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1 February 1, 2011
Sodium Fluoride (NaF-18)PET Bone Imaging
National Oncologic PET Registry
Outline
• Background – NaF-18 NCD (CMS manual 220.6.19)
• Differences– FDG 2009 Registry vs NaF-18 Registry
• Billing• Educational Information and Announcements• Questions
2 February 1, 2011
NCA Tracking SheetPositron 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&
3 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
4 February 1, 2011
NOPR: A Nationwide Collaborative Program
Sponsored by
Managed by
Advisor
Endorsed by
• 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
5 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)
6 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?
7 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
8 February 1, 2011
• 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
9 February 1, 2011
NOPR (NaF-PET): Goals
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
• Medicare beneficiaries, including those with Medicare HMO coverage, who are referred for NaF-PET to evaluate for osseous metastasis are eligible.
• 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.
10 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 Pre-
and Post-PET Forms.
11 February 1, 2011
Interpreting Physician Responsibilities
• Complete Scan Assessment Form after NaF-PET scan. • Consent is necessary for inclusion in the NOPR research dataset.
NOPR Web Site• Information for
– PET Facilities– Referring Physicians– Patients
• Blank Forms• Register PET Facilities• Register Patients• PET Facility Tools
– Case Status Reports– Account Balance– Fund Account by Credit Card
12 February 1, 2011
http://www.cancerPETregistry.org
Referring MD requests PETReferring MD requests PET
Pre-PET Form
Pre-PET Form
PETdonePETdone
PET interpreted,
reported, andinterpreting physician
assessment submitted
PET interpreted,
reported, andinterpreting physician
assessment submitted
Post-PETForm sent,
including question for referring MD consent
Post-PETForm sent,
including question for referring MD consent
Post-PET Form completed.
Claim submitted
Post-PET Form completed.
Claim submitted
Ongoingpatient
management
Ongoingpatient
management
NOPR (NaF-PET) Workflow
Ask patient for consent
Ask patient for consent
13 February 1, 2011
14 February 1, 2011
Pre-PET Form for NaF-PET• 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
• Intended Patient Management Plan• Details/Type Intended Treatment (expanded cf. FDG-PET)
• Additional Questions for Treatment Monitoring• Physician Attestation of Data Accuracy
15 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 ResponseDuring: (1) systemic therapy (including chemotherapy, biologic modifiers, hormonal therapy, and immunotherapy); (2) radiation therapy; or (3) both (additional questions)
16 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 non-
osseous sites
17 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
18 February 1, 2011
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”.
Tissue DiagnosisHas 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
19 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
20 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
21 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
22 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)
23 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.
24 February 1, 2011
Additional Pre-PET Treatment Monitoring Questions
25 February 1, 2011
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
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:
26 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
• Submitted within 30 days of PET (but optimally along with the PET report)
27 February 1, 2011
NaF-PET Report Submission
• Only free text submission permitted(no pdf or jpg uploads as for FDG-PET)
• Document patient consent
28 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
• Must be submitted within 30 days of PET
29 February 1, 2011
Welcome Page for NOPR (NaF-PET)
New PET interpreting Physician Scan Assessment Form – Submit with PET report.
30 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
31 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
32 February 1, 2011
PET Oncology Modifiers
HCPCSModifier
Descriptor
Effective October 30, 2009 on Claims With DOS April 3, 2009 for covered FDG-PET Oncologic-Related Claims
PI
(eye)
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
PET tumor initial
treatment strategy
“Diagnosis” or
“initial staging”
PS 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.
PET tumor subsequent
treatment strategy
“Restaging” or
“monitoring”
Identifier for CMS PET Claims: HCPCS Modifier
33 February 1, 2011
CED (PET NOPR) Identifying ModifierCPT 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 FormIDE# not required for NOPR claims
Identifier for CMS PET Claims: CPT Modifier
34 February 1, 2011
CED (PET NOPR) Identifying ModifierICD 9 CM Description Comments
V70.7 Exam of Participants in Clinical TrialsEnter NOPR Identifier in FL 68Placed in the second diagnosis position with no period
Condition Code 30
Qualifying Clinical Trials Non-research services provided to all patients, including managed care enrollees enrolled in a Qualified Clinical Trial.
Form Locator 24-30:
Use with Hospital Outpatient Prospective Payment System (HOPPS) UB-04 1450 Claim Form
Identifier for CMS PET Claims
35 February 1, 2011
Medicare CED-Covered PET Radiopharmaceutical
HCPCS Level II
Trade /Common
Name
Description
A9580 NaFSodium Fluoride
Sodium fluoride F-18, diagnostic, per study dose, up to 40 millicuries
36 February 1, 2011
PET Oncology NaF Bone Scan Modifiers
HCPCSModifier
Descriptor CMS Transmittal
KXRequirements specified in the medical policy have been met
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.
CMS PET Claims: HCPCS Modifier for NaF-PET
37 February 1, 2011
Medicare Advantage Plans – NOPRMedicare 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
38 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.
39 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%20Guideline%20NaF%20PET%20V1.1.pdf.
40 February 1, 2011
Continuing Education Article
J Nucl Med 2008;49:68-78
41 February 1, 2011
NOPR Educational Materials
42 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]
43 February 1, 2011