Trigger Point Injections

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Trigger Point Injections-OH MCD-MM-0011 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 assessmen t 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 o r treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunctio n 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 Cover age 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 t o 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 pla n 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 ………………………….. ………………………….. ………………………….. … 4 F. Related Policies/R ules ………………………….. ………………………….. ………………………….. ….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. .. 4 H. References ………………………….. ………………………….. ………………………….. …………………. 5 Trigger Point Injections-OH MCD-MM-0011Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTrigger Point Injections B. BackgroundMyofascial trigger points are self-sustaining hyper-irritative foci in any skeletal muscle, often occurring in response to strain produce d by acute or chronic overload. There is no associated neurologic deficit, and the pain may be aggravated by hyperextension of the spine, standing , and walking. These trigger points produce a referred pain pattern characteristic for that individual muscle. Each pattern becomes part of a single muscle myofascial pain syndrome (MPS) which is responsive to appropriate treatment. To successfully treat ch ronic myofascial pain syndrome, each single muscle syndrome needs to be identified along with every perpetuating factor. The purpose of a trigger point injection (TPI) is to treat not only the symptom but also the cause through the injection of a single su bstance (eg, a local anesthetic) or a mixture of substances (eg, a corticosteroid with a local anesthetic) directly into the affected body part in order to alleviate inflammation and pain. Interventional procedures for management of pain should be part of a comprehensivepain management care plan that incorporates an initial trial of conservative treatment utilizing appropriate medications, physical therapy modalities , and behavioral support as needed. Interventional procedures for the management of pain unresponsive to conservativetreatment should be provided only by healthcare providers acting within their scope of practice who are qualified to deliver these health services. C. Definitions Acute Pain Pain that lasts less than 4 weeks. Physician Supervi sed Home Exercise Program (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 the 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. Subacute Pain Pain that has lasted between 4 weeks and 12 weeks. Trigger P oint A hyper excitable area of the body, where the application of a stimulus will provoke pain to a greater degree than in the surrounding area. D. PolicyI. Trigger Point Injections Initial Injections A. Trigger point injections of anesthetic and/or corticosteroid for back pain, neck pain , or myofascial pai n syndrome is considered medically necessary when pain has persisted despite appropriate medical management and ALL the following criteria are met: Trigger Point Injections-OH MCD-MM-0011Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 1. Patient presents with new (acute or subacute) localized pain, occurring in the last 3 months . 2. Patient has been refractory or intolerant of conservative therapies for at least 1 month, including at least 1 of the following: a. bed rest b. active exercise c. ultrasound d. range of motion e. heati ng or cooling treatments f. massage 3. TPIs are being given as a part of an overall conservative management (usually short term) plan, including at least 1 of the following: a. physical therapy b. occupational therapy c. physician supervised home exercise plan (HEP) d. manipulative therapy 4. Pharmacotherapies are being administered, including at least 1 of the following : a. non-steroidal anti-inf lammatory drugs ( NSAIDS ) b. muscle relaxants c. non-narcotic analgesics d. anti-depressants 5. The patient must have a diagnosis for whi ch the trigger point injection is an appropriate treatment . ALL the following information must be documented in the patient’s medical record: a. proper evaluation including a patient history and physical examination leading to diagnosis of the trigger point b. reason (s) for select ing this therapeutic option c. affected muscle or muscles d. muscle or muscles injecte d and the number of injections e. frequency of injections required f. name of the m edication used in the injection g. results of any prior treatment h. corroborating evidence that the injection is medic ally necessary B. Localization techniques to image or otherwise identify trigger point anatomic locations are not indicated and will not be covered for payment when associated with trigger point injection procedures. II. Trigger Point Injections Subsequent InjectionsA. Trigger point injections should be repeated only if doing so is reasonable and medically necessary . No more than 8 dates of service per calendar year per member may be reimbursed . B. Injections may be repeated only with documented positive results to the most recent trigger point injection of the same anatomic site. Documentation should Trigger Point Injections-OH MCD-MM-0011Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 indicate a decrease in pain, improvement in function, and/or increase in activity tolerance .III. There is no laboratory or imaging test for establishing the diagnosis of trig ger points .Diagnosis is dependent upon a detailed history and a thorough directed examination. The following clinical features are present most consistently and are helpful in making the diagnosis: A. history of onset and its cause (injury, sprain, etc.) B. distribution of pain C. restriction of movement D. mild muscle specific weakness E. focal tenderness of a trigger point F. palpable taut band of muscle in which trigger point is located G. local taut respo nse to snapping palpitation H. reproduction of referred pain pattern upon most sustained mechanical stimulation of the trigger point IV. Payment InformationA. Certain trigger point injection procedure codes specify the number of injection sites. For these codes, the unit of service is different from the number of inject ions given. B. Payment may be made for 1 unit of service of the appropriate procedure code reported on a claim for service rendered to a particular patient on a particular date. C. A trigger point injection is normally considered to be a stand-alone service. N o additional payment will be made for an office visit on the same date of service unless there is an indication on the claim (eg, in the form of a modifier appended to the evaluation and management procedure code) that a separate evaluation and management service was performed. D. Dry needling is not an acceptable alternative to trigger point injections by an appropriately licensed clinician. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 02/10/2015Date Revised 03/06/2019 06/10/2020 Annual Update: No changesAnnual Update: Prior authorization is now required; removal of payment information defer policy PY-1100. Trigger Point Injections-OH MCD-MM-0011Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 09/01/202105/26/202104/12 /202203/29/202302/28/202402/12 /2025Revisions include: such as was changed to ONE of the following : I. B. 2. and 3. Annual Update: Removed PA language. Annual Review; updated references, formatting, separated criteria into initial and subsequent injections, added active conservative therapy options Annual review: updated references, added definition and payment information. Approved at Committee Annual review: editorial changes, updated references, approved at Committee Review: updated references, approved at Committee. Date Effective 06/01/2025 Date Archived H. References1. Appasamy M, Lam C, Alm J, et al . Trigger point injections. Phys Med Rehabil Clin N Am . 2022;33(2):307-333. doi:10.1016/j.pmr.2022.01.011 2. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate . Updated May 15, 2024 . Accessed January 15, 202 5. www.uptodate.com 3. Gerwin R. Myofascial trigger point pain syndromes. Semin Neurol . 2016;36(5):469 – 473. doi:10.1055/s-0036-1586262 4. Hammi C, Schroader JD, Yeung B. Trigger point injection. StatPearls . StatPearls Publishing; 2024. Updated July 24, 2023. Accessed January 15, 202 5. www.ncbi.nlm.nih.gov 5. Hamzoian H, Zograbyan V. Trigger point injections versus medical manage ment for acute myofascial pain: a systematic review and meta-analysis. Cureus. 2023;15(8):e43424. doi:10.7759/cureus.43424 6. Immunizations, Injections and Infusions ( Including Trigger-Point Injections), Skin Substitutes, and Provider-Administered Pharmaceuticals , OHIO ADMIN CODE 5160-4- 12 (2022). 7. Isaac Z. Management of non-radicular neck pain in adults. UpToDate . Updated November 14 , 2024. Accessed January 15, 202 5. www.uptodate.com 8. Khoury AL, Keane H, Varghese F, et al. Trigger point injection for post-mastectomy pain: a simple intervention with high rate of long-term relief. NPJ Breast Cancer . 2021;7:123. doi:10.1038/s41523-021-00321-w 9. Meyer GW. Anterior cutaneous nerve entrapment s yndrome. UpToDate . Updated December 31, 2024 . Accessed January 15, 202 5. www.uptodate.com 10. Moynihan LK, Elkadry E. Myofascial pelvic pain syndrome in females: treatment. UpToDate. Updated January 11, 2023 . Accessed January 15, 202 5. www.uptodate.com 11. Tu FF, As-Sanie S. Chronic pelvic pain in adult females: treatment. UpToDate . Updated August 16, 2024 . Accessed January 15, 202 5. www.uptodate .com Independent Medical Review January 2025ODM Approved 0 2/27/2025

Neonatal Discharge Criteria

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Neonatal Discharge Criteria-OH MCD-MM-1229 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 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 ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Neonatal Discharge Criteria-OH MCD-MM-1229Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNeonatal Discharge Criteria B. BackgroundInfants who require neonatal admission remain at increased risk for morbidity and mortality following discharge. These infants require comprehensive discharge planning to ensure a smooth transition from the neonatal intensive care unit (NICU) and reduce morbidity and mortality after discharge. Despite the inability to predict the exact timing of a NICU discharge, discharge planning should begin at NICU admission in an effort to avoid overwhelming parents and hospital staff. This planning will aid in minimizing discharge delays and will promote s afe andhealthy discharges to home.Discharge may be appropriate when the establishment of physiologic competencies, including, but not limited to, thermoregulation, feeding, respiratory control, and stability regardless of weight or corrected gestational age, have been achieved.C. Definitions Acceptable Bilirubin Level Defined per American Academy of Pediatrics (AAP) guidelines. Bilirubin Blood test to measure liver function. Car Seat Test Eligibility An infant tolerance test for sitting usually occurring 36.4 Caxillary while clothed in an open bed/crib. D. PolicyI. CareSource considers neonatal discharge medically appropriate for non-technology dependent infants when ALL of the following clinical criteria are met: A. Thermoregulation Stability 1. Infant demonstrates the ability to maintain normal body temperature while clothed in an open crib. Up to 48 hours of stable body temperature is typically adequate for infants born

Sacroiliac Joint Procedures

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Sacroiliac Joint Procedures-OH MCD-MM-0010 05/01/2025 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 asses sment 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 diagnos is 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, dysfunctio n of a body organ or part, or significant pain and discomfort. These services m eet 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 C overage 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 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 a s 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/Rules ………………………….. ………………………….. ………………………….. ……… 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 6 Sacroiliac Joint Procedures-OH MCD-MM-0010Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectSacroiliac Joint Procedures B. BackgroundNearly 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 are persistent. Persistent pain is categorized as subacute when lasting between four a nd twelve weeks , and chronic when persisting for at least three months. Up to 10% to 25% of patients with persistent low back pain may have a component of pain related to sacroiliac joints (SIJ) . Comprehensive pain management care plans aremost effective in managing a patients chronic pain. These plans focus on a person-centered approach and incorporate conservative treatment with other modalities. These multidisciplinary treatments include promoting patient self-management and aim to reduce the impact o f pain on a patients daily life, even if the pain cannot be relieved completely. In addition to conservative therapy, additional treatment options may include nonpharmacologic or pharmacologic treatments, nonsurgical interventions, and surgical interventi ons. Interventional procedures for the management of pain unresponsive to conservative treatment should be provided only by physicians qualified to deliver these health services. Sacroiliac joint injections using local anesthetic and/or corticosteroid med ication have been shown to be effective for diagnostic purposes but provide limited short-term relief from pain resulting from SI Jdysfunction. Long-term use has not be en adequately studied to establish standards of care. Radiofrequency ablation (RFA) is a nother treatment method, which uses heat to destroy nerves. RFA for the treatment of low back pain has inconsistent results in the peer-reviewed medical literature with limited follow – up. However, clinical experience suggests that some patients obtain more significant relief from these procedures, making it reasonable to offer SIJ injections and/or RFA when conservative management has failed. C. Definitions Conservative Therapy A multimodality plan of care includ ing both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen supporting muscle groups and target key spinal structures, including physical therapy, occupational therapy, 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 the HEP due to a stated physical reason (ie, incre ased pain, inability to physically perform exercises). Patient inconvenience or noncompliance without explanation does not constitute an inability to complete. Sacroiliac Joint Procedures-OH MCD-MM-0010Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o Inactive Conservative Therapies Passive activities that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices, TENS unit, and/or pharmacotherapy (prescription or over the counter [non-steroidal anti-inflammatory drugs, acetaminophen]) . Transcutaneous Electrica l 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 stimulat ing 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 during the period of prior authorization request. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial branches of the dorsal spinal nerves. Sacroiliac Joint (SIJ) Injections Corticosteroid and local anesthetic therapeutic injecti ons into the SIJ to treat pain that hasnt responded to conservative therapies. Functional Disability Acquired difficulty in performing basic everyday tasks or more complex tasks needed for independent living. D. PolicyI. Sacroiliac Joint Injections A. Diagnostic injections: CareSource considers up to 2 diagnostic sacroiliac joint injection s for the treatment of chronic low back pain medically necessary when ALL the following criteria are met: 1. somatic or nonradicular low back and lower extremity pain experienced for at least 3 months 2. pain and tenderness are located in sacroiliac joint region and cause functional disability 3. positive response to at least one SIJ pain provocation test (e g, distraction, compression, thigh thrust, Gaenslens, Patricks test/FABER test, sacral thrust) 4. failure of conservative therapy, as evidenced by ALL the following: a. documentation in the medical record of a t 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 a t least 6 weeks of inactive conservative therapy ( as defined above ) within the past 6 months 5. If a second diagnostic injection is requested, at least 1 week has passed since the initial injection. B. Therapeu tic i njections : CareSource considers therapeutic sacroiliac joint injections medically necessary when ALL the following criteria are met: 1. previous SIJ injection led to significant functional pain relief as measured by a decrease in pain level (demonstrated on a qualitative pain scale), decrease in pain medications, and/or increase in physical function Sacroiliac Joint Procedures-OH MCD-MM-0010Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 2. member experiences return of pain or deterioration in function3. injection is used in conjunction with conservative therapy (as defined above) 4. injections should not be repeated more frequently than every 2 months 5. no more than 4 injections total ( diagnostic and therapeutic ) have been administered at the same site the last 12 months C. Exclusions/Limitations: 1. Codes 64451 and 27096 may not be billed tog ether (on the same date for the same side of the body). Only one code will be reimbursed . 2. Image guidance and/or injection of contrast is included in sacroiliac injection procedures and may not be billed separately. 3. If neural blockade is applied for different regions or different sides, injections are performed at least one week apart. 4. Pain m anagement literature highlighting controlled studies of SI Jpain management has not demonstrated injections of the SI Jto be effective as a long-term management modality. Long-term continuation may be subject to medical necessity review. 5. Monitored anesthes ia and conscious sedation are not medically necessary. 6. The use of SI Jinjections for the treatment of pain as a result of Herpes Zoster is not indicated due to insufficient evidence demonstrating efficacy in the peer-reviewed published literature. II. Radiof requency Ablation of the SIJA. Initial radiofrequency ablation of the SI J 1. Radiofrequency ablation is considered medically necessary when ALL the foll owing have been met in the last 6 month s: a. The clinical criter ia above for failed conservative therapy (I.A. 4.a. and I.A.4. b.) has been met . b. One diagnostic injection per joint to evaluate pain and attain therapeutic effect has been performed , with significant functional pain relief as measured by a decrease in pain level (demonstrated on a qualitative pain scale), decrease in pain medications, and/or increase in physical function . B. Repeat radiofrequency ablation of the SI J 1. Conservative therapy and diagnostic injections are not required if there has been a reduction in pain for at least 12 months or more from the initial RFA within the last 36 months. 2. When there has not been a repeat RFA in the last 36 months, a diagnostic injection is required. 3. A maximum of 1 radiofrequency ablation for SI Jpain per side per rolling 12 months is considere d medically necessary. C. Exclusions/Limitations 1. Codes 64451 and 27096 are considered the same procedure and may not be billed together. Only one code will be reimbursed. Sacroiliac Joint Procedures-OH MCD-MM-0010Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 2. The use of cooled RFA for SI joint-mediated low back pain is considered not medically n ecessary due to insufficient evidence demonstrating efficacy in the peer-reviewed published literature. 3. Pain management literature highlighting controlled studies of SI joint pain management has not demonstrated the effectiveness of RFA as a long-term mana gement modality. Long-term continuation may be subject to medical necessity review. III. Implantable Spinal Cord StimulatorsPatients with indwelling implanted spinal cord stimulators or pain pumps should have a device interrogation report submitted with medical records for a prior authorization request for proposed interventional pain injections. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. E. Conditions of CoverageNA F. Related Polices/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 02/10/2015 New PolicyDate Revised 07/28/2015 07/26/2016 02/08/2018 03/06/2019 10/8/201905/13/202004/28/202103/29/202203/01 /202301/31 /202401/29 /2025Removed Herpes CriteriaAnnual Update: Removed start and end dates. Addition of PA clarification and documentation requirements. Revision of injection frequency. Removed joint fusion denial language. This service will be addressed in the Sacroiliac Joint Fusion policy. Annual U pdate: Added clinical criteria for coverage of radiofrequency ablation of the SI Joint. Added coding information. Annual Update: Removed PA language. Annual Review: Updated background and references, re – organized criteria into initial and subsequent procedures, type of procedure. Annual Review: restructured conservative management and clinical criteria, added provocation tests Annual review: updated formatting and references, approved at Committee. Review: upd ated references, approved at Co mmittee Sacroiliac Joint Procedures-OH MCD-MM-0010Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 Date Effective 05/01/2025Date Archived H. References1. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 2. Chou R. Subacute and chronic low back pain: nonsurgical in terventional treatment. UpToDate. Updated May 15, 202 4. Accessed January 15, 20 25 . www.uptodate.com 3. Cine HS, Uysal E, Demirkol M, Cetin E. Under what conditions is the intra-articular steroid injection superior to nonsteroidal anti-inflammatory drugs for treating sacroiliac joint pain? Eur Rev Med Pharmacol Sci . 2023;27(21):10539-10546. doi:10.26355/eurrev_202311_34331 4. Immunizations, Injections and Infusions ( Including Trigger-Point Injections), Skin Substitutes, an d Provider-Administered Pharmaceuticals , OHIO ADMIN . CODE 5160-4- 12 (2022 ). 5. Jamjoom AM, Saeedi RJ, Jamjoom AB. Placebo effect of sham spine procedures in chronic low back pain: a systematic review. JPain Res . 2021;14:3057-3065. doi:10.2147/JPR.S317697 6. Janapala RN, Knezevic E, Knezevic NN, et al. Systematic review and meta-analysis of effectiveness of therapeutic sacroilic joint injections. Pain Phys ician . 2023;26:E413-E435. Accessed January 15, 2025 . www.painphysicianjournal.com 7. Lee DW, Pritzlaff S, Jung MJ, et al. Latest evidence-based application for radiofreq uen cy neurotomy (LEARN): best practice guidelines from the American Society of Pain and Neuroscience (ASPN). JPain Res . 2021;14:2807-2831. doi:10.2147/JPR.S235665 8. Maas ET, Ostelo RWJG, Niemisto L, et al. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev . 2015(10):CD008572. doi:10.1002/14651858.CD008572.pub2 9. Manchikanti L, Kaye AD, Soin A, et al. Comprehensive evidence-based guidelines for face t joint interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) guidelines facet joint inerventions 2020 guidelines. Pain Phys ician . 2020;23(3S):S1-S127. Accessed January 15, 2025 . www.painp hysicianjournal.com 10. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3728-3832. doi:10.2147/JPR.S386879 11. Stevens AC, Carroll DD, Courtney-Long EA, et al. Adults with one or more functional disabilisties United States, 2011-2014. MMWR Morb Mortal Wkly Rep 2016;65:1021-1025. doi:10.15585/mmwr.mm6538a1 12. Szadek K, Cohen SP, de Andres Ares J, et al. Sacroiliac joint pain. Pain Pract. 2023 ;00:1-20. doi:10.1111/papr.13338 13. Wu L, Tafti D, Varacallo M. Sacroiliac joint injection. StatPearls . StatPearls Publishing; 2023. Updated August 4, 2023. Accessed January 15, 2025 . www.ncbi.nlm.nih.g ov Sacroiliac Joint Procedures-OH MCD-MM-0010Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Independent Medical Review January 2025Approved by ODM 02/20/2025

Non-Emergency Facility to Facility Transfers

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 05/01/2025 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 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 Medica l 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 Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 Effective Dat e: 05/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNon-Emergency Facility to Facility Transfers B. BackgroundThis policy addresses the necessity of transferring a patient to a second acute care facility (receiving facility) when the individual requires care not available at the original facility. The goal of any transfer is to maintain the optimal health of the patient. This is accomplished by transferring the patient to the nearest facility that provides the highest specialized care needed. Inter-hospital patient transfer is an important aspect of patient care, most often toimprove patient management. During such transfers, there must be continuity of medical care. Key elements include the decision to transfer and communication, pre-transfer stabilization and preparation, choosing the appropriate mode of transfer, personnel accompanying the patient, equipment and monitoring required during the transfer, and documentation and handover of the patient at the receiving facility. Transfer, admission , and subsequent care to the receiving facility is not medicallynecessary when the needed care is available at the originating facility.C. Definitions Non-Emergency A situation for which immediate response is not needed for the provision of medical treatment. Inter-Facility Transfer The transfer of patients between two healthcare facilities. Intra-Facility Transfer The transfer of patients within the same facility. Originating Facility The current facility to which an individual has been admitted for care and from which a transfer is planned. Participating (In-Network) Facility Facility that is contracted with CareSource. Non-Participating (Out-of-Network) Facility Facility that is not contracted with CareSource. Receiving Facility The facility to which a transfer is planned. D. PolicyI. The following non-emergency transfers require a prior authorization: A. A non-emergency transfer from a participating inpatient facility to a participating inpatient facility that is not within the same healthcare system. B. A non-emergency transfer from a non-participating facility to a participating facility. C. A non-emergency transfer from a non-participating facility to a non-participating facility. II. For non-emergency transfers that require a prior authorization , the receiving facility submits the prior authorization request to CareSource. Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 Effective Dat e: 05/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 III. Requests for transfers that require a prior authorization must meet the following criteria: A. Member must be medically stable for transfer AND 1. Member requires transfer to a level of care which is not available at the originating facility . 2. Member requires transfer for a medically necessary diagnostic or therapeutic service which is not available at the originating facility . 3. Member requires transfer for services of a specialist to evaluate, diagnose , or treat their condition when that specialist is not available at the originating facility . 4. Member requires transfer because member has received care at a specific prior institution for a condition not normally managed at the originating facility and return to that prior institution is needed to diagnose, manage, or treat a complication or other acute issue . 5. Member requires transfer to improve the health and welfare of the member (ie, parental bonding) . 6. Transfer to allow a parent who gave birth to remain with the neonate is considered medically necessary when the neonate transfer meets the medically necessary criteria listed above and the parent who gave birth requires continued hospitalization due to birth complications or other medically necessary conditions . IV. The following non-emergency transfers do not require a prior authorization:A. Inter-facility transfers within the same healthcare system . B. Intra-facility transfers within the same facility . V. Non-emergency (elective) transfers are not a covered service for the following:A. The criteria above have not been met . B. The transfer is for the convenience of the member , the members family, the physician, or the originating facility . E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/15/2023 New policy. Approved at CommitteeDate Revised 02/14/2024 01/15/2025Annual review. No changes. Updated references. Approved at Committee.Annual review. Updated references. Approved at Committee. Date Effective 05/01/2025 Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 Effective Dat e: 05/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 Date ArchivedH. References1. Appropriate interhospital patient transfer. American College of Emergency Physicians. January 2022. Accessed December 16, 2024. www.acep.org 2. Discharges and Transfers, 42 C.F.R. 412.4 (2024). 3. Heaton J K. EMS Inter-Facility Transport. StatPearls . StatPearls Publishing; 2022. 4. Obstetric Care Consensus Number 9. Levels of Maternal Care. American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM); 2019. Accessed December 16, 2024. www.acep.org Independent med ical review 02/21/2023ODM Approved on 01/23/2025

Intraosseous Basivertebral Nerve Ablation

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Intraosseous Basivertebral Nerve Ablation-OH MCD-MM-1295 05/01/2025 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 a s 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 ………………………….. ………………………….. ………………………….. ……………………. 5 Intraosseous Basivertebral Nerve Ablation-OH MCD-MM-1295Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectIntraosseous Basivertebral Nerve Ablation B. BackgroundInterventional procedures for management of acute and chronic pain are part of a comprehensive pain management care plan that incorporates conservative treatment in a multimodality approach. Multidisciplinary treatments include promoting patient self – management and aim to reduce the impact of pain on a patients daily life, even if t he pain cannot be relieved completely. Interventional procedures for the management of pain unresponsive to conservative treatment should be provided only by physicians qualified to deliver these health services. Chronic low back pain (CLBP) is a common disabling condition, estimated to afflict 80%of adults at some point. Degenerative disc disease (DDD) is an important cause ofCLBP. While discs are avascular with limited nerve distribution, vertebral endplates have the potential to trigger a cascade of degenerative events if there is a loss of integrity. Vertebral endplates are a thin interface between bone marrow and discs and contain neural elements. Breakdown of the endplate is believed to cause v ertebrogenic chronic low back pain , a type of chronic l ow back pain . Endplate degeneration can be observed on MRI through Modic changes (MC). Histologically in MC type I (MC I) lesions, the endplate is disrupted as fibrous tissuereplaces bone marrow causing the disc-bone interface to be filled with vasculari zed granulation tissue. MC I represents bone marrow edema and inflammation. In MC t ype II (MC II) lesions, there is demonstration of fatty marrow replacement in addition to MC type I findings. MC II represents conversion of hematopoietic marrow into fatty, yellow bone marrow. MC type III (MC III) lesions are related to subchondral bone sclerosis. Analysis of Modic lesion s shows that MC I is characterized by high bone turnover, MC II is character ized by decreased bone turnover, and MC III are stable. Radiofrequency ablation (RFA) is a minimally invasive, percutaneous treatment which uses heat to ablate the nerve pathway that conducts the pain signal. The goal of RFA is to interrupt the pain pathw ay without causing excessive sensory loss, motor dysfunction,or other complications. Intracept is an RFA system designed to ablate the basivertebral nerve of the vertebral endplate. C. Definitions Chronic Low Back Pain Persistent pain in the lumbar regio n lasting for more than 12 weeks. 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, including physical therapy, occupational Intraosseous Basivertebral Nerve Ablation-OH MCD-MM-1295Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 therapy, 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 the 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 inab ility 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, TENS u se , acupuncture, and/or pharmacotherapy (prescription or over the c ounter [eg, 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 perce ption of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating 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 during the period of prior authorization request. Modic Changes Vertebral bone marrow signal intensity changes that are observable on MRI and are commonly associated with degenerative disc disease. o Modic Change Type I Characterized by hypo-and hyper-intense signal intensities on T1-and T2-weighted spin-echo (T1W1 and T2W1), respectively. o Modic Change Type II Characterized by hyper-intense signal intensities on both T1W1 and T2W1. o Modic Change Type III Characterized by hypo-intense signal intensities on both T1W1 and T2W1. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial or lateral branches of the dorsal spinal nerves. D. PolicyI. CareSource considers intraosseous basivertebral nerve ablation medically necessary when ALL the following clinical criteria are met: A. Member has a diagnosis and documentation of chronic low back pain of at least 6 months duration . B. 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 (see definition above) 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 of inactive conservative therapy (see definition above) within the past 6 months C. MRI demonstrates Type I or Type II mo dic changes at one or more vertebra l endplates from level L3 to S1 , as demonstrated by Intraosseous Basivertebral Nerve Ablation-OH MCD-MM-1295Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 1. hypointense T1-weighted signal and hyperintense T2-weighted signal (ie,bone marrow edema and inflammation) , or 2. hyperintense T1-weighted signal and hyperintense T2-weighted signal (ie, bone marrow ischemia) D. Device is FDA-approved (eg, Intracept System) . E. Member does not have any of the following contraindications: 1. severe cardiac or pulmonary compromise 2. targeted ablation zone less than 10mm from a sensitive structure not intended to be ablated (including vertebral foramen) 3. active systemic infection or localized infection in the area to be treated 4. member is currently pregnant 5. skeletal immaturity 6. implantable pulse generator (eg, pacemaker, defibrillator) or other electronic implant 7. scoliosis 8. spinal instability II. Repeat or additional intraosseous basivertebral nerve ablation is not considered medically necessary, as it has not been adequat ely studied in the peer-reviewed medical literature. III. Monitored anesthesia and conscious sedation during intraosseous basivertebral nerve ablation are considered not medically necessary and will therefore not be reimbursed.IV. Coverage is limited to the abov e criteria. Intraosseous basivertebral nerve ablation isconsidered not medically necessary for all other indications.E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/30/2022 New PolicyDate Revised 03/01/2023 01/31/202401/29 /202 5Annual review: restructured conservative therapy, added HEP and TENS to definitions . Annual review: updated references. Approved at Committee Review: updated references, approved at Committee. Date Effective 05/01/2025 Date Archived Intraosseous Basivertebral Nerve Ablation-OH MCD-MM-1295Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. References1. Becker S, Hadjipavlou A, Heggeness MH. Ablation of the basivertebral nerve for treatment of back pain: a clinical study. Spine J. 2017;17(2):218-223 . doi :10. 1016/j.spinee.2016.08.032 2. Evidence Ba sed Clinical Guidelines for Multidisciplinary Spine Care : Diagnosis and Tr eatment of Low Back Pain . North American Spine Society ; 2020 . Accessed January 2, 2025 . www.spine.org 3. Evolving Evidence Review: Intracept Intraosseous Nerve Ablation System (Relievant Medsystems Inc.) for Treatment of Adults with Low Back Pain. Hayes ; 2023. Reviewed April 17, 2024. Accessed January 2, 202 5. www.evidence.hayesinc.com 4. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study. Int JSpine Surg . 2019;13(2):110-119. doi :10.1 4444/6015 5. Lorio M, Clerk-Lamalice O, Beall DP, Julien T. ISASS guideline : intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain. Int JSpine Surg . 2020;14(1):18-25. doi:10.14444/7002 6. Lorio M, Clerk-Lamalice O, Rivera M, L ewandrowski K. ISASS policy statement 2022: literature review of intraosseous basivertebral nerve ablation. Int JSpine Surg. 2022;16(6):1084-1094. doi:10.14444/8362 7. McCormick ZL, Curtis T, Cooper A, Wheatley M, Smuck M. Low back pain-related healthcare ut ilization following intra osseous basivertebral nerve radiofrequency ablation: a pooled analysis from three prospective clinical trials. Pain Med . 2024;25:20-32. doi:10.1093/pm/pnad114 8. Nwosu M, Agyeman WY, Bisht A, et al. The effectiveness of intraosseous basivertebral nerve ablation in the treatment of nonradiating vertebrogenic pain: a systematic review. Cureus . 2023;15(4):e37114. doi:7759/cureus.37114 9. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3728-3832. doi:10.2147/JPR.S386879 10. Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain and basivertebral n erve ablation from the American Society of Pain and Neuroscience. JPain Res . 2022;15:2801-2819. doi:10.2147/JPR.S378544 11. Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the t reatment of chronic low back pain: 12-month result. Reg Anesth Pain Med. 2021;46:683-693. doi:10.1136/rapm-2020 – 102259 12. Smuck M, McCormick ZL, Gilligan C, et al. A cost-effectiveness analysis of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J . 2024;S1529-9430(24)01040-4. doi:10.1016/j.spinee.2024.09.016 13. U.S. Food and Drug Administration. 510(k) Premarket Notification: Intracept Intraosseous Nerve Ablation System , 510( k) approval K 222281; 2022. Accessed January 2, 202 5. www.accessdata.fda.gov Intraosseous Basivertebral Nerve Ablation-OH MCD-MM-1295Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 14. U.S. Food and Drug Administration. 510(k) Premarket Notification: RelievantMedsystems RF Generator , 510( k) number: K171143; 201 7. Accessed January 2, 202 5. www.accessdata.fda.gov 15. Viswan athan VK, Shetty AP, Rajasekaran S. Modic changes an evidence-based, narrative review on its pathophysiology, clinical significance and role in chronic low back pain. JClin Orthop Trauma . 2020;11(5):761-769. doi:10.1016/j.jcot.2020.06.025 Independent med ical review March 2022 Approved by ODM 02/ 06/2 025

Inhaled Nitric Oxide

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Inhaled Nitric Oxide-OH MCD-MM-1053 05/01/2025 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 ………………………….. ………………………….. ………………………….. ………………………. 7 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 7 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …….. 8 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ………. 8 G. Review/Revision History ………………………….. ………………………….. ………………………….. ……. 8 H. References ………………………….. ………………………….. ………………………….. ……………………… 9 Inhaled Nitric Oxide-OH MCD-MM-1053Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectInhaled Nitric Oxide (iNO) B. BackgroundInhaled Nitric oxide (iNO) is a lipophilic gas that is naturally produced in numerous cells in the body and is readily absorbed across pulmonary membranes in the ventilated lung after inhalation. In the body, nitric oxide is involved in oxygen transport to the tissues, the transmission of nerve impulses, and other physiological activities. When administered via inhalation, it is a potent endogenous vasodilator that induces relaxation of vascular and bronchial smooth muscle, vasodilation of blood vessels, and can increase the partial pressure of arterial oxygen. iNO was initially approved by the U.S. Food and Drug Administration (FDA) in 1999. A complete nitric oxide delivery system is comprised of a nitric oxide administration apparatus, a nitric oxide gas analyzer, and a nitrogen dioxide gas analyzer. Additional warnings and precautions were added in 2013, including rebound hypertension following abrupt discontinuation, hypoxia from methemoglobinemia, and airway injury from nitrous dioxide. Dilation of pulmonary vessels in well-ventilated lung areas redistributes blood flow awayfrom lung areas where ventilation/perfusion ratios are poor. iNO has been used in conjunction with ventilator support as a treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN), in infants who are at term or near-term (greater than 34 weeks gestation) to improve oxygenation,and to decrease the need for extracorporeal membrane oxygenation (ECMO). Respiratory failure is a clinical state that is defined either by the inability to rid the bodyof carbon dioxide or establish an adequate blood oxygen level. Acute respiratory failure is the most common clinical problem seen in term, near-term (born at 34 or more weeks of gestation), and pre-term (less than 34 weeks of gestation) infants admitted to neonatal intensive care units. Acute respiratory failure is frequently associated with meconium aspiration syndrome, sepsis, pulmonary hypoplasia, and/or prima ry pulmonary hypertension of the newborn. Management of infants with respiratory failure includes administration of high concentrations of oxygen, hyperventilation, high-frequency ventilation, neuromuscularblockade, antenatal steroids for the prevention of respiratory distress syndrome, use of po st-natal steroids to decrease inflammation, as well as iNO therapy.Clinical studies have shown that iNO is a selective pulmonary vasodilator without significant effects on the systemic circulation. There is scientific evidence that iNO therapy improves oxygenation and ventilation, reduces the need for extracorporealmembrane oxygenation (ECMO), and lowers the incidences of chronic lung disease and death among infants with respiratory failure. Moreover, the literature indicates that iNO does not appear to increase the incidence of adverse neurodevelopmental, behavioral, Inhaled Nitric Oxide-OH MCD-MM-1053Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 or medical sequelae in these high-risk neonates. Infants with congenital diaphragmatic hernia (CDH) have not been shown to benefit from iNO therapy. Clark, et al (2000) concluded iNO does not lead to reduced ECMO use and Putnam, et al (2016) concluded iNO use in CDH may be associated with increased mortality. In preterm infants, the most common cause of acute respiratory failure is respiratory distress syndrome as a result of surfactant deficiency. According to the available literature, treatment of preterm infants usually entails exogenous surfactant administr ation. A systematic review of the evidence (Barrington and Finer, 2003)concluded: “The currently published evidence from randomized trials does not support the use of inhaled nitric oxide in preterm infants with hypoxic respiratory failure.” Carey, et al (2018) also concluded, Off-label prescription of iNO is not associated with reduced in-hospital mortality among premature infants with respiratory distress syndrome (RDS). In an Agency for Healthcare Research and Qualitys assessment on Inhaled Nitric Oxidein Preterm Infants , Allen, et al (2010) systematically reviewed the evidence on the use of iNO in preterm infants born at or before 34 weeks gestation age who receive respiratory support. They searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Studies (CENTRAL) and PsycInfo in June 2010. They also searched the proceedings of the 2009 and 2010 Pediatric Academic Societies Meeting and ClinicalTrials.gov. They identified addition al studies from reference lists of eligible articles and relevant reviews, as well as from technical experts. Questions were developed in collaboration with technical experts, including the chair of the upcoming National Institutes of Health Office of Medi cal Applications of Research Consensus Development Conference. These researchers limited their review to randomized controlled trials (RCTs) for the question of survival or occurrence of bronchopulmonary dysplasia (BPD), and for the question on short-term risks. All study designs were considered for long-term pulmonary or neurodevelopmental outcomes, and for questions about whether outcomes varied by subpopulation or by intervention characteristics. Two investigators independently screened search results an d abstracted data from eligible articles. These investigators identified a total of 14 RCTs, reported in 23 articles, and 8 observational studies. Chronic Lung Disease (CLD) or BPD studies have shown that there is insufficient evidence to support iNO for t he treatment of CLD or BPD. Mortality rates in the neonatal intensive care unit (NICU) did not differ for infants treatedwith iNO versus those not treated with iNO (RR 0.97 (95 % CI: 0.82 to 1.15)). Broncho-pulmonary dysplasia at 36 weeks for iNO and control groups also did not differ (RR 0.93 (0.86, 1.003) for survivors). A small difference was found between iNO and control infants in the composite outcome of death or BPD (RR 0.93 (0.87, 0.99)). There was inconsistent evidence about the risk of brain injury from individual RCTs, but meta – analyses showed no difference between iNO and control groups. These researchers found no evidence of differences in other short-term risks. There was no evidence to suggest a difference in the incidence of cerebral pa lsy (RR 1.36 (0.88, 2.10)), Inhaled Nitric Oxide-OH MCD-MM-1053Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 neurodevelopmental impairment (RR 0.91 (0.77, 1.12)), or cognitive impairment (RR 0.72 (0.35, 1.45)). Evidence was limited on whether the effect of iNO varies by subpopulation or by characteristics of the therapy (timing, dose and duration, mode of deliver y, or concurrent therapies). The authors concluded that there was a 7% reduction in the risk of the composite outcome of death or BPD at 36 weeks PMA for infants treated with iNO compared to controls, but no reduction in death or BPD alone. They stated that further studies are needed to explore subgroups of infants and to assess long-term outcomes including function in childhood. There is currently no evidence to support the use of iNO in preterm infants with respiratory failure outside the context of rigorously conducted RCTs. To provide health care professionals, families, and the general public with a responsible assessment of currently available data regarding the benefits and risks of iNO in premature infants, the Eunice Kennedy Shriver National Institute of Child Health andHuman Development, the National Heart, Lung, and Blood Institute, and the Office of Medical Applications of Research of the National Institutes of Health (Cole, et al, 2011) convened a consensus-development conference. Findings from a substantial body of experimental work in developing animals and other model systems suggest that iNO may enhance lung growth and reduce lung inflammation independently of its effects on blood vessel resistance. Although this work demonstrates biological plausibility and the results of RCTs in term and near-term infants were positive, combined evidence from the 14 RCTs of iNO treatment in premature infants of gestation of 34 weeks or less shows equivocal effects on pulmonary outcomes, survival, and neurodevelopmental outcomes. A National Institutes of Health Consensus Development Conference for inhaled nitricoxygen in premature infants (Cole, et al, 2010) recommended the following:1. Taken as a whole, the available evidence does not support use of iNO in early routine, early rescue, or later rescue regimens in the care of premature infants

Home Health Services

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Home Health Services-OH MCD-MM-1243 05/01/2025 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 ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 8 F. Related Policies/R ules ………………………….. ………………………….. ………………………….. …….. 8 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 8 H. References ………………………….. ………………………….. ………………………….. ……………………. 8 Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectHome Health Services B. BackgroundHome health services are skilled and supportive care services provided in the members home to meet skilled care needs and associated activities of daily living (ADLs) to allow the member to safely stay in the home. Home health services incorporate a wide variety of skilled healthcare and supportive services provided by licensed and unlicensed professionals. These services are designed to meet the needs of members with acute, chronic, and terminal illnesses or disabilities, who without this support might ot herwise require services in an acute care or residential facility. These guidelines for medical necessity determination s identify clinical information thatCareSource uses to determine medical necessity for home health services. These guidelines are base d on generally accepted standards of practice, review of medical literature, as well as federal and state policies and laws applicable to Medicaid programs. Providers should consult Chapter 5160-12 of the Ohio Administrative Code for detailsabout coverag e, limitations, service conditions, and prior-authorization requirements.C. Definitions HealthChek Program The Ohio-administered version of the early and periodic screening, diagnosis, and treatment (EPSDT) program , which is a federally mandated program of comprehensive preventive health services available to Medicaid-eligible individuals from birth through age twenty years and administered by the County Department of Job and Family Services (CDJFS). Home Health Agency A pers on or government entity, other than a nursing home, residential care facility, or hospice care program , that has the primary function of providing any of the following services to a patient at a place of residence used as the patients home: o skilled nursin g care o physical therapy o speech-language pathology o occupational therapy o medical social services o home health aide services, which means any of the following services provided by an employee of a home health agency: hands-on bathing or assistance with a tub bath or shower assistance with dressing, ambulation, and toileting catheter care but not insertion meal preparation and feeding Home Health Aide Services Services that use the skills of and are performed by a home health aide employed or contracted b y the Medicare Certified Home Health Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Agency ( MCHHA ) providing the service. Home health aide services include, but are not limited to, the following: o bathing, dressing, grooming, hygiene, including shaving, skin care, foot care, ear care, hair, nail and oral care, that are needed to facilitate care or prevent deterioration of the individual’s health, and including changing bed linens of an incontinent or immobile individual o feeding, assistance with elimination including administering enemas (unless the sk ills of a home health nurse are required), routine catheter care, routine colostomy care, assistance with ambulation, changing position in bed, and assistance with transfers o assisting with activities such as routine maintenance exercises and passive range of motion as specified in the plan of care. These activities are directly supportive of skilled therapy services but do not require the skills of a therapist to be safely and effectively performed. The plan of care is developed by either a licensed therapi st or a licensed registered nurse within their scope of practice o performing routine care of prosthetic and orthotic devices Home Health Nursing Services Services that require the skills of and are performed by a registered nurse or a licensed practical n urse at the direction of a registered nurse. The nurse performing the home health service must possess a current, valid, and unrestricted license with the Ohio Board of Nursing and must be employed or contracted by an MCHHA that has an active Medicaid prov ider agreement. A service is not considered a nursing service merely because it is performed by a licensed nurse. 1. Home health nursing services include, but are not limited to, the following: a. IV insertion, removal, or discontinuation b. IV medication administr ation c. programming of a pump to deliver medications including, but not limited to, epidural, subcutaneous IV (except routine doses of insulin through a programmed pump) d. insertion or initiation of infusion therapies e. central line dressing changes f. blood produc t administration 2. Home health nursing services do not include a visit when the sole purpose is for the supervision of the home health aide. Medical Necessity Must meet ALL of the following conditions: o meets generally accepted standards of medical practice o clinically appropriate in its type, frequency, extent, duration, and delivery setting o appropriate to the adverse health condition for which it is provided and is expected to produce the desired outcome o is the lowest cost alternative that effective ly addresses and treats the medical problem o provides unique, essential, and appropriate information if it is used for diagnostic purposes o not provided primarily for the economic benefit of the provider nor for the convenience of the provider or anyone els e other than the recipient Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 Skilled Therapies A collective term encompassing physical therapy, occupational therapy, speech-language pathology, and audiology. D. PolicyI. Home health services , including home health aide and home health nursing , are provided to any CareSource Ohio Medicaid member when considered medically necessary. II. Duplicative services are not covered.A. There must be documentation of all other therapies/services the member is receiving, when relevant to home health services. B. If the member is receiving other assistance (eg, meal delivery program, family caregiver, additional supportive services), this information and the hours involved must be pr ovided to adequately evaluate medical necessity of home health services. C. The aid provided must be appropriate to the member. Guidelines are provided (see Table below) to assist in determining the amount of care a member requires. III. Home Health Services for Individuals Age d 21 Years and OlderA. Routine home health services are considered medically necessary for individuals age d 21 years and older when ALL the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services or within 30 days following the start of home health services . 3. There is a written plan of treatment, as evidenced by one of the following: the Ohio Department of Medicaid (ODM) 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services OR the individual’s plan of care if all of the dat a elements specified for home health services on the ODM 07137 are included . 4. At the time of billing, the plan of care /treatment plan contains the signature, credentials , and the date of the signature of the qualifying treating physician, advanced practice registered nurse , or physician assistant . 5. The home health services will be provided by a Medicare Certified Home Health Agency (MCHHA) . 6. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for private duty nursing, which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapie s c. Total Hours Per Week: 14 hours combined per week of home health nursing and home health aide services Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 NOTE: additional hours of care may be considered based upon medical necessity . B. Following discharge from an inpatient hospital stay, home health services are considered medically necessary for individuals age 21 years and older when ALL the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services, or within 30 days following the start of home health services . 3. There is a written plan of treatment as evidenced by the ODM 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services . 4. The individual is discharged from a covered inpatient hospital stay of at least 3 days, with the discharge date recorded on form ODM 07137 . 5. The individual has a comparable level of care as evidenced by either: enrollment in a home and community-based services (HCBS) waiver OR a medical condition that temporarily meets the criteria for an institutional level of care . 6. The individual requires home health nursing, or a combination of private duty nursing, home health nursing, or waiver nursing and/or skilled therapy services at least 1 per week . 7. The home health services will be provided by a Medicare Certified Home Health Agency (MCHHA) . 8. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for private duty nursing, which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapies c. Total Hours Per Week: 28 hours combined per week of home health nursing and home health aide services for up to 60 consecutive days from the date of discharge from an inpatient hospital stay Note: additional hours of care may be considered based upon medical necessity. IV. Routine Home Health Servi ces for Individuals Under Age 21 YearsA. Routine home health services are considered medically necessary for individuals under age 21 years when ALL of the following criteria are met: 1. There has been a face-to-face encounter between the individual and a quali fying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services, or within 30 days following the start of home health services . Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 3. There is a w ritten plan of treatment, as evidenced by one of the following: theOhio Department of Medicaid (ODM) 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services OR the individual s plan of care if all of the data elements specified for home health services on the ODM 07137 are included . 4. At the time of billing, the plan of care contains the signature, credentials , and the date of the signature of the qualifying treating physician, advanced practice registe red nurse or physician assistant . 5. The home health services will be provided by a Medicare Certified Home Health Agency (MCHHA) . 6. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for private duty nursing, which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapie s c. Total Hours Per Week: 14 hours combined per week of home health nursing and home health aide services d. A member may qualify for increased home health services when ALL the following criteria are met: 01. The services are required for treatment in accordance w ith the Healthchek program (EPSDT) . 02. The member has a comparable level of care as evidenced by either enrollment in a HCBS waiver or a level of care evaluated initially and annually by ODM or its designee for an individual not enrolled in an HCBS waiver . 03. Th e member needs home health nursing or a combination of PDN, home health nursing, waiver nursing, and skilled therapies at least once per week . 04. The member needs more than, as ordered by the treating clinician, 8 hours per day of any home health service, or a combined total of 14 hours per week of home health aide and home health nursing. B. Following discharge from an inpatient hospital stay, home health services are considered medically necessary for individuals under age 21 years when ALL the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physi cian assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services, or within 30 days following the start of home health services . 3. There is a written plan of treatment as evidenced by the ODM 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services . 4. The home health services will be provided by a Medicare Certified Home Health Agency (MCHHA) . Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 5. The individual is discharged from a covered inpatient hospital stay of at least 3 days , with the discharge date recorded on form ODM 07137 .6. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for private duty nu rsing, which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapies c. Total Hours Per Week: 28 hours combined per week of home health nursing and home health aide ser vices for up to 60 consecutive days from the date of discharge from an inpatient hospital stay d. A member may qualify for increased home health services when ALL the following criteria are met: 01. The services are required for treatment in accordance with the Healthchek program (EPSDT) . 02. The individual has a comparable level of care as evidenced by either: enrollment in a home and community-based services (HCBS) waiver OR a medical condition that temporarily meets the criteria for an institutional level of care . 03. The individual requires home health nursing, or a combination of private duty nursing, home health nursing, or waiver nursing and/or skilled therapy services at least 1 per week . 04. The member needs more than, as ordered by the treating clinician, a combined total of 28 hours per week of home health nursing and home health aide for up to 60 days. V. Incidental services may be included durin g a home health visit, as long as the services do not substantially extend the time of the visit. A. Incidental services are necessary household tasks that must be performed by someone to maintain a home and can include light chores, laundry, light house clea ning, preparation of meals, and taking out the trash. B. The main purpose of a home health aide visit cannot be solely to provide these incidental services since the services are not health related services. C. Incidental services are to be performed only for th e individual and not for other people in the individuals place of residence. VI. Home health services do NOT include any of the following :A. a visit when the sole purpose is for the supervision of the home health aide B. patient assessment services C. patient consul tation services D. transporting the member to grocery stores, pharmacies, banks, etc. E. homemaker services (eg, shopping, laundry, cleaning, meal preparation) F. chores (eg, running errands, picking up prescriptions) G. sitter or companion services (eg, activity plan ning, escorting member to events) H. respite care Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 VII. General guidelines for care based on the Aide Norms ToolTask Type General Guideline Mobility (bed, transfer, locomotion) 5min/ADL inside and 15min outside. Positioning Q2 hr Bathing 30 min/day includes prep/clean up; transfers Grooming 15 min/day includes all hair care, oral care, nails general hygiene care Medication 5 min/dose time regardless of number of medications Toileting Bladder : 10 min/2 hr awake; 2x/night; add 5 min if incontinent. Bowel: 10 min/BM, add 10 min if incontinent Dressing 15 min/day; plus 5 min/device (prosthetic) Eating 30 min/meal with 3 meals and 2 snacks per day Linen Changes 30 min/week E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 1/19/2022 New policy.Date Revised 06/16/2022 02/01/202301/17 /202401/15 /2025Out-of-cycle update: split criteria III.A.3 and IV.A.3 so latter states at time of billing. Annual review: updated references, clarified hours of care based on medical necessity . Annual review: updated references and formatting. Approved at Committee. Review: updated references. Approved at Committee. Date Effective 05/01/2025 Date Archived H. References1. Administrative Procedures for Comprehensive Health Care for Children in Placement, OHIO ADMIN . CODE 5101:2-42-66 (2019). 2. Definitions, OHIO ADMIN . CODE 3701-19-01 (2020). 3. Definitions, OHIO ADMIN . CODE 3701-60-01 (20 23 ). 4. Home Health and Private Duty Nursing: Visit Policy, OHIO ADMIN . CODE 5160-12-04 (2021). Home Health Services-OH MCD-MM-1243Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 5. Home Health Services: Provision Requirement s, Coverage and ServiceSpecification, OHIO ADMIN . CODE 5160-12-01 (2021). 6. Managed Care: Covered Services, OHIO ADMIN . CODE 5160-26-03 (2022). 7. Medicare Certified Home Health Agencies: Qualification and Requirements, OHIO ADMIN . CODE 5160-12-03 (2015). 8. Payment For Home Health Nursing Services and Home Health Aide Services , OHIO ADMIN . CODE 4123-6-38 (2022). 9. Payment For Nursing and Caregiver Services Provided by Persons Other Than Home Health Agency Employees, OHIO ADMIN . CODE 4123-6-38.1 (2022). 10. Reimbursement: Exceptions, OHIO ADMIN . CODE 5160-12-07 (2015). 11. Reimbursement: Home Health Services, OHIO ADMIN . CODE 5160-12-05 (202 4). Approved by ODM on 01/2 3/202 5

Epidural Steroid Injections

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Epidural Steroid Injections-OH MCD-MM-0007 05/01/2025 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 ut ilization 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 which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunctio n 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 service s 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 pa yment 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., E vidence 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 treatmen t 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 ………………………….. ………………………….. ……………….. 6 H. Re ferences ………………………….. ………………………….. ………………………….. ……… 6 Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 05/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectEpidural Steroid Injections B. BackgroundNearly 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 are persistent . Persistent p ain is categorized as subacute when lasting between four a nd twelve weeks and chronic when persisting for at least three months. Comprehensive pain management care plan s are most effective in managing a patientschronic pain. These plans focus on a person-centered approach and incorporate conservative treatmen t with other modalities . These m ultidisciplinary treatments include promoting patient self-management and aim to reduce the impact of pain on a patient’s daily life, even if the pain cannot be relieved completely. In addition to conservative therapy, addit ional treatment options may include nonpharmacologic or pharmacologic treatments, nonsurgical interventions, and surgical interventions. Interventional procedures for the management of pain unresponsive to conservative treatment should be provided only by physicians qualified to deliver these health services. Epidural steroid injections (ESIs) are a nonsurgical, minimally-invasive intervention for chronic low back pain. ESIs may be administered through the translaminar approach (via the interlaminar space in the spine), the transforaminal approach (through the neuroforamen dorsal to the nerve root), or the caudal approach (through the sacral hiatus at the sacral canal ). There is conflicting evidence on the efficacy of ESIs and a lack of consensus on frequency and number of epidural steroid injections from professional organizations. However, clinical experience suggests that some patients obtain more significant relief, making it reasonable to offer a trial of steroid injections when conservative mana gement has failed. Imaging studies of the symptomatic region may be performed to evaluate suspected specific causes of spinal pain (eg, herniated disc, spinal stenosis, degenerative vertebral disease, rule out fracture or tumor). However, evidence does n ot support the routine useof imaging or other diagnostic tests in patients with nonspecific low back pain. Diagnostic imaging and testing are only recommended when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination. C. Definitions Conservative Therapy A multimoda l 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, including physical therapy, occupational therapy, a physician supervised home exercise program (HEP), and/or chiropractic care. Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 05/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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 the HEP due to a stated physical reason (ie, increased pain, inability to physically per form exercises). Patient inconvenience or n oncompliance without explanation does not consistute 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 u se , and/or pharmacotherapy (prescription or over the counter [eg, non-steroidal anti-inflammatory drugs, acetaminophen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes place d 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 use, frequency, duration, and start dates must be documented in the m edical record to be considered part of conservative therapy during the period of prior authorization request. Epidural Steroid I njection Administration of steroids via a needle inserted in the space between the ligamentum flavum and the dura and adm inistered by translaminar, tranforaminal , or caudal approach es . Injections are intended to cause a short-term reduction in pain in the affected region. D. PolicyI. Epidural steroid injections for labor and delivery in childbirth or post-surgical pain do not require medical necessity review . II. Initial (Diagnostic) InjectionCareSource considers an initial (diagnostic) epidural steroid injection (maximum of 2injections) medical ly necessary for the management of chronic pain when ALL the following clinical criteria are met: A. Pain is located in either the cervical, thoracic, or lumbar spine and is predominantly radiating or shooting in nature . B. Pain is causing functional disability . C. Signs or symptoms are consistent with radiculopathy, as indicated by at least one of the following: 1. diminished or absent deep tendon reflexes 2. paresthesia, numbness, sensory change, or weakness in dermatomal distribution 3. positive femoral nerve stretch test 4. positive Spurling test 5. positive straight leg raising test D. Conservative therapy has failed to alleviate symptoms, as evidenced by ALL the following: 1. documentation in the medical record of at least 6 weeks of active conservative therapy ( see definition above ) within the past 6 months OR Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 05/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 inability to complete active conservative therapy due to contraindication, increased pain, or intolerance2. documen tation in the medical record of at least 6 weeks of inactive conservative therapy ( see definition above ) within the past 6 months E. Imaging (eg, x-ray, CT, MRI), if performed, demonstrates that there are no conditions present that would preclude the safety of the performance of the procedure. III. Subsequent (Therapeutic) InjectionsCareSource considers therapeutic epidural steroid injections medically necessary when ALL the following criteria are met: A. The diagnostic or last therapeutic injection for current episode of pain provided significant functional pain relief as measured by a significant decrease in pain level (as demonstrated on a qualitative pain scale) , decrease in pain medications, and/or increase in physical function . B. The member continues to have ongoing pain or documented functional disability . C. At least 3 weeks have passed since the prior injection in order to reach pharmacodynamic effect . D. No more than 3 procedures in a 12-week period of time per region are considered medically necessary. E. The member continues to engage in conservative therapy (see definition above). IV. Limitations and ExclusionsA. In general, most individuals should not require more than 6 total epidural injections in 12 months. Additional injections may be considered on a case by case basis when the individual has multiple treatment sites.B. For interlaminar or caudal epidural injections , no more than 1 epidural injection per treatment date should be performed . C. For t ransforaminal epidurals or selective nerve root blocks (SNRBs) , no more than 2 vertebral levels per treatment date, whether unilatera l or bilateral, should be performed . D. Real-time image guidance and any injection of contrast are inclusive components of epidural injections and are not compensated for separately or unbu ndled for coverage. E. Conscious sedation, if required for co-morbidities or patient/physician preference, may be provided without a medical necessity review but services will be considered part of the procedure and are not eligible for additional reimbursement if administered by a second provider. F. Monitored anesthesia is considered not medically necessary . G. Patients with indwelling implanted spinal cord stimulators or pain pumps must have a device interrogation report and an interpretation submitted with medical records, and included in the prior authorization request for p ropos ed interventional pain injectio ns. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 05/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. Clinical evaluations and care of candidate patients for epidural injections should also address, at t he discretion of the phy sician and according to prevailing standards of medical care: 1. no acute spinal cord compression 2. selected body imaging evaluation s to evaluate the area of pain, particularly for acute pain, or to evaluate escal ations in chronic baseline pain 3. appropriate imaging to rule out red flag conditions may be indicated if potential issues of trauma, osteomyelitis or malignancy , or other diagnoses are a concern I. Contraindications include any of the following: 1. pain related to cancer etiology 2. local or systemic infection 3. cauda equina syndrome 4. spinal trauma (eg, hematoma, hemorrhage, mass, ischemia) 5. coagulopathy V. Inconclusive or Non-Supportive EvidenceA. Evidence reported in the medical literature is inconclusive as to the use of epidural injections for lon g term relief or treatment of chronic pain. Long-term continuation (epidural injections beyond 1 year) may be subject to medical necessity review. B. For both cervical and lumbar transforaminal (TF) ESIs, using particulate steroid is associated with a rare ri sk of catastrophic neurovascular complications such as stroke or death. Cervical transforaminal injections are risky because arterial supply may be densely concentrated in and around the intervertebral foramen. TF ESIs can be performed without contrast in patients with documented contraindication to its use. In these circumstances , particulate steroids are contraindicated and only the preservative free, particulate fre e steroids which are available should be used. C. Cervical transforaminal ESIs have sparse l iterature for cervical radicular pain, and , if performed , should be performed by injecting contrast medium under real – time fluoroscopy and/or digital subtraction angiography (DSA) in a frontal plane, before injecting any substance potentially hazardous to the patient. Particulate steroids should not be used for cervical TF injections as per the contraindication established by the FDA warning. E. Conditions of CoverageNA F. Related Policies/RulesNA Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 05/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 G. Review/Revision HistoryDATES ACTIONDate Issued 01/27/2015 New PolicyDate Revised 03/06/2019 05/13/202004/28/202103/ 16 /2022 11/03/202203/15 /202301/31/202401/15 /2025Annual Update: Removed start and end dates. Addition of PA clarification and documentation requirements. Annual Update : Updated language around benefit limits. Annual Update: Removed PA language. Annual Review. Updated formatting and references, consoli dated background and evidence , separated indic ations into initial and subsequent injections, frequency restrictions, and limitations/exclusions, added contraindications. Removed anti-platelet therapy contraindication Annual review: reorganized criteria, simplified conservative therapy, added provocation tests . Approved at Committee. Annual review: updated references and formatting. Approved at Committee. Review: removed US limitation, updated references, approved at Co mmittee. Date Effective 05/01/2025 Date Archived H. References1. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate . Updated May 15, 2024 . Accessed December 18 , 2024. www.uptodate.com 2. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back p ain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 3. Chou R, Hashimoto R, Friedly J, et al. Epidural corticosteroid injections for radiculopathy and spinal ste nosis: a systematic review and meta-analysis. Ann Intern Med . 2015;163(5):373-381. doi:10.7326/M15-0934 4. Conger A, Cushman DM, Speckman RA, et al. The effectiveness of fluroscopically guided cervical transforaminal epidural steroid injection for the treatment of radicular pain; a systematic review and meta-analysis. Pain Med. 2020;21(1):41-54. doi:410.1093/pm/pnz127 5. Goel A, Singh S, Shukla NK, et al . Efficacy o f caudal epidural steroid injections in chronic low backache patients. JPharm Bioallied Sci. 2023;15(Suppl 1):S669-S672. doi:10.4103/jpbs.jpbs_89_23 6. Helm S, Harmon PC, Noe C, et al. Transforaminal epidural steroid injections: a systematic review and meta-analysis of efficacy and safety. Pain Phys ician . 2021;24:S209-S232. Accessed December 18 , 2024. www.painphysicianjournal.com Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 05/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 7. Kennedy DJ, Levin J, Rosenquist R, et al. Epidural steroid injections are safe and effective: multisociety letter in support of the safety and effectiveness of epidural steroid injections. Pain Med. 2015;16(5):833-838. doi:10.1111/pme.12667 8. Lee JH, Shin K, Bahk SJ, et al. Comparison of clinical efficacy of transforaminal and caudal epidural steroid injection in lumbar and lumbosacral disc herniation: a systematic review and meta-analysis. Spine J . 2018;18(12):2343-2353. doi:10 .1016/j.spine e.2018.06.720 9. Manchikanti L, Benyamin RM, Falco FJ, et al. Do epidural injections provide short – and long-term relief for lumbar disc herniation? A systematic review. Clin Orthop Relat Res. 2015;473(6):1940-1956. doi:10.1007/s11999-014-3490-4 10. Manchikanti L, Knezevic NN, Boswell MV, et al. Epidural injections for lumbar radiculopathy and spinal stenosis: a comparativ e systematic review and meta – analysis. Pain Physician. 2016;19(3):E365-410. Accessed December 18 , 2024. www.painphysicianjournal.com 11. Manchikanti L, Knezevic NN, Navani A, et al. Epidural interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) comprehensive evidence-based guidelines. Pain Physician. 2021;24(S1): S27-S208. Accessed December 18 , 2024. www.painphysicianjournal.com 12. Oliveira CB, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections for lumbosacral radicular pain. Cochrane Database Syst Rev. 2020;4(4):CD013577. doi: 10.1002/14651858.CD013577 13. Qassem A, Wilt TJ, McLean RM et al. Noninvasive treatments for acute, subacute and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Inter n Med . 2017 ;166(7):514-530 . doi:10.7326/M16-2367 14. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3729-3832. doi:10.2147/JPR.S386879 15. Taskaynatan MA, Tezel K, Yavuz F, et al. The effectiveness of transforaminal epidural steroid injection in patients with radicular low back pain due to lumbar disc herniation two years after treatment. JBack Musculoskelet Rehabil. 2015;28(3):447 – 451. doi: 10.3233/BMR-140539 16. Verheijen EJA, Bonke CA, Amorij EMJ, et al . Epidural steroid compared to placebo injection for sciatica: a systematic review and meta-analysis. Euro Spine J . 2021;30:3255-3264. doi:10.1007/s00586-021-06854-9 17. Woo JH, Park HS. Cervical transforaminal epidural block using low-dose local anesthetic: a prospective, randomized, double-blind study. Pain Med. 2015;16(1):61 – 67. doi:10.1111/pme.12582 18. Yang S, Kim W, Kong HH, et al. Epidural steroid injection versus conservative treatment for patients with lumbosacral radicular pain: a meta-analysis of randomized controlled trials. Med. 2020;99(30):e21283. doi:10/1097/MD. 0000000000021283 Approved by ODM 01/23/2025

Durable Medical Equipment Repairs

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Durable Medical Equipment Repairs-OH MCD-MM-1579 05/01/2025 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 Durable Medical Equipment Repairs-OH MCD-MM-1579Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectDurable Medical Equipment Repairs B. BackgroundDurable medical equipment (DME) is equipment that serves a medical purpose, helps complete activities of daily living (ADLS), can withstand repeated use , and is primarily used in the home . DME includes items, such as wheelchairs, hospital beds, continuous positive airway pressure (CPAP), walkers, oxygen tanks, etc. DME is dispensed when medical necessity is established to meet the needs of the member s medical condition. DME is likely to last 3 years or more but may require maintenance, service, or repairperiodically. When service is required, the DME provider may request authorization to perform the required maintenance, service, or repair to restore the DME item to working order. C. Definitions Durable Medical Equipment (DME) Equipment that can stand repeated use, is primarily and customarily used to serve a medical purpose, is not useful to a person in the absence of illness or injury and is appropriate for use in the home . Healthcare Common Procedure Coding System (HCPCS) A numeric and alphanumeric code set maintained and distributed by the Centers for Medicare and Medicaid Services for the uniform designation of certain medical procedures and related services. Repair The repairs, including the replacement of essential accessories, such as hoses, tubes, mouth pieces, etc., for necessary DME are covered when required to make the item/device serviceable. Replacement Replacement of DME is for the same or similar type of equipment , which is beyond its reasonable useful life span and has become irreparable. D. PolicyI. A review of medical necessity is required for all DME repairs. II. If the DME item was not originally approved by CareSource, medical necessity must be established before any repair is authorized.III. Providers should submit ODM form 01904 and must include the following:A. specification of the item, including manufacturer, model, and serial number , if applicable B. date on which the item was originally purchased or dispensed or, if the date is not known, the approximate age of the item C. any warranty period and the type of warranty (manufacturer or dealer) D. a full description of the wear, damage, or malfunction E. a full description of the repair F. a description, with dates, of previous repairs (both major and minor) Durable Medical Equipment Repairs-OH MCD-MM-1579Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 G. a complete itemization of partsH. an estimate of labor time needed (Labor should be billed with K0739 for 15 – minute increments, 4 units = 60 minutes of labor .) IV. During the medical necessity reviewA. Providers should advise CareSource when, in a professional opinion, replacement of an item would be more cost-effective than repair. B. CareSource may consider whether the purchase of a new piece of equipment may be more cost-effective than continued repair. CareSource will not reimburse a repair that exceed s the cost of a replacement item. C. Multiple repairs requested within a short time span may suggest deliberate or malicious damage or destruction. In these cases, repair may be denied. V. Separate payment will not be made for the following items or services:A. temporary replacement (“loaner”) equipment provided while an individual’s own equipment is being repaired B. repair of an item if within the preceding 12 months Medicaid payment was made for the repair of a duplicate or conflicting item currently in the individual’s possession C. repair of an item that is no longer deemed to be medically necessary VI. CareSource considers a replacement part as a new equipment purchase and modifier NU should be used instead of modifier RB.E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 02/14/2024 New policy. Approved at Committee.Date Revised 01/15/2025 Annual review. Updated references and medical necessity lanaguge. Approved at Committee. Date Effective 05/01/2025 Date Archived H. References1. DMEPOS: Repair, OHIO ADMIN . CODE 5160-10-02 (2024). 2. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . CODE 5160-10-01 (2024). 3. DMEPOS: Wheelchairs, OHIO ADMIN . CODE 5160-10-16 (2021). 4. Definitions, OHIO REV . CODE 4752.01 (2018) Durable Medical Equipment Repairs-OH MCD-MM-1579Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 5. Definitions, 42 U.S.C. 1395x (2024).ODM Approved on 01/23/2025

Adaptive Seating for Special Needs

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Adaptive Seating for Special Needs-OH MCD-MM-1718 05/01/2025 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 ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectAdaptive Seating for Special Needs B. BackgroundCerebral palsy, developmental delays, Down syndrome , and other health conditions may compromise an individuals ability to maintain a sitting posture , muscle tone, and movement . Depending on the severity and type of health condition, individuals may require support for the head, trunk, pelvis, and legs limit ing the ability to interact with others, eat, dress, work, and play. In addition, the se individuals may lack the stability and strength for mobility or transfers. Adaptive seating systems (AdSS) may be used by individuals to achieve and hold anupright sitting position , enabl ing individuals to engage with others and conduct activities of daily living. AdSS can be individualized to meet the unique needs of the person with accessories that allow for the seats to tilt, adjust seat height, increase posture support, transfers, and for limited mobility in the local environment . C. Definitions Adaptive Desks Generally considered furniture and used to support physical and educational needs in a school setting. Adaptive Seating Systems (AdSSs) Equipment designed to improve safety, efficiency of movement , and optimize positioning while promoting active participation in daily activities . There are 2 types : o Activity Chairs Seats that o ptimiz e positioning (eg, adaptive chairs, special needs chairs, pediatric positioning chairs, sitters, and therapy chairs ). o High-Low Chairs Height adjustable seats that secure the individual at the midline with adjustable trunk support, shoulder straps, and hip belts. Adaptive Strollers Strollers with increased seating and positioning options than a basic stroller . D. PolicyI. Adaptive Seating Systems (AdSS) and Accessories A. Adaptive Seating Systems A review of medical necessity must occur prior to purchase/delivery of the item. CareSource considers AdSS medically necessary when ALL the following clinical criteria are met: 1. A prescription valid for 1 year is written by any of the following providers with an established relationship with the member and appropriate certifications or training after document ing a completed face-to-face encounter : a. physician b. advanced practice registered nurse c. physician assistant Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 2. Documentation that the member cannot safely sit in conventional seating due to a medical condition, modifications to the members current seating equipment cannot meet their needs, and at least 1 of the following criteria: a. significant head and/or trunk instability or weakness with decreased motor control b. requires external support to maintain an upright position and proper body alignment c. has no functional protective or righting reaction d. must be in an upright su pported position for safe and effective feeding and would otherwise have to be held by the caregiver for feeding e. severe seizure activity f. orthopedic condition resulting in significant bony fragility or significant fracture 3. A physical therap ist (PT) or occupational therapist (OT) experienced in an appropriate specialty and independent from the equipment vendor completed an evaluation and documented that the member can benefit from and safely use the item requested. 4. An y person-centered service plans for the member, when applicable, must list use of AdSS. 5. A complete description of the item requested, including: a. manufacturer b. model of style c. size d. all bundled components e. any accessories or not-included components f. any itemization of all charges B. Accessories 1. Accessorie s are considered medically necessary when they provide additional functional support than is offered by a chair alone and any of the following criteria are met : a. cannot maintain head control in an upright position b. unable to perform a functional weight shift requiring relief to prevent pressure injuries c. needs additional trunk support that is not provided by the chair alone d. changes in muscle tone affecting body tilt or needs additional support for proper digestion or avoidance of severe gastro esophageal reflux e. needed for independent movement in and out of the chair or repositioning the chair to complete daily activities II. Exclusions and LimitationsA. AdSS does not include ANY of the following: 1. adaptive desks 2. adaptive strollers 3. any items not meeting the medical necessity criteria in this policy Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 B. Duplicative equipment is excluded. Equipment with the same function as an existing AdSS will not be reviewed for medical necessity. C. AdSS must be the lowest cost alternative that addresses the members health condition. D. AdSS is for the benefit of the member and not for any caregiver, family member, or provider convenience. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 12/04/2024 New policy. Approved at Committee.Date Revised Date Effective 05/01/2025 Date Archived H. References1. Angsupaisal M, Maathuis CGB, Hadders-Algra M. Adaptive seating systems in children with severe cerebral palsy across International Classification of Functioning, Disability, and Health for children and youth version domains: a systematic review. Dev Med Child Neurol . 2015;57(10):919-930. doi:10.1111/dmcn.12762 2. Barkoudah E, Whitaker A. Cerebral palsy: treatment of spasticity, dystonia, and associated orthopedic issues. UpToDate. Updated Nov 17, 2023. Accessed January 3, 2025 . www.uptodate.com 3. Hale LW, Martin C. Autism spectrum disorder in children and adolescents: behavioral and educational interventions. UpToDate. Updated October 22, 2024. Accessed January 3, 2025 . www.uptodate.com 4. Inthachom R, Prasertsukdee S, Ryan SE, et al. Evaluation of the multidimensional effects of adaptive seating interventions for young children with non-ambulatory cerebral palsy. Disabil Rehabil Assist Technol . 2021;16(7):780-788. doi:10.1080/17483107.2020.1731613 5. Khan I, Leventhal BL. Developmental Delay . StatPearls Publishing; 2023. Accessed January 3, 2025 . www.ncbi.nlm.nih.gov 6. Lyman J. Complex rehabilitation fact sheet. Cerebral Palsy Foundation. Published August 16, 2022. Accessed January 3, 2025 . cpresource.org 7. Paleg G, Livingstone R, Rodby-Bousquet E, et al. Care Pathways central hypotonia. American Academy of Cerebral Palsy and Developmental Medicine. Accessed January 3, 2025 , 2024. www.aacpdm.org Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 8. Provider recommendations for FY 2024 budget medical care advisory committee meeting June 2022. National Council for Assistive & Rehab Technology. Accessed January 3, 2025 , 2024. www.ncart.us9. Ryan SE. Lessons learned from studying the functional impact of adaptive seating interventions for children with cerebral palsy. Dev Med Child Neurol . 2016;58 (Suppl 4):78-82. doi:10.1111/dmcn.13046 10. Saihinoglu D, Coskun G, Bek N. Effects of different seating equipment on postural cont rol and upper extremity function in children with cerebral palsy. Prosthet Orthot Int . 2017;41(1):85-94. doi:10.1177/0309364616637490 Independent medical review December 2024ODM approved 1/23/2025

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System Details