Commercial

Medical Policy

Notification

Reimbursement for Radiopharmaceutical Agents

Notification Issue Date:

This version of the policy will become effective 9/02/2024. This policy has been updated to address the changes in reimbursement for radiopharmaceutical agents based on revisions to the Center for Medicaid and Medicare's Outpatient Prospective Payment System.

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

A9591 and A9592

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

Title:

Reimbursement for Radiopharmaceutical Agents

Policy #:

09.00.32al

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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, radiopharmaceutical agents are covered under the medical benefits of the Company's 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 Services (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.

Company Benefit Contracts.

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 ONLY USED FOR POSITRON EMISSION TOMOGRAPHY (PET) SCANS

ELIGIBLE FOR REIMBURSEMENT


A9515	Choline C-11, diagnostic, per study dose up to 20 mCi
A9586	Florbetapir F18, diagnostic, per study dose, up to 10 mCi
A9587	Gallium Ga-68, dotatate, diagnostic, 0.1 mCi
A9588	Fluciclovine 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, diagnostic, (ucla), 1 millicurie
A9595	Piflufolastat f-18, diagnostic, 1 millicurie
A9596	Gallium ga-68 gozetotide, diagnostic, (illuccix), 1 millicurie
A9601	Flortaucipir f 18 injection, diagnostic, 1 millicurie
A9602	Fluorodopa f-18, diagnostic, per millicurie
A9608	Flotufolastat f 18, diagnostic, 1 millicurie
A9611	Flurpiridaz f 18, diagnostic, 1 millicurie
A9616	Gallium ga-68 gozetotide (gozellix), diagnostic, 1 millicurie
A9800	Gallium ga-68 gozetotide, diagnostic, (locametz), 1 millicurie
Q9982	Flutemetamol F18, diagnostic, per study dose, up to 5 mCi
Q9983	Florbetaben F18, diagnostic, per study dose, up to 8.1 mCi

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

A9526	Nitrogen N-13 ammonia, diagnostic, per study dose, up to 40 mCi
A9552	Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 mCi
A9555	Rubidium Rb-82, diagnostic, per study dose, up to 60 mCi
A9580	Sodium fluoride F-18, diagnostic, per study dose, up to 30 mCi
A9590	Iodine I-131, iobenguane, 1 mCi
A9597	Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified
A9598	Positron emission tomography radiopharmaceutical, diagnostic, for nontumor identification, not otherwise classified
A9609	Fludeoxyglucose f18 up to 15 millicuries

RADIOPHARMACEUTICAL AGENTS FOR USES/MODALITIES OTHER THAN POSITRON EMISSION TOMOGRAPHY (PET) SCANS

ELIGIBLE FOR REIMBURSEMENT TO PROFESSIONAL PROVIDERS

A4642	Indium In-111 satumomab pendetide, diagnostic, per study dose, up to 6 mCi
A9500	Technetium Tc-99m sestamibi, diagnostic, per study dose
A9501	Technetium Tc-99m teboroxime, diagnostic, per study dose
A9502	Technetium Tc-99m tetrofosmin, diagnostic, per study dose
A9503	Technetium Tc-99m medronate, diagnostic, per study dose, up to 30 mCi
A9504	Technetium Tc-99m apcitide, diagnostic, per study dose, up to 20 mCi
A9505	Thallium Tl-201 thallous chloride, diagnostic, per mCi
A9507	Indium In-111 capromab pendetide, diagnostic, per study dose, up to 10 millicuries
A9508	Iodine I-131 iobenguane sulfate, diagnostic, per 0.5 mCi
A9509	Iodine I-123 sodium iodide, diagnostic, per mCi
A9510	Technetium Tc-99m disofenin, diagnostic, per study dose, up to 15 mCi
A9512	Technetium Tc-99m pertechnetate, diagnostic, per mCi
A9516	Iodine I-123 sodium iodide, diagnostic, per 100 mcCi, up to 999 mcCi
A9517	Iodine I-131 sodium iodide capsule(s), therapeutic, per mCi
A9520	Technetium Tc-99m, tilmanocept, diagnostic, up to 0.5 mCi
A9521	Technetium Tc-99m exametazime, diagnostic, per study dose, up to 25 mCi
A9524	Iodine I-131 iodinated serum albumin, diagnostic, per 5 mcCi
A9527	Iodine I-125, sodium iodide solution, therapeutic, per mCi
A9528	Iodine I-131 sodium iodide capsule(s), diagnostic, per mCi
A9529	Iodine I-131 sodium iodide solution, diagnostic, per mCi
A9530	Iodine I-131 sodium iodide solution, therapeutic, per mCi
A9531	Iodine I-131 sodium iodide, diagnostic, per mcCi (up to 100 mcCi)
A9532	Iodine I-125 serum albumin, diagnostic, per 5 mcCi
A9536	Technetium Tc-99m depreotide, diagnostic, per study dose, up to 35 mCi
A9537	Technetium Tc-99m mebrofenin, diagnostic, per study dose, up to 15 mCi
A9538	Technetium Tc-99m pyrophosphate, diagnostic, per study dose, up to 25 mCi
A9539	Technetium Tc-99m pentetate, diagnostic, per study dose, up to 25 mCi
A9540	Technetium Tc-99m macroaggregated albumin, diagnostic, per study dose, up to 10 mCi
A9541	Technetium Tc-99m sulfur colloid, diagnostic, per study dose, up to 20 mCi
A9542	Indium In-111 ibritumomab tiuxetan, diagnostic, per study dose, up to 5 mCi
A9543	Yttrium Y-90 ibritumomab tiuxetan, therapeutic, per treatment dose, up to 40 mCi
A9546	Cobalt Co-57/58, cyanocobalamin, diagnostic, per study dose, up to 1 mcCi
A9547	Indium In-111 oxyquinoline, diagnostic, per 0.5 mCi
A9548	Indium In-111 pentetate, diagnostic, per 0.5 mCi
A9550	Technetium Tc-99m sodium gluceptate, diagnostic, per study dose, up to 25 mCi
A9551	Technetium Tc-99m succimer, diagnostic, per study dose, up to 10 mCi
A9553	Chromium Cr-51 sodium chromate, diagnostic, per study dose, up to 250 mcCi
A9554	Iodine I-125 sodium iothalamate, diagnostic, per study dose, up to 10 mcCi
A9556	Gallium Ga-67 citrate, diagnostic, per mCi
A9557	Technetium Tc-99m bicisate, diagnostic, per study dose, up to 25 mCi
A9558	Xenon Xe-133 gas, diagnostic, per 10 mCi
A9559	Cobalt Co-57 cyanocobalamin, oral, diagnostic, per study dose, up to 1 mcCi
A9560	Technetium Tc-99m labeled red blood cells, diagnostic, per study dose, up to 30 mCi
A9561	Technetium Tc-99m oxidronate, diagnostic, per study dose, up to 30 mCi
A9562	Technetium Tc-99m mertiatide, diagnostic, per study dose, up to 15 mCi
A9563	Sodium phosphate P-32, therapeutic, per mCi
A9564	Chromic phosphate P-32 suspension, therapeutic, per mCi
A9566	Technetium Tc-99m fanolesomab, diagnostic, per study dose, up to 25 mCi
A9567	Technetium Tc-99m pentetate, diagnostic, aerosol, per study dose, up to 75 mCi
A9568	Technetium Tc-99m arcitumomab, diagnostic, per study dose, up to 45 mCi
A9569	Technetium Tc-99m exametazime labeled autologous white blood cells, diagnostic, per study dose
A9570	Indium In-111 labeled autologous white blood cells, diagnostic, per study dose
A9571	Indium In-111 labeled autologous platelets, diagnostic, per study dose
A9572	Indium In-111 pentetreotide, diagnostic, per study dose, up to 6 mCi
A9582	Iodine I-123 iobenguane, diagnostic, per study dose, up to 15 mCi
A9584	Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 mCi
A9600	Strontium Sr-89 chloride, therapeutic, per mCi
A9603	Injection, pafolacianine, 0.1 mg
A9604	Samarium Sm-153 lexidronam, therapeutic, per treatment dose, up to 150 mCi
A9606	Radium RA-223 dichloride, therapeutic, per mcCi
A9607	Lutetium lu 177 vipivotide 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

A4641	Radiopharmaceutical, diagnostic, not otherwise classified
A9699	Radiopharmaceutical, therapeutic, not otherwise classified

Revenue Code Number(s)

0343 Diagnostic Radiopharmaceuticals

0344 Therapeutic Radiopharmaceuticals

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 09.00.32al:

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 09.00.32ak:

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 09.00.32aj:

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 09.00.32ai:

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 09.00.32ah:

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 09.00.32ag:

12/16/2024

This 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 Medicare & Medicaid Services' Outpatient Prospective Payment System.

Revisions From 09.00.32af:

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 09.00.32ae:

01/02/2024

This policy has been identified and updated for the CPT/HCPCS code update effective 01/02/2024.

HCPCS codes A9608 and A9609 have been added to the policy.

Revisions From 09.00.32ad:

10/01/2023

This 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 09.00.32ac:

12/19/2022

This 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 09.00.32ab:

10/01/2022

This 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 09.00.32aa:

07/01/2022

This 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 09.00.32z:

01/01/2022

This 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 09.00.32y:

08/16/2021

This 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 09.00.32x:

07/01/2021

This 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 09.00.32w:

04/01/2021

This 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 09.00.32v:

01/01/2021

This 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 09.00.32u:

12/02/2019

This 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 09.00.32t:

09/24/2018

This policy will be effective 09/24/2018. This policy has undergone a routine review, the coverage position remains unchanged. Policy language was revised to clarify the Professional Provider and Facility reimbursement.

Revisions From 09.00.32s:

01/01/2018

This policy has been identified for the CPT code update.

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

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

1/1/2026

Version Issued Date:

2/3/2026

Version Reissued Date: