CMS Pub. 100-04, ch. 13, § 60.14

Indications

(Rev. 527, Issued: 04-15-05, Effective: 01-28-05, Implementation: 04-18-05)

For services performed on or after January 28, 2005, contractors shall accept claims with

the following HCPCS code for non-covered PET indications:

- G0235: PET imaging, any site not otherwise specified

Short Descriptor: PET not otherwise specified

Type of Service: 4

NOTE: This code is for a non-covered service.

60.15 - Billing Requirements for CMS - Approved Clinical Trials and

Coverage With Evidence Development Claims for PET Scans for

Neurodegenerative Diseases, Previously Specified Cancer Indications,

and All Other Cancer Indications Not Previously Specified

(Rev. 3227, Issued: 04-02-15, Effective; ASC-X12: January 1, 2012 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid

Tumors: June 11, 2013, ICD-10: Upon Implementation of ICD-10

Implementation: ASC X12: November 10, 2014 Fluorodeoxyglucose (FDG) Positron

Emission Tomography (PET) for Solid Tumors: May 19, 2014 - MAC Non-Shared

System Edits; July 7, 2014 - CWF development/testing, FISS requirement

development; October 6, 2014 - CWF, FISS, MCS Shared System Edits), ICD-10:

Upon Implementation of ICD-10)

A/B MACs (A and B)

Effective for services on or after January 28, 2005, contractors shall accept and pay for

claims for Positron Emission Tomography (PET) scans for lung cancer, esophageal

cancer, colorectal cancer, lymphoma, melanoma, head & neck cancer, breast cancer,

thyroid cancer, soft tissue sarcoma, brain cancer, ovarian cancer, pancreatic cancer, small

cell lung cancer, and testicular cancer, as well as for neurodegenerative diseases and all

other cancer indications not previously mentioned in this chapter, if these scans were

performed as part of a Centers for Medicare & Medicaid (CMS)-approved clinical trial.

(See Pub. 100-03, National Coverage Determinations (NCD) Manual, sections 220.6.13

and 220.6.17.)

Contractors shall also be aware that PET scans for all cancers not previously specified at

Pub. 100-03, NCD Manual, section 220.6.17, remain nationally non-covered unless

performed in conjunction with a CMS-approved clinical trial.

Effective for dates of service on or after June 11, 2013, Medicare has ended the coverage

with evidence development (CED) requirement for FDG (2-[F18] fluoro-2-deoxy-D-

glucose) PET and PET/computed tomography (CT) and PET/magnetic resonance

imaging (MRI) for all oncologic indications contained in section 220.6.17 of the NCD

Manual. Modifier -Q0 (Investigational clinical service provided in a clinical research

study that is in an approved clinical research study) or -Q1 (routine clinical service

provided in a clinical research study that is in an approved clinical research study) is no

longer mandatory for these services when performed on or after June 11, 2013.

A/B MACs (B) Only

A/B MACs (B) shall pay claims for PET scans for beneficiaries participating in a CMS-approved clinical trial submitted with an appropriate current procedural terminology

(CPT) code from section 60.3.1 of this chapter and modifier Q0/Q1 for services

performed on or after January 1, 2008, through June 10, 2013. (NOTE: Modifier QR

(Item or service provided in a Medicare specified study) and QA (FDA investigational

device exemption) were replaced by modifier Q0 effective January 1, 2008.) Modifier

QV (item or service provided as routine care in a Medicare qualifying clinical trial) was

replaced by modifier Q1 effective January 1, 2008.) Beginning with services performed

on or after June 11, 2013, modifier Q0/Q1 is no longer required for PET FDG services.

A/B MACs (A) Only

In order to pay claims for PET scans on behalf of beneficiaries participating in a CMS-approved clinical trial, A/B MACs (A) require providers to submit claims with, if ICD-9-

CM is applicable, ICD-9 code V70.7; if ICD-10-CM is applicable, ICD-10 code Z00.6 in

the primary/secondary diagnosis position using the ASC X12 837 institutional claim

format or on Form CMS-1450, with the appropriate principal diagnosis code and an

appropriate CPT code from section 60.3.1. Effective for PET scan claims for dates of

service on or after January 28, 2005, through December 31, 2007, A/B MACs (A) shall

accept claims with the QR, QV, or QA modifier on other than inpatient claims. Effective

for services on or after January 1, 2008, through June 10, 2013, modifier Q0 replaced the-

QR and QA modifier, modifier Q1 replaced the QV modifier. Modifier Q0/Q1 is no

longer required for services performed on or after June 11, 2013.