LCD L33461

Coverage Guidance

Title XVIII Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII Social Security Act, §1862(a)(1)(D) addresses items and services related to research and experimentation.

42 CFR §411.15(k)(1) defines particular services excluded from coverage.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.7 Denial of Medicare Payment for Compounded Drugs Produced in Violation of Federal Food, Drug, and Cosmetic Act

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps

Indications and Limitations of Coverage

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: 1 for bolus injections and 1 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.

Medicare will consider implantable infusion pumps, and associated services, medically reasonable and necessary for the conditions listed in the CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps.

For the indication of opioid drugs used for the treatment of chronic intractable pain, 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.

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.

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

In those patients with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription, it is recommended that all devices be checked for possible crosstalk at the time of implantation of the infusion pump, and that appropriate surveillance for such interactions be continued.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

As stated in the applicable section of the Local Coverage Determination (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 the A/B MAC upon request.

Bibliography

Azur Pharma Inc. (2010). PRIALT®: Highlights of prescribing information. Philadelphia, PA: Author.

Brown, DL. Regional Anesthesia & Analgesia. 3rd Ed. Philadelphia, PA: W.B. Saunders; 1996.

Dorland's Illustrated Medical Dictionary. 28th Ed. Philadelphia, PA: W.B. Saunders; 1994.

Drug Facts and Comparisons®. St. Louis, MO; 2016.

Nursing 2008 Drug Handbook. 28th Ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2008.

Salerno E, Willens J. Pain Management Handbook: An interdisciplinary approach. St. Louis, MO; 1996.