Summary Of Evidence

N/A

Analysis of Evidence

N/A

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

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. An implantable infusion pump is utilized to administer many types of medications through the intra-arterial or intrathecal route.

Covered Indications

Medicare will consider implantable infusion pumps and associated services medically reasonable and necessary for the conditions listed in CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 280.14 Infusion Pumps. Refer to the NCD for complete coverage details. 

With opioid drugs for treatment of chronic intractable pain, it is useful to distinguish between pain caused by a malignancy from which the patient is expected to recover and pain 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.

In order for opioid drugs for treatment of chronic intractable pain to be considered medically reasonable and necessary, all of the following criteria must be met:

• The administration of the medication must require administration through the intrathecal route and be effective on a long-term basis.
• The history of the patient's prior treatment should show oral or subcutaneous medication treatment was ineffective or complicated by unacceptable side effects.
• The patient's medical condition must require the use of an infusion pump for pain relief.
• The type and dosage of the medication must reasonably be expected to alleviate or reduce the pain.

In addition, an evaluation by an orthopedic surgeon, neurologist, neurosurgeon, oncologist, pain management physician or other specialist familiar with the underlying disease is required to validate that other treatments have failed to alleviate the pain, unless such a provider is currently managing the patient and documents that such a situation exists in the record. Documentation to support that the patient is unresponsive to less invasive medical therapy must be in the patient's medical record and made available upon request. It is particularly important to have this documentation available if the beneficiary is new to the provider or pharmacy involved with this service or new to the Contractor, as it may be requested to establish validity.

If the above criteria have been met, a preliminary trial of intraspinal opioid or non-opioid drug administration with a temporary intrathecal catheter to substantiate acceptable pain relief, degree of side effects including effects on the activities of daily living, and patient acceptance is considered reasonable and necessary. This trial could also be verified with a single-shot intrathecal injection rather than a continuous infusion.

Any drug(s) used to fill the implantable pump must be appropriate for the treatment of the individual patient. Drugs compounded for the special needs of a patient may be covered. Drugs filling the pump are often obtained singly or mixed with other drugs from compounding pharmacies. Unless the medications are administered in the exact concentrations available from national pharmaceutical companies, the medications will be considered as compounded. (Refer to the Local Coverage Article, A54100 Compounded Drugs Used in an Implantable Infusion Pump)

FDA approved drugs used for indications other than what is accepted on the official label of the drug or the infusion pump may be covered under Medicare if the contractor determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature, and/or accepted standards of medical practice. Additional medications may be added to the off-label coverage list for infusion into an implantable pump for pain or spasticity only upon the submission of appropriate documentation in a reconsideration request.

Compounded medications created by a pharmacist in accordance with the Federal Food, Drug and Cosmetic Act may be covered under Medicare. A compounded drug is defined as a combination of drugs mixed by a pharmacist. This definition does not include a simple reconstitution of a drug as directed by the package insert. Compounded drugs that are self-administered are not usually a covered Medicare service, unless they are shipped by a pharmacy for use in a medically necessary situation to the home of a beneficiary for infusion through an implantable infusion pump, consistent with the coverage guidelines of this policy. 

Drugs currently approved for pain management, through an implantable infusion pump include: (Refer to Local Coverage Article A54100 Compounded Drugs Used in an Implantable Infusion Pump for additional information on billing and coding for non-compounded and compounded drugs.)

• Bupivacaine
• Clonidine
• Droperidol
• Fentanyl
• Hydromorphone (Dilaudid^®)
• Ketamine
• Morphine
• Prialt
• Sufentanil
• Tetracaine

Limitations

The following are considered not reasonable and necessary and therefore will be denied:

1. Refer to CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 280.14.2e for contraindications.
2. A physician’s service will not be utilized to fill the pump with the drug to be infused when dispensed by the pharmacy to the patient. Refer to CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Sections 10 and 20 for more information regarding drugs dispensed directly to a beneficiary for administration “incident to” a physician service, such as refilling an implanted drug pump.
3. Refer to IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 50 for information regarding drugs furnished to a physician for administration to a Medicare beneficiary.
   
   

LCD Individual Consideration

Coverage of other combinations of drugs used in an implanted infusion pump may be considered on an individual consideration basis, on appeal, if the above conditions are met and if the drugs or combinations thereof can be supported by levels of evidence as outlined in Local Coverage Article A53049, Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents, for the diagnoses requested.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Implantable Infusion Pump, A56778, for applicable CPT/HCPCS codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.