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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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
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.
03/07/2014: Policy reviewed; no changes.
08/31/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure codes 03.02, 03.90, and 86.09.
06/09/2016: Policy number added. Policy Guidelines updated to add medically necessary definition.
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.