National Medical Policy

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1 National Medical Policy Subject: Policy Number: Infusion Pumps for Pain: External, Portable and Implantable NMP45 Effective Date*: October 2003 Updated: October 2017 Archive: This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Infusion Pumps (280.14): X National Coverage Manual Citation Local Coverage Determination (LCD)* External Infusion Pumps: X Article (Local)* External Infusion Pumps: X Other Medicare National Coverage Determinations Manual. Chapter 1, Part 4 (Sections ). Coverage Determinations: Guidance/Guidance/Manuals/downloads/ncd103 c1_part4.pdf Infusion Pumps: External, Portable and Implantable Oct 17 1

2 Jurisdiction D DME MAC Supplier Contacts and Resources. 2015: / /DME+Happenings+Issue+46 +March+2015/2ed305a4-ea b2c8-3acb81f73923 None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement External portable infusion pumps External portable infusion pumps are considered medically necessary for treatment of severe, chronic cancer pain that is resistant to conventional therapy. Implantable Infusion Pumps Implantable infusion pumps are medically necessary for treatment of severe, chronic, intractable pain (intravenous, intrathecal, or epidural infusion of Duramorph, Dilaudid and Clonidine) of malignant or non-malignant origin in patients who have a life expectancy of at least 3 months and who have proven unresponsive to less invasive medical therapy as determined by the following: 1. The patient's history indicates that he-she would not respond adequately to non-invasive pain control methods (such as systemic opioids); and 2. A preliminary trial of intraspinal opioids with a temporary intrathecal/epidural/intravenous catheter must be undertaken to substantiate acceptable pain relief, degree of side effects, and patient acceptance. A minimum trial of 72 hours is required for chronic intractable pain for cancer patients, while the trial period for non-cancer patient with chronic intractable pain is a minimum of 7 days. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or non- Infusion Pumps: External, Portable and Implantable Oct 17 2

3 covered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. ICD-10 Codes G89.21-G89.29 Chronic pain, not elsewhere classified G89.3 Neoplasm related pain G89.4 Chronic pain syndrome CPT Codes Insertion, revision, removal of implantable intra-arterial pump code range Insertion of tunneled centrally inserted central venous access device with subcutaneous pump Repair of tunneled or non-tunneled central venous access catheter, without subcutaneous port or pump, central or peripheral insertion site Repair of central venous access device, with subcutaneous port or pump, central or peripheral insertion site Replacement, catheter only, of central venous access device, with subcutaneous port or pump, central or peripheral insertion site Replacement, complete, of a tunneled centrally inserted central venous catheter, without subcutaneous port or pump, through same venous access Replacement, complete, of a tunneled centrally inserted central venous access device, with subcutaneous port, through same venous access Replacement, complete, of a peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, through same venous access Replacement, complete, of a peripherally inserted central venous access device, with subcutaneous port, through same venous access Removal of tunneled central venous access device, with subcutaneous port or pump, central or peripheral insertion Insertion of subcutaneous reservoir, pump, or continuous infusion system for connection to ventricular catheter Implantation, revision, or repositioning of tunneled intrathecal or epidural catheter for long term medication administration via an external pumpor implantable reservoir/infusion pump; without laminectomy Implantation, revision, or repositioning of tunneled intrathecal or epidural catheter for long term medication administration via an external pumpor implantable reservoir/infusion pump; with laminectomy Implantation or replacement of device for intrathecal or epidural drug infusion; subcutaneous reservoir Implantation or replacement of device for intrathecal or epidural drug infusion; non-programmable pump Implantation or replacement of device for intrathecal or epidural drug infusion; programmable pump, including preparation of pump, with or without programming Infusion Pumps: External, Portable and Implantable Oct 17 3

4 62365 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 with reprogramming Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) or brain (intraventricular), includes electronic analysis of pump, when performed. HCPCS Codes A4220 A4221 A4222 E0782 E0783 E0785 E0786 Refill kit for implantable infusion pump Supplies for maintenance of drug infusion catheter, per week (list drug separately) Supplies for external drug infusion pump, per cassette or bag (list drug separately) Infusion pump, implantable, nonprogrammable (includes all components, e.g., pump, catheter, connectors, etc.) Infusion pump, 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) Scientific Rationale A portable infusion pump (PP) is a device intended to provide ambulatory continuous drug infusion therapy over an extended time period. It is also known as an external pump, ambulatory pump, or a mini-infuser; and can be worn on a belt around the member's waist or from a shoulder harness. Acceptable routes are subcutaneous (SC) and intravenous (IV). A catheter from the pump is attached to a needle in the desired access route for drug delivery. Driving mechanisms include motor-driven gear syringes, or positive-displacement valves. An implantable pump (IP) is intended to provide long-term continuous or intermittent drug infusion. Possible routes of administration include intravenous, intra-arterial, subcutaneous, intraperitoneal, intrathecal, epidural, and intraventricular. The IP is surgically placed in a subcutaneous pocket under the infraclavicular fossa or in the abdominal wall, and a catheter is threaded into the desired position. A drug is infused over an extended period of time, and the drug reservoir may be refilled as needed by an external needle injection through a self-sealing septum in the IP. Bacteriostatic water or physiological saline is often used to dilute therapeutic drugs. A heparinized saline solution may also be used during an interruption of drug therapy to maintain catheter patency. The driving mechanisms may include peristalsis, fluorocarbon propellant, osmotic pressure, piezoelectric disk binders, or the combination of an osmotic pressure with an oscillating piston. Review History Infusion Pumps: External, Portable and Implantable Oct 17 4

5 October 16, 2003 April 2006 March 2007 April 2008 March 2011 November 2011 October 2012 October 2013 October 2014 October 2015 October 2016 October 2017 Medical Advisory Council Coding Updates no changes to policy Coding Updates Changed title of policy to Infusion Pumps for Pain: External, Portable and Implantable Update. Added Medicare Table with link to NCD. No revisions. Update no revisions Update no revisions Update no revisions. Codes updated. Update no revisions. Codes updated. Update no revisions. Codes updated. Update - no revisions. Codes updated. Update no revisions This policy is based on the following evidence-based guidelines: 1. Hayes. Medical Technology Directory. Intrathecal Opioid Therapy for Chronic Nonmalignant Pain. October 14, Updated September 29, Archived November National Cancer Comprehensive Network (NCCN) Guidelines. Version Adult Cancer Pain. Updated Version Updated Version Updated Version References Update October U.S. FDA. What Is an Infusion Pump? 10/31/14. Available at: italdevicesandsupplies/infusionpumps/ucm htm References Update October Malhotra VT1, Root J, Kesselbrenner J. et al. Intrathecal pain pump infusions for intractable cancer pain: an algorithm for dosing without a neuraxial trial. Anesth Analg Jun;116(6): doi: /ANE.0b013e31828d670e. Epub 2013 Apr 4. References Update October Kaplan R, Portenoy RK. Cancer pain management: Interventional therapies. UpToDate. August 30, Portenoy RK, Mehta Z, Ahmed E. Cancer pain management with opioids: Optimizing analgesia. UpToDate. April 1, Reddy A, Yennurajalingam S, Pulivarthi K, et al. Frequency, outcome, and predictors of success within 6 weeks of an opioid rotation among outpatients with cancer receiving strong opioids. Oncologist 2013; 18:212. References Update October Duarte RV, Raphael JH, Sparkes E, et al. Long-term intrathecal drug administration for chronic nonmalignant pain. J Neurosurg Anesthesiol Jan;24(1): Hayek SM, Deer TR, Pope JE, et al. Intrathecal therapy for cancer and noncancer pain. Pain Physician May-Jun;14(3): Hayek SM, Veizi IE, Narouze SN, Mekhail N. Age-dependent intrathecal opioid escalation in chronic noncancer pain patients. Pain Med Aug;12(8): Infusion Pumps: External, Portable and Implantable Oct 17 5

6 References Update November Coffey RJ, Owens ML, Broste SK, et al. Medical practice perspective: identification and mitigation of risk factors for mortality associated with intrathecal opioids for non-cancer pain. Pain Med Jul;11(7): Duse G, Davià G, White PF. Improvement in psychosocial outcomes in chronic pain patients receiving intrathecal morphine infusions. Anesth Analg Dec;109(6): Goucke CR, Dusci LJ, Van Leeuwen S, et al. Stability and tolerability of high concentrations of intrathecal bupivacaine and opioid mixtures in chronic noncancer pain: an open-label pilot study. Pain Med Nov;11(11): doi: /j x 4. Kongkam P, Wagner DL, Sherman S, et al. Intrathecal narcotic infusion pumps for intractable pain of chronic pancreatitis: a pilot series. Am J Gastroenterol May;104(5): Lara NA Jr, Teixeira MJ, Fonoff ET. Long term intrathecal infusion of opiates for treatment of failed back surgery syndrome. Acta Neurochir Suppl. 2011;108: Patel VB, Manchikanti L, Singh V, et al. Systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain. Pain Physician Mar-Apr;12(2): References Update March Hoving MA, van Raak EP, Spinc le GH, et al. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: A randomised controlled trial. Eur J Paediatr Neurol. 2009;13(3): Logtenberg SJ, Kleefstra N, Houweling ST, et al. Improved glycemic control with intraperitoneal versus subcutaneous insulin in type 1 diabetes: A randomized controlled trial. Diabetes Care. 2009;32(8): References Initial 1. Ackerman LL, Follett KA, Rosenquist RW. Long-term outcomes during treatment of chronic pain with intrathecal clonidine or clonidine/opioid combinations. J Pain Symptom Manage Jul;26(1): Bruera E, Brenneis C, Michaud M, Chadwick S, MacDonald RN. Continuous sc infusion of narcotics using a portable disposable device in patients with advanced cancer. Cancer Treat Rep Jun;71(6): Cherry DA, Gourlay GK, Eldredge KA. Management of chronic intractable angina - spinal opioids offer an alternative therapy. Pain Mar;102(1-2): Dennis GC, DeWitty RL. Long-term intraventricular infusion of morphine for intractable pain in cancer of the head and neck. Neurosurgery Mar;26(3): Hernandez-Palazon J, Tortosa Serrano JA, Martinez-Perez M, Piqueras-Perez C, Burguillos Lopez S. Bupivacaine in continuous epidural infusion using a portable mechanical devise for postoperative analgesia after surgery for hernia of the lumbar disk. Rev Esp Anestesiol Reanim Feb;48(2): Hoenecke HR Jr, Pulido PA, Morris BA, Fronek J. The efficacy of continuous bupivacaine infiltration following anterior cruciate ligament reconstruction. Arthroscopy Oct;18(8): Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebocontrolled study. Anesthesiology Jun;96(6): Infusion Pumps: External, Portable and Implantable Oct 17 6

7 8. Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology Oct;97(4): Komatsu H, Matsumoto S, Nagasaki G, Hori M. The effect of continuous epidural infusion of combination of buprenorphine and bupivacaine for postoperative pain relief using a portable 0.5 ml.h-1 type infuser with patient control module. Masui Jun;45(6): Krames E. Implantable devices for pain control: spinal cord stimulation and intrathecal therapies. Best Pract Res Clin Anaesthesiol Dec;16(4): Kumar K, Kelly M, Pirlot T. Continuous intrathecal morphine treatment for chronic pain of nonmalignant etiology: long-term benefits and efficacy. Surg Neurol Feb;55(2): Lamer TJ. Treatment of cancer-related pain: when orally administered medications fail. Mayo Clin Proc May;69(5): Matsumoto S, Hasegawa J, Mitsuhata H, Komatsu H, Mizunuma T, Matsuoka T. Is a portable disposable pump useful in managing postoperative pain? Masui Apr;41(4): Moulin DE, Johnson NG, Murray-Parsons N, Geoghegan MF, Goodwin VA, Chester MA. Subcutaneous narcotic infusions for cancer pain: treatment outcome and guidelines for use. CMAJ Mar 15;146(6): Rainov NG, Heidecke V, Burkert W. Long-term intrathecal infusion of drug combinations for chronic back and leg pain. J Pain Symptom Manage Oct;22(4): Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE; Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol Oct 1;20(19): Zuniga RE, Perera S, Abram SE. Intrathecal baclofen: a useful agent in the treatment of well-established complex regional pain syndrome. Reg Anesth Pain Med Jan-Feb;27(1):90-3. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. Infusion Pumps: External, Portable and Implantable Oct 17 7

8 The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Infusion Pumps: External, Portable and Implantable Oct 17 8

9 Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Infusion Pumps: External, Portable and Implantable Oct 17 9