Implantable Infusion Pump

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for implantable infusion pump. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for implantable infusion pump and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and Biologicals
• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 4, Section 280.14 Infusion Pumps
• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  
  • Chapter 12, Section 30.5 Payment for Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions
  • Chapter 17, Section 10 Payment Rules for Drugs and Biologicals; Section 20 Payment Allowance Limit for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis; Section 40 Discarded Drugs and Biologicals; Section 50 Assignment Required for Drugs and Biologicals
• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Change Request References:

• Change Request (CR) 7397 Pharmacy Billing for Drugs Provided "Incident To" a Physician Service, effective date January 1, 2013

Social Security Act (Title XVIII) Standard References:

• 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. 
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare 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 1862(a)(7). This section excludes routine physical examinations.

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.

N/A

N/A

Refer to Local Coverage Article: Billing and Coding: Implantable Infusion Pump, A56778, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. All documentation must be maintained in the patient’s medical record and available to the contractor upon request. The National Coverage decision, 280.14, regarding infusion pumps, will govern the coverage of services related to implantable infusion pumps. All criteria must be fulfilled in order to be considered for coverage. The medical record for the initial infusion must contain the diagnosis, why other therapies failed, a record or the response of the patient to temporary infusion and the reason the pump was implanted. This must be available to the Contractor upon request.
5. The indication for the implantable infusion pump is for reasons noted in NCD 280.14. It must be medically necessary for an approved drug to go through the implantable pump for delivery and should be approved for use in the pump, either by the device labeling of the pump itself or by pre-approved review by the Contractor.
6. Ziconotide (Prialt^®) intrathecal infusion documentation must meet 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.
7. The Medical Record must demonstrate that there has been an improvement in the pain level with the addition of drugs such as Duraclon, methadone, sufentanil or bupivacaine added to the compounded drug regimen for chronic intractable pain versus a pre-existing regimen without them, such that the addition of these drugs would be considered medically necessary for the treatment of chronic pain in a particular patient.
8. See the Local Coverage Article A53049, Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents, for additional information on labeled vs. off labeled uses of drugs with regard to acceptable levels of evidence.
9. Drugs for use in implantable pumps, unlike other drugs referred to in Local Coverage Article A53049, Approved Drugs and Biologicals, must be pre-approved by the Contractor if they do not appear on the current approved list for infusion through an implantable infusion pump. (Reference Local Coverage Article A54100 Compounded Drugs Used in an Implantable Infusion Pump for the list of covered compounded drugs).
10. At the time of the pump refill or the pump interrogation or the pump reprogramming, documentation should include at a minimum:
    
    • the pump status before and after the refill,
    • the patient’s response to the current medication dose and rate,
    • the reasons for any change in dose or the types of medications,
    • any necessary reassessment of the patient's overall condition and treatment goals (this may be an E&M service),
    • proof that all applicable "incident to" requirements are met, and
    • proof that any medication used represents a cost to the physician or group accepting Medicare payment, such as the inclusion of an invoice.
11. A preliminary trial of the intraspinal (intrathecal) opioid drug or non-opioid administration must be undertaken with a temporary intrathecal catheter or by direct intrathecal injection to substantiate adequate acceptable pain relief and the degree of side effects (including the effects on the activities of daily living) and the patient’s acceptance of the therapy must be documented in the patient's record.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

A periodic reassessment of the patient should be performed according to the needs of the patient and the applicable medical standards.

The frequency for interrogating/reprogramming the pump should be supported by the patient's symptoms. The frequency for refill must take into account the size of the pump.

Contractor is not responsible for the continued viability of websites listed.

Other Contractor Policies

Original JH ICD-9 Source LCD L32740, Implantable Infusion Pump

Contractor Medical Directors

1. Deer T, Kim C, Bowman R, et al. Intrathecal Ziconotide and Opioid Combination Therapy for Noncancer Pain: An Observational Study. Pain Physician 2009;12:E291-E296.
2. Deer TR, Prager J, Levy R, et al. Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel. Neuromodulation 2012;15:436–466.
3. Myers J, Chan V, Jarvis V, et al. Intraspinal techniques for pain management in cancer patients: A systematic review. Support Care Cancer 2010;18:137–149.
4. Wallace MS, Kosek PS, Staats P, et al. Phase II, Open-Label, Multicenter Study of Combined Intrathecal Morphine and Ziconotide: Addition of Ziconotide in Patients Receiving Intrathecal Morphine for Severe Chronic Pain. Pain Medicine 2008;9(3):271-281.
5. Wallace MS, Rauck RL, Deer T. Ziconotide Combination Intrathecal Therapy: Rationale and Evidence. Clin J Pain 2010; 26(7):635-44.
6. Webster LR, Fakata KL, Charapata S, Fisher R, MineHart M. Open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of morphine in patients receiving ziconotide for severe chronic pain. Pain Med 2008;9(3):282-90.