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

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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 pet_registry@phila.acr.org

43 February 1, 2011