CMS-10152 Pre-PET Form

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

[0938-0968 Form #3]
Pre-PET Form
National Oncologic PET Registry
Comment to Clinician:
•

•

You have requested an F-18 Fluoride PET scan, a test for which the Centers for Medicare and Medicaid Services
(CMS) requires pre- and post-PET information from the referring physician as a condition for reimbursement. In order
for the imaging center to be reimbursed this form must be completed and returned to the PET facility before the PET
scan is performed.
You will be required to complete a follow-up form in a timely fashion after the PET scan is done. Thank you for your
assistance completing the brief pre- and post-PET forms. The required follow-up questionnaire will be sent to you by
the PET facility. By requesting that this patient be entered on the NOPR you agree to also complete the post-PET follow-up
form and return it to the PET scan facility within 30 days of the PET scan.

PATIENT INFORMATION
Date:

Social Security #:

Last name: ________________________________
Date of Birth:

First name: __________________________________
Patient's Zip Code:

REFERRING PHYSICIAN INFORMATION
UPIN #: ___________________________________

or

NPI #:__________________________________

Last name: ________________________________

First name: __________________________________

Office Telephone:

Office Fax:

1. SPECIFIC REASON FOR F-18 FLUORIDE PET STUDY
See page 6 of this form for definitions / instructions to assist you in completing Question 1.
a. Check the single best match for the reason for the PET (you must check only one of the following)

 Diagnosis of suspected osseous metastatic disease in a patient without a pathologically proven diagnosis of
cancer
[If this option is selected, answer only questions 1.b, 2, 3, and 6. Also, note that guidance to help you
answer parts a, b, and c of question 2 is provided on page 7 of this form.]

 Initial staging of newly diagnosed cancer
 Suspected new osseous metastasis as a site of recurrence or progression
 Suspected progression of known osseous metastasis
 Monitoring Treatment Response during chemotherapy (including biologic modifiers and hormonal therapy)

Pre-PET Form
National Oncologic PET Registry
 Monitoring Treatment Response during radiation therapy
 Monitoring Treatment Response during combined modality therapy

F18 Fluoride PET Scan

(e.g., chemotherapy ± radiation ± surgery)

b. Symptoms, signs, or other findings prompting F-18 fluoride PET bone imaging

 NONE








[If selected, go directly to Question 2; otherwise select all of the following that apply]
Skeletal pain
New focal neurologic signs or symptoms
Findings on other imaging studies suggesting osseous metastatic disease
Hypercalcemia
Elevated or increasing tumor marker(s) (including alkaline phophatase)
Evidence of new metastases in non-osseous sites
[Do not select this option if reason for study is “Diagnosis of suspected osseous metastatic disease in a patient
without a pathologically proven diagnosis of cancer”.]
Evidence of progression of known metastatic disease in non-osseous sites
[Do not select this option if reason for study is “Diagnosis of suspected osseous metastatic disease in a patient
without a pathologically proven diagnosis of cancer”.]
See page 7 of this form for guidance in the completion of Question 2 when the PET bone scan is requested for
“Diagnosis of suspected osseous metastatic disease in a patient without a pathologically proven diagnosis of cancer”..

2. CANCER TYPE
•

Please mark the corresponding box of the pathologically proven or strongly suspected primary cancer type in section
2a and answer question 2b.

•

If your patient’s cancer is not listed, check the “Other or not listed” box and enter as text the cancer type.

•

For a patient with pathologically proven or strongly suspected metastatic cancer of unknown primary origin, please
also mark the corresponding box of the site of metastatic disease in section 2c.

a. Cancer Type - check the one pathologically proven or strongly suspected cancer type that most closely relates
to the specific reason for the PET study indicated in response to Question 1. (Check only one)







Lung
Female breast
Prostate
Metastatic cancer of unknown primary origin (also answer question 2c below)
Other

If other,
please describe cancer type: ____________________________________________________________
and give the first 3 digits of the ICD-9 code.

b. Has this cancer diagnosis been pathologically proven?

.XX
 Yes  No

c. Unknown primary: dominant site of pathologically proven or strongly suspected metastatic disease

 Lymph node(s)
 Lung

 Liver
 Brain

 Bone/bone marrow
 Other

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

If other,
please describe cancer type: ____________________________________________________________
and give the first 3 digits of the ICD-9 code.
are 196-199]

.XX

[Acceptable responses

3. YOUR WORKING SUMMARY STAGE FOR THE PATIENT BEFORE THE PET
SCAN IS:
(you must check only one)








No evidence of disease / In remission
Localized only
Regional by direct extension or lymph node involvement or both
Metastatic (distant) with a single suspected site
Metastatic (distant) with multiple suspected sites
Unknown or uncertain

4. ADDITIONAL RESPONSES REQUIRED ONLY IF THE SPECIFIC REASON FOR
THE PET STUDY IS MONITORING TREATMENT RESPONSE
a. Which of the following types of treatment is this patient now receiving?
(check all that apply)

 Radiation therapy
 Chemotherapy (including biologic modifiers and hormonal therapy)
 Immunotherapy (e.g., sipuleucel T (Provenge®) for prostate cancer)
b. What is your impression (before PET) of your patient’s response to currently
ongoing therapy?
(check one)






Probable complete response
Possible partial response, but uncertain about degree of response
Suspect no response (stable disease)
Suspect progressive disease

c. If you were to continue your patient’s management without doing any other
testing first (e.g., PET, CT, MRI, biopsy), what would be your treatment plan
today?
(check one)

 Continue and complete currently ongoing therapy
 Modify dose or schedule of currently ongoing therapy
 Switch to another therapy or add another mode of therapy

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

 Stop therapy and switch to supportive care
5. MANAGEMENT PLAN
If the F-18 fluoride PET bone scan were not available, which ONE of the following
would be the next step in your current management strategy?
[Note: For purposes of this question, you should assume that neither an F-18 fluoride PET bone
scan nor a conventional bone would be available as the next step.]
(check only one)

 Observation (with close follow-up)
 Additional Imaging (CT, MRI, FDG-PET)
[Note: Do not check this option if you would order a conventional bone scan if the F-18
fluoride PET bone scan were not available.]

 Tissue Biopsy (surgical, percutaneous, or endoscopic).
Note: If concurrent biopsy and a surgical procedure are planned, then mark “treatment”
below.

 Supportive care only (e.g., pain management, hospice care)
 Treatment for the cancer
If treatment is selected, please also answer the following (1, 2 and 3):
a. Treatment Goal:
(check one)

 Curative
 Palliative
b. Treatment will be directed to:
(check all that apply)

 Primary tumor and/or locoregional disease
 Non-osseous distant metastatic disease
 Osseous distant metastatic disease
c. Type(s):
(check all that apply)








Surgery
Radiation
Chemotherapy (including biologic modifiers)
Hormonal therapy
Bisphosphonate therapy
Immunotherapy (e.g., sipuleucel T (Provenge®) for prostate cancer)

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

 Radiopharmaceutical therapy (strontium-89, samarium-153, etc.)
 Other
Specify type: ________________________________________________________________

6. NAME OF PERSON WHO COMPLETED THE PAPER FORM
First Name: __________________

Last Name: ______________________

Date:

7. PHYSICIAN ATTESTATION OF DATA ACCURACY
By signing below I verify that, to the best of my knowledge, the information on this form is
accurate.
Physician Signature: _______________________________________________

Date:

Printed Name of Physician: __________________________________________

Thank you for your assistance.

PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection
of information unless it displays a valid OMB control number. The valid OMB control number for this
information collection is 0938-0968. The time required to complete this information collection is
estimated to average five (5) minutes per response, including the time to review instructions, search
existing data resources, gather the data needed, and complete and review the information collection.
If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving
this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850.

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

ADDITONAL INSTRUCTIONS FOR COMPLETING PRE-PET FORM
QUESTION 1
The following definitions/instructions are provided to assist you in the completion of
Question 1 (“SPECIFIC REASON FOR PET STUDY”) on the next page of this form. This
information is derived from the Medicare National Coverage Determination for F-18
Fluoride PET.
< http://www.cms.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=233&>
Indications for F-18 Fluoride PET Scans and Limitations/Requirements for Usage

Initial Treatment Strategy
F-18 Fluoride PET performed as part of an evaluation for determination of an initial treatment
strategy is covered by CMS only with participation in this registry. F-18 fluoride PET may be used
both for diagnosis of strongly suspected bone metastases in a patient without a pathologically
proven diagnosis of cancer and as part of initial staging in a patient with a pathologically proven
cancer.
Note: F-18 fluoride PET is covered only in clinical situations in which (1) the PET results may assist in
avoiding an invasive diagnostic procedure, or in which (2) 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 doing a PET bone scan and therefore the scan is performed
for staging rather than diagnosis.
PET is not covered as a screening test (i.e., testing patients without specific signs and symptoms of
disease).

Subsequent Treatment Strategy
F-18 fluoride PET is also covered by CMS only with participation in this registry when used in
subsequent treatment strategy to identify bone metastases in a patient with a pathologically proven
cancer.
F-18 fluoride PET is covered for restaging and detection of suspected recurrences:
(1) after completion of treatment for the purpose of detecting residual disease; or
(2) for detecting suspected recurrence or metastasis; or
(3) to determine the extent of a known recurrence:
(4) 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.
(5) Restaging applies to testing after a course of treatment is completed, and is covered subject
to the conditions above.
Comment: As noted above, F-18 fluoride PET is not covered as a screening test (i.e., testing patients
without specific signs and symptoms of disease) and thus is not covered for surveillance of patients
treated for cancer in whom there is no clinical reason to suspect recurrent disease.

Treatment Monitoring
Treatment monitoring refers to use of PET to monitor tumor response to treatment during the planned
course of therapy (i.e., when a change in therapy is anticipated).

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

Comment: As an example, F-18 fluoride PET performed under NOPR may be covered for monitoring
after 2 or 3 of a planned 6 cycles of chemotherapy in a patient considered not to be responding as
expected.

Pre-PET Form
National Oncologic PET Registry

F18 Fluoride PET Scan

ADDITIONAL INSTRUCTIONS FOR COMPLETING PRE-PET FORM
QUESTION 2
The following guidance is provided to assist you in answering Questions 2a, b, and
c when the PET bone scan is requested for “Diagnosis of suspected osseous
metastatic disease in a patient without a pathologically proven diagnosis of
cancer”.
Below are several common clinical scenarios that serve as illustrations.
•

A man with back pain, a markedly elevated PSA and sclerotic lesions in several vertebrae on a
recent chest radiograph. Answer “Prostate (185)” to question 2a and “No” to question 2b. Do
not answer question 2c.

•

A woman with a long smoking history, now with a left upper lobe mass, mediastinal
adenopathy, and an adrenal nodule on CT. Answer “Lung, non-small cell lung (162)” to
question 2a and “No” to question 2b. Do not answer question 2c.

•

A man with multifocal bone pain and several ill-defined lytic osseous lesions on a recent chest,
abdomen and pelvis CT (with no evidence of a primary tumor on the CT study). Answer
“Metastatic cancer of unknown primary origin” to question 2a, “No” to question 2c, and
“Bone/bone marrow” to question 2c.

•

A woman with severe headache and multiple enhancing lesions on brain MRI. Answer
“Metastatic cancer of unknown primary origin” to question 2a, “No” to question 2c, and “Brain”
to question 2c.