CMS Pub. 100-04, ch. 13, § 60

Positron emission tomography (PET) is a noninvasive imaging procedure that assesses perfusion and the

level of metabolic activity in various organ systems of the human body. A positron camera (tomograph)

is used to produce cross-sectional tomographic images which are obtained by detecting radioactivity

from a radioactive tracer substance (radiopharmaceutical) that emits a radioactive tracer substance

(radiopharmaceutical FDG) such as 2 –[F-18] flouro-D-glucose FDG, that is administered intravenously

to the patient.

The Medicare National Coverage Determinations (NCD) Manual, chapter 1, §220.6, contains additional

coverage instructions to indicate the conditions under which a PET scan is performed.

A. Definitions

For all uses of PET, excluding Rubidium 82 for perfusion of the heart, myocardial viability and

refractory seizures, the following definitions apply:

• Diagnosis: PET is covered only in clinical situations in which the PET results may assist in

avoiding an invasive diagnostic procedure, or in which the PET results may assist in determining the

optimal anatomical location to perform an invasive diagnostic procedure. In general, for most solid

tumors, a tissue diagnosis is made prior to the performance of PET scanning. PET scans following a

tissue diagnosis are generally performed for the purpose of staging, rather than diagnosis. Therefore, the

use of PET in the diagnosis of lymphoma, esophageal and colorectal cancers, as well as in melanoma,

should be rare. PET is not covered for other diagnostic uses, and is not covered for screening (testing of

patients without specific signs and symptoms of disease).

• Staging: PET is covered in clinical situations in which (1) (a) the stage of the cancer remains in

doubt after completion of a standard diagnostic workup, including conventional imaging (computed

tomography, magnetic resonance imaging, or ultrasound) or, (b) the use of PET would also be

considered reasonable and necessary if it could potentially replace one or more conventional imaging

studies when it is expected that conventional study information is insufficient for the clinical

management of the patient and, (2) clinical management of the patient would differ depending on the

stage of the cancer identified.

NOTE: Effective for services on or after April 3, 2009, the terms “diagnosis” and “staging” will be

replaced with “Initial Treatment Strategy.” For further information on this new term, refer to Pub. 100-

03, NCD Manual, section 220.6.17.

• Restaging: PET will be covered for restaging: (1) after the completion of treatment for the

purpose of detecting residual disease, (2) for detecting suspected recurrence, or metastasis, (3) to

determine the extent of a known recurrence, or (4) if it could potentially replace one or more

conventional imaging studies when it is expected that conventional study information is to determine the

extent of a known recurrence, or if study information is insufficient for the clinical management of the

patient. Restaging applies to testing after a course of treatment is completed and is covered subject to

the conditions above.

• Monitoring: Use of PET to monitor tumor response to treatment during the planned course of

therapy (i.e., when a change in therapy is anticipated).

NOTE: Effective for services on or after April 3, 2009, the terms “restaging” and “monitoring” will be

replaced with “Subsequent Treatment Strategy.” For further information on this new term, refer to Pub.

100-03, NCD Manual, section 220.6.17.

B. Limitations

For staging and restaging: PET is covered in either/or both of the following circumstances:

• The stage of the cancer remains in doubt after completion of a standard diagnostic workup,

including conventional imaging (computed tomography, magnetic resonance imaging, or ultrasound);

and/or

• The clinical management of the patient would differ depending on the stage of the cancer

identified. PET will be covered for restaging after the completion of treatment for the purpose of

detecting residual disease, for detecting suspected recurrence, or to determine the extent of a known

recurrence. Use of PET would also be considered reasonable and necessary if it could potentially

replace one or more conventional imaging studies when it is expected that conventional study

information is insufficient for the clinical management of the patient.

The PET is not covered for other diagnostic uses, and is not covered for screening (testing of patients

without specific symptoms). Use of PET to monitor tumor response during the planned course of

therapy (i.e., when no change in therapy is being contemplated) is not covered.

60.1 - Billing Instructions

(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. Billing and Payment Instructions or Responsibilities for A/B MACs (B)

Claims for PET scan services must be billed using the ASC X12 837 professional claim format or on

Form-CMS 1500 with the appropriate HCPCS or CPT code and diagnosis codes to the A/B MAC (B).

Effective for claims received on or after July 1, 2001, PET modifiers were discontinued and are no

longer a claims processing requirement for PET scan claims. Therefore, July 1, 2001, and after the MSN

messages regarding the use of PET modifiers can be discontinued. The type of service (TOS) for the

new PET scan procedure codes is TOS 4, Diagnostic Radiology. Payment is based on the Medicare

Physician Fee Schedule.

B. Billing and Payment Instructions or Responsibilities for A/B MACs (A)

Claims for PET scan procedures must be billed to the A/B MAC (A) on the ASC X12 837 institutional

claim format or on Form CMS-1450 with the appropriate diagnosis and HCPCS “G” code or CPT code

to indicate the conditions under which a PET scan was done. These codes represent the technical

component costs associated with these procedures when furnished to hospital and SNF outpatients. They

are paid as follows:

• under OPPS for hospitals subject to OPPS

• under current payment methodologies for hospitals not subject to OPPS

• on a reasonable cost basis for critical access hospitals.

• on a reasonable cost basis for skilled nursing facilities.

Institutional providers bill these codes under Revenue Code 0404 (PET Scan).

Medicare contractors shall pay claims submitted for services provided by a critical access hospital

(CAH) as follows: Method I technical services are paid at 101% of reasonable cost; Method II technical

services are paid at 101% of reasonable cost, and professional services are paid at 115% of the Medicare

Physician Fee Schedule Data Base.

C. Frequency

In the absence of national frequency limitations, for all indications covered on and after July 1, 2001,

contractors can, if necessary, develop frequency limitations on any or all covered PET scan services.

D. Post-Payment Review for PET Scans

As with any claim, but particularly in view of the limitations on this coverage, Medicare may decide to

conduct post-payment reviews to determine that the use of PET scans is consistent with coverage

instructions. Pet scanning facilities must keep patient record information on file for each Medicare

patient for whom a PET scan claim is made. These medical records can be used in any post-payment

reviews and must include the information necessary to substantiate the need for the PET scan. These

records must include standard information (e.g., age, sex, and height) along with sufficient patient

histories to allow determination that the steps required in the coverage instructions were followed. Such

information must include, but is not limited to, the date, place and results of previous diagnostic tests

(e.g., cytopathology and surgical pathology reports, CT), as well as the results and reports of the PET

scan(s) performed at the center. If available, such records should include the prognosis derived from the

PET scan, together with information regarding the physician or institution to which the patient

proceeded following the scan for treatment or evaluation. The ordering physician is responsible for

forwarding appropriate clinical data to the PET scan facility.

Effective for claims received on or after July 1, 2001, CMS no longer requires paper documentation to

be submitted up front with PET scan claims. Contractors shall be aware and advise providers of the

specific documentation requirements for PET scans for dementia and neurodegenerative diseases. This

information is outlined in section 60.12. Documentation requirements such as physician referral and

medical necessity determination are to be maintained by the provider as part of the beneficiary’s medical

record. This information must be made available to the A/B MAC (A or B) upon request of additional

documentation to determine appropriate payment of an individual claim.