Implantable Infusion Pump

LCD Information Document Information Source LCD ID N/A LCD ID L33461 Original ICD-9 LCD ID Not Applicable LCD Title Implantable Infusion Pump Proposed LCD in Comment Period N/A Source Proposed LCD DL33461 Opens in a new window Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 03/07/2024 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 12/15/2016 Notice Period End Date 01/29/2017 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. 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Issue Issue Description This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Title XVIII Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII Social Security Act, §1862(a)(1)(D) addresses items and services related to research and experimentation. 42 CFR §411.15(k)(1) defines particular services excluded from coverage. CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.7 Denial of Medicare Payment for Compounded Drugs Produced in Violation of Federal Food, Drug, and Cosmetic Act CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps Coverage Indications, Limitations, and/or Medical Necessity The implantable pump is a sealed, self-powered system, which is inserted under the skin by a physician. It provides a continuous controlled infusion of a drug to a select body site and can be refilled by percutaneous injection. Two separate ports are available: 1 for bolus injections and 1 for continuous infusion. Both may be utilized for blood or cerebrospinal fluid (CSF) withdrawals. An implantable infusion pump is utilized to administer many types of medications through the intra-arterial, intrathecal or epidural route.Medicare will consider implantable infusion pumps, and associated services, medically reasonable and necessary for the conditions listed in the CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps. For the indication of opioid drugs used for the treatment of chronic intractable pain, it is useful to distinguish between pain caused by a malignancy from which the patient is not expected to recover from those non-malignant conditions that are longer term in nature. For terminal malignant conditions, the progression from a non-invasive pain control modality to a more invasive modality, such as use of an implanted pump, may occur more rapidly with less emphasis on behavioral approaches to pain control. Ziconotide (Prialt® Opens in a new window) intrathecal infusion documentation must meet the Food and Drug Administration (FDA)-approved indication that the patient is intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal therapy morphine in the treatment of severe, chronic pain. ContraindicationThe implantation of an infusion pump is contraindicated in the following patients: Those with a known allergy or hypersensitivity to the drug being used (e.g., oral baclofen and morphine) Those who have an infection Those whose body size is insufficient to support the weight and bulk of the device In those patients with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription, it is recommended that all devices be checked for possible crosstalk at the time of implantation of the infusion pump, and that appropriate surveillance for such interactions be continued. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

The implantable pump is a sealed, self-powered system, which is inserted under the skin by a physician. It provides a continuous controlled infusion of a drug to a select body site and can be refilled by percutaneous injection. Two separate ports are available: 1 for bolus injections and 1 for continuous infusion. Both may be utilized for blood or cerebrospinal fluid (CSF) withdrawals. An implantable infusion pump is utilized to administer many types of medications through the intra-arterial, intrathecal or epidural route. Medicare will consider implantable infusion pumps, and associated services, medically reasonable and necessary for the conditions listed in the CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps. For the indication of opioid drugs used for the treatment of chronic intractable pain, it is useful to distinguish between pain caused by a malignancy from which the patient is not expected to recover from those non-malignant conditions that are longer term in nature. For terminal malignant conditions, the progression from a non-invasive pain control modality to a more invasive modality, such as use of an implanted pump, may occur more rapidly with less emphasis on behavioral approaches to pain control. Ziconotide ( Prialt® ) intrathecal infusion documentation must meet the Food and Drug Administration (FDA)-approved indication that the patient is intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal therapy morphine in the treatment of severe, chronic pain. Contraindication The implantation of an infusion pump is contraindicated in the following patients: Those with a known allergy or hypersensitivity to the drug being used (e.g., oral baclofen and morphine) Those who have an infection Those whose body size is insufficient to support the weight and bulk of the device In those patients with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription, it is recommended that all devices be checked for possible crosstalk at the time of implantation of the infusion pump, and that appropriate surveillance for such interactions be continued.