Article - External Infusion Pumps - Policy Article (A52507)

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor 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. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).External infusion pumps are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Drugs are only covered as a supply to a covered DME infusion pump. Drugs billed alone (without a covered pump being used) will be denied as statutorily noncovered (no benefit).Infusion drugs started in a practitioners office, whether with or without a pump, must be billed to the local carrier and not the DME MAC. In these cases, the drug or biological may potentially be covered under section 1861(s)(2)(A) and (B) of the Act and is billable to the A/B MAC even though the entire administration of the drug or biological did not occur in the practitioners office or the hospital outpatient department. Equipment, such as an external infusion pump used to begin administration of the drug or biological that the patient takes home to complete the infusion, is not separately billable as durable medical equipment for a drug or biological paid under the section 1861(s)(2)(A) and (B) incident to benefit. These claims will be rejected as wrong jurisdiction.Disposable drug delivery systems, including elastomeric infusion pumps (A4305, A4306, A9274) are non-covered devices because they do not meet the Medicare definition of durable medical equipment. Drugs and supplies used with disposable drug delivery systems are also non-covered items.Catheter insertion devices for use with external insulin infusion pump infusion cannulas are included in the allowance for code A4224 and are not separately payable.The DME MACs do not process claims for implantable infusion pumps (E0782, E0783, E0785, and E0786) or drugs and supplies used in conjunction with an implantable infusion pump. Claims for these items must be submitted to the A/B MAC.Replacement batteries (K0601, K0602, K0603, K0604, K0605) are not separately payable when billed with a rented infusion pump.Medicare only pays for one pump (K0455) for administering epoprostenol and treprostinil; the supplier is responsible for ensuring that there is an appropriate and acceptable contingency plan to address any emergency situations or mechanical failures of the equipment. A second pump provided as a backup will be denied as not separately payable.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD- related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSCoverage of an external infusion pump for the administration of continuous subcutaneous insulin as outlined in the related LCDs Coverage Indications, Limitations, and/or Medicalsectionunder criteria IV. C. and D. requires a frequency of glucose self-testing an average of at least 4 times per day. A beneficiary using a continuous glucose monitor (CGM) is inherently testing more than the 4 times per day glucose monitoring requirement. Documentation of the use of a CGM device in the beneficiarys medical records would meet the testing requirement in the External Infusion Pump LCD.In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.DME INFORMATION FORM (DIF)Providers and suppliers no longer need to submit a DME Information Form (DIF) for services rendered on or after January 1, 2023.For claims with dates of service on or after January 1, 2023  Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023  If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.For dates of service for which a DIF is required, a DIF which has been completed, signed, and dated by the supplier, must be kept on file by the supplier and made available upon request.The DIF for External Infusion Pumps is CMS Form 10125. The initial claim must include an electronic copy of the DIF.For claims with dates of service prior to January 1, 2023 the following requirements for new initial and revised DIFs remain in effect:A revised DIF must be submitted if:A beneficiary begins using an infusion for one drug and subsequently the drug is changed, another drug is added, or if the code for a current drug changes. The additional new or changed drug or the new HCPCS code for the existing drug must be listed along with all other drugs for which the pump is used.There is a change in the route of administration or a change in the method of administration of a drug.The length of need previously entered on the DIF has expired and the ordering practitioner is extending the length of need for the item(s).If information on an inotropic drug is requested, the supplier must submit a copy of the order and clinical documentation which includes information relating to each of the criteria (D1-D4) defined in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD. This information must come from the medical record.For parenteral inotropic drugs, the cardiologist with training in the management of advanced heart failure who performs the initial evaluation does not need to be the prescriber for the parenteral inotropic drug. However, the prescribing practitioner must:Verify that an initial evaluation was performed by a cardiologist with training in the management of advanced heart failure; andHave documentation of the evaluation; and,Provide a copy of the initial evaluation and the prescription for the item(s) to the DMEPOS supplier.Parenteral inotropic claims that are grandfathered must also be in compliance with Medicare Claims Processing Manual (CMS Internet Only Manual 100-04) Chapter 20 break-in-service rules.If additional information on epoprostenol or treprostinil is requested, the supplier should submit signed and dated information from the treating practitioner stating the beneficiary's diagnosis, the beneficiary's current symptoms caused by pulmonary hypertension, and date and results of the pulmonary artery pressure. There must be a statement that the pulmonary hypertension is not secondary to pulmonary venous hypertension or a disorder of the respiratory system. There must be a statement of whether oral calcium channel blocking agents were tried and if so, the results, and if not, why a trial was not conducted.MODIFIERSJB MODIFIERFor immune globulins (J1551, J1555, J1558, J1559, J1561, J1562 and J1569) and associated infusion pump (E0779) claims where the route of administration is subcutaneous, a JB modifier must be added to each HCPCS code.For immune globulin (J1551, J1558 and J1575) and associated infusion pump (E0781) claims where the route of administration is subcutaneous, a JB modifier must be added to each HCPCS code.For other methods of administration, no modifier should be added.JK AND JL MODIFIERSThe JK and JL modifiers will be effective for claims with dates of service on or after April 1, 2023, for insulin (J1817) administered through an external insulin infusion pump (E0784), and for claims with dates of service on or after July 1, 2023, for insulin (fiasp) (J1811) and insulin (lyumjev) (J1813) administration through an external insulin infusion pump (E0784).For a one-month or less supply of insulin, JK modifier must be added to HCPCS codes J1811, J1813 or J1817For a three-month supply of insulin, JL modifier must be added to HCPCS codes J1811, J1813 or J1817Effective for claims with dates of service on or after July 1, 2023, a beneficiarys coinsurance for a months supply of insulin (J1811, J1813 or J1817) furnished through an external insulin infusion pump (E0784) is not to exceed $35. In order to ensure beneficiaries are not charged more than the $35 maximum allowed for the month of July 2023, suppliers must not bill a three-month supply of insulin (J1817) between May 1, 2023 and June 30, 2023.For claims with dates of service in May or June 2023, suppliers must only bill a one-month supply of insulin (J1817) and append the JK modifier. Claims with dates of service in May or June 2023 with the JL modifier appended will be returned as unprocessable.JW AND JZ MODIFIERSEffective for claims with dates of service on or after January 1, 2017, the JW modifier is required when billing for unused and discarded amounts of drugs and biologicals from single-dose containers that are administered by the supplier.Effective for claims with dates of service on or after July 1, 2023, the JZ modifier is required when billing for drugs and biologicals from single-dose containers that are administered by the supplier but have no unused and discarded amounts. Effective January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers that are dispensed by the supplier but self-administered by the beneficiary or the beneficiarys caregiver.The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or caregiver in the beneficiary's home,as it is not expected that the beneficiary or their caregiver provide discarded drug information to the supplier. The JZ modifier is required in this scenario (effective for claims with dates of service on or after January 1, 2024).Multi-use vials are not subject to payment for discarded amounts of drug or biologicals.The DME MACs expect rare use of the JW modifier on claims due to HCPCS code descriptors and their associated Units of Service (UOS) for DMEPOS in addition to the limited instructions for use.Below are two scenarios in regard to the JW modifier.Scenario 1When the HCPCS code UOS is less than the drug quantity contained in the single use vial or single dose package, the following applies:The quantity administered is billed on one claim line without the JW modifier; and,The quantity discarded is billed on a separate claim line with the JW modifier.In this scenario, the JW modifier must be billed on a separate line to provide payment for the amount of discarded drug or biological. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 1 mg.95 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.5 mg remaining in the vial are discarded.The 95 mg dose is billed on one claim line as 95 UOS.The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.Both claim line items would be processed for payment.Scenario 2When the HCPCS code UOS is equal to or greater than the total of the actual dose and the amount discarded, use of the JW modifier is not permitted. As of July 1, 2023, the JZ modifier is required in this situation. If the quantity of drug administered is less than a full UOS, the billed UOS is rounded to the appropriate UOS. For example: