Implantable Intrathecal or Epidural Pain Pump (PDF) Form

An implantable, intrathecal drug delivery system consists of an implanted pump and catheter that delivers a drug directly into the spinal fluid. The device can be programmed for continuous or variable rates of infusion. Intrathecal drug delivery systems offer an invasive alternative for the long-term management of select patients with intractable pain. Refer to CP.PHAR.149 Intrathecal Baclofen (Gablofen, Lioresal) for requests for Baclofen. Refer to the CP.MP.107 Durable Medical Equipment (DME) section on Pumps for criteria for other indications. Policy/Criteria
I. It is the policy of health plans affiliated with Centene Corporation® that a preliminary trial of epidural or intrathecal administration of an opioid drug is medically necessary for either of the following indications: A. Chronic intractable pain of malignant origin when all of the following criteria is met:

1. Inadequate response to, or intolerable side effects from, noninvasive methods of pain control such as systemic opioids;
   2. Life expectancy > three months;
   3. No evidence of epidural metastatic lesion(s) or tumor encroachment of the thecal sac by imaging;
2. No active infection. B. Chronic intractable pain of nonmalignant origin (e.g. failed back surgery syndrome, complex regional pain syndrome) when all the following criteria are met:
   1. Pathology for the pain has been identified;
   2. Life expectancy is > three months;
   3. Failure or inability to tolerate other conservative treatment methods, including but not limited to, systemic pharmacotherapy, physical therapy, behavioral health treatment for pain, and appropriate nonsurgical treatment;
3. Compliance with previous attempts to treat the condition;
   5. No current drug and/or alcohol disorder, including but not limited to, opioid use disorder or addiction;
4. A psychological evaluation confirms a mental health condition is not a major contributor to chronic pain symptoms;
5. Active participation in psychotherapeutic interventions (e.g. cognitive behavioral therapy, relaxation training, biofeedback, coping skills training, stress management);
6. Further surgical intervention or other treatment is not indicated or likely to be effective;

7. No active infection;

   10. Prior to the trial, systemic opioids have been weaned by at least 50%; Page 1 of 10

   CLINICAL POLICY Implantable Intrathecal or Epidural Pain Pump

8. Opioid induced hyperalgesia has been ruled out as a possible cause of the chronic pain symptoms. II. It is the policy of health plans affiliated with Centene Corporation that implantation of a permanent epidural or intrathecal pain pump to administer an opioid drug, alone or in combination with other non-opioid drugs, is medically necessary when meeting either of the following: A. Chronic intractable pain of malignant origin when the above criteria for the preliminary trial are met, and all the following:
   1. The trial provided ≥ 50% reduction in pain with minimal side effects;*
   2. Body size is sufficient to support the weight and bulk of the device;
   3. No other implanted programmable devices for which the interaction between devices may inadvertently change the prescription;
9. No known allergy or hypersensitivity to the drug being used; B. Severe chronic pain of non-malignant origin when the above criteria for the preliminary trial is met and all of the following:
   1. Preliminary trial provided ≥ 50% reduction in pain and increase in function with minimal side effects;
10. There is a plan in place to continue to wean systemic opioids;
    3. No active coagulopathy;
    4. Body size is sufficient to support the weight and bulk of the device;
    5. No other implanted programmable devices for which the interaction between devices may inadvertently change the prescription;
11. No known allergy or hypersensitivity to the drug being used;
    7. No evidence of increased intracranial pressure;
    8. No spinal anomalies that may complicate the implantation and fixation of a catheter for drug delivery;

12. Continued active participation in any behavioral health or psychological treatment modalities. *Note: The trial requirement for a percutaneous intrathecal or epidural drug delivery system for pain of malignant origin may be reviewed by a medical director on a case-by- case basis for instances of advanced disease, when survival time is limited, or considered high risk for procedures. Background
    Chronic pain is often defined as pain that persists longer than six months. The American Society of Interventional Pain Physicians (ASIPP) defines chronic pain as, “a complex and multifactorial phenomenon with pain that persists six months after an injury and/or beyond the usual course of an acute disease or a reasonable time for a comparable injury to heal, that is associated with chronic pathologic processes that cause continuous or intermittent pain for months or years, that may continue in the presence or absence of demonstrable pathology and may not be amenable to routine pain control methods with healing never occurring.”5 Numerous health conditions can cause chronic pain, including, but not limited to, chronic cancer pain, failed back surgery syndrome, complex regional pain syndrome, diabetic neuropathy, and post-herpetic neuralgia.2 Page 2 of 10

    CLINICAL POLICY Implantable Intrathecal or Epidural Pain Pump Opioid therapy for the treatment of chronic non-cancer pain is controversial, due to insufficient evidence of long-term efficacy and the risk of serious harm, including addiction and abuse, especially in the context of the ongoing opioid epidemic in the United States. For patients with chronic non-cancer pain, opioids should only be used when other potentially effective and safer therapies have not provided sufficient pain relief or experience intolerable side effects, and pain is adversely affecting a patient's function and/or quality of life. The potential benefits of opioid therapy should outweigh potential harms. Opioids should be combined with non-opioid pharmacotherapy and nonpharmacologic therapies as appropriate.7 Intrathecal therapy offers an invasive alternative for the long-term management of select patients with recalcitrant pain after all other methods have failed, including conservative and surgical treatment. Implantable intrathecal infusion systems, also referred to as intrathecal drug delivery (IDD) systems, provide targeted drug delivery to the central nervous system. They are most commonly used for cancer-related pain. Their use for management of pain of non-malignant origin is controversial and generally reserved for treatment of last resort. A number of medications are used, including opioids (e.g. morphine) or a combination of opioids along with a local anesthetic (e.g., ziconotide, clonidine.)
    An implantable intrathecal drug delivery system (pain pump) consists of an implanted catheter and either a constant-flow or programmable pump. The implantation of a pump for intrathecal opioid infusion is preceded by an intrathecal or epidural trial infusion, with or without a catheter, to determine whether the patient exhibits an adequate response, consisting of a predefined improvement in pain (usually ≥ 50%) without intolerable adverse effects. If the trial is successful, the drug infusion system is implanted under general anesthesia. The catheter is introduced into the intrathecal space of the spine (generally at the lumbar level), tunneled subcutaneously, and typically positioned under fluoroscopic guidance so that the tip is located at the corresponding spinal level for processing the patient’s pain. The catheter is connected to an infusion pump placed in a subcutaneous pocket in the abdomen.2 The literature evaluating intrathecal infusion systems for long-term management of chronic non- cancer pain is limited. Peer reviewed literature to date consists of observational studies, uncontrolled retrospective studies, case studies and systematic reviews using variable methodologies and inclusion criteria. Some studies suggest that intrathecal opioids reduce pain long-term in a small proportion of individuals with chronic, non-cancer pain, however, large randomized controlled trials are lacking. A health technology assessment of Intrathecal Drug Delivery Systems for Noncancer Pain reported, “Compared with oral opioid analgesia alone or a program of analgesia plus rehabilitation, intrathecal drug delivery systems significantly reduced pain (27% additional improvement) and morphine consumption. Despite these reductions, intrathecal drug delivery systems were not superior in patient-reported well-being or quality of life. There is no evidence of superiority of intrathecal drug delivery systems over oral opioids in global pain improvement and global treatment satisfaction. Comparative evidence of harms was not found.” 8 American Society of Interventional Pain Physicians (ASIPP) Page 3 of 10

    CLINICAL POLICY Implantable Intrathecal or Epidural Pain Pump The evidence is limited for implantable intrathecal drug administration systems in managing patients with failed back surgery syndrome. 9 American Society of Anesthesiologists/American Society of Regional Anesthesia and Pain Medicine Studies with observational findings indicate that intrathecal opioid injections can provide effective pain relief for assessment periods ranging from 1 to 12 months for patients with neuropathic pain (Category B2 evidence). Consultants, ASA members, and ASRA members are equivocal with regard to whether intrathecal opioid injection or infusion should be used for neuropathic pain. However, they strongly agree that neuraxial opioid trials should be performed before considering permanent implantation of intrathecal drug delivery systems.6 North American Spine Society (NASS) NASS has developed coverage recommendation on spinal intrathecal drug delivery systems for the treatment of chronic nonmalignant pain. Per NASS, the implantable infusion may benefit a small subgroup of patients with chronic nonmalignant pain and a clear spinal pathology, who have exhausted all other options to treat their symptoms. These patients should have a psychological evaluation to rule out drug and alcohol disorders and other psychological conditions.9 Coding Implications
    This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2021, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage.
    Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT® Codes 62320 62321 62322

    Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (ie, fluoroscopy or CT) Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance Page 4 of 10

    CLINICAL POLICY Implantable Intrathecal or Epidural Pain Pump CPT® Codes 62323 62326 62327 62350 62351 62355 62360 62361 62362 62365 62367 62368 62369 62370

    Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT) Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT) Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; without laminectomy Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; with laminectomy Removal of previously implanted intrathecal or epidural catheter Implantation or replacement of device for intrathecal or epidural drug infusion; subcutaneous reservoir. Implantation or replacement of device for intrathecal or epidural drug infusion; nonprogrammable pump Implantation or replacement of device for intrathecal or epidural drug infusion; programmable pump, including preparation of pump, with or without programming Removal of subcutaneous reservoir or pump, previously implanted for intrathecal or epidural infusion Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); without reprogramming or refill Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); with reprogramming Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); with reprogramming and refill Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, Page 5 of 10

    CLINICAL POLICY Implantable Intrathecal or Epidural Pain Pump CPT® Codes

    drug prescription status); with reprogramming and refill (requiring skill of a physician or other qualified health care professional) HCPCS Codes A4300 A4301 E0782 E0783 E0785 E0786 C1772 C1755 J2274 S0093

    Implantable access catheter, (e.g., venous, arterial, epidural subarachnoid, or peritoneal, etc.) external access Implantable access total catheter, port/reservoir (e.g., venous, arterial, epidural, subarachnoid, peritoneal, etc.) Infusion pump, implantable, nonprogrammable (includes all components, e.g., pump, catheter, connectors, etc.) Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.) Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) Infusion pump, programmable (implantable) Catheter, intraspinal Injection, morphine sulfate, preservative free for epidural or intrathecal use, 10 mg Injection, morphine sulfate, 500 mg (loading dose for infusion pump) Reviews, Revisions, and Approvals Policy developed. Specialist reviewed. Added CPT codes: 62320, 62321, 62351, 62361 Changed “no local infection at catheter site” in trial and permanent placement criteria to state “no active infection.” References reviewed and updated. References reviewed and updated. Added ICD-10 codes: G90.511, G90.512, and G90.513. Replaced “member” with “member/enrollee” in disclaimer. Annual review. Reference reviewed, updated, and reformatted. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” Updated “Refer to” note. In I. added “epidural or” intrathecal administration. In I.A.1. added Inadequate response “to or intolerable side effects from.” II.A added when “the above criteria for” the preliminary trial is met “and the following: Body size is sufficient to support the weight and bulk of the device; No other implanted programmable devices for which the interaction between devices may inadvertently change the prescription; Revision Date 02/19 07/19 01/20 Approval Date 02/19 01/20 12/20 01/21 01/22 01/22 Page 6 of 10

    CLINICAL POLICY Implantable Intrathecal or Epidural Pain Pump Reviews, Revisions, and Approvals No known allergy or hypersensitivity to the drug being used.” II.A. added “Note: The trial requirement for a percutaneous intrathecal or epidural drug delivery system for pain of malignant origin may be reviewed on a case-by-case basis for instances of advanced disease, when survival time is limited, or considered high risk for procedures.” II.B added “when the above criteria for the preliminary trial is met and all of the following.” Removed duplicate criteria from II.B “no active infection.” Updated policy title from "Implantable Intrathecal Pain Pump" to “Implantable Intrathecal or Epidural Pain Pump." Annual review. References reviewed and updated. ICD-10 code table removed. Minor rewording with no clinical significance. Reviewed by external specialist. Revision Date Approval Date 01/23 01/23