NOPR National Oncologic PET Registry.

NOPR National Oncologic PET Registry

Medicare Reimbursement for Oncologic PET (2005) Diagnosis, arranging, and restaging of: Non-little cell lung cancer Lymphoma Esophageal cancer Malignant melanoma Colorectal cancer Head and neck malignancy Staging, restaging, and Rx observing of bosom tumor Detection of TG+/RAI– thyroid disease Staging of cervical growth (– CT/MRI outside pelvis) All different diseases/signs National registry

NOPR Is a CMS-affirmed "Scope with Evidence Development" Program Developed for the November 2004 extension by CMS All different growths and signs aside from: Breast disease analysis and axillary organizing Melanoma local nodal organizing All PET offices can partake (for an expense) Requires auspicious Pre-PET and Post-PET data All information will be submitted to CMS Cases with patient and doctor assent will be utilized by the NOPR to survey change in expected administration

NOPR National Oncologic PET Registry NOPR National Oncologic PET Registry Sponsored by Advisor Managed by Endorsed by

Objectives & Goals Objectives Assess the impact of PET on alluding doctors' arrangements of proposed patient administration over a wide range of tumor signs for PET that are at present not secured by the Medicare program, and in connection to growth sort, sign, execution status, doctor's part in administration, and kind of PET. Objective Acquire information that can be utilized to assess PET in a way that does not meddle with patient clinical care and limits the weight to the patient, PET focus, and alluding doctor.

Data Analysis and Expected Results Data broke down by malignancy sort and sign (purpose behind PET). For the most regular tumor signs, interval investigation will be performed at N=200 to refine test measure gauges. On the off chance that the recurrence of progress in expected administration for a specific disease sign is adequate to recommend advantage, information (alongside synopsis of distributed writing) will be furnished to CMS with demand for scope. Possible objective is to accomplish expansive scope through examination of information over all malignancies and signs.

Institutional Review Board (IRB) Approval & Subject Informed Consent Is this examination? Yes, yet just for the NOPR. Singular PET offices and alluding doctors are not occupied with research. Is IRB endorsement required? Yes. ACR IRB has endorsed the NOPR. Singular PET offices and alluding doctors don't have to acquire IRB endorsement to take part. All information will be sent to CMS. CMS is not occupied with research. Patients and alluding doctors will be given an IRB-endorsed data sheet and requested oral agree to have their information incorporated into NOPR investigate. Just situations where both patient and doctor give assent will be incorporated into the NOPR look into dataset.

Patient Informational Sheet Available at CancerPETregistry.org Available in English and Spanish Referring Physician Information Sheet Also Sent with Post-PET Form to Referring Physician

HIPAA Requirements HIPAA necessities met through execution of a Business Associates Agreement with the American College of Radiology as an operator for the Academy of Molecular Imaging and CMS.

Participation Requirements - PET Facilities Any PET office that is endorsed to bill CMS for either specialized or worldwide charges can take an interest in the NOPR. Offices are not required to have or acquire ACR or ICANL accreditation. Investment Requirements - Patients Medicare recipients, incorporating those with Medicare HMO scope, who are alluded for FDG-PET for basically all oncologic signs that are not at present reimbursable under Medicare. The Indications table records the malignancies and signs that are and are not qualified for the Registry. Oral assent is essential for consideration in the NOPR look into dataset; notwithstanding, no agree is important to submit information to NOPR that will be sent to CMS.

PET Facility Responsibilities Collect and enter every single required dat through the NOPR Web website. Quiet should be enrolled inside 14 days of the PET output date Give persistent the Patient Information Sheet Pre-PET Form must be entered by midnight of the PET sweep date PET Completion Form must be entered inside 14 days of case enlistment The PET Report & Post-PET structures must be entered inside 30 days of output PET office is qualified to bill CMS when every required dat are gotten at NOPR Operations Office. Alluding Physician Responsibilities Complete Pre-PET Form (5 inquiries) and return it to PET Facility before PET sweep. Finish Post-PET Form (4 - 7 inquiries) and return it to PET Facility inside 30 days of PET output. Pre-and Post-PET structures can be come back to the PET office by means of FAX, mail, or hand conveyance.

Ineligible Indications

Cancers & Indications Eligible for Entry in the NOPR proceeded next slide

Cancers & Indications Eligible for Entry in the NOPR ( proceeded)

Does NOPR Apply to Oncologic PET with Radiopharmaceuticals other than FDG? No

Facility and Patient Registration Register by means of the NOPR Web webpage www.cancerPETregistry.org Complete Facility Registration Form PET office data including Medicare Provider Number PET office chairman (the individual in charge of overseeing registry exercises at the office) Participating deciphering physician(s) Equipment points of interest Submit Executed Business Associates Agreement (BAA) $50 Facility Application Fee $50 Processing Fee for Each Patient Advance installment held retained record

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 with Credit Card

Pre-PET Form – 5 Questions Reason for the PET Scan Cancer Site/Type Summary of Disease Stage NED, Localized, Regional, Metastatic, Unknown Performance Status Asymptomatic, Symptomatic, Bedridden Intended Patient Management Plan

Pre-PET Form: Specific Reason For PET 1. Check the absolute best match for the explanation behind the PET. Determination: To figure out whether a suspicious sore is disease Diagnosis Unknown essential tumor: To identify an essential tumor site in a patient with an affirmed or firmly speculated metastatic sore Paraneoplastic: To distinguish an essential tumor site in a patient with an assumed paraneoplastic disorder Initial organizing of histologically affirmed, recently analyzed growth Monitoring treatment reaction: amid chemotherapy, radiotherapy, or consolidated methodology treatment Restaging after consummation of treatment Suspected repeat of a formerly treated malignancy

Pre-PET Form: Intended Patient Management Plan 5. If PET were not accessible, your ebb and flow administration procedure would be (select one)? Perception (with close development) Additional imaging (CT, MRI) or other non-obtrusive analytic tests Tissue biopsy (surgical, percutaneous, or endoscopic). Treatment (if treatment is chosen, then likewise entire the accompanying) Treatment Goal: (check one)  Curative  Palliative Type(s): (check all that apply)  Surgical  Chemotherapy (counting biologic modifiers)  Radiation  Other  Supportive care

Pre-PET Web Form 2. 42 Primary and Metastatic Sites Listed

Pre-PET Web Form proceeded with

Post-PET Form – 4 to 7 Questions Customized by Specific Reason for PET (Indication) 4 - 7 Questions for each Indication Most Require a Yes or No Answer 2 Questions are Repeated from the Pre-PET Form Intended Patient Management Plan Planned Cancer Care Provider Referring Physician Consent

NOPR Workflow PET Reviewed & Reported Clinical Actions Ongoing Referring MD Requests PET Done Ask Patient For Consent Questionnaire Completed $$ Post-PET Questionnaire Sent Includes Question for Referring Physician Consent Pre-PET Questionnaire

Timeline accessible on NOPR Website.

Billing Hold claims until all information is entered in the Registry Notify perusing doctors when all information is gone into NOPR and the PET office has the NOPR email confirmation

Timeline No Waiting Period Providers Bill Medicare Using Appropriate Claim Form & Codes Hospitals Use UB/1450 Claim Form Technical Only Non-Hospitals Use 1500 Claim Form Professional/Technical/Global

FDG-PET Procedure and Supply Codes

FDG-PET/CT Procedure and Supply Codes

For Carriers on 1500 Claim Form Use Modifier Use by Providers to Identify NOPR Claims Use just with methodology, a bit much with the radiopharmaceutical charged on an indistinguishable DOS from the technique. CMS Transmittal 956, 5/19/06

Hospitals ONLY on 1450 Claim Form (UB) V70.7 Use in the Second Diagnosis Position FL 68 From Current CMS approach CR 3741

Case 1 A 72-year-old lady with diffuse expansive cell non-Hodgkin's lymphoma is experiencing chemotherapy with R-CHOP. PET/CT (skull-base to proximal thigh) is asked for after the second cycle of treatment for checking of treatment.

Use of PET for Treatment Monitoring under NOPR One potential issue might be "crash" of NOPR expectation with individual transporter recurrence limits for PET reviews Could prompt to dismissal of claim (or refusal of Medicare Advantage plan to pre-approve contemplate) Please inform NOPR staff if this happens!

Case 2 A 67-year-old man has a background marked by glioblastoma multiforme of left parietal lobe treated with surgery, radiation treatment, and temazolamide. Follow-up MRI shows another 8 mm center of difference upgrade neighboring the first tumor bed. Mind PET is asked for restaging, to recognize