Description

Implantable infusion pumps (IIPs) for pain or spasticity (also referred to as implantable drug delivery systems [IDDS] or targeted drug delivery [TDD] systems) are devices that deliver medications via intrathecal catheters directly into the cerebrospinal fluid in the spine. IIPs can be programmed for continuous or variable rates of infusion.

Examples of IIPs include, but may not be limited to:

• Prometra Programmable Infusion Pump System
• Prometra II Programmable Pump
• SynchroMed II (may include the myPTM remote control programmer)

Postoperative disposable ambulatory regional anesthesia pumps may be single use elastomeric or spring-loaded devices which deliver a continuous, preset dose of pain medication; some newer models also allow for bolus injections with adjustable lockout times. These devices are placed at the end of the procedure in or near the surgical area in an attempt to control postoperative pain and are sent home with the individual at discharge. The individual or caregiver is instructed on removal of the device.

Examples of these devices include, but may not be limited to:

• ACTion Block Pain Pump
• Action Fuser Pain Pump
• AutoFuser Disposable Pain Pump
• On-Q Fixed Flow Rate Pump
• On-Q Pump with ONDEMAND Bolus Button
• On-Q Pump with Select-A-Flow Variable Rate Controller
• On-Q with Select-A-Flow Variable Rate Controller and ONDEMAND Bolus Button

Another type of pump used for the immediate postoperative period for an individual after they are discharged from the hospital or surgery center is the single-use (i.e., used for one individual, and then disposed of via a recycling center) Nimbus PainPRO Postoperative Pain Pump. It differs from the elastomeric or spring-loaded devices in that it is battery powered and uses a programmed intermittent bolus (PIB) which purportedly puts pressure and volume behind the catheter infusion, enhancing medication spread.

Coverage Determination

Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication used with an implantable infusion pump.

Services provided by a psychiatrist, psychologist or other behavioral health professionals are subject to the provisions of the applicable behavioral health benefit.

Antispasmodic Drugs for Severe Spasticity

Humana members may be eligible under the Plan for an implantable intrathecal infusion pump used to administer antispasmodic drugs (Lioresal [baclofen]) when the following criteria are met:

• Chronic intractable spasticity of cerebral or spinal origin; AND

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Absence of contraindications; AND
• Drug is approved by the US Food & Drug Administration (FDA) for the intended use (see Appendix A); AND
• FDA-approved labeling for the pump must specify that the drug being administered and the purpose for which it is administered is an indicated use for the pump (see Appendix A); AND
• Individual cannot be maintained on noninvasive methods of spasm control such as oral antispasmodic drugs*, either because these methods fail to adequately control the spasticity or produce intolerable side effects, as evidenced by a minimum trial of 6 consecutive weeks; AND
• Individual has a baseline average Ashworth score of at least 3 (see Appendix B); AND
• Prior to pump implantation, the individual must have responded favorably to a trial of an intrathecal dose of antispasmodic drug (eg, improved function and decreased spasticity, as evidenced by at least a 2-point reduction in the Ashworth score [see Appendix B] for 4 hours following the intrathecal trial bolus of the antispasmodic drug)

*A trial of oral baclofen is not required as a prerequisite to intrathecal baclofen therapy in children 12 years of age or younger, due to increased risk of adverse effects from oral baclofen in this age group.

DRUGS FOR TREATMENT OF SEVERE INTRACTABLE PAIN

Humana members may be eligible under the Plan for an implantable intrathecal infusion pump when used to administer opioid or nonopiate analgesic drugs for the following:

Temporary Trial

A temporary trial may be covered for spinal (intrathecal or epidural) opioid or nonopiate analgesic drugs when ALL of the following criteria are met:

• Absence of contraindications; AND
• Any drug(s) used to fill the implantable infusion pump must be appropriate for the treatment of the individual’s pain condition; AND
• Submission of a signed patient-agreement contract, in which the individual agrees to a decrease in systemic opiate intake upon insertion of the infusion pump; AND ONE of the following:
• Severe intractable pain due to malignant origin (pain associated with cancer) AND all of the following:
  • Life expectancy of at least 3 months; AND
  • Individual’s history must indicate that there was not an adequate response to noninvasive methods of pain control (eg, systemic opioids); OR
• Severe chronic intractable pain due to nonmalignant origin AND all of the following:
  • Further surgical intervention is not indicated; AND
  • Other noninvasive pain management treatments, under the direction of a healthcare professional, have been tried for 6 consecutive months within the past 12 months and failed to provide satisfactory pain control (including attempts to eliminate physical or behavioral abnormalities which may cause an exaggerated reaction/response to pain), to include ALL of the following:
    • Cognitive behavioral therapy to address any behavioral conditions which may cause an exaggerated reaction/response to pain; AND
    • Pharmacological management if medically appropriate and not contraindicated; AND

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Individual failed to experience adequate pain relief with, or could not tolerate the side effects of, pain medications (e.g., systemic opioids, non-narcotic analgesics); AND

Medications were prescribed and taken via oral or transdermal routes of administration per a fixed schedule (not on an as needed basis [PRN]); AND

Records are submitted documenting compliance with attempted pharmacological management; AND

Physical therapy, including a home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND

• Pain-focused psychological evaluation by a licensed mental health professional has been obtained within the past 12 months and indicates that the individual is a favorable candidate for permanent intrathecal pump implantation; AND
• The individual has undergone screening, physical evaluation and diagnosis by a multidisciplinary team prior to implantation

Permanent Implantation

Permanent implantation of an intrathecal (intraspinal) infusion pump for the administration of opioid or nonopiate analgesic medications to treat severe intractable pain may be covered when a temporary trial has been successful. Successful is defined as:

• Temporary trial of spinal drug administration must have been completed with ALL the criteria listed above having been met; AND
• Temporary trial has been successful, as defined by a 50% reduction in pain

Implantable Infusion Pumps for Pain or Spasticity Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0307-023 Page: 6 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Replacement

Replacement/upgrade of an implantable intrathecal infusion pump or programmer may be considered medically necessary IF the existing device malfunctions (including impending end of battery life) and cannot be repaired OR replacement is required due to a change in the individual’s condition that makes the present device nonfunctional. The malfunction or catheter migration/kink should be documented by objective studies such as rotor/catheter dye studies, imaging studies, etc.

Replacement of the entire implantable infusion pump system (the catheter and programmer) is generally NOT required at the time of pump replacement due to the end of battery life.

Postoperative Disposable Ambulatory Pumps

Postoperative disposable ambulatory regional anesthesia pumps including the Nimbus Pain Pro Postoperative Pain Pump are considered integral to the primary procedure and not separately reimbursable. Additionally, these devices do not meet the certificate definition of durable medical equipment (DME) (can withstand repeated use; could normally be rented and used by successive individuals). Please refer to the member’s individual certificate for the specific definition.

Note: The criteria for implantable infusion pumps are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members.

Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for implantable intrathecal infusion pumps for any indications other than those listed above including, but may not be limited to:

• Replacement/upgrade of an implantable infusion pump or programmer when requested for convenience OR to upgrade to newer technology when the current components remain functional

Implantable Infusion Pumps for Pain or Spasticity Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0307-023 Page: 7 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Replacement of the entire implantable infusion pump system (the catheter and programmer) is NOT generally required at the time of pump replacement due to the end of battery life.

All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for implantable intrathecal infusion pumps for the following indications:

• Dystonia; OR
• Simultaneous use of a spinal cord stimulator with intrathecal drug therapy

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Contraindications

Humana members may NOT be eligible under the Plan for implantable intrathecal infusion pumps for an individual with ANY of the following contraindications:

• Active infection; OR
• Body size is insufficient to support the weight and bulk of the device; OR
• Known allergy or hypersensitivity to the drug being used (eg, baclofen, morphine, Prialt)

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Implantable Infusion Pumps for Pain or Spasticity Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0307-023 Page: 8 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Additional Information

Background

Additional information about chronic intractable spasticity, cerebral palsy and spinal cord injury may be found from the following websites:

• American Academy of Neurology
• National Institute of Neurological Disorders and Stroke
• National Library of Medicine

Chronic Pain

Additional information about chronic pain may be found from the following websites:

• American Society of Interventional Pain Physicians
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.