CMS Pub. 100-04, ch. 32, § 411.6

MCS shall create a new edit to identify when there is more than one of the following six HCPCS ‘G0068’,

‘G0069’ ‘G0070’, ‘G0088’, ‘G0089’, or ‘G0090’ with Date of Service on or after 1/1/2021 for the same

Date of Service on the same Part B Professional claim.

CWF shall create a new reject for a Part B Professional claim with one of the following six HCPCS codes

‘G0068’, ‘G0069’ ‘G0070’, ‘G0088’, ‘G0089’, or ‘G0090’ with Date of Service on or after 1/1/2021 and

there is no DME claim in history with one of the identified J-codes within 30 days prior to the incoming

Date of Service.

NOTE: This edit shall have override capability at the claim detail line

CWF and contractors shall recycle ‘G0068’, ‘G0069’ ‘G0070’, ‘G0088’, ‘G0089’, or ‘G0090’ claim up to

three times for a total of 15 days until a claim containing an allowable drug J-code from above is received

with the same line item date of service or within 30 days prior to the line item date of service of the G-code.

CWF shall create a new reject for a Part B Professional claim with one of the following six ‘G0068’,

‘G0069’ ‘G0070’, ‘G0088’, ‘G0089’, or ‘G0090’ codes with a Date of Service on or after 1/1/2021 when

there is a Part B claim in history with one of the identified six ‘G0068’, ‘G0069’ ‘G0070’, ‘G0088’,

‘G0089’, or ‘G0090’ codes for the same Date of Service.

NOTE: This edit shall have override capability at the claim detail line

CWF shall create a new reject for a Part B Professional claim with one of the new ‘G0088’, ‘G0089’, or

‘G0090’ codes and in history is an allowed DME or Part B Professional claim with any of the six ‘G0068’,

‘G0069’ ‘G0070’, ‘G0088’, ‘G0089’, or ‘G0090’ codes and the Dates of Service is within 60 days prior to

the incoming claim’s Dates of Service. The incoming claim has Dates of Service on or after 1/1/2021.

CWF should still subject an incoming Part B Professional claim to the edit if it is within 60 days of posted

DME claim, and if the claim in history is DME and has one of the three existing ‘G0068’, ‘G0069’ ‘G0070’

codes and has Dates of Service prior to 1/1/2021.

CWF shall create a new Informational Unsolicited Response (IUR) when a Part B Professional claim or a

DME claim with one of the six ‘G0068’, ‘G0069’ ‘G0070’, ‘G0088’, ‘G0089’, or ‘G0090’ codes is

received and in history is a Part B Professional claim with one of the three new ‘G0088’, ‘G0089’, or

‘G0090’ codes with Dates of Service within 60 days after the incoming claim’s Dates of Service.

CWF shall ensure that all new edits and the IUR appear on the ORPN Report.

412 – Monoclonal Antibodies Directed Against Amyloid for the Treatment of

Alzheimer’s Disease (AD) Policy and Overview

(Rev. 12649; Issued: 05-23-2024; Effective: 04-07-22) Implementation: 06-24-24)

Effective April 7, 2022, CMS covers Food and Drug Administration (FDA)-approved monoclonal

antibodies directed against amyloid for the treatment of Alzheimer’s Disease (AD) when furnished in

accordance with the coverage criteria below, under coverage with evidence development (CED) for patients

who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both

with confirmed presence of amyloid beta pathology consistent with AD. For further information related to

coverage, refer to Publication 100-03, National Coverage Determination (NCD) Section 200.3

412.1 - Coding Information

(Rev. 12649; Issued: 05-23-2024; Effective: 04-07-22) Implementation: 06-24-24)

- ICD-10 diagnosis code Z00.6, along with one of the following additional diagnosis codes: G30.0,

G30.1, G30.8, G30.9, G31.84, the Q0 or Q1 modifier, and condition code 30 (for institutional claims

only).

- Procedure code HCPCS J0174, Injection, lecanemab-irmb, 1 mg, (Leqembi®), OR,

- Procedure code HCPCS J3490 or J3590 or C9399 (for an FDA-approved therapy that is covered under

NCD 200.3 that hasn’t received a dedicated HCPCS code), OR,

- Dedicated HCPCS code for any future FDA-approved therapies covered under NCD 200.3 (a

subsequent instruction would follow),

- National Clinical Trial (NCT) number consisting of 8 digits, OR,

- Default NCT number 99999999.

412.2 - Claims Processing Instructions

(Rev. 12649; Issued: 05-23-2024; Effective: 04-07-22) Implementation: 06-24-24)

Effective for claims with dates of service on or after April 7, 2022, contractors shall accept and pay for

claims for monoclonal antibodies for the treatment of AD with an appropriate HCPCS, along with one of

the diagnosis codes listed in Section 412.1 and condition code 30 (institutional claims only).

The following bill types are applicable for claims for monoclonal antibodies for the treatment of AD:

- 012X, 013X, or 085X.

412.3 - Messaging

(Rev. 12649; Issued: 05-23-2024; Effective: 04-07-22) Implementation: 06-24-24)

--Contractors shall return to provider/return as unprocessable any monoclonal antibody claims that do not

include an NCT number as indicated in 412.1 and use the following messages:

CARC 16 - Claim/service lacks information or has submission/billing error(s).

RARC MA50 – Missing/incomplete/invalid Investigational Device Exemption number or Clinical Trial

number

Group Code: CO

---Contractors shall deny any monoclonal antibody claims that do not have the specified diagnosis codes

listed in 412.1 and use the following messages:

MSN 15.20 - “The following polices were used when we made this decision: NCD 200.3.”

Spanish Version – “Las siguientes políticas fueron utilizadas cuando se tomó esta decisión: NCD 200.3.”

NOTE: Due to system requirement, the Fiscal Intermediary Shared System (FISS) has combined messages

15.19 and 15.20 so that, when used for the same line item, both messages will appear on the same MSN.

CARC 96 – Non-covered charge(s). At least one Remark Code must be provided (May be comprised of

either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT).

RARC N386 – This decision was based on a National Coverage Determination (NCD). An NCD provides

a coverage determination as to whether a particular item or service is covered.

Group Code - CO or PR

---Contractors shall return to provider/return as unprocessable any monoclonal antibody claims that do not

have the specified modifiers listed in Section 412.1 and use the following messages:

CARC 16 - Claim/service lacks information or has submission/billing error(s).

RARC N823 – Incomplete/invalid Procedure Modifier(s).

Group Code: CO

--Contractors shall deny claims from any bill type other than those listed 412.1 and use the following

messages:

MSN 9.4 - This item or service was denied because information required to make payment was incorrect.

Spanish Version: Este servicio fue denegado debido a que la información requerida para hacer el pago fue

incorrecta.

CARC 16 - Claim/service lacks information or has submission/billing error(s).

RARC MA30 - Missing/incomplete/invalid type of bill.

Group Code: CO