MEDICAL POLICY STATEMENT KENTUCKY MEDICAID Policy Name Policy Number Date Effective Sacroiliac Joint Procedures MM-0777 9/1/2019 Policy Type MEDICAL Administrative Pharmacy Reimbursement Medical Policy Statement prepared by CSMG Co. and its affiliates (including Humana CareSource) are derived from literature based on and supported by clinical 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 which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including Humana CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Table of Contents A. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions …………………………………………………………………………………………………………… 4 D. Policy …………………………………………………………………………………………………………………. 5 E. Conditions of Coverage …………………………………………………………………………………………. 7 F. Related Polices/Rules …………………………………………………………………………………………… 7 G. Review/Revision History ……………………………………………………………………………………….. 7 H. References …………………………………………………………………………………………………………. 7 Sacroiliac Joint Procedures KENTUCKY MEDICAID MM-0777 Effective Date: 9/1/2019 2 A. SUBJECT Sacroiliac Joint Procedures B. BACKGROUND Interventional 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 patient’s daily life, even if the 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. Up to 10% to 25% of patients with persistent low back pain may have a component of pain related to sacroiliac joints. However, no clear conservative, interventional, or surgical management alternatives definitively manage sacroiliac joint pain. Clinicians apply various techniques with wide variation. Available evidence for the diagnostic accuracy of sacroiliac joint injections is good, the evidence for provocation maneuvers is fair, but evidence for imaging of the SI joint is inadequate. In a recent review, pain researchers reported that evidence is poor for short and long-term pain relief from both intra-articular and peri-articular injections of these joints with steroids. Professional Society Recommendations: The following professional societys recommendations are derived from the latest guidelines and scientific based literature available. American College of Physicians (ACP) & American Pain Society (APS) (October 2007) Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or back pain potentially associated with another specific spinal cause. The history should include assessment of psychosocial risk factors, which predict risk for chronic disabling back pain. Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain. Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination. Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection. Clinicians should provide patients with evidence-based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective self-care options. For patients with low back pain, clinicians should consider the use of medications with proven benefits in conjunction with back care information and self-care. Clinicians should assess severity of baseline pain and functional deficits, potential benefits, risks, and relative lack of long-term efficacy and safety data before initiating therapy. For most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs. For patients who do not improve with self-care options, clinicians should consider the addition of nonpharmacological therapy with proven benefitsfor acute low back pain, spinal manipulation; for chronic or subacute low back pain, intensive interdisciplinary Sacroiliac Joint Procedures KENTUCKY MEDICAID MM-0777 Effective Date: 9/1/2019 3 rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive relaxation. American College of Physicians (ACP) (April 2017) The ACPs recommendations for Noninvasive Treatments for Acute, Subacute and Chronic Low Back Pain: A Clinical Practice Guideline are as follows: Clinicians and patients should select nonpharmacological treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desire, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). Clinicians and patients should initially select nonpharmacological treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relation, electromyography biofeedback, low level laser therapy, operant therapy, cognitive behavioral therapy or spinal manipulation. In patients with chronic low back pain who have had an inadequate response to nonpharmacological therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option. in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. C. DEFINITIONS Conservative therapy is a multimodality plan of care. Start and end dates in the medical record substantiate duration of treatment. Multimodality care plans include BOTH of the following: o Active conservative therapies such as physical therapy, occupational therapy or a physician supervised home exercise program (HEP) Home Exercise Program (HEP): includes two components that are both required to meet Humana CareSource policy for completion of conservative therapy: Information provided for an exercise prescription and/or plan documented in the medical record AND follow up documented in the medical record with member with information provided regarding completion of HEP (after suitable six (6) week period), or inability to complete HEP due to a stated physical reason-i.e. increased pain, inability to physically perform exercises. (Patient inconvenience or noncompliance without explanation does not constitute inability to complete). o Passive conservative therapies such as rest, ice, heat, medical devices, acupuncture, TENS unit, prescription medications. If a TENS unit is part of the care plan, the frequency of use, and duration of use with dates must be documented in the medical record. General statements in the medical record such as Patient has a TENS unit do not document use, and will not suffice to meet this policy criterion. A TENS unit is a Transcutaneous Electrical Nerve Stimulator is a durable medical equipment device dispensed by prescription.Sacroiliac Joint Procedures KENTUCKY MEDICAID MM-0777 Effective Date: 9/1/2019 4 D. POLICY Criteria A prior authorization (PA) is required for each sacroiliac joint injection for pain management. I. Injection Frequency: A. When the medical criteria below is met four (4) sacroiliac injections per joint may be given in a 12 month period. 1. Two (2) diagnostic injections per joint to evaluate pain and attain therapeutic effect, repeating no more than once every seven (7) days and with at least a 75% or > reduction in pain after the first injection. 2. Once the diagnostic injections are performed and the diagnosis is established, two (2) therapeutic injections per joint may be performed over a 12 month period. 3. Injections should not be repeated more frequently than every two (2) months with no more than a total of four (4) injections (including both diagnostic and therapeutic) per joint in 12 months. II. Sacroiliac joint injection for chronic back pain is medically necessary when pain has persisted despite appropriate medical management and ALL of the following criteria are met: A. Pain and tenderness are located in sacroiliac joint region. B. ACTIVE conservative therapy as part of a multimodality comprehensive approach is addressed in the patients care plan with documentation in the medical record that includes at least ONE of the following: 1. The patient has received ACTIVE conservative therapy lasting for six (6) weeks or more within the past six (6) months with start and end dates in the medical record substantiating the duration of treatment including ONE of the following: 1.1 physical therapy 1.2 occupational therapy 1.3 a physician supervised home exercise program (HEP) as defined in Humana CareSource policy 2. Or, the medical record documents at least ONE of the following exceptions to the 6 weeks ACTIVE conservative therapy requirement in the past 6 months: 2.1 at least moderate pain with significant functional loss at work or home 2.2 severe pain unresponsive to outpatient medical management 2.3 inability to tolerate non-surgical, non-injection care due to co-existing medical condition(s) 2.4 prior successful injections for same specific condition with relief of at least 3 months duration C. PASSIVE conservative therapy as part of a multimodality comprehensive approach is addressed in the patients care plan with documentation in the medical record lasting for six (6) weeks or more within the past six (6) months with start and end dates in the medical record substantiating the duration of treatment that includes at least ONE of the following: 1. rest 2. ice 3. heat 4. medical devices 5. acupuncture 6. TENS unit use as defined in Humana CareSource policy 7. Pain medications (RX or OTC) such as: non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen. Opioid narcotics are not required for consideration. Sacroiliac Joint Procedures KENTUCKY MEDICAID MM-0777 Effective Date: 9/1/2019 5 Sacroiliac joint injections using local anesthetic and/or corticosteroid medication have been shown to be effective for diagnostic purposes but provide limited short term relief from pain resulting from SI joint dysfunction. Image guidance and/or injection of contrast for sacroiliac joint injections for pain will be denied for coverage as not medically necessary. In a recent review, pain researchers reported that evidence is poor for short-and long-term pain relief from both intra-articular and peri-articular injections of these joints with steroids. If neural blockade is applied for different regions, or different sides, injections are performed at least one week apart. III. Inconclusive or Non-Supportive Evidence Pain management literature highlighting controlled studies of SI joint pain management has not demonstrated injections of the SI joint to be effective as a long-term management modality. Monitored anesthesia and conscious sedation will be denied for coverage for sacroiliac joint injections as not medically necessary. Thermal or pulsed, cooled sacroiliac neurotomy by Radio-Frequency Ablation (RFA) or other techniques for sacroiliac pain are not covered due to insufficient, limited, or inconclusive published data. Also, sacroiliac neurotomy billed as a facet medical branch nerve block are not allowed coverage. Studies provide limited evidence regarding the efficacy and safety of thermal radiofrequency ablation (TRA), for individuals with SI joint pain, and contain insufficient data that allows for definitive conclusions. A randomized placebo-controlled study in 28 patients was performed by Cohen et al for injection-diagnosed sacroiliac joint pain. One, 3, and 6 months after the procedure, 11 (79 %), 9 (64 %), and 8 (57 %) RF-treated patients experienced pain relief of 50 % or greater and significant functional improvement. The authors stated that larger trials with long-term follow-up and comprehensive outcome measures were needed to confirm their results. Stelzer and colleagues retrospectively evaluated the use of cooled RFA neurotomy for SIJ-mediated low back pain in European subjects. No control group was present. The authors concluded that results showed promising improvements in pain, quality of life, and medication usage some subjects experiencing relief at 20 months after treatment. The study noted missing data for some subjects, and a variable length of time to final follow-up. Sacroiliac joint fusion procedures are not covered due to limited data, mixed outcomes, and inconclusive evidence. A systematic review in 2015 and evaluated 16 peer reviewed articles with follow up a year or more. Mean duration of follow-up was 60 months for open surgery and 21 months for minimally invasive surgery. Patient satisfaction with surgery ranged from 56% to 100%, and a mean of 84% for 430 patients evaluated. Major complication occurred in 5% to 20%, with 1 study reporting a 56% adverse event rate. The authors concluded that surgical intervention for SIJ pain is beneficial in a subset of patients. However, with the difficulty in accurate diagnosis and evidence for the efficacy of SIJ fusion itself lacking, serious consideration of the cause of pain and treatment options should be given before performing the operation.[10] An industry-sponsored prospective randomized controlled crossover trial in 148 patients evaluated minimally invasive sacroiliac joint fusion using triangular titanium Sacroiliac Joint Procedures KENTUCKY MEDICAID MM-0777 Effective Date: 9/1/2019 6 implants vs nonsurgical management evaluated patients at 6-and 12-months follow-up. Surgical titanium implants were more effective than non-surgical management in relieving pain, improving function and improving quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions. Six month success rates were higher in the surgical group and sustained at 12 months. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). A narrow group of patients were selected for randomization. The patient candidates included only those with unilateral pain caudal to the lumbar spine, 3 physical exam criteria, and 3 positive provocative tests, including a 75% reduction in SI joint pain on 2 occasions, and a trial of at least one SI joint injection, for example with corticosteroids. Patients 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. Pain management literature does not support the use of sacroiliac joint injections for the treatment of pain as a result of Herpes Zoster. E. CONDITIONS OF COVERAGE F. RELATED POLICIES/RULES G. REVIEW/REVISION HISTORY DATES ACTION Date Issued 9/1/2019 New Policy Date Revised Date Effective 9/1/2019 H. REFERENCES 1. R. Chou, A. Qaseem, V. Snow, D. Casey, J. T. Cross, Jr., P. Shekelle, et al., “Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society,” Ann Intern Med, vol. 147, pp. 478-91, Oct 2 2007 2. R. Chou, R. Deyo, et al., “Nonpharmacologic Therpies for Low Back Pain: A Systematic Reivew for an American College of Physicians Clinical Practice Guideline,” Ann Intern Med, vol. 166, pp. 493-505, April 4, 2017 3. R. Chou, J. D. Loeser, D. K. Owens, R. W. Rosenquist, S. J. Atlas, J. Baisden, et al., “Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society,” Spine, vol. 34, pp. 1066-1077, 2009 4. L. Manchikanti, S. Abdi, S. Atluri, R. M. Benyamin, M. V. Boswell, R. M. Buenaventura, et al., “An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations,” Pain Physician, vol. 16, pp. S49-283, Apr 2013 5. L. Manchikanti, F. J. Falco, V. Singh, R. M. Benyamin, G. B. Racz, S. Helm, 2nd, et al., “An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part I: introduction and general considerations,” Pain Physician, vol. 16, pp. S1-48, Apr 2013 6. H. Hansen, L. Manchikanti, T. T. Simopoulos, P. J. Christo, S. Gupta, H. S. Smith, et al., “A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions,” PainSacroiliac Joint Procedures KENTUCKY MEDICAID MM-0777 Effective Date: 9/1/2019 7 Physician, vol. 15, pp. E247-78, May-Jun 2012 7. T. T. Simopoulos, L. Manchikanti, V. Singh, S. Gupta, H. Hameed, S. Diwan, et al., “A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions,” Pain Physician, vol. 15, pp. E305-44, May-Jun 2012 8. W. Stelzer, M. Aiglesberger, D. Stelzer, and V. Stelzer, “Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series,” Pain Med, vol. 14, pp. 29-35, Jan 2013 9. H. A. Zaidi, A. J. Montoure, and C. A. Dickman, “Surgical and clinical efficacy of sacroiliac joint fusion: a systematic review of the literature,” JNeurosurg Spine, vol. 23, pp. 59-66, Jul 2015 10. D. W. Polly, D. J. Cher, K. D. Wine, P. G. Whang, C. J. Frank, C. F. Harvey, et al., “Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes,” Neurosurgery, vol. 77, pp. 674-90; discussion 690-1, Nov 2015 11. P. Whang, D. Cher, D. Polly, C. Frank, H. Lockstadt, J. Glaser, et al., “Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial,” Int JSpine Surg, vol. 9, p. 6, 2015 12. I. Medtronic, Medtronic Patient Programmer 37746. Pain therapy user manual for neurostimulation system models 37702, 37711, 37713, 37701, 37712, 37714, 37703, 37704, 37022. Minneapolis, MN: Medtronic, 2012 The Medical Policy Statement detailed above has received due consideration as defined in the Medical Policy Statement Policy and is approved. Independent medical review 2/2018 KY-HUCP0-1242 KDMS Approved: 06/24/2019
MEDICAL POLICY STATEMENT KENTUCKY MEDICAID Policy Name Policy Number Date Effective Trigger Point Injections MM-0220 9/1/2019 Policy Type MEDICAL Administrative Pharmacy Reimbursement Medical Policy Statement prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical 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 which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Table of Contents A. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage …………………………………………………………………………………………. 4 F. Related Polices/Rules …………………………………………………………………………………………… 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Trigger Point Injections KENTUCKY MEDICAID MM-0220 Effective Date: 9/1/2019 2 A. SUBJECT Trigger Point Injections B. BACKGROUND Myofascial trigger points are self-sustaining hyper-irritative foci in any skeletal muscle, often occurring in response to strain produced 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); each of these single muscle syndromes is responsive to appropriate treatment. To successfully treat chronic 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 substance (e.g., a local anesthetic) or a mixture of substances (e.g., 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 comprehensive pain 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 conservative treatment should be provided only by healthcare providers within their scope of practice who are qualified to deliver these health services. Professional Societies The following professional societys recommendations are derived from the latest guidelines and scientific based literature available. American Society of Anesthesiologists (ASA) recommendations include trigger point injections be considered as treatment for patients with myofascial pain as part of a multimodal approach to pain management (ASA Practice Guidelines for Chronic Pain Management 2010). C. DEFINITIONS A trigger point is 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. The purpose of a trigger-point injection is to treat not only the symptom but also the cause through the injection of a single substance (e.g., a local anesthetic) or a mixture of substances (e.g., a corticosteroid with a local anesthetic) directly into the affected body part in order to alleviate inflammation and pain D. POLICY I. Criteria A. Trigger-point injections of anesthetic and/or corticosteroid for back pain, neck pain, or myofascial pain syndrome will be considered as medically necessary when pain has persisted despite appropriate medical management and ALL of the following criteria are met: 1. Patient presents with new localized pain, occurring in the last 3 months 2. Patient has been refractory or intolerant of conservative therapies for at least one month, such as: 2.1 Bed rest Trigger Point Injections KENTUCKY MEDICAID MM-0220 Effective Date: 9/1/2019 3 2.2 Active exercise 2.3 Ultrasound 2.4 Range of motion 2.5 Heating or cooling treatments 2.6 Massage 3. TPIs are being given as a part of an overall management (usually short term) plan, which may include: 3.1 Physical therapy 3.2 Occupational therapy 4. Pharmacotherapies are being administered, including: 4.1 NSAIDS 4.2 Muscle relaxants 4.3 Non-narcotic analgesics 4.4 Anti-depressants 4.5 Opioid narcotics are not required for consideration 5. The patient must have a diagnosis for which the trigger-point injection is an appropriate treatment; and the following information must be documented in the patient’s medical record: 5.1 Proper evaluation including a patient history and physical examination leading to a diagnosis of the trigger point 5.2 The reason or reasons for selecting this therapeutic option 5.3 The affected muscle or muscles 5.4 The muscle or muscles injected and the number of injections 5.5 The frequency of injections required 5.6 The name of the medication used in the injection 5.7 The results of any prior treatment 5.8 Corroborating evidence that the injection is medically necessary B. Trigger-point injections should be repeated only if doing so is reasonable and medically necessary. For trigger-point injections of a local anesthetic or a steroid, payment will be made for no more than eight dates of service per calendar year per patient. C. Injections may be repeated only with documented positive results to prior trigger point injection of the same anatomic site. Documentation should include at least 50% improvement in pain, functioning and activity tolerance D. 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. There is no laboratory or imaging test for establishing the diagnosis of trigger points; it depends therefore, upon the detailed history and 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 response to snapping palpitation H. Reproduction of referred pain pattern upon most sustained mechanical stimulation of the trigger point. III. 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 injections given. Payment may be Trigger Point Injections KENTUCKY MEDICAID MM-0220 Effective Date: 9/1/2019 4 made for one unit of service of the appropriate procedure code reported on a claim for service rendered to a particular patient on a particular date. IV. A trigger-point injection is normally considered to be a stand-alone service. No additional payment will be made for an office visit on the same date of service unless there is an indication on the claim (e.g., in the form of a modifier appended to the evaluation and management procedure code) that a separate evaluation and management service was performed. E. CONDITIONS OF COVERAGE F. RELATED POLICIES/RULES Pain Management KY MCD PY-0106 G. REVIEW/REVISION HISTORY DATES ACTION Date Issued 02/22/2018 New Policy Date Revised 6/1/2019 Annual Update: no changes Date Effective 9/1/2019 H. REFERENCES 1. Staal, J.B., et al., Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976), 2009. 34(1): p. 49-59. 2. Chou, R., et al., Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine, 2009. 34(10): p. 1066-1077. 3. Manchikanti, L. (2001). Interventional Techniques in the Management of Chronic Pain: Part 2.0. Retrieved from http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.655.8386&rep=rep1&type=pdf 4. Rosenquist, MD, R. W. (2010, April). Practice Guidelines for Chronic Pain Management. The American Society of Anesthesiologist 5. Cms.gov. (2017). Current Procedural Terminology (CPT) and National Uniform Billing Committee (NUBC) Licenses. [online] Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34588&ver=13 [Accessed 7 Dec. 2017]. The Medical Policy Statement detailed above has received due consideration as defined in the Medical Policy Statement Policy and is approved. Independent medical review 2/2018 KY-HUCP0-1242 KDMS Approved: 06/24/2019
MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 06/01/2012 07/15/201 7 06/28 /2016 Policy Name Policy Number Acute In-Patient Detoxification (Opioid) PA Criteria MM-0019Policy Type Medical Administrative PaymentMedicaid Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) apply to Medicaid health benefit pl ans administered by CSMG and its affiliates and are derived from literature based on and supported by applicable federal or state c overage mandates, clinical 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 lim ited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illn ess, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of functio n, 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 pro vider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medic aid Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan benefit document (i.e., Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medicaid Policy Statement and the plan benefit document, then the plan benefit document will be the controlling document used to make the determination. In the absence of any applicable controlling federal or state coverage mandate, benefits are ultimately determined by the applicable plan benefit documentA.SUBJECTAcute In-Patient Detoxification (Opioid) Prior Authorization CriteriaB. BACKGROUNDOpioid Use Disorder is a major public health concern leading to extensive morbidity and mortality. It is often a treatment-resistant and chronic condition. Effective treatment requires motivation and adherence to a comprehensive addiction management program. Such a program should involve well-coordinated care between the inpatient environment when appropriate, and the various modalities in the outpatient setting (residential, intensive outpatient,and office-based treatment). Even with intensive treatment options yearly relapse rates remain well over 70%. C.DEFINITIONSOpioids are naturally-occurring and synthesized drugs with indications for moderate to severe pain. Additional uses include relief of cough and diarrhea. There are also nonprescription, illicit forms of opioids such as heroin. Due to their potential to be abused and diverted, these are controlled substances under the Drug Enforcement Administration.Detoxification is the controlled and medically-supervised withdrawal from a drug of addiction in order to minimize severe symptoms . Opioids have the potential to cause dependence;ho wever they are not known to cause a life-threatening withdrawal due to physiologic dependence. In some instances, a medically-precipitated withdrawal in the presence of a co-occurring chronic medical or behavioral health condition has the potential to be life-threatening. Archived D. POLICY All admissions that are not screened through a CareSource representative to receive a Prior Authorization within 24 hours of admission will be retroactively reviewed to ensure they meet admission guidelines for Acute Inpatient Opioid detoxification treatment. I. Opiate withdrawal is often accomplished on an outpatient basis. CareSource will approve the use of acute inpatient opiate detoxification treatment as medically necessary when essential criteria have been met. Authorization of inpatient detoxification for a diagnosis of opioid use disorder will include a review of documentation showing that 1 or more of the following is present, including how it interferes with opioid use disorder detoxification at a lower level of care: A. The member has a medical condition that clearly warrants acute inpatient detoxification (e.g. uncontrolled diabetes) B. The member has a co-occurring substance use disorder with potential for life-threatening withdrawal (e.g. alcohol use disorder), which is also active at the time of admission C. The member has a co-occurring psychiatric disorder, which is unstable or complicated by threats to self or others, or causes member to be unable to care for basic needs D. Th e members home or community environment is not supportive of outpatient detoxification (e.g. homeless or has other individuals actively using at members residence) E. The member has sustained/reported an accidental overdose leading to a life-threatening event and medical intervention F. The member has severely complicated opioid withdrawal symptoms (i.e. moderate to severe withdrawal) that require around-the-clock care as manifested by ALL of the following: 1. Vomiting or diarrhea due to opioid withdrawal 2. Marked dehydration or electrolyte abnormality that cannot be corrected (to near normal) in an emergency department or other ambulatory setting (e.g., serum potassium less than 2.5 mEq/L (mmol/L), serum sodium less than 130 mEq/L (mmol/L)) G. Acute toxicity or instability from substance use requiring inpatient care ( e.g., hallucinations in the absence of delirium) is present for which treatment at lower level of care ( e.g., emergency department, observation care) is not feasible or is inappropriate ( e.g. , less intensive level is unavailable or not suitable to patient condition or treatment history). H. Other inpatient medical or psychiatric care is needed due to risk or comorbidity as indicated by ALL of the following : 1. Treatment is needed because of patient risk due to 1 or more of the following 1.1 Imminent danger to self-due to 1 or more of the following: a. Imminent risk for recurrence of suicide attempt or act of serious harm to self as indicated by ALL of the following: (1) Very recent suicide attempt or deliberate act of serious harm to self (2) There has not been sufficient relief of factors that precipitated attempt or act. b. Current plan for suicide or serious harm to self c. Command auditory hallucinations for suicide or serious harm to self d. Patient has persistent thoughts of suicide or serious harm to self that cannot be adequately monitored at lower level of care due to 1 or more of the following: (1) Insufficient behavioral care available to meet patient needs (such as required provider or lower level facility not available) (2) Patient characteristics such as high impulsivity or unreliabilityArchived(3) Environment does not support recovery. (4) Ready access to lethal means 1.2 Imminent danger to others due to 1 or more of the following: a. Imminent risk for recurrence of attempt to seriously harm another as indicated by ALL of the following: (1) Very recent attempt to seriously harm another (2) There has not been sufficient relief of factors that precipitated attempt or act b. Current plan for homicide or serious harm to another c. Command auditory hallucinations or paranoid delusions contributing to risk for homicide or serious harm to another d. Patient has persistent thoughts of homicide or serious harm to another that cannot be adequately monitored at lower level of care because of 1 or more of the following: (1) Insufficient behavioral care available to meet patient needs (e.g., required provider or lower level facility not available) (2) High impulsivity or unreliability (3) Environment does not support recovery (4) Ready access to lethal means 1 .3 Severe dysfunction in daily living related to substance use disorder as indicated by 1 or more of the following: a. Extreme deterioration in social interactions (e.g., threatening behaviors with little or no provocation) b. Complete withdrawal from all social interactions c. Complete neglect of self-care with associated impairment in physical status d. Extreme disruption in vegetative function (e.g., life-sustaining functions such as eating) e. Complete inability to maintain any appropriate aspect of personal responsibility in any adult roles (e.g., occupational, parental) 1.4 Other severe emotional, behavioral, or cognitive symptoms which preclude ability to engage in recovery without 24-hour monitoring and treatment 1.5 Patient requires monitoring due to substance use in combination with medical, psychiatric, or environmental factors that prevent adequate management at lower level of care as indicated by ALL of the following: a. Significant substance use effects, medical conditions, or psychiatric comorbidities as indicated by 1 or more of the following: (1) Substance toxicity or withdrawal requiring medical monitoring (2) Severe emotional, behavioral, or cognitive symptoms which limit o r preclude ability to engage in treatment b. Conditions, barriers, or environmental factors preventing treatment at lower level of care as indicated by 1 or more of the following (1) Psychiatric comorbidity or opposition to treatment requires 24-hour setting to ensure adherence with medical treatment or adequate motivating interventions (2) Severe behavioral problems (e.g., escalating relapse behaviors, acute psychiatric or substance use crisis, inability to recognize signs and symptoms of relapse) require 24-hour setting for relapse prevention. (3) Living environment outside of 24-hour setting is inadequate to meet patient needs (e.g., lacking resources necessary to support recovery) . 2. Treatment situation and needs are appropriate for inpatient level (instead of usingArchivedlower level of care) as indicated by 1 or more of the following: 2.1 Patient is unwilling to participate voluntarily and requires treatment (e.g., legal commitment) in involuntary unit. 2.2 Voluntary treatment at lower level is not feasible (e.g., lower level care unavailable or inappropriate for patient condition). 2.3 Physical restraint, seclusion, or other involuntary control is needed (e.g., actively violent patient for whom treatment in involuntary unit is deemed necessary in accord with applicable medical and legal criteria). 2.4 Around-the-clock medical or nursing care to address symptoms and initiate interventions is required; specific need is identified. I.There is clear medical necessity for inpatient opioid detoxification treatment and substantial justification as to why alternative levels of care are inappropriate (e.g.treatment with buprenorphine, buprenorphine/naltrexone in an outpatient setting)J. The member must demonstrate clear motivation for rapid detoxification from opioid substances without subsequent further usage. Rapid detoxification in a chronic opioid user as an isolated acute treatment has a low likelihood of sustained abstinence in such situations. To assess readiness for change an assessment could include standardized scales such as URICA, SOCRATES, or Readiness to Change Scales specific to opiate dependency that assess readiness for change.K. If a member has had a previous admission for inpatient detoxification within the past 365days, there is documentation that the member had demonstrated success (e.g. kept appointments, had negative urine drug screens) from the prior detoxification before current relapse. The inpatient detoxification program has a written Affiliation Agreement so that members are connected/ensured access to outpatient care in timely manner upon discharge due to the high relapse rates from detoxification alone. There are policies and procedures in place to monitor its affiliations. II.Some state-specific considerations: A.Ohio Program must be certified by the Ohio Dept. of Mental Health & Addiction Services. Since de toxification is not by itself treatment, but part of a comprehensive approach to the continuum care needed for evidence-based substance use disorder treatment, the inpatient program shall have a clearly-documented affiliation agreement with at least one alcohol and drug addiction services treatment program certified by the state of Ohio to ensure member access to outpatient care in a timely manner (e.g. IOP program,residential program, sober housing, or outpatient treatment). B.Kentucky Program must be licensed by the Kentucky Cabinet for Health Services. The facility shall have written affiliation with other licensed alcohol and drug services available in the community such as: chemical dependency treatment services and services licensed under902 KAR Chapter 3 including situation, identification, and disposition (SID) units, thirty (30)day residential units, halfway houses and outpatient services. Requires ventilation, crash cart, oxygen and suction are available in the program.For Medicare Plan members, reference the below link to search for Applicable National Coverage Descriptions (NCD) and Local Coverage Descriptions (LCD): If there is no NCD or LCD present, reference the CareSource Policy for coverage. Archived CONDITIONS OF COVERAGE HCPCSCPT AUTHORIZATION PERIOD E.RELATED POLICIES/RULES F.REVIEW/REVISION HISTORYDate Issued: 06/01/2012 Date Reviewed: 06/01/2012, 7/01/2013, 7/01/2014, 07/15/2015 , 06/xx/2016 Date Revised: 07/01/2013, 07/01/2014 07/15 /2015 Add definitions, revision to criteria regarding criteria , affiliation agreement, State OAC and KAR considerations G.REFERENCES1. Suboxone [package insert]. Richmond, VA,: Reckitt Benckiser Pharmaceuticals Inc.; April 20142. Subutex [package insert}. Richmond, VA,: Reckitt Benckiser Pharmaceuticals Inc.; April 20143. Drugs. 2009; 69 (5):577-607. 4. McConnaughy, E.N., Prochaska, J.O., & Velicer, W.F. (1983). Stages of change in psychotherapy: Measurement and sample profiles. Psychotherapy: Theory, Research andPractice, 20, 368-375. 5.Miller, W. R., & Tonigan, J. S. (1996). Assessing drinkers’ motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychology ofAddictive Behaviors 10, 81-89.6. National Drug Abuse Treatment Clinical Trials Network Prescription Opioid AddictionTreatment Study. This article describes research presented at the American PsychiatricAssociation 2010 Annual Meeting.Symposium 36, presentation 4. Presented May 23, 2010.New Orleans, Louisiana.7. International Psychopharmacology Algorithm Project, Opioid Algorithm (2013 update).8. 902 KAR 20:111. Medical detoxification services9. OAC 5122-29-37 Detoxification program certification10. MCG, 20 thEdition Guidelines; Substance Related Disorders, Clinical Indications forAdmission to Inpatient Care This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. The med ical Policy Stateme nt det ailed a bove has r eceived due consi deration as defined in the Medic al Policy Stateme nt Policy a nd is approve d.Archived
MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 06/19/2015 06/19/2017 05/17/2016 Policy Name Policy Number Insulin Infusion Pump Therapy for Diabetes MM-0032Policy Type Medical Administrative PaymentMedical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) apply to Medical health benefit plans administered by CSMG and its affiliates and are derived from literature based on and supported by applicable federal or state coverage m andates, clinical 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 which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfun ction 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 m ember or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan benefit document (i.e., Evidence of Coverage) for the service(s) referenced in the Medical Policy St atement. If there is a conflict between the Medical Policy Statement and the plan benefit document, then the plan benefit document will be the controlling document used to make the determination. In the absence of any applicable controlling federal or state coverage mandate, benefits are ultimately determined by the applicable plan benefit document. A.SUBJECTInsulin Infusion Pump Therapy for DiabetesB. BACKGROUNDInsulin infusion pump therapy for diabetes mellitus delivers continuous short-acting or rapid-acting insulin at a slow basal rate via a subcutaneous small bore cannula 24 hours a day. At mealtimes,patient-activated bolus insulin may also be delivered. The cannula should be changed every 2-3days to a new anatomical location to avoid infection and lipohypertrophy. An insulin pump is typically a small battery-operated pump about the size of a personal pager or cell phone, and is filled with short-acting or rapid-acting insulin. C.DEFINITIONSCGM Continuous glucose monitoringDME-Durable medical equipment D.POLICYI. For selected patients an insulin pump provides glucose control that may be difficult to achieve b y intermittent insulin injections. Fewer highs and lows in blood sugars may help prevent or delay serious complications of diabetes such as retinopathy, nephropathy, and neuropathy.Disadvantages of insulin pumps include the time and learning it takes to program and use the device. The management of a subcutaneous catheter may be complicated by catheter kinking, occlusion, or catheter migration and the person may not receive insulin. Carrying a Archived pump and its delivery system can be bothersome. Skin sites for catheter entry can become infected. Some members are at high risk for preventable complications of diabetes. Early signs of diabetic complications include micro-albuminuria demonstrating persistent difficulty in achieving optimal control of blood sugar levels despite good compliance with an intensive, intermittent, multiple-injection insulin regimen. II. A physicians order given to the durable medical equipment (DME) provider is a requirement for an insulin pump to be medically necessary. III. Pumps, Supplies, and Prior Authorizations The point of service (POS) for insulin pumps includes out-patient/home. Requests for ancillary supplies totaling less than $750 do not require a prior authorization. IV . Clinical Indications for Procedure Continuous subcutaneous insulin infusion using insulin infusion pump may be indicated when ALL of the following are present: A. Diagnosis of diabetes as indicated by Type 1 diabetes mellitus .Type 2 diabetics with insulinopenia or gestational diabetics will be considered on a case-by-case evaluation. B. Failure of multiple daily injection insulin administration, as indicated by 1 (one) or more of the following: 1. HbA1c greater than 7% (0,07), despite intensified multiple daily injection insulin therapy 2. Abnormal early-morning increase in blood glucose (dawn phenomenon), with fasting blood sugars often >200 mg/DL 3. Diabetes complication (e.g., neuropathy, nephropathy, retinopathy), and need for more intensive management 4. Extreme insulin sensitivity 5. Recurring hypoglycemia which may require third-party assistance, including unconsciousness, seizure, glucagon administration, and emergency attendance or admission to hospital 6. Patient is pregnant 7. Wide swings in glycemic control as documented on blood sugar log forms 8. Child for whom multiple daily insulin injections are impractical or inappropriate C. Patient or caregiver is motivated, adherent, knowledgeable, and able to monitor blood glucose 3 (three) or more times per day as indicated by 1 (one) of the following: 1. This is an initial insulin pump for a patient where ALL of the following are met: 1.1 Member administers 3 (three) or more daily insulin injections to self for at least 6 (six) months 1.2 Member must self-test glucose levels at least 4 (four) times daily for at least 2 (two) months as documented by glucose logs 1.3 Documentation of diabetes education must be on file 2. This is a replacement insulin pump for an existing pump greater than or equal to 5 (five) years old, or the current pump is unrepairable D. Provider team is experienced and expert in management and support of patient with insulin infusion pumps. CONDITIONS OF COVERAGE HCPCS A4230, A4231, A4232, C1772, C1891, C2626, E0779, E0780, E0781, E0782, E0783, E0784, E0786, E0791 CPT Archived AUTHORIZATION PERIOD B.For Medic aid Ohio coverage determinations (OAC 5160-10-29): 1. C-Peptide =
MEDICAL POLICY STATEMENTOriginal Effective Date Next Annual Review Date Last Review / Revision Date 06/01/ 2009 02/01/ 2017 02/11/2016 Policy Name Policy Number Mastectomy for Gynecomastia MM-0002 Policy Type Medical Administrative Payment Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical manage ment 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, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical prac tice 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 Stat ements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan c ontract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract ( i.e., Evidence of Coverage), then the plan contract ( i.e., Evidence of Coverage) will be the controlling document used to make the determination.A. SUBJECT Mastectomy for Gynecomastia B. BACKGROUND Gynecomastia is the benign proliferation, either unilateral or bilateral, of glandular tissue of the breast in males. This develops most often in the setting of altered estrogen/androgen balance or increased sensitivity of breast tissue to estrogen. Causes may include among others) androgen d efic ie ncy states (e.g. treatments for prostate carcinoma), congenital disorders (e.g. Kl einfel ter s Syndrom e (4 7XX Y)), medications (estrogen replacement therapy, calcium channel blockers, cimetidine, phenothiazines, spironolactone, theophylline, HAART for HIV/AIDS), chronic medical conditions (e.g. cirrhosis, chronic kidney disease), tumors (e.g. adrenal or testicular) or endoc rin e diso rders (e .g ., h yperth yroidis m). As a result of this hormonal imbalance medical therapy may be offered in the treatment of gynecomastia (i.e. anti-estrogens, androgens, or aromatase inhibitors) . Gynecomastia sh ould not b e c onfu se d w ith pse udo-g ynec om asti a which is usual ly transi ent and resolves in 6-24 mo nths. C. DEFINITIONS Persistent pubertal gynecomastia : The persistence of breast enlargement following the end of puberty and occasionally lasting into adulthood. Pseudo-gynecomastia: Enlargement of the breast due to fat deposition (without glandular involvement), typically occurring in the setting of obesity. Pubertal gynecomastia: A benign process occurring most commonly between the ages of 10 to 13 typically followed by regression in most cases.
MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 10/06/2015 10/06/2016 10/06/2015 Policy Name Policy Number Serum Biomarker Panel Testing in Systemic Lupus Erythematosus and Rheumatoid Arthritis MM-0037 Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical manage ment 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, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract ( i.e., Evidence of Coverage), then the plan contract ( i.e., Evidence of Coverage) will be the controlling document used to make the determination. F or Medicare plans please reference the below link to search for Applicable National Coverage Descriptions (NCD) and Local Coverage Descriptions (LCD): A.SUBJECTSerum Biomarker Panel Testing in Systemic Lupus Erythematosus and RheumatoidArthritisB. B ACKGROUNDRheumatic diseases such as Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis contribute significantly to many who are affected through reduced quality of life, increas ed di sability and premature mort ality. The Centers for Disease Control and Prevention (CDC)estimate for SLE an incidence between 1.8 and 7.6 per 100,000 persons per year in th e c ontinental United States. Estimates for RA from 2005, suggest prevalence among women 9. 8 per 1000 and 4.1 per 1000 for men.The widely variable clinical expression of these disorders combined with the limited specificity and sensitivity in many diagnostic tests can contribute to the challenge of unequivocally a nd pr omptly establishing a specific diagnosis in these disorders. Clinical societies have establishe d c lassification criteria for clinical trials and epidemiologic studies. Their utility in clinical practic e ho wever may be limited and requ ires further investigation. T he diagnosis of SLE or RA is often based upon clinical judgement, careful integrati on of the patients history and physical findings combined with selected laboratory and radiographic tests , of ten with serial assessments over time . W ith the development of effective disease-modifying anti-rheumatic drugs (DMARDS) and their early introduction into treatment regimens as a standard of care in RA the importance of early a nd ac curate diagnosis and the ability to monitor treatment response has been heightened. Archived A variety of scoring systems are utilized to assess disease activity in RA (including but not limited to: Disease Activity Score (DAS), Disease Activity Score employing 28 joint counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data-3 (RAPID3). In establishing the diagnosis of SLE routine laboratory tests are often supplemented with more specialized tests including: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), complement levels (C3, C4 and CH50), antiphospholipid antibodies and antinuclear antibodies (ANA). Among the latter are a constellation of antibodies that include Anti-double-stranded DNA (anti-dsDNA), anti-smooth muscle antibodies (Anti-Sm Abs), anti-Ro/SSA and anti-La/SSB, anti-U1 RNP antibodies, anti-ribosomal Pprotein antibodies. In RA rheumatoid factor (RF) and anti-citrullinated peptide/protein antibodies (anti CCP antibodies) are often measured along with ESR and CRP. The sensitivity and specificity of these serum immune biomarkers varies considerably among patients , limiting their value . As a result investigative laboratories have sought to establish proprietary algorithms and index scoring methodologies to assist in establishing a diagnosis, estimating prognosis, and monitoring disease activity. Among these include, but are not limited to, the following: The Vectra DA Test (Crescendo Bioscience Inc.) is a multi-biomarker panel developed by analysis of clinical disease activity (DAS28) and the levels of serum immune markers. Utilizing a weighted algorithm a single number (ranging from 0 to 100) reflecting the multi-biomarker disease activity (MBDA) is calculated. This value is proposed to correlate with disease activity. (i.e. low =1 to 29, moderate =30 to 44, or high > 44). While Vectra DA is not a diagnostic test and does not guide selection of specific pharmacologic agents it has been suggested that results may inform treatment decisions of rheumatologists in the outpatient setting when used in combination with more standard clinical assessments. A single prospective cohort study (N =101) and 7 retrospective studies (n+74 to 235) have addressed the predictive capacity of this panel to assess prognosis and manage early disease in RA. While evidence suggested some degree of correlation between the MBDA and these functions the overall quality of the evidence is low (retrospective design in 7 of the 8 studies). Further, there was some conflicting data and none of the studies assessed long term outcomes. The Avise 2.0 (Exagen Diagnostics) is a commercially available panel of 22 biomarkers combining a 10 marker panel of immune tests that may be utilized in the diagnosis of SLE (Avise SLE 2.0) with a 12 marker panel directed toward other autoimmune disorders (Avise SLE + Connective Tissue 2.0) utilizing a tiered protocol. The collection of biomarkers included in this panel include various auto-antibodies (ANA, Anti-dsDNA, Anti-mutated citrullinated vimentin (Anti-MCV), C4d erythrocyte-bound complement fragment (EC4d), C4d lymphocyte-bound complement (BC4d), Anti-Sm, Jo-1, Sci-70, CENP, SS-B/La, U1RNP, RNP70 and SS-A/Ro); Rheumatoid auto antibodies (Rheumatoid factor IgM, Rheumatoid factor IgA, Anti-cyclic citrullinated peptide IgG), antiphospholipid antibodies (Cardiolipin IgM, Cardiolipin IgG, B2-glycoprotein 1 IgG, B2-glycoprotein 1 IgM), and anti-thyroid antibodies (Thyroglobulin IgG, Thyroid peroxidase IgG). A panel designed to offer prognostic information related to thrombotic and other cardiovascular complications of SLE such as lupus cerebritis and nephritis is offered by Exagen (Avise SLE Prognostic Reflex). This panel measures: anti-C1q, anti-ribosomal P, anti-Archived phosphatidylserine/prothrombin IgM and IgG, anti-cardiolipin IgM, IgG and IgA and anti-B2-glycoprotein 1 IgM, IgG and IgA. A multicenter cross sectional study of 210 patients with SLE reported on a 5 marker panel that included the components of the Avise test for SLE. This study which was co-authored by investigators from Exagen Diagnostics has not been independently validated in order to assess the safety or impact on health outcomes or patient management. Clinical laboratories may develop, validate and market tests under the regulatory standards of the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Act (CLIA) of 1988. The above reference tests comply with CLIA specifications. C. DEFINITIONS Rheumatoid Arthritis: (RA) is a symmetric, inflammatory, peripheral polyarthritis of unknown etiology. It typically leads to deformity through the stretching of tendons and ligaments and destruction of joints through the erosion of cartilage and bone. If it is untreated or unresponsive to therapy, inflammation and joint destruction lead to loss of physical function, inability to carry out daily tasks of living, and difficulties in maintaining employment. Systemic Lupus Erythematosu s: (SLE) is a chronic inflammatory disease of unknown cause that can affect virtually any organ of the body. Immunologic abnormalities, especially the production of a number of antinuclear antibodies (ANA), are a prominent feature of the disease. Biomarkers: a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention . D. POLICY I. Based on a lack of evidence in current peer reviewed medical literature CareSource considers the Vectra DA panel for the diagnosis, prognosis and /or management of RA and other indications to be experimental, investigational and not medically necessary. II. Based on a lack of evidence in current peer reviewed medical literature CareSource considers the Avise SLE 2.0, the Avise SLE + Connective Tissue 2.0, and the Avise SLE Prognostic Reflex panels for the diagnosis, prognosis and/or management of SLE and other i ndications to be experimental, investigational and not medically necessary. For Medicare Plan members, reference the Applicable National Coverage Determinations (NCD) and Local Coverage Determinations (LCD). Compliance with NCDs and LCDs is required where applicable.CONDITIONS OF COVERAGE HCPCS CPT 81479 Unlisted Molecular procedure A UTHORIZATION PERIOD E. RELATED POLICIES/RULES F. REVIEW/REVISION HISTORY Date Issued: 10/06/2015 Date Reviewed: 10/06/2015 Date Revised: ArchivedG. REFERENCES 1. Centers for Disease Control and Prevention. Systemic lupus erythematosus (SLE or lupus). Accessed: July 27, 2012. http://www.cdc.gov/arthritis/basics/lupus.htm/#2 2. Myasoedova E, Crowson CS, Kremers HM, Therneau TM, Gabriel SE. Is the incidence of rheumatoid arthritis rising?: results from Olmsted County, Minnesota, 1955-2007. Arthritis and rheumatism. 2010 Jun; 62(6):1576-82. 3. UpToDate, 2015. 4. Clin Pharmacol Ther. 2001 Mar;69(3):89-95. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework 5. Petri M, Orbai AM, Alarcn GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum 2012; 64:2677. 6. Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40:1725. 7. Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiati ve. Ann Rheum Dis 2010; 69:1580 8. Hayes, Inc. Hayes Medical Technology Directory Report. Vectra DA Test (Crescendo Bioscience Inc.) for Management of Patients with Rheumatoid Arthritis. Lansdale, PA: Hayes, Inc.; January 2015. 9. Cabas-Vargas J, Chitkara P, Christianakis S, Putterman C. Finding the Best Approach to Autoimmune Conn ective Tissue Disease Diagnosis. http://avisetest.com/images/stories/publications/Avise_2_Clinical_Utility.pdf10. Kalunian KC, Chatham WW, Massarotti EM. Dervieux T, et al. Arthritis & Rheumatism. 64(12):4040-7, December 2012. 11. Hayes, Inc. Hayes Medical Technology Directory Report, Avise SLE (Exagen Diagnostics) for Diagnosis of Systemic Lupus Erythematosus. Lansdale, PA: Hayes, Inc.; January 2015. 12. Biomarkers Definition Working Group, convened by the National Institutes of Health Director’s Initiative on Biomarkers and Surrogate Endpoints . Clin Pharmacol Therapeutics. 2001;69: 89 95. This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. The Med ical Policy Stateme nt detailed a bove has r eceived due con side ration as defined in the Medic al Policy Stateme nt Policy and is a pprove d. Archived
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