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DESCRIPTIONAn implantable infusion pump (IIP) is intended to provide long-term continuous or intermittent drug infusion. Possible routes of administration include intravenous, intra-arterial, subcutaneous, intraperitoneal, intrathecal, epidural, and intraventricular. The IIP is surgically placed in a subcutaneous pocket under the infraclavicular fossa or in the abdominal wall, and a catheter is threaded into the desired position.
A drug is infused over an extended period of time, and the drug reservoir may be refilled as needed by an external needle injection through a self-septum in the IIP. Bacteriostatic water or physiological saline is often used to dilute drugs. A heparinized saline solution may also be used during an interruption of drug therapy to maintain catheter patency.
The driving mechanisms may include peristalsis, fluorocarbon propellant, osmotic pressure, piezoelectric disk benders, or the combination of osmotic pressure with an oscillating piston.
Several implantable infusion pumps have been approved by the FDA through the premarket approval process including the SynchroMed family of pumps (Medtronic), the Codman 3000 (Codman), Model 3000 Constant Flow Implantable Infusion Pump (Arrow International) and the Infusaid implantable infusion pump (Strato/Infusaid, a subsidiary of Pfizer).
POLICYFor Coding Guidelines see the Anesthesia Coding Policy.
Implantable infusion pumps are considered medically necessary when used to deliver drugs having FDA approval for this route of access and for the related indication for the treatment of:
Implantable infusion pumps are considered investigational for all other uses (e.g., chemotherapy for patients with head and neck cancers or gastric cancer, heparin for thromboembolic disease, antibiotics for osteomyelitis).
POLICY EXCEPTIONSImplantable infusion pumps are considered investigational for all other uses (e.g., heparin for thromboembolic disease, insulin for diabetes, antibiotics for osteomyelitis) for FEP (added 8-16-2001).
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/1993: Approved by Medical Policy Advisory Committee (MPAC)
11/1997: Revision approved by MPAC
8/2001: Reviewed by MPAC; expanded indications to provide coverage of insulin (via implantable infusion pump) for diabetes
2/13/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
5/28/2002: Code Reference section updated, HCPCS code A4222 deleted
3/6/2003: Code Reference section updated, code ranges 36260-36262, 36530-36532, 62350-62368, E0782-E0783 listed separately
8/20/2003: ICD-9 diagnosis code range 140.0-49.9, 160.0-160.8, 190.0-190.9, 191.0-191.9, 192.0-192.9, 342.0-342.92, 344.3-344.32, 344.4-344.5, 344.8-344.89 listed separately
1/6/2004: Code Reference section updated, ICD-9 procedure code 38.91, 38.93 deleted, ICD-9 diagnosis codes 155.2, 342.00, 342.01, 342.02, 342.80, 342.81, 342.82, 342.90, 342.91, 342.92, 344.2, 344.30, 344.31, 344.32, 344.40, 344.41, 344.42, 344.5 deleted
10-25-2005: Code Reference section updated: CPT codes 36530, 36531, 36532 deleted from covered codes, CPT codes 36563, 36576, 36578, 36590, 95991 added to covered codes, ICD9 Diagnosis code ranges revised, ICD9 Diagnosis codes 250.00 - 250.90, 250.03 - 250.93 added, HCPCS code S9328 added.
03/10/2006: Coding updated: CPT4 2006 revisions added to policy.
7/18/2008: Anesthesia Coding Policy hyperlink added
9/28/2009: Coding Section updated with New ICD-9 Diagnosis codes for 10-1-2009 under Covered Codes Table- 209.31, 209.32, Verbiage added to Covered Codes Table, "* Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section."
10/6/2009: Coding reference section updated. New ICD-9 code 209.72 added to covered table.
08/12/2010: Policy description updated regarding available devices. The policy statement regarding implantable infusion pumps for severe, chronic, intractable pain was revised to indicate that it is only considered medically necessary following a successful trial, defined as at least a 50% reduction in pain, of spinal (epidural or intrathecal) opioid or non-opioid analgesics. FEP verbiage added to the Policy Exceptions section.
11/10/2011: In the medically necessary policy statement for severe, chronic, intractable pain, added "by the same route of administration as the planned treatment" to the policy statement.
04/18/2013: Primary epithelial ovarian cancer (intraperitoneal infusion as component of chemotherapy) added to policy statement as medically necessary. Policy statement revised to delete the following from the medically necessary policy statement: Head/neck cancers (intra-arterial injection of chemotherapeutic agents). Added the following to the investigational policy statement: chemotherapy for patients with head and neck cancers or gastric cancer. Added ICD-9 codes 183.0 - 183.9 to the Code Reference section.
SOURCE(S)A search of literature was completed through the MEDLINE database for the period of January 1992 through December 1995. The search strategy focused on references containing the Medical Subject Heading; Infusion Pumps, Implantable. Research was limited to English-language journals on humans.
Technology Evaluation and Coverage 1988: p. 150
Technology Evaluation and Coverage 1986: p. 135
Hayes Medical Technology Directory
Blue Cross Blue Shield Association policy # 7.01.41
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
For Coding Guidelines see the Anesthesia Coding Policy.