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Reimbursement for Radiopharmaceutical Agents
MA09.009aa

Policy

RADIOPHARMACEUTICAL AGENTS WITH POSITRON EMISSION TOMOGRAPHY (PET) SCANS

The Company covers medically necessary ​​radiopharmaceutical agents used in conjunction with PET scans. However, reimbursement is included in the payment for the associated procedure. Therefore, radiopharmaceutical agents used in conjunction with PET scans are not eligible for separate reimbursement. Participating providers may not bill members for this service.

Radiopharmaceutical agents granted pass-through payment status through the Centers for Medicare & Medicaid Services​​ Outpatient Prospective Payment System (OPPS) may be eligible for separate reimbursement. 
​
​RADIOPHARMACEUTICAL AGENTS FOR OTHER USES/MODALITIES

Medically necessary radiopharmaceutical agents used in conjunction with diagnostic and therapeutic procedures other than PET scans are covered and eligible for reimbursement consideration by the Company when purchased by a professional provider and administered in an office setting.

The Company covers medically necessary radiopharmaceutical agents used in conjunction with diagnostic and therapeutic procedures​ other than PET scans and administered in a facility. Medically necessary radiopharmaceutical agents administered in a facility are reimbursed in accordance with the facility contract or agreement. ​However, radiopharmaceutical agents are not eligible for reimbursement to professional providers​ as payment is included in the facility reimbursement. 

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, ​and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be made available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

Radiopharmaceutical agents not represented by a specific code may be billed with Not Otherwise Classified (NOC) codes A4641 (diagnostic agent) or A9699 (therapeutic agent). When reporting procedure code A4641 or A9699, the provider should report only one unit and include a description of the agent and the actual amount administered.
​
Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.​

Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, radiopharmaceutical agents are covered under the medical benefits of the Company’s Medicare Advantage products.

In geographical areas with a capitated outpatient radiology program, radiopharmaceutical agents are not included in the capitated radiology program and may be eligible for fee-for-service reimbursement when all of the policy requirements are met.

Description

Radiopharmaceutical agents are radioactive chemicals or drugs that have a specific affinity for a particular body tissue or organ. They can be used in conjunction with diagnostic procedures to obtain images of structures. They can also be used in conjunction with therapeutic procedures to treat radiation-sensitive diseases.

The Centers for Medicare & Medicaid Service's (CMS) Outpatient Prospective Payment System (OPPS) typically packages the cost of ancillary services and items into the payment for the primary service. However, at times for new-to-market drugs with relatively high costs, the OPPS provides separate payment through its pass-through system. A drug can receive pass-through status typically for a period of not less than 2 years but not exceeding 3 years.​​

References

Centers for Medicare & Medicaid Services (CMS). Billing and Coding Guidelines for Radiopharmaceutical Agents (RAD-026). 90.2 Drugs, Biologicals, and Radiopharmaceuticals. Coding Radiopharmaceuticals. [CMS Web site]. Available at: http://www.cms.gov/medicare-coverage-database/lcd_attachments/31361_1/L31361_RAD026_CBG_060111.pdf. Accessed April 30, 2024​.

Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 17: Drugs and Biologicals. 90.2: Drugs, Biologicals, and Radiopharmaceuticals. [CMS Web site]. 08/08/20. Available at: https://www.cms.gov/manuals/downloads/clm104c17.pdf. Accessed April 30, 2024.

Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 13: Radiology services and other diagnostic procedures. 110.3: Payment for radiopharmaceuticals. [CMS Web site]. 03/27/19. Available at: https://www.cms.gov/manuals/downloads/clm104c13.pdf. Accessed April 30, 2024.

The Medicare Payment Advisory Commission (MedPAC). Separately payable drugs in the hospital outpatient prospective payment system​. Report to Congress: CMS and HC Deliv Sys.​ June 2020​:163-164. Also available on the MedPAC Web site at: jun20_ch6_reporttocongress_sec.pdf (medpac.gov)​. Accessed April 30, 2024.​

Novitas Solutions, Inc. Reimbursement Guidelines for Diagnostic Radiopharmaceutical Procedure Codes. 06/19/20. Available at:
Provider Specialty: Reimbursement Guidelines for Radiopharmaceutical Procedure Codes (novitas-solutions.com)​. Accessed April 30, 2024.​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)

RADIOPHARMACEUTICAL AGENTS USED ONLY WITH POSITRON EMISSION TOMOGRAPHY (PET) SCANS

ELIGIBLE FOR REIMBURSEMENT
A9515Choline C-11, diagnostic, per study dose up to 20 mCi
A9586Florbetapir F18, diagnostic, per study dose, up to 10 mCi
A9587Gallium Ga-68, dotatate, diagnostic, 0.1 mCi
A9588Fluciclovine F-18, diagnostic, 1 mCi
A9591​Fluoroestradiol f 18, diagnostic, 1 millicurie
​A9592​Copper cu-64, dotatate, diagnostic, 1 millicurie​
​A9593​Gallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie
​A9594​Gallium ga-68 psma-11, di​agnostic, (ucla), 1 millicurie
A9595Piflufolastat f-18, diagnostic, 1 milli​curie
A9596Gallium ga-68 gozetotide, diagnostic, (illuccix), 1 millicurie
​A9601​Flortaucipir f 18 injecti​on, diagnostic, 1 millicurie
A9602Fluorodopa f-18, diagnostic, per millicurie
​A9608​Flotufolastat f 18, diagnostic, 1 millicurie​
​A9611​​Flurpiridaz f 18, diagnostic, 1 millicurie
A9616Gallium ga-68 gozetotide (gozellix), diagnostic, 1 millicurie
A9800Gallium ga-68 gozetotide, diagnostic, (locametz), 1 millicurie
Q9982Flutemetamol F18, diagnostic, per study dose, up to 5 mCi
Q9983Florbetaben F18, diagnostic, per study dose, up to 8.1 mCi​​​​

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT
A9526Nitrogen N-13 ammonia, diagnostic, per study dose, up to 40 mCi
A9552Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 mCi
A9555Rubidium Rb-82, diagnostic, per study dose, up to 60 mCi
A9580Sodium fluoride F-18, diagnostic, per study dose, up to 30 mCi
A9590Iodine I-131, iobenguane, 1 mC​i
A9597Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified
A9598Positron emission tomography radiopharmaceutical, diagnostic, for nontumor identification, not otherwise classified
​A9609Fludeoxyglucose f18 up to 15 millicuries

​RADIOPHARMACEUTICAL AGENTS FOR USES/MODALITIES OTHER THAN POSITRON EMISSION TOMOGRAPHY (PET) SCANS
​ELIGIBLE FOR REIMBURSEMENT TO PROFESSIONAL PROVIDERS

A4642Indium In-111 satumomab pendetide, diagnostic, per study dose, up to 6 mCi​
A9500Technetium Tc-99m sestamibi, diagnostic, per study dose
A9501Technetium Tc-99m teboroxime, diagnostic, per study dose
A9502Technetium Tc-99m tetrofosmin, diagnostic, per study dose
A9503Technetium Tc-99m medronate, diagnostic, per study dose, up to 30 mCi
A9504Technetium Tc-99m apcitide, diagnostic, per study dose, up to 20 mCi
A9505Thallium Tl-201 thallous chloride, diagnostic, per mCi
A9507Indium In-111 capromab pendetide, diagnostic, per study dose, up to 10 millicuries
A9508Iodine I-131 iobenguane sulfate, diagnostic, per 0.5 mCi
A9509Iodine I-123 sodium iodide, diagnostic, per mCi
A9510Technetium Tc-99m disofenin, diagnostic, per study dose, up to 15 mCi
A9512Technetium Tc-99m pertechnetate, diagnostic, per mCi
A9516Iodine I-123 sodium iodide, diagnostic, per 100 mcCi, up to 999 mcCi
A9517Iodine I-131 sodium iodide capsule(s), therapeutic, per mCi
A9520Technetium Tc-99m, tilmanocept, diagnostic, up to 0.5 mCi
A9521Technetium Tc-99m exametazime, diagnostic, per study dose, up to 25 mCi
A9524Iodine I-131 iodinated serum albumin, diagnostic, per 5 mcCi
A9527Iodine I-125, sodium iodide solution, therapeutic, per mCi
A9528Iodine I-131 sodium iodide capsule(s), diagnostic, per mCi
A9529Iodine I-131 sodium iodide solution, diagnostic, per mCi
A9530Iodine I-131 sodium iodide solution, therapeutic, per mCi
A9531Iodine I-131 sodium iodide, diagnostic, per mcCi (up to 100 mcCi)
A9532Iodine I-125 serum albumin, diagnostic, per 5 mcCi
A9536Technetium Tc-99m depreotide, diagnostic, per study dose, up to 35 mCi
A9537Technetium Tc-99m mebrofenin, diagnostic, per study dose, up to 15 mCi
A9538Technetium Tc-99m pyrophosphate, diagnostic, per study dose, up to 25 mCi
A9539Technetium Tc-99m pentetate, diagnostic, per study dose, up to 25 mCi
A9540Technetium Tc-99m macroaggregated albumin, diagnostic, per study dose, up to 10 mCi
A9541Technetium Tc-99m sulfur colloid, diagnostic, per study dose, up to 20 mCi
A9542Indium In-111 ibritumomab tiuxetan, diagnostic, per study dose, up to 5 mCi
A9543Yttrium Y-90 ibritumomab tiuxetan, therapeutic, per treatment dose, up to 40 mCi
A9546Cobalt Co-57/58, cyanocobalamin, diagnostic, per study dose, up to 1 mcCi
A9547Indium In-111 oxyquinoline, diagnostic, per 0.5 mCi
A9548Indium In-111 pentetate, diagnostic, per 0.5 mCi
A9550Technetium Tc-99m sodium gluceptate, diagnostic, per study dose, up to 25 mCi
A9551Technetium Tc-99m succimer, diagnostic, per study dose, up to 10 mCi
A9553Chromium Cr-51 sodium chromate, diagnostic, per study dose, up to 250 mcCi
A9554Iodine I-125 sodium iothalamate, diagnostic, per study dose, up to 10 mcCi
A9556Gallium Ga-67 citrate, diagnostic, per mCi
A9557Technetium Tc-99m bicisate, diagnostic, per study dose, up to 25 mCi
A9558Xenon Xe-133 gas, diagnostic, p​er 10 mCi
A9559Cobalt Co-57 cyanocobalamin, oral, diagnostic, per study dose, up to 1 mcCi
A9560Technetium Tc-99m labeled red blood cells, diagnostic, per study dose, up to 30 mCi
A9561Technetium Tc-99m oxidronate, diagnostic, per study dose, up to 30 mCi
A9562Technetium Tc-99m mertiatide, diagnostic, per study dose, up to 15 mCi
A9563Sodium phosphate P-32, therapeutic, per mCi
A9564Chromic phosphate P-32 suspension, therapeutic, per mCi
A9566Technetium Tc-99m fanolesomab, diagnostic, per study dose, up to 25 mCi
A9567Technetium Tc-99m pentetate, diagnostic, aerosol, per study dose, up to 75 mCi
A9568Technetium Tc-99m arcitumomab, diagnostic, per study dose, up to 45 mCi
A9569Technetium Tc-99m exametazime labeled autologous white blood cells, diagnostic, per study dose
A9570Indium In-111 labeled autologous white blood cells, diagnostic, per study dose
A9571Indium In-111 labeled autologous platelets, diagnostic, per study dose
A9572Indium In-111 pentetreotide, diagnostic, per study dose, up to 6 mCi
A9582Iodine I-123 iobenguane, diagnostic, per study dose, up to 15 mCi
A9584Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 mCi
A9600Strontium Sr-89 chloride, therapeutic, per mCi
​A9603​Injection, pafolacianine, 0.1 mg
A9604Samarium Sm-153 lexidronam, therapeutic, per treatment dose, up to 150 mCi
A9606Radium RA-223 dichloride, therapeutic, per mcCi
​A9607​Lutetium lu 177 vi​pivotide tetraxetan, therapeutic, 1 millicurie
​A9615​Injection, pegulicianine, 1 ​mg​​
​C9176
​Tc-99m from domestically produced non-heu mo-99, [minimum 50 percent], full cost recovery add-on, per study dose

THE FOLLOWING NOT OTHERWISE CLASSIFIED (NOC) CODES SHOULD BE USED TO REPORT THE SUPPLY OF RADIOPHARMACEUTICAL AGENTS WHEN NOT LISTED ABOVE
A4641Radiopharmaceutical, diagnostic, not otherwise classified
A9699Radiopharmaceutical, therapeutic, not otherwise classified​

Revenue Code Number(s)

0343 Diagnostic Radiopharmaceuticals

0344 Therapeutic Radiopharmaceuticals


Coding and Billing Requirements

Policy History

Revisions From​ MA09.009aa:
01/01/2026
​This policy has been identified and updated for the CPT/HCPCS code update effective 1/01/2026.​

Procedure code C9176 has been added to the policy.

Procedure code Q9969 has been deleted from this policy.

Revisions From​ MA09.009z:
10/01/2025
​This policy has been identified and updated for the CPT/HCPCS code update effective 10/01/2025.​

Procedure code A9616 has been added to the policy.

Revisions From​ MA09.009y:
04/01/2025
This version of the policy issued 06/16/2025 with a retroactive effective date of ​04/01/2025.​ The policy is being updated to communicate a revised reimbursement position for HCPCS code A9611.

The reimbursement position for the following HCPCS code has been revised from Not Eligible for Separate Reimbursement to Eligible for Reimbursement:

A9611: Flurpiridaz f 18, diagnostic, 1 millicurie

Revisions From​ MA09.009x:
04/01/2025
This policy has been identified and updated for the CPT/HCPCS code update effective 04/01/2025.​

Procedure code A9611 has been added to the policy.

Revisions From​ MA09.009w:
01/01/2025
This policy has been identified and updated for the CPT/HCPCS code update effective 01/01/2025.​

Procedure code A9615 has been added to the policy.

Procedure code A9590 has been revised from Eligible to Not Eligible for Separate Reimbursement.

The following procedure have been revised from Not Eligible for Separate Reimbursement to Eligible:

A9591, A9592, A9593, A9594, A9515, A9586, A9587, A9588, Q9982, and Q9983

Revisions From ​MA09.009v:
12/16/2024This version of the policy will become effective 12/16/2024​. 

This policy has been updated to clarify the Company's reimbursement coverage for radiopharmaceutical ​​agents granted pass-through payment status by the Centers for Medicaid and Medicare's Outpatient Prospective Payment System.

Revisions From​ MA09.009​u​:
10/01/2024
This policy has been identified and updated for the CPT/HCPCS code update effective 10/01/2024.​
​
The following HCPCS codes have been revised from Eligible to Not Eligible for Separate Reimbursement:
A9591, A9592, A9593, and A9594

HCPCS code A9601 has been revised from Not Eligible for Separate Reimbursement to Eligible​

Revisions From​ MA09.009​t:
01/02/2024This policy has been identified and updated for the CPT/HCPCS code update effective 01/02/2024.​
​
HCPCS code A9608 and A9609 have been added to the policy.​​

Revisions From​ MA09.009s:
​01/01/2024

​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
10/01/2023This policy has been identified and updated for the CPT/HCPCS code update effective 10/01/2023.​
​
HCPCS code A9603 has been added to the policy.​​

Revisions From​ MA09.009r:
12/19/2022This version of the policy will become effective 12/19/2022​. ​The policy has been updated to clarify the reimbursement position for procedure code A9607. 

Revisions From​ MA09.009q:
10/01/2022This policy has been identified and updated for the CPT/HCPCS code update effective 10/01/2022.​
​
HCPCS codes A9602, A9607, and A9800 have been added to the policy.​​

Revisions From​ MA09.009​p:
07/01/2022This policy has been identified and updated for the CPT/HCPCS code update effective 07/01/2022.​
​
HCPCS codes A9596​ and A9601 have been added to the policy.​​

Revisions From​ MA09.009​o:
01/01/2022This policy has been identified and updated for the CPT/HCPCS code update effective 01/01/2022.​
​
HCPCS code A9595 have been added to the policy.​
​
The Company's reimbursement position for following radiopharmaceutical agents used with PET Scans have been have changed from Not Eligible for Separate Reimbursement to eligible:
A9593 and A9594

Revisions From ​MA09.009n:
08​​/16/2021This version of the policy will become effective 08/16/2021. This policy has been updated to address the Company's reimbursement criteria for radiopharmaceutical ​​agents granted payment on the Center for Medicaid and Medicare's Outpatient Prospective Payment System.

The following criteria has been added to the policy:
Separate reimbursement may be considered for radiopharmaceutical agents granted pass-through payment status through the Centers for Medicare and Medicaid Service's Outpatient Prospective Payment System (OPPS)​. ​

HCPCs code A9590​ (eligible) has been added to the policy.​

Revisions From​ MA09.009m:
07/01/2021This policy has been identified and updated for the CPT/HCPCS code update effective 07/01/2021.​
​
Procedure codes A9593 and A9594​ have been added to the policy.​​

Revisions From MA09.009l:
04/01/2021This policy has been identified and updated for the CPT/HCPCS code update effective 04/01/2021.​
​
Procedure code A9592​ was added to the policy.​​

Revisions From MA09.009k:
01/01/2021This policy has been identified and updated for the CPT/HCPCS code update effective 01/01/2021.​
​
Procedure code A9591​ was added to the policy.​

Revisions From MA09.009j:
12/02/2019This version of the policy will become effective 12/02/2019. The policy communicates the Company’s continuing position on Reimbursement for Radiopharmaceutical Agents for Professional Providers. Language was made more concise. The following procedure code was added to the section Radiopharmaceutical Agents Used With Procedures Other Than Positron Emission Tomography (PET) Scans:

A9584 Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 mCi

Revisions From MA09.009i:
09/24/2018This version of the policy will become effective 09/24/2018.

This policy was updated to communicate the Company's continuing coverage position. Policy language was revised to clarify Professional Provider and Facility reimbursement.

Revisions From MA09.009h:
01/01/2018This policy has been identified for the CPT code update.

The following CPT code has been deleted from this policy, effective 12/31/2017: A9599

Revisions From MA09.009g:
01/01/2017This policy has been identified for the CPT code update.

The following CPT codes have been added to this policy, effective 01/01/2017, policy under the DIAGNOSTIC RADIOPHARMACEUTICALS USED WITH PET category as this service is only done with PET, and therefore not eligible for reimbursement.:

A9515, A9587, A9588, A9597, A9598


The following CPT codes has been deleted from this policy, effective 12/31/2016:

A9544, A9545, C9461


The following CPT codes have been revised in this policy, effective 01/01/2017:

FROM:

A9599 radiopharmaceutical, diagnostic, for beta-amyloid positron emission tomography (pet) imaging, per study dose

TO:

A9599 Radiopharmaceutical, diagnostic, for beta-amyloid positron emission tomography (pet) imaging, per study dose, not otherwise specified

Revisions From MA09.009f:
01/01/2017HCPCS code A9584 is being removed from this policy and added to policy #12.01.01ai: Experimental/Investigational Services, effective 01/01/2017.

Revisions From MA09.009e:
07/01/2016This policy has been identified for the HCPCS/CPT code update.

The following HCPCS codes have been removed from this policy, effective 6/30/2016:

C9458: Florbetaben f18, diagnostic, per study dose, up to 8.1 millicuries
C9459: Flutemetamol f18, diagnostic, per study dose, up to 5 millicuries

The following HCPCS codes have been added to this policy, effective 7/1/2016:

Q9982: Flutemetamol F18, diagnostic, per study dose, up to 5 millicuries
Q9983: Florbetaben f18, diagnostic, per study dose, up to 8.1 millicuries

Revisions From MA09.009d:
04/01/2016This policy has been identified for the HCPCS code update, effective 04/01/2016.

The following HCPCS codes have been added to this policy:
C9461: Choline C 11, diagnostic, per study dose

Revisions From MA09.009c:
01/01/2016This policy has been identified for the HCPCS code update, effective 01/01/2016.

The following HCPCS codes have been added to this policy:
C9458: Florbetaben f18, diagnostic, per study dose, up to 8.1 millicuries
C9459: Flutemetamol f18, diagnostic, per study dose, up to 5 millicuries

Revisions From MA09.009b:
12/01/2015Policy # MA09.009b has been identified for a coding change, effective 12/01/2015.

(HCPCS) Service code A9582 (Iodine I-123 Iobenguane, diagnostic, per study dose, up to 15 millicuries) was incorrectly applied as a PET radiopharmaceutical code. The policy was updated to remove service code A9582 from the title: DIAGNOSTIC RADIOPHARMACEUTICALS USED WITH PET and add to the title: DIAGNOSTIC RADIOPHARMACEUTICALS USED FOR NUCLEAR IMAGING PROCEDURES OTHER THAN POSITRON EMISSION TOMOGRAPHY (PET) SCANS.

Revisions From MA09.009a:
03/18/2015The following HCPCS code has been added to the policy under the following categories:

THERAPEUTIC RADIOPHARMACEUTICALS

A9606: Radium ra-223 dichloride, therapeutic, per microcurie

Revisions From MA09.009:
01/01/2015This is a new policy.

1/1/2026
2/3/2026
MA09.009
Claim Payment Policy Bulletin
Medicare Advantage
No
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