CMS Pub. 100-04, ch. 18, § 250.3

Effective for claims with dates of service on or after September 30, 2024:

A. Contractors shall accept and pay for PrEP for HIV claims using antiretroviral drugs

(HCPCS J0739, J0799, J0750, or J0751) approved by the US Food and Drug

Administration (FDA) to prevent HIV infection in individuals at increased risk of

HIV acquisition using one of the diagnosis codes listed in 250.2(D).

Contractors shall accept and pay for up to (8) counseling sessions related to PrEP for

HIV medications every 12 months using HCPCS G0011or G0013.

Contractors shall not apply the deductible or co-insurance for PrEP claims for HIV

prevention medications or related services, including counseling, HIV and HBV

screening.

B. Contractors shall pay for code G0011 on 085X TOB claims submitted with revenue

code 96x, 97x, or 98x.

NOTE: Payment is based on 115% of the Medicare Physician Fee Schedule.

C. Contractors shall pay code G0011 on Rural Health Clinics (RHCs) and Federally

Qualified Health Centers (FQHCs) claims. RHCs shall bill G0011 with a -CG

Modifier and payment is at the all-inclusive rate (AIR). FQHCs shall bill G0011

along with the appropriate FQHC specific payment code (G0466 or G0467). Payment

is at the lessor of charges or the FQHC PPS rate. PrEP for HIV Counseling HCPCS

Code G0011 is considered a visit for RHCs and FQHCs when furnished by an RHC

or FQHC Practitioner.

D. Contractors shall accept and pay up to eight HIV screening tests (codes G0432 -

Infectious agent antibody detection by enzyme immunoassay (EIA) technique, HIV-1

and/or HIV-2, screening; G0433 - Infectious agent antibody detection by enzyme-linked immunosorbent assay (ELISA) technique, HIV-1 and/or HIV-2, screening;

G0435 - Infectious agent antibody detection by rapid antibody test, HIV-1 and/or

HIV-2, screening; G0475 - Hiv antigen/antibody, combination assay, screening; or

80081 – Organ Disease Oriented Panel) every 12 months when providing individual

counseling for PrEP for HIV.

E. Contractors shall accept and pay a single Hep B Virus (HBV) screening test (codes

G0499, 87340, 87341, 86704, 86706) for individuals being assessed for or using PrEP

to prevent HIV. This is a once per life-time allowance.

NOTE: A single (one-time) screening for HBV is available under this NCD. NCD

210.6 Screening for Hepatitis B Virus (HBV) Infection is a separate benefit and

continues to apply to eligible beneficiaries

F. Contractors shall only allow payment for supplying fees if billed on the same claim as

the payable covered drug. RHCs and FQHCs do not need to enroll as a Medicare Part

B pharmacy supplier or a DMEPOS pharmacy supplier to bill for PrEP for HIV

drugs.

G. Deductible and coinsurance do not apply.

250.4 Messaging

(Rev. 12987; Issued: 12- 05-24 Effective: 09-30-24; Implementation:04-07-25)

Contractors shall deny the CWF rejected claims for G0011 or G0013 for more than eight

separate LIDOS visit encounter claims within a 12-month period (for both professional

and institutional claims combined) and use the following messages:

CARC 96 - Non-covered charge(s). At least one Remark Code must be provided (may be

comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark

Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification

Segment (loop 2110 Service Payment Information REF), if present.

RARC N640 - Exceeds number/frequency approved/allowed within time period.

Claim Adjustment Group Code - CO (Contractual Obligation) or PR (Patient

Responsibility) dependent upon liability. (Use PR when Occurrence Code 32

(Institutional claim) or the GA modifier (Professional claim) is appended to the line

item).

MSN message: 41.14: This service/item was billed incorrectly. 41.14- Este servicio o

artículo fue facturado incorrectamente.

Contractors shall deny the CWF rejected claim for G0432 ‘G0433’ G0435’ G0475’ or

‘80081’ for more than eight claims with different LIDOS within a 12-month period and

use the following messages:

CARC 96 - Non-covered charge(s). At least one Remark Code must be provided (may be

comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark

Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification

Segment (loop 2110 Service Payment Information REF), if present.

RARC N640 - Exceeds number/frequency approved/allowed within time period.

Claim Adjustment Group Code - CO (Contractual Obligation) or PR (Patient

Responsibility) dependent upon liability. (Use PR when Occurrence Code 32

(Institutional claim) or the GA modifier (Professional claim) is appended to the line

item).

MSN message: 41.14: This service/item was billed incorrectly. 41.14- Este servicio o

artículo fue facturado incorrectamente.

Contractors shall deny the CWF rejected claim if an HBV screening is received with

primary diagnosis code of Z29.81 and no PrEP HIV service have been submitted.

and use the following messages:

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

comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark

Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification

Segment (loop 2110 Service Payment Information REF), if present.

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

Claim Adjustment Group Code - CO (Contractual Obligation) or PR (Patient

Responsibility) dependent upon liability. (Use PR when Occurrence Code 32

(Institutional claim) or the GA modifier (Professional claim) is appended to the line

item).

MSN message: 15.20 The following policies were used when we made this decision:

NCD 210.15

Contractors shall deny the CWF rejected claim when the primary diagnosis code of

Z29.81 is present on the Part B or Outpatient claim and claim has service for HIV or

HBV that should apply to PrEP HIV services and use the following messages:

CARC 96 - Non-covered charge(s). At least one Remark Code must be provided (may be

comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark

Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification

Segment (loop 2110 Service Payment Information REF), if present.

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

Claim Adjustment Group Code - CO (Contractual Obligation) or PR (Patient

Responsibility) dependent upon liability. (Use PR when Occurrence Code 32

(Institutional claim) or the GA modifier (Professional claim) is appended to the line

item).

MSN message: 15.20 The following policies were used when we made this decision:

NCD 210.15

Contractors shall deny claims that contain a pharmacy supplying fees HCPCS code listed

in Section 250.2 and a covered drug for PrEP for HIV HCPCS code listed in Section

250.2 is not present on the same claim using the following messages:

CARC 107: The related or qualifying claim/service was not identified on this

claim.

MSN 17.11: This item or service cannot be paid as billed.

Group Code - CO (Contractual Obligation)

Contractors shall deny the claim if there is an acquisition HCPCS listed in Section 250.2

without a diagnosis code listed in Section 250.2 and use the following messages:

RARC N386 – This decision was based on a National Coverage Determination

(NCD).

CARC 50 – These are non-covered services because this is not deemed a ‘medical

necessity’ by the payer. Usage: Refer to the 835 Healthcare Policy Identification

Segment (loop 2110 Service Payment Information REF), if present.

Claim Adjustment Group Code - CO (Contractual Obligation) or PR (Patient

Responsibility) dependent upon liability. (Use PR when Occurrence Code 32

(Institutional claim) or the GA modifier (Professional claim) is appended to the

line item).

MSN message: 15.20 The following policies were used when we made this

decision: NCD 210.15. Spanish version 15.20 - Las siguientes políticas fueron

utilizadas cuando se tomó esta decisión: NCD-210.15.

Contractors shall deny claims that contain a visit HCPCS (G0011 or G0013) listed

without one of the diagnosis codes in Section 250.2 for PreP for HIV claims and use the

following messages:

RARC N386 – This decision was based on a National Coverage Determination

(NCD).

CARC 50 – These are non-covered services because this is not deemed a ‘medical

necessity’ by the payer. Usage: Refer to the 835 Healthcare Policy Identification

Segment (loop 2110 Service Payment Information REF), if present.

Claim Adjustment Group Code - CO (Contractual Obligation) or PR (Patient

Responsibility) dependent upon liability. (Use PR when Occurrence Code 32

(Institutional claim) or the GA modifier (Professional claim) is appended to the

line item).

MSN message: 15.20 The following policies were used when we made this

decision: NCD 210.15