1. No category

National Oncologic PET Registry
Sodium Fluoride (NaF-18)
PET Bone Imaging
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February 1, 2011
Outline
• Background – NaF-18 NCD (CMS manual 220.6.19)
• Differences
– FDG 2009 Registry vs NaF-18 Registry
• Billing
• Educational Information and Announcements
• Questions
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February 1, 2011
NCA Tracking Sheet
Positron Emission Tomography (NaF-18) to Identify
Bone Metastasis of Cancer (CAG-00065R)
• Multi-society discussions with CMS-CAG (February 2009)
• CMS internally generated request to open a formal
reconsideration for NaF-18 PET (June 4, 2009)
• Proposed Decision (November 30, 2009)
• Final Decision (February 26, 2010)
• NOPR begins development of a registry
CMS National Coverage Decision (NCD) Reference:
https://www.cms.gov/mcd/viewtrackingsheet.asp?from2=viewtrackingsheet.asp&id=233&
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February 1, 2011
NOPR (NaF-PET)
Registry for PET with F-18 Sodium Fluoride to
Identify Bone Metastasis
 The National Oncologic PET Registry (NOPR) has
implemented a registry for NaF-PET similar to that
now in place for FDG-PET
 Launch date Monday February 7, 2011
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February 1, 2011
NOPR:
A Nationwide Collaborative Program
Sponsored by
Advisor
Managed by
Endorsed by
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Chair, Bruce Hillner, MD, Virginia Commonwealth University
Co-chair, Barry A. Siegel, MD, Washington University
R. Edward Coleman, MD, Duke University
Anthony Shields, MD, PhD Wayne State University
Statistician: Fenghi Duan, PhD, Brown University
•
Epidemiologist: Ilana Gareen, PhD, Brown University
February 1, 2011
NOPR (NaF-PET)
• NOPR is a CMS-approved “Coverage with Evidence Development”
(CED) Program
– Now expanded to include NaF-PET
• All Medicare-eligible PET facilities can participate (for a fee)
• Requires timely Pre-PET, PET evaluation, and Post-PET data
• All data submitted to CMS
• Cases with patient and both referring and interpreting physician
consent will be used by the NOPR to assess impact of PET
(change in intended management)
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February 1, 2011
CMS questions to be answered with CED registry:
Does use of NaF-PET in Medicare beneficiaries inform
treating physicians to guide antitumor strategies that lead
to:
• A change in patient management to more appropriate
palliative care; or
• A change in patient management to more appropriate
curative care; or
• Improved quality of life; or
• Improved survival?
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February 1, 2011
NOPR (NaF-PET): Primary Objective
• To assess the effect of NaF-PET on referring
physicians’ plans of intended management of
patients with known or suspected bone
metastases
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February 1, 2011
NOPR (NaF-PET): Goals
• Provide access to bone PET for patients with cancer
• Minimize the burden to patients, PET centers, and
referring physicians
• Generate evidence of reasonable quality to assist
CMS in deciding whether to expand coverage of PET
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February 1, 2011
Participation Requirements/Responsibilities - PET Facilities
•
Any PET facility approved to bill CMS for either technical or global charges
can participate in the NOPR. Facilities already registered to participate in
NOPR 2009 do not need to re-register to participate in NOPR (NaF-PET).
•
Willingness to take on the burden and additional cost of collecting data and
sending to NOPR. New for NOPR (NaF-PET) is an interpreting physician
scan assessment form with consent submission.
Participation Requirements - Patients
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Medicare beneficiaries, including those with Medicare HMO coverage, who
are referred for NaF-PET to evaluate for osseous metastasis are eligible.
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Oral consent is necessary for inclusion in the NOPR research dataset.
No consent necessary to submit data to NOPR that must be sent to CMS.
February 1, 2011
Referring Physician Responsibilities
• Complete Pre-PET Form and send to PET Facility before scan.
• Complete Post-PET Form and send to PET Facility within 30 days of
PET scan.
• Post-PET form consent is necessary for inclusion in the NOPR
research dataset.
• No Medicare payment to referring physicians for completing the Preand Post-PET Forms.
Interpreting Physician Responsibilities
• Complete Scan Assessment Form after NaF-PET scan.
• Consent is necessary for inclusion in the NOPR research dataset.
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February 1, 2011
NOPR Web Site
• Information for
– PET Facilities
– Referring Physicians
– Patients
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Blank Forms
Register PET Facilities
Register Patients
PET Facility Tools
– Case Status Reports
– Account Balance
– Fund Account by Credit Card
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February 1, 2011
http://www.cancerPETregistry.org
NOPR (NaF-PET) Workflow
Referring MD
requests PET
Pre-PET
Form
Ask patient
for consent
PET
done
PET
interpreted,
reported, and
interpreting
physician
assessment
submitted
Post-PET
Form sent,
including question for referring
MD consent
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February 1, 2011
Ongoing
patient
management
Post-PET Form
completed.
Claim submitted
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February 1, 2011
Pre-PET Form for NaF-PET
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Reason for NaF-PET Scan (more granular than for FDG-PET)
Symptoms, Signs, Other Findings Prompting PET (NEW)
Cancer Site/Type/Tissue Diagnosis
Summary of Disease Stage
– NED, Localized, Regional, Metastatic, Unknown
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Intended Patient Management Plan
Details/Type Intended Treatment (expanded cf. FDG-PET)
Additional Questions for Treatment Monitoring
Physician Attestation of Data Accuracy
February 1, 2011
Specific Reason for NaF-PET Study
 Diagnosis of suspected osseous metastatic disease in a patient
without a pathologically proven diagnosis of cancer
 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: (1) systemic therapy (including chemotherapy, biologic modifiers,
hormonal therapy, and immunotherapy); (2) radiation therapy; or (3) both
(additional questions)
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February 1, 2011
Symptoms, Signs, Other Findings Prompting NaF-PET
 None
Or select all of the following that apply
 Skeletal pain
 New focal neurologic signs or symptoms
 Other imaging findings suggesting osseous metastatic disease
 Hypercalcemia
 Elevated or increasing tumor marker(s)
 Evidence of new metastases in non-osseous sites
 Evidence of progression of known metastatic disease in nonosseous sites
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February 1, 2011
Cancer Type
Check the one pathologically proven or strongly suspected
cancer type that most closely relates to the specific reason for
PET study
 Lung
 Female breast
 Prostate
 Metastatic cancer of unknown primary origin
 If other, describe cancer type and give 3 digit ICD-9 code
See guidance on Pre-PET form about completion of suspected cancer type
when NaF-PET is requested for “Diagnosis of suspected osseous metastatic
disease in a patient without a pathologically proven diagnosis of cancer”.
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February 1, 2011
Tissue Diagnosis
Has this cancer diagnosis been pathologically proven?
 Yes
 No
Unknown primary: dominant site of pathologically proven
or strongly suspected metastatic disease
 Liver
 Bone/bone marrow
 Lymph node(s)
 Lung
 Brain
 Other
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February 1, 2011
Working Stage
Your working summary stage for the patient before the PET
scan is:
 No evidence of disease / In remission
 Localized only
 Regional by direct extension, lymph node involvement or both
 Metastatic (distant) with a single suspected site
 Metastatic (distant) with multiple suspected sites
 Unknown or uncertain
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February 1, 2011
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?
[Must assume that neither an F-18 fluoride PET bone scan nor a
conventional bone scan would be available as the next step.]
 Observation (with close follow-up)
 Additional Imaging (CT, MRI, FDG-PET) [Do not check this
option if you would order a conventional bone scan]
 Tissue Biopsy (surgical, percutaneous, or endoscopic).
 Supportive care only (e.g., pain management, hospice care)
 Treatment for the cancer
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February 1, 2011
If Treatment, Provide Details as Follows:
Treatment Goal: (check one)
 Curative
 Palliative
Treatment will be directed to: (check all that apply)
 Primary tumor and/or loco-regional disease
 Non-osseous distant metastatic disease
 Osseous distant metastatic disease
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February 1, 2011
Treatment Type (check all that apply)
 Surgery
 Radiation
 Chemotherapy (including biologic modifiers)
 Hormonal therapy
 Bisphosphonate therapy
 Immunotherapy (e.g., sipuleucel T (Provenge®) for
prostate cancer)
 Radiopharmaceutical therapy (Sr-89, Sm-153, etc.)
 Other (specify type)
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February 1, 2011
Additional Questions if Treatment Monitoring
Definition of 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).
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.
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February 1, 2011
Additional Pre-PET Treatment Monitoring Questions
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
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
 Stop therapy and switch to supportive care
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February 1, 2011
Pre-PET Form: Last Step
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:
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February 1, 2011
Interpreting Physician Scan Assessment Form
• Overall assessment of the NaF-PET study using a
categorical scale
• Asks whether NaF-PET was compared with prior study
(conventional bone scintigraphy or NaF-PET), and
whether there was a change in the scan appearance
• Consent to use the data for NOPR research
•
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Submitted within 30 days of PET (but optimally along
with the PET report)
February 1, 2011
NaF-PET Report Submission
• Only free text submission permitted
(no pdf or jpg uploads as for FDG-PET)
• Document patient consent
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February 1, 2011
Post-PET Forms for NaF-PET
• Tailored to reason for scan
• Repeat intended management question (except where
NaF-PET being done to diagnosis metastasis in
patients without known cancer)
• Consent to use the data for NOPR research
•
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Must be submitted within 30 days of PET
February 1, 2011
Welcome Page for NOPR (NaF-PET)
New PET interpreting Physician Scan Assessment Form – Submit with PET report.
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February 1, 2011
CMS Transmittal Claims Processing & Billing
• November 19, 2010 Transmittal 2096 CR 7125
– Billing Clarification for Positron Emission Tomography
(Sodium Fluoride-18) (NaF-18) PET for Identifying Bone
Metastasis of Cancer in Context of a Clinical Trial
• http://www.cms.gov/transmittals/downloads/R2096CP.pdf
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February 1, 2011
Coding NaF-PET Bone Imaging Under CED
Transmittal 2096, Change Request 7125 (November 19, 2010)
Choose the most appropriate code for study performed (78811-78816)
• Apply all appropriate Oncology PET modifier(s)
– PI or PS, Q0, KX and V70.7 (condition code 30)
• HCPCS code A9580 F-18 Sodium Fluoride, per study dose
• What will you be paid?
– The same rate as you get for all other NOPR PET cases for the
setting in which you perform the study
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February 1, 2011
Identifier for CMS PET Claims: HCPCS Modifier
PET Oncology Modifiers
HCPCS
Modifier
PI
(eye)
PS
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February 1, 2011
Descriptor
Positron emission tomography (PET) or
PET/computed tomography initial treatment
strategy of tumors that are biopsy proven or
suspected of being cancerous based on other
diagnostic testing
Positron emission tomography (PET) or
PET/computed tomography (CT) to inform the
subsequent treatment strategy of cancerous
tumors when the beneficiary's treating physician
determines that the PET study is needed to
inform subsequent anti-tumor strategy.
Effective October 30, 2009 on
Claims With DOS April 3, 2009 for
covered FDG-PET OncologicRelated Claims
PET tumor initial
treatment strategy
“Diagnosis” or
“initial staging”
PET tumor subsequent
treatment strategy
“Restaging” or
“monitoring”
Identifier for CMS PET Claims: CPT Modifier
CED (PET NOPR) Identifying Modifier
CPT Modifier
Description
Comments
Q0 (Zero)
Investigational clinical service
provided in a clinical research study
that is in an approved clinical
research study
QR was deleted effective
Dec 31, 2007; Q0 (zero) is
used for DOS effective
January 1, 2008 to present
to identify a claims covered
under CED/ NOPR PET
study.
Use with Medicare Physician Fee Schedule (MPFS)-1500 Claim Form
IDE# not required for NOPR claims
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February 1, 2011
Identifier for CMS PET Claims
CED (PET NOPR) Identifying Modifier
ICD 9 CM
V70.7
Condition Code
30
Description
Exam of Participants in Clinical Trials
Qualifying Clinical Trials Non-research
services provided to all patients, including
managed care enrollees enrolled in a
Qualified Clinical Trial.
Comments
Enter NOPR Identifier in FL 68
Placed in the second
diagnosis position with no
period
Form Locator 24-30:
Use with Hospital Outpatient Prospective Payment System (HOPPS)
UB-04 1450 Claim Form
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February 1, 2011
Medicare CED-Covered PET Radiopharmaceutical
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HCPCS
Level II
Trade /
Common
Name
Description
A9580
NaF
Sodium
Fluoride
Sodium fluoride F-18, diagnostic, per study dose,
up to 40 millicuries
February 1, 2011
CMS PET Claims: HCPCS Modifier for NaF-PET
PET Oncology NaF Bone Scan Modifiers
HCPCS
Modifier
Descriptor
Requirements specified in the medical policy
have been met
KX
CMS Transmittal
Use for professional
services modifier -26 to
identify CED covered
NaF-18 services for
metastatic cancer to bone
Used to allow professional-only claims with a -26 modifier e to be identified and paid.
Global or TC claims have NaF code (A9580) on the claim to identify it separately from FDG code (A9552).
KX is not necessary on NaF claims billed for global or technical services, nor is it
necessary for Hospitals, as those claims are technical.
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February 1, 2011
Medicare Advantage Plans – NOPR
Medicare Advantage (MA) beneficiaries are eligible to be included in the registry
and CMS will make payments for MA enrollees on a fee-for-service basis for
covered clinical trial costs. CMS determined that the policy of making payments on
a fee-for-service basis for covered clinical trial items and services provided MA
enrollees is appropriate because the capitation rates do not account for costs of
scans provided through NOPR as part of a Coverage with Evidence Development
clinical study. Effective April 3, 2009, NOPR claims should be billed to the
Medicare intermediaries and carriers who will make payments on behalf of
MA organizations directly to providers of the PET scan, on a fee-for-service
basis. This policy is explained in more detail in Publication 100-16, Chapter 8:
Managed Care Manual 40.4.3 - Special Rules for the September 2000 NCD on
Clinical Trials (Rev. 89; Issued: 11-02-07; Effective/Implementation: 11-02-07).
http://www.cms.gov/Transmittals/2010Trans/itemdetail.asp?filterType=dual,%20keyword&filterValue=R1937&
filterByDID=0&sortByDID=2&sortOrder=descending&itemID=CMS1234255&intNumPerPage=10
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February 1, 2011
NOPR (NaF-PET): Educational Materials
The Society of Nuclear Medicine has made a recent educational
webinar entitled “F-18 Sodium Fluoride PET Imaging” available.
 NOPR investigators believe this educational program is of interest
to physicians who plan to interpret NaF-PET studies, as well as to
referring physicians and technical staff.
 The webinar can be accessed free of charge at
http://webinars.snm.org/?meeting=8022110.
 Individuals who prefer to obtain continuing education credit for this
webinar (for a fee) can access it via www.snm.org/onlinelectures,
and follow the instructions at that site.
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February 1, 2011
NOPR (NaF-PET):
Educational Materials
 The NOPR investigators and staff
encourage technical and professional
staff at PET facilities to review the
recently published “SNM Practice
Guideline for Sodium 18F-Fluoride
PET/CT Bone Scans 1.1” accessible at
http://interactive.snm.org/docs/Practice%20Guid
eline%20NaF%20PET%20V1.1.pdf.
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February 1, 2011
Continuing Education Article
J Nucl Med 2008;49:68-78
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February 1, 2011
NOPR Educational Materials
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February 1, 2011
QUESTIONS?
Type in your question in the on-line screen box
located on the right side of the screen
If you have questions after the seminar, contact
[email protected]
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February 1, 2011