthcare professional with education and training in genetic issues relevant to the genetic tests under consideration . B. Counseling is provided to enable members informed decision making concerning proposed testing (eg, purpose of testing, management that may be informed by result, heritable nature informed by 3-generation family history, range of possible results, potentia l benefits and risks of testing (eg, psychological, social, economic). V. Somatic genetic testing (eg, cancer testing) does not require genetic counseling described above. VI. Human leukocyte antigen (H LA ) typing is not part of the genetic testing policy and do es not require pre-authorization. VII. W hile most inherited genetic testing is only necessary on ce in a lifetime, CareSource recognizes that a germline genetic test could be appropriately repeated in extraordinary circumstances due to changes in technology. This situation will be considered with the proper medical necessity documentation. E. Conditions of CoverageNAF. Related Polices/RulesMedical Necessity Determinations Cystic Fibrosis Testing Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision HistoryDATE ACTIONDate Issued 02/24/2015 New PolicyDate Revised 06/05/2019 09/03/2020 07/07/2021 05/25/2022 05/10 /202304/10/202407/03/2024 04/23 /2025Revised title, removed MCG table, condensed backgroundReviewed, updated referencesAnnual review: updated definitions, background, and references, re-organized criteria Annual review: updated background, definitions, and references , rephrased genetic counseling process. Approved at Committee. Review: updated references, approved at Committee Review: clarified genetic counseling requirements, added language regarding MCG. Approved at Committee Review: updated references, approved at Committee. Date Effective 08/01/2025 Date Archived H. References1. Ambulatory care : genetic medicine. MCG Health . 28 th ed. Accessed April 8, 2025 . www.careweb.careguidelines.com 2. Cohen SA, Bradbury A, Henderson V, et al. Genetic counseling and testing in a community setting: quality, access, and efficiency. Am Soc Clin Oncol Educ Book . 2019;e34-e44. doi:10.1200/EDBK_238937 3. Crooke A, Jacobs C, Newton-John T, et al. Genetic counseling and testing practices for late-onset neurodegenerative disease: a systematic review. JNeurol. 2022;269(2):676-692. doi:10.1007/s00415-021-10461-5 4. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Updated July 22, 2024 . Accessed April 8, 2025 . www.uptodate.com 5. Mundy J, Davies HL, Radu M, et al. Research priorities in psychiatric genetic counselling: how to talk to children and adolescents about genetics and psychiatric disorders. Eur JHum Genet . 2023;31(3):262-264. doi:10.1038/s41431-022-01253-0 6. National Center for Biotechnology Information (NCBI). Genetic Testing Registry (GTR) National Library of Medicine. Accessed April 8, 2025 . www.ncbi.nlm.nih.gov 7. National Human Genome Research Institute. Coverage and Reimbursement of Genetic Tests. National Institutes of Health. Updated February 6, 2024 . Accessed April 8, 2025 . www.genome.gov 8. National Human Genome Research Institute. Regulation of Genetic Tests. National Institutes of Health. Updated February 19, 2024 . Accessed April 8, 2025 . www.genome.gov 9. Raby BA, Kohlmann W. Genetic counseling: family history interpretation and risk assessment. UpToDate. Updated April 9 , 2024. Accessed April 8, 2025 . www.uptodate.com Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 10. Sarata AK. Genetic Testing: Background and Policy Issues . Congressional ResearchService Report ; 2015 . RL33832. Accessed April 8, 2025 . www.sgp.fas.org 11. Senter L, Austin JC, Carey M, et al. Advancing the genetic counseling profession through research: identification of priorities by the National Society of Genetic Counselors research task force. JGenet Couns. 2020;29(6):884-887. doi:10.1002/jgc4.1330 12. White S, Jacobs C, Phillips J. Mainstreaming genetics and genomics: a systematic review of the barriers and facilitators for nurses and physicians in secondary and tertiary care. Genet Med. 2020;22(7):1149-1155. doi:10.1038/s41436-020-0785-6 Approved by ODM 05/13/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 07/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standar ds, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………….. ………………………….. ………………………….. ……………………. 2 B. Background ………………………….. ………………………….. ………………………….. ……………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………… 4 D. Policy ………………………….. ………………………….. ………………………….. ………………………. 5 E. Conditions Of Coverage ………………………….. ………………………….. ………………………… 13 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. 14 G. Review/Revision History ………………………….. ………………………….. ……………………….. 15 H. References ………………………….. ………………………….. ………………………….. …………….. 15 Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectApplied Behavior Analysis Therapy for Autism Spectrum Disorder B. BackgroundThe Diagnostic and Statistical Manual of Mental Disorders, 5 th Edition, Text Revised (DSM-5-TR) classifies Autism Spectrum Disorder (ASD) as a neurodevelopmental disorder var ies widely in severity and symptoms, depending on the developmental level and chronological age of the individual . ASD is characterized by specific developmental deficits that affect socialization, communication, academic and personal functioning . Individuals are typically diagnosed before entering grade school, and symptoms are noticed acr oss multiple contexts, including social reciprocity, nonverbal communicative behaviors, and skills in developing, maintaining and understanding relationships. Restricted, repetitive patterns of behavior, interests or activities are also often present. Currently, th ere is no cure for ASD, nor is there any single treatment for the disorder.The diagnosis may be managed through a combination of therapies, including behavioral, cognitive, pharmacological, and educational interventions with a goal of minimiz ing the severity of ASD symptoms, maximiz ing learning, facilitat ing social integration, and improv ing quality of life for the member and fami ly/caregiver (s). Applied behavior analysis (ABA), one such therapy, may be provided in centers or at home and provi des an evidence-ba se d practice for the treatment of ASD. ABA is based on the science of behavior, which was founded on the premise that understanding behavior functioning, how it is affected by the environment, and how learning to change behavior can improve the human condition. It is a flexible treatment in tha t it should always be adapted to the needs of each individual, teaches skills that areuseful and generalizable, and involves individual, group and family training. Qualified and trained practitioners provide and/or oversee ABA programs and are accountable to state boards for registration, certification, or licensure requirements. Clinical decisions on telehealth service delivery models should be selected based on the individual needs, strengths, preference of service modality, caregiver availability , and environmental support available. CareSource follows the Ohio Administrative Code (OAC) and Ohio Department of Medicaid (ODM) guidelines in the provision of ABA services, based on a diagnosis from the DSM-5-TR . Severity levels are divided into 2 domains, social communication and restricted, repetitive behaviors: Severity Levels for Autism Spectrum DisorderSeverity Level Social Communication Restricted, repetitive behaviors Level 3 Requiring very substantial support Severe deficits in verbal & nonverbal social communication skills cause severe impa irments in functioning, very limited initiation of social interactions, Inflexibility of behavior, extreme difficulty coping with change, or other restricted/ repetitive behaviors markedly interfere with functioning in all spheres. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 and minimal response to social overtures from others. Great distress/difficulty changing focus or action. Level 2 Requiring substantial support Marked deficits in verbal and nonverbal social communication skills, social impairments apparent even with supports in place, limited initiation of social interactions, and reduced or abnormal responses to social overtures from others. Inflexibility of behavior, difficulty coping with change, or other restricted/ repetitive behaviors appear frequently enough to be obvious to the casual observer and interfere with functioning in a variety of contexts. Distress and/or difficulty changing f ocus or action. Level 1 Requiring support Without supports in place, deficits in social communication cause noticeable impairments. Difficulty initiating social interactions and clear examples of atypical or unsuccessful responses to social overtur es of others. May appear to have decreased interest in social interactions. Inflexibility of behavior causes significant interference with functioning in one or more contexts. Difficulty switching between activities. Problems of organization and planning hamper independence. Social skills instruction is an important component of management of the diagnosis.Although additional studies are necessary, a 2012 meta-analysis of five randomized trials (196 participants) found evidence that participation in social skills groups improved overall social competence and friendship quality in the short term. A 2020 study demonstrated efficacy of a modified group cognitive behavioral therapy program in children delivered in a community context. A 2021 study demonstrated benefits of group cognitive behavioral treatment in adolescents diagnosed with autism and intellectual disabilities. As children near entry in a public or private school system, research supports the use of group therapy for school readiness and improved social skills. Training must be an integral component of the management of the underlying disorder and in clude clearly defined goals, teach desired behaviors, provide prompting for natural display of desired behaviors, provide reinforcement of demonstrated behaviors, and include practice of desired behaviors with goals of generalizability outside the therapeu tic setting (eg, impairments in social-emotional reciprocity, restrictive or obsessional interests, aggressive behaviors). As the child becomes eligible for school-based services (the age varies depending uponthe state), the public school system becomes responsible for the provision of services and education. The services provided are outlined in an individualized education program (IEP), which is reviewed at a minimum of once a year, for children eligible. ASD services do not include education services otherwise available through a program funded under 20 US Code Chapter 3, section 1400 of the Individuals with Disabilities Ed ucation Act (IDEA). Congress reauthorized the IDEA in 2004 and most recently amended the IDEA through Public Law 114-95, Every Student Succeeds Act, in December 2015 Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 C. Definitions Applied Behavior Analysis (ABA ) The design, implementation, and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvement in human behavior, including the use of direct observation, measurement, and functional analysis of the relationship between environment and behavior. Caregiver/Family Trainin g Therapist teaches parents/caregivers to implement methods utilized in a clinical setting i nto other environments, such as the home or community, to maximize member outcomes by furthering the generalization of skills and reinforcing methods being taught to the member in other sessions. Functional Assessment The determination of underlying function or purpose of behavior to develop an effective treatment plan, including a variety of systematic, information gathering techniques regarding factors influencing behavior occurrence (eg, antecedents, consequences, s etting events and motivating operations), such as interview, indirect assessment, direct observation, descriptive assessment, experimental analysis, and systematic manipulation of environmental variables to demonstrate a relationship between an event and t argeted behavior. Independent Practitioner All ABA services must be provided by a provider/practitioner compliant with Ohio Revised Code 4783.02 with approved supervision, as applicable , including the following (not an all-inclusive list): o Board Certified Assistant Behavior Analyst (BCaBA) o Certified Ohio Behavioral Analyst (COBA) or Board-Certified Behavior Analyst (BCBA) o Board Certified Behavior Analyst – Doctoral (BCBA-D) o Registered Behavior Technician (RBT) Medically Unlikely Edit (MUE) Maximum units of service for 1 Current Procedural Terminology (CPT) code a provider can report for 1 member on 1 date of service. Standardized Diagnostic Assessment Tool s Direct assessment, e vidence – based tools designed to assist with identification of symptoms and criteria for a diagnosis or disorder. SMART Goal s Goals that are specific (S) , measurable (M) , attainable (A) , relevant (R) , and time-bound (T) . Supervisio n Directing, guiding, training , and assessing individuals who provide behavior-analytic services with responsibilities in accordance with the board from which the practitioner received a license. o BCaBAs ervices must be supervised by a COBA/ BCBA, BCBA-D, or a licensed psychologist who has tested in ABA and is certified by the American Board of Professional Psychology in Behavioral and Cognitive Psychology . Treatment Plan A written document describing presenting behavior problem(s) and behavioral goals and interventions selected to alter behavior based on information gathered from in-person assessments, review of records from other professionals, direct observation, and clinical interview data, including an estimate of the length of time and/or number of sessions anticipated to achieve goals and specific statements about the measurement of progress toward achieving goals. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 D. PolicyI. General Guidelines A. Medical necessity review is required for all ABA services initially with a baseline and then, again, every 6 months. Medical review must be submitted with appropriate documentation as indicated in this policy and align with the States definition of medical necessity that includes that treatment is not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results. B. ABA therapy should begin early in life, ideally by the age of 2, typically lasting up to 3 to 4 years and is subject to the members response to treatment. C. Members under the age of 21 will be assessed. Treatment goals and intensity will be based on individual needs and progress in treatment with a focus on remediation of symptoms. D. The members treatment record (eg, plans of care, treatment plans, behavior support plans, functional assessments ) must be completed by the provider or practitioner and submitted to CareSource prior to claim submission. Claims will not be accepted without accompanying treatment documentation. II. Initia tion of ABA ServicesA. Documentation: CareSource must receive documentation that confirms the following medical criteria: 1. definitive, primary diagnosis of ASD made by one of the following practitioner s upon evaluation : a. child and adolescent psychiatrist b. psychologist c. child neurologist d. developmental pediatrician 2. standardized diagnostic assessment tools that are considered multidisciplinary evaluations, including a. Autism Diagnostic Observation Schedule (ADOS) b. Autism Diagnostic Interview Revised (ADI-R) c. Childhood Autism Rating Scale, 2 nd edit. (CARS-2) 3. written documentation ( eg, provider letter ) that d escri bes DSM clinical symptoms present within the past year requir ing treatment if the submitted diagnostic evaluation was completed more than 24 months from date of request B. Initial Behavior Assessment: Before services are provided, an initial behavior identification assessment will be performed by a fully credentialed BCBA with state licensure, if available, and devel op a treatment plan. Generally, b ehavioral assessments are not to exceed 6-10 hours every 6 months , unless additional justification is provided. C. Initial Treatment Plan: An initial ABA treatment plan individualized to the caregiver/family needs, values, priorities and circumstances for member goals and parent/caregiver training will be developed by the member, family/caregiver, and provide r and m ust include the following: Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 1. biopsychosocial information, including, but not limited to:a. current family structure b. medication history, including dosage and prescribing physician c. medical history d. school placement and hours in school per week, including homeschool instruction and any individualized education plans (IEP) e. history of ABA services, including service dates and progress notes f. all behavioral health diagn oses and services, including any hospitalizations g. other services member is receiving (eg, speech therapy [ST] , occupational therapy [OT], physical therapy [PT]) , including evidence of coordination with other disciplines involved in the assessment h. caregiver proficiency and involvement in treatment i. any major life changes 2. rationale for ABA services (eg, how ABA addresses current areas of need ), including the following : a. history with symptom intensity and symptom duration, including how symptoms affect the members ability to function in various settings b. evidence of previous therapy ( eg, outcomes from previous ABA treatment, ST, OT, PT) and how result s influence proposed treatment c. type, duration, frequency for services 3. goals related to core deficits ( eg, communication problems, relationship development, social and problem behaviors) must includ e the following: a. outcome driven , performance-based, and individualized measures focused on targeted symptoms, behaviors, and functional impairments b. based on the direct behavioral assessment and a standardized developmental and functional skills assessment/curriculum ( eg, Verbal Behavior Milestones Assessment and Placement Program [VB-MAPP ], Assessment of Basic Language and Learning Skills [ABLLS-R]). c. a description of treatment activities and documentation of active participation by member and caregiver/family in the implementation of treatment OR documentation detailing barriers to family/ caregiver participation and how those barriers are being actively addressed d. SMART goals that define how improvement will be noted, frequency of treatment (number of hours per week), and duration of treatment 4. Behavioral Intervention Plan and/or a Plan of Care (POC) 5. requested number of ABA hours per week based on the members specific needs , not on a general program structure , as evidenced by all of the following: a. Treatment is provided at the lowest level of intensity appropriate to the members clinical needs and goals with the number of hours requested reflecting the actual number of hours intended to be provided . b. A d etailed description of problems, goals and interventions support the requested intensity of treatment . Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 6. a plan to modify the intensity and duration of treatment over time based on the members progress, including an individualized discharge plan specific to treatment needs7. coordination with other behavioral health and medical providers III. Continuation of ABARequests for continuation of ABA services are to be submitted every 6 months, and documentation must meet EITHER of the following criteria: A. A d efinitive diagnosis of ASD persists , and m ember continues to demonstrate ASD symptoms that will benefit from treatment in at least 2 set tings . B. A t reatment plan as noted in D. II. C., including the following: 1. an updated progress report with assessment scores that note improvement and member response to treatment from baseline targeted symptoms, behaviors, and functional impairments using the same modes of measurement utilized for baseline measurements 2. a plan to transition services in intensity over time C. Parent/caregiver(s) are involved and making progress in development of behavioral interventions. OR D. When requesting continuation with inadequate progress on targeted symptoms or behaviors or no demonstrable progress within a 6-month period, an assessment of the reasons for lack of progress should be documented and provided. Treatment interventions should be modified to achieve adequate progress. Documentation should include 1. change in possible treatment techniques 2. increased parent/caregiver training 3. increased time and/or frequency working on specific targets 4. identification and resolution of barriers to treatment efficacy 5. any newly identified co-existing disorders and possible treatment 6. modified or removed goals and interventions IV. Discontinuation of ABA TherapyTitration or discontinuation of ABA therapy should occur when any of the following conditions are met (not an all-inclusive list): A. Treatment ceases to produce significant meaningful progress or maximum benefit has been reached . B. Member behavior does not demonstrate meaningful progress for two successive 6-month authorization periods as demonstrated via standardized assessments. C. ABA therapy worsens symptoms, behaviors or impairments. D. Symptoms stabilize allowing member to transition to less intensive treatment or level of care. E. Parents/caregivers have refused treatment recommendations, are unable to participate in the treatment program, and/or do not follow through on treatment recommendations to an extent that compromises the effectiveness of the services for member progress. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 V. Parent/ Caregiver TrainingTraining will evolve as goals are met . Parent/caregiver should be actively working on at least 1 unmet goal . ABA services must include documentation of the following: A. understand ing and agree ment to comply with the requirements of treatment B. how the parents/caregivers will be trained in skills that can be generalized to the home and other environments C. methods by which the parents/caregivers will demonstrate trained skills D. barriers to parent involvement and plans to address (eg, are treatment goals addressed when treatment professionals are not present , overall skill abilities ) E. time involvement, including materials or meetings occurring on a routine basis VI. TelehealthParent/caregiver training and supervision may be provided by telehealth . 1:1 ABA services may be provided via telehealth in instances deemed medically necessary with supporting documentation that provides a plan for the provision of service delivery. Providers utilizing telehealth for the delivery of services must make decisions that are consistent with best, currently available evidence and clinical consensus. Clinical rationale must consider assessed needs, strengths, preferences, and available resou rces of members and caregivers. The same professional ethics governing in-person care must be followed and limitations considered, including interstate licensure challenges, state regulatory issues, member or caregiver discomfort with technology, technolog y limitations, and cultural acceptance of virtual visits. Providers must identify protocols for clinical appropriateness (eg, risk assessment, safety planning, patient/caregiver characteristics), ensure therapeutic benefit for recipients, and ensure provid er competence of delivering care via telehealth modalities. Peer reviewed studies and other best evidence literature provides guidance on appropriate screeners and questionnaires for use in the determination of appropriateness of telehealth services for pa rticular clients. VII. Documentation RequirementsThe State of Ohio enacts code related to requirements for documentation expectations for client records maintained for third party billing. Each dated entry in the professional record is maintained for a period of not less than 7 years after the last date of service or not less than the length of time required by other regulations if longer. Records documenting services rendered to minors must be retained for not less than 2 years after the minor reaches the age of majority or for 7 years after the last da te of service, whichever is longer. All written, electronic and other records will be stored and disposed of in such a manner as to ensure confidentiality . All must be legible . A. Minimum documentation requirements for ABA client records include the following: 1. presenting problem, including any relevant diagnosis and any recommendation for ABA services rendered by a licensed professional Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 2. date(s) and purpose of each service contact (eg, service note)3. treatment plan and functional assessment on which behavior plan is based 4. data collected to ascertain efficacy of ABA and any subsequent modifications of the plan 5. notation and results of formal contacts with other providers 6. authorizations, if any, by the client for release of records or information B. Minimum documentation requirements for all service s rendered include 1. name of provider organization clearly visible on the record 2. members name on each page (ie, legal name) with date of birth or unique identifier 3. start and stop times of the session , including any pauses in services (must indicate time paused and time resumed) 4. date and location of rendered service and date of note creation if different from date of rendered service 5. type/ code of service provided 6. provider rendering the service with appropriate credentials and dated signature 7. identification of others present, including the relationship to the member and number of individuals participating in group sessions 8. interventions occurring during the session that directly relate to the POC and client response to interventions 9. any needed modifications to treatment or items requiring follow up from previous sessions , including any addendums to the record VIII. Codes of ConductCodes of conduct exist to meet credentialing needs of professionals but also function to protect members by establishing, disseminating, and managing professional standards. Ohio mandates that providers of ABA services understand and follow codes of conduct supporting the profession. CareSource supports professional standards established by licensing and credentialing bodies, and therefore, encourages professional compliance to any and all standards across disciplines for the protection of members and famil ies. The ethics code written by the Behavior Analyst Certificat ion Board includes the following standards (not all-inclusive): A. Family oversight must occur by/with the BCBA or BCaBA. An RBT may be present during a family training session to provide assistance with interventions, but the training or supervision of interventions cannot be completed by the RBT. B. Providers will create a contract for consent to services ( eg, Declaration of Professional Practices and Procedures) at the onset of services that defines and documents, in writing, the professional role with relevant parties. C. Appropriate effort will be made to involve members and stakeholders in treatment, including selecting goals, designing assessments and interventions, and conducting continual progress monitoring. D. Providers will identify and address environmental conditions ( eg, behavior of others, hazards to client or staff) that may interfere with service delivery, Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 including the identification of effective modifications to interventions and appropriate documentation of conditions, actions taken, and eventual outcomes.E. Continuity of services will be facilitated to avoid interruption or disruption of services for members, including documentation of actions taken and eventual outcomes. F. Providers will address any possible circumstances when relevant stakeholders are not complying with the behavior-change intervention(s) despite documented and appropriate efforts to address barriers to treatment. IX. Supervision ExpectationsThe State of Ohio enacts code for supervision requirements and documentation expectations for providers within the profession . The BACB provides guidelines for supervision requirements and documentation expectations for providers within the profession. If there are discrepancies with supervision documentation, the associated claims are subject to recoupment. A. At a minimum, supervision must include the following activities : 1. consultation with the supervisee(s) prior to initiation of the treatment plan 2. training regarding implementation of the treatment plan, data collection regarding effectiveness, and measurement of client progress 3. consultation with the supervisee(s) prior to modification of the treatment plan 4. periodic direct observation of each supervisee implementing assessment and treatment procedures with clients, including performance evaluation and additional instruction as necessary B. Record Maintenance Supervision records will be maintained by certified Ohio behavior analysts for a period of 5 years , BCBAs /RBTs for 7 years , following the termination of supervision, which include the following documents , at a minimum: 1. supervision plans for each client treatment plan 2. dates of training on treatment plans, procedures, and interventions 3. supervision provided when treatment plans are reviewed or modified C. General supervision documentation records must include the following information (not an all-inclusive list) : 1. date and start/stop time s of supervision session 2. names, credentials and/or relationship of individuals present at each session 3. type of supervision (general or direct) 4. purpose of supervision, including any collaborati on of care among providers 5. outcome of supervision, including any modification to treatment inventions or plans of care, including the following information: a. review of services provided b. review of data forming basis of a continued treatment plan c. review of client progress, including results of tools noting progress 6. name and credentials of the supervisor (if documenting for billing purposes, the supervisors National Provider Identifier), included dated signature 7. dated signature of supervisee, including credentials Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 D. The BACB outlines the following minimum provisions for supervision documentation:1. RBTs must document the following during supervision (not all-inclusive): a. days and times behavior-analytic services were provided b. dates and duration of supervision c. supervision format (individual, group) d. dates of direct observation e. names of supervisors providing supervision f. noncertified RBT supervisor form, if applicable g. proof of supervisors relationship to the client h. additional documentation in the event of discrepant records (session notes) 2. Supervisors must document the following for any supervision hours conducted (not an all-inclusive list): a. date with start and stop times b. fie ldwork type c. supervision type (group, individual) d. activity category (restricted or unrestricted) e. summary of supervision activity, including 01. discussion of activities completed during independent hours and any feedback provided 02. progress toward individual member goals 03. outcome of supervision, including any modification to treatment interventions or plans of care 04. collaboration of care among providers f. dated signatures of supervisor and supervisee, including credentials 3. Observations must include the following (at a minimum): a. date with start and stop times b. fieldwork type c. setting name d. supervisor name e. activity category (restricted or unrestricted) E. CareSource supports BACB published ethical codes related to supervision for the provision of services to clients, including, but not limited to 1. Behavior analysts (BA) are knowledgeable about and comply with all applicable supervisory requirements, funder and organization policies), including those related to supervision modalities and structure. 2. BAs supervise and train others only within an individual identified scope of competence. 3. BAs take on only the number of supervisees allowing effective supervision and training. When a threshold volume for providing effective supervision has been met, documentation of this self-assessment and communication of results to employer(s) and rel evant parties must occur. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 4. BAs are accountable for supervisory practices and professional activities(eg, client services, supervision, training, research activity, public statements) of supervisees occurring as part of that relationship. 5. BAs ensure that documentation, and the documentation of supervisees or trainees, is accurate and complete. 6. BAs deliver supervision and training in compliance with applicable requirements (eg, BACB rules, licensure requirements, funder and organization policies) and design and implement supervision and training procedures that are evidence based, focus on p ositive reinforcement, and are individualized for each supervisee and circumstances. 7. BAs actively engage in continual evaluation of supervisory practices using feedback from others and client and supervisee outcomes. Self – evaluations are documented and timely adjustments made to supervisory and training practices as indicated. X. Special Provisions Related to RBTsA. Current Standards for RBTs 1. RBT services must be supervised by a qualified RBT supervisor. RBTs must obtain ongoing supervision for a minimum of 5% of the hours spent providing ABA services per month. Additionally, the BACB publishes information regarding the structure of supervision and parameters for group and individual supervision in the RBT Handbook. 2. An RBT who is certified by the BACB may provide ABA under the supervision of an independent practitioner if enrolled in the Medicaid program and affiliated with the organization under which the provider is employed or contracted. If the independent practitioner leaves the affiliated organization and no longer provides supervision, the RBT may not continue to provide services under that independent practitioner . Additionally, if the RBT leaves the affiliated organization and no longer receives mandated supervision, the RBT may not continue to provide services to the member. 3. RBTs must use appropriate modifiers that indicate qualifications of staff delivering services , if appropriate. B. Upcoming RBT Changes from the Behavior Analyst Certification Board 1. Effective January 1, 2026: In the interest of consumer protection, the BACB Board of Directors approved a recommendation that RBT supervisors must hold BCBA or BCaBA certification. Noncertified supervisors will not be allowed to provide BACB-required supervision to RBTs. During this transition, RBT Requirements Coordinators who currently attest to the qualifications of noncertified supervisors should make preparations to ensure continuity of care for clients. 2. Effective January 1, 2026: New rules regarding e ligibility for and maintenance of certification for RBTs were adopted by the BACB Board of Directors and can be located in the BACB Newsletter: December 2023 at www.bacb.com. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.13 XI. ExclusionsA. reimbursement for the following services or activities is not permitted: 1. any services not documented in the treatment pla n 2. behavioral methods or modes considered experimental 3. education-related services or activities described under Individuals with Disabilities Education Improvement Act of 2004, 20 U.S.C. 1400 (IDEA) , amended through Public Law 114-95, the Every Student Succeeds Act 4. vocational services in nature or those available through program s funded under Section 110 of the Rehabilitation Act of 1973 5. components of adult day care programs B. treatment solely for the benefit of the family, caregiver , or therapist C. treatment focused on recreational or educational outcomes D. treatment worsening symptoms or prompting member regression E. treatment for sy mptoms and behaviors not part of core symptoms of ASD ( eg, impulsivity due to ADHD, reading difficulties due to learning disabilities, excessive worry due to an anxiety disorder) F. goals focused on academic targets ( eg, treatment should address autistic symptoms impeding deficits in the home environment , such as reduc tion of frequency of self-stimulatory behavior to follow through with toilet training or complet ing a mathematic sorting task) G. treatment unexpected to cause measurable , functional improvement or improvement is not documented H. duplicative t herapy services addressing the same behavioral goals using the same techniques as the treatment plan, including services under an IEP I. services provided by family or household members J. care primarily custodial in nature and not requir ing trained/professional ABA staff K. shadowing, para-professional, or companion services in any setting L. personal training or life coaching M. services more costly than an alternative service(s), which are as likely to produce equivalent diagnostic or therapeutic results for the member N. any program or service performed in nonconventional settings, even if performed by a licensed provider ( eg, spas/resorts, vocational or recreational settings, Outward Bound, wilderness, camp or ranch programs) E. Conditions Of CoverageI. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis, subsequent medical review audits, recovery of overpayments identified, and provider prepayment review. Program Integrity will be engaged for an annual review of data. II. When a member has other insurance, Medicaid is always the pay er of last resort.CareSource will not pay more than the Medicaid rate totals for service. Primary payer must provide evidence of determinations for consideration of Medicaid coverage for services. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.14 III. CareSource reserves the right to request supervision documentation, particularly related to telehealth services.IV. Providers cannot submit multiple dates of service on a single claim line. Each claim line must be specific to a single date of service and the units provided on that single date of service.V. CareSource complies with the Centers for Medicare and Medicaid Services (CMS)medically unlikely edit (MUE) table. If CMS updates the MUE list, the update will take precedence over this policy. The following applies to ABA CPTs: CPT Max imum Unit s Allowed 97151 32 97152 16 97153 32 97154 18 97155 24 97156 16 97157 16 97158 16 0362T 16 0373T 32 VI. Treatment codes are based on daily total units of service in 15-minute increments. A unit of time is att ained when the mid-point is passed. The following are time interval examples: Unit (s) Number of Minutes 1 unit >8-22 minutes 2 units >23 – 37 minutes 3 units >38 – 52 minutes 4 units >53 – 67 minutes 5 units >68 – 82 minutes 6 units >83 – 97 minutes 7 units >98 – 112 minutes 8 units >113 – 127 minutes VII. ODM allows Mental Health Community Behavioral Health Centers (CBHCs), provider type 84, to render and be reimbursed for ABA services using the service code H0036-Community Psychiatric Supportive Treatment (CPST). CareSource strongly encourages CBHCs to use ABA CPT codes outlined above for billing purposes but does accept H0036 when submitted by an appropriately certified CBHC. Expectations of this policy apply to all ABA services , whether billed using ABA CPTcodes or H0036. F. Related Policies/RulesMedical Necessity Determinations Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.15 G. Review/Revision HistoryDATE ACTIONDate Issued 10/04/2018Date Revised 01/27/2020 01/25/202108/04/202103/30/202201/04/202304/ 12 /202303/13 /202409/25/202410/23/202403/26/2025Added program attributes, definitions of provider types and ABA ; title change ; clarified PAd services ; changed NP to healthcare provider trained in ASD ; added IV , willingness to participate , description of p oc, ages ; clarified provider requirements ; added ASD diagnosis, home school /IEP, doc requirements, type of ASD treatment program with PA ; revised continuation of A BA therapy requirements . Added AFLS, ESDM and PEAK-DT assessments & section on ABA transition to school , revised discontinuation criteria & exclusions; removed PA checklist. Clarified telehealt h, moved doc requirements to Medical Records Doc for Practitioners ; re moved transition to school section ; updated school section & RBT supervision ; u pdated definitions & ABA criteria. Removed PA language. III.B.1. Primary diagnosis by a qualified practitioner. Added to section 5. F.02: Removed old section M. to sec. DIII 5.g. added ABA services must include parent/family training . Edited Sec. V. Removed VII. A E-voted ODM changes Sec. B. 1 and 2 Consolidated information into Sec. IV. Initial ABA Treatment Plan. Added Sec. V.J. Pare nt/Caregiver Involvement. Updated references. Reorganized policy & updated definitions. Removed 1:1 telehealth ABA exclusion. Removed I under Exclusions . Annual review. Added VII-X. Merged AD policy info to Cond of Coverage section. Updated H. Approved at Committee. Out of cycle review. Adde d backgroun d, D.I.D, IX.E., E.IV. Updated references. Approved at Committee . Out of cycle review. Removed parent signature as requirement per ODM. Approved at Committee. Removed VII. A.3. and B.7. Approved at Committee. Date Effective 07/01/2025 Date Archived H. References1. 2024 Q2 NCCI MUE Edits-Practitioner Services . Centers for Medicare and Medicaid Services. Accessed September 16 , 2024. www.cms.gov 2. Additional Medicaid Waiver Components for Home and Community-Based Services, OHIO REV . CODE 5166.20 (2016). 3. Anglim M, Conway EV, Barry M, et al. An initial examination of the psychometric properties of the Diagnostic Instrument for Social and Communication Disorders (DISCO-11) in a clinical sample of children with a diagnosis of autism spectrum disorder. Ir JPsychol Med . 2022;39(3):251-260. doi:10.1017/ipm.2020.100 4. Applied Behavior Analysis: B-806-T. MCG. 2 8th ed. Updated March 14 , 202 4. Accessed September 16 , 2024. www.careweb.careguidelines.com 5. Augustyn M. Autism spectrum disorder in children an d adolescents: evaluation and diagnosis. Up ToDate. Updated May 16, 2022. Accessed September 16, 2024 . www.uptodate.com Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.16 6. Augustyn M. Autism spectrum disorder (ASD) in children and adolescents: terminology, epidemiology, and pathogenesis. Up ToDate. Updated January 24,2024. Accessed September 16, 2024 . www.uptodate.com 7. Augustyn M, Von Hahn E. Autism spectrum disorder in children and and adolescents: clinical features. Up ToDate. Updated May 17, 2023. Accessed September 16, 2024 . www.uptodate.com 8. Autism spectrum disorder. American Academy of Pediatrics . Updated April 5, 2023. Accessed September 16, 2024 . www.aap.org 9. Autism spectrum disorder in young children: screening. U.S. Preventive Services Task Force; 2016. Accessed September 16 , 2024. www.uspreventiveservicestaskforce.org 10. Autism Spectrum Disorders: M-7075. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 11. Autism Spectrum Disorders: B-012-HC. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 12. Autism Spectrum Disorders, Adult, Inpatient Care: B-012-IP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 13. Autism Spectrum Disorders, Child or Adolescent: B-019-IP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 14. Autism Spectrum Disorders, Intensive Outpatient Program: B-012-IOP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 15. Autism Spectrum Disorders, Outpatient Care: B-012-AOP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 16. Autism Spectrum Disorders, Partial Hospitalization Program: B-012-PHP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 17. Autism Spectrum Disorders, Residential Care: B-012-RES. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 18. BACB Newsletter . Behavior Analyst Certfication Board; September 2023. Accessed September 16, 2024 . www.bacb.com 19. BACB Newsletter: Introducing the 2026 RBT Examination and Certification Requirements . Behavior Analyst Certification Board; December 2023. Accessed September 16, 2024 . www.bacb.com 20. Bak M, Plavnick J, Dueas A, et al. The use of automated data collection in applied behavior analytic research: a systematic review. Behavior Analysis: Res Practice. 2021;21(4), 376 405. https://doi.org/10.1037/bar0000228 21. Board Certified Behavior Analyst Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed September 16 , 2024. www.bacb.com 22. Board Certified Assistant Behavior Analyst Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed September 16 , 2024. www.bacb.com 23. Buckley A, Hirtz D, Oskoui M, et al; Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Practice guideline: treatment for insomnia an d disrupted sleep behavior in children and Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.17 adolescents with autism spectrum disorder. Neurology . 2020;94(9):392-404. doi:10.1212/WNL0000000000009033 24. Certified Ohio behavior analyst supervision. State of Ohio Board of Psychology. Accessed September 16, 2024 . www.psychology.ohio.gov 25. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems , I: common clinical challenges of patients with mental health or behavioral emergencies. Pediatr. 2016;138(3):e20161570. doi:10.1542/peds.2016-1570 26. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems , II: recognition of clinically challenging mental health related conditions presenting with medical or uncertain symptoms. Pediatr. 2016;138(3):e20161573. doi:10.1542/peds.2016-1573 27. Coverage for Autism Spectrum Disorder, OHIO REV . CODE 1751.84 (2021). 28. Crockett, JL, Fleming RK, Doepke K, et al. Parent training: acquisition and gene ralization of discrete trials teaching skills with parents of children with autism. Res Dev Disabilities . 2007; 28 (1):23-36. doi :10.1016/j.ridd.2005.10.003 29. Ethics Code for Behavior Analysts . Behavior Analyst Certification Board; 2020. Updated January 1, 2023. Accessed September 16 , 2024. www.bacb.com 30. Evidence Analysis Research Brief: Applied Behavior Analysis Training Via Telehealth for Caregivers of Children with Autism Spectrum Disorder . Hayes; 2022. Accessed September 16 , 2024. www.evidence.hayesinc.com 31. Evidence Analysis Research Brief: Direct-To-Patient Applied Behavior Analysis Telehealth for Children with Autism Spectrum Disorder . Hayes; 2022. Accessed September 16 , 2024. www.evidence.hayesinc.com 32. Gonzlez MC, Vsquez M, Hernndez-Chvez M. Autism spectrum disorder: clinical diagnosis and ADOS Test. Rev Chil Pediatr . 2019;90(5):485-491. doi:10.32641/rchped.v90i5.872 33. Health Technology Assessment: Comparative Effectiveness Review of Intensive Behavioral Intervention for Treatment of Autism Spectrum Disorder . Hayes; 2019. Updated February 10, 2022. Accessed September 16 , 2024. www.evidence.hayesinc.com 34. Hyman S, Levy S, Myers S ; Council on Children with Disabilities. Developmental and behavioral pediatrics : identification, evaluation, and management of children with autism spectrum disorder . Pediatr . 2020 ;145(1) :e20193447 . d oi:10.1542/peds.2019 – 3447 35. Information on autism spectrum disorder for healthcare providers. Centers for Disease Control and Prevention (CDC). Updated December 6, 2022. Accessed September 16 , 2024. www.cdc.gov 36. Lebersfeld JB, Swanson M, Clesi CD, et al. Systematic review and meta-analysis of the clinical utility of the ADOS-2 and the ADI-R in diagnosing autism spectrum Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18 disorders in children. JAutism Dev Disord . 2021;51(11):4101-4114. doi:10.1007/s10803-020-04839-z 37. Lefort-Besnard J, Vogeley K, Schilbach L, et al. Patterns of autism symptoms: hidden structure in the ADOS and ADI-R instruments. Transl Psychiatry . 2020;10(1):257. doi:10.1038/s41398-020-00946-8 38. Lim N, Russell-George A. Home-based early behavioral interventions for young children with autism spectrum disorder. Clin Psycho l. 2022;29(4):415-416. doi:10.1037/cps0000117 39. Registered Behavior Technician Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed September 16 , 2024. www.bacb.com 40. Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services; 2024. Publication # 100-04 . Accessed September 16 , 2024. www.cms.gov 41. Sneed L, Little S, Akin-Little A. Evaluating the effectiveness of two models of applied behavior analysis in a community-based setting for children with autism spectrum disorder. Behav Anal: Res Pract . 2023;23(4):238-253. doi:10.1037/bar0000277 42. Society guideline links: autism spectrum disorder. Up ToDate. Accessed September 16 , 2024. www.uptodate.com 43. Standards for Telehealth Services, OHIO REV . CODE 4743.09 (2023). 44. State Board of Psychology-Certified Ohio Behavior Analysts, OHIO ADMIN . CODE 4783-1 to 11 (2023). 45. Volkmar F, Siegel M, Woodbury-Smith M, et al.; American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice parameter for the assessment and treatment of children and adolescents with autism spectrum disorder. JAm Acad Child Adolesc Psychiatry . 2014;53(2):237-57. doi:10.1016/j.jaac.2013.10.013 46. Weissman L. Autism spectrum disorders in children and adolescents: behavioral and educational interventions . Up ToDate. Updated December 4, 2023. Access ed September 16 , 2024. www.uptodate.com 47. Weissman L. Autism spectrum disorder in children and adolescents: overview of management. Up ToDate. Updated September 8, 2023. Accessed September 16 , 2024. www.uptodate.com 48. Weissman L. Autism spectrum disorder in children and adolescents: pharmacologic interventions. Up ToDate. Updated May 30, 2024 . Accessed September 16 , 2024. www.uptodate.com 49. Weissman L. Autism spectrum disorder in children and adolescents: screening tools. Up ToDate. Updated January 24, 2024. Accessed September 16 , 2024. www.uptodate.com 50. Weissman L. Autism spectrum disorder in children and adolescents: surveillance and screening in primary care. Up ToDate. Updated May 5, 2022. Accessed September 16 , 2024. www.uptodate.com 51. Weissman L, Harris H. Autism spectrum disorder in children and adolescents: complementary and alternative therapies. Up ToDate. Updated June 20, 2022. Accessed September 16 , 2024. www.uptodate.com 52. Wergeland J, Posserud M, Fjermestad K, et al. Early behavioral interventions for children and adolescents with autism spectrum disorder in routine clinical care: a Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 07/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.19 systematic review and metaanalysis. Clin Psycho l. 2022;29(4):400-414. doi:10.1037/cps0000106 53. Witwer A, Walton K, Held M. Taking an evidence-based child-and family-centered perspective on early autism intervention. Clin Psychol . 2022;29(4):420-422. doi:10.1037/cps0000122 Approved by Ohio Department of Medicaid 04/01/2025
MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230 07/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 5 H. References ………………………….. ………………………….. ………………………….. …………………….. 5 Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPeripheral Nerve Blocks for Treatment of Pain B. BackgroundPeripheral n erve blocks are injection s of medication into a specific area of the body where nerves cause pain to a specific organ or body region . Nerve block s cause the temporary interruption of impulse conduction in peripheral nerves or nerve trunks and may or may not contain a steroid , which can be used to treat pain. Various areas of pain require different types of nerve blocks that can be administered in numerous parts of the body , with some of the most common blocks being sympathetic, peripheral , and occipital. Sacroiliac and facet j oint interventions , epidural steroid injections , and trigger pointinjections are addressed in other policies.C. Definitions Acute Pain Pain that lasts less than 4 weeks. Ambulatory Surgery Surgery performed in a hospital-based or freestanding ambulatory surgery center (ASC) with patient discharge the same day . Chronic Pain Pain lasting more than 3 months, which is considered beyond normal healing time. Conservative Therapy A multimodality plan of care including both active and inactive conservative therapies . o Active Conservative Therapies Action or activit ies that strengthen supporting muscle groups and target key spinal structures, including physical therapy, occupational therapy, a physician-supervised home exercise program (HEP), and/or chiropractic care. HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion , or documentation of the inability to complete HEP due to a stated physical reason (ie , increased pain, inability to physically perform exercise). Patient inconvenience and/or noncompliance without explanation does not constitute an inability to complete . o Inactive Conservative Therapies Passive activities that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices, acupuncture, a TENS device, and/or pharmacotherapy (prescription or over the counter [non-steroidal anti-inflammatory drugs, acetaminophen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins . Its u se, frequency, duration, and start dates must be documented in the medical record. Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Emergent Medically necessary care, which is immediately needed to preserve life,prevent serious impairment to bodily functions, organs, or parts, or prevent placing the physical or mental health of a patient in serious jeopardy. Low-Risk Procedure Procedures associated with minimal physiologic effect and excludes any intrathoracic, intra-abdominal, vascular, or orthopedic procedures. Sub-Acute Pain Pain lasting between 4 to 12 weeks. D. PolicyI. CareS ource considers p eripheral nerve blocks (PNB) , single injection , medically necessary when appropriate documentation for the treatment of acute pain or chronic pain are included , only as part of an active component of a comprehensive pain management program . CareSource uses MCG Health guidelines to address criteria for specific nerve blocks. Documentation must include indications that ALL the following criteria are met: A. Ambulatory or outpatient procedure that is not emergent, is low risk , and requires no inpatient care for a preoperative disease or condition (eg, altered mental status , hypotension, hypoxemia, tachycardia) B. Acute, sub-acute or c hronic, neuropathic or radicular pain, as indicated by ONE or more of the following: 1. cancer-related pain 2. Com plex regional pain syndrome (CRPS) 3. peripheral neuropathy with pain that limits activit ies of daily living , e xcluding diabetic neuropathy 4. peripheral vascular disease with rest pain 5. acute herpes zoster of face or neck and prevention of postherpetic neuralgia 6. pancreatic pain, pelvic pain, or abdominal pain related to malignancy 7. chronic, relapsing pancreatitis C. Symptoms poorly controlled by maximum medical therapy or intolerable side effects to such therapy D. Failure of non-invasive treatment (s) (eg, non-steroidal anti-inflammatory drugs (NSAIDs), exercise, physical therapy, spinal manipulation therapy) E. No coagulopathy or thrombocytopenia F. No infection at or underlying the injection site II. Acute or Sub-Acute PainPNB may provide means of analgesia for acute pain in the following (not an all – inclusive list): A. Patients at risk of respiratory depression related to systemic or neuraxial opioids (eg, obstructive sleep apnea, severe obesity, underlying pulmonary disease, advanced age) . B. Patients with another indication to minimize opioid use (eg, chronic opioid use, intolerance to opioids) . C. Patients with acute, severe pain poorly managed with systemic medication . Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 D. Patients who cannot tolerate chiropractic or other physical and/or manipulative therapies . III. Chronic PainCareSource considers PNB , single injection, medically necessary when appropriate documentation for the treatment of chronic pain is included, only as part of an active component of a comprehensive pain management program when the following criteria are met: A. Failure of conservative therapy, as evidenced by ALL the following: 1. documentation in the medical record of at least 6 weeks of active conservative therapy within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance 2. documentation in the medical record of at least 6 weeks inactive conservative therapy within the past 6 months B. Insufficient evidence support s the use of PNB for chronic pain: 1. genicular nerve or branches for chronic knee pain 2. cluneal nerve injections or blocks for chronic low back pain or pelvic pain 3. pudendal blocks for chronic pelvic pain conditions IV. Radiofrequency Ablation (RFA) or NeurotomyRadiofrequency ablation and/or neurotomy are considered experimental and investigational , or unproven for any indication, including but not limited to the treatment of acute or chronic pain due to insufficient evidence of efficacy in the peer reviewed literature. V. Limitations and ExclusionsA. A member can receive a maximum of 6 injections in a rolling 12 month period .B. Up to 2 anatomic sites (eg, specific nerve, plexus, or branch as defined by CPT code descripti on) can be injected at any one session . C. Nerve blocks used as part of a surgical procedure or other medical procedure are not separately reimbursable but an inclusive component of that procedure . These injections will not be compensated separately or unbundled for coverage. D. Any procedure submitted for payment with an incorrect CPT code or description will be denied. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provide d. If requesting a block to a specific part of the body, coding to the highest level of specificity should be used. E. Exclusions 1. Treatment of peripheral neuropathy due to diabetes. 2. Use of nerve blocks with or without use of electrostimulation for treatment of multiple neuropathies or peripheral neuropathies caused by underlying systemic diseases. Medical management using systemic medications is clinically indicated for the treatment of these conditions. Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 E. Conditions of CoverageInterventional procedures for the management of pain unresponsive to conservative treatment should be provided only by healthcare providers within their scope of practice who are qualified to deliver these health services . F. Related Policies/RulesEpidural Steroid Injections Facet Joint Interventions Sacroiliac Joint Procedures Trigger Point Injections G. Review/Revision HistoryDATE ACTIONDate Issued 10/01/2022Date Revised 02/15/2023 02/28/202402/26/2025Annual review. Changed conservative therapy from 6 months in past 12 months to 6 weeks in past 6 months. Annual review-editorial changes ; Approved at Committee Annual review-references updated. Approved at Committee. Date Effective 07/01/2025 Date Archived H. References1. Ailani J, Burch RC, Robbins MS; American Headache Society. The American Headache Society consensus statement: update on integrating new migraine treatments into clinical practice. Headache . 2021;61(7):1021-1039. doi:10.1111/head.14153 2. Allen SM, Mookadam F, Cha SS, et al. Greater occipital nerve block for acute treatment of migraine headache: a large retrospective cohort study. JAm Board Fam Med . 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188 3. American Headache Society. AHS consensus statement: The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache . 2019;59(1):1-18. doi:10.1111/head.13456 4. Antolak S, Antolak C, Lendway L. Measuring the quality of pudendal nerve perineural injections. Pain Physician . 2016;19:299-306. Accessed February 9, 2024. www.pubmed.ncbi.nlm.nih.gov 5. Caponnetto V, Ornello R, Frattale I, et al. Efficacy and safety of greater occipital nerve block for the treatment of cervicogenic headache: a systematic review. Expert Rev Neurotherapeutics . 2021; 21(5):591-597. doi:10.1080/14737175.2021.1903320 6. Chang A, Dua A, Singh K, White BA. Peripheral nerve blocks. StatPearls . StatPearls Publishing; 2024. Accessed February 9, 2025 . www.ncbi.nlm.nih.gov 7. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate. Updated May 15, 2024. Accessed February 9, 2025. www.uptodate.com Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 8. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC clinical practice guideline for prescribing opioids for pain. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1 9. Evidence Analysis Research Brief: Pudendal Nerve Decompression Surgery for Treatment of Pudendal Neuralgia. Hayes; 2022. Accessed February 9, 2025. www.evidence.hayesinc.com 10. Evidence Analysis Research Brief: Radiofrequency Ablation of Cluneal Nerve for Treatment of Chronic Low Back Pain. Hayes; 2023. Accessed February 9, 2025. 11. Evolving Evidence Review: Middle Cluneal Nerve Block for Treatment of Low Back Pain. Hayes; 2022. Reviewed April 4, 2023. Accessed February 9, 2025. www.evidence.hayesinc.com 12. Evolving Evidence Review: Superior Cluneal Nerve Block for Treatment of Low Back Pain. Hayes; 2021. Reviewed December 18, 2024. Accessed February 9, 2025. www.evidence.hayesinc.com 13. Frank FT, Sawsan A. Chronic pelvic pain in adult females: treatment. UpToDate. Updated August 16, 2024. Accessed February 9, 2025. www.uptodate.com 14. Garza I. Occipital neuralgia. UpToDate. Updated December 17, 2024. Accessed February 9, 2025. www.uptodate.com 15. Garza I, Schwedt TJ. Chronic migraine. UpToDate. Updated October 3, 2024. Accessed February 9, 2024. www.uptodate.com 16. Gautam S, Gupta N, Khuba S, et al. Evaluation of the efficacy of superior cluneal nerve block in low back pain: a prospective observational study. JBodyw Mov Ther . 2022;30:221-225. doi:10.1016/j.jbmt.2022.03.001 17. Headaches in Over 12s: Diagnosis and Management . National Institute for Excellence; 2012. CG150. Updated December 17, 2021. Accessed February 9, 2025. www.nice.org 18. Health Technology Assessment: Genicular Nerve Block for the Treatment of Knee Osteoarthritis. Hayes; 2023. Reviewed December 19, 2024. Accessed February 9, 2025 . www.evidence.hayesinc.com 19. Health Technology Assessment: Greater Occipital Nerve Blocks for Treatment of Migraine. Hayes; 2019. Reviewed October 10, 2022. Accessed February 9, 202 5. www.evidence.hayesinc.com 20. Health Technology Assessment: Local Injection Therapy for Cervicogenic Headache and Occipital Neuralgia. Hayes; 2017. Reviewed November 15, 2021. Accessed February 9, 2025. www.evidence.hayesinc.com 21. Health Technology Assessment: Peripheral Nerve Field Stimulation for Treatment of Chronic Low Back Pain. Hayes; 2021. Reviewed April 17, 2024. Accessed February 9, 2025 . www.evidence.hayesinc.com 22. Hui J, Seko K, Shrikhande G, et al. A novel, nonopiod-based treatment approach to men with urologic chronic pelvic pain syndrome using ultrasound-guided nerve hydrodissection and pelvic floor musculature trigger point injections. Neurourol Urodyn . 2020;39(2):658-664. doi:10.1002/nau.24242 Peripheral Nerve Blocks for Treatment of Pain-OH MCD-MM-1230Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 23. Inan L, Inan N, Unal-Artik H, et al. Greater occipital nerve block in migraine prophylaxis: narrative review. Cephalalgia . 2019;39:908-920. doi:10.1177/0333102418821669 24. Isu T, Kim K, Morimoto D, Iwamoto N. Superior and middle cluneal nerve entrapment as a cause of low back pain. Neurospine . 2018;15(1):25-32. doi:10.14245/ns.1836024.012 25. Jeng C, Rosenblatt M. Overview of peripheral nerve blocks. UpToDate. Updated January 10, 2024. Accessed February 9, 2025. www.uptodate.com 26. Matsumoto J, Isu T, Kim K, et al. Middle cluneal nerve entrapment mimics sacroiliac joint pain. Acta Neurochir (Wien) . 2019;161(4):657-661. doi:10.1007/s00701-019 – 03861-0 27. Mustafa A, Brooks B, Leishear K, et al. A novel treatment approach for women with chronic pelvic pain syndrome leading to increased pelvic functionality. JWomens Health Gyn . 2020;7:1-10. doi:10.17303/jwhg.2020.7.402 28. Nielsen TD, Moriggl B, Barckman J, et al. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med . 2019;44:772-780. doi:10.1136/rapm-2018-100174 29. Ornello R, Lambru G, Caponnetto V, et al. Efficacy and safety of greater occipital nerve block for the treatment of cluster headache: a systematic review and meta – analysis. Expert Rev Neurotherapeutics . 2020;20(11):1157-1167. doi:10.1080/14737175.2020.1809379 30. Pilitsis JG, Khazen O. Occipital neuralgia. American Academy of Neurological Surgeons (AANS). Accessed February 9, 2025. www.aans.org 31. Plavnik K, Tenaglia A, Hill C, et al. A novel, non-opioid treatment for chronic pelvic pain in women with previously treated endometriosis utilizing pelvic-floor musculature trigger-point injections and peripheral nerve hydrodissection. PM R . 2020;12(7):655 – 662. doi:10.1002/pmrj.12258 32. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on chronic pain management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology . 2010;112(4):810-833. doi:10.1097/ALN.0b013e3181c43103 33. Shauly O, Gould DJ, Sahai-Srivastava S, et al. Greater occipital nerve block for the treatment of chronic migraine headaches: a systematic review and meta-analysis. Plast Reconstr Surg . 2019;144(4):943-952. doi:10.1097/PRS.0000006059 34. Tu FF, As-Sanie S. Chronic pelvic pain in adult females: evaluation. UpToDate. Updated August 16, 2024. Accessed February 9, 2025. www.uptodate.com 35. Watson JC. Cervicogenic headache. UpToDate. Updated March 12, 2024. Accessed February 9, 2025. www.uptodate.com 36. Wray JK, Dixon B, Przkora R. Radiofrequency ablation. StatPearls . StatPearls Publishing; 2025. Accessed February 9, 2025. www.ncbi.nlm.nih.gov Approved by O DM 04/01/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Mechanical Stretching Devices-OH MCD-MM-1225 07/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4Mechanical Stretching Devices-OH MCD-MM-1225 Effective Date: 07/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Mechanical Stretching Devices B. Background Mechanical stretching devices are intended to restore range of motion (ROM) for joint stiffness or contracture by stretching joints. These devices provide passive stretching to an adjustable degree for a selected duration for multiple sessions. A variety of mechanical stretching devices are available for extension or flexion of the shoulder, elbow, wrist, fingers, knee, ankle, and toes. These devices can provide stretching for longer periods than a physical therapist and are generally used as adjunct treatm ent to physical therapy and/or exercise. Mechanical Stretching Devices (also known as dynamic splinting systems) include: Low-load prolonged duration stretch devices (LLPS) Static progressive stretch (SPS) splint devices Patient actuated serial stretch (PASS) devices C. DefinitionsLow-L oad Prolonged Duration Stretch Devices (LLPS) These devices permit resisted active and passive motion (elastic traction) within a limited range. LLPS devices maintain a set level of tension by means of incorporated rubber bands or springs. Patient Actuated Serial Stretch (PASS) Devices These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). This type of device itself does not exert a stress on the tissue unless the joint angle is set at the maximum ROM . Static Progressive Stretch Devices (SP S) These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction) . D. Policy I. CareSource considers dynamic splinting devices medically necessary durable medical equipment (DME) as an adjunct treatment to physical therapy, massage, and/or exercise for an existing joint contracture when the following clinical criteria is met: A. m edically necessary only for the following joints: knee, elbow, wrist, finger , ankle and toe B. after 3 weeks of exercise and skilled therapy in the initial subacute injury or post-operative period in members with: 1. signs and symptoms of persistent joint stiffness or contracture 2. limited range of motion that poses a meaningful functional limitation as judged by a physician C. m ay be used for an initial period of 4 weeks , a subsequent 4-week period with reevaluation, and then up to 4 months based on continued improvement . Mechanical Stretching Devices-OH MCD-MM-1225 Effective Date: 07/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3II. In the acute post-operative period for members who have undergone additional surgery to improve the range of motion of a previously affected joint , CareSource considers use of an LLPS device medically necessary for : A. an initial four-week period B. an additional four-week period, if improvement was noted after the initial four weeks, for up to 4 months . III. Non-C overed Services A. CareSource considers the use of dynamic splinting experimental and investigational for the following indications, including but not limited to: 1. adhesive capsulitis 2. carpal tunnel syndrome 3. cerebral palsy 4. foot drop associated with neuromuscular diseases, 5. hallux valgus 6. head and spinal cord injuries 7. improvement of outcomes following botulinum toxin injection for treatment of limb spasticity 8. injuries of the ankle and shoulder 9. multiple sclerosis 10. muscular dystrophy 11. plantar fasciitis 12. rheumatoid arthritis 13. stroke 14. trismus B. CareSource considers the following devices experimental and investigational due to insufficient scientific evidence of efficacy: 1. patient Actuated Serial Stretch (PASS) devices (for example, ERMI Knee Extensionater and ERMI Shoulder Extensionater) 2. static Progressive Stretch devices (SPS) (for example, Joint Active Systems (JAS) splints (for example, JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination)E. Conditions of CoverageAll claims for LLPS are subject to post-payment review by CareSource. F. Related Policies/Rules NA Mechanical Stretching Devices-OH MCD-MM-1225 Effective Date: 07/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4G. Review/Revision History DATE ACTIONDate Issued 11/09/2023 New PolicyDate Revised 02/15/2023 06/07/2023 05/22/2024 03/12/2025e-voted addition of ankle and toe to policy to match fee schedule and MCG. Annual review. Added examples of PASS and SPS devices. Annual review. Updated references. Approved at Committee. Updated references. Approved at Committee. Date Effective 07/01/2025 Date Archived H. References1. Furia JP, Willis FB, Shanmugam R, et al. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther . 2013;30(8):763-770. Accessed January 26, 2025. www.ncbi.nlm.nih.gov 2. Dynamic Joint Extension and Flexion Devices: ACG A-0882. MCG. 28th ed. 2024. Accessed January 26, 2025. www.careweb.careguidelines.com 3. Glasgow C, Tooth LR, Fleming J, et al. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution predictors of contracture resolution. JHand Ther . Accessed January 26, 2025. www.jhandtherapy.org 4. Harvey LA, Katalinic OM, Herbert RD, et al. Stretch for the treatment and prevention of contractures. Cochrane Database of Systematic Reviews. 2017. Accessed January 6, 2025. www.pubmed.ncbi.nlm.nih.gov 5. Medical Technology Directory. Mechanical Stretching Devices for the Treatment of Joint Contractures of the Extremities. Hayes , Inc. 2022. Accessed January 26, 2025. www.hayesinc.com 6. Jongs RA, Harvey LA, Gwinn T, et al. Dynamic splints do not reduce contracture following distal radial fracture: a randomised controlled trial. JPhysiother . 2012;58(3):173-180. Accessed January 26, 2025. www.reader.elsevier.com 7. Zatarain LA, Smith DK, Deng J, et al. A randomized feasibility trial to evaluate use of the jaw dynasplint to prevent trismus in patients with head and neck cancer receiving primary or adjuvant radiation-based therapy. Integr Cancer Ther . 2018. I nde pendent med ica l rev iew 12/21Approved by ODM 03/20/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Facet Joint Interventions-OH MCD-MM-0967 07/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence o f Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the cont rolling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less fav orable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 5 F. Related Polices /R ules ………………………….. ………………………….. ………………………….. ………. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 5 H. References ………………………….. ………………………….. ………………………….. …………………….. 6 Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectFacet Joint Interventions B. BackgroundAn estimated 84% of adults experience back pain during their lifetime . Long-term outcomes are largely favorable for most patients, but a small percentage of patients symptoms persist . Persistent pain is categorized as subacute when it lasts between 4 and 12 weeks and chronic when it persists for at least 3 months. Facet joint pain comprises 27% -40% of patients with chronic low back pain (LBP) . Comprehensive pain management care plans are most effective in managing a patients chronic pain. These plans focus on a person-centered approach and incorporateconservative treatment with other modalities. These multidisciplinary treatments promot e self-management and aim to reduce the impact of pain on a patients daily life, even if the pain cannot be relieved compl etely. In addition to conservative therapy, treatment options may include nonpharmacologic or pharmacologic treatments, and nonsurgical or surgical interventions. Only physicians qualified in i nterventional procedures for pain unresponsive to conservative treatment should perform these health services. Spinal structures may be the source of LBP, including intervertebral discs, facet joints, sacroiliac joints, and nerve roots. While some of these can be diagnosed by imaging, discogenic pain without disc herniation and facet joint or sacroi liac joint pain are difficultto diagnose with imaging alone. M edial branch nerve blocks are a diagnostic tool to identify the cause of pain and can provi de short term pain relief with certain medications. Following a presumptive diagnosis of facet joint pain through a physical examination and plain radiography or axial imaging , the diagnosis may be confirmed by relief of pain through injection of local anesthetic to the medial branches of the posterior rami of the dor sal spinal nerves supplying the proposed facet joint(s). Medial branch nerve blocks may be performed at the targeted joint itself, one joint above and one joint below on the same side, or bilaterally per treatment session. Medial branch nerve block injecti ons should be performed with fluoroscopy or computed tomography . A patient may receive a diagnostic injection of a short-acting local anesthetic agent to identify the pain generator. If pain is relieved by the injection, then a radiofrequency ablation (RFA), which uses energy to destroy the nerve , can be performed . A successful radiofrequency facet ablation of the affected nerve (same anatomic location of the positive diagnostic block) may relieve pain for a period of months up to a year or more until nerve regeneration occurs. C. Definitions Conservative Therapy A multimodality plan of care including both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, i nclud ing physical therapy, occupational Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 therapy, a physician supervised home exercise program (HEP), and/or chiropractic care. HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to com plete a HEP due to a stated physical reason (ie, increased pain, inability to physically perform exercises). Patient inconvenience or noncompliance without explanation does not constitute an inability to complete. o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms associated with pain including rest, ice, heat, medical devices, acupuncture, TENS use , and/or pharmacotherapy (prescription or over the counter [eg, NSAIDS, acetaminophen]) . Transcutaneous El ectrical Nerve Stimulator (TENS) A device that utilizes electrical current directed through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or st imulating the release of endorphins. Its use, frequency, duration, and start dates must be documented in the medical record to be considered part of conservative therapy . Medial Branch Nerve Block Injection A diagnostic procedure in which a short – acting anesthetic (eg, lidocaine) is injected near small medial nerves connected to a specific facet joint. It may also be performed to treat back pain caused by facet joint(s) with a longer acting anesthetic (eg, bupivacaine). o Successful Diagnostic Injection An injection that achieves greater than 80% reduction in pain within the duration of effectiveness for the anesthetic used. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial branches of the dorsal spinal nerves. D. PolicyCareSource considers facet joint interventions for management of chronic back pain medically necessary when the clinical criteria in this policy are met. Documentation, including dates of service for conservative therapies , are not required for medical nec essity review but must be available upon request. I. Medial Branch Nerve Block InjectionsA. Up to 2 diagnostic medial branch nerve block injections in the cervical , thoracic , or lumbar regions are considered medically necessary when ALL of the following criter ia are met: 1. Initial d iagnostic block confirm s facet joint as source of spinal pain and provides 80% or greater primary pain relief and duration of relief is consistent with agent employed. 2. Second diagnostic block confirms validity of the initial injection and is injected at the same level where the initial produced a positive response. 3. Each diagnostic block may treat up to 3 spinal levels (unilateral or bilateral) for a maximum of 6 spinal levels per spinal region per session . Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 4. Radiofrequency ablation is being considered as a therapeutic intervention.5. Injections should be at least 2 weeks apart . 6. Imaging studies and physical exam ruled out other causes of spinal pain (eg, fracture, tumor, infection, herniated disk, spinal stenosis, significant deformity) . 7. Patient history with at least 3 months of moderate to severe pain with functional impairment that has not adequately responded to active and inactive conservative therapy . 8. Failure of conservative therapy as evidenced by ALL of the following: a. Documentation in the medical record of at least 6 weeks of active conservative therapy (as defined above) within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance. b. Documentation in the medical record of at least 6 weeks of inactive conservative therapy (as defined above) within the past 6 months. 9. No coagulopathy . 10. No current infection at the injection site. B. Diagnostic medial branch nerve blocks are NOT considered medically necessary when RFA is not being considered as a treatment option. II. Radiofrequency Ablation (RFA) for Facet Joint PainA. Initial RFA for Facet Joint Pain is considered medically necessary when in the past 36 months 1. The clinical criteria above (I.A.1-10 ) have been met . 2. 2 successful medial branch nerve block injections were performed at the same spinal region and achiev ed 80% or more pain relief . B. Repeat RFA for facet joint pain is considered medically necessary when in the past 36 months 1. Prior successful single or multilevel facet RFA in the same spinal region (cervical, thoracic, or lumbar) and side provid ed at least 50% pain relief over a minimum of 6 months . 2. The m ost recent RFA was at least 6 months prior . 3. No more than 4 RFAs per rolling 12 months ( 2 left and 2 right per spinal region) are considered appropriate . III. SedationA. Neither conscious sedation nor monitored anesthesia care (MAC) is routinely necessary for intra-articular facet joint injections or medial branch blocks and are not routinely reimbursable. B. Individual consideration may be given for payment in rare unique circumstances if the medical necessity of sedation is unequivocal and clearly documented. IV. Inconclusive or Non-Supportive EvidenceFacet Joint Interventions-OH MCD-MM-0967Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 A. Medial branch nerve block inje ctions are unproven for the treatment of chronic spinal pain. Routine therapeutic injections will not be authorized for chronic pain management . B. Intra-articular facet joint injections for neck and back pain are not considered medically necessary as there is limited evidence and the efficacy has not been established. C. Intra-articular facet joint injections do not qualify as diagnostic information for a proposed neurotomy . V. Spinal Cord Stimulators/Pain PumpsPatients with indwelling implanted spinal cord stimulators or pain pumps should include a device interrogation report with the required medical records for medical necessity review r equests. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. E. Conditions of CoverageN/A F. Related Polices /R ulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 05/13/20 20 This policy replaces the Facet Medial Branch Nerve Block and Radiofrequency Facet Ablation policies. Added c riteria re: exclusion of repea t diagnostic injections for RFA. Date Revised 07/22/2020 11/11/202007/21/202106/22/2022 06 /21 /202305/08/202404/09 /2025 Revisions: Medial Branch Nerve Block injection clinical criteria; requirement of one successful RFA session. Revision: RFA language revised around benefit limit for clarity. (This revision does not require a network notification or a change of the Effective Date). Annual Update: Removed PA language. Annual Review: updated background, references, definitions, re-organized criteria, added coagulopathy and infection language Annual Review: revised language, added RFA requirement for diagnostic injections, updated references; Approved at Committee. Annual review: updated references, approved at Committee Review: upd ated references, approved at Committe e. Date Effective 07/01/2025 Date Archived Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 H. References 1. Ashmore ZM, Bies MM, Meiling JB, et al. Ultrasound-guided lumbar medial branch blocks and intra-articular facet joint injections: a systematic review and meta – analysis. Pain Rep. 2022;7(3):e1008. doi:10.1097/ PR9. 0000000000001008 2. Boswell MV, Manchikanti L, Kaye AD, et al. A best-evidence systematic appraisal of the diagnostic accuracy and utility of facet (zygapophysial) joint injections in chronic spinal pain . Pain Physician . 2015;18(4):E497-E533. Accessed March 20, 2025. www.painphysicianjournal.com 3. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate . Updated May 15, 2024 . Access ed March 20, 2025 . www.uptodate.com 4. Chou R. Subacute and chronic low back pain: surgical treatment. UpToDate . Updated September 27, 2023 . Access ed March 20, 2025 . www.uptodate.com 5. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic revie w for an American College of Physicians clinical practice guideline . Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 6. Cohen SP, Bhaskar A, Bhatia A, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispec ialty, international working group. Reg Anesth Pain Med . 2020;45(6):424-467. doi:10.1136/rapm-2019-101243 7. Cohen SP, Moon JY, Brummett CM, et al . Medial branch blocks or intra-articular injections as a prognostic tool before lumbar facet radiofrequency denervation: a multicenter, case-control study . Reg Anesth Pain Med . 2015;40(4):376-383. doi:10.1097/AAP.0000000000000229 8. Copenhaver DJ, Pritzlaff SG, Jung M, et al. Interventional therapies for chronic pain. UpToDate. Updated January 23, 2025 . Accessed March 20, 2025 . www.uptodate.com 9. Curtis L, Shah N, Padalia D. Facet joint disease. StatPearls . StatPearls Publishing; updated January 9, 2023. Accessed March 20, 2025 . www.ncbi.nlm.nih.gov 10. Facet Joint Injection. MCG Health. 28th ed. MCG Health; 2024. Updated March 14, 2024. Accessed March 20, 2025 . www.careweb.careguidelines.com 11. Hurley RW, Adams MCB, Barad M, et al. Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group. Reg Anesth Pain Med . 2022;47(1):3-59. doi:10.1136/rapm-2021 – 103031 12. Isaac Z, Kelly H. Evaluation of the adult patient with neck pain. UpToDate. Updated Ma y 31, 2023. Accessed March 20, 2025 . www.uptodate.com 13. Le DT, Alem N. Facet Joint Injection. StatPearls . StatPearls Publishing; updated February 5, 2023 . Accessed March 20, 2025 . www.ncbi.nlm.nih.gov 14. Lee DW, Pritzlaff S, Jung MJ, et al. Latest Evidence-Based Application for Radiofrequency Neurotomy (LEARN): best practice guidelines from the American Society of Pain and Neuroscience (ASPN). JPain Res . 2021;14:2807-2831. doi:10.2147/JPR.S325665 15. Manchika nti L, Kaye AD, Soin A, et al. Comprehensive evidence-based guidelines for facet joint interventions in the management of chronic spinal pain : American Society of Interventional Pain Physicians (ASIPP) guidelines facet joint interventions Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 2020 guidelines . Pain Physician . 2020;23(3S):S1-S127. Accessed March 20, 2025 .www.painphysicianjournal.com 16. Perolat R, Kastler A, Nicot B, et al. Facet joint syndrome: from diagnosis to interventional management. Insights Imaging . 2018;9(5):773-789. doi:10.1007/s13244-018-0638x 17. Won HS, Yang M, Kim YD. Facet joint injections for management of low back pain: a cli nically focused review. Anesth Pain Med (Seoul) . 2020;15(1):8-18. doi:10.17085/apm.2020.15.1.8 Approved by ODM 04/14/2025 .
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Breast Reduction Surgery-OH MCD-MM-0020 07/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 7 H. References ………………………….. ………………………….. ………………………….. …………………….. 7 Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectBreast Reduction Surgery B. BackgroundWomen diagnosed wit h macromastia (excessively large breasts) seeking breast reduction typically present with complaints of a feeling of heaviness, chronic pain , and tension in the neck, shoulders , and upper back. Macromastia commonly causes permanent grooving and ulceration of the shoulder following years of wearing support bras to try to minimize symptoms. The physical and psychological symptoms of macromastia can significantly and negatively impact an individuals life and should be taken into consideration when evaluating s urgical intervention. Reduction mammoplasty is a surgical procedure that reduces the weight and volume ofthe breast. As much as 1 to 5 pounds of excess breast tissue is routinely removed during a reduction mammoplasty depending on breast and body mass . Indications for surgery include chronic pain and skin symptoms , neuropathy, breast discomfort, physical impairment , and psychological symptoms that can be associated with poor self-esteem and loss of desire to engage in activities. Gynecomastia is the benign proliferation of glandular tissue of the breast in males. This condition may be caused by androgen deficiency, congenital disorders, medications,chronic medical conditions, tumors, or endocrine disorders. Depending on the cause of the tissue proliferation, surgical removal may be considered cosmetic or medically necessary.C. Definitions Body Surface Area (BSA) A metric used for physiologic measurements, pharmacologic dosing, and therapeutic calculations, including the Schnur Sliding Scale for breast reduction surgery. Cosmetic Procedures Procedures performed for aesthetic purposes that do not improv e or restor e physiologic function. Functional/Physical or Physiological Impairment Impairment caus es deviation from the normal function of a tissue or organ. This results in a significantly limited, impaired , or delayed capacity to move and coordinate actions, or perform physical activities and is exhibited by difficulties in physical and motor tasks , independent movement , and performing basic life functions. Gynecomastia Enlargement of the male breast secondary to a proliferation of ductal, stromal, and/or fatty tissue. Gynecomastia Scale A qualitative classification system for gynecomastia developed by the American Society of Plastic Surgeons (ASPS). o Grade I Small breast enlargement with localized button of tissue that is concentrated around the areola. o Grade II Moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest. Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o Grade III Moderate breast enlargement exceeding areola boundaries with edges that are distinct from the chest with skin redundancy present. o Grade IV Marked breast enlargement with skin redundancy and feminization of the breast. Intertriginous Rash Dermatitis occurring between juxtaposed folds of skin, caused by retention of moisture and warmth and providing an environment favoring overgrowth of normal skin micro-organisms. Kyphosis Over-curvature of the thoracic vertebrae (upper back) associated with degenerative diseases , such as arthritis, developmental problems, or with osteoporotic compression fractures of vertebral bodies. Macromastia (Breast Hypertrophy) An increase in the volume and weight of breast tissue relative to the general body habitus. Symptomatic Breast Hypertrophy A syndrome of persistent neck and shoulder pain, shoulder grooving from brassiere straps, chronic intertriginous rash of the infra – mammary fold , and/or frequent episodes of headache, backache, and upper extremity neuropathies caused by an increase in the volume and weight of breast tissue beyond normal proportions. Schnur Sliding Scale Use d in calculating the amount of breast tissue to be removed in reduction mammoplasty (Appendix A). D. PolicyI. CareSource considers breast reduction surgery for macromastia medically necessary when ALL the following criteria are met and have been documented : A. Member is 18 years or older , or under 18 years with evidence that breasts have finished growing for a minimum of one year . Parental/guardian consent is required for members under age 18 . B. Breast size interferes with activities of daily living, as indicated by 1 or more of the following: 1. arm numbness consistent with brachial plexus compression syndrome 2. cervical pain 3. chronic breast pain 4. headaches 5. nipple position greater than 21 cm below suprasternal notch 6. persistent redness and erythema (intertrigo) below breasts 7. restriction of physical activity 8. severe bra strap grooving or ulceration of shoulder 9. shoulder pain 10. thoracic kyphosi s 11. upper or lower back pain C. Preoperative evaluation by surgeon concludes that the amount of breast tissue to be removed (by mass or volume) will provide a reasonable expectation of symptomatic relief. D. No evidence of breast cancer Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 1. physical exam completed by a physician within the last year if under 40 years of age 2. women 40 to 54 years of age or older with mammogram negative for cancer performed within the year prior to the date of the planned breast reduction surgery 3. women 55 years of age and older with negative mammograms negative for cancer every 2 years 4. women with family history of breast cancer with mammogram s starting at least 7 years prior to when the youngest family member was diagnosed with breast cancer (as early as 30 years old) II. Breast reduction surgery following mastectomy to achieve symmetry is covered as part of the Womens Health and Cancer Rights Act (WHCRA). Please refer to theCareSource Medical policy titled Breast Reconstruction Surgery for additional information. III. CareSource considers breast reduction surgery for gynecomastia medically necessary when ALL the following clinical criteria are met and have been documented: A. Member is 18 years or older , or under 18 years with evidence that breasts have finished growing for a minimum of one year . Parental/guardian consent is required for members under age 18 . B. A physical exam has been conducted by an appropriately credentialed provider and confirms the presence of gynecomastia: 1. pubertal male (adolescent) a. gynecomastia present for more than 1 year after pathological causes ruled out b. Gynecomastia Grade II, III, or IV 2. postpubertal male a. gynecomastia present for more than 3 months after pathological causes ruled out b. Gynecomastia Grade III or IV C. The tissue being removed is glandular breast tissue and not the result of obesity, adolescence, or reversible effects of drug treatment that can be discontinued. D. The gynecomastia is attributed to an underlying condition (not an all-inclusive list), including: 1. androgen deficiency 2. chronic liver disease that causes decreased androgen availability 3. Klinefelter syndrome 4. adrenal tumors that cause androgen deficiency or increased secretion of estrogen 5. brain tumors that cause androgen deficiency 6. testicular tumors that cause androgen deficiency or tumor secretion of estrogen 7. endocrine disorders (eg, hyperthyroidism) Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 E. The gynecomastia causes functional impairment (eg, pain, chronic irritation ) and breast reduction surgery is not for cosmetic reasons. F. Breast malignancy was ruled out. IV. Schnur Sliding ScaleThe S chnur Sliding Scale is one of several evalu ation tools used to de termine the appr opriate volume of tissue to be r emoved relati ve to a members total body surface area ( BSA ). This esti mation can be instr umental in determining whet her br east reducti on sur gery is being planned for cos metic reas ons or as a medical ly neces sary procedure. A. The weight of tiss ue to be r emoved from each brea st is recommended to be above t he 22nd percentile on the Sc hn ur Sliding Scale ( App endix A belo w) based on t he members BSA. B. The BSA in met ers s quar ed ( m2) is c alcula ted using the Mos teller f ormu la (square root of the result of height (inches) multiplied by weight (lbs) and divided by 3131 ). App endix A: Schnur Sliding Sca leBody Su rface Ar ea an d M inim um Re quirement for Breast Tissue R emoval Body Surface Area (m2)Gr ams per Br east of Minimum Breast T issue to be Remo ved 1.350-1.374 199 1.375-1.399 208 1.400-1.424 218 1.425-1.449 227 1.450-1.474 238 1.475-1.499 249 1.500-1.524 260 1.525-1.549 272 1.550-1.574 284 1.575-1.599 297 1.600-1.624 310 1.625-1.649 324 1.650-1.674 338 1.675-1.699 354 1.700-1.724 370 1.725-1.749 386 1.750-1.774 404 Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 1.775-1.799 4221.800-1.824 441 1.825-1.849 461 1.850-1.874 482 1.875-1.899 504 1.900-1.924 527 1.925-1.949 550 1.950-1.974 575 1.975-1.999 601 2.000-2.024 628 2.025-2.049 657 2.050-2.074 687 2.075-2.099 717 2.100-2.124 750 2.125-2.149 784 2.150-2.174 819 2.175-2.199 856 2.200-2.224 895 2.225-2.249 935 2.250-2.274 978 2.275-2.299 10 22 2.300-2.324 10 68 2.325-2.349 11 17 2.350-2.374 11 67 2.375-2.399 12 19 2.400-2.424 12 75 2.425-2.449 13 33 2.450-2.474 13 93 2.475-2.499 14 55 2.500-2.524 15 22 2.525-2.549 15 90 2.550 or grea ter 16 62 Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 E. Conditions of Coverage N/A F. Related Polic ies /R ulesBreast Reconstruction Surgery G. Review/Revision HistoryDATE ACTIONDate Issued 07/20/2004Date Revised 05/25/2005 07/05/2006 09/18/2007 07/01/2009 02/01/2012 12/31/2014 12/01/2015 07/26/2017 03/16/202203/15/202302/28/202403/12/2025Annual update, minor editorial revisions, minor changes to policy, removed redundant mastectomy criteria from policyAdded male breast reduction surgery criteria. Updated references. Approved at PGC.Revised D.I, D.I.A., D.II. and D.II.A. Updated references. Approved at Committee. Revision: expanded policy to cover members under 18 years of age, removed definitions, and updated references. Approved at Committee. Annual review: updated background and definitions, added D.I.D.4., revised gynecomastia criteria, and updated references. Approved at Committee. Date Effective 07/01/2025 Date Archived H. References1. ASPS recommended insurance coverage criteria for third-party payers : gynecomastia. American Society of Plastic Surgeons. Accessed March 3, 2025. www.plasticsurgery.org 2. ASPS recommended insurance coverage criteria for third-party payers: reduction mammaplasty. American Society of Plastic Surgeons. Accessed March 3, 2025. www.plasticsurgery.org 3. Billa E, Kanakis GA, Goulis DG. Imaging in gynecomastia. Andrology . 2021;9(5):1444-1456. doi:10.1111/andr.13051 4. Biro F M, Chan Y M. Normal puberty. UpToDate. Updated September 24, 2024 . Accessed January 31, 2025 . www.uptodate.com Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 5. Braunstein G D, Anawalt BD. Clinical features, diagnosis, and evaluation of gynecomastia in adults. UpToDate. Updated April 26, 2023. Accessed January 31, 2025 . www.uptodate.com 6. Braunstein G D, Anawalt BD . Management of gynecomastia. UpToDate. Updated September 27, 2024 . Accessed January 31, 2025 . www.uptodate.com 7. Briefing paper: plastic surgery for teenagers. American Society of Plastic Surgeons. Accessed January 31, 2025 . www.plasticsurgery.org 8. Guliyeva G, Cheung JY, Avila FR, et al. Effect of reduction mammoplasty on pulmonary function tests: a systematic review. Ann Plast Surg . 2021;87(6):694-698. doi:10.1097/SAP.0000000000002834 9. Hansen J, Chang S. Overview of breast reduction. UpToDate. Updated April 19, 2023. Accessed January 31, 2025 . www.uptodate.com 10. Holzmer SW, Lewis PG, Landau MJ, et al. Surgical management of gynecomastia: a comprehensive review of the literature. Plast Reconstr Surg Glob Open . 2020;8(10):e3161. doi:10.1097/GOX.0000000000003161 11. Kanakis GA, Nordkap L, Bang AK, et al. EAA clinical practice guidelines – gynecomastia evaluation and management. Andrology . 2019;7(6):778-793. doi:10.1111/andr.12636 12. Kimia R, Magee L, Caplan HS, et al. Trends in insurance coverage for adolescent reduction mamm aplasty. Am JSurg . 2022;224(4):1068-1073. doi:10.1016/j.amjsurg.2022.07.030 13. Klement KA, Hijjawi BJ, Neuner J, et al. Discussion of preoperative mammography in women undergoing reduction mamm aplasty. Breast J . 2019;25(3):439-44. doi:10.1111/tbj.13237 14. Knox JA, Nelson DA, Latham KP, et al. Objective effects of breast reduction surgery on physical fitness. Ann Plast Surg . 2018;80(1):14-17. doi:10.1097/SAP.0000000000001167 15. Lewin R, Liden M, Lundberg J, et al. Prospective evaluation of health after breast reduction surgery using the Breast-Q, Short-Form 36, Breast-Related Symptoms Questionnaire, and Modifed Breast Evaluation Form. Ann Plast Surg . 2019;83(2):143-151. doi:10.1097/SAP.0000000000001849 16. Magny SJ, Shikhman R, Keppke AL. Breast Imaging Reporting and Data System. StatPearls . StatPearls Publishing; 2024. Accessed January 31, 2025 . www.ncbi.nlm.nih.gov 17. Mastectomy for gynecomastia. MCG. 28 th ed draft. Updated March 14, 2024. Accessed March 3, 2025. www.careweb.careguidelines.com 18. Morrison KA, Vernon R, Choi M, et al. Quantifying surgical complications for reduction mammaplasty in adolescents. Plast Reconstr Surg . 2023;151(3):376e – 383e. doi:10.1097/PRS.0000000000009905 19. NCCN guidelines for patients 2022: breast cancer screening and diagnosis. NCCN. www.nccn.org 20. Nuzzi LC, Firriolo JM, Pike CM, et al. The effect of reduction mamm aplasty on quality of life in adolescents with macromastia. Pediatrics . 2017;140(5):e20171103. doi:10.1542/peds.2017-1103 Breast Reduction Surgery-OH MCD-MM-0020Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 21. Nuzzi LC, Pramanick T, Walsh LR, et al. Optimal timing for reduction mamm aplasty in adolescents. Plast Reconstr Surg . 2020;146(6):1213-1220. doi:10.1097/PRS.0000000000007325 22. Patel K, Corcoran J. Breast reduction surgery in adolescents. Pediatr Ann . 2023;52(1):e31-e35. doi:10.3928/19382359-20221114-06 23. Perdikis G, Dillingham C, Boukovalas S, et al. American Society of Plastic Surgeons evidence-based clinical practice guideline revision : reduction mammaplasty. Plast Reconstr Surg . 2022;149(3):392e-409e. doi:10.1097/PRS.0000000000008860 24. Perez-Panzano E, Gascon-Catalan A , Sousa-Dominguez R, et al. Reduction mamm aplasty improves levels of anxiety, depression and body image satisfaction in patients with symptomatic macromastia in the short and long term. JPsychosom Obstet Gynaecol . 2017;38(4):268-275. doi:10.1080/0167482X.2016.1270936 25. Reduction mamm aplasty. MCG . 28 th ed draft. Updated March 14, 2024 . Accessed January 31, 2025 . www.careweb.careguidelines.com 26. Reeves RA, Kaufman T. Mammography. StatPearls . StatPearls Publishing; 2023.. Accessed January 31, 2025 . www.ncbi.nlm.nih.gov 27. Sears ED, Lu YT, Swiatek PR, et al. Use of preoperative mammography during evaluation for nononcologic breast reduction surgery. JAMA Surg . 2019;154(4):356 – 358. doi:10.1001/jamasurg.2018.4875 28. Taylor SA. Gynecomastia in children and adolescents. UpToDate. Updated July 12, 2024 . Accessed January 31, 2025 . www.uptodate.com 29. Womens Health and Cancer Rights Act (WHCRA). Centers for Medicare and Medicaid Services . Accessed January 31, 2025 . www.cms.gov 30. Xia TY, Scomacao I, Duraes E, Cakmakoglu C, Schwarz G. Aesthetic, quality-of-life, and clinical outcomes after inferior pedicle oncoplastic reduction mammoplasty. Aesthetic Plast Surg . 2023;47(3):905-911. doi:10.1007/s00266-023-03257-7 31. Zeiderman MR, Kelishadi SS, Tutela JP, et al. Reduction mammoplasty: intraoperative weight versus pathology weight and its implications . Eplasty . 2017;17:e32. Accessed January 31, 2025 . www.pubmed.ncbi.nlm.nih.gov Approved ODM 3/ 20/202 5
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Breast Reconstruction Surgery-OH MCD-MM-0001 07/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 4 H. References ………………………….. ………………………….. ………………………….. …………………….. 4 Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectBreast Reconstruction Surgery B. BackgroundWith an estimated 272,000 new cases yearly, breast cancer continues to be the leading cause of new cancer among women in the United States and a leading cause of cancer death. Breast reconstruction is intended to reduce post-mastectomy complications , es tablish symmetry between the surgical breast and the contralateral breast , and improve quality of life following breast cancer surgery . Breast reconstruction procedures may include breast reduction, breast augmentation with FDA-approved breast implants, nippl e reconstruction (including surgery, tattooing, or both) , and breast contouring. Reconstruction may be performed immediately following a mastectomy or can be delayed for weeks or years until the member has undergone radiation, chemotherapy, or decides th at reconstruction is want ed . Breast augmentation with an FDA-approved implant can be performed in one stage ,during which the implant is inserted during the same surgical visit as the mastectomy , or in two stages using an implanted tissue expander in the first stage followed by removal of the expander and insertion of the permanent breast implant. Complications may occur from breast implants immediately postoperatively or years later and can include exposure, extrusion, infection, contracture, rupture, and /or pain. Clinically significa nt complications may require implant removal. Autologous tissue/muscle breast flap reconstruction is a safe and effective alternative to breast implants. Muscle, subcutaneous tissue, and skin can be transposed from the donor site either locally (eg, latissimus dorsi myocutaneous [LD ] flap, pedicledtransverse rectus abdominus myocutaneous [TRAM ] flap) or distally (eg, free TRAMflap, deep inferior epigastric perforator [DIEP ] flap, superficial inferior epigastric artery perforator [SIEP ] flap, inferior or superior gluteal flap, superior gluteal artery perforator flab, Reubens flap, transverse upper gracilis [TUG ] flap). The choice of procedure can be affected by the members age and health, contralateral breast size and shape, personal preference, and expertise of the surgeon. Individuals may also select non-invasive options , such as mastectomy bras and externalbreast prostheses.Refer to MCG for complete mastectomy.C. Definitions Breast Conserving Surgery (Lumpectomy, Partial Mastectomy) Surgical removal of tumor and small amount of surrounding breast tissue. Contralateral Breast Unaffected/nonsurgical breast. Cosmetic Procedures Procedures completed to improve appearance and self – esteem and to reshape normal structures of the body. Mastectomy Surgical remov al of one or both breasts. Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.D. Policy I. Breast reconstruction is not gender specific. II. Surgical OptionsA. CareSource considers breast reconstruction following treatment for breast cancer medically necessary when ANY of the following apply: 1. following mastectomy or breast conserving surgery of the affected breast 2. producing a symmetrical appearance on the contralateral breast B. Breast reconstruction surgery to improve breast function after conservatory therapy and related to significant abnormalities or deformities is considered medically necessary when ANY of the following apply : 1. malignant breast disease 2. congenital deformities affect ing the members physical and psychological being 3. severe fibrocystic breast disease that limits the members function 4. unintentional trauma or injuries 5. complications after breast surgery for non-malignant conditions (eg, pain, irritation, bleeding, discharge, complications causing difficulty with lactation) III. CareSource considers bilateral risk-reducing mastectomy medically necessary. Refer to MCG Guidelines Mastectomy, Complete for more information. IV. CareSource considers treatment of physical complications , including lymphedema ,following breast reconstruction medically necessary. V. Surgical Exclusions:A. CareSource does not cover any breast reconstruction procedures that are considered experimental, investigational, or unproven. B. CareSource does not cover: 1. procedures that are considered cosmetic in nature , including natural changes due to aging and weight loss/gain 2. lipectomy for donor site symmetry 3. suction lipectomy or ultrasonically assisted suction lipectomy (liposuction) for correction of surgically induced donor site asymmetry (eg, trunk or extremity) that results from one or more flap breast reconstruction procedures VI. Non-Surgical AlternativesCareSource covers external breast prostheses and mastectomy bras following mastectomy or breast conserving surgery. All other indications are considered not medically necessary. VII. Breast reconstruction with free flap procedures, regardless of technique, applies to CPT code 19364 .Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 08/23/2004Date Revised 07/01/2009 07/01/2014 04/17/2015 04/18/2019 04/01/2020 02/17/2021 07/01/2021 03/16/2022 11/09/2022 09/27/2023 10/23/202404/09/2025Updated with more specific criteria . Reviewed criteria .No changes to content. Updated reference dates. Approved atPGC. Added section V, updated background and references. Annual review. Approved at committee. Annual review: updated risk reduction mastectomy and reorganized policy section for clarity. Review : elevated post-lumpectomy criteria, updated risk – reducing mastectomy and references . Approved at Committee. Date Effective 07/01/2025 Date Archived H. References1. Alder L, Zaidi M, Zeidan B, et al. Advanced breast conservation and partial breast reconstruction a review of current available options for oncoplastic breast surgery. Ann RColl Surg Engl . 2022;104(5):319-323. doi:10.1308/rcsann.2021.0169 2. Breast reconstruction surgery. American Cancer Society . Updated September 19 , 2022 . Accessed March 18, 2025 . www.cancer.org 3. Breast cancer statistics. Centers for Disease Control and Prevention. Accessed March 18, 2025 . www.cdc.gov 4. Centers for Medicare and Medicaid Services. Womens Health and Cancer Rights Act (WHCRA) . Accessed March 18, 2025 . www.cms.gov 5. Colwell AS, Taylor EM. Recent advances in implant-based breast reconstruction. Plast Reconstr Surg . 2020;145(2):421e-432e. doi:10.1097/PRS.0000000000006510 6. Costanzo D, Klinger M, Lisa A, et al . The evolution of autologous breast reconstruction. Breast J . 2020;26(11):2223-2225. doi:10.1111/tbj.14025 7. Friedrich M, Kramer S, Friedrich D, et al. Difficulties of breast reconstruction problems that no one likes to face. Anticancer Res . 2021;41(11):5365-5375. doi:10.21873/anticanres.15349 Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8. Gradishar WJ, Moran MS, Abraham J, et al . NCCN guidelines insights: breast cancer, version 4.2023. JNatl Compr Canc Netw . 2023;21(6):594-608 . doi:10.6004/jnccn.2023.0031 9. Griffin C, Fairhurst K, Stables I, et al. Outcomes of women undergoing mastectomy for unilateral breast cancer who elect to undergo contralateral mastectomy for symmetry: a systematic review. Ann Surg Oncol . 2024;31(1):303-315. doi:10.1245/s10434-023-14294-6 10. Guliyeva G, Torres RA, Avila FR, et al. The impact of implant-based reconstruction on persistent pain after breast cancer surgery: a systematic review. JPlast Reconstr Aesthet Surg . 2022;75(2):519-527. doi:10.1016/j.bjps.2021.09.079 11. Health technology assessment : c omparative effectiveness review of human acellular dermal matrix for breast reconstruction. Hayes; 2019. Reviewed February 28, 2022. Accessed March 18, 2025 . evidence.hayesinc.com 12. Health technology assessment : a utologous fat grafting for breast reconstruction after breast cancer surgery. Hayes ; 2015 . Review ed November 1 3, 202 3. Accessed March 18, 2025 . evidence.hayesinc.com 13. Mastectomy, complete: S-860. MCG Health, 2 9th ed draft . Updated January 25, 2025 . Accessed March 20, 2025 . careweb.careguidelines.com 14. Nahabedian M. Options for autologous flap-based breast reconstruction. UpToDate. Updated April 29, 2024 . Accessed March 18, 2025 . www.uptodate.com 15. Nahabedian M. Overview of breast reconstruction. UpToDate. Updated May 24, 2023. Accessed March 18, 2025. www.uptodate.com 16. Pappalardo M, Starnoni M, Franceschini G, et al. Breast cancer-related lymphedema: recent updates on diagnosis, severity and available treatments. JPers Med . 2021;11(5):402. doi:10.3390/jpm11050402 17. Sab el MS. Breast conserving therapy. UpToDate. Updated September 11 , 2023. Accessed March 18, 2025 . www.uptodate.com 18. Tomita K, Kubo T. Recent advances in surgical techniques for breast reconstruction. Int JClin Oncol . 2023;28(7):841-846. doi:10.1007/s10147-023-02313-1 19. Toyserkani NM, Jorgensen MG, Tabatabaeifar S, Damsgaard T, Sorensen JA. Autologous versus implant-based breast reconstruction: a systematic review and meta-analysis of Breast-Q patient-reported outcomes. JPlast Reconstr Aesthet Surg . 2020;73(2):278-285. doi:10.1016/j.bjps.2019.09.040 20. Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer . 2020;27(4):534-566. doi:10.1007/s12282-020-01076-1 Approved ODM 4/14/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 06/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 Effective Date: 06/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Metabolic and Bariatric Surgery: Revision B. Background Revision procedures are typically done because of complications from or a failure of the initial surgical procedure. Complications may include surgical or anatomical complications, as well as nutritional or metabolic complications. A failure of the initial bariatric surgery may result in an inadequate weight loss or a weight regain. C. Definitions Revisional Bariatric Surgery (RBS) surgery to address those patients whose original operation was unsuccessful in achieving satisfactory weight loss goals, or in whom complications from the original operation have occurred . Inadequate Weight Loss Less than 50% expected weight loss and/or weight remains greater than 40% over ideal body weight (normal body weight BMI parameter = 18.5-24.9). D. Policy I. CareSource considers surgical revision of a bariatric surgery procedure a covered service when medically necessary. II. An inadequate weight loss due only to non-compliance with dietary , behavior, or exercise recommendations is not a medically necessary indication for a revision procedure . III. A revision procedure is medically necessary when all of the following criteria are met and documented in the medical record: A. surgery/procedure selected is a proven procedure and not considered experimental/investigational and B. a technical failure or major complication has occurred from the initial procedure that cannot be managed medically. Technical failure and major complication examples include the following: 1. persistent pain and recurrent bleeding occur 2. chronic stenosis remains after multiple dilations 3. faulty component or malfunction that cannot be repaired 4. candy cane roux syndrome 5. complications that cannot be corrected with band manipulation, adjustments or replacement including band slippage and port leakage or a. obstruction confirmed by imaging studies . NOTE: Stretching of a stomach pouch formed by a previous bariatric surgery due to overeating is not considered a complication and therefore is not considered an indication for revision . Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 Effective Date: 06/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3IV. In the absence of a technical failure or major complication, individuals with weight loss failure 2 years following the initial bariatric surgery procedure must meet medical necessity requirements in the medical policy that applies to an initial bariatric surgery. V. CareSource does not consider endoscopic bariatric and metabolic therapies such as Intragastric balloon (IGB) , e ndoscopic sleeve gastroplasty (ESG), or aspiration therapy (AT) to be weight loss surgery. Individuals with weight loss failure from prior endoscopic therapies must meet medical necessity requirements in the medical policy that applies to an initial bariatric surgery. E. Conditions of Coverage N/A F. Related Polic ies/Rules Medical Necessity Determinations Metabolic and Bariatric Surgery Experimental and Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 07/22/2020 New policy Separated out from adolescent and adult policies Date Revised 06/23/2021 06/22/2022 06/21/2023 06/19/2024 02/26/2025PA language replaced by medical necessity criteria. PA enforced by inclusion on the PA list. Updated references. Re-wording of section IV re: medical necessity for revision bariatric surgery. Sec. V. Added IGB, ESG and AT non-coverage. Updated references. Annual review; no changes, Updated references, Approved at committee. Added definition of Revisional bariatric surgery (RBS) . Updated references. Approved at Committee. Updated references. Approved at Committee. Date Effective 06/01/2025 Date Archived H. References1. Eisenberg D, Shikora SA, Aarts E, et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federal for the Surgery of Obesity and Metabolic Disorders (IFSO): indications for metabolic and bariatric surgery. Surg Obes Relat Dis. 2022;18(12):1345-1356. Accessed January 14, 2025. www.soard.org 2. Ellsmere J. Bariatric operations: late complications with subacute presentations. Updated July 18, 2023. Accessed January 17, 2025. www.uptodate.com Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 Effective Date: 06/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.43. Gastric Restrictive Procedure with Gastric Bypass (S-512). MCG. 28th ed. 2024. Accessed January 14, 2025. www.careweb.careguidelines.com 4. Mechanisk J, Apovian C, et al. Clinical practice Guidelines for the Perioperative Nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures 2020 Update: Cosponsored by American Association of Clinical Endocrinologist/American college of Endocrinology, The obesity society, American Society for metabolic & Bariatric surgery, Obesity medicine Association, and American Society of Anesthesiologists. Obesity . 2020;28(4):01-58. doi:10.1002/oby.22719 5. Palep J. Reoperative bariatric surgery. Recent Advances in Minimal Access Surgery . JP Medical Ltd; 2019:14-151. 6. Weight-Loss and Weight-Management Devices . Federal Drug Administration; 2020. Accessed January 17, 2025. www.fda.gov 7. Yung-Chieh Y, Huang C, Tai C. Psychiatric aspects of bariatric surgery. Curr Opin Psychiatry . 2014;27(5):374-379. doi:10.1097/YCO.00000000000000085. Inde pendent med ica l r e view 7/2020 Approved by ODM 3/13/2025
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