CMS Pub. 100-04, ch. 13, § 60.16

Services on or After April 3, 2009

(Rev. 3650, Issued: 11-10-16, Effective: 02-10-17, Implementation: 02-10-17)

A. Summary of Changes

Effective for services on or after April 3, 2009, Medicare will not cover the use of FDG

PET imaging to determine initial treatment strategy in patients with adenocarcinoma of

the prostate.

Medicare will also not cover FDG PET imaging for subsequent treatment strategy for

tumor types other than breast, cervical, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, myeloma, non-small cell lung, and ovarian, unless

the FDG PET is provided under the coverage with evidence development (CED)

paradigm (billed with modifier -Q0/-Q1, see section 60.15 of this chapter).

Medicare will cover FDG PET imaging for initial treatment strategy for myeloma.

Effective for services performed on or after June 11, 2013, Medicare has ended the CED

requirement for FDG PET and PET/CT and PET/MRI for all oncologic indications

contained in section 220.6.17 of the NCD Manual. Effective for services on or after June

11, 2013, the Q0/Q1 modifier is no longer required.

Beginning with services performed on or after June 11, 2013, contractors shall pay for up

to three (3) FDG PET scans when used to guide subsequent management of anti-tumor

treatment strategy (modifier PS) after completion of initial anti-cancer therapy (modifier

PI) for the exact same cancer diagnosis.

Coverage of any additional FDG PET scans (that is, beyond 3) used to guide subsequent

management of anti-tumor treatment strategy after completion of initial anti-tumor

therapy for the same cancer diagnosis will be determined by the A/B MACs (A or B).

Claims will include the KX modifier indicating the coverage criteria is met for coverage

of four or more FDG PET scans for subsequent treatment strategy for the same cancer

diagnosis under this NCD.

A different cancer diagnosis whether submitted with a PI or a PS modifier will begin the

count of one initial and three subsequent FDG PET scans not requiring the KX modifier

and four or more FDG PET scans for subsequent treatment strategy for the same cancer

diagnosis requiring the KX modifier.

NOTE: The presence or absence of an initial treatment strategy claim in a beneficiary’s

record does not impact the frequency criteria for subsequent treatment strategy claims for

the same cancer diagnosis.

NOTE: Providers please refer to the following link for a list of appropriate diagnosis

codes,

http://cms.gov/medicare/coverage/determinationprocess/downloads/petforsolidtumorsonc

ologicdxcodesattachment_NCD220_6_17.pdf

For further information regarding the changes in coverage, refer to Pub.100-03, NCD

Manual, section 220.6.17.

B. Modifiers for PET Scans

Effective for claims with dates of service on or after April 3, 2009, the following

modifiers have been created for use to inform for the initial treatment strategy of

biopsy-proven or strongly suspected tumors or subsequent treatment strategy of

cancerous tumors:

PI Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform

the initial treatment strategy of tumors that are biopsy proven or strongly suspected of

being cancerous based on other diagnostic testing.

Short descriptor: PET tumor init tx strat

PS Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform

the subsequent treatment strategy of cancerous tumors when the beneficiary's treatment

physician determines that the PET study is needed to inform subsequent anti-tumor

strategy.

Short descriptor: PS - PET tumor subsq tx strategy

C. Billing for A/B MACs (A and B)

Effective for claims with dates of service on or after April 3, 2009, contractors shall

accept FDG PET claims billed to inform initial treatment strategy with the following

CPT codes AND modifier PI: 78608, 78811, 78812, 78813, 78814, 78815, 78816.

Effective for claims with dates of service on or after April 3, 2009, contractors shall

accept FDG PET claims with modifier PS for the subsequent treatment strategy for

solid tumors using a CPT code above AND a cancer diagnosis code.

Contractors shall also accept FDG PET claims billed to inform initial treatment

strategy or subsequent treatment strategy when performed under CED with one of the

PET or PET/CT CPT codes above AND modifier PI OR modifier PS AND a cancer

diagnosis code AND modifier Q0/Q1. Effective for services performed on or after June

11, 2013, the CED requirement has ended and modifier Q0/Q1, along with condition

code 30 (institutional claims only), or ICD-9 code V70.7, (both institutional and

practitioner claims) are no longer required.

D. Medicare Summary Notices, Remittance Advice Remark Codes, and Claim

Adjustment Reason Codes

Effective for dates of service on or after April 3, 2009, contractors shall return as

unprocessable/return to provider claims that do not include the PI modifier with one of

the PET/PET/CT CPT codes listed in subsection C. above when billing for the initial

treatment strategy for solid tumors in accordance with Pub.100-03, NCD Manual,

section 220.6.17.

In addition, contractors shall return as unprocessable/return to provider claims that do

not include the PS modifier with one of the CPT codes listed in subsection C. above

when billing for the subsequent treatment strategy for solid tumors in accordance with

Pub.100-03, NCD Manual, section 220.6.17.

The contractor shall use the following remittance advice messages and associated codes

when returning claims under this policy. This CARC/RARC combination is compliant

with CAQH CORE Business Scenario Two.

Group Code: CO

CARC: 4

RARC: MA130

MSN: N/A

Effective for claims with dates of service on or after April 3, 2009, through June 10,

2013, contractors shall return as unprocessable/return to provider FDG PET claims

billed to inform initial treatment strategy or subsequent treatment strategy when

performed under CED without one of the PET/PET/CT CPT codes listed in subsection C.

above AND modifier PI OR modifier PS AND a cancer diagnosis code AND modifier

Q0/Q1.

The contractor shall use the following remittance advice messages and associated codes

when returning claims under this policy. This CARC/RARC combination is compliant

with CAQH CORE Business Scenario Two.

Group Code: CO

CARC: 4

RARC: MA130

MSN: N/A

Effective April 3, 2009, contractors shall deny claims with ICD-9/ICD-10 diagnosis code

185/C61 for FDG PET imaging for the initial treatment strategy of patients with

adenocarcinoma of the prostate.

For dates of service prior to June 11, 2013, contractors shall also deny claims for FDG

PET imaging for subsequent treatment strategy for tumor types other than breast,

cervical, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma,

melanoma, myeloma, non-small cell lung, and ovarian, unless the FDG PET is provided

under CED (submitted with the Q0/Q1 modifier) and use the following messages:

The contractor shall use the following remittance advice messages and associated codes

when rejecting/denying claims under this policy. This CARC/RARC combination is

compliant with CAQH CORE Business Scenario Three.

Group Code: PR (if claim is received with a GA modifier) otherwise CO

CARC: 50

RARC: N/A

MSN: 15.4

Effective for dates of service on or after June 11, 2013, contractors shall use the

following messages when denying claims in excess of three for PET FDG scans for

subsequent treatment strategy when the KX modifier is not included, identified by CPT

codes 78608, 78811, 78812, 78813, 78814, 78815, or 78816, modifier PS, HCPCS

A9552, and the same cancer diagnosis code.

The contractor shall use the following remittance advice messages and associated codes

when rejecting/denying claims under this policy. This CARC/RARC combination is

compliant with CAQH CORE Business Scenario Three.

Group Code: PR (if claim is received with a GA modifier) otherwise CO

CARC: 96

RARC: N435

MSN: 23.17