CPT CODE e1399, a9274, a4222 - external infusion pumpl

HCPCS CODES: and Descripiton

EQUIPMENT

Group 1 Codes:

E0776 IV POLE

E0779 AMBULATORY INFUSION PUMP, MECHANICAL, REUSABLE, FOR INFUSION 8 HOURS OR GREATER

E0780 AMBULATORY INFUSION PUMP, MECHANICAL, REUSABLE, FOR INFUSION LESS THAN 8 HOURS

E0781 AMBULATORY INFUSION PUMP, SINGLE OR MULTIPLE CHANNELS, ELECTRIC OR BATTERY OPERATED, WITH ADMINISTRATIVE EQUIPMENT, WORN BY PATIENT

E0784 EXTERNAL AMBULATORY INFUSION PUMP, INSULIN

E0791 PARENTERAL INFUSION PUMP, STATIONARY, SINGLE OR MULTI-CHANNEL

E1399 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS

K0455 INFUSION PUMP USED FOR UNINTERRUPTED PARENTERAL ADMINISTRATION OF MEDICATION, (E.G., EPOPROSTENOL OR TREPROSTINOL)

Group 2 Paragraph: SUPPLIES

Group 2 Codes:

A4221 SUPPLIES FOR MAINTENANCE OF DRUG INFUSION CATHETER, PER WEEK (LIST DRUG SEPARATELY)

A4222 INFUSION SUPPLIES FOR EXTERNAL DRUG INFUSION PUMP, PER CASSETTE OR BAG (LIST DRUGS SEPARATELY)

A4223 INFUSION SUPPLIES NOT USED WITH EXTERNAL INFUSION PUMP, PER CASSETTE OR BAG (LIST DRUGS SEPARATELY)

A4305 DISPOSABLE DRUG DELIVERY SYSTEM, FLOW RATE OF 50 ML OR GREATER PER HOUR

A4306 DISPOSABLE DRUG DELIVERY SYSTEM, FLOW RATE OF LESS THAN 50 ML PER HOUR

A4602 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, LITHIUM, 1.5 VOLT, EACH

A9270 NON-COVERED ITEM OR SERVICE

A9274 EXTERNAL AMBULATORY INSULIN DELIVERY SYSTEM, DISPOSABLE, EACH, INCLUDES ALL SUPPLIES AND ACCESSORIES

K0552 SUPPLIES FOR EXTERNAL DRUG INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH

K0601 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, SILVER OXIDE, 1.5 VOLT, EACH

K0602 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, SILVER OXIDE, 3 VOLT, EACH

K0603 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, ALKALINE, 1.5 VOLT, EACH

K0604 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, LITHIUM, 3.6 VOLT, EACH

K0605 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, LITHIUM, 4.5 VOLT, EACH


Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Medicare does not automatically assume payment for a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee For Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary, may be required upon request of the DME MAC.

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

For some items in this policy to be covered by Medicare, a written order prior to delivery (WOPD) is required. Refer to the DOCUMENTATION REQUIREMENTS section of this LCD and to the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy Article for information about WOPD prescription requirements.

An external infusion pump is covered for the following indications (I-V):

An infusion pump described by codes E0779, E0780, E0781, and E0791 is covered for indications I – III, V(A) – V(D), V(F), V(G), V(I) and V(J). Coverage of other pumps is addressed under indications IV, V (E), and V (H).
Administration of deferoxamine for the treatment of chronic iron overload.

Administration of chemotherapy for the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable or where the beneficiary refuses surgical excision of the tumor. Anticancer chemotherapy drugs used in these conditions are not required to meet the criteria described by indication V, situation A.

Administration of morphine when used in the treatment of intractable pain caused by cancer.

Administration of continuous subcutaneous insulin for the treatment of diabetes mellitus (See Diagnosis Codes Group 1 that Support Medical Necessity section below) if criterion A or B is met and if criterion C or D is met:
C-peptide testing requirement – must meet criterion 1 or 2 and criterion 3:

C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method.
For beneficiaries with renal insufficiency and a creatinine clearance (actual or calculated from age, weight, and serum creatinine) less than or equal to 50 ml/minute, a fasting C-peptide level is less than or equal to 200 per cent of the lower limit of normal of the laboratory’s measurement method.
A fasting blood sugar obtained at the same time as the C-peptide level is less than or equal to 225 mg/dl.

Beta cell autoantibody test is positive.

The beneficiary has completed a comprehensive diabetes education program, 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 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 meets one or more of the following criteria (1 - 5) while on the multiple injection regimen:
Glycosylated hemoglobin level (HbA1C) greater than 7 percent
History of recurring hypoglycemia
Wide fluctuations in blood glucose before mealtime
Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
History of severe glycemic excursions

The beneficiary has been on an external insulin infusion pump prior to enrollment in Medicare and has documented frequency of glucose self-testing an average of at least 4 times per day during the month prior to Medicare enrollment.

If criterion A or B is not met, the pump and related accessories, supplies, and insulin will be denied as not reasonable and necessary. If criterion C or D is not met, the pump and related accessories, supplies, and insulin will be denied as not reasonable and necessary.

Continued coverage of an external insulin pump and supplies requires that the beneficiary be seen and evaluated by the treating physician at least every 3 months. In addition, the external insulin infusion pump must be ordered and follow-up care rendered by a physician who manages multiple beneficiaries on continuous subcutaneous insulin infusion therapy and who works closely with a team including nurses, diabetic educators, and dieticians who are knowledgeable in the use of continuous subcutaneous insulin infusion therapy.

Subcutaneous insulin is administered using ambulatory infusion pump E0784. Claims for usage of infusion pumps other than E0784 will be denied as not reasonable and necessary.

Administration of other drugs if either of the following sets of criteria (1) or (2) are met:

Criteria set 1:
Parenteral administration of the drug in the home is reasonable and necessary
An infusion pump is necessary to safely administer the drug
The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy
The therapeutic regimen is proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hours

Criteria set 2:
Parenteral administration of the drug in the home is reasonable and necessary
An infusion pump is necessary to safely administer the drug
The drug is administered by intermittent infusion (each episode of infusion lasting less than 8 hours) which does not require the beneficiary to return to the physician's office prior to the beginning of each infusion
Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug Information

Coverage for the administration of other drugs, based on criteria set (1) or (2), using an external infusion pump is limited to the following situations (A) - (J):
Administration of the anticancer chemotherapy drugs cladribine, fluorouracil, cytarabine, bleomycin, floxuridine, doxorubicin (non-liposomal), vincristine (non-liposomal) or vinblastine by continuous infusion over at least 8 hours when the regimen is proven or generally accepted to have significant advantages over intermittent administration regimens

Administration of narcotic analgesics (except meperidine) in place of morphine to a beneficiary with intractable pain caused by cancer that has not responded to an adequate oral/transdermal therapeutic regimen and/or cannot tolerate oral/transdermal narcotic analgesics

Administration of the following antifungal or antiviral drugs: acyclovir, foscarnet, amphotericin B, and ganciclovir

Administration of parenteral inotropic therapy using the drugs dobutamine (J1250), milrinone (J2260) or dopamine (J1265) for beneficiaries with American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Stage D heart failure (HF) or New York Heart Association (NYHA) Class IV HF, if a beneficiary meets all of the following criteria:

Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,
As “Bridge” therapy for patients eligible for and awaiting mechanical circulatory support (MCS)/cardiac transplantation, or as palliative care for patients not eligible for either MCS/cardiac transplantation; and,
Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,
There has been a documented improvement in beneficiary symptoms of heart failure while on the selected inotropic drug at the time of discharge from an inpatient or skilled nursing care facility; and,
An evaluation every three months by the prescribing provider or a heart failure team with oversight by a cardiologist with training in the management of advanced heart failure, which documents the beneficiary’s cardiac symptoms and the continuing response and need for therapy. The heart failure team or physician may have no financial relationship with the supplier.

Guideline-directed medical therapy (GDMT) is compliance with optimal medical therapy as defined by ACCF/AHA guideline–recommended therapies (primarily Class I recommendations). These include the use of diuretics, ACE inhibitors or ARB antagonists, beta-blockers, aldosterone antagonists, hydralazine & isosorbide dinitrate, and statins, as appropriate.

For an external infusion pump and related inotropic drugs covered prior to 12/01/2015, if the Medicare coverage criteria in effect on the initial date of service were met, the pump and drug(s) will continue to be covered for claims with dates of service on or after 12/01/2015 as long as the beneficiary continues to meet medical need.

Administration of epoprostenol (J1325) or treprostinil (J3285) for beneficiaries with pulmonary hypertension if they meet the following disease criteria:
The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease, etc.) or disorders of the respiratory system (e.g., chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders, etc.); and,
The beneficiary has primary pulmonary hypertension or pulmonary hypertension, which is secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection, cirrhosis, diet drugs, congenital left to right shunts, etc. If these conditions are present, the following criteria must be met:
The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and,
The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion; and,
The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and,
Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.
Epoprostenol/treprostinil is administered using ambulatory infusion pump K0455. Claims for usage of infusion pumps other than K0455 will be denied as not reasonable and necessary.

Gallium nitrate (J1457) is covered for the treatment of symptomatic cancer-related hypercalcemia (See Diagnosis Codes Group 2 that Support Medical Necessity section below). In general, beneficiaries with serum calcium (corrected for albumin) less than 12 mg/dl would not be expected to be symptomatic.

The recommended usage for gallium nitrate is daily for five consecutive days. Use for more than 5 days will be denied as not reasonable and necessary.

More than one course of treatment for the same episode of hypercalcemia will be denied as not reasonable and necessary.

Ziconotide (J2278) is covered for the management of severe chronic pain in beneficiaries for whom intrathecal (IT or epidural) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

Subcutaneous immune globulin (J1559, J1561, J1562, J1569, J1575) is covered only if criteria 1 and 2 are met:
The subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and,
The beneficiary has a diagnosis of primary immune deficiency disease (See Diagnosis Codes Group 3 that Support Medical Necessity section below).

Coverage of subcutaneous immune globulin applies only to those products that are specifically labeled as subcutaneous administration products. Intravenous immune globulin products are not covered under this LCD.

For the administration of subcutaneous immune globulins with the following HCPCS codes - J1559, J1561, J1562 and J1569, only an E0779 infusion pump is covered. If a different pump is used, it will be denied as not reasonable and necessary.

For the administration of subcutaneous immune globulin with HCPCS code J1575, only an E0781 infusion pump is covered. If a different pump is used, it will be denied as not reasonable and necessary.

Levodopa-Carbidopa enteral suspension (J7340) is only covered for treatment of motor fluctuations in beneficiaries with Parkinson’s disease (PD), who meet all of the following criteria (See Diagnosis Codes Group 4 that Support Medical Necessity section below):
The beneficiary has been evaluated by a neurologist, who prescribes and manages treatment with the drug; and,
Idiopathic PD based on the presence of bradykinesia and at least one other cardinal PD features (tremor, rigidity, postural instability); and,
L-dopa responsive with clearly defined “On” periods; and,
Persistent motor complications with disabling “Off” periods for a minimum of 3 hours/day, despite medical therapy with levodopa-carbidopa, and at least one other class of anti-PD therapy i.e. COMT inhibitor or MAO-B inhibitor.
Levodopa-Carbidopa enteral suspension is not reasonable and necessary for patients with any of the following:
Atypical Parkinson’s syndrome (“Parkinson’s Plus” syndrome) or secondary Parkinson’s; or,
Non-levodopa responsive PD; or,
Contraindication to percutaneous endoscopic gastro-jejunal (PEG-J) tube placement or long-term use of a PEG-J.

Establishment of the transabdominal port with a PEG-J is performed under endoscopic guidance by a gastroenterologist or other healthcare provider experienced in this procedure. The PEG-J is considered a supply provided incident to a physician's service, and claims for this item are processed by the A/B MAC contractor. Claims to the DME MAC for the PEG-J will be rejected as wrong jurisdiction.

Blinatumomab (J9039) is only covered for treatment of adult beneficiaries with Philadelphia chromosome negative relapsed/refractory acute lymphoblastic leukemia (See Diagnosis Codes Group 5 that Support Medical Necessity section below).

Maximum utilization is 25 vials per month. Claims for more than 25 vials will be denied as not reasonable and necessary. Refer to the CODING GUIDELINES section of the related Policy Article for information regarding units of service.

GENERAL


External infusion pumps and related drugs and supplies will be denied as not reasonable and necessary when the criteria described by indication (I), (II), (III), (IV) or (V) are not met.

When an infusion pump is covered, the drug necessitating the use of the pump and necessary supplies are also covered. When a pump has been purchased by the Medicare program, other insurer, the beneficiary, or the rental cap has been reached, the drug necessitating the use of the pump and supplies are covered as long as the coverage criteria for the pump are met.

An external infusion pump and related drugs and supplies will be denied as not reasonable and necessary in the home setting for the treatment of thromboembolic disease and/or pulmonary embolism by heparin infusion.

An infusion controller device (E1399) is not reasonable and necessary.

An IV pole (E0776) is covered only when a stationary infusion pump (E0791) is covered. It is considered not reasonable and necessary if it is billed with an ambulatory infusion pump (E0779, E0780, E0781, E0784, or K0455).

Supplies for the maintenance of a parenteral drug infusion catheter (A4221) are covered during the period of covered use of an infusion pump. They are also covered for the weeks in between covered infusion pump use, not to exceed 4 weeks per episode.

Supplies used with an external infusion pump, A4222 or K0552, are covered during the period of covered use of an infusion pump. Allowance is based on the number of cassettes or bags (A4222) prepared or syringes (K0552) used. For intermittent infusions, no more than one cassette or bag is covered for each dose of drug. For continuous infusion, the concentration of the drug and the size of the cassette, bag, or syringe should be maximized to result in the fewest cassettes, bags, or syringes in keeping with good pharmacologic and medical practice.

Drugs and supplies that are dispensed but not used for completely unforeseen circumstances (e.g., emergency admission to hospital, drug toxicity, etc.) are covered. Suppliers are expected to anticipate changing needs for drugs (e.g., planned hospital admissions, drug level testing with possible dosage change, etc.) in their drug and supply preparation and delivery schedule.

Charges for drugs administered by a DME infusion pump may only be billed by the entity that actually dispenses the drug to the Medicare beneficiary and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed in the state where they are physically located may bill for infusion drugs. Drugs and related supplies and equipment billed by a supplier who does not meet these criteria will be denied as not reasonable and necessary.

Compounded drugs NOC (J7999) billed with an external infusion pump will be denied as not reasonable and necessary. Refer to the CODING GUIDELINES section of the related Policy Article for information about J7999 coding requirements.

Claims for compounded drugs that do not use code Q9977 or J7999 will be denied as incorrect coding.


REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized. (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-08, Chapter 5, Section 5.2.8-9).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three (3) - month quantity at a time.

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
N/A




Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

CPT/HCPCS Codes

Group 1 Paragraph: The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:


EY – No physician or other licensed health care provider order for this item or service


GA – Waiver of liability statement issued as required by payer policy, individual case


GY - Item or service statutorily excluded or does not meet the definition of any Medicare benefit


GZ – Item or service expected to be denied as not reasonable and necessary


JB - Administered Subcutaneously


KX - Requirements specified in the medical policy have been met



Coverage Guidance for heating Pads


For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations, and/or medical necessity.

Medicare does not automatically assume payment for a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee For Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary, may be required upon request of the DME MAC.

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

A standard electric heating pad (E0210) is covered to relieve certain types of pain, decrease joint and soft tissue stiffness, relax muscles, or reduce inflammation.

A heating pad is not reasonable and necessary to treat pain due to peripheral neuropathy, including but not limited to diabetic neuropathy.

It has not been established that a moist electric heating pad (E0215) or water circulating heat pad with pump (E0217) is reasonable and necessary compared to a standard electric heating pad (E0210); therefore, if code E0215 or E0217 is provided it will be denied as not reasonable and necessary.

Heating pads that do not meet the definitions listed in the Coding Guidelines section of the related Policy Article and that are billed with code E1399 will be denied as not reasonable and necessary.

Because a water circulating heating pad system is not medically necessary, a replacement pump (E0236) or pad (E0249, A9999) will be denied as not reasonable and necessary.

The safety and effectiveness of using a heat lamp (E0200, E0205) in the home setting is not established. Claims for these items will be denied as not reasonable and necessary.



Group 1 Codes:

A9273 HOT WATER BOTTLE, ICE CAP OR COLLAR, HEAT AND/OR COLD WRAP, ANY TYPE

A9999 MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED

E0200 HEAT LAMP, WITHOUT STAND (TABLE MODEL), INCLUDES BULB, OR INFRARED ELEMENT

E0205 HEAT LAMP, WITH STAND, INCLUDES BULB, OR INFRARED ELEMENT

E0210 ELECTRIC HEAT PAD, STANDARD

E0215 ELECTRIC HEAT PAD, MOIST

E0217 WATER CIRCULATING HEAT PAD WITH PUMP

E0225 HYDROCOLLATOR UNIT, INCLUDES PADS

E0236 PUMP FOR WATER CIRCULATING PAD

E0239 HYDROCOLLATOR UNIT, PORTABLE

E0249 PAD FOR WATER CIRCULATING HEAT UNIT, FOR REPLACEMENT ONLY

E1399 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS