1. Implantable Infusion Pumps

   Aetna considers implanted infusion pumps medically necessary durable medical equipment (DME) when all of the following criteria are met:

   • The drug is medically necessary for the treatment of members (see medical necessity criteria for various types of infusion pumps below); and
   • It is medically necessary that the drug be administered by an implanted infusion pump; and

   • The infusion pump has been approved by the FDA for infusion of the particular drug that is to be administered.
     
     

   1. Anti-spasmodic drugs

      Aetna considers an implantable infusion pump medically necessary when used to intrathecally administer anti-spasmodic drugs (e.g., baclofen) to treat chronic intractable spasticity in persons who have proven unresponsive to less invasive medical therapy as determined by the following criteria: 

      1. Member has failed a six-week trial of non-invasive methods of spasticity control, such as oral anti-spasmodic drugs, either because these methods fail to adequately control the spasticity or produce intolerable side effects; and

      2. Member has a favorable response to a trial intrathecal dosage of the anti-spasmodic drug prior to pump implantation. 

      Intrathecal baclofen (Lioresal) is considered medically necessary for the treatment of intractable spasticity caused by spinal cord disease, spinal cord injury, or multiple sclerosis.  Baclofen is considered medically necessary for persons who require spasticity to sustain upright posture, balance in locomotion, or increased function.

      Documentation in the member's medical record should indicate that the member's spasticity was unresponsive to other treatment methods and that the oral form of baclofen was ineffective in controlling spasticity or that the member could not tolerate the oral form of the drug.  A trial of oral baclofen is not a required prerequisite to intrathecal baclofen therapy in children ages 12 years old or less due to the increased risk of adverse effects from oral baclofen in this group.

      The medical record should document that the member showed a favorable response to the trial dosage of the baclofen before subsequent dosages are considered medically necessary.  An implanted pump for continuous fusion is considered not medically necessary for members who do not respond to a 100 mcg intrathecal bolus.

   2. Opioid drugs for treatment of chronic intractable pain

      An implantable infusion pump is considered medically necessary when used to administer opioid drugs (e.g., morphine) and/or clonidine intrathecally or epidurally for treatment of severe chronic intractable pain in persons who have proven unresponsive to less invasive medical therapy as determined by the following criteria: 

      1. The member's history must indicate that he or she has not responded adequately to non-invasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities which may cause an exaggerated reaction to pain); and

      2. A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief, the degree of side effects (including effects on the activities of daily living), and acceptance. 

   3. Intrahepatic chemotherapy infusion for liver metastases from colorectal cancer

      Implantable infusion pumps are considered medically necessary for administration of intrahepatic chemotherapy (e.g., floxuridine) to members with colorectal cancer and liver metastases.
      
      Aetna considers "one-shot" arterial chemotherapy for persons with liver metastases from colorectal cancer experimental and investigational.

      Note: An average 3 to 5 days inpatient hospitalization is medically necessary for intrahepatic chemotherapy. Hospital discharge is dependent on resolution of pain, nausea and vomiting which complicate the procedure. 

   4. Contraindications to implantable infusion pumps

      Implantable infusion pumps are considered not medically necessary for persons with the following contraindications to implantable infusion pumps: 

      1. Members with known allergy or hypersensitivity to the drug being used (e.g., oral baclofen, morphine, etc.); or 
      2. Members who have an active infection that may increase the risk of the implantable infusion pump; or 
      3. Members whose body size is insufficient to support the weight and bulk of the device; or 

      4. Members with other implanted programmable devices where the crosstalk between devices may inadvertently change the prescription.

   5. Experimental and investigational uses of implanted infusion pumps

      Implanted infusion pumps are considered experimental and investigational for all other indications, including any of the following:

      1. Implantable pumps for the infusion of insulin to treat diabetes; or 
      2. Implantable pumps for the infusion of heparin for recurrent thromboembolic disease; or 
      3. Implantable infusion pumps for intrahepatic administration of chemotherapy for indications other than noted above, including treatment of primary hepatocellular carcinoma or hepatic metastases from cancers other than colorectal cancer; or
      4. Implantable pumps for the infusion of baclofen for chronic neuropathic pain.

      See also CPB 607 - Anesthetic Infusion Pumps.

2. External Infusion Pumps

   Aetna considers external infusion pumps medically necessary DME for administration of any of the following medications:

   1. Deferoxamine for the treatment of acute iron poisoning and iron overload (only external infusion pumps are considered medically necessary); or
   2. Heparin for the treatment of thromboembolic disease and/or pulmonary embolism (only external infusion pumps used in an institutional setting are considered medically necessary); or
   3. Heparin to adequately anticoagulate women throughout pregnancy (warfarin compounds are not routinely used for this indication); or.
   4. Chemotherapy for primary hepatocellular carcinoma or colorectal cancer where the tumor is unresectable or the member refuses surgical excision of the tumor; or 
   5. Morphine or other narcotic analgesics (except meperidine) for intractable pain caused by cancer; or
   6. Parenteral inotropic therapy with dobutamine, milrinone, and/or dopamine; or
   7. Parenteral epoprostenol or treprostinil for persons with pulmonary hypertension; or
   8. Certain parenteral antifungal or antiviral drugs (e.g., acyclovir, foscarnet, amphotericin B, or ganciclovir); or
   9. Certain parenteral anticancer chemotherapy drugs (e.g., cladribine, fluorouracil, cytarabine, bleomycin, floxuridine, doxorubicin, vincristine, vinblastine, cisplatin, paclitaxel) if the drug is part of an evidence-based chemotherapy regimen and parenteral infusion of the drug at a strictly controlled rate is necessary to avoid systemic toxicity or adverse effects, and the drug is administered either:(i) by continuous infusion over 8 hours; or(ii) by intermittent infusions lasting less than 8 hours that do not require the person to return to the physician's office prior to the beginning of each infusion; or
   10. Insulin for persons with diabetes mellitus who meet the selection criteria for external insulin infusion pumps for diabetes set forth below; or

   11. Other parenterally administered drugs where an infusion pump is necessary to safely administer the drug at home. 

   Aetna considers external infusion pumps experimental and investigational for all other indications.

3. External Insulin Infusion Pumps for Diabetes

   Aetna considers external insulin infusion pumps medically necessary DME for the following persons with diabetes who meet the criteria in section A or in section B below:

   • children 12 years of age or younger with type 1 diabetes; or

   • adults and adolescents older than 12 years of age with diabetes who are beta cell autoantibody positive or have a documented fasting serum C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method*.
     

   1. Members must meet all of the following criteria: 

      1. The member has completed a comprehensive diabetes education program; and 
      2. The member has been on a program of multiple daily injections of insulin (i.e., at least 3 injections per day), with frequent self-adjustments of insulin dose for at least 6 months prior to initiation of the insulin pump**; and  
      3. The member has documented frequency of glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump**; and 

      4. The member meets at least one of the following criteria while on multiple daily injections (more than 3 injections per day) of insulin: 

         1. Elevated glycosylated hemoglobin level (HbA1c greater than 7.0%, where upper range of normal is less than 6.0%; for other HbA1c assays, 1% over upper range of normal); or
         2. History of recurring hypoglycemia (less than 60 mg/dL); or
         3. Wide fluctuations in blood glucose before mealtime (e.g., pre-prandial blood glucose levels commonly exceed 140 mg/dL); or
         4. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or

         5. History of severe glycemic excursions;

      or

   2. The member has been on a pump prior to enrollment in Aetna, and has documented frequency of glucose self-testing an average of at least 4 times per day during the month prior to Aetna enrollment. 

      Aetna considers external infusion pumps for diabetes experimental and investigational where the above-listed criteria are not met.

      Footnotes:

      * Fasting C-peptide levels will be considered valid only with a concurrently obtained fasting glucose less than 225 mg/dL.  For persons with renal insufficiency and creatinine clearance (actual or calculated from age, gender, weight, and serum creatinine) less than 50 ml/minute, insulinopenia is defined as a fasting C-peptide level that is less than or equal to 200% of the lower limit of normal of the laboratory's measurement method. 

      ** It may be considered medically necessary to initiate the use of insulin infusion pumps during pregnancy earlier than the criteria stated above to avoid fetal and maternal complications of diabetes and pregnancy. It may be considered medically necessary for poorly controlled women with diabetes to sometimes get started on the pump pre-pregnancy or in the first trimester. 

      Notes on external insulin infusion pumps: 

      • External subcutaneous insulin infusion pumps are only considered medically necessary for persons who have demonstrated ability and commitment to comply with a regimen of pump care, frequent self-monitoring of blood glucose, and careful attention to diet and exercise.
      • The pump must be ordered by and follow-up care of the member must be managed by a physician with experience managing persons with insulin infusion pumps and who works closely with a team including nurses, diabetic educators, and dieticians who are knowledgeable in the use of insulin infusion pumps.
      • Documentation of continued medical necessity of the external insulin infusion pump requires that the member be seen and evaluated by the treating physician at least once every 6 months. 
      • Some external insulin infusion pumps (e.g., Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System) are able to take results of the blood glucose reading, calculate the appropriate insulin infusion rate, wirelessly transmit the results from the blood glucose monitor to the pump, and automatically adjust the insulin infusion rate, saving the member some extra steps. These insulin pump features, when present, are considered integral to the external insulin infusion pump and blood glucose monitor.
      • Aetna considers a disposable external insulin infusion pump (e.g., OmniPod Insulin Management System) an acceptable alternative to a standard insulin infusion pump for persons who meet medical necessity criteria for external insulin infusion pumps.
      • Aetna's medical necessity criteria for external infusion pumps for diabetes have been adapted from Medicare national policy on external insulin infusion pumps, as outlined in CMS's Coverage Issues Manual Section 60-14.

      See also CPB 070 - Diabetes Tests, Programs and Supplies.

4. Supplies and Drugs used with Implantable or External Infusion Pumps

   Aetna considers supplies that are needed for the effective use of the DME medically necessary. 

   Such supplies include those drugs and biologicals that must be put directly into the equipment in order to achieve the therapeutic benefit of the DME or to assure the proper functioning of the equipment.

5. Replacement Pumps

   1. The replacement of infusion pumps that are out of warranty, are malfunctioning, and cannot be refurbished is considered medically necessary.
   2. Replacement of an external insulin pump is considered medically necessary for children who require a larger insulin reservoir.
   3. Replacement of a functioning insulin pump with an insulin pump with wireless communication to a glucose monitor is considered not medically necessary as such wireless communication has not been shown to improve clinical outcomes.

Baclofen (Lioresal) is a derivative of gamma aminobutyric acid (GABA) that acts specifically at the spinal end of the upper motor neurons to cause muscle relaxation.  Intrathecal baclofen may be indicated for patients with severe chronic spasticity of spinal cord origin. An implantable infusion pump is required for the administration of intrathecal baclofen.  Intrathecal baclofen therapy is indicated for persons with severe chronic spasticity of spinal cord origin (including multiple sclerosis) that is refractory to oral baclofen or where there are unacceptable side effects from oral baclofen at the effective dose. The patient should be shown to respond to a single intrathecal bolus dose of up to 100 mcgs of baclofen. A positive response is defined as an average two-point drop on an objective muscle tone or spasm screening system (e.g., The Ashworth and Spasm scale). According to available guidelines, intrathecal baclofen therapy is not considered appropriate if the patient has a history of hypersensitivity to Lioresal, is pregnant or has inadequate birth control, has severely impaired renal function, has severe hepatic or gastrointestinal disease, or has cerebral lesions as the source of spasticity.

Brennan and Whittle (2008) stated that continuous infusion of intrathecal baclofen (ITB) via a subcutaneously implanted pump has developed over the past 2 decades as a powerful tool in the management of spasticity in various adult and pediatric neurological conditions. Acting more focally on spinal GABA receptors, ITB causes fewer systemic side effects than orally administered baclofen. The result is facilitation of daily caring, and symptomatic relief from painful spasm. With increasing experience of ITB use, novel applications and indications are emerging. These include the management of dystonia and chronic neuropathic pain. However, despite some recent authoritative reviews, there is still uncertainty about optimal use and evaluation of this therapy.

Shilt et al (2008) stated that ITB is an effective treatment of spasticity in patients with cerebral palsy (CP). However, several recent reports have raised concerns that the treatment may be associated with a rapid progression of scoliosis. The objective of this study was to further examine the effect of ITB treatment on the progression of scoliosis in patients with CP. Spastic CP patients who were ITB candidates were followed radiographically. Baseline Cobb angles of the primary curve were measured during the period of ITB pump insertion and at the most recent follow-up visit. Each patient was matched with a control patient by the diagnosis of CP, age, sex, topographical involvement, and initial Cobb angle. The mean rate of change in Cobb angle was compared between ITB and control patients using paired-t test. A multiple linear regression model was used to examine the difference, controlling for age, sex, topographical involvement, and initial Cobb angle. A total of 50 ITB patients and 50 controls were included in the analysis. There was no statistically significant difference between the mean change in Cobb angle in ITB patients (6.6 degrees per year) compared with the matched control patients (5.0 degrees per year, p = 0.39). The results from the multiple regression analysis also failed to show a statistically significant difference (0.92 degrees per year difference between ITB patients and controls, p = 0.56). The authors concluded that the progression of scoliosis in CP patients with ITB treatment is not significantly different from those without ITB treatment. The findings suggest that patients receiving ITB experience a natural progression of scoliosis similar to the natural history reported in the literature.

The discovery of spinal opiate receptors, and that the binding of morphine at relatively low concentrations to these receptors produced effective analgesia have led to the development of intraspinal analgesia for the management of pain.  This mode of opioid administration has become an attractive alternative for cancer patients whose pain is not relieved by conventional drugs and/or routes; and for others who cannot tolerate the side effects of systemic administration of opioids in the dose needed for adequate analgesia as the disease progresses.  A popular procedure for intraspinal administration of opioids analgesics is the implantation of an infusion pump which allows the direct delivery of opioids to the receptors in the spinal cord continuously and/or in an intermittent manner.

Available evidence indicates that chronic intrathecal opioids administration via implantable pumps can provide satisfactory pain relief for patients who suffer from intractable cancer pain.  In addition, it allows the patients to be less dependent on hospital services, thus improving the quality of their lives. Studies have also shown that the same method of treatment was successful in providing quality analgesia to carefully selected patients who experienced chronic pain from nononcologic origins, although reductions in pain and improvements in function is observed less consistently in noncancer pain. Some investigators have reported untoward side effects of intrathecal opioid administration, including development of a fibrous mass around the tip of the catheter, resulting in compression of the intrathecal space with displacement of the spinal cord.

To be considered for spinal analgesia, a patient must have a normal platelet count and no coagulation disorder, infection, or other problems that might preclude the use of spinal drugs.  Before the implantation of a permanent infusion system, an efficacy test is usually performed to assess the patient's response and dose.  One or several trial doses of 5 to 10 mg of epidural morphine, or 0.5 to 1.0 mg intrathecal morphine is/are administered while all other analgesic medications are stopped.  Subjective pain ratings and undesirable side effects are evaluated for several days.  A decision to implant the pump is made only if pain is markedly reduced and other opioid analgesics are not needed by the patient.

Aetna's medical necessity criteria for external infusion pumps for diabetes have been adapted from Medicare national policy on external insulin infusion pumps, as outlined in CMS's Coverage Issues Manual Section 60-14.

There is insufficient evidence that external insulin infusion pumps improve glycemic control over multiple daily injections in persons with type 2 diabetes (Hammond, 2004; Pickup & Renard, 2008; Fatourechi, et al., 2009). The results of studies of the impact of external insulin infusion pumps on glycemic control in persons with type 2 diabetes has been inconsistent (see, e.g., Raskin, et al., 2003; Herman, et al., 2005; Berthe, et al., 2007; Parkner, et al., 2008).

Fatourechi, et al. (2009) reported on a metaanalysis of randomized controlled clinical trials of continuous subcutaneous insulin infusion (CSII) over multiple daily injections (MDI) in persons with diabetes.  The investigators identified 15 eligible randomized trials of moderate quality, with elevated baseline and end-of-study hemoglobin A1c (HbA1c) levels. The investigators reported that patients with type 1 diabetes using CSII had slightly lower HbA1c [random-effects weighted mean difference, -0.2%; 95% confidence interval (CI), -0.3, -0.1, compared with MDI], with no significant difference in severe (pooled odds ratio, 0.48; 95% CI, 0.23, 1.00) or nocturnal hypoglycemia (pooled odds ratio 0.82, 95% CI 0.33, 2.03). Adolescents and adults with type 1 diabetes enrolled in crossover trials had nonsignificantly fewer minor hypoglycemia episodes per patient per week (-0.08; 95% CI, -0.21, 0.06) with CSII than MDI; children enrolled in parallel trials had significantly more episodes (0.68; 95% CI, 0.16, 1.20; p (interaction) = 0.03). The investigators reported that outcomes were not different in patients with type 2 diabetes. The investigators concluded that "[c]ontemporary evidence indicates that compared to MDI, CSII slightly reduced HbA1c in adults with type 1 diabetes, with unclear impact on hypoglycemia. In type 2 diabetes, CSII and MDI had similar outcomes. The effect in patients with hypoglycemia unawareness or recurrent severe hypoglycemia remains unclear because of lack of data."

Guidelines from the American Association of Clinical Endocrinologists (Robard, et al., 2007) state that, for patients with type 2 diabetes, "[c]onsider use of continuous subcutaneous insulin infusion in insulin-treated patients." However, this is a grade C recommendation, based upon low quality evidence. Guidelines from the National Institute for Health and Clinical Excellence (2008) do not recommend use of CSII in persons with type 2 diabetes.

A systematic evidence review by Mukhopadhyay, et al. (2007) found no advantage of using continuous subcutaneous insulin infusion (CSII) over multiple daily injections in pregnant women with diabetes. The investigators identified randomized controlled clinical trials of the effects of CSII versus multiple daily insulin injections on glycemic control and pregnancy outcome in women with diabetes. Studies were rated for quality independently by two reviewers. Summary weighted mean differences and odds ratios were estimated for insulin dose, birthweight, gestational age, mode of delivery, hypoglycemic/ketotic episodes, worsening retinopathy, neonatal hypoglycemia, and rates of intrauterine fetal death. Six randomized clinical trials met the inclusion criteria. The investigators found that pregnancy outcomes and glycemic control were not significantly different among treatment groups. The investigators found higher numbers of ketoacidotic episodes and diabetic retinopathy in the CSII group, but these differences did not reach statistical significance. The investigators found that this systematic review did not find any advantage or disadvantage of using CSII over multiple daily injections in pregnant diabetic women.