Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Reimbursement for Radiopharmaceutical Agents for Professional Providers
Policy #:MA09.009j

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage contract.

RADIOPHARMACEUTICAL AGENTS WITH POSITRON EMISSION TOMOGRAPHY (PET) SCANS

Reimbursement for medically necessary radiopharmaceutical agents used in conjunction with PET scans is included in the reimbursement for the associated procedure. Therefore, the radiopharmaceutical agents are not eligible for separate reimbursement.

RADIOPHARMACEUTICAL AGENTS --- OTHER USES

Reimbursement for medically necessary radiopharmaceutical agents other than those used in conjunction with PET scans are eligible for reimbursement as follows:
  • Medically necessary radiopharmaceutical agents purchased by a professional provider and administered in an office setting are eligible for reimbursement.
  • Medically necessary radiopharmaceutical agents administered in a facility setting are not eligible for reimbursement to a professional provider as payment is included in the facility reimbursement.
  • Medically necessary radiopharmaceutical agents administrated by facilities are reimbursed in accordance with the facility contract or agreement.

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, and therapies, as well as 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.
Policy 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.
References

Centers for Medicare and 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. September 12, 2019.

Centers for Medicare and Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 17: Drugs and Biologicals. 90.2: Drugs, Biologicals, and Radiopharmaceuticals. [CMS Web site]. 02/08/19. Available at: https://www.cms.gov/manuals/downloads/clm104c17.pdf. Accessed September 12, 2019.

Centers for Medicare and 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 September 12, 2019.

Novitas Solutions, Inc. Reimbursement Guidelines for Diagnostic Radiopharmaceutical Procedure Codes. 08/27/19. Available at:
https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00024985. Accessed October 15, 2019.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)





Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)




HCPCS Level II Code Number(s)

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

The following radiopharmaceuticals should only be reported when used with PET scans. They are not eligible for separate reimbursement.

A9515Choline C-11, diagnostic, per study dose up to 20 mCi
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
A9586Florbetapir F18, diagnostic, per study dose, up to 10 mCi
A9587Gallium Ga-68, dotatate, diagnostic, 0.1 mCi
A9588Fluciclovine F-18, diagnostic, 1 mCi
A9597Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified
A9598Positron emission tomography radiopharmaceutical, diagnostic, for nontumor identification, not otherwise classified
Q9982Flutemetamol F18, diagnostic, per study dose, up to 5 mCi
Q9983Florbetaben F18, diagnostic, per study dose, up to 8.1 mCi

RADIOPHARMACEUTICAL AGENTS USED WITH PROCEDURES OTHER THAN POSITRON EMISSION TOMOGRAPHY (PET) SCANS

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
A9555Rubidium Rb-82, diagnostic, per study dose, up to 60 mCi
A9556Gallium Ga-67 citrate, diagnostic, per mCi
A9557Technetium Tc-99m bicisate, diagnostic, per study dose, up to 25 mCi
A9558Xenon Xe-133 gas, diagnostic, per 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
A9604Samarium Sm-153 lexidronam, therapeutic, per treatment dose, up to 150 mCi
A9606Radium RA-223 dichloride, therapeutic, per mcCi
Q9969Tc-99m from nonhighly enriched uranium source, 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 MA09.009j
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.




Version Effective Date: 12/02/2019
Version Issued Date: 12/02/2019
Version Reissued Date: N/A