External Infusion Pumps - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**

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. 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 beneficiary's
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 practitioner's 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 practitioner's
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 available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

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 REQUIREMENTS**

Coverage of an external infusion pump for the administration of continuous
subcutaneous insulin as outlined in the related LCD's "Coverage Indications,
Limitations, and/or Medical" section  under 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 beneficiary's 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; and
  * Have 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.

**MODIFIERS**

JB MODIFIER

For 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 MODIFIERS

The 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 J1817
  * For a three-month supply of insulin, JL modifier must be added to HCPCS codes J1811, J1813 or J1817

Effective for claims with dates of service on or after July 1, 2023, a
beneficiary's coinsurance for a month's 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 MODIFIERS

Effective 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.

The JW and JZ modifiers are not required for drugs dispensed by the supplier
and self-administered by the patient or caregiver in the patient's home.

Multi-use vials are not subject to payment for discarded amounts of drug or
biologicals.

The DME MACs expect rare use of the JW or JZ modifiers on claims due to HCPCS
code descriptors and their associated Units of Service (UOS) for DMEPOS in
addition to the limited instructions for use.

There are two scenarios that can occur when billing with the JW modifier:

Scenario 1  
When 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 2  
When 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. If the
quantity of drug administered is less than a full UOS, the billed UOS is
rounded to the appropriate UOS. For example:

  * A single use vial is labeled to contain 100 mg of a drug.
  * The drug's HCPCS code UOS is 1 UOS = 100 mg.
  * 70 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.
  * 30 mg remaining in the vial are discarded.
  * The 70 mg dose is billed correctly by rounding up to one UOS (representing the entire 100 mg vial) on a single line item.
  * The single line item of 1 UOS would be processed for payment of the combined total 100 mg of administered and discarded drug.
  * The discarded 30 mg must not be billed as another 1 UOS on a separate line item with the JW modifier. Billing an additional 1 UOS for the discarded drug with the JW modifier is incorrect billing and will result in an overpayment. 

GA, GY, GZ AND KX MODIFIERS

For claims submitted on or after March 1, 2023 suppliers must add the KX
modifier to claim lines billed for the external infusion pump, drugs and
supplies for dates of service on or after January 1, 2023, only if all of the
coverage criteria in the "Coverage Indications, Limitations, and/or Medical
Necessity" section in the related LCD have been met. Evidence supporting the
use of the KX modifier must be retained in the supplier's files and available
to the DME MAC upon request. The KX modifier requirement will continue to be
required for HCPCS E0784 and J1817 for any date of service billed, if
applicable.

If all of the criteria in the "Coverage Indications, Limitations, and/or
Medical Necessity" section of the related LCD have not been met, the GA or GZ
modifier must be added to the code. When there is an expectation of a medical
necessity denial, suppliers must enter the GA modifier on the claim line if
they have obtained a properly executed Advance Beneficiary Notice (ABN) or the
GZ modifier if they have not obtained a valid ABN.

Claim lines billed for the above services without a KX, GA, or GZ modifier
will be rejected as missing information for claims submitted on or after March
1, 2023 for all codes.

An infusion drug not administered using a durable infusion pump must be billed
using the appropriate HCPCS code plus the GY modifier.

**CODING GUIDELINES**

An ambulatory infusion pump (E0781) is an electrical or battery operated
device, which is used to deliver solutions containing a parenteral drug under
pressure at a regulated flow rate. It is small, portable, and designed to be
carried by the beneficiary.

A stationary infusion pump (E0791) is an electrical device, which serves the
same purpose as an ambulatory pump but is larger and typically mounted on a
pole.

A disposable drug delivery system (A4305, A4306, A9274) is a device used to
deliver solutions containing injectable drugs that is not reusable, i.e., it
is used by a single beneficiary for a limited time and then discarded.

An infusion controller (E1399) is an electrical device, which regulates the
flow of parenteral solutions under gravity pressure.

A reusable mechanical infusion pump (E0779) is a device used to deliver
solutions containing parenteral drugs under pressure at a constant flow rate
determined by the tubing with which it is used. It is small, portable, and
designed to be carried by the beneficiary. It must be capable of a single
infusion cycle of at least 8 hours.

Code E0780 describes a mechanical infusion pump which is similar to an E0779
pump, but which is only capable of a single infusion cycle of less than 8
hours.

Code K0455 describes an ambulatory electrical infusion pump, which is used for
the administration of epoprostenol (J1325) and treprostinil (J3285).

Code A4221 describes all necessary supplies, such as dressings for the
catheter site and flush solutions, not directly related to non-insulin drug
infusions. The catheter site may be a peripheral intravenous line, a
subcutaneous infusion catheter, a peripherally inserted central catheter
(PICC), a centrally inserted intravenous line with either an external or a
subcutaneous port, or an epidural catheter.

Code A4222 includes the cassette or bag, diluting solutions, tubing and other
administration supplies, port cap changes, compounding charges, and
preparation charges. This code is not used for a syringe-type reservoir.

Code K0552 describes a syringe-type reservoir that is used with the K0455 pump
when it is used to administer epoprostenol/treprostinil, or with an E0779 pump
used to administer subcutaneous immune globulin. The reservoir may be either
glass or plastic and includes the needle for drawing up the drug. This code
does not include the drug for use in the reservoir. Code A4232 is invalid for
submission to Medicare and should not be used for this purpose.

Claims for codes A4221, A4222 and K0552 must only be used with a non-insulin
external infusion pump (E0779, E0780, E0781, E0791 or K0455). Claims with
dates of service on or after January 01, 2017 for codes A4221, A4222 and K0552
used with an external infusion pump HCPCS code E0784 are incorrectly coded.

Code A4224 is all-inclusive and describes all necessary supplies (excluding
the insulin reservoir - see code A4225) used with an external infusion pump
(E0784) for the administration of continuous subcutaneous insulin and
includes, but is not limited to, all cannulas, needles, dressings and infusion
supplies. Separate billing for any item including an item using a specific
HCPCS code, if one exists, will be denied as unbundling.

Code A4225 describes a syringe-type reservoir that is used with the external
insulin infusion pump (E0784).

Claims for codes A4224 and A4225 must only be used with insulin infusion pumps
(E0784). Claims with dates of service on or after January 01, 2017 for codes
A4224 and A4225 used with an external infusion pump other than code E0784 are
incorrectly coded.

HCPCS Supply Codes Associated with External Infusion Pumps HCPCS Codes

The following table describes HCPCS supply codes that are used with different
types of external infusion pumps. The HCPCS codes listed in the "Associated
Codes" column should be used with the corresponding "Pump HCPCS code." Claims
for supply codes listed in the "Non-Associated Codes" column will be denied as
incorrect coding, if they are being used with an external infusion pump listed
in the "Pump HCPCS Code" column of the same line.

**Pump HCPCS Code** | **Associated Codes** | **Non-Associated Codes**  
---|---|---  
E0779 | A4221, A4222, K0552* | A4224, A4225  
E0780 | A4221, A4222 | A4224, A4225, K0552  
E0781 | A4221, A4222 | A4224, A4225, K0552  
E0784 | A4224, A4225, A4238**, A4239** | A4221, A4222, K0552  
E0791 | A4221, A4222 | A4224, A4225, K0552  
K0455 | A4221, A4222, K0552* | A4224, A4225  
  
  
*For E0779 and K0455 pumps, either A4222 or K0552 may be billed, but not both.

**For E0784 pumps, either A4238 or A4239 may be billed if used in conjunction
with an integrated adjunctive or non-adjunctive CGM, respectively.

Prior to January 1, 2023, insulin infusion pumps with integrated continuous
glucose sensing capabilities must be coded using HCPCS codes E0784 (EXTERNAL
AMBULATORY INFUSION PUMP, INSULIN) and K0554 (RECEIVER (MONITOR), DEDICATED,
FOR USE WITH THERAPEUTIC GLUCOSE CONTINUOUS MONITOR SYSTEM). On or after
January 1, 2023, insulin infusion pumps with integrated continuous glucose
sensing capabilities must be coded using HCPCS codes E0784 (EXTERNAL
AMBULATORY INFUSION PUMP, INSULIN) and E2103 (NON-ADJUNCTIVE, NON-IMPLANTED
CONTINUOUS GLUCOSE MONITOR OR RECEIVER).

Prior to January 1, 2023, the related accessories/supplies for these
integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR
MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR
EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and
K0553 (SUPPLY ALLOWANCE FOR THERAPEUTIC CONTINUOUS GLUCOSE MONITOR (CGM),
INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE). On
or after January 1, 2023, the related accessories/supplies for these
integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR
MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR
EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and
A4239 (SUPPLY ALLOWANCE FOR NON-ADJUNCTIVE, NON-IMPLANTED CONTINUOUS GLUCOSE
MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT
OF SERVICE).

For claims with dates of service on or before March 31, 2022, insulin infusion
pumps with integrated adjunctive continuous glucose monitor receiver
functionality must be coded using HCPCS codes E0784 (EXTERNAL AMBULATORY
INFUSION PUMP, INSULIN) and E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS)
for an adjunctive continuous glucose monitor or receiver. Suppliers must bill
as a rental (RR) both E0784 and E1399 to describe the rental of an insulin
pump with integrated adjunctive CGM receiver functionality. When submitting a
claim for E1399, suppliers must enter "adjunctive" in loop 2300 (claim note)
and/or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI X12N, version
5010A1 professional electronic claim format or in Item 19 of the paper claim
form, so that the items can be identified as adjunctive CGM devices when
processing the claim. The related accessories/supplies for these integrated
units must be coded using HCPCS codes A4224 (SUPPLIES FOR MAINTENANCE OF
INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR EXTERNAL INSULIN
INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and A9999
(MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED) for supplies
and accessories used in conjunction with an insulin pump, which also performs
the functions of an adjunctive continuous glucose monitor or receiver.
Suppliers may bill 1 UOS per thirty (30) days. Code A9999 is all-inclusive;
when used to bill for adjunctive CGM supplies and accessories it includes, but
is not limited to, the CGM sensor, CGM transmitter and insertion devices. When
submitting a claim for A9999, suppliers must enter "adjunctive" in loop 2300
(claim note) and/or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI
X12N, version 5010A1 professional electronic claim format or in Item 19 of the
paper claim form, so that the items can be identified as adjunctive CGM
supplies and accessories when processing the claim.

For claims with dates of service on or after April 1, 2022, insulin infusion
pumps with integrated adjunctive continuous glucose monitor receiver
functionality must be coded using HCPCS codes E0784 (EXTERNAL AMBULATORY
INFUSION PUMP, INSULIN) and E2102 (ADJUNCTIVE, NON-IMPLANTED CONTINUOUS
GLUCOSE MONITOR OR RECEIVER). The related accessories/supplies for these
integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR
MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR
EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and
A4238 (SUPPLY ALLOWANCE FOR ADJUNCTIVE, NON-IMPLANTED CONTINUOUS GLUCOSE
MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT
OF SERVICE).

Please refer to the Glucose Monitors LCD-related Policy Article (A52464) for
more information regarding coding guidelines for continuous glucose monitors.

Codes A4230 (INFUSION SET FOR EXTERNAL INSULIN PUMP, NON-NEEDLE CANNULAS TYPE)
and A4231 (INFUSION SET FOR EXTERNAL INSULIN PUMP, NEEDLE TYPE) are not valid
for claim submission to the DME MAC because they are included in code A4224.

Use A4223 for infusion supplies not used with a covered external infusion
pump.

Drugs used in a durable external infusion pump must be coded using the
appropriate HCPCS codes. If the drug does not have a distinct code, then use
the unclassified drug code J7799. Do not use code J9999 - this code is not
valid for claims billed to the DME MAC.

An infusion drug not administered using a durable infusion pump must be billed
using the appropriate HCPCS code plus the GY modifier. If the drug does not
have a unique code, use the unclassified drug code, J3490.

Use code J2274 only for morphine sulfate that is labeled "preservative free."
Morphine sulfate that is not labeled "preservative free" must be coded J2270.

Use code J1811, J1813 or J1817 for insulin administered through an external
insulin pump (E0784).

Codes A4602, K0604 and K0605 describe lithium batteries commonly used in
external infusion pumps. Note that each code has an associated voltage. Claims
for lithium batteries for external insulin infusion pumps (E0784) that do not
use a voltage described by either code A4602, K0604 and K0605 must be billed
using code A9999.

Levodopa-Carbidopa enteral suspension is supplied as a single-use cassette.
One unit of service contains 2000 mg levodopa and 500 mg carbidopa in 100 mL
of enteral suspension.

Claims for levodopa-carbidopa for dates of service on or after January 09,
2015 through December 31, 2015, must be submitted using the DME miscellaneous
code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).

Claims for levodopa-carbidopa for dates of service on or after January 01,
2016 must be submitted using the HCPCS code J7340 (CARBIDOPA 5 MG/LEVODOPA 20
MG ENTERAL SUSPENSION, 100 ML).

One unit of service (UOS) of blinatumomab (J9039) equals one (1) microgram
(mcg), and thus, 1 vial equals 35 UOS. Reconstituted blinatumomab must be
prepared using the combination of vials that result in the least amount of
wastage for the dosage amount being administered. There are two alternative
infusion protocols that can be used. For each protocol, the following apply:

  * For beneficiaries using a 2-day infusion protocol, five (5) vials (175 UOS) should be used to reconstitute three bags, each containing 56 mcg (56 UOS) of blinatumomab, which can be refrigerated (2C to 8C), and used within six-days.
  * For beneficiaries utilizing a 7-day infusion protocol, six (6) vials (210 UOS) should be used to reconstitute one bag (containing 210 mcg of blinatumomab), which is infused over 7 days.

Claims for blinatumomab for dates of service on or after December 03, 2014
through December 31, 2015, must be submitted using the DME miscellaneous code
J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).

Claims for blinatumomab for dates of service on or after January 01, 2016,
must be submitted using the HCPCS code J9039 (INJECTION, BLINATUMOMAB, 1
MICROGRAM).

HYQVIA is administered subcutaneously through an E0781 pump that is pre-
programmed, and the E0781 pump must be delivered to the Medicare beneficiary
in a "locked mode" (i.e., the patient is unable to self-adjust the infusion
rate).

Claims for HYQVIA for dates of service on or after September 12, 2015 through
December 31, 2015, must be submitted using the DME miscellaneous code J7799
(NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).

Claims for HYQVIA for dates of service on or after January 01, 2016 must be
submitted using the HCPCS code J1575 (INJECTION, IMMUNE
GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN).

Code J7999 (COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED) must be used for any
compounded drugs administered using an external infusion pump for dates of
service on or after January 01, 2016.

When Q9977 or J7999 is billed for a compounded drug, the claim must be
accompanied by the standard written order information, and a clear statement
of the amount dispensed.

Claims for CUVITRU for dates of service on or before December 31, 2017 must be
submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS,
ADMINISTERED THROUGH DME). One UOS equals one hundred (100) milligrams (mg).

Claims for CUVITRU for dates of service on or after January 01, 2018 must be
submitted using HCPCS code J1555 (INJECTION, IMMUNE GLOBULIN (CUVITRU), 100
MG). One UOS equals one hundred (100) mg.

Claims for Xembify for dates of service on or after July 3, 2019 through June
30, 2020 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN
INHALATION DRUGS, ADMINISTERED THROUGH DME). One UOS equals one hundred (100)
mg. Claims for Xembify for dates of service on or after July 1, 2020 must be
submitted using the HCPCS code J1558 (INJECTION, IMMUNE GLOBULIN (XEMBIFY),
100 MG).

Claims for Cutaquig for dates of service on or after December 12, 2018 through
June 30, 2022 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER
THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). One UOS equals one hundred
(100) mg. Claims for Cutaquig for dates of service on or after July 1, 2022
must be submitted using HCPCS code J1551 (INJECTION, IMMUNE GLOBULIN
(CUTAQUIG), 100 MG).

Claims for Hizentra for beneficiaries with CIDP for dates of service on or
after July 18, 2021 must be submitted using the HCPCS code J1559 (INJECTION,
IMMUNE GLOBULIN (HIZENTRA), 100 MG). One UOS equals one hundred (100) mg.

Specific infusion pump HCPCS codes are used with specific SCIg preparations
according to the table below.

**Infusion Pump** | **SCIg Preparation**  
---|---  
E0779 | J1555, J1559, J1561, J1562, J1569  
E0781 | J1575  
E0779 or E0781 | J1551, J1558  
  
**  
Professional Services**

Professional services include nursing services, training and education (not
otherwise paid for as durable medical equipment), remote monitoring, and
monitoring services for the provision of home infusion therapy furnished by a
qualified home infusion supplier with administration of certain transitional
home infusion drugs administered through an item of DME.

For claims with dates of service on or after January 01, 2019 through December
31, 2020, codes G0068, G0069, and G0070 are used to bill for the professional
services rendered on the applicable infusion drug administration calendar day
for each payment category. Providers should report visit length in 15-minute
increments (15 minutes = 1unit). Suppliers must ensure that the appropriate
drug associated with the visit is billed with the visit or no more than 30
days prior to the visit.

In the event that multiple visits occur on the same date of service, suppliers
must only bill for one visit and should report the highest paying visit with
the applicable drug. Claims reporting multiple visits on the same line item
date of service will be returned as unprocessable.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
Contractor for guidance on the correct coding of these items.