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  April 9, 2008

NOPR Billing Alert: Q0 Modifier Operational

As previously announced, claims with a DOS after January 1, 2008 must be coded with the Q0 modifier. The implementation date for providers was April 7th so facilities may now submit their claims to their providers.

On Friday January 18, 2008, CMS released Transmittal R1418CP, CR 5805 notifying PET facilities and Medicare Administrator Contractors that the discontinued QR (and QA) and QV HCPCS modifiers are replaced by the new modifiers Q0 (zero) and Q1, respectively, to identify investigational and routine clinical services provided in a clinical research study approved by Medicare. These two new modifiers are included in the 2008 Annual HCPCS Level II Update.

Specifically, effective for dates of service (DOS) on or after January 1, 2008, modifier QR currently used in the National Oncologic PET Registry (NOPR) is replaced with modifier Q0 (Zero). Additionally, QA is also replaced by Q0 and QV is replaced by Q1. CMS gave the contractors until April 7, 2008 to implement these changes.

Claims with a DOS prior to January 1, 2008 should continue to be submitted with the QR modifier.



March 23, 2008

NOPR Update: NOPR Confirms that FDG-PET Has Major Impact on Cancer Patient Management

National Oncologic PET Registry (NOPR) Data Confirm FDG-PET Has Major Impact on Management of Cancer Patient Care

Philadelphia - Clinicians changed the intended care of more than one in three cancer patients as the result of FDG-PET scan findings, according to a study of data from the National Oncologic PET Registry, published online March 24 in the Journal of Clinical Oncology (JCO) (see http://jco.ascopubs.org/cgi/reprint/JCO.2007.14.5631v1 and the acconpanying editorial at http://jco.ascopubs.org/cgi/reprint/JCO.2007.15.6935v1).

The study analyzed data regarding nearly 23,000 patients contributed to the NOPR by more than 1200 facilities nationwide providing positron emission tomography (PET) scans.

"The NOPR working group sought to measure the impact of PET findings on patient management in a manner minimally intrusive to care providers. This was critical for successfully collecting the large amount of data required for a robust analysis," said Bruce Hillner, M.D., lead author for the study and professor and eminent university scholar in the Department of Internal Medicine at Virginia Commonwealth University.

Sponsored by the Academy of Molecular Imaging (AMI) and managed by the American College of Radiology (ACR) and the ACR Imaging Network (ACRIN), the NOPR was designed to collect questionnaire data from referring physicians on intended patient management before and after a FDG-PET scan

The NOPR participating PET facility collects from referring physicians both a pre-PET questionnaire (documenting study indication, cancer type and anticipated stage, and planned management if PET were not available) and one of several post-PET questionnaires that assess the referring physician's planned management in light of the FDG-PET findings.

Analysis of data collected found that FDG-PET is associated with a 36.5% change in the decision of whether or how to treat a patient's cancer. NOPR working group co-chair R. Edward Coleman, MD, professor of radiology and chief of the Division of Nuclear Medicine at Duke University School of Medicine and an AMI founding member, comments, "We were especially surprised by the impact of the PET findings on patients who were originally planned to have a biopsy. The procedure was avoided in approximately three-quarters of these patients."

The NOPR was launched in May 2006 in response to the Center for Medicare and Medicaid Services' (CMS) novel "Coverage with Evidence Development" policy to collect data through a clinical registry to inform the center's FDG-PET coverage determination decisions for currently non-covered cancer indications.

Cancer types Medicare currently covers for reimbursement only through the NOPR include those of the ovary, uterus, prostate, pancreas, stomach, kidney and bladder. (For a complete list of NOPR covered cancer types and indications, go to the Indications Page.)

Oncologist and NOPR working group co-chair, Anthony Shields, MD, professor of medicine and oncology at the Karmanos Cancer Institute at Wayne State University and chair of ACRIN's Oncology Committee says of the research results, "These results confirm what we suspected from increasing experience with PET. However, we lacked the significant data required to prove the benefit of PET for many uncovered indications. It's very encouraging that oncologists and other clinicians may have access to the valuable information PET affords for ensuring the best patient care."

NOPR has formally asked CMS to reconsider the current National Coverage decision on FDG-PET and to end the data collection requirements for diagnosis, staging and restaging. Medicare will review the published data and determine the next steps related to reimbursement for PET scans now only covered through the NOPR. Barry Siegel, MD, FACR, professor of radiology and chief of the Division of Nuclear Medicine at the Mallinckrodt Institute of Radiology at Washington University and chair of ACRIN's PET Imaging Core Laboratory, also serves as an NOPR working group co-chair. "Based on these data, Medicare should strongly consider opening up the coverage to include diagnosis, staging and restaging for all cancers, states Dr Siegel."

The ACR and ACRIN worked to develop the NOPR in collaboration with registry sponsor, the Academy for Molecular Imaging since CMS announced its intent to support a PET registry in January 2005. The American Society of Clinical Oncology and the Society for Nuclear Medicine also have played key roles in guiding the project's development.



February 29, 2008

NOPR Billing Alert: CMS Posts Instructions Regarding Deletion of QR Modifier used for NOPR Claims - Effective January 1, 2008 Use Q0 Modifier

On Friday January 18, 2008, CMS released Transmittal R1418CP, CR 5805 notifying PET facilities and Medicare Administrator Contractors that the discontinued QR (and QA) and QV HCPCS modifiers are replaced by the new modifiers Q0 (zero) and Q1, respectively, to identify investigational and routine clinical services provided in a clinical research study approved by Medicare. These two new modifiers are included in the 2008 Annual HCPCS Level II Update. The CR 5805 instructions are to be implemented by the Medicare Contractors no later than April 7, 2008.

Specifically, effective for dates of service (DOS) on or after January 1, 2008, modifier QR currently used in the National Oncologic PET Registry (NOPR) is replaced with modifier Q0 (Zero). Additionally, QA is also replaced by Q0 and QV is replaced by Q1. CMS has given the contractors until April 7, 2008 to implement these changes; however, we anticipate that some contractors might be ready to accept these claims sooner. PET facilities are encouraged to update their charge-masters to include theses new modifiers. While all contractors are required to accept claims with the new modifiers as of April 7th, facilities are advised to check with their local contractors to ascertain the exact date the contractors' systems will be ready to process claims.

Claims with a DOS prior to January 1, 2008 should continue to be submitted with the QR modifier.

The NOPR investigators and staff are fully aware that participating PET facilities are understandably distressed by CMS' announcement late in 2007 that the QR modifier was being eliminated at the end of the year and that the new modifier would not be implemented until early in April 2008. We have expressed our concerns to CMS, but unfortunately that is all we could do, as these changes were entirely beyond our control.



December 31, 2007

NOPR BILLING ALERT - QR Modifier Deleted Effective 2008

The QR modifier used in conjunction with CPT and HCPCS codes to submit NOPR claims on the Medicare billing forms is deleted as of January 1, 2008. If you submit the QR modifier on or after January 1, 2008, your claims may reject. Additionally, following HIPPA rules, providers are required to use accurate coding for that date of service. CMS has not published the new billing instructions yet; therefore, PET facilities may want to consider holding NOPR claims until the CMS instructions are available. We will post the new information as soon as it is publicly available. We will also send out an alert once the transmittal is posted.



November 03, 2007

NOPR Update: Design & Analysis Plan Paper Published

The design and analysis plan of the National Oncologic PET Registry (NOPR) has been published in the November 1st issue of the Journal of Nuclear Medicine. It is available at: http://jnm.snmjournals.org/cgi/content/abstract/48/11/1901?etoc.

The paper, "The National Oncologic PET Registry (NOPR): Design and Analysis Plan," provides insight into the NOPR's development, workflow, and statistical design. It also details how the data collected by the over 1600 participating PET facilities will be evaluated and reported to the Centers for Medicare and Medicaid (CMS).



November 2, 2007

NOPR Update: Covered Indications

On August 23, 2006, the NOPR investigators reported that we had noted a number of studies included in the NOPR for which the type of cancer and the indication for the PET scan potentially should be covered by Medicare outside of the conditions of the registry. Nearly 4% of studies reported to the NOPR met these criteria at that time, and the types of problems encountered were reviewed in detail (see 8/15/07 News entry). We have continued to monitor the frequency of such cases in the NOPR and are still finding that such cases are being included, with relatively little change in the frequency since our prior notification

From a practical point of view, the results of our continued monitoring suggest that PET facilities still need to carefully review all clinical requests for PET in Medicare patients to determine whether the study is routinely covered or covered only under NOPR. Ultimately, it is up to the PET facility to make certain that it is submitting correct claims to Medicare. Please note that patients should not be registered in the NOPR for a covered indication because the ICD-9 code provided by the referring physician does not support medical necessity per the carrier's local coverage determination. [One recent example that has come to our attention is the denial of claims, by one carrier, submitted with ICD-9 codes 202.90 - 202.98 ("other and unspecified malignant neoplasms of lymphoid and histocytic tissue") for PET or PET/CT for lymphoma staging or restaging. Our advice in such cases is to check with the referring physician to determine whether a more precise ICD-9 code can be provided based on the pathologic classification of the lymphoma.] Such studies can be performed, and the claim appealed for medical necessity if it is rejected. If it is consistent with your facility's policy, patients can be asked to sign an Advance Beneficiary Notice (ABN) under these circumstances.

Additionally, we are aware that some carriers have imposed frequency limitations for certain PET or PET/CT studies done for covered indications. Registering patients who have exceeded the established frequency edits/limitations in the NOPR is not an appropriate way to overcome these frequency limitations. Review your local carrier's guidelines for the appropriate way to appeal these claim denials. Again, such patients can be requested to sign an ABN.

Please contact the NOPR investigators or staff at pet_registry@phila.acr.org if you would like further clarification of any of the issues addressed in this announcement.



September 20, 2007

NOPR Update: Referring Physician's Responsibilities for NOPR Participation

Under the terms of the CMS Coverage Policy for oncologic indications included in the NOPR, a beneficiary's PET study is eligible for CMS reimbursement only if the Pre-PET Form is completed and returned to the PET facility prior to the PET scan and the Post-PET Form is completed and returned within 30 days of the PET scan. The data collection forms consist of approximately 5 questions regarding the beneficiary's planned management and must be completed by the beneficiary's referring physician.

The obligations for the referring physician are found in the NOPR Operations Manual and Frequently Asked Questions section (see http://www.cancerpetregistry.org/clinicians.htm). In order to ensure the accuracy of the NOPR data, the referring physician has the obligation to provide the answer to the intended management question and review any responses prepared by ancillary personnel. The PET Forms can be returned to the PET facility via FAX, mail, or hand delivery with all entries completed and verified.

The Pre- and Post-PET Forms properly completed by the beneficiary's referring physician represent the critical data being collected by the NOPR, and failure to meet this obligation will jeopardize the quality of the data collected by the NOPR. Please direct any questions concerning this statement of referring physician responsibilities to NOPR staff by email at pet.registry@phila.acr.org or by calling (215) 717-0859.



August 15, 2007

NOPR Update: NOPR RSNA 2007 Presentations

NOPR Presentations at the 2007 Annual Meeting of the Radiological Society of North America (RSNA).


The initial results of the NOPR will be presented by Dr. Bruce Hillner in an RSNA scientific session on Sunday, November 25. 2007. In that same session Dr. R. Edward Coleman will present an overview of the NOPR and its data collection methods.
Date: Sunday November 25
Session Time: 10:45 - 12:15 PM;
Room: E353C
In addition, Dr. Barry Siegel will present an update on NOPR activities on Tuesday November 27, 2007 as part of the "RSNA Categorical Course in Diagnostic Radiology: Clinical PET and PET/CT Imaging". Those interested in this presentation should register for RSNA Refresher Course RC411."



May 24, 2007

NOPR Update: IMPORTANT NOTICE - Recording of the Region Scanned on the PET Completion From

In December 2006, the data collection procedures of the NOPR were changed to allow us to capture more information about the PET imaging procedure. Specifically, after that date, PET facilities were required to note on the PET completion form which one of the following characterized the study performed:
  1. body PET or PET/CT only (examination billed with one CPT code in the range from 78811 through 78816);
  2. dedicated brain PET only (examination billed with CPT code 78608); or
  3. body PET or PET/CT AND dedicated brain PET (examination billed with one CPT code in the range from 78811 through 78816 AND with CPT code 78608).
The purpose of this additional data collection was to allow us to identify those cases in which brain PET was performed, so that we could analyze the impact of PET brain imaging on management of cancer patients.

After the institution of this new data collection requirement, we found that the frequency of these three options was as follows: (1) body only - 92%; (2) brain only - 1%; and (3) brain + body -7%. The frequency in this latter category was considerably higher than we had expected, given the rather narrow circumstances under which combined body and brain PET imaging is indicated for patient management (see the guidance provided by the Society of Nuclear Medicine Coding and Reimbursement Committee at http://interactive.snm.org/index.cfm?PageID=5408&RPID= 1995).

To better understand how we would analyze the data in the third group (and to understand why this combination was occurring so frequently), we did a review of a random sample of the pre-PET forms and the PET reports of 53 patients said to have had both body and brain PET. We found that none of the reports described an indication for dedicated brain PET imaging. Moreover, the descriptions of the technique of the PET studies suggested that nearly all of the examinations were either skull-thigh body imaging (with extension of the scan field to the skull vertex) or whole-body imaging (vertex to toes). In fact, not a single report clearly described that a separate, dedicated brain acquisition was performed. If a dedicated brain PET study were done, this generally would be expected to be documented in the report, because of different patient preparation (uptake phase in a quiet dimly lit room), longer imaging time (typically 5-15 minutes for 3D and 20-30 minutes for 2D acquisition) usually with smaller pixel size (zoom), and different interpretation strategies for cancer indications (e.g., comparison or fusion with brain MRI).

Our findings suggest that one or more of the following problems may be occurring. Suggested corrections are noted, as well.
  • The individuals responsible for data entry at some PET facilities are answering this question on the Pre-PET Form incorrectly. We believe this is the most likely explanation in most of these cases. Accordingly, we request that staff at each PET facility review the procedures they are using to determine what specific PET procedures have actually been performed and will be billed to Medicare. In addition, we will be adding some further instructions about this on the PET Completion Form.
  • The dedicated brain PET studies were reported separately from the body PET studies, but only the body PET reports were uploaded to the NOPR database. We think this is unlikely based on the reports reviewed. However, we are requesting that PET facilities upload both brain and body reports when both have been performed. We will add a reminder to this effect on the Web screen for PET Report Submission Form.
  • The studies have been coded and billed incorrectly, e.g. the study was billed with CPT codes 78815 and 78608 when only billing for 78815 was justified based on the request from the referring physician and/or the technical details of the study performed and interpreted. If this is the case, it could present a compliance problem for the PET facility. Accordingly, we encourage staff at participating PET facilities to review their billing processes and the criteria they use to determine when to bill for dedicated brain PET. We further suggest that PET facilities forward a copy of this notice to individuals responsible for billing and compliance (and to the corresponding individuals in the physician practice, if professional-component billing is performed separately).
Finally, we are requesting that all participating PET facilities provide the NOPR with corrected information for any of the cases that were incorrectly designated as combined body/brain studies. This will need to done for the period since we began collecting this data on December 16, 2006 until the present. Specifically, if a case entry was designated as "Both Brain and Body PET" and should have correctly been designated as "Body PET", we are requesting that you send an email message to Sharon Hartson (shartson@phila.acr.org) with the following information:
  • your facility name;
  • your facility number; and
  • he case ID number(s) needing to be corrected.
If you are unable to identify cases that were coded incorrectly at your facility, you may send a request to Ms. Hartson, and she will send you a listing of all cases at your facility designated as "Both Brain and Body PET".

We hope this information is useful, and appreciate your cooperation in helping us to obtain the most accurate possible data for the NOPR. The NOPR Working Group.



February 21, 2007

NOPR Update: Patient & Referring Physician Information Sheets

As is discussed in detail on the NOPR website (http://www.cancerpetregistry.org/pdf/nopr_regulatory.pdf), the only entity considered to be engaged in the research conducted by NOPR is the NOPR itself. The NOPR investigators and staff are aware that some PET facilities have elected to have their own institutional review boards or privacy offices review the NOPR before the facility participates, typically as a matter of institutional policy requiring such review. The official NOPR Patient and Referring Physician Information Sheets (available at http://www.cancerpetregistry.org/forms.htm) have been approved by American College of Radiology Institutional Review Board, and must be used as the primary vehicles for obtaining patient and referring physician consent for use of NOPR data for research purposes. Institutional consent documents cannot be substituted for the official NOPR forms. However, if necessary, an addendum to the official NOPR documents may be provided to patients and/or referring physicians to incorporate any specific institutional requirements. For further information or clarification regarding this policy, please contact NOPR staff at pet_registry@phila.acr.org.



January 31, 2007

NOPR Update: Coding the Cancer Type on the Pre-PET Form

New instructions have been added to the Pre-PET Form and a new version has been posted to the NOPR Web site. The instructions for question 2.a Cancer Type (ICD-9 Code) state:
a. Cancer Type (ICD-9 Code) - check the one cancer that most closely relates to the specific reason for the PET study indicated in response to Question 1. (Check only one)

Note: The three-digit ICD-9 codes included on this form are for purposes of identifying the cancer type in the NOPR database, but the one selected is not necessarily the one that should be used for claim submission.
The revised Pre-PET Form also now includes a list of the ICD-9 codes that the database will accept if the "Other" box is checked for question 2.a.
Acceptable responses are 159, 165, 173, 181, 184, 192, 194, 195, and 235-238
We hope that this alleviates some of the questions that have arisen regarding the proper coding of the cancer type ID for the NOPR Pre-PET Form.



December 15, 2006

NOPR Update: Change to PET Completion Form

The PET Completion Form has been revised to capture information about the region(s) scanned for the PET study.
  • New Question 3 added:
    • 3. Region(s) Scanned (you must check only one)
      • Body Only (CPT 78811-78816)
      • Brain Only (CPT 78608)
      • Both Body AND Brain (CPT 78811-78816 AND 78608)
  • Original Question 3 renumbered as Question 4 and original Question 4 renumbered as Question 5.




October 22, 2006

NOPR Update: Consistency in the Completion of Pre-PET Forms

The purpose of this announcement is to request that PET facilities participating in the National Oncologic PET Registry (NOPR) routinely review their Pre-PET forms to ensure that the correct reason for the study has been selected. The rationale for this request is described below. If this review suggests that the reason selected might be incorrect, please contact the referring physician or his/her staff to verify that the response to this important question on the Pre-PET form is correct. A quality assessment review of initial data submitted to the NOPR has identified inconsistencies in the completion of the Pre-PET forms with regard to the responses to one of the questions on the Pre-PET Form. This question (Question 1) asks for the specific reason for the PET or PET/CT study; the reasons are listed below:
  • Diagnosis: To determine if a suspicious lesion is cancer
  • Diagnosis/Unknown Primary Tumor: To detect a primary tumor site in a patient with a confirmed or strongly suspected metastatic lesion
  • Diagnosis/Paraneoplastic: To detect a primary tumor site in a patient with a presumed paraneoplastic syndrome
  • Initial Staging of histologically confirmed, newly diagnosed cancer
  • Monitoring Treatment Response during treatment
  • Restaging after completion of therapy
  • Suspected Recurrence of a previously treated cancer
The most common error that we have identified is the selection of the "Diagnosis: To determine if a suspicious lesion is cancer" response on the Pre-PET Form, when the clinical PET report clearly shows that one of the other reasons is more likely. We believe that the inconsistency in selecting the appropriate response to this question occurs due to the incorrect assumption that since PET is a diagnostic test, the PET or PET/CT study is being performed for "diagnosis." The "Diagnosis: To determine if a suspicious lesion is cancer" response should be used ONLY for the initial diagnosis of a suspected cancer, and NOT for detection of a recurrence of a known cancer. The latter reason should be marked on the Pre-PET Form as "Suspected Recurrence of a previously treated cancer." Note that the Pre-PET form was recently modified to provide better definitions of the specific reasons for which PET examinations are requested. We anticipate this will help to reduce the frequency of these errors, but also request this review of submitted forms by participating PET facilities. If the correct reason for the study is not provided in Question 1, the evaluation of the NOPR data may result in incorrect conclusions about the impact of PET and PET/CT on patient management.

Thank you for your continuing support and interest in making NOPR a success.



October 7, 2006

NOPR Update: Changes to the PET Completion and PET Report Submission Forms and E-mail Reminders
  • The PET Completion and the PET Report Submission Forms have been changed. The question asking the name of the interpreting radiologist has been moved from the PET Completion Form to the PET Report Submission Form. This change is intended to prevent delays in the submission of the PET Completion Form when the name of the interpreting radiologist is not known until the PET report is completed.
  • As a further aid to the timely submission of time-critical data, due dates for future form submissions have been added to several of the e-mail reminders.
    • Pre-PET Form Submission Confirmation - the due date for the PET Completion Form has been added to this e-mail.
    • PET Form Reminder - the due date for the PET Completion Form has been added to this e-mail.
    • Post PET Form Reminder - the due date for the Post-PET Form has been added to this e-mail.




September 26, 2006

NOPR Update: Potential Limitations of FDG-PET for Cancers and Indications Covered by NOPR and Changes to the Indications Table

The following changes have been made to the NOPR Indications Table that is available on the NOPR Web site and in the NOPR Operations Manual, Appendix III:
  • A note concerning potential limitations of FDG-PET for cancers and indications covered by NOPR has been added:
    • IMPORTANT NOTE: The scientific evidence concerning the clinical utility of FDG-PET is generally less robust for cancers and indications that are currently covered by Medicare only in the NOPR than for cancers and indications that are currently covered without clinical data submission to the NOPR. For this reason, Medicare has conditioned coverage of FDG-PET under the NOPR on the collection of clinical data. These data will be used to help determine the clinical utility of FDG-PET for conditionally covered cancers and indications. The billing physician remains responsible for documenting medical necessity, which is required for the coding and billing of both covered and NOPR-eligible PET studies. Eligibility for the NOPR does not constitute a clinical management recommendation for the use of PET for the conditionally covered cancers and indications, by either the Medicare program or NOPR investigators. Referring and interpreting physicians are thus advised to refer to the published literature to better understand the potential limitations of FDG-PET for NOPR-eligible uses.
  • The entry for Male Breast Cancer has been changed to reflect its eligibility for inclusion into the NOPR, which is identical to that for Female Breast Cancer.
  • The following footnote was added for Diagnosis of both Female and Male Breast Cancer:
    • PET is non-covered for "Diagnosis" of breast cancer to evaluate a suspicious breast mass. However, a patient with suspected breast cancer is eligible for entry in NOPR for the indications (1) "Diagnosis: Unknown Primary Site" in a patient with axillary nodal metastasis but no evident primary breast cancer by conventional evaluation and (2) "Diagnosis: Paraneoplastic Syndrome".
  • A footnote was added for Anal Cancer eligibility:
    • Some Medicare carriers include anal cancer in their coverage of "colorectal cancer"; for PET facilities served by those carriers, PET for anal cancer diagnosis, initial staging, or restaging/suspected recurrence would be a covered indication.
  • A General Note was added:
    • GENERAL NOTE: PET imaging of the brain with CPT code 78608 for diagnosis, initial staging, treatment monitoring, or restaging/suspected recurrence of any type of cancer is covered only under NOPR.




September 13, 2006

NOPR Update: Empire Resolves NOPR Claims Processing Problems

The Society for Nuclear Medicine (SMN) has published information regarding the resolution of NOPR claims denials (QR modifier issues) for Empire CMS contractors on their Web site. For more information please go to: http://interactive.snm.org/index.cfm?PageID=5507&RPID=10.



September 12, 2006

NOPR Update: Patient Charges

NOPR has received reports of PET facilities charging patients for the $50 per-case NOPR registration fee at the time of the PET scan. This practice is inconsistent with the NOPR registration requirements set forth in the Operations Manual, and with the statute and regulations governing the administration of the NOPR.

Neither the NOPR Operations Manual, the January 2005 CMS National Coverage Determination announcing the NOPR, nor the statute and regulations governing the Medicare program, authorizes providers to charge the $50 per case registration fee to the Medicare beneficiaries participating in the NOPR. The Medicare statute provides that the program will pay 80% of the reasonable charges for covered services, and establishes a beneficiary copayment of 20%. The NOPR Operations Manual provides that facilities themselves shall pay the $50 per case fee through an escrow account established with the NOPR. CMS and NOPR administrators expect that facilities will bear this expense as a routine cost of doing business, and will not pass the charge on to patients.



September 8, 2006

NOPR Update: Changes to the Web Application

Several changes to the NOPR Web application will be implemented on Saturday, September 9th. The major changes are detailed below.
  • Case Registration Form - Scan Date - You will once again be able to enter the correct date if the scan date is the date of case entry.
  • Pre-PET Form - the ICD-9 code must be entered for all patients' whose cancer type (question 2a and 2c) is entered as "Other, or not listed." This was explained in greater detail in the NOPR Update of September 1, 2006 and the reminder sent on September 5, 2006.
  • PET Report Submission Form - The entry of text of less than 500 characters in the text box for the PET report will cause a pop-up window to appear asking for confirmation that the complete PET report has been entered.
There may be some temporary downtime on Saturday morning when these changes are being implemented. If you experience any problems please send an email to pet_registry@phila.acr.org.



NOPR Update September 1, 2006

Pre-PET Form Changes

ICD-9 Codes for "Other or Not Listed" Responses to Questions 2a and 2c
A review of the NOPR data has revealed that "Other or Not Listed" is being selected as the response to questions 2a (or 2c) on the Pre-PET Form for cancer types (or metastatic disease sites) that are already listed in the question 2a and 2c code tables. For example, Other or Not Listed is selected, and the text entry indicates "Renal cell carcinoma"; in this case, the proper choice should have been "Kidney and Other Urinary Tract (189)". To ensure accurate responses to questions 2a and 2c, the Pre-PET form has now been modified to require entry of the first 3 digits of the ICD-9 code for all cancer types or metastatic disease sites entered as "Other or Not Listed" for question 2a or 2c. The application will notify the user if the ICD-9 code for an "Other or Not Listed" entry is already included in the corresponding code table for that question.

A new version of the Pre-PET Form that includes the ICD-9 code entries for questions 2a and 2c is now available on the NOPR Web site. To give sites adequate time to begin collecting this additional information from referring physicians, the on-line application will not immediately require entry of the ICD-9 code data. We will notify all facilities when entry of data in this field becomes mandatory. However, we encourage all sites to begin using the revised hard-copy version of the Pre-PET Form and make it available to referring physicians immediately. This will ensure that ICD-9 code data will be available for patients whose Pre-PET Form information is entered on or after the actual date of implementation.

New Instructions: Specific Reasons for PET Study, Pre-PET Form, Question 1
New instructions have been added to the Pre-PET Form to aid referring physicians in choosing the correct category for Question 1: Specific Reason For PET Study.

Revised Materials on NOPR Web Site
New versions of the NOPR Operations Manual and Case Report Forms are available on the NOPR Web site. They have been changed as indicated below.

Operations Manual
  • Revised to emphasize that the PET Completion Form must be entered in the database within 14 days of case registration. Revised sections include: Schema, Section 7.0, and Appendix I.
Pre-PET Form
  • A section, "Covered Indications for PET Scans and Limitations/Requirements for Usage," has been added to the instructions for question 1, "Specific Reason for PET Study."
  • Question 2a and 2c revised to collect the ICD-9 code for all cancer types or metastatic disease sites entered as "Other or not listed."




NOPR Update August 28, 2006

Paraneoplastic Syndromes

The National Oncologic PET Registry (NOPR) was designed to evaluate the impact of PET and PET/CT on the ordering physicians' plans for intended patient management. One use of PET being evaluated by the NOPR is its role as a diagnostic tool in patients who present with so-called paraneoplastic syndromes (see below). During an early review of the data submitted to the NOPR, the investigators found that the reason for the scan indicated on the Pre-PET Form was "Diagnosis/Paraneoplastic (To detect a primary tumor site in a patient with a presumed paraneoplastic syndrome)" in approximately 1.3% of all studies. A review of a sample of such cases was undertaken to learn more about the specific types of patients being referred for this indication. Based on an assessment of PET reports, we found in nearly half of the reviewed cases that the PET study was probably not ordered to evaluate a suspected paraneoplastic syndrome. In addition to the potential impact of this problem on the quality of the NOPR data used to evaluate this specific indication for PET, it also could have practical implications for payment of PET facilities for these studies. This is because most PET scans ordered for "Diagnosis", including those ordered for indications currently covered by Medicare, will be submitted for payment with an ICD-9 code for a symptom or sign, rather than one for a diagnosed cancer. These ICD-9 codes will generally not be in the list of codes that a carrier designates as documenting the medical necessity of the PET study. Hence, in many such cases, the claim is initially rejected for payment, and is only paid on appeal if the study is judged to be medically necessary. It is thus important to be sure that PET studies ordered for "Diagnosis" are medically appropriate and that the rationale for the study is clearly documented in the PET report.

To assist staff at PET facilities to evaluate studies requested for "Diagnosis/Paraneoplastic", the following brief review of these conditions is provided below.

Paraneoplastic Syndromes
Different cancers may produce signs and symptoms at sites distant from the primary tumor or its metastases. These signs and symptoms, including their laboratory test manifestations, are referred to as paraneoplastic syndromes.

Paraneoplastic syndromes can be characterized by primary organ or system affected: endocrine, hematological, gastrointestinal, renal, cutaneous or neurological syndromes.

The two most frequent endocrine paraneoplastic syndromes are hypercalcemia in cancer patients without known osseous metastases and the syndrome of inappropriate antidiuretic hormone (SIADH).

The most common cause of hypercalcemia in patients with nonmetastatic solid tumors and in some patients with non-Hodgkin's lymphoma is secretion of parathyroid hormone-related protein (PTHrP). Humoral hypercalcemia should be suspected as the cause of hypercalcemia in any patient with a solid tumor in the absence of bony metastases. It should also be suspected in patients with otherwise unexplained hypercalcemia and a low serum PTH concentration. Patients with PTHrP-induced hypercalcemia typically have advanced cancer and a poor prognosis. Thus, a nonmalignant disorder is more likely in a patient with chronic hypercalcemia.

SIADH is a well-described syndrome most commonly associated with small cell lung cancer (SCLC) and, less often, with non-small cell lung cancer and head and neck cancers. SIADH is a diagnosis of exclusion. The cardinal features of SIADH are water intoxication, hyponatremia, a decreased serum osmolarity, and an inappropriate elevation of urine osmolarity in a patient who is clinically euvolemic. In most situations, identifying the primary cancer site is not difficult.

While anorexia and cachexia are universal problems in advanced cancer patients, protein-losing enteropathies, defined as a disorder of excessive loss of serum proteins into the GI tract, is an uncommon but well defined paraneoplastic condition. AIDS-associated Kaposi sarcoma, as well as Waldenstrom's macroglobulinemia, and Hodgkin's and non-Hodgkin's lymphomas are the most cancers causing protein-losing enteropathy.

Renal manifestations of nonrenal cancer are much more often due to treatment related toxicities (chemotherapy, radiation, antibiotics, analgesics, and radiographic contrast) than paraneoplastic syndromes. The two dominant forms of paraneoplastic syndromes are tubular interstitial diseases in lymphomas and leukemias and membranous nephropathy associated with most common solid tumors. Again, it is infrequent that the renal paraneoplastic syndromes are the first manifestation of a patient's cancer.

There are a wide variety of cutaneous syndromes that are associated with malignancies; these may precede, be concurrent with, or follow the discovery of the underlying malignancy. The initial evaluation of a patient with a biopsy-confirmed skin condition associated with cancer is a standard detailed history and physical examination with routine laboratory testing and chest radiographs. Further specific testing should be guided by an expert dermatologist.

Most cancer patients have some mild degree of neuromuscular dysfunction usually in the form of myopathy or peripheral neuropathy. However for most solid tumors, the incidence of paraneoplastic neurologic syndromes is less than 1%.

The more common syndromes are Lambert-Eaton myasthenic syndrome , which affects about 3% of patients with SCLC, and myasthenia gravis, which affects 15% of all patients with thymoma. The list of uncommon neurologic syndromes is long including subacute cerebellar degeneration, peripheral sensory and motor neuropathies, and encephalitis. Most of these syndromes are due to an autoimmune reaction associated with a wide variety of paraneoplastic autoantibodies. Paraneoplastic peripheral neuropathies affect 5% to 15% of patients with plasma cell dyscrasias associated with malignant monoclonal gammopathies. More than 50% of patients with the rare osteosclerotic form of myeloma develop a predominantly motor paraneoplastic peripheral neuropathy. Patients with all forms of myeloma, but usually the osteosclerotic type, can develop a severe, symmetric, sensorimotor neuropathy with muscle atrophy in association with the POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin).

Polymyositis, an inflammatory myopathy, that may be accompanied by skin lesions (dermatomyositis) occurs as a paraneoplastic syndrome associated with breast, lung, and GI tract cancers.

Role of PET and PET/CT in Paraneoplastic Syndrome
The role of PET and PET/CT in patients with paraneoplastic syndromes is still being evaluated. Several small studies have demonstrated that PET and PET/CT can detect an occult primary cancers as the cause of the paraneoplastic syndrome in some patients (1,2). Many patients with paraneoplastic syndromes have negative PET scans or false-positive PET scans (3). At this time, the NOPR Working Group does not recommend PET or PET/CT as the initial imaging procedure in a patient with paraneoplastic syndrome. For most suspected paraneoplastic syndromes, conventional imaging (e.g., CT) should be used first to detect an underlying malignancy. If the conventional evaluation is negative or equivocal, a PET or PET/CT scan may be indicated in an effort to detect an occult primary malignancy. If the CT scan is abnormal and suggests an etiology for the paraneoplastic syndrome, a PET or PET/CT scan may be indicated to confirm this finding, to find the most readily accessible tumor focus for biopsy confirmation, and to stage more completely the presumptive malignancy detected by CT.

References
  1. Berner U, Menzel C, Rinne D, et al. Paraneoplastic syndromes: detection of malignant tumors using [(18)F]FDG-PET. Q J Nucl Med 2003; 47:85-9.
  2. Rees JH, Hain SF, Johnson MR, et al. The role of [18F]fluoro-2-deoxyglucose-PET scanning in the diagnosis of paraneoplastic neurological disorders. Brain 2001; 124: 2223-31.
  3. Younes-Mhennia S, Janier MF, Cinotti L, et al. FDG-PET improves tumour detection in patients with paraneoplastic neurological syndromes. Brain 2004; 127:2331-8.




NOPR Update August 23, 2006

Covered Indications

Based on an early review of the data coming into the NOPR, the NOPR investigators have noted a number of studies for which the type of cancer and the indication for the PET scan potentially should be covered by Medicare outside of the conditions of the registry. Nearly 4% of studies reported to the NOPR met these criteria. Because of this, the NOPR investigators did a more complete audit of a random sample of these studies, reviewing the Pre-PET Forms and the actual PET Reports. The findings of this analysis are reported below.

Approximately 40% of these cases appear to be eligible for coverage by Medicare outside of NOPR. An additional 26% of cases, obtained for cancer diagnosis, also appear to be eligible for coverage by Medicare outside of NOPR. However, the nature of these cases (based on the clinical reports) is such that payment likely would have required a medical necessity review/appeal after an initial rejection of the claim. This is because it appeared that proper ICD-9 coding of these claims would have required a "non-cancer" ICD-9 code as the reason the patient was being referred for PET to diagnose cancer (for example, a patient with lymphadenopathy being referred to diagnose suspected lymphoma).

In a few cases, we were unable to make a determination of eligibility because the patients had anal cancer; some carriers consider anal cancer as a covered indication (included in the colorectal cancer group), and others do not (in those jurisdictions, anal cancer cases would need to be registered to NOPR). In other cases, we were unable to make a determination because the patients were undergoing initial staging for cervical cancer, and the report did not indicate whether pre-PET CT or MRI had been performed to document the absence of extrapelvic metastatic disease (as is required for routine coverage).

In about 10% of cases, the report indicated that the patient had small cell lung cancer, but the Pre-PET form incorrectly indicated that the cancer type was non-small cell lung cancer.

In only about 10% of cases was it completely clear that the patient had been correctly registered to NOPR.

From a practical point of view, the results of our audit suggest that PET facilities need to carefully review all clinical requests for PET in Medicare patients to determine whether the study is routinely covered or covered only under NOPR. We are aware that many referring physicians have begun to submit a Pre-PET form for all of their Medicare cases (to save time just in case one may be required), but ultimately it is up to the PET facility to make certain that it is submitting correct claims to Medicare. We would greatly appreciate special attention by the staff at PET facilities to the important distinction between small cell lung cancer and non-small cell lung cancer.

We are considering making modifications to the data-entry software on the NOPR web-site to alert users when they enter a cancer type/indication pair on the Pre-PET Form that could be a routinely covered indication. In addition, the Society of Nuclear Medicine will soon issue some guidance regarding the appeals process for studies that are rejected because they do not meet the carrier medical-necessity (ICD-9 code) criteria. This guidance will apply both to routinely covered indications and to studies done under NOPR (most often PET studies done for Diagnosis).

Please contact the NOPR investigators or staff at pet_registry@phila.acr.org if you would like further clarification of any of the issues addressed in this announcement.



NOPR Update August 13, 2006

Claims Denials for CMS Noridian & Empire Contractors

The Society for Nuclear Medicine (SMN) has published information regarding NOPR claims denials (QR modifier issues) for Noridian and Empire CMS contractors on their Web site. For more information please go to: http://interactive.snm.org/index.cfm?PageID=5457



NOPR Update July 13, 2006

Physician Payment for NOPR PET Registry Participation

Neither the NOPR Operations Manual nor the January 2005 National Coverage Determination announcing the Department of Health and Human Service's authorization of a PET registry, provide for the payment of physicians for their time spent completing case report forms. Providers are required to pay to the NOPR a one-time registration fee of fifty dollars. Any payments to physicians by providers or others intended to compensate physicians for their time must comply with state and federal law, including kickback laws, which impose limits on the solicitation, receipt, offer or payment of any form of remuneration in exchange for arranging, recommending or furnishing any item or service that may be paid under certain health care programs. Any questions regarding the appropriateness of payments for physicians should be directed to your own compliance personnel or your counsel.



NOPR Update - July 6, 2006

Effective July 8, 2006 the NOPR is changing its procedure for routing the Pre- and Post-PET Forms to referring physicians.

Beginning on July 8, NOPR will no longer send e-mails to the referring physician. We will continue to send the Pre- and Post-PET Forms by e-mail to the PET facility and it will be the PET facility's responsibility to deliver (by hand, fax, or mail) the forms to the referring physician for completion. To aid in their delivery, the NOPR will also e-mail the PET facility a pre-populated fax cover sheet for use in sending the forms to the referring physician. (As before, the Pre-PET Form will not be included in the confirmatory e-mail after patient registration if the PET facility indicates that it has already received a completed Pre-PET Form from the referring physician at the time of patient registration.) Also effective on July 8, all e-mail transmissions from the NOPR will no longer contain patient names or birthdates. We are making these changes to ensure the highest degree of security for patient protected health information.

In addition, several changes have been made to the Operations Manual, Patient and Physician Information Sheets (consent documents), and the data collection forms. These changes are listed below. Please make sure to download the latest copy of these materials - all now have a version date of 6/29/06. If you have previously distributed copies of any of these documents (e.g., the Patient Information Sheet or the Pre-PET Form) to referring physicians, these physicians or members of their staff should be provided with the new versions (or download them form the NOPR web site) and asked to discontinue use of the old versions of these forms.
  • Patient Information Sheet - updated to include contact information for questions concerning research subjects' rights and research-related injury. An updated version of the Spanish translation will be posted when available.
  • Physician Information Sheet - updated to include:
    • Notification that records will be stored "permanently".
    • Notification of right to withdraw from, or not participate in, the study with no loss of benefits.
    • Contact information for questions concerning research subjects' rights and research-related injury.
  • Case Registration Form
    • Clarification of question 1, "Ethnicity." Added: [Note: "Hispanic" is defined as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.]
    • Referring physician e-mail address will no longer be collected.
  • Pre-PET Form
    • Revised to reflect the new delivery procedures described above.
    • Question 1, Specific Reason for PET Study. Answer for "Diagnosis/Unknown Primary Tumor" amended to read: "To detect a primary tumor site in a patient with a confirmed or strongly suspected metastatic lesion (answer 2c)"
    • Question 2.c - Amended to read: "Unknown primary: site of pathologically proven or strongly suspected metastatic disease (196-199)"
    These changes will allow for inclusion of patients where pathologic confirmation of metastatic disease is not possible or not in the patient's best interest. The most common example of this situation would be a patient presenting with multiple brain lesions seen on MRI that are most consistent with metastases, and without an apparent primary cancer after a conventional diagnostic assessment. In this situation, PET is typically ordered not only to find the occult primary tumor, but also to find a more accessible site for biopsy.
  • Post-PET Forms - revised to reflect the new delivery procedures described above.
  • HIPAA Compliance and IRB Approval for the NOPR (Appendix IV)
    • Revised to reflect the new Pre- and Post-PET Form delivery procedures
    • Added ACR IRB "Statement Regarding Use of Individual Protected Health Information in NOPR"
  • Operations Manual - updated to incorporate all changes listed above. Revised sections include: Schema, Section 5.0 Registry Workflow, Appendix I, Appendix II, and Appendix IV.

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