Medical Policy

Effective Date:12/07/2011 Title:Implantable Infusion Pump
Revision Date:04/01/2019 Document:BI320:00
CPT Code(s):36260, 61215, 62350, 62351, 62360-62362
Public Statement

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Implantable infusion pumps are covered for delivery of certain chemotherapy agents, treatment of severe chronic pain, and treatment of severe spasticity.

2)    Request for implantable infusion pumps for chronic intractable (non-cancer related pain) requires that the member is considered an appropriate candidate for long term opioid use and has failed or is intolerant to all other pharmacologic, non-pharmacologic and behavioral management. (Please see medical policy section for details.)

3)    Contact Care Management for any assistance.

Medical Statement

1)    Implantable infusion pumps are considered medically necessary and are covered when used to deliver drugs having FDA approval or recommendation by the AHFS or Clinical Pharmacology Online drug compendia and for the related indication for the treatment of: 

a.    Primary liver cancer (intrahepatic artery injection of chemotherapeutic agents);

b.    Metastatic colorectal cancer where metastases are limited to the liver (intrahepatic artery injection of chemotherapeutic agents);

c.    Head/neck cancers (intra-arterial injection of chemotherapeutic agents);

2)    Implantable infusion pumps are considered medically necessary and are covered for patients with severe, chronic, intractable (non-cancer related) pain (e.g., morphine, clonidine, buprenorphine, Ziconotide, fentanyl) when:

a.    The member has had a thorough evaluation to categorize the cause(s) of chronic pain and participated in a comprehensive treatment plan tailored to individual needs.

b.    There is documentation of trial and failure of all of the following alternatives to outpatient opioid maintenance therapy for chronic pain:

i)             Multidisciplinary pain rehabilitation.

ii)            Physical treatments (eg, monitored exercise therapy, weight loss)

iii)           Psychological treatments (eg, cognitive behavioral therapy, relaxation            techniques, stress-reduction techniques)

iv)           Non-opioid medications (eg, nonsteroidal anti-inflammatory drugs (NSAIDs), tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), anticonvulsants)

 

c.    Member is determined to be suitable candidate for long-term opioid analgesia and the benefits outweigh risks based on assessments including for high risk for opioid misuse validated screening instruments (such as DIRE > 13, ORT < 8, or SOAPP-R < 18).

d.    Member has no contraindications to opioid therapy. Absolute contraindications to opioid therapy include severe respiratory instability, acute psychiatric instability or uncontrolled suicide risk, diagnosed substance-related disorder (other than nicotine) not in remission or for which the patient currently is receiving active treatment, opioid allergy that cannot be resolved by switching agents, co-administration of a drug capable of inducing life-threatening drug-drug interaction, QTc interval greater than 500 milliseconds (for methadone), active diversion of controlled substances (ie, providing medication to someone for whom it was not prescribed), or history of prior opioid trials that were discontinued (eg, due to intolerance, non-treatable serious adverse effects, or lack of efficacy).

e.    The patient been tried on and is unable to get adequate pain relief or has unacceptable side effects from short acting and long acting opioids. Please refer to BI566 Short Acting Opioids and BI583 Long acting Opioids, for specific criteria. ; AND

f.     Only medication that are FDA approved for intrathecal use may be used for intrathecal pumps.

g.    Renewal of Intrathecal medications: Requests for continuation of intrathecal infusion medications require:

                          i.        Member continues to meet criteria for long term opioid therapy per BI583 and for and appropriate dosing based on standard Centers for Disease Control and Prevention (CDC) guidelines for Opioid Prescribing for Chronic Pain AND The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines.

                         ii.        There is no documentation of opioid abuse as indicate by opioid misuse screening tools scores ((such as DIRE > 13, ORT < 8, or SOAPP-R < 18) and by regular checks of the Arkansas Prescription Monitoring Program (PMP) by the provider.

                        iii.        Member continues to have 50% or greater improvement in functional capacity.

                        iv.        At any time a member does not meet the Opioid Misuse screening scores screening instruments (such as DIRE > 13, ORT < 8, or SOAPP-R < 18), she/he will no longer be considered a suitable candidate for long term opioid therapy and should be referred to a substance rehab program.

h.    The infusion pump is used as one part of an integrated pain management program; AND

i.      The pump is being managed by a board certified pain management specialist; AND

j.      Use of an implantable pump for epidural or intrathecal infusion requires a successful trial (at least 50% reduction in pain and improvement in function) of short term epidural or intrathecal injection.

3)    Implantable infusion pumps are covered when used to provide intrathecal injection of baclofen in patients with severe spasticity of cerebral or spinal cord origin in patients who are unresponsive to or who cannot tolerate oral baclofen therapy

a.    A successful trial (at least 50% reduction in spasticity and improvement in function) of intrathecal injection of baclofen must precede implantation.

4)    Cancer diagnoses require a life expectancy of at least three months.

5)    Supplies for an Implantable Infusion pump do not require preauthorization.

Codes Used In This BI:

36260

Insertion of implantable intra-arterial infusion pump (e.g., for chemotherapy of liver)

61215

Insertion of subcutaneous reservoir, pump or continuous infusion system for connection to ventricular catheter

62350

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

62351

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

62360

Implantation or replacement of device for intrathecal or epidural drug infusion; subcutaneous reservoir

62361

Implantation or replacement of device for intrathecal or epidural drug infusion; nonprogrammable pump

62362

Implantation or replacement of device for intrathecal or epidural drug infusion; programmable pump, including preparation of pump, with or without programming

Limits

Use for any other indication is considered investigational and experimental and is not covered.

Reference

1.    Deer TR, Pope JE, Hayek SM, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Neuromodulation. 2017 Feb;20(2):96-132. doi: 10.1111/ner.12538. Epub 2017 Jan 2.

2.    Bateman, B., Avorn, J., Choudhry, N.K., et al.  Managing Pain Without Overusing Opioids.  Alosafoundation.org

3.    Ehde, D.M., Dilworth, T.M., Turner, J.A. Cognitive-Behavioral Therapy for Individuals With Chronic Pain.  American Psychologist 2014; 69(2), 153-166.

4.    Clauw, Daniel. Hijacking the Endogenous Opioid System to Treat Pain. Pain. 2017; 158(12):2283-2284.

5.    Agency for Healthcare Research and Quality. The effectiveness and risks of long-term opioid treatment of chronic pain. 2014.

6.    Edlund MJ, Martin BC, Russo JE, DeVries A, Braden JB, Sullivan MD. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription. The Clinical journal of pain. 2014; 30(7):557-564.

7.    Juurlink DN and Dhalla IA. Dependence and Addiction During Chronic Opioid Therapy. J Med Toxicology. 2012; 8(4)393-399

8.    Franklin, Gary M. Opioids for Chronic Noncancer Pain - A position paper of the American Academy of Neurology. Neurology. 2014; 83(14):1277-1284.

9.    Bottemiller, Shelby. Opioid-Induced Hyperalgesia: An Emerging Clinical Challenge. US Pharm. 2012;37(5):HS-2-HS-7.

10. Lee M, Silverman S, Hansen H, et al. A Comprehensive Review of Opioid-Induced Hyperalgesia. Pain Physician. 2011; (14):145-161.

11. Yi P and Pryzbylkowski P. Opioid Induce Hyperaglesia. Pain Medicine. 2015; (16):S32-S36.

12. Vella-Brincat J and Macleod AD. Adverse Effects of Opioids on the Central Nervous Systems of Palliative Care Patients. J Pain & Pall Care Pharmacotherapy. 2007; 21(1):15-25.

13. Krebs EE, Gravely A, Nugent S, et al. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients with Chronic Back Pain of Hip or Knee Osteoarthritis Pain—The SPACE Randomized Clinical Trial. JAMA. 2018; 319(9):872-882.

14. Peltz G and Sudhoff TC. The Neurobiology of Opioid Addiction and the Potential for Prevention Strategies. JAMA. 2018; 319(20):2071-2072.

15. Argoff CE and Silverstein DI. A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain: Tailoring Therapy to Meet Patient Needs. Mayo Clin Proc. 2009: 84(7):602-612.

16. Dowell D, Hargerich TM and Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain—United States 2016. MMWR. 2016: 65(1):1-49.

17. Moberg, Kirk. The Role of Managed Care Professionals and Pharmacists in Combating Opioid Abuse.  AM J Manag Care. 2018; 24:S215-S223.

18. Kominek, Courtney. Current and Emerging Options to Combat the Opioid Epidemic. Am J Manag Care. 2018; 24:S207-S214.

19. Hagemeier, NE. Introduction to the Opioid Epidemic: The Economic Burden on the Healthcare System and Impact on Quality of Life. Am J Manag Care. 2018; 24:S200-S206.

20. Fatodu H, Garofoli M, Johnson GL, et al. A Dialogue on Opioid Misuse and Abuse: Best Practices for Population Health. Am J Manag Care. 2018; 24(12):S251-S261.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.