Local Coverage Determination (LCD)

External Infusion Pumps

L33794

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Contractor Information

LCD Information

Document Information

LCD ID
L33794
LCD Title
External Infusion Pumps
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33794
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 07/18/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
06/03/2021
Notice Period End Date
07/17/2021
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CMS National Coverage Policy

CMS Pub. 100-03, (National Coverage Determinations Manual), Chapter 1, Section 280.14

Coverage Guidance

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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • Refer to the Supplier Manual for additional information on documentation requirements.
  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment or to assure the proper functioning of the equipment. However, the coverage of such drugs or biologicals does not preclude the need for a determination that the drug or biological itself is reasonable and necessary for treatment of the illness or injury or to improve the functioning of a malformed body member.

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).

  1. Administration of deferoxamine for the treatment of chronic iron overload.
  2. 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.
  3. Administration of morphine when used in the treatment of intractable pain caused by cancer.
  4. Administration of continuous subcutaneous insulin for the treatment of diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.) if criterion A or B is met and if criterion C or D is met:
    1. C-peptide testing requirement – must meet criterion 1 or 2 and criterion 3:
      1. C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method.
      2. 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.
      3. A fasting blood sugar obtained at the same time as the C-peptide level is less than or equal to 225 mg/dl.
    2. Beta cell autoantibody test is positive.
    3. 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:
      1. Glycosylated hemoglobin level (HbA1C) greater than 7 percent
      2. History of recurring hypoglycemia
      3. Wide fluctuations in blood glucose before mealtime
      4. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
      5. History of severe glycemic excursions
    4. 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 practitioner at least every 3 months. In addition, the external insulin infusion pump must be ordered and follow-up care rendered by a practitioner 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.

    The HCPCS code combination of E0784 plus K0554 is used to describe external ambulatory insulin infusion pumps that incorporate dose rate adjustment using therapeutic continuous glucose sensing. Coverage for this HCPCS code combination is only met if the beneficiary meets all the coverage criteria for insulin pumps outlined in this policy and all criteria for a therapeutic Continuous Glucose Monitor (CGM) as outlined in the Glucose Monitors policy (LCD L33822).

    Refer to the GENERAL section below, and to the CODING GUIDELINES section in the LCD-related Policy Article for additional information regarding supplies used in conjunction with insulin infusion pumps (E0784).

    Claims with dates of service on or after January 01, 2017 for supply HCPCS codes A4221, A4222 and K0552, when used with an external infusion pump HCPCS code E0784 will be denied as incorrect coding.

  5. 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 practitioner'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):

    1. 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 
    1. 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
    1. Administration of the following antifungal or antiviral drugs: acyclovir, foscarnet, amphotericin B, and ganciclovir
    1. 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: 
      1. Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,
      2. 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,
      3. Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,
      4. 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,
      5. 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 practitioner 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.

    1. Administration of epoprostenol (J1325) or treprostinil (J3285) for beneficiaries with pulmonary hypertension if they meet the following disease criteria:
      1. 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
      2. 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:
        1. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and,
        2. The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion; and,
        3. The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and,
        4. Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.
        5. 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.
    2. Gallium nitrate (J1457) is covered for the treatment of symptomatic cancer-related hypercalcemia (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.). 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.

    3. 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.
    4. Subcutaneous immune globulin (SCIg) (see Group 3 HCPCS codes) is covered when criteria 1-3, AND criterion 4 or 5 are met:
      1. The subcutaneous immune globulin preparation is a pooled plasma derivative which is FDA-approved; and,
      2. The SCIg is administered in the home; and,
      3. The treating practitioner has determined that administration of the SCIg in the patient's home is medically necessary and appropriate; and,
      4. The beneficiary has a primary immune deficiency disorder (Refer to the Group 3 ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.); OR,
      5. The beneficiary has a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) that has responded to IVIg treatment (Refer to the Group 6 ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.).

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.

If a drug and pump combination is used, other than those listed in the table in the LCD-related Policy Article, the pump and drug will be denied as not reasonable and necessary (see Coding Guidelines section of the LCD-related Policy Article).

    1. 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 (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.):
      1. The beneficiary has been evaluated by a neurologist, who prescribes and manages treatment with the drug; and,
      2. Idiopathic PD based on the presence of bradykinesia and at least one other cardinal PD features (tremor, rigidity, postural instability); and,
      3. L-dopa responsive with clearly defined “On” periods; and,
      4. 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:

      1. Atypical Parkinson’s syndrome (“Parkinson’s Plus” syndrome) or secondary Parkinson’s; or
      2. Non-levodopa responsive PD; or,
      3. 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.

    1. Blinatumomab (J9039) is only covered for:
      1. Up to nine (9) cycles for adult and pediatric beneficiaries with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL); or
      2. Up to four (4) cycles for adult and pediatric beneficiaries with B-cell precursor ALL in first or second remission with minimal residual disease (MRD) greater than or equal to 0.1%.

(Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.)

Maximum utilization is 875 units of service (UOS), which is equivalent to 25 vials per month. Claims for more than 875 UOS (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) or supplies for the maintenance for an insulin infusion pump (A4224) 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 and K0552 or supplies used with an insulin infusion pump (A4225) 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 (A4225, 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.

Claims with dates of service on or after January 01, 2017 for supply HCPCS codes A4224 and A4225 used with an external infusion pump other than HCPCS code E0784 will be denied as incorrect coding.

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.

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.


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.

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 treating practitioners 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.


DRUG WASTAGE

Claims for drugs billed to Medicare must use drug dosage formulations and/or unit dose sizes that minimize wastage. Medicare provides payment for the amount of a single use vial or other single use package of drug or biological discarded, in addition to the dose administered.

Effective for claims with dates of service on or after January 1, 2017, Medicare requires the use of the JW modifier when billing for drug wastage.

Because of the HCPCS code descriptors and the associated UOS for DMEPOS items, the DME MACs expect rare use of the JW modifier on claims.

The amount of drug discarded must be billed on a separate claim line using the JW modifier. Review the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article for additional instructions regarding the use of the JW modifier.

Effective for claims with dates of service on or after January 1, 2017, if the coverage criteria for the infusion drugs are not met, claims billed for drug wastage with the JW modifier will be denied as not reasonable and necessary.

Effective for claims with dates of service on or after January 1, 2017, claims lines billed for drug wastage without a JW modifier will be denied as not reasonable and necessary.

Summary of Evidence

Background

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, acquired disorder of peripheral nerves and nerve roots with an assumed autoimmune pathogenesis. It is characterized by a progressive, relapsing-remitting, or monophasic course of weakness and impaired sensory function in the legs and arms caused by damage to the myelin sheath of peripheral nerves and is treatable with immunomodulatory therapies, including immune globulins.

Hizentra is an Immune Globulin Subcutaneous (Human) (SCIg), 20% Liquid, with FDA approval for the treatment of primary immunodeficiency diseases (PIDD) in adults and pediatric patients 2 years of age and older, and maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy.1 Hizentra therapy is initiated 1 week after the last IVIg infusion and is intended for subcutaneous administration using an infusion pump with a recommended dose of 0.2 g/kg (1 mL/kg) body weight per week, administered in 1 or 2 sessions over 1 or 2 consecutive days.

See: https://www.fda.gov/media/78466/download 

Hizentra was approved by the Food & Drug Administration (FDA) for the treatment of CIDP on March 15, 2018.2

See: https://www.fda.gov/media/111603/download.

Literature Analysis

In a prospective, randomized, single-blind, crossover study,3 Markvardsen et al. investigated if SCIg infusions of Hizentra were as effective as conventional IVIg maintenance therapy in CIDP in 20 patients naïve to immune modulatory therapy. Both SCIg and IVIg treatment were successful in reaching the primary endpoint of increased combined isokinetic muscle strength (cIKS) to a similar degree (7.4 ± 14.5%, 6.9 ± 16.8%, respectively). Side effects of SCIg were mild, and the authors concluded that in treatment-naïve patients with CIDP, SCIg and IVIg therapy improved motor performance to a similar degree during a 10-week period.

In a 4-month, multi-center, prospective, observational study,4 Cocito, et al. examined the clinical efficacy of SCIg (16 % solution of human IgG; n=6 patients or 20 % solution of human IgG; n=81) in 87 patients with CIDP (n=66) or multifocal motor neuropathy (MMN; n=21) previously treated with IVIg evaluated by means of the Overall Neuropathy Limitation Scale (ONLS) and Medical Research Council (MRC) Scale. The ONLS total scores significantly improved in CIDP patients from baseline (time of switch to SCIg) to the 4-month follow-up (p=0.018); and, a non-significant improvement in the MRC score in CIDP patients was seen (p=0.342). The authors concluded these results confirmed the short-term clinical equivalence of SCIg to IVIg infusion.

The Polyneuropathy and Treatment with Hizentra (PATH) study5 was a 24 week, pivotal, phase III trial that described the efficacy testing of Hizentra for the maintenance treatment of CIDP compared to placebo in 172 IgG dependent CIDP patients randomized for treatment with one of two (low or high) doses of SCIg or placebo. Hizentra treatment reduced CIDP relapse or withdrawal from the study in both low- and high-dose treatment groups compared to the placebo group (p=0.007 and p=0.0005, respectively), with no difference between the low and high-dose treatments (p=0.48). Relapse occurred in 56% of placebo treated patients, 33% of low-dose, and 19% of high-dose SCIg treated patients. The study concluded both doses of Hizentra were safe, well-tolerated, and efficacious in maintaining stable disease and preventing relapse in IgG dependent CIDP patients. The PATH extension study,6 investigated the long-term safety and efficacy of weekly subcutaneous Hizentra for maintenance treatment of CIDP patients. A total of 66 patients (80%) completed the study, with relapse rates of 10% in 0.4g/kg treated patients and 48% in 0.2g/kg treated patients. Efficacy findings confirmed that Hizentra at 0.4 g/kg weekly (high dose), offered higher likelihood for maintaining patients’ health status than 0.2 g/kg weekly (low dose); however, a substantial proportion of patients could be titrated down to low dose without further worsening. There were 180 adverse events in 62 patients (76%) of which 62% were mild, 29% were moderate, and 9% were severe, however no severe adverse events were causally related except for 3 local reactions from 1 patient. The authors concluded that the safety findings in the extension study were consistent with those from the PATH study and the known safety profile for Hizentra.

In a prospective, observational study,7 the early initiation and long-term treatment (24-months) with SCIg on neurophysiological parameters and their clinical correlates were investigated by Cirillo, et al. in 16 CIDP patients who were identified as immune globulin responders after a single IVIg cycle. Nerve conduction studies, modified Rankin Scale (mRS), MRC sum score, Inflammatory Neuropathy Cause and Treatment (INCAT) sum score, and overall disability sum score (ODSS) were evaluated. Significant effects of SCIg on neurophysiological parameters were noted, with improvement in global strength, sensory deficits and overall disability. The authors concluded that the data supported the use of early and long-term treatment of CIDP with SCIg. Cirillo, et al.8 investigated the efficacy of continued SCIg treatment through 48-months in 14 of their original 16 CIDP patient cohort (two patients excluded after 24 months due to clinical remission) in a prospective, observational study and found preservation in neurophysiological parameters and associated clinical improvement from baseline.

A meta-analysis9 by Racosta et al. compared the efficacy and safety of SCIg versus IVIg for inflammatory demyelinating polyneuropathies, including MMN and CIDP. The authors concluded that SCIg could be considered as a valid alternative to IVIg in patients with CIDP based on its comparable efficacy and seemingly better safety profile. A systematic literature review10 by Querol, et al. examined the burden of illness associated with CIDP, including current treatments. The authors concluded that SCIg has similar efficacy to IVIg and confirmed that patients prefer SCIg due to reductions in adverse events (AEs) and improved independence relative to IVIg. In a review article,11 Allen, et al. aimed to describe the clinical and patient considerations when selecting immunoglobulin therapy and concluded that the decision to use SCIg or IVIg is one that is best individualized to each patient's disease characteristics, treatment goals, and lifestyle.

Evidence Based Guidelines

No evidence-based guideline recommendations for SCIg products for the treatment of CIDP were identified. (Note: All relevant guidelines were updated prior to FDA approval of Hizentra for the treatment of CIDP.) However, the following evidence-based guidelines for IVIg for the treatment of CIDP were identified.

American Academy of Neurology Evidence-based guideline: Intravenous immunoglobulin in the treatment of neuromuscular disorders12

Summary of Guideline (in relevant part):

Conclusions.

    1. Based on 2 Class I studies, IVIg is effective for the long-term treatment of CIDP.
    2. Data are insufficient to address the comparative efficacy of prednisolone and IVIg in treating CIDP.

Recommendation. IVIg should be offered for the long-term treatment of CIDP (Level A).

National Advisory Committee on Blood and Blood Products of Canada (NAC) and Canadian Blood Services: Guidelines on the Use of Intravenous Immune Globulin for Neurologic Conditions13

Summary of Guideline (in relevant part):

Intravenous immune globulin is recommended as an option for the short-term management of new-onset CIDP or CIDP relapses. Based on consensus by the expert panel, IVIg may be considered as an option in combination with other immunosuppressive therapy for the long-term management of CIDP. If IVIg is to be used in the long-term management of CIDP, the patient should be under the care of a qualified expert with specialized knowledge of CIDP and a systematic approach should be taken to determine the minimal effective dose.

Professional Society Guidelines

No professional society guideline recommendations for SCIg products for the treatment of CIDP were identified. However, the following professional society guidelines for IVIg for the treatment of CIDP were identified.

European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society — First Revision14

Summary of Guideline (in relevant part):

Recommendations for treatment

For induction of treatment

    1. IVIg (level A recommendation) or corticosteroids (level C recommendation) should be considered in sensory and motor CIDP in the presence of disabling symptoms. PE is similarly effective (level A recommendation) but may be less tolerated. The presence of relative contraindications to any of these treatments should influence the choice (good practice point). The advantages and disadvantages should be explained to the patient who should be involved in the decision making (Good Practice Point).
    2. The advantages and disadvantages should be explained to the patient who should be involved in the decision making (Good Practice Point).
    3. In pure motor CIDP, IVIg should be considered as the initial treatment (Good Practice Point).

For maintenance treatment

    1. If the first-line treatment is effective, continuation should be considered until the maximum benefit has been achieved and then the dose reduced to find the lowest effective maintenance dose (Good Practice Point).
    2. If the response is inadequate or the maintenance doses of the initial treatment (IVIg, steroids, or PE) result in adverse effects, the other first-line treatment alternatives should be tried before considering combination treatments or adding an immunosuppressant or immunomodulatory drug may be considered, but there is no sufficient evidence to recommend any particular drug (Good Practice Point).
Analysis of Evidence (Rationale for Determination)

Overall Certainty of Evidence: MODERATE15

Critical Outcomes reviewed: relapse rate, muscle strength, long-term effects of SCIg treatment

Conclusion

Chronic inflammatory demyelinating polyneuropathy is a rare, acquired, immune-mediated neuropathy affecting peripheral nerves and nerve roots that is treatable with immunomodulatory therapies, including immune globulins. National and international clinical practice guidelines recommend the use of IVIg for the treatment of CIDP. Current evidence supports the clinical equivalency of SCIg to IVIg and superiority compared to placebo for the maintenance therapy of CIDP patients who respond to IVIg treatment. Long-term SCIg use has been associated with sustained improvement in overall strength, sensory deficit, disability and QoL. Additionally, data suggest SCIg may be better tolerated than IVIg and is associated with fewer AEs.

Based on a review of the available clinical literature, there is sufficient evidence to support that Hizentra improves health outcomes, and is reasonable and necessary for the treatment of Medicare beneficiaries with a diagnosis of CIDP for maintenance therapy. Coverage for Hizentra for maintenance treatment of CIDP will be extended under the External Infusion Pumps LCD (L33794).

Coding Information

CPT/HCPCS Codes

Group 1

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

 

JW - Drug amount discarded/not administered to any patient

KX - Requirements specified in the medical policy have been met

 

HCPCS CODES:



EQUIPMENT

Group 1 Codes
CodeDescription
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

Group 2 Paragraph

SUPPLIES

Group 2 Codes
CodeDescription
A4221 SUPPLIES FOR MAINTENANCE OF NON-INSULIN DRUG INFUSION CATHETER, PER WEEK (LIST DRUGS 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)
A4224 SUPPLIES FOR MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK
A4225 SUPPLIES FOR EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH
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 NON-INSULIN 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

Group 3

Group 3 Paragraph

SUBCUTANEOUS IMMUNE GLOBULIN DRUGS

 

Group 3 Codes
CodeDescription
J1555 INJECTION, IMMUNE GLOBULIN (CUVITRU), 100 MG
J1558 INJECTION, IMMUNE GLOBULIN (XEMBIFY), 100 MG
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG
J1561 INJECTION, IMMUNE GLOBULIN, (GAMUNEX-C/GAMMAKED), NON-LYOPHILIZED (E.G., LIQUID), 500 MG
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG
J1569 INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), NON-LYOPHILIZED, (E.G., LIQUID), 500 MG
J1575 INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN
J7799 NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME

Group 4

Group 4 Paragraph

Drugs for other indications

Group 4 Codes
CodeDescription
J0133 INJECTION, ACYCLOVIR, 5 MG
J0285 INJECTION, AMPHOTERICIN B, 50 MG
J0287 INJECTION, AMPHOTERICIN B LIPID COMPLEX, 10 MG
J0288 INJECTION, AMPHOTERICIN B CHOLESTERYL SULFATE COMPLEX, 10 MG
J0289 INJECTION, AMPHOTERICIN B LIPOSOME, 10 MG
J0895 INJECTION, DEFEROXAMINE MESYLATE, 500 MG
J1170 INJECTION, HYDROMORPHONE, UP TO 4 MG
J1250 INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250 MG
J1265 INJECTION, DOPAMINE HCL, 40 MG
J1325 INJECTION, EPOPROSTENOL, 0.5 MG
J1455 INJECTION, FOSCARNET SODIUM, PER 1000 MG
J1457 INJECTION, GALLIUM NITRATE, 1 MG
J1570 INJECTION, GANCICLOVIR SODIUM, 500 MG
J1817 INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS
J2175 INJECTION, MEPERIDINE HYDROCHLORIDE, PER 100 MG
J2260 INJECTION, MILRINONE LACTATE, 5 MG
J2270 INJECTION, MORPHINE SULFATE, UP TO 10 MG
J2274 INJECTION, MORPHINE SULFATE, PRESERVATIVE-FREE FOR EPIDURAL OR INTRATHECAL USE, 10 MG
J2278 INJECTION, ZICONOTIDE, 1 MICROGRAM
J3010 INJECTION, FENTANYL CITRATE, 0.1 MG
J3285 INJECTION, TREPROSTINIL, 1 MG
J7340 CARBIDOPA 5 MG/LEVODOPA 20 MG ENTERAL SUSPENSION, 100 ML
J7799 NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME
J7999 COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED
J9000 INJECTION, DOXORUBICIN HYDROCHLORIDE, 10 MG
J9039 INJECTION, BLINATUMOMAB, 1 MICROGRAM
J9040 INJECTION, BLEOMYCIN SULFATE, 15 UNITS
J9065 INJECTION, CLADRIBINE, PER 1 MG
J9100 INJECTION, CYTARABINE, 100 MG
J9190 INJECTION, FLUOROURACIL, 500 MG
J9200 INJECTION, FLOXURIDINE, 500 MG
J9360 INJECTION, VINBLASTINE SULFATE, 1 MG
J9370 VINCRISTINE SULFATE, 1 MG

General Information

Associated Information

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO
  • Medical Record Information (including continued need/use if applicable)
  • Correct Coding
  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.


POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met to justify Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.


MISCELLANEOUS


APPENDICES

American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Stage D heart failure (HF) patients have advanced structural heart disease and marked symptoms of heart failure at rest despite maximal medical therapy, and require specialized interventions. J Am Coll Cardiol. 2001;38(7):2101-2113.

New York Heart Association (NYHA) Heart Failure Symptom Class IV patients are unable to carry on any physical activity without discomfort resulting from symptoms of heart failure such as dyspnea, or have symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. The Criteria Committee of the New York Heart Association. (1994).

Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. (9th ed.). Boston: Little, Brown & Co. pp. 253–256.

Bridge Therapy: For purposes of this policy, bridge therapy is not time-circumscribed.


UTILIZATION GUIDELINES

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information

N/A

Bibliography

 

  1. CSL Behring. Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid, Hizentra [highlights of prescribing information]. Revised March, 2018; https://www.fda.gov/media/78466/download. Accessed October 7, 2020.
  2. U.S. Food and Drug Administration. Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid, Hizentra BL 125350/641 Approval Letter. 2018; https://www.fda.gov/media/111603/download. Accessed October 7, 2020.
  3. Markvardsen LH, Sindrup SH, Christiansen I, et al. Subcutaneous immunoglobulin as first-line therapy in treatment-naive patients with chronic inflammatory demyelinating polyneuropathy: randomized controlled trial study. Eur J Neurol. 2017;24(2):412-418.
  4. Cocito D, Merola A, Peci E, et al. Subcutaneous immunoglobulin in CIDP and MMN: a short-term nationwide study. J Neurol. 2014;261(11):2159-2164.
  5. van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35-46.
  6. van Schaik IN, Mielke O, Bril V, et al. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study. Neurol Neuroimmunol Neuroinflamm. 2019;6(5).
  7. Cirillo G, Todisco V, Tedeschi G. Long-term neurophysiological and clinical response in patients with chronic inflammatory demyelinating polyradiculoneuropathy treated with subcutaneous immunoglobulin. Clin Neurophysiol. 2018;129(5):967-973.
  8. Cirillo G, Todisco V, Ricciardi D, Tedeschi G. Clinical-neurophysiological correlations in chronic inflammatory demyelinating polyradiculoneuropathy patients treated with subcutaneous immunoglobulin. Muscle Nerve. 2019;60(6):662-667.
  9. Racosta JM, Sposato LA, Kimpinski K. Subcutaneous versus intravenous immunoglobulin for chronic autoimmune neuropathies: A meta-analysis. Muscle Nerve. 2017;55(6):802-809.
  10. Querol L, Crabtree M, Herepath M, et al. Systematic literature review of burden of illness in chronic inflammatory demyelinating polyneuropathy (CIDP). J Neurol. 2020.
  11. Allen JA, Gelinas DF, Freimer M, Runken MC, Wolfe GI. Immunoglobulin administration for the treatment of CIDP: IVIG or SCIG? J Neurol Sci. 2020;408:116497.
  12. Patwa HS, Chaudhry V, Katzberg H, Rae-Grant AD, So YT. Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012;78(13):1009-1015.
  13. Feasby T, Banwell B, Benstead T, et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev. 2007;21(2 Suppl 1):S57-107.
  14. Van den Bergh PY, Hadden RD, Bouche P, et al. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision. Eur J Neurol. 2010;17(3):356-363.
  15. GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University dbEP, Inc.). Available from gradepro.org.
  16. Barnett C, Sadeghian H. Evidence of persistent improvements with long-term subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy. Muscle Nerve. 2019;60(6):643-644.
  17. Cocito D, Paolasso I, Peci E, Spagone E, Lopiano L. Improvement of quality of life in patients with chronic inflammatory demyelinating polyneuropathy shifting from 16 to 20% subcutaneous immunoglobulins. Neurol Sci. 2013;34(11):2061-2062.
  18. Hughes RA, Donofrio P, Bril V, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008;7(2):136-144.
  19. Leger JM, De Bleecker JL, Sommer C, et al. Efficacy and safety of Privigen((R)) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013;18(2):130-140.
  20. Markvardsen LH, Harbo T. Subcutaneous immunoglobulin treatment in CIDP and MMN. Efficacy, treatment satisfaction and costs. J Neurol Sci. 2017;378:19-25.
  21. Rajabally YA, Cavanna AE. Health-related quality of life in chronic inflammatory neuropathies: a systematic review. J Neurol Sci. 2015;348(1-2):18-23.
  22. Bunschoten C, Jacobs BC, Van den Bergh PYK, Cornblath DR, van Doorn PA. Progress in diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy. Lancet Neurol. 2019.
  23. Gorson KC, van Schaik IN, Merkies IS, et al. Chronic inflammatory demyelinating polyneuropathy disease activity status: recommendations for clinical research standards and use in clinical practice. J Peripher Nerv Syst. 2010;15(4):326-333.
  24. Mathey EK, Park SB, Hughes RA, et al. Chronic inflammatory demyelinating polyradiculoneuropathy: from pathology to phenotype. J Neurol Neurosurg Psychiatry. 2015;86(9):973-985.
  25. Nobile-Orazio E, Gallia F, Terenghi F, Bianco M. Comparing treatment options for chronic inflammatory neuropathies and choosing the right treatment plan. Expert Rev Neurother. 2017;17(8):755-765.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
07/18/2021 R22

Revision Effective Date: 07/18/2021
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: V(H) to point to Group 3 HCPCS list, instead of listing out HCPCS codes

Revised: Criteria V(H) to allow non-primary immune deficiency disorder that responds to IVIg treatment
SUMMARY OF EVIDENCE:
Added: Information related to Hizentra
ANALYSIS OF EVIDENCE:
Added: Information related to Hizentra
HCPCS CODES:
Revised: Group 3 paragraph and group 3 codes to include only subcutaneous immune globulin HCPCS codes
Added: Group 4 paragraph and codes to identify drugs for other indications
BIBLIOGRAPHY:
Added: Information related to Hizentra
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments document (A58802)

  • Provider Education/Guidance
  • Reconsideration Request
01/01/2021 R21

Revision Effective Date: 01/01/2021
HCPCS CODES:
Removed: HCPCS codes G0068, G0069, G0070 from Group 3 Codes. These HCPCS codes are invalid for submission to the DME MACs, effective 01/01/21.

12/31/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to CMS HCPCS coding determinations.

 

  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
09/15/2020 R20

Revision Effective Date: 09/15/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Information related to HCPCS code E0787, which is invalid for Medicare submission for DOS on or after 9/15/2020
Added: Information regarding external ambulatory insulin infusion pumps that incorporate dose rate adjustment using therapeutic continuous glucose sensing
CODING INFORMATION:
Removed: HCPCS code E0787 from Group 1 HCPCS Codes
Removed: HCPCS code A4226 from Group 2 HCPCS Codes

09/17/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are due to Non-Discretionary HCPCS code changes rendering them invalid for submission to Medicare.

  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
09/06/2020 R19

Revision Effective Date: 09/06/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: J7799 (Xembify) to J1558 for Dates of Service on or after 07/01/2020
Clarification: Coverage for Xembify effective for Dates of Service on or after 07/3/2019 (FDA Approval Date)
Added: Cutaquig to coverage criteria V(H) effective for Dates of Service on or after 12/12/2018 (FDA Approval Date)
Added: Statement regarding covered pumps for Cutaquig
SUMMARY OF EVIDENCE:
Added: Information related to Cutaquig
ANALYSIS OF EVIDENCE:
Added: Information related to Cutaquig
CODING INFORMATION:
Added: HCPCS code J1558 to Group 3 table
BIBLIOGRAPHY:
Added: Section related to Cutaquig
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments document A58288

  • Provider Education/Guidance
  • Reconsideration Request
05/31/2020 R18

Revision Effective Date: 05/31/2020

Revision History Number R18 was a duplicate of Revision History Number R17 and did not represent additional updates.

 

  • Provider Education/Guidance
  • Reconsideration Request
05/31/2020 R17

Revision Effective Date: 05/31/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Statement regarding base and related accessories and supplies (BPM Ch. 15, Section 110.3)
Revised: “physician” to “practitioner”
Added: Xembify® to coverage criteria V(H)
Added: Statement regarding covered pumps for Xembify®
Revised: “physicians” to “practitioners”
GENERAL:
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: “ordering physicians” to “treating practitioners”
SUMMARY OF EVIDENCE:
Added: Information related to Xembify®
ANALYSIS OF EVIDENCE:
Added: Information related to Xembify®
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
DOCUMENTATION REQUIREMENTS:
Revised: “physician's” to “treating practitioner's”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO
BIBLIOGRAPHY:
Added: Section related to Xembify®
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments document

  • Provider Education/Guidance
  • Reconsideration Request
01/01/2020 R16

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Coverage information for E0787
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 code list in the LCD-related Policy Article
Added: E0787 to IV pole paragraph
HCPCS CODES:
Added: E0787 to Group 1 and A4226 to Group 2

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R15

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Statement to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
Revised: Effective for claims with dates of service on or after 03/29/2018 allow additional cycles of Blinatumomab (J9039)
HCPCS CODES:
Added: HCPCS codes G0068, G0069, and G0070 to Group 3 codes
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis code moved to LCD-related Policy Article noncovered diagnosis section per CMS instruction

  • Revisions Due To CPT/HCPCS Code Changes
  • Reconsideration Request
  • Other (ICD-10 code relocation per CMS instruction)
03/29/2018 R14

Revision Effective Date: 03/29/2018
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY: 
Added: Expanded Coverage Indications for Blinatumomab
CODING INFORMATION:
Added: ICD-10 code to Group 5

06/07/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the: LCD are applicable as noted in this policy.

  • Provider Education/Guidance
01/01/2018 R13

Revision Effective Date: 01/01/2018
HCPCS CODES:
Removed: J1555 from Group 3: Paragraph
Added: J1555 to Group 3: Codes

04/19/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the: LCD are applicable as noted in this policy.

 

  • Revisions Due To CPT/HCPCS Code Changes
07/11/2017 R12

Revision Effective Date: 07/11/2017
HCPCS CODES:
Revised: Short descriptors of J2274 and J3010. Policy indicates long descriptors which have not been revised.

12/21/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To CPT/HCPCS Code Changes
07/11/2017 R11

Revision Effective Date: 07/11/2017
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Expanded coverage for adult and pediatric patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL)
Revised: Clarified 875 UOS equals 25 vials per month
HCPCS CODE:
Added: J1555 (Effective 01/01/2018)
ICD-10 Codes that Support Medical Necessity:
Added: C91.00 to Group 5 coverage

11/30/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
  • Revisions Due To CPT/HCPCS Code Changes
  • Reconsideration Request
01/01/2017 R10

Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Typographical error K0522 to correct code of K0552
Added: Coverage for Cuvitru (J7799) - effective 9/13/2016
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: verbiage "prior to" to "to justify" Medicare reimbursement

  • Provider Education/Guidance
  • Typographical Error
01/01/2017 R9 Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and Directions to Standard Documentation Requirements
Added: Billing instructions for A4224 and A4225
Added: General Requirements
Revised: Refill Requirements
Revised: Drug Waste verbiage
HCPCS MODIFIERS:
Added: Codes A4224 and A4225
Revised: Code narratives for HCPCS A4221, J7340 and K0552
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and Directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Information from Miscellaneous
Removed: PIM citation from under Appendices
SOURCES OF INFORMATION AND BASIS FOR DECISION:
Removed: Links
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2017 R8 Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Denial verbiage for JW Modifier when coverage criteria not met
HCPCS MODIFIERS:
Added: JW Modifier
DOCUMENTATION REQUIREMENTS:
Added: JW Modifier instructions
  • Provider Education/Guidance
  • Other (Addition of JW Modifier )
10/01/2016 R7 Revision Effective Date: 10/01/2016:
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 Codes to Group 1 per Annual ICD-10 Codes Updates
Deleted: Non-valid ICD-10 Codes per Annual ICD-10 Codes Updates


  • Revisions Due To ICD-10-CM Code Changes
07/01/2016 R6 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
01/01/2016 R5 Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: HCPCS CODE J1575 to Subcutaneous immune globulin coverage
Added: HCPCS CODE J7340 to Levodopa-Carbidopa coverage
Added: HCPCS CODE J9039 to Blinatumomab coverage
Updated: HCPCS Code Q9977 crosswalked to J7999
HCPCS CODES:
Group 3 Codes:
Added: HCPCS Code J1575, J7340, J9039 (previously J7799)
Deleted: HCPCS Code Q9977
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 3 Codes:
Added: ICD-10 Code D83.1 to Group 3 Codes
Group 3 Paragraph:
Added: HCPCS Code J1575
Group 4 Paragraph:
Added: HCPCS Code J7340
Group 5 Paragraph:
Added: HCPCS Code J9039
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/5/2015)
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
  • Revisions Due To ICD-10-CM Code Changes
12/01/2015 R4 Revision Effective Date: 12/01/2015
Draft LCD promoted to final
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Criteria for reimbursement of intravenous inotropic medication
Added: Denial for Compound Drugs NOC Q9977
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Instructions for Q9977

  • Provider Education/Guidance
10/01/2015 R3 Revision Effective Date: 01/01/2015 (March 2015 Publication)
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Maximum utilization for Blinatumomab; inadvertently omitted
DOCUMENTATION REQUIREMENTS:
Revised: Instructions for Revised DIF
Added: Instructions for Recertification DIF
  • Provider Education/Guidance
  • Typographical Error
10/01/2015 R2 Revision Effective Date: 10/01/2015
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Coverage for levodopa-carbidopa enteral suspension (effective for dates of service on or after 01/09/2015)
Added: Coverage for blinatumomab (effective for dates of service on or after 12/03/2014)
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
HCPCS CODES AND MODIFIERS:
Added: Codes A4602 and J2274
Deleted: Codes J2271 and J2275
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 4 Paragraph:
Added: HCPCS Code for levodopa-carbidopa enteral suspension
Group 4 Codes:
Added: ICD-10 Code G20
Group 5 Paragraph:
Added: HCPCS Code for blinatumomab
Group 5 Codes: C91.02
Added: ICD-10 Code
DOCUMENTATION REQUIREMENTS: Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for equipment retained from a prior payer
Added: Repair /Replacement section
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 Revision Effective Date: 10/01/2015
DOCUMENTATION REQUIREMENTS:
Removed: Suggested form for inotrope information
  • Provider Education/Guidance

Associated Documents

Attachments
EIP DIF CMS 10125 (88 KB) (Uploaded on 03/31/2020)
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
05/28/2021 07/18/2021 - N/A Currently in Effect You are here
12/22/2020 01/01/2021 - 07/17/2021 Superseded View
09/08/2020 09/15/2020 - 12/31/2020 Superseded View
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