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External Infusion Pumps - Policy Article

Article A52507 · 41 versions, 2015 to today · last changed 2026-10-01 (R40)

Version 160 of Article A52507: in force by CMS's dates 2026-10-01 onward. The policy text on this page comes from this archived version.

DME MAC jurisdictions
JA · Noridian 16013
CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT
JB · CGS 17013
IL, IN, KY, MI, MN, OH, WI
JC · CGS 18003
AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, PR, SC, TN, TX, VI, VA, WV
JD · Noridian 19003
AK, AS, AZ, CA, GU, HI, ID, IA, KS, MO, MT, NE, NV, ND, MP, OR, SD, UT, WA, WY
source

CMS's Who are the MACs jurisdiction pages (DME facts as of 2025-09-30) name each contractor and its states; the MCD's Contractor Information table on every DME LCD prints the contract numbers. Both read 2026-10-09. Verzi adds the state lookup only.

Codes Verzi's coverage labels map to this document: J1559

CMS's newest revision note (R40, 2026-10-01), quoted

Revision Effective Date: 10/01/2026 CODING GUIDELINES: Added: “An ambulatory infusion pump (E0788) is an electrical or battery-operated device, approved by the FDA to be used with a specific drug (i.e., FDA-approved as a device-drug combination). It is used to deliver solutions containing a parenteral drug under pressure at a regulated flow rate. It is designed to be worn or carried by the beneficiary.” Added: “Code A4228 includes all necessary supplies to maintain a specific device-drug combination, per week.  This includes, but is not limited to, cassettes, syringe reservoirs or bags, diluting solutions, infusion sets, tubing and other administration supplies, port cap changes, compounding charges, and preparation charges.” Revised: The table that describes HCPCS supply codes that are used with different types of external infusion pumps, by adding a row that contains E0788 in the Pump HCPCS Code column, A4228 in the Associated Codes column, and A4221, A4222, A4224, A4225, and K0552 in the Non-Associated Codes column Removed: J7799 billing information for foslevodopa/foscarbidopa injection for continuous subcutaneous infusion (effective for dates of service on or after October 17, 2024 through June 30, 2025) due to being past the timely filing limit for claims Removed: E1399 and A9999 billing information for the VYAFUSER pump and related administration supplies, respectively (effective for dates of service before January 24, 2025) due to being past the timely filing limit for claims Revised: “Claims for the VYAFUSER pump, used to administer foslevodopa/foscarbidopa continuous subcutaneous infusion, for dates of service on or after January 24, 2025 must be submitted using the HCPCS code E0781” to “Claims for the VYAFUSER pump, used to administer foslevodopa/foscarbidopa continuous subcutaneous infusion, for dates of service on or after January 24, 2025 through September 30, 2026 must be submitted using the HCPCS code E0781” Added: Billing information for the VYAFUSER pump for dates of service on or after October 1, 2026 10/08/2026: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
source

This quote comes from CMS's revision-history file, not from the version's own file: Our archived file.

Sections in this version: Article Text. Plus 4 sections marked N/A in this version.

ICD-10-CM Codes that Support Medical Necessity (460 codes)

Group 1: 426 codes. CMS's group paragraph, quoted

The presence of an ICD-10 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on "Coverage Indications, Limitations and/or Medical Necessity" for other coverage criteria and payment information.

For HCPCS codes E0784 and J1811, J1813 or J1817:

Group 2: 1 code. CMS's group paragraph, quoted

For gallium nitrate:

Group 3: 25 codes. CMS's group paragraph, quoted

For primary immune deficiency disorders HCPCS codes J1551, J1555, J1558, J1559, J1561, J1569 and J1575:

Group 4: 4 codes. CMS's group paragraph, quoted

For HCPCS code for J7340 and J7356:

Group 5: 3 codes. CMS's group paragraph, quoted

For HCPCS code for J9039:

Group 6: 1 code. CMS's group paragraph, quoted

For HCPCS codes J1559, J1575 for CIDP:

ICD-10-CM Codes that DO NOT Support Medical Necessity (CMS lists no codes)

Group 1: CMS lists no codes in this group. CMS's group paragraph, quoted

For the specific HCPCS codes indicated above, all ICD-10 codes that are not specified in the previous section.

For all other HCPCS codes, ICD-10 codes are not specified.

CMS's list for version 160. The full code table serves customers with an API key.

source

CMS's ICD-10-CM lists in the Medicare Coverage Database download, archived 2026-10-09: Our archived file.

Full verbatim text serves to customers · Customer? Log in

Version history, Article A52507

CMS numbers each version. Each box shows the version's window by CMS's stated dates. Select a version to show it on this page. Versions superseded the same day they took effect never governed a claim, so the page hides them until you ask. Version numbers CMS never published to its archive do not exist as documents.

Revision history, every version

CMS's own change log, quoted, 40 entries. It does not change with the version shown. A revision (R-number) is a change CMS logged. The version (vN) is the snapshot that carries it.

R40 · 2026-10-01 · v160
Revision Effective Date: 10/01/2026
CODING GUIDELINES:
Added: “An ambulatory infusion pump (E0788) is an electrical or battery-operated device, approved by the FDA to be used with a specific drug (i.e., FDA-approved as a device-drug combination). It is used to deliver solutions containing a parenteral drug under pressure at a regulated flow rate. It is designed to be worn or carried by the beneficiary.”
Added: “Code A4228 includes all necessary supplies to maintain a specific device-drug combination, per week.  This includes, but is not limited to, cassettes, syringe reservoirs or bags, diluting solutions, infusion sets, tubing and other administration supplies, port cap changes, compounding charges, and preparation charges.”
Revised: The table that describes HCPCS supply codes that are used with different types of external infusion pumps, by adding a row that contains E0788 in the Pump HCPCS Code column, A4228 in the Associated Codes column, and A4221, A4222, A4224, A4225, and K0552 in the Non-Associated Codes column
Removed: J7799 billing information for foslevodopa/foscarbidopa injection for continuous subcutaneous infusion (effective for dates of service on or after October 17, 2024 through June 30, 2025) due to being past the timely filing limit for claims
Removed: E1399 and A9999 billing information for the VYAFUSER pump and related administration supplies, respectively (effective for dates of service before January 24, 2025) due to being past the timely filing limit for claims
Revised: “Claims for the VYAFUSER pump, used to administer foslevodopa/foscarbidopa continuous subcutaneous infusion, for dates of service on or after January 24, 2025 must be submitted using the HCPCS code E0781” to “Claims for the VYAFUSER pump, used to administer foslevodopa/foscarbidopa continuous subcutaneous infusion, for dates of service on or after January 24, 2025 through September 30, 2026 must be submitted using the HCPCS code E0781”
Added: Billing information for the VYAFUSER pump for dates of service on or after October 1, 2026


10/08/2026: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R39 · 2026-01-25 · v156
Revision Effective Date: 01/25/2026
MODIFIERS:
Removed: J1562 from JB modifier section
CODING GUIDELINES:
Removed: Past timely filing directions regarding billing for E0784, E1399 (for an adjunctive continuous glucose monitor or receiver), A4224, A4225, and A9999 (for supplies and accessories used in conjunction with an insulin pump, which also performs the functions of an adjunctive continuous glucose monitor or receiver)
Removed: Past timely filing directions regarding billing for levodopa-carbidopa
Clarification
: Alternative infusion protocol information pertaining to beneficiaries using a 3-day infusion protocol and pertaining to beneficiaries using a 4-day infusion protocol is effective for dates of service on or after 12/17/2024 (FDA Approval Date)
Removed: Past timely filing directions regarding billing for the following: blinatumomab, HYQVIA, CUVITRU, Xembify, and Cutaquig
Added: Billing direction for gallium nitrate
Removed: J1562 from SCIg preparations column in the table
PROFESSIONAL SERVICES:
Removed: Past timely filing directions for G0068, G0069, and G0070
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: “For HCPCS code J1457” to “For gallium nitrate” in Group 2 Paragraph
Removed: J1562 from Group 3 Paragraph
02/05/2026: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R38 · 2026-01-25 · v151
Revision Effective Date: 01/25/2026
DME INFORMATION FORM (DIF):
Removed: DME INFORMATION FORM (DIF) section due to timely filing
CODING GUIDELINES:
Revised: “Claims for levodopa-carbidopa” to “Claims for levodopa-carbidopa enteral suspension”
Added: Billing information for foslevodopa/foscarbidopa injection for continuous subcutaneous infusion for October 17, 2024 through June 30, 2025
Added: Billing information for foslevodopa/foscarbidopa injection for continuous subcutaneous infusion for dates of service on or after July 1, 2025
Added: Billing information for Foslevodopa/foscarbidopa injection for continuous subcutaneous infusion
Added: Billing information for the VYAFUSER pump
Revised: “
There are two alternative infusion protocols that can be used
” to “
There are four alternative infusion protocols that can be used
” for blinatumomab
Added: Alternative infusion protocol information pertaining to beneficiaries using a 3-day infusion protocol and pertaining to beneficiaries using a 4-day infusion protocol
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: J7356 to Group 4 Paragraph


12/11/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R37 · 2025-02-19 · v146
Revision Effective Date: 02/19/2025
CODING GUIDELINES:
Added: “Claims for K0552 (SUPPLIES FOR EXTERNAL NON-INSULIN DRUG INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH) are not separately payable if an infusion drug is pre-packaged and supplied in a syringe type cartridge.” as clarification
08/21/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R36 · 2025-02-19 · v143
Revision Effective Date: 02/19/2025
MODIFIERS:
Revised: “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 beneficiary’s caregiver.” to “Effective for claims with dates of service on or after January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers dispensed by the supplier but have no unused and discarded amounts that are self-administered by the beneficiary or the beneficiary’s caregiver.”
Added: “Effective for claims with dates of service on or after January 1, 2025, the JW modifier is also required if a billing supplier is not administering a drug or biological, but there are unused and discarded amounts during the preparation process before supplying the drug or biological to the patient as described in scenario 3 below.”
Revised: “The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or the beneficiary’s 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).” to “The JZ modifier is required for drugs and biologicals that are dispensed by the supplier but have no unused and discarded amounts during the preparation process and are self-administered by the beneficiary or the beneficiary’s caregiver in the beneficiary’s home.”
Revised: “drug” to “drugs” in “Multi-use vials are not subject to payment for discarded amounts of drugs or biologicals.”
Revised: “Below are two scenarios in regard to the JW modifier.” to “Below are three (3) scenarios in regard to the JW and JZ modifiers.”
Added: “claim” to “In this scenario, the JW modifier must be billed on a separate claim line to provide payment for the amount of discarded drug or biological.,” as clarification
Added: “claim” to “The 70 mg dose is billed correctly by rounding up to 1 UOS (representing the entire 100 mg vial) on a single claim line item with the JZ modifier.,” as clarification
Added: “claim” to “The single claim line item of 1 UOS would be processed for payment of the combined total of 100 mg of the administered and discarded amounts.,” as clarification
Added: “claim” to “The discarded 30 mg must not be billed as another 1 UOS on a separate claim line item with the JW modifier.,” as clarification
Added: Scenario 3 billing information and example


05/22/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R35 · 2025-02-19 · v139
Revision Effective Date: 02/19/2025
CODING GUIDELINES:
Added: Single asterisks to A4222 and K0552 in the Associated Codes column of the table for HCPCS supply codes associated with external infusion pumps HCPCS codes
Revised: “*For E0779, E0780, E0781, E0791 and K0455 pumps, either A4222 or K0552 may be billed, but not both” to "*For E0779, E0780, E0781, E0791 and K0455 pumps, either A4222 and/or K0552 may be billed”


03/13/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R34 · 2025-01-23 · v134
Revision Effective Date: 01/23/2025
CODING GUIDELINES:
Revised: Code K0552 to indicate use with HCPCS codes K0455, E0779, E0780, E0781 or E0791 when used to administer a drug utilizing a syringe-type reservoir.
Revised: “The reservoir may be either glass or plastic and includes the needle for drawing up the drug.” to “The reservoir may be either glass or plastic and includes the needle or equivalent for drawing up or transferring the drug to the reservoir.”
Revised: Table in the HCPCS Supply Codes Associated with External Infusion Pumps HCPCS Codes section by removing "K0552" from the Non-Associated Codes column in the rows pertaining to E0780, E0781, and E0791, and by adding "K0552" to the Associated Codes column in the rows pertaining to E0780, E0781, and E0791
Revised: Statement under table “*For E0779 and K0455 pumps, either A4222 or K0552 may be billed, but not both." to "*For E0779, E0780, E0781, E0791 and K0455 pumps, either A4222 or K0552 may be billed, but not both."


01/23/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R33 · 2024-01-12 · v130
Revision Effective Date: 01/12/2024
MODIFIERS:
Added: "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 beneficiary’s caregiver."
Revised: "
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." to "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, 20
24)."
Removed: The JZ modifier from the statement regarding expected rare use
Added: "
As of July 1, 2023, the JZ modifier is required in this situation." to Scenario 2
Added: Information to include the JZ modifier in the billing instructions for the 70 mg dose in Scenario 2


03/14/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R32 · 2024-01-12 · v124
Revision Effective Date: 01/12/2024
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: “J1575” to Group 6 Paragraph


02/08/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R31 · 2023-10-01 · v122
Revision Effective Date: 10/01/2023
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Removed: ICD-10-CM code G20 from Group 4 Codes due to ICD-10-CM code updates
Added: ICD-10-CM codes G20.A1, G20.A2, G20.B1, G20.B2 to Group 4 Codes due to ICD-10-CM code updates


09/21/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R30 · 2023-07-01 · v119
Revision Effective Date: 07/01/2023
CODING GUIDELINES
Revised: Non-associated supply HCPCS codes for E0781 to remove duplicate HCPCS code A4224 and replace with A4225


08/03/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R29 · 2023-07-01 · v117
Revision Effective Date: 07/01/2023
MODIFIERS:
Added: HCPCS codes J1811 and J1813 to the JK and JL modifier instructions to comply with the Inflation Reduction Act insulin coinsurance cap
CODING GUIDELINES:
Added: J1811 and J1813 to instruction for billing insulin administered through an external insulin pump (E0784)
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: HCPCS codes J1811 and J1813 to Group 1 Paragraph


06/22/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R28 · 2023-04-01 · v114
Revision Effective Date: 04/01/2023
MODIFIERS:
Revised: JW and JZ modifier instructions to align with the CMS 2023 Physician Fee Schedule final rule (effective 01/01/2023)


06/15/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R27 · 2023-04-01 · v110
Revision Effective Date: 04/01/2023
MODIFIERS:
Added: JK and JL modifier instructions to comply with the Inflation Reduction Act insulin coinsurance cap


03/30/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R26 · 2023-01-01 · v106
Revision Effective Date: 01/01/2023
MODIFIERS:
Revised: GA, GZ and KX modifier instructions to include external infusion pumps, drugs and supplies submitted on or after March 1, 2023 for dates of service on or after January 1, 2023


01/19/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R25 · 2023-01-01 · v103
Revision Effective Date: 01/01/2023
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Documented use of continuous glucose monitor meets glucose self-testing of at least 4 times per day within criterion IV. C. and D. of the related LCD
MODIFIERS:
Added: JZ modifier instructions
Revised: GA, GY, GZ and KX modifier instructions to include external infusion pumps, drugs and supplies


01/12/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R24 · 2023-01-01 · v99
Revision Effective Date: 01/01/2023
CODING GUIDELINES:
Added: “A4238**, A4239**” to table describing associated codes with pump codes for pump code row E0784
Added: “**For E0784 pumps, either A4238 or A4239 may be billed if used in conjunction with an integrated adjunctive or non-adjunctive CGM, respectively.” after table describing associated codes
Revised: Billing direction dates for HCPCS codes K0554 and K0553
Added: Billing direction for HCPCS codes E2103 and A4239 on or after January 1, 2023
Removed: Language describing “non-therapeutic”
Added: “NON-IMPLANTED” to the description of CGM code E2102 and CGM supply code A4238


12/29/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R23 · 2023-01-01 · v95
Revision Effective Date: 01/01/2023
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Billing information relevant to DIFs, for DOS affected by the DIF elimination


11/17/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R22 · 2022-10-01 · v91
Revision Effective Date: 10/01/2022
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM code D81.82 to Group 3 Codes due to ICD-10-CM code updates


09/22/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R21 · 2022-07-01 · v88
Revision Effective Date: 07/01/2022
MODIFERS:
Revised: J7799 (Cutaquig) to HCPCS code J1551 in JB modifier requirements
CODING GUIDELINES:
Revised: Billing direction dates for Cutaquig under HCPCS code J7799
Added: Billing direction for Cutaquig for HCPCS Code J1551, effective on or after July 1, 2022
Revised: specific SCIg preparations table to list HCPCS J1551, instead of J7799 (Cutaquig)
CODING INFORMATION:
Revised: Cutaquig HCPCS code to J1551 under Group 3


07/28/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R20 · 2022-02-28 · v84
Revision Effective Date: 02/28/2022
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Removed: “The link will be located here once it is available.”
Added: “The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list


04/14/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R19 · 2022-02-28 · v80
Revision Effective Date: 02/28/2022
CODING GUIDELINES:
Added: Billing directions for insulin infusion pumps with integrated adjunctive or non-therapeutic continuous glucose monitor receiver functionality, and supply codes A4224, A4225, and A9999 for dates of service on or before March 31, 2022
Added: Billing directions for HCPCS codes E0784 and E2102 for insulin infusion pumps with integrated adjunctive or non-therapeutic continuous glucose monitor receiver functionality, and supply codes A4224, A4225, and A4238 for dates of service on or after April 1, 2022
CODING INFORMATION:
Removed: ICD-10-CM codes O24.415, O24.425, O24.435 from Group 1 codes


03/24/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R18 · 2021-07-18 · v77
Revision Effective Date: 07/18/2021
MODIFIERS:
Removed: Registered trademark symbol from first use of Cutaquig
CODING GUIDELINES:
Added: Supply codes associated with external infusion pumps HCPCS codes table
Added: Billing instruction for Hizentra for beneficiaries with CIDP using the HCPCS code J1559
Removed: Registered trademark symbol from first use of Xembify
Added: A table to identify which infusion pump is used for which specific SCIg preparations
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Group 3 paragraph to include “primary immune deficiency disorders”
Added: Group 6 listing for HCPCS code J1559, for CIDP


06/03/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R17 · 2020-09-15 · v73
Revision Effective Date: 09/15/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Information related to HCPCS code E0787, which is invalid for Medicare submission for DOS on or after 09/15/2020
MODIFIERS:
Removed: HCPCS code E0787
CODING GUIDELINES:
Removed: Guidelines for HCPCS codes E0787 and A4226
Added: Coding guidelines for insulin infusion pumps with integrated continuous glucose sensing capabilities
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Removed: HCPCS code E0787 from Group 1 Paragraph


09/17/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R16 · 2020-09-06 · v70
Revision Effective Date: 09/06/2020
MODIFIERS:
Added: J1558 and J7799 (Cutaquig) to the JB modifier requirements
CODING GUIDELINES:
Added: Billing instructions for Xembify based on DOS
Added: UOS billing instruction for J7799 (Cutaquig)
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: J1558 and J7799 (Cutaquig) to the Group 3 paragraph
07/23/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R15 · 2020-05-31 · v63
Revision Effective Date: 05/31/2020
 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
 Revised: “physician’s” to “practitioner’s”
 Removed: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO 42 CFR 410.38(g) section
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217):
Added: Section and related information based on Final Rule 1713
 DME INFORMATION FORM (DIF):
 Revised: “physician” to “practitioner”
 MODIFIERS:
Added: J7799 (
Xembify
®
) to the JB modifier requirements
 CODING GUIDELINES:
Revised: 'detailed order' to 'standard written order'
Added: UOS billing instruction for J7799 (Xembify
®
)
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: J7799 (
Xembify
®
) to the Group 3 paragraph
04/16/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R14 · 2020-01-01 · v55
Revision Effective Date: 01/01/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
Added: PDAC approval requirement for HCPCS code E0787
KX, GA, GY and GZ MODIFIERS:
 Added: HCPCS code E0787
 CODING GUIDELINES:
 Added: Coding information for E0787 and A4226
 Added: All-inclusive statement to A4224
 ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
 Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
 Added: E0787 to Group 1
 ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
 Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”


12/19/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R13 · 2019-08-13 · v51
Revision Effective Date: 08/13/2019
ICD-10 CODES THAT ARE COVERED:
Added: Codes D80.2, D80.3, D80.4, D80.6, D80.7, D81.5, D82.1, D82.4, and G11.3 to Group 3 per update to Medicare Benefit Policy Manual, Chapter 15, section 50.6


07/25/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R12 · 2019-01-01 · v47
Revision History Effective Date: 01/01/2019
 CODING GUIDELINES:
 Added: Professional services description
ICD-10 CODES THAT ARE COVERED:
 Added: All diagnosis codes formerly listed in the LCD
 ICD-10 CODES THAT ARE NOT COVERED:
 Added: Notation excluding all unlisted diagnosis codes from coverage


02/14/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
R11 · 2018-01-01 · v41
Revision Effective Date: 01/01/2018
 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
 Added: Clarified claims adjudication of pumps when an infusion is started in the physician’s office


06/07/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.
R10 · 2018-01-01 · v38
Revision Effective Date: 01/01/2018
CODING GUIDELINES:
Added: Treprostinil to K0455
Added: HCPCS code J9039
Updated: Levodopa-Carbidopa UOS
Removed: Coding instructions for HCPCS Q9977 for DOS between July 01, 2015 through December 31, 2015


04/19/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.
R9 · 2017-07-11 · v35
Revision Effective Date: 07/11/2017
 CODING GUIDELINES:
 Revised: Clarified blinatumomab UOS, and added instructions  for a 7-day infusion protocol


Revised: Added HCPCS code J1555 for CUVITRU effective for claims on or after 01/01/2018


11/30/2017: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.
R8 · 2017-01-01 · v29
Revision Effective Date: 01/01/2017
CODING GUIDELINES:
Revised: A4221 descriptor to include subcutaneous infusion catheter
Revised: Typographical error K0522 to correct code of K0552
Added: Coding guidelines for Cuvitru (J7799) - effective 9/13/2016
R7 · 2017-01-01 · v24
Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Replaced: A4221 with A4224 when using catheter insertion devices
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: 42 CFR 410.38(g), DIF and Modifiers requirements
CODING GUIDELINES:
Added: Billing instructions for A4224 and A4225
RELATED LOCAL COVERAGE DOCUMENTS:
Added: The LCD-related Standard Documentation Requirements Language Article
R6 · 2016-07-01 · v16
Revision Effective Date: 07/01/2016
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Language regarding payment rules for infusion drugs started in a physician’s office or hospital outpatient department. – Effective 4/25/2016
R5 · 2016-07-01 · v11
Effective July 1, 2016 oversight for DME MAC Articles 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 Articles.
R4 · 2016-01-01 · v10
Revision Effective Date: 01/01/2016
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Standard Documentation Language to remove start date verbiage from Prescription Requirements (Effective 11/5/2015)
CODING GUIDELINES:
Updated: HCPCS Code Q9977 cross-walked to J7999
Added:  J1575, J7340, J9039 (previously J7799)
Updated: Billing instructions, by HCPCS code, based on dates of service.
R3 · 2015-12-01 · v7
Revision Effective Date: 12/01/2015
Draft Policy Article promoted to final
CODING GUIDELINES:
Added: Q9977 (Compounded drug NOC)
R2 · 2015-10-01 · v5
Revision Effective Date: 01/01/2015 (March 2015 Publication)
CODING GUIDELINES:
Revised: Units of service for blinatumomab
Added: Instructions for least wastage of blinatumomab; inadvertently omitted from previous publication
R1 · 2015-10-01 · v4
Revision Effective Date: 10/01/2015
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: “When required by state law” from ACA new prescription requirements
Revised: Face-to-Face Requirements for treating practitioner
CODING GUIDELINES:
Added: Coding requirements for lithium batteries
Deleted: References to codes J2271 and J2275
Added: Levodopa-Carbidopa enteral suspension (effective for dates of service on or after 01/09/2015)
Added: Blinatumomab (effective for dates of service on or after 12/03/2014)
Receipts for auditors

Version 160 of Article A52507, shown on this page: in force by CMS's dates 2026-10-01 onward. Archived 2026-10-09. CMS's copy · Our archived file. 5 of 5 sections are proven word-identical to the archived file.

Every archived version of Article A52507 (41 versions, CMS's dates, window by the as-of rule).

DocumentVersionIn forceArchived onVerify
Article A52507version 22015-10-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 42015-10-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 52015-10-01 to 2015-11-302026-09-26CMS's copy · Our archived file
Article A52507version 72015-12-01 to 2015-12-312026-09-26CMS's copy · Our archived file
Article A52507version 102016-01-01 to 2016-06-302026-09-26CMS's copy · Our archived file
Article A52507version 112016-07-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 162016-07-01 to 2016-12-312026-09-26CMS's copy · Our archived file
Article A52507version 242017-01-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 292017-01-01 to 2017-07-102026-09-26CMS's copy · Our archived file
Article A52507version 352017-07-11 to 2017-12-312026-09-26CMS's copy · Our archived file
Article A52507version 382018-01-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 412018-01-01 to 2018-12-312026-09-26CMS's copy · Our archived file
Article A52507version 472019-01-01 to 2019-08-122026-09-26CMS's copy · Our archived file
Article A52507version 512019-08-13 to 2019-12-312026-09-26CMS's copy · Our archived file
Article A52507version 552020-01-01 to 2020-05-302026-09-26CMS's copy · Our archived file
Article A52507version 632020-05-31 to 2020-09-052026-09-26CMS's copy · Our archived file
Article A52507version 702020-09-06 to 2020-09-142026-09-26CMS's copy · Our archived file
Article A52507version 732020-09-15 to 2021-07-172026-09-26CMS's copy · Our archived file
Article A52507version 772021-07-18 to 2022-02-272026-09-26CMS's copy · Our archived file
Article A52507version 802022-02-28, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 842022-02-28 to 2022-06-302026-09-26CMS's copy · Our archived file
Article A52507version 882022-07-01 to 2022-09-302026-09-26CMS's copy · Our archived file
Article A52507version 912022-10-01 to 2022-12-312026-09-26CMS's copy · Our archived file
Article A52507version 952023-01-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 992023-01-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 1032023-01-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 1062023-01-01 to 2023-03-312026-09-26CMS's copy · Our archived file
Article A52507version 1102023-04-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 1142023-04-01 to 2023-06-302026-09-26CMS's copy · Our archived file
Article A52507version 1172023-07-01, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 1192023-07-01 to 2023-09-302026-09-26CMS's copy · Our archived file
Article A52507version 1222023-10-01 to 2024-01-112026-09-26CMS's copy · Our archived file
Article A52507version 1242024-01-12, superseded same day2026-09-26CMS's copy · Our archived file
Article A52507version 1302024-01-12 to 2025-01-222026-09-26CMS's copy · Our archived file
Article A52507version 1342025-01-23 to 2025-02-182026-09-26CMS's copy · Our archived file
Article A52507version 1392025-02-19, superseded same day2026-10-09CMS's copy · Our archived file
Article A52507version 1432025-02-19, superseded same day2026-10-09CMS's copy · Our archived file
Article A52507version 1462025-02-19 to 2026-01-242026-10-09CMS's copy · Our archived file
Article A52507version 1512026-01-25, superseded same day2026-10-09CMS's copy · Our archived file
Article A52507version 1562026-01-25 to 2026-09-302026-09-26CMS's copy · Our archived file
Article A52507version 160 shown2026-10-01 to today2026-10-09CMS's copy · Our archived file

The related LCDs each have their own receipts: LCD L33794.

Each archived file's page gives its sha256 fingerprint. A copy of the file hashes to the same value, byte for byte.

CMS's live page shows only the current version. To check a passage by eye, open CMS's copy of the same version number. A version's window ends on the earlier of CMS's stated end date and the day before the next version starts.

Every policy word on this page is CMS's, from the archived version named beside it. Verzi adds labels, highlights, citations and links only. Verzi-written summary content on this page: none.