This version of the policy will become effective 02/17/2020.
This policy has been updated in consideration of a Safety Communication issued by the US Food and Drug Administration (FDA):
When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Infusion of chemotherapeutic drugs directly into the hepatic artery at a constant rate, known as hepatic arterial infusion (HAI), can occur when an infusion pump is surgically implanted in the abdomen, with the catheter delivering medication into the hepatic artery. HAI chemotherapy is a favored treatment approach due to the effective delivery of high concentrations of cytotoxic agents directly to liver metastases with minimal systemic toxicity. Tumor cells from gastrointestinal malignancies, particularly colorectal cancer, spread through the blood via the portal circulation, the circulatory path to the liver from the small intestine, colon, and spleen. This makes the liver the first site of metastases in the majority of patients, such that direct treatment of hepatic metastases may prevent tumor dissemination to other sites.
A number of chemotherapy drugs are available for the treatment of liver cancer and colorectal cancer (e.g. gemcitabine, oxaliplatin, doxorubicin, 5-fluorouracil, cisplatin). For use in HAI chemotherapy, the ideal agent is 5-fluoro-2’-deoxyuridine (i.e. 5-fluorodeoxyuridine, floxuridine, 5-FUdR, FUDR), due to its high dose-response curve, high extraction rate, and rapid total-body clearance post-infusion. 5-FUdR administered via HAI has been confirmed to result in 16-fold higher concentration in hepatic tumors as compared to venous administration. Intravenous infusion, which distributes the medication systemically via the general circulation, is also an option for treatment of colorectal cancer.
NEUROMODULATION OF SPASTICITY
Spasticity, a condition in which certain muscles are continuously contracted, is typically caused by damage to the areas of the central nervous system which control voluntary movement. As a result, there is a change in the balance of signals between the nerves and the muscles, which leads to increased activity in the muscles. Treatment options vary depending upon etiology and case severity, with intrathecal administration of the drug baclofen as an option for severe cases of intractable spasticity. Baclofen, a gamma-aminobutyric acid receptor agonist, helps reestablish inhibitory cortical influences on spinal cord interneurons. It received FDA approval in 1992 for the intrathecal treatment of spasticity of spinal origin, after having shown to be highly effective in reducing spasticity and associated pain, particularly in the extremities, with fewer side effects that oral medication treatment. Individuals with spasticity receiving intrathecal administration of baclofen via an implantable infusion pump may experience a reduction in rigidity and muscle spasms.
NEUROMODULATION OF PAIN
Pain may be the result of a number of conditions, ranging from those which are primarily neuropathic in origin, such as ankylosing spondylitis, to illnesses such as cancer or sickle cell disease, in which pain is a symptom of the underlying, non-neurologic disease. As defined by the American Chronic Pain Association, chronic pain is ongoing or recurrent pain, lasting beyond the usual course of acute illness or injury, or more than 3-6 months, and which adversely affects the individual’s well-being. In the case of individuals with intractable chronic pain that is refractory to standard medical management, intrathecal drug delivery systems can be used for continuous administration of pain medication. FDA-approved medication, including morphine and ziconotide, is delivered directly into the cerebrospinal fluid by way of implanted catheter; because the agent is administered at the pain source, less is required than via the oral administration route, which reduces systemic side effects. Morphine for intrathecal use in implantable infusion pumps is available as Infumorph® and Mitigo™, which are preservative-free, injectable morphine sulfate formulations specifically for intrathecal or epidural infusion by a continuous microinfusion device. The single ziconotide intrathecal infusion product available is marketed by Elan Pharmaceuticals as Prialt® and is intended for continuous delivery via a surgically implanted infusion system.
In 2018, the FDA released a communication regarding the risk of using non-approved medications for intrathecal pump pain management, reiterating that only specific pain medications are permitted to be used for each pump. Because the central nervous system is highly sensitive to preservatives and infectious agents (e.g. bacteria and viruses), analgesics delivered via cerebrospinal fluid must meet additional safety standards to be granted FDA approval. As such, it is important that only drugs approved for use with a specific infusion pump be used for that pump. Although individual patients may experience some relief from using pain medications not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns. Improper use of non-approved medications used with implanted infusion pump may lead to patient symptoms such as pain, opioid withdrawal, fever, vomiting, muscle spasm, cognitive changes, weakness, and cardiac and respiratory distress. Due to the high risk of adverse events, the use of non-approved pain medications with intrathecal drug delivery systems is deemed not medically necessary.
MITIGO™ (morphine sulfate), preservative free, injectable solution
*PRIALT® (preservative free ziconotide sterile solution)
ANY mixture of two or more different kinds of medicines
Any compounded medicine (for example, to achieve higher concentration or different formulation of an FDA approved medicine)
J0475 Injection, baclofen, 10 mg
J0476 Injection, baclofen, 50 mcg for intrathecal trial
J2270 Injection, morphine sulfate, up to 10 mg
J2274 Injection, morphine sulfate, preservative free for epidural or intrathecal use, 10 mg
J2278 Injection, ziconotide, 1 mcg
S0093 Injection, morphine sulfate, 500 mg (loading dose for infusion pump)
NOT MEDICALLY NECESSARY
THE IMPLANTABLE INFUSION PUMPS DESCRIBED IN THIS POLICY ARE NOT MEDICALLY NECESSARY WHEN USED IN COMBINATION WITH THE FOLLOWING DRUG CODES FOR PAIN MANAGEMENT:
J0735 Injection, clonidine HCl, 1 mg
J1170 Injection, hydromorphone, up to 4 mg
J3010 Injection, fentanyl citrate, 0.1 mg
S0020 Injection, bupivicaine HCl, 30 ml
NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT
THE FOLLOWING SERVICES ARE INTEGRAL TO REFILLING AND MAINTENANCE OF IMPLANTABLE PUMP SERVICES (95990, 95991, 96522, 96523):
A4220 Refill kit for implantable infusion pump
A4221 Supplies for maintenance of non-insulin drug infusion catheter, per week (list drugs separately)
Policy: 05.00.05l:Equipment, Supplies, and Pharmaceuticals for the Treatment of Diabetes
Policy: 08.00.15f:Off-label Coverage for Prescription Drugs and/or Biologics