CMS Pub. 100-04, ch. 13, § 60.3.2

An applicable tracer/radiopharmaceutical code, along with an applicable Current

Procedural Technology (CPT) code, is necessary for claims processing of any Positron

Emission Tomography (PET) scan services. While there are a number of PET tracers

already billable for a diverse number of medical indications, there have been, and may be

in the future, additional PET indications that might require a new PET tracer. Under

those circumstances, the process to request/approve/implement a new code could be

time- intensive. To help alleviate inordinate spans of time between when a national

coverage determination is made, or when the Food and Drug Administration (FDA)

approves a particular radiopharmaceutical for an oncologic indication already approved

by the Centers for Medicare & Medicaid Services (CMS), and when it can be fully

implemented via valid claims processing, CMS has created two new PET

radiopharmaceutical unclassified tracer codes that can be used temporarily. This time

period would be pending the creation/approval/implementation of permanent CPT codes

that would later specifically define their function by CMS in official instructions.

Effective with dates of service on or after January 1, 2018, the following Healthcare

Common Procedure Coding System (HCPCS) codes shall be used ONLY AS

NECESSARY FOR AN INTERIM PERIOD OF TIME under the circumstances

explained here. Specifically, there are two circumstances that would warrant use of the

CPT Code Description

78814 Tumor imaging, positron emission tomography (PET) with concurrently acquired

computed tomography (CT) for attenuation correction and anatomical localization;

limited area (e.g., chest, head/neck)

78815 Tumor imaging, positron emission tomography (PET) with concurrently acquired

computed tomography (CT) for attenuation correction and anatomical localization;

skull base to mid-thigh

78816 Tumor imaging, positron emission tomography (PET) with concurrently acquired

computed tomography (CT) for attenuation correction and anatomical localization;

whole body

below codes: (1) After FDA approval of a PET oncologic indication, or, (2) after CMS

approves coverage of a new PET indication, and ONLY if either of those situations

requires the use of a dedicated PET radiopharmaceutical/tracer that is currently non-existent. Once permanent replacement codes are officially implemented by CMS, use of

the temporary code for that particular indication will simultaneously be discontinued.

NOTE: The following two codes were effective as of January 1, 2017, with the January

2017 quarterly HCPCS update.

A9597 - Positron emission tomography radiopharmaceutical, diagnostic, for tumor

identification, not otherwise classified

A9598 - Positron emission tomography radiopharmaceutical, diagnostic, for non-tumor

identification, not otherwise classified

Effective for claims with dates of service on and after January 1, 2018, when PET

tracer code A9597 or A9598 are present on a claim, that claim must also include:

-an appropriate PET HCPCS code, either 78429, 78430, 78431, 78432, 78433, 78434, 78459, 78491,

78492, 78608, 78811, 78812, 78813, 78814, 78815, or 78816,

-if tumor-related, either the -PI or -PS modifier as appropriate,

-if clinical trial, registry, or study-related outside of NCD220.6.17, PET for Solid

Tumors, clinical trial modifier –Q0,

-if clinical trial, registry, or study-related, all claims require the 8-digit clinical trial

number,

-if Part A OP and clinical trial, registry, or study-related outside of NCD220.6.17, PET

for Solid Tumors, also include condition code 30 and ICD-10 diagnosis Z00.6.

Effective for claims with dates of service on and after January 1, 2018, A/Medicare

Administrative Contractors (MACs) shall line-item deny, and B/MACs shall line-item

reject, PET claims for A9597 or A9598 that don't include the elements noted above as

appropriate.

Contractors shall use the following messaging when line-item denying (Part A) or line-item rejecting (Part B) PET claims containing HCPCS A9597 or A9598:

Remittance Advice Remark Codes (RARC) N386

Claim Adjustment Reason Code (CARC) 50, 96, and/or 119.

Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a

claim is received with a GZ modifier indicating no signed ABN is on file).

(The above new verbiage will supersede any existing verbiage in chapter 13,

section 60.3.2.)