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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system A9278 Receiver (monitor); external, for use with interstitial continuous glucose monitoring system E0607 Home blood glucose monitor E0784 External ambulatory infusion pump, insulin S1030 Continuous noninvasive glucose monitoring device, purchase (for physician interpretation of data, use cpt code) S1031 Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use cpt code)

ICD 9 Diagnosis Codes:

250.01 Diabetes mellitus without mention of complication, type I [juvenile type], not stated as uncontrolled 250.03 Diabetes mellitus without mention of complication, type I [juvenile type], uncontrolled 250.11 Diabetes with ketoacidosis, type I [juvenile type], not stated as uncontrolled 250.13 Diabetes with ketoacidosis, type I [juvenile type], uncontrolled 250.21 Diabetes with hyperosmolarity, type I [juvenile type], not stated as uncontrolled 250.23 Diabetes with hyperosmolarity, type I [juvenile type], uncontrolled 250.31 Diabetes with other coma, type I [juvenile type], not stated as uncontrolled Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline 250.33 Diabetes with other coma, type I [juvenile type], uncontrolled 250.41 Diabetes with renal manifestations, type I [juvenile type], not stated as uncontrolled 250.43 Diabetes with renal manifestations, type I [juvenile type], uncontrolled 250.51 Diabetes with ophthalmic manifestations, type I [juvenile type], not stated as uncontrolled 250.53 Diabetes with ophthalmic manifestations, type I [juvenile type], uncontrolled 250.61 Diabetes with neurological manifestations, type I [juvenile type], not stated as uncontrolled 250.63 Diabetes with neurological manifestations, type I [juvenile type], uncontrolled 250.71 Diabetes with peripheral circulatory disorders, type I [juvenile type], not stated as uncontrolled 250.73 Diabetes with peripheral circulatory disorders, type I [juvenile type], uncontrolled 250.81 Diabetes with other specified manifestations, type I [juvenile type], not stated as uncontrolled 250.83 Diabetes with other specified manifestations, type I [juvenile type], uncontrolled 250.91 Diabetes with unspecified complication, type I [juvenile type], not stated as uncontrolled 250.93 Diabetes with unspecified complication, type I [juvenile type], uncontrolled This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline TITLE: Core Decompression For Avascular Necrosis Authorized By: Medical Management Guideline Committee

Adoption Date: 09/16/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.





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Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the use of core decompression to relieve the pressure within the bone marrow that is thought to be associated with avascular necrosis. The goal of this procedure is to relieve pain and delay the need for more complicated surgery by slowing disease progression.

Core Decompression For Avascular Necrosis - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Core decompression is proven for the treatment of early (pre-collapse) avascular necrosis of the femoral head.

Core decompression is unproven for the treatment of late avascular necrosis of the femoral head or for avascular necrosis elsewhere, including the humeral head, the distal femur, the talus, or the mandibular condyle. The quality and quantity of the evidence for core decompression for these conditions is limited and insufficient. Most studies involved a small number of patients and have lacked proper controls and therefore, there is insufficient data to allow conclusions regarding the safety and efficacy of core decompression in these patient populations.

Regulatory Requirements U.S. Food and Drug Administration (FDA): Core decompression is performed with ordinary surgical instruments. The FDA has not approved any devices specifically for core decompression. Approval has been granted to numerous bone

graft substitutes (product code LYC), some of which may be used in conjunction with core decompression. Available at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed February 2009.

Research Evidence Background In avascular necrosis (AVN), also known as osteonecrosis, ischemic necrosis, and aseptic necrosis, bone tissue dies as the result of impaired vascular supply. The condition occurs most often in the femoral head but can affect other bones and joints. Traumatic causes include fractures and dislocations, particularly when treatment of these injuries is delayed.

Atraumatic causes are thought to be related to elevated intraosseous pressure. Some of the known risk factors for atraumatic AVN are prolonged use or high doses of corticosteroids, alcohol abuse, and decompression sickness, but cases are often idiopathic.

AVN is a progressive disorder that often results in the eventual collapse of the bone and the need for joint replacement or other arthroplasty. Diagnosis of AVN is based primarily on radiographic evidence, which is used to assign stage of progression. The diagnosis can be confirmed by biopsy. Because AVN of the hip and shoulder tends to occur in middleaged adults, the avoidance of joint replacement is especially desirable. Standard conservative treatment for AVN includes avoidance of weight bearing (for hip and lower extremity involvement), change in activity (for shoulder involvement), orthotics (for talus involvement), nonsteroidal anti-inflammatory drugs (NSAIDs), and physical therapy and/or exercises.

However, such treatment usually fails to prevent disease progression. Cortisone injections may also be used to relieve pain in the shoulder but this increases the potential for progression of AVN as well as the risk of introducing infection.

Originally conceived as a biopsy technique for the purpose of confirming AVN, core decompression was found to provide immediate pain relief for patients in the early stages of AVN. Besides alleviating pain, decompression is intended to reduce intraosseous pressure and, thereby, restore normal vascular flow. The procedure consists of drilling one or a few very small channels into the necrotic area. It may be performed as an open procedure, in which the core is removed, or percutaneously with a needle. Core decompression takes less time to perform than other surgical prophylactic options such as osteotomy and debridement and thus has a lower risk of side effects.

Core decompression is currently the most common form of surgical treatment for early stages of AVN. It is sometimes combined with other procedures that are intended to stimulate formation of new bone tissue. These adjunct procedures include nonvascularized bone grafts (either allografts or demineralized bone matrix [DBM]), vascularized bone grafts (VBG), and stimulation with electrical current or with electromagnetic fields. However, these procedures are beyond the scope of this policy.

Core Decompression For Avascular Necrosis - Commercial Medical Management Guideline Research Evidence The majority of studies focused on the use of core decompression for avascular necrosis (AVN) of the hip joint. Criteria for excluding studies were traumatic etiology of AVN, disorders other than AVN, outcomes defined in terms of radiographic progression, studies restricted to pediatric patients, and case reports. Additional studies were excluded because they reported on groups of patients that were covered in other published studies.

Studies of Core Decompression of the Femoral Head (Hip), Published in 1996 or Later: The literature search yielded eleven studies investigating the effectiveness of core decompression alone for treatment of AVN of the femoral head: six retrospective, uncontrolled studies (Iorio et al. 1998; Aigner et al., 2002; Markel et al., 1996; Mont et al., 1998; Bozic et al., 1999; Lavernia and Sierra, 2000); three prospective (Powell et al., 1997; Maniwa et al., 2000; Kane et al., 1996) and one retrospective (Scully et al., 1998) comparison with vascularized bone grafting (VBG); and one retrospective comparison with osteotomy. (Simank et al., 2001) Although study design was weak, controlled comparisons were lacking, and sample sizes were small for this set of studies, results were consistent and support the conclusions of earlier research: core decompression is safe and may result in prevention or deferral of partial or complete arthroplasty if performed in hips with AVN at stage I or II, with a substantially higher likelihood of success at stage I. Joint survival rates for hips at stage I were quite high (92% to 100%).

In all studies, joint survival declined with increasing baseline disease stage.

Rates are difficult to interpret and to compare among studies because follow-up times varied by patient and follow-up means and ranges varied widely by study. Follow-up times ranged from a required minimum of 2 years to a mean of 12 years (exception: Scully et al. (1998) reported a range of 21 to 50 months). Follow-up time was often not reported by stage. Three studies included only patients with a minimum of 2 years of follow-up data, thus generating the proportion of hips that survived for at least 2 years. Kane et al. (n=39 hips) and Lavernia and Sierra (n=67 hips) observed survival rates of 100% for stage I, 36% to 81% for all stage II, and 50% to 60% for stage III. Bozic et al. reported rates of 92% for stage I, 100% for stage IIA sclerotic, 31% for stage IIA cystic or sclerocystic, 20% for stage IIB, and no survival for stage III.

Two studies calculated Kaplan-Meier survivorship curves, which take into account the follow-up time for each hip. Bozic et al. (n=37 hips) compared Kaplan-Meier curves between hips that were at stage I or precystic stage IIA with hips in all other more advanced stages (cystic IIA, IIB, IIC, and III) and found a statistically significant difference, with survival of 166 months for the first group and 57 months for the second. Simank et al. (n=94 hips) demonstrated Kaplan-Meier probabilities of joint survival of 84% at 4 years and 78% at 6 years for patients with hips at stage I or II, excluding patients who had a history of corticosteroid use because it was shown to be predictive of failure. Those probabilities dropped to 63% at 4 years and 56% at 6 years for patients with hips at stage III, IV, or V.



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