Somedays I wonder who is working for whom!!

[Guest guest]

Priscilla and I have been going back and forth off board about trying to get

Phil's pump paid for. The charge is over $10,000 for the surgery and pump

and Aetna (quoted below) refused it as experimental. When you read HOW the pump

is covered and NOT experimental ummm don't all of us Stage 4's fit the bill?

AGGGGGGHHHHHHHHHHHHH!!!!

Makes my blood boil

Narice

Document Utilities

Home > Clinical Policy Bulletins > Medical > Infusion Pumps

Clinical Policy Bulletins

Number: 0161

(Revised)

(Replaces CPB 110, CPB 338)

Subject: Infusion Pumps

Reviewed: April 12, 2005

Important Note

This Clinical Policy Bulletin expresses Aetna's determination of whether

certain services or supplies are medically necessary, experimental and

investigational, or cosmetic. Aetna has reached these conclusions based upon a

review

of currently available clinical information (including clinical outcome

studies in the peer-reviewed published medical literature, regulatory status of

the technology, evidence-based guidelines of public health and health research

agencies, evidence-based guidelines and positions of leading national health

professional organizations, views of physicians practicing in relevant

clinical areas, and other relevant factors). Aetna makes no representations and

accepts no liability with respect to the content of any external information

cited or relied upon in this Bulletin. The discussion, analysis, conclusions

and

positions reflected in this Bulletin, including any reference to a specific

provider, product, process or service by name, trademark, manufacturer,

constitute Aetna's opinion and are made without any intent to defame. Aetna

expressly reserves the right to revise these conclusions as clinical

information

changes, and welcomes further relevant information including correction of any

factual error. Each benefit plan defines which services are covered, which

are excluded, and which are subject to dollar caps or other limits. Members and

their providers will need to consult the member's benefit plan to determine

if there are any exclusions or other benefit limitations applicable to this

service or supply. The conclusion that a particular service or supply is

medically necessary does not constitute a representation or warranty that this

service or supply is covered (i.e., will be paid for by Aetna) for a particular

member. The member's benefit plan determines coverage. Some plans exclude

coverage for services or supplies that Aetna considers medically necessary. If

there is a discrepancy between this policy and a member's plan of benefits,

the benefits plan will govern. In addition, coverage may be mandated by

applicable legal requirements of a State, the Federal government or CMS for

Medicare

and Medicaid members. CMS's Coverage Issues Manual can be found on the

following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

Implantable Infusion Pumps

Aetna considers implanted infusion pumps medically necessary durable medical

equipment (DME) when all of the following criteria are met:

The drug is medically necessary for the treatment of members (see medical

necessity criteria for various types of infusion pumps below); and

It is medically necessary that the drug be administered by an implanted

infusion pump; and

The infusion pump has been approved by the FDA for infusion of the

particular drug that is to be administered.

Anti-spasmodic drugs

Aetna considers an implantable infusion pump medically necessary when used

to intrathecally administer anti-spasmodic drugs (e.g., baclofen) to treat

chronic intractable spasticity in persons who have proven unresponsive to less

invasive medical therapy as determined by the following criteria:

Member has failed a six-week trial of non-invasive methods of spasticity

control, such as oral anti-spasmodic drugs, either because these methods fail

to

adequately control the spasticity or produce intolerable side effects; and

Member has a favorable response to a trial intrathecal dosage of the

anti-spasmodic drug prior to pump implantation.

Intrathecal baclofen (Lioresal) is considered medically necessary for the

treatment of intractable spasticity caused by spinal cord disease, spinal cord

injury, or multiple sclerosis. Baclofen is considered medically necessary for

persons who require spasticity to sustain upright posture, balance in

locomotion, or increased function.

Documentation in the member's medical record should indicate that the

member's spasticity was unresponsive to other treatment methods and that the

oral

form of baclofen was ineffective in controlling spasticity or that the member

could not tolerate the oral form of the drug. A trial of oral baclofen is not

a required prerequisite to intrathecal baclofen therapy in children ages 12

years old or less due to the increased risk of adverse effects from oral

baclofen in this group.

The medical record should document that the member showed a favorable

response to the trial dosage of the baclofen before subsequent dosages are

considered medically necessary. An implanted pump for continuous fusion is

considered

not medically necessary for members who do not respond to a 100 mcg

intrathecal bolus.

Members must be monitored closely in a fully equipped and staffed

environment during the screening phase and dosage-titration period immediately

following the implant.

Opioid drugs for treatment of chronic intractable pain

An implantable infusion pump is considered medically necessary when used to

administer opioid drugs (e.g., morphine) intrathecally or epidurally for

treatment of severe chronic intractable pain in persons who have proven

unresponsive to less invasive medical therapy as determined by the following

criteria:

The member's history must indicate that he or she has not responded

adequately to non-invasive methods of pain control, such as systemic opioids

(including attempts to eliminate physical and behavioral abnormalities which

may

cause an exaggerated reaction to pain); and

A preliminary trial of intraspinal opioid drug administration must be

undertaken with a temporary intrathecal/epidural catheter to substantiate

adequately acceptable pain relief, the degree of side effects (including

effects on

the activities of daily living), and acceptance.

Intrahepatic chemotherapy infusion for liver metastases from colorectal

cancer

Implantable infusion pumps are considered medically necessary for

administration of intrahepatic chemotherapy (e.g., floxuridine) to members with

colorectal cancer and liver metastases.

Note: An average 3 to 5 days inpatient hospitalization is medically

necessary for intrahepatic chemotherapy. Hospital discharge is dependent on

resolution of pain, nausea and vomiting which complicate the procedure.

Contraindications to implantable infusion pumps

Implantable infusion pumps are considered not medically necessary for

persons with the following contraindications to implantable infusion pumps:

Members with known allergy or hypersensitivity to the drug being used (e.g.,

oral baclofen, morphine, etc.); or

Members who have an active infection that may increase the risk of the

implantable infusion pump; or

Members whose body size is insufficient to support the weight and bulk of

the device; or

Members with other implanted programmable devices where the crosstalk

between devices may inadvertently change the prescription.

Experimental and investigational uses of implanted infusion pumps

Implanted infusion pumps are considered experimental and investigational for

the following indications:

Implantable pumps for the infusion of insulin to treat diabetes; or

Implantable pump for the infusion of heparin for recurrent thromboembolic

disease; or

Implantable infusion pumps for intrahepatic administration of chemotherapy

for indications other than noted above, including treatment of primary

hepatocellular carcinoma or hepatic metastases from cancers other than

colorectal

cancer.

Note: Aetna also considers “one-shot†arterial chemotherapy for persons

with liver metastases from colorectal cancer experimental and investigational.

External Infusion Pumps

Aetna considers external infusion pumps medically necessary DME for

administration of any of the following medications:

Deferoxamine for the treatment of acute iron poisoning and iron overload

(only external infusion pumps are considered medically necessary); or

Heparin for the treatment of thromboembolic disease and/or pulmonary

embolism (only external infusion pumps used in an institutional setting are

considered medically necessary); or

Heparin to adequately anticoagulate women throughout pregnancy (Warfarin

compounds are not routinely used for this indication); or.

Chemotherapy for primary hepatocellular carcinoma or colorectal cancer where

the tumor is unresectable or the member refuses surgical excision of the

tumor; or

Morphine or other narcotic analgesics (except meperidine) for intractable

pain caused by cancer; or

Parenteral inotropic therapy with dobutamine, milrinone, and/or dopamine; or

Parenteral epoprostenol or treprostinil for persons with pulmonary

hypertension; or

Certain parenteral antifungal or antiviral drugs (e.g., acyclovir,

foscarnet, amphotericin B, or ganciclovir); or

Certain parenteral anticancer chemotherapy drugs (e.g., cladribine,

fluorouracil, cytarabine, bleomycin, floxuridine, doxorubicin, vincristine,

vinblastine, cisplatin, paclitaxel) if the drug is part of an evidence-based

chemotherapy regimen and parenteral infusion of the drug at a strictly

controlled rate

is necessary to avoid systemic toxicity or adverse effects, and the drug is

administered either: 1) by continuous infusion over 8 hours; or 2) by

intermittent infusions lasting less than 8 hours that do not require the person

to

return to the physician's office prior to the beginning of each infusion; or

Insulin for persons with diabetes mellitus who meet the selection criteria

for external insulin infusion pumps for diabetes set forth below; or

Other parenterally administered drugs where an infusion pump is necessary to

safely administer the drug at home.

Medical necessity criteria for external insulin infusion pumps for diabetes

Aetna considers external insulin infusion pumps medically necessary DME for

persons with diabetes who have a documented fasting serum C-peptide level that

is less than or equal to 110% of the lower limit of normal of the

laboratory's measurement method*, and who meet the criteria in section 1 or in

section

2:

Members must meet all of the following criteria:

The member has completed a comprehensive diabetes education program; and

The member has been on a program of multiple daily injections of insulin

(i.e., at least 3 injections per day), with frequent self-adjustments of

insulin

dose for at least 6 months prior to initiation of the insulin pump**; and

The member has documented frequency of glucose self-testing an average of at

least 4 times per day during the 2 months prior to initiation of the insulin

pump**; and

The member meets at least one of the following criteria while on multiple

daily injections (more than 3 injections per day) of insulin:

Elevated glycosylated hemoglobin level (HbA1c greater than 7.0%, where upper

range of normal is less than 6.0% for other HbA1c assays, 1% over upper

range of normal); or

History of recurring hypoglycemia (less than 60 mg/dL); or

Wide fluctuations in blood glucose before mealtime (e.g., pre-prandial blood

glucose levels commonly exceed 140 mg/dL); or

Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or

History of severe glycemic excursions;

or

The member has been on a pump prior to enrollment in Aetna, and has

documented frequency of glucose self-testing an average of at least 4 times per

day

during the month prior to Aetna enrollment.

Footnotes:

* Fasting C-peptide levels will be considered valid only with a concurrently

obtained fasting glucose less than 225 mg/dL. For persons with renal

insufficiency and creatinine clearance (actual or calculated from age, gender,

weight, and serum creatinine) less than 50 ml/minute, insulinopenia is defined

as

a fasting C-peptide level that is less than or equal to 200% of the lower

limit of normal of the laboratory's measurement method.

** It may be considered medically necessary to initiate the use of insulin

infusion pumps during pregnancy earlier than the criteria stated above to

avoid fetal and maternal complications of diabetes and pregnancy. It may be

considered medically necessary for poorly controlled women with diabetes to

sometimes get started on the pump pre-pregnancy or in the first trimester.

Notes on external insulin infusion pumps:

External subcutaneous insulin infusion pumps are only considered medically

necessary for persons who have demonstrated ability and commitment to comply

with a regimen of pump care, frequent self-monitoring of blood glucose, and

careful attention to diet and exercise.

The pump must be ordered by and follow-up care of the member must be managed

by a physician with experience managing persons with insulin infusion pumps

and who works closely with a team including nurses, diabetic educators, and

dieticians who are knowledgeable in the use of insulin infusion pumps.

Documentation of continued medical necessity of the external insulin

infusion pump requires that the member be seen and evaluated by the treating

physician at least once every 6 months.

The Paradigm Insulin Pump (Medtronic MiniMed, Northridge, CA) is an external

insulin infusion pump that is able to take results of the blood glucose

reading, calculate the insulin dose, and transmit the results to the pump,

saving

the member some extra steps Since there is no clinical evidence that the

deluxe features of this device improves clinical outcomes, Aetna considers the

Paradigm pump experimental and investigational.

Note: Aetna's medical necessity criteria for external infusion pumps for

diabetes have been adapted from Medicare national policy on external insulin

infusion pumps, as outlined in CMS's Coverage Issues Manual Section 60-14.

See also CPB 070 - Diabetic Supplies Coverage.

Supplies and drugs used with implantable or external infusion pumps

Aetna considers supplies that are needed for the effective use of the DME

medically necessary.

Such supplies include those drugs and biologicals that must be put directly

into the equipment in order to achieve the therapeutic benefit of the DME or

to assure the proper functioning of the equipment.