Infusion Pumps & Related Drugs

Affected Providers

DME suppliers submitting claims to Medicare Administrative Contractors (MACs) for supplies and services provided to Medicare patients.

HCPCS & CPT Codes

Local Coverage Determination (LCD): External Infusion Pumps (L33794) and LCD: Implantable Infusion Pump (L33461) have the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for infusion pumps and related drugs is 14.1%, with a projected improper payment amount of $89.5 million.

You must meet reasonable and necessary requirements. You must also meet the provisions in National Coverage Determination (NCD): Infusion Pumps (280.14). We outline other policy requirements in LCD L33794 and Article: External Infusion Pumps (A52507).

Denial Reasons

Insufficient documentation accounted for 72.5% of improper payments for infusion pumps and related drugs during the 2024 reporting period, while medical necessity (6.9%), incorrect coding (2.2%), no documentation (1.1%), and other errors (17.3%) caused the remaining improper payments. “Other” errors include duplicate payment, non-covered or unallowable service, or ineligible Medicare patient errors.

Preventing Denials

We may pay for supplies necessary for effective DME use, including drugs and biologicals that must go directly into the equipment to get the therapeutic benefit of DME or to make sure the equipment works. Coverage of these drugs or biologicals doesn’t prevent the need for a determination that the drug or biological itself is reasonable and necessary for treating an illness or injury or to improve the functioning of a malformed body member.

Items or services are correctly coded when they meet all the coding guidelines listed in our HCPCS guidelines, LCDs, Articles, or DME MAC articles. We deny claims that don’t meet coding guidelines as not reasonable and necessary and as incorrectly coded.

Infusion pumps are medical devices used to deliver solutions that have parenteral drugs under pressure at a regulated flow rate.

We cover external infusion pumps and implantable infusion pumps for certain indications.

External Infusion Pumps

Covered indications include:

• Iron Poisoning: We cover the administration of deferoxamine for treating acute iron poisoning and iron overload, only by external infusion pump
• Thromboembolic Disease: We cover the administration of heparin for treating thromboembolic disease or pulmonary embolism, only by external infusion pump used in an institutional setting
• Chemotherapy for Liver Cancer: We cover an external chemotherapy infusion pump for treating primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable or when the patient refuses surgical excision of a tumor
• Morphine for Intractable Cancer Pain: We cover morphine infusion through an external infusion pump when treating intractable pain caused by cancer (in either an inpatient or outpatient setting, including a hospice)
• Continuous Subcutaneous Insulin Infusion (CSII) Pumps: We cover CSII pumps and related drugs and supplies as medically reasonable and necessary in the home setting for treating diabetic patients who both satisfy the criteria for insulin pump therapy as described in criterion A or B and either:
  • Meet the updated fasting C-Peptide testing requirement
  • Are beta cell autoantibody positive

Criterion A: The patient completed a comprehensive diabetes education program and has been on a program of multiple daily injections of insulin (at least 3 injections per day), with frequent self-adjustments of insulin doses for at least 6 months before initiating the insulin pump; has documented glucose self-testing frequency an average of at least 4 times per day during 2 months before initiating the insulin pump; and meets 1 or more of these criteria while on the multiple daily injection regimen:

• Glycosylated hemoglobin level (HbA1c) > 7.0%
• History of recurring hypoglycemia
• Wide fluctuations in blood glucose before mealtime
• Dawn phenomenon with fasting blood sugars often exceeding 200 mg/dl
• History of severe glycemic excursions

Criterion B: The patient with diabetes has been on a pump before enrolling in Medicare and has documented glucose self-testing frequency an average of at least 4 times per day during the month before enrolling in Medicare.

General CSII Criteria

Besides meeting Criterion A or B above, the patient with diabetes must be insulinopenic per the updated fasting C-Peptide testing requirement or must be beta cell autoantibody positive. See NCD 280.14.

For continued coverage of an external insulin pump and supplies, the treating practitioner must see the patient at least every 3 months.

Other Uses

We cover other uses of external infusion pumps if MAC medical staff verifies the right therapy and prescribed pump for the individual patient.

Implantable Infusion Pumps

The DME MAC doesn’t process claims for implantable infusion pumps or drugs and supplies used with an implantable infusion pump. Submit claims for these items to your A/B MAC.

Covered Indications

• Chemotherapy for Liver Cancer: We cover an implantable infusion pump for intra-arterial infusion of 5-FUdR for treating liver cancer patients with primary hepatocellular carcinoma or Duke’s Class D colorectal cancer who have metastases limited to the liver, where this disease is unresectable or when the patient refuses surgical excision of a tumor
• Anti-Spasmodic Drugs for Severe Spasticity: We cover an implantable infusion pump when administering anti-spasmodic drugs (for example, baclofen) intrathecally to treat chronic intractable spasticity in patients who have proven unresponsive to less invasive medical therapy
  • As found by at least a 6-week trial, you can’t keep the patient on non-invasive spasm control methods, like oral anti-spasmodic drugs, because these methods either fail to adequately control the spasticity or produce intolerable side effects
  • Before pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti-spasmodic drug
• Opioid Drugs for Treating Chronic Intractable Pain: We cover an implantable infusion pump when administering opioid drugs (for example, morphine) intrathecally or epidurally for treating severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at least 3 months and who have proven unresponsive to less invasive medical therapy
  • The patient’s history must show they wouldn’t adequately respond to non-invasive pain control methods, like systemic opioids (including attempts to eliminate physical and behavioral abnormalities which may cause exaggerated pain reaction)
  • You must conduct a preliminary trial of intraspinal opioid drugs with a temporary intrathecal or epidural catheter to verify acceptable pain relief, acceptable degree of side effects (including activities of daily living effects), and patient acceptance
• Coverage of Other Uses of Implanted Infusion Pumps: We may determine coverage for other implanted infusion pump uses if the MAC medical staff verifies that:
  • The drug is reasonable and necessary for treating the individual patient
  • It’s medically necessary that the drug is administered by an implanted infusion pump
  • FDA-approved labeling for the pump specifies the drug being given, and the purpose for giving it, is an indicated use for the pump

Infusion pump implantation is contraindicated in patients:

• Who have a known allergy or hypersensitivity to the used drug (for example, oral baclofen, morphine)
• Who have an active infection
• Whose body size can’t support weight and bulk of the device
• Who have other implanted programmable devices, since crosstalk between devices may accidentally change the prescription

Non-Covered Indications

• External Infusion Pumps
  • Vancomycin: We don’t cover vancomycin as a DME infusion pump benefit
  • There’s insufficient evidence to support the need for an external infusion pump, instead of a disposable elastomeric pump or the gravity drip method, to administer vancomycin in a safe and proper manner
• Implantable Infusion Pump
  • Thromboembolic Disease: There’s insufficient clinical data to support the safety and effectiveness of the heparin implantable pump. We don’t cover using an implantable infusion pump for infusion of heparin to treat recurrent thromboembolic disease.
  • Diabetes: We don’t cover an implanted infusion pump for infusing insulin to treat diabetes. Data doesn’t prove that the pump administers insulin more effectively.

Refill Requirements

For DMEPOS items and supplies provided on a recurring basis, base your billing on prospective, not retrospective use.

Documentation Requirements

To justify payment for external infusion pumps, you must meet specific requirements when ordering DMEPOS.

Example of Improper Payments Due to Insufficient Documentation for Infusion Pumps

A supplier bills the claim for HCPCS code E0779 (Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater) and submits the following documentation per the review contractor’s request:

• Standard written order with correct HCPCS coding
• Patient’s history and medical records with a diagnosis of thromboembolic disease
• Proof of delivery

What Documentation Was Missing?

The medical record didn’t include a covered indication for an external infusion pump.

What Happens Next?

The review contractor completes the claim as an insufficient documentation error, and the MAC recoups payment.

Recommendation

To prevent claim denials and improper payments, the certifying physician must collect and submit proper documentation when billing for infusion pumps.