For services prior to June 18, 2011, see policy N-122.

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: one for bolus injections and one 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.

Implantable infusion pumps, and associated services, are considered medically reasonable and necessary for the conditions listed in Medicare National Coverage Determinations Manual , Pub. 100-03, Section 280.14.

• Opioid Drugs for Treatment of Chronic Intractable Pain (J7799KD, E0782, E0783, E0785, E0786, 62350, 62351, 62355, 62361, 62362, 62365, 62367, 62368, 95990 and 95991)

For this indication, 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.

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.
  
  
• Those with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription.

Documentation Requirements

• As stated in the applicable section of the LCD, medical record documentation maintained in the patient's file should support indications. This information is normally found in the office records, history and physical and/or Certificate of Medical Necessity (CMN).
  
  
• If the indication for the implantable infusion pump is for reasons other than chemotherapy for liver cancer (primary hepatocellular carcinoma or Duke's Class D colorectal cancer in whom the metastases are limited to the liver), antispasmodic drugs for severe spasticity, or opioid drugs for treatment of chronic intractable pain, or the diagnosis is not indicated in the applicable covered indication, documentation supporting medical necessity for the pump and/or medication must be submitted with the redetermination request.
  
  
• Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
  
  
• 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.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Compounded medications are created by a pharmacist in accordance with the Federal Food, Drug and Cosmetic Act and may be covered under Medicare when their use meets all other criteria for services incident to a physician’s service.

Compounded medications do not have a National Drug Code (NDC) number, an average sales price (ASP) or an average wholesale price (AWP). Accordingly, the specific J codes for the drugs in the compounded formulation may not be submitted. Instead, providers must use code J7799 (unclassified drug) for reimbursement of the compound medications.

The use of compounded drugs has been especially prevalent in the filling of implantable infusion pumps. Whether a single agent or a combination of agents is used, the compounded medication must be submitted with code J7799, even though the compound is similar to or includes a drug with a specific code (e.g., code J2275 for preservative free morphine).

Providers who document and use the true off-the-shelf product without compounding may continue to use the specific code. Because non-compounded drugs administered via DME are reimbursed at 95 percent of AWP instead of ASP + 6 percent, the KD modifier must be used to indicate this situation.

When billing for the use of compounded medications, use code J7799 on a single claim line, quantity billed = '1', and enter the name and total dose (in mg or mcg) of each drug of the refill in Box 19 of the HCFA 1500 or the appropriate comment loop of electronic claims. If box 19 cannot accommodate all the information, attach the information to the paper claim. Evaluation and management codes, pump refilling codes, and pump adjustment codes are also reimbursable if clinically appropriate during the visit.

Example: Unit of 1 J7799 claim line detail: Entered in Box 19/4010a comment field 'Morphine Sulfate XX mg + Fentanyl YY mcg + Clonidine ZZ mcg'

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Medicare Benefit Policy Manual - Pub. 100-02.

Medicare National Coverage Determinations Manual - Pub. 100-03.

Medicare Claims Processing Manual - Pub. 100-04, Chapter 32, Section 120.

Correct Coding Initiative - Medicare Contractor Beneficiary and Provider Communications Manual - Pub. 100-09, Chapter 5.

Social Security Act (Title XVIII) Standard References, Sections:

• 1832(a)(2)(F) ASC Surgical Services.
• 1833(t)(1)(B)(iii) Implantable Items Covered in Hospital Outpatient Departments.
• 1861(s)(1) Physicians’ Services.
• 1861(s)(2)(A) Incident To Physician’s Professional Service.
• 1861(s)(2)(B) Incident To Physician’s Professional Service furnished to Hospital Outpatients.
• 1861(s)(8) Eyeglasses or Contact Lenses Furnished after Cataract Surgery With Insertion of IOL.
• 1862 (a)(1)(A) Medically Reasonable & Necessary.
• 1862 (a)(1)(D) Investigational or Experimental.
• 1862(a)(7) Refractive Eye Examinations.

Covered Diagnosis Codes

Chemotherapy used in the treatment of Liver Cancer (E0782, E0783, E0785, E0786, 36260, 36261, 36262, J7799KD (floxuridine) and 96522:

Use 153.0*-154.8* to represent colorectal cancer (Duke’s Class D colorectal cancer) (inclusive)

Anti-spasmodic drugs used in the treatment of severe spasticity (E0782, E0783, E0785, E0786, J0475KD (non-compounded baclofen), J7799KD (compounded baclofen), 62350, 62351, 62355, 62361, 62362, 62365, 62367, 62368, 95990 and 95991:

Opioid and other approved drugs used in the treatment of intractable pain (E0782, E0783, E0785, E0786, J7799KD (morphine sulfate, fentanyl, hydromorphone), J7799KD [ziconotide (Prialt®)], 62350, 62351, 62355, 62361, 62362, 62365, 62367, 62368, 95990 and 95991):