NOPR Operations Manual - The National Oncology PET Registry

Transcription

The National Oncologic PET Registry (NOPR):
Development, Design and Methods of Data Collection, and Analysis
NOPR Operations Manual
Sponsored by: Academy of Molecular Imaging
Managed by: American College of Radiology
American College of Radiology Imaging Network
Endorsed by: American College of Radiology
American Society of Clinical Oncology
Society of Nuclear Medicine
Advisor: Centers for Medicare and Medicaid Services (CMS)
NOPR Working Group
Chair
Bruce Hillner, M.D.
Virginia Commonwealth University
(804) 828-5129
[email protected]
Co-Chair
Barry A. Siegel, M.D.
Washington University
(314) 362-2809
[email protected]
Co-Chair
R. Edward Coleman, M.D.
Duke University
(919) 684-7244
[email protected]
Co-Chair
Anthony Shields, M.D.
Wayne State University
(313) 576-8735
[email protected]
Statistician
Fenghai Duan, Ph.D.
Center for Statistical Sciences
Brown University
(401) 863-2175
[email protected]
Epidemiologist
Ilana Gareen, Ph.D.
Center for Statistical Sciences
Brown University
(401) 863-1758
[email protected]
NOPR Operations Office
American College of Radiology
1818 Market Street, Suite 1600
Philadelphia, PA 10103
(215) 717-0859
Version Date: November 30, 2009
Case Report Forms Version Date:
November 30, 2009
ClinicalTrials.gov Identifier NCT00868582
Version: November 30, 2009
(Page last revised November 30, 2009)
National Oncologic PET Registry
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Table of Contents
Schema
Abstract
1.0
Objectives
2.0
Introduction
3.0
PET Facility Eligibility & Registration
4.0
Patient Eligibility & Registration
5.0
Registry Workflow
6.0
Registry Specifications
7.0
NOPR Web Site & Data Collection
8.0
Endpoint Definitions
9.0
Statistical Considerations
10.0
References
Appendix I
Workflow & Programming Requirements
Appendix II
Case Report Forms
Appendix III
Eligible Indications Table
Appendix IV
HIPAA Compliance and IRB Review Requirements
Appendix V
Resources for Project Management, Data Security and Quality Assurance
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National Oncologic PET Registry – Schema
Referring Physician
PET FACILITY
• Registers Patient via Web
Patient Registration Form
• Refers Patient to
PET Facility
PET Registry Database
at ACRIN HQ
• Sends Confirmation E-Mail*
• Sends Pre-PET Form*
• Confirms Referring MD
Received Pre-PET Form
• Completes Pre-PET Form
(can use blank form)
• Returns it to PET Facility
• Enters Pre-PET Form
in Database by
Midnight of Scan Day
• Reminder Sent q 7 Days if
Pre-PET Form not Received*
• Gives Patient the Patient Information Sheet n
PET must be done and PET
Completion Form must be
entered within 14 calendar
days of patient registration
• Performs PET
• Notifies Database via
PET Completion Form
• Sends Report to Referring MD
• Sends Report and Records If Patient gave
Consent to Database via PET Report Form
• Reviews PET Report
• Completes Post-PET
Form, Indicates if Consent
Giveno, and Returns it to
PET Facility
Post-PET Form must be entered
within 30 calendar days of PET
• Contacts Referring MD if
Post-PET Form not
received by Day 14
• Enters Post-PET
Form into Database
• Case Complete
• CMS Invoiced
• Reminder E-mailed q 7 Days
if PET Completion or Report
Forms not Received
• Sends Appropriate Post-PET
Form Based on Pre-PET
Indications*
• Reminder Sent q 7 Days if
Post-PET Form not
Received*
• E-mails Case Completion
Notice
• Data Sent to CMS Quarterly
• Research Subset Createdp
• Pre- and Post-PET forms can be sent to and from the referring physician via FAX, mail, or hand delivery.
• All forms are entered into the database by the PET Facility. All forms must be entered within 30 calendar days
of the PET scan for the case to be eligible for CMS reimbursement.
* E-mailed to PET Facility
n Patient Information Sheet asks patient for oral consent to use data for research purposes. The Patient Information
Sheet can be given to the patient at any time prior to the PET scan.
o Referring physician is asked to provide consent for use of treatment management data in research.
p All data sent to CMS. Data included in research dataset only if BOTH patient and referring MD information sheets
are given.
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Abstract
The National Oncologic PET Registry (NOPR) [http://www.cancerpetregistry.org/] was developed and began
collecting data in 2006. The NOPR was created in response to the Centers for Medicare and Medicaid Services
(CMS) proposal to expand coverage for positron emission tomography (PET) with F-18 fluorodeoxyglucose
(FDG) to include cancers and indications not eligible for Medicare reimbursement at that time. Medicare
reimbursement for these cancers became available if the patient's referring physician and the provider submit
data to a clinical registry to assess the impact of PET on cancer patient management (“coverage with evidence
development” [CED]).
Any PET facility that is approved to bill CMS for either technical or global charges can apply to participate in
the NOPR. Medicare beneficiaries who are referred for PET for essentially all oncologic indications that are
not currently reimbursable under Medicare are eligible to participate in the NOPR.
The PET facility is responsible for collecting and entering patient data into the Registry database through a web
application at http://www.cancerPETregistry.org/.
The case 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 NOPR database will notify the PET facility when all case data have been entered. The PET facility can then
bill CMS for the study.
NOPR data collection has been designed to be fully compliant with the requirements for protection of patient
confidentiality required by HIPAA. The primary goal of this registry is to provide CMS with data needed to
make payment determinations and is not considered research. All data entered in the registry database will be
delivered to CMS as part of its payment determination process. The, secondary, or research, goal of the NOPR
is to assess the effect of PET on referring physicians’ plans of intended patient management across the spectrum
of the expanded cancer indications. The subjects of the NOPR research, patients and referring physicians, can
consent (or not) to allow their data to be used for purposes of the research being conducted at NOPR, just as
subjects can consent to being involved in research conducted through a survey or other similar activity at any
institution. The dataset used by NOPR investigators will contain only the data of patients and physicians when
both have consented to have the data included.
The NOPR officially began accepting patient registrations on May 8, 2006. During nearly three years of
operation, over 100,000 patients have undergone PET under NOPR’s mechanism that allows for Medicare
coverage of these scans. The NOPR investigators have published several peer-reviewed manuscripts
documenting the impact of PET on referring physicians’ intended management in patients with cancer. Based
in part on these results, the NOPR investigators asked CMS in March 2008 to reconsider its coverage policy for
PET. On January 6, 2009, CMS released its draft coverage decision related to PET that proposes major changes
to current coverage (http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=218). In response to this
proposal, the NOPR investigators have revised the registry based on the proposed changes in coverage and to
conform to additional requirements for a new CED program. On April 3, 2009, CMS announced its new
coverage policy (http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=218). Under this new policy,
CMS expanded coverage for the use of PET for initial evaluation of patients with cancer to nearly all cancer
types and also allows for use of PET in subsequent treatment strategy evaluations for an expanded number of
cancers. However, for certain other cancers, the use of PET in initial treatment strategy evaluations and,
particularly, in subsequent treatment strategy evaluations will still be covered by CMS only if patients are
enrolled in an approved clinical trial or registry. The NOPR has sought and obtained CMS approval to continue
its data collection to allow for coverage of PET scans performed for these cancers and indications under this
successor CED program. CMS announced a further expansion of coverage for initial staging of cervical cancer
on November 10, 2009, and the NOPR data collection has been altered accordingly
(https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=232&).
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This manual addresses the structure and goals of the revised NOPR program effective November 10, 2009.
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1.0 Objectives
1.1 Primary objective
To assess the effect of FDG-PET on referring physicians’ plans of intended patient management of patients
with cancer types eligible for inclusion in the National Oncologic PET Registry.
1.2 Secondary objectives
1.2.1 To confirm by linking NOPR data to Medicare claims the extent to which physicians’ plans of
intended patient management match the management received by patients.
1.2.2 To assess the effect of FDG-PET on referring physicians’ plans of intended patient management in
relation to:
1.2.2.1
Specific type of cancer
1.2.2.2
Specific indication for FDG-PET
1.2.2.3
Patient performance status
1.2.2.4
Physician’s role as provider of cancer treatment
Data will be collected from the referring physician before and after the FDG-PET study. If complete and timely
data are reported to the National Oncologic PET Registry within 30 days of the PET scan, the PET facility and
interpreting physician (nuclear physician/radiologist) will be eligible for reimbursement by CMS (see Appendix
I).
2.0 Introduction
2.1 Background, Context and Rationale
Positron emission tomography (PET) performed with the radiopharmaceutical F-18 fluorodeoxyglucose (FDG)
is a minimally invasive diagnostic imaging procedure that allows for the assessment of regional glucose
metabolism in normal and diseased organs and tissues. It is used for evaluation of various neurological and
cardiac disorders, as well as for diagnosing, staging and restaging, and treatment monitoring of many different
cancers. Its use in cancer imaging is based on the principle that most malignant neoplasms exhibit increased
utilization of glucose (and accordingly, increased uptake of FDG) by comparison with normal tissues.
Currently, most FDG-PET studies in the United States are performed using integrated PET/computed
tomography (CT) scanners that provide both metabolic and anatomic images in a single examination. In this
manual of operations, the acronym PET, when used, refers exclusively to FDG-PET or FDG-PET/CT,
collectively.
Beginning in 1998, the Centers for Medicare and Medicaid Services (CMS) established coverage for PET for
two specific indications in lung cancers. Other indications and other cancers have been approved for coverage
since then. On 28 January 2005, CMS issued a decision memorandum (CAG-00181N) establishing coverage of
PET for initial staging of newly diagnosed cervical cancer subsequent to conventional imaging that is negative
for extra-pelvic metastasis. Additionally, CMS indicated its intent to establish coverage for PET for essentially
all other cancers and indications when the provider is participating in and patients are enrolled in one of certain
prospective clinical studies (“coverage with evidence development”). Based on subsequent communications
with CMS, one such acceptable project type would be a prospective registry that would collect information on
patients undergoing PET for cancers and indications not presently covered by CMS. Accordingly, the National
Oncologic PET Registry (NOPR) was developed as a means to obtain coverage from CMS for PET for these
cancers and indications and to provide CMS with data it can use subsequently to determine whether it is
reasonable and necessary to provide coverage for these additional cancers and indications outside of the
controlled conditions of participation in a national registry.
In January 2009, CMS proposed expanded coverage (CAG-00181R for PET to include payment for one PET
scan to help with initial treatment decision making for patients with a wide range of solid tumors (with only a
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few exclusions).
Additionally, CMS proposed to continue or provide coverage for PET performed for
subsequent treatment strategy evaluation (restaging, detection of suspected recurrence and treatment
monitoring) for several cancer types. However, CMS has determined that coverage under the CED program
will still be required for PET scans for subsequent treatment strategy evaluation for all other cancer types, and
for initial treatment strategy evaluations in some patients with cervical cancer and in patients with leukemia.
The proposed policy was finalized as a National Coverage Determination on April 3, 2009 (CAG-00181R).
On November 10, 2009, CMS announced a further change to the National Coverage Determination, providing
coverage for initial staging of cervical cancer in all cases, thereby lifting the previous restriction to use of PET
in patients who had undergone prior CT or MRI and were found to have no evidence of extrapelvic metastatic
disease (CAG-00181R2). At the same time, use of PET for diagnosis of cervical cancer was determined to be a
nationally noncovered service.
This manual of operations outlines the mechanics and clinical specifics of the data that will be collected and
subsequently analyzed by the registry. The Registry is sponsored by the Academy of Molecular Imaging (AMI)
and managed by the American College of Radiology through the American College of Radiology Imaging
Network (ACRIN). The Registry is endorsed by the ACR, the American Society of Clinical Oncology and the
Society of Nuclear Medicine. CMS is an advisor to the Registry.
2.2 Prior NOPR Findings (2006-2009)
Impact of PET on Patient Management. The NOPR investigators have published a series of peer-reviewed
publications addressing the impact associated with PET on referring physicians’ intended management.
A report using the first year of data, from nearly 23,000 scans, collected in NOPR demonstrated clinicians
changed the intended care of more than one in three cancer patients as the result of PET scan findings. In
patients with planned biopsy before PET, biopsy was avoided in approximately 70%. If the pre-PET strategy
was treatment, the post-PET strategy involved a major change in type of treatment in 8.7% and in goal of
treatment in 5.6%. When intended management was classified as either treatment or nontreatment, the post-PET
plan was three-fold more likely to lead to treatment than to nontreatment (28.3% v 8.2%). 1
In a subsequent paper, the NOPR researchers analyzed data for over 40,000 PET studies performed at 1,368
facilities participating in the NOPR during the registry’s first two years. The focus was on the individual cancer
type. The impact of PET was assessed for 18 specific cancer types in patients with pathologically confirmed
cancer for initial cancer staging, restaging, or detection of suspected cancer recurrence. When intended
management was classified as treatment or nontreatment, physicians changed their intended management for
38.0% of cases. Comparisons across testing indications revealed that only in multiple myeloma did PET have a
consistently greater impact on intended management by comparison with other cancers. When the intended
management plan before PET was treatment, a change in the intent of treatment (curative vs. palliative) or a
major change in the modality of treatment occurred at similar frequencies across different cancer types. The
investigators concluded that the impact of PET on physicians’ intended management for patients with known
cancer was consistent across cancer types.2
Lastly, the NOPR team reported two years of data from over 8000 patients having PET done as part of
treatment monitoring of chemotherapy, radiation therapy or combined modality therapy. Ovarian, pancreatic
and lung cancers accounted for 37% of the cohort. In 54% of scans, the pre-PET summary stage of patients
participating was metastatic disease in 54%. If PET had not been available, then the pre-PET plan would have
been other imaging (53%), ongoing treatment (41%), or biopsy or watching (6%). Change in the post-PET
intended management was similar in the imaging and treatment groups: 26% to 28% of scans led to switching to
another therapy, and 16% to 19% scans led to adjustment of the dose or duration of therapy. Changes in
management were more frequent if the referring physician judged that the post-PET prognosis was worse rather
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than improved or unchanged (78% vs 40%). 3
3.0 PET Facility Eligibility and Registration
Table 3 lists the eligibility criterion, fees, and initial registration information required from each participating
PET Facility.
Table 3: PET Facility Eligibility and Registration Requirements
Eligibility
PET facility in good standing approved to bill Medicare.
The entity applying as a PET facility should be the entity that bills
Medicare for either the technical charges or the global charges for PET
studies. Mobile PET providers must submit a separate application for each
location of service. The PET facility must submit an executed business
associate agreement (BAA) to the NOPR before patient registration can
begin. The required BAA is available on the NOPR Web site.
Fees
$50 initial facility registration fee
$50 per case registered (prepaid)
PET Facility Information
Name of Imaging Center and entity responsible for payment
Address, Telephone number, FAX number
Fixed or Mobil Scanner; Hospital or Free Standing
PET Facility Administrator Name and e-mail address of individual who will serve as official point of
contact for correspondence
Physicians interpreting
Names, UPINs
PET scans
Staff eligible to register
Names, e-mail addresses
patients and enter data
Equipment description
Scanner Designation (if facility has more than one scanner)
Manufacturer and Model
4.0 Patient Eligibility
Except as noted by the following exclusions, all Medicare beneficiaries who are referred for PET for oncologic
indications are eligible to be included in the NOPR (see Appendix III).
4.1 Exclusions
4.1.1 PET for cancer type and specific indication currently designated as a covered service by the
Medicare program. (See Appendix III).
4.1.2 PET for cancer type and specific indication currently designated as a non-covered service by the
Medicare program. The current specific exclusions are PET performed for breast cancer diagnosis
or initial staging of axillary lymph nodes, initial staging of regional lymph nodes in malignant
melanoma, diagnosis and initial staging of prostate cancer., and diagnosis of cervical cancer
4.1.3 PET performed as part of a clinical trial approved by CMS
5.0 Registry Workflow
The schema (page 3) presents a diagram of the tasks that a participating PET facility and the referring physician
must fulfill in order to obtain CMS reimbursement for patients receiving a PET scan for one of the registry
indications, (i.e., a study requested on a Medicare beneficiary with a cancer or for an indication not presently
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covered by CMS). Appendix I contains an expanded narrative description of the NOPR workflow and
programming requirements and Appendix II contains the case report forms.
5.1 Patient Registration
When a referring physician contacts a PET facility to schedule a patient for a PET scan that is eligible for
inclusion in the Registry, the PET facility will register the case in the database via a secure Web-based
application by providing identifying information about the patient and referring physician on the Patient
Registration Form. The database will issue a unique registry case number for that patient and send a
confirmation e-mail to the PET facility.
At some time before the PET study, or when the patient arrives for the PET scan, the PET facility will provide
the patient with the ACR IRB approved standard NOPR Patient Information Sheet that is posted on the NOPR
Web site. The patient will be able to contact the NOPR directly for more information, if necessary. The patient
will indicate his or her consent verbally to staff at the PET facility, either on the day of the PET study or by
telephone within two working days after the PET study is completed. Written consent is not required. The PET
facility will note in the database, on the PET Report Form, if the patient gave or withheld consent for use of his
or her data in future NOPR research.
5.2 Pre-PET Form Submission
In addition to the confirmation e-mail sent to the PET facility, if the PET facility indicates on the Case
Registration Form that the Pre-PET Form has not yet been received, the NOPR will also send the PET facility a
case-specific fax cover sheet and Pre-PET Form. These materials can be used to notify the referring physician
that the PET scan will be done under the conditions of the Registry, and that he/she will be required to complete
both a Pre-PET Form and a Post-PET Form in order for the procedure to be covered by CMS. The referring
physician must complete and sign the Pre-PET Form and deliver it to the PET facility for entry into the
database by the PET facility by midnight on the day the scan is performed or the case will be declared
ineligible. The referring physician may also download a blank Pre-PET Form from the NOPR Web site and
send the completed and signed form with the initial patient referral to the PET facility. For all cases, the paper
Pre-PET Form that is completed and signed by the referring physician must be retained by the PET facility as a
source document (and as a document that a Medicare intermediary may require in the event of an audit).
The data to be collected in the Pre-PET Form and Post-PET Form are compared in Table 5. The Pre-PET
Form will collect the following information: (1) the specific reason for the PET study; (2) the patient’s cancer
type (if known) and working stage assessment; (3) the patient’s ECOG performance status; (4) whether or not
the referring physician will also be the treating physician; (5) the referring physician’s assessment of ongoing
treatment, if treatment monitoring is the reason for the scan; and (5) the referring physician’s planned
management if PET were not available.
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Table 5: Timing, Type and Number of Questions in the Case Report Forms
Pre-PET Questions
Specific Clinical Indication
Number of
Questions
1
Cancer Type and Working Stage
2
Patient Performance Status
1
Assessment of ongoing treatment
(for treatment monitoring only)
Ordering Physician Role as
Treating Physician
Intended Management (see Section
8, Figure 1)
1
Total
1
1
7
Number of
Questions
2-4
Post-PET Questions
Questions Specific to Indication
Did the PET scan enable you to avoid
more tests or procedures?
1
Ordering Physician Role as Treating
Physician
Intended Management (see Section 8,
Figure 1)
Ordering Physician Consent for Research
use of Data by NOPR
Total
1
1
1
6-8
5.3 PET Scan Completion and Report Forms
The PET scan must be completed within two weeks of entering the Patient Registration Form. If the PET
scan is delayed for more than two weeks from the time of initial registration, the registration will be cancelled,
the PET facility will be notified that this has occurred, and the $50 registration fee will be refunded. If the PET
scan is still to be performed at a later date, it will be necessary for the patient to be registered again, with the
expectation that the information on the pre-PET form will be updated, as necessary. When the PET scan has
been completed, the PET facility documents this by submitting the PET Completion Form via the Web site and
uploads the PET report to the database by completing the PET Report Submission Form on the Web site and
submitting the report as free text on that form or as an attached text file, jpeg, or PDF. The PET facility will
note on the PET Report Form if the patient gave or withheld consent for use of his or her data in future NOPR
research
5.4 Post-PET Form Submission
After the PET scan has been performed, the PET facility will be e-mailed a case-specific Post-PET Form and
fax cover sheet for delivery to the referring physician. Although the Post-PET Forms differ slightly from each
other depending on the reason for the PET study, all assess the referring physician’s planned management of the
patient in light of the PET findings. As was the case for the Pre-PET Form, the referring physician must
complete and sign the Post-PET Form and send it to the PET facility for data entry into the Registry. This form
will also include an ACR IRB approved Referring Physician Information Sheet for the physician. Additionally,
the physician will indicate on the Post-PET Form whether consent for use of the response data in future NOPR
research has been given or withheld. A reminder notice to the facility will be sent every 7 days if the Post-PET
form is not received by the registry.
5.5 Case Completion & Reimbursement
After all the required Registry forms have been entered into the database, the Registry will notify the PET
facility that it can submit its claim to CMS for the PET study (global or separate professional and technical
claims). Note: All data must be entered into the Registry database within 30 days of the PET scan or the
case will not be eligible for CMS reimbursement. The NOPR will submit all collected data to CMS. The
dataset compiled for use by NOPR investigators will only contain only the data for those PET scans where both
the patient’s and the referring physician’s consent have been obtained.
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5.6 Institutional Review Board (IRB) Approval for Registry Participation
The only entity engaged in research is the registry itself (i.e., NOPR); the NOPR intends to use the data it is
collecting for research purposes when both the patient and the referring physician have consented to the use of
the information for this purpose. The ACR IRB has granted approval for the NOPR to engage in research using
these data (see Appendix IV for further detail).
Individual PET facilities and referring physicians and their respective staffs are not engaged in research and
therefore are not required to have IRB approval for their participation in the activities of the NOPR.
Submission of the information for the registry (pre-PET and post-PET case report forms and the PET scan
report) is required by CMS for payment for PET studies for all Medicare-insured patients with cancer
indications included in the registry. Additionally, CMS is not conducting research.
Any participating PET facility may nevertheless elect to have its local IRB review its participation in the
NOPR. Some IRBs require, as a matter of institutional policy, that they review all research conducted in the
institution, even if only to determine that the facility is not engaged in the research. Materials are provided in
Appendix IV to assist in this process. The Office of Human Research Protections (OHRP) has reviewed the
NOPR procedures for protection of human research subjects and finds them to be in compliance with the
applicable DHHS regulations. Any individual IRB with questions can contact OHRP.
6.0 Comparison of National Oncologic PET Registry and CMS Suggested Design Specifications
In its decision memorandum (CAG-00181R) to expand coverage of PET for new cancer indications, CMS
suggested a series of design specifications for a national registry. In its subsequent “Draft Guidance for
Coverage with Evidence Development (April 7, 2005),” CMS provided a list of suggested design elements.
Table 6 lists these suggested elements and notes whether they are included in the design for the NOPR as well
as how and when the data will be collected.
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Table 6: CMS Suggested Registry Elements and NOPR Elements
CMS Suggested Elements
NOPR
Comment
Data Elements for All Coverage with Evidence Development
Qualified scientific oversight
9
Specific hypotheses are pre-planned
targeting patient safety, benefit and
physician decision making.
Pre-specified data collection methods
Sample size
Patient safety and monitoring
9
9
9
Time Frame
Training and explaining the reasons for the
project
Patient confidentiality and protection
9
Data security and quality assurance
9
Hospitals and providers are appropriately
credentialed to provide the PET scan and
interpret the results.
9
Efficiency and data collection burden
9
9
Multidisciplinary team of individuals’ expert in
PET and outcomes analysis. The NOPR
Working Group will oversee all aspects of data
collection.
See statistical section.
Outlined in the manual of operations (MOO).
See statistical section.
Not applicable for this registry. It will be
collecting information from referring physicians
regarding patients undergoing a routine clinical
procedure.
See statistical section. Anticipated maximum
registry duration is two years of data collection.
See Section 9.2 for selected conditions.
See description of NOPR Web site (Section 7).
All data will be entered through the secure
NOPR Web site. Each PET facility is assigned a
unique identifier and each registered user has a
unique user ID# and password.
See background description of the ACRIN data
center and its certification as an NCI research
organization (Appendix V).
Not applicable for this registry, this will be
collecting information from all Medicareapproved PET facilities providing this routine
clinical procedure.
The manual of operations has been reviewed and
revised by appropriate groups representing
patients, referring physicians and providers of
PET services with the goal of achieving the
essential impact endpoint information while
minimizing the data collection burden.
(continued on next page)
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Table 6: CMS Suggested Registry Elements and NOPR Elements (continued from preceding page)
NOPR
Comment
Specific Elements Applicable to the PET Registry
Participating hospitals and providers report
data on all enrolled patients undergoing
FDG PET scans for cancer therapeutic or
diagnostic indications.
9
Necessary for bill payment.
Hospitals and providers who do not comply
with the data collection requirements are
removed from the registry.
9
The NOPR requirements must be met before
submission of a claim for payment is
appropriate. Any claim for payment submitted
without meeting the Registry requirements may
constitute a violation of the False Claims Act and
result in severe federal civil monetary penalties
of up to $11,000 per claim plus triple the amount
of the claim.
Baseline patient characteristics
Scan type and characteristics
Scan results
Results of all other imaging studies
9
9
9
Facility and provider characteristics
9
Cancer type, grade, and stage.
9
Disease management changes
9
Anti-cancer treatment received.
9
Long-term patient outcomes.
9
Included
Included
Included as free text.
Determined to be impractical to collect. Whether
other imaging studies were performed before or
after PET will be assessed by subsequent linkage
of CMS administrative claims analysis.
Facility demographics and provider UPIN or NPI
numbers will be collected during the registration
process.
Cancer type, summary stage collected. Grade
and cell type not collected.
Intended management assessed directly. Actual
management will be assessed by subsequent
linkage of CMS administrative claims analysis.
Intended treatment assessed directly. Actual
treatment will be assessed by subsequent linkage
of CMS administrative claims analysis.
To be assessed in subsequent linkage of CMS
administrative claims analysis.
Data Elements in the PET Registry
In its April 3, 2009 decision memorandum (CAG-00181R) to further expand coverage of PET for cancer
indications, CMS listed additional design specifications as follows. “An FDG PET clinical study that is
designed to collect additional information at the time of the scan to assist in patient management. Qualifying
clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected;
hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals
and providers accurately report data on all enrolled patients not included in other qualifying trials through
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adequate auditing mechanisms; and all patient confidentiality, privacy, and other Federal laws must be
followed.”
The study must adhere to the following standards of scientific integrity and relevance to the Medicare
population listed in Table 7. Table 7 also details NOPR’s design features in compliance with these
requirements.
Table 7: CMS Required FDG-PET Study Elements and NOPR Elements
NOP
R
Comment
a. The principal purpose of the research study is to test
whether a particular intervention potentially improves the
participants’ health outcomes.
9
b. The research study is well-supported by available
scientific and medical information or it is intended to
clarify or establish the health outcomes of interventions
already in common clinical use.
c. The research study does not unjustifiably duplicate
existing studies.
9
d. The research study design is appropriate to answer the
research question being asked in the study.
9
e. The research study is sponsored by an organization or
individual capable of executing the proposed study
successfully.
9
f. The research study is in compliance with all applicable
Federal regulations concerning the protection of human
subjects found in the Code of Federal Regulations (CFR) at
45 CFR Part 46. If a study is regulated by the Food and
Drug Administration (FDA), it also must be in compliance
with 21 CFR Parts 50 and 56.
9
Improvements in participants’ health
outcomes will require indirect comparisons
since the registry is not a randomized trial.
The Operation Manual outlines the several
approaches that will be used in coordination
with the AHRQ. As noted in the statistical
section, these approaches are likely initially to
be for hypothesis generation or feasibility
testing rather than definitive given the
inherent limitations of comparing a registry
cohort to either historical controls or
concurrent controls, when confounding by
indication bias is a persistent concern.
The research study is both well supported by
substantial scientific evidence and it is
intended clarify the health outcomes
associated with the widespread use of PET.
There is no other registry and there are no
known randomized trials incorporating PET
for subsequent treatment strategy evaluation
for the relatively infrequent cancers to be
included in NOPR.
We will be assessing change in intended
management and confirmation of this by
claims analysis; this has never been done
before on a national scale. The impact of
PET during treatment monitoring as a
prognostic tool has never been assessed
prospectively.
The NOPR has already demonstrated its
capability to conduct such a registry study
during its nearly three years of operation to
date.
Yes
9
Page 15
g. All aspects of the research study are conducted
according to the appropriate standards of scientific
integrity.
h. The research study has a written protocol that clearly
addresses, or incorporates by reference, the Medicare
standards.
i. The clinical research study is not designed to exclusively
test toxicity or disease pathophysiology in healthy
individuals. Trials of all medical technologies measuring
therapeutic outcomes as one of the objectives meet this
standard only if the disease or condition being studied is
life-threatening as defined in 21 CFR § 312.81(a) and the
patient has no other viable treatment options.
j. The clinical research study is registered on the
www.ClinicalTrials.gov website by the principal
sponsor/investigator prior to the enrollment of the first
study subject.
k. The research study protocol specifies the method and
timing of public release of all pre-specified outcomes to be
measured including release of outcomes if outcomes are
negative or study is terminated early. The results must be
made public within 24 months of the end of data collection.
If a report is planned to be published in a peer-reviewed
journal, then that initial release may be an abstract that
meets the requirements of the International Committee of
Medical Journal Editors. However, a full report of the
outcomes must be made public no later than three (3) years
after the end of data collection.
l. The research study protocol must explicitly discuss
subpopulations affected by the treatment under
investigation, particularly traditionally underrepresented
groups in clinical studies, how the inclusion and exclusion
criteria affect enrollment of these populations, and a plan
for the retention and reporting of said populations on the
trial. If the inclusion and exclusion criteria are expected to
have a negative effect on the recruitment or retention of
underrepresented populations, the protocol must discuss
why these criteria are necessary.
9
Yes
9
Yes
9
Patients eligible for inclusion in the NOPR
are undergoing clinically indicated PET
studies for documented cancer.
9
The NOPR is registered (Trial #
NCT00868582)
9
The NOPR investigators agree to and will
meet all of these requirements. Results will
be released by presentations at scientific
meetings and/or by peer-reviewed
publications as data become mature for
analysis, but definitely within 24 months of
the end of data collection, with full reporting
of results publicly within three (3) years after
the end of data collection.
9
m. The research study protocol explicitly discusses how the
results are or are not expected to be generalizable to the
Medicare population to infer whether Medicare patients
may benefit from the intervention. Separate discussions in
the protocol may be necessary for populations eligible for
Medicare due to age, disability or Medicaid eligibility.
Social Security Act.
9
Participation in the NOPR is open to all
Medicare beneficiaries, irrespective of
gender, race or ethnicity, who are referred for
clinically indicated PET studies with cancer
types and study indications eligible for
inclusion in the registry. Certain
subpopulations that are often
underrepresented in clinical trials (children,
pregnant women) will be underrepresented in
the NOPR because few such patients are
Medicare beneficiaries.
Since participation in the NOPR is limited to
Medicare beneficiaries (but open to all
Medicare beneficiaries who are referred for
clinically indicated PET studies with cancer
types and study indications eligible for
inclusion in the registry) and since the NOPR
has broad participation of nearly all PET
facilities in the United States, the results are
expected to be immediately generalizable to
the Medicare population.
Page 16
7.0 NOPR Web Site & Data Collection
The NOPR Web site (http://www.cancerPETregistry.org) is the portal for all facility registrations, case
registrations and data entry of the CRFs. The manual of operations, blank CRFs, as well as instructional and
informational material are available for downloading from the Web site by participating facilities and other
interested parties.
Table 8: Data Collection Timeline
Form
Completed by
Case Registration Form
PET Facility
Pre-PET Form
PET Completion Form*
Referring
Physician
PET Facility
PET Report Submission*
PET Facility
Post-PET Form*
Referring
Physician
Submitted to
Due Date
Database
No more than 2
weeks prior to the
PET scan
PET Facility for entry Before Midnight on
into Database
date of PET scan
Database
Within 14 days of
registration
Database
Within 30 days after
PET scan performed
PET Facility for entry Within 30 days after
into Database
PET scan performed
*The PET Completion form must be entered within 14 days of registration and the PET Report
Submission, and the Post-PET Form must be entered within 30 days after the PET scan is completed or
the PET scan will not be eligible for CMS reimbursement.
Page 17
8.0 Endpoint Definitions
The primary objective of the Registry is to assess the effect of PET on intended patient management across the
spectrum of cancers for management beyond their initial treatment or when used to monitor an in-process
course of the treatment.. The key questions that will be asked before and after the PET study are shown below:
Figure 1: Management Questions from Pre- and Post-PET CRF
Primary Endpoint: Change in Management
Question: If PET were not available, your current management strategy would be? (Pre-PET)
or
In light of PET findings, your current management strategy will be? (Post-PET)

Observation (with close follow-up)
Additional Imaging (CT, MRI) or other non-invasive diagnostic tests
Tissue Biopsy (surgical, percutaneous, or endoscopic).
Note: If concurrent biopsy and total surgical resection are planned, then mark “surgical”
treatment below.
Treatment (see additional required responses below)
Treatment Goal: (check one)
Curative
Palliative
Type(s): (check all that apply)
Surgical
Chemotherapy (including biologic modifiers)
Radiation
Other
Supportive care
Will treatment be directly provided by you? (check one)
Yes
No
Table 9 lists different approaches of increasing complexity for classifying intended management. The
simplistic approach considers three categories: watch, gather additional information (e.g., imaging, endoscopy,
or tissue biopsy), and treatment. A second approach separates the category of gather additional information into
non-invasive information tests and tissue biopsies. A third approach adds the distinction between curative and
palliative treatment intent. The last approach combines treatment intent and the specifics of the therapy.
Therefore, depending on the definition used, three to fifteen different categories of management changes could
occur between the pre- and post-PET intended management.
Two different broad types of categorical change can occur: intra-mode or inter-mode. For example, an intermode change would be from a “watch” strategy to a “treat” strategy. An intra-mode change would be a change
within the category such as a change from “surgery” to “radiation.” A second intra-mode change would be a
change in treatment goal from “curative” to “palliative” even if the modality did not change.
Page 18
Table 9: Classification Options of Intended Clinical Management Categories
Baseline
Differences in
additional information
Differences
including treatment
goal
1. Watch
2. Gather
additional
information
3. Treatment
1. Watch
2. Imaging or other noninvasive tests
3. Biopsy
4. Treatment
1, 2, and 3.
4. Treat with curative
intent
5. Treat with
palliative intent
Differences between therapy
1, 2, and 3.
4. Surgery
5. Surgery plus chemotherapy or
radiation therapy
6. Chemotherapy
7. Chemotherapy + radiation
therapy
8. Radiation therapy
9. Other treatments
The primary analysis plan will permit one of five options: watch, non-invasive testing, biopsy, treat with
curative intent, and treat with palliative intent. Secondary analysis will use the full fifteen categories that
include the specific types of treatment and therapeutic intent.
Secondary endpoints or subsets for analysis are listed in Table 10 The categories of interest are the effect of
PET on intended management for specific types of cancer, specific cancer indications, patient performance
status, impact if the referring physician is the intended care provider, and scan type.
Table 10: Secondary Endpoints or Subsets
By Cancer Type
e.g., small cell lung cancer, pancreas cancer,
ovarian cancer, brain tumors, others
By Cancer Indication
Restaging or suspected recurrence
Treatment monitoring
By Patient Performance Status
ECOG 0 or 1 vs. ECOG 2,3, or 4
By Referring Physician as Provider of Care
Treating vs. non-treating referring physician
By Pre-PET
Working Summary Stage
Established vs. suspected metastatic disease
By PET Facility Characteristics
Hospital or free standing; fixed or mobile
By PET Scan Type
PET-CT vs. PET only
In addition, NOPR will link its data to the Medicare Claims Database to determine whether physicians’
intended management plans match actual patient management. This validation of intended management and
actual management will require defining a ‘cross-talk’ between CPT codes for the various clinical actions.
Such cross talk definitions will be relatively easy to define for infusional chemotherapy, radiation therapy, and
the most common alternative imaging methods (CT, MRI or ultrasonography of various organs (e.g., head,
chest, abdomen, or pelvis). However, changes to and from oral chemotherapies will require an extensive
potential list of alternatives that will need to be customized for each major cancer group in consultation with
medical oncologists. The same challenge exists for the potential universe of biopsy and surgical procedures.
The validation of intended vs. claims-based actual management will first be done for selected high-volume
cancers: bladder, kidney, small cell lung and pancreas. An initial time frame of 30 days will be used for
comparing the date of intended to actual management.
Page 19
9.0 Statistical Considerations
The subjects of the NOPR research, patients and referring physicians, can consent (or not) to allow their data to
be used for purposes of the research being conducted by the NOPR. The dataset used by the NOPR
investigators will contain only the data of patients and physicians when both have consented to have the data
included. The NOPR will track the fraction of PET scans for which consent to use the data for research is
withheld by the patient, the referring physician, or both.
The principal purpose of this registry is to provide a means for Medicare coverage of PET for currently
non-covered indications, while simultaneously allowing for the acquisition of data that CMS can use to guide
subsequent coverage decisions. To these ends, the primary scientific objective of this registry is to assess the
effect of PET on referring physicians’ plans of intended patient management when used for restaging, detection
of suspected recurrence, and for therapy monitoring.
The registry is expected to provide adequate numbers of patients to allow great precision in this estimate across
all cancers. Based on the current NOPR data, the estimate of the intended management change is about 35%
across all indications and cancers.2 While the rate of change in management for restaging, recurrence and
treatment monitoring appear to be slightly higher than this overall estimate, this is a conservative estimate on
which to evaluate the precision of the estimates of rates of change in intended management among new NOPR
cases. If rates of enrollment for the indications and cancers still eligible for NOPR are similar to those observed
in the current NOPR data, about 22,000 to 23,000 cases would be enrolled into the registry each year. This will
bring the total number of expected cases to 45,000 if the registry remains open for two years. Without
separating the cancer type and the cancer indication, the width of the 99% CI is 0.012, i.e., 0.35 (0.344, 0.356).
Estimates of the rates of change in intended management will be made by indication over all cancers, as well.
Out of 45,000 cases, about 18,000 are expected to be referred for restaging and the estimate with 99% CI will
be 0.35 (0.341, 0.359), i.e., 99% CI width is 0.018. About 13,700 will be referred for suspected recurrences and
the estimate with 99% CI will be 0.35 (0.339, 0.361), i.e., 99% CI width is 0.021. Out of 45,000 cases, about
9,900 are treatment monitoring cases and the estimate with 99% CI will be 0.35 (0.338, 0.362), i.e., 99% CI
width is 0.025.
Table 11 provides estimates for the width of the confidence interval for change in management for each cancer
eligible for NOPR, estimated across the indications of restaging, suspected recurrence and treatment
monitoring. The table shows the actual enrollment to NOPR 1.0 and expected enrollment to NOPR 1.1, both
calculated across just these three indications, over two years. Because the enrollment by any type of cancer will
be small relative to the whole registry, 95% rather than 99% confidence intervals will be used. We have
continued to use an expected rate of the change in management of 35% despite expecting some variation.
Page 20
Table 11: Precision of Estimates Based on Expected Sample Size
Cancer
Estimated rate of
Total enrolled per Projected Total over
change
in intended
year 1
2 years
management (95%
(NOPR 1.0)
(NOPR 1.1)
CI)
Width of 95% CI
Bladder
3606
2728
0.35 (0.332, 0.368)
0.036 Bone/cartilage
218
165
0.35 (0.274, 0.426)
0.152 Cervix
1020
772
0.35 (0.316, 0.384)
0.068 Connective/other soft tissue
1573
1190
0.35 (0.322, 0.378)
0.056 Gallbladder / extrahepatic bile
ducts
781
591
0.35 (0.311, 0.389)
0.078 GIST
179
136
0.35 (0.266, 0.434)
0.168 Kidney/ other urinary tract
3525
2667
0.35 (0.332, 0.368)
0.036 Leukemia
613
464
0.35 (0.306, 0.394)
0.088 Liver and intrahepatic bile
ducts
889
673
0.35 (0.313, 0.387)
0.074 Lung, small cell
3621
2740
0.35 (0.332, 0.368)
0.036 Merkel Cell Carcinoma
444
336
0.35 (0.298, 0.402)
0.104 Pancreas
3923
2968
0.35 (0.333, 0.367)
0.034 Pleura
270
205
0.35 (0.282, 0.418)
0.136 Primary Brain
466
353
0.35 (0.299, 0.401)
0.102 Prostate
4541
3436
0.35 (0.334, 0.366)
0.032 Retroperitoneum and
peritoneum
512
388
0.35 (0.301, 0.399)
0.098 Skin, non-melanoma
397
301
0.35 (0.294, 0.406)
0.112 Small Intestine
467
354
0.35 (0.299, 0.401)
0.102 Stomach
2750
2081
0.35 (0.329, 0.371)
0.042 Testis
202
153
0.35 (0.271, 0.429)
0.158 Thymus, heart, mediastinum
208
158
0.35 (0.272, 0.428)
0.156 Uterus, body
2451
1855
0.35 (0.328, 0.372)
0.044 Uterus, unspecified
1024
775
0.35 (0.316, 0.384)
0.068 Eye, Kaposi sarcoma,
penis/male genitalia and other
unspecified cancers
<150 cases each
Total
34041
45000
Page 21
The analysis plan will include:
1) Estimate the rate of change in management from Pre- to the Post-PET for overall cancers and indications.
Estimates of the rate of change for each of the definitions of change presented in Table 9 and their
confidence intervals will be calculated.
2) Estimate the effect of various factors (refer to Table 10) on the rate of change in intended management due
to PET.
Our previous work showed only small differences in the impact of PET as a function of specific cancer type.
For this next generation of evaluation, we intend to focus on the specific indication for PET; the potential
differences associated with the pre-PET summary stage (disease burden) and patient performance status, and
will explore in more detail the physician’s role as provider of the intended management.
Logistic regression models will be used to assess the impact of PET on intended management by controlling
for a number of covariates in secondary analyses, such as those listed above and in Table 10. The dependent
variable is whether the referring physicians reported change of intended management after PET. Also,
explorations of finer classifications of change in intended management will be performed using regression
models. For example, change in intended management may be categorized using an ordinal scale such as no
change, intra-mode change, and inter-mode change.
3) Compare intended to actual patient management using CMS claims data to identify the actual course of
management received by patients pre- and post-PET and data from the Post-PET form to identify the
intended management plan. Our preliminary plan is to use a 30-day time frame to assess concordance. As
noted earlier, the cross-talk definitions will vary in complexity across treatment types and specific cancers.
To date, only limited studies in selected cancers have prospectively compared physician intended vs. actual
management.5-8 Therefore, pre-planned judgments about the quality of the levels of agreement as assessed
by kappa statistics and intra-class co-efficient will be deferred and these evaluations will be judged as
exploratory and hypothesis generating.
a. Assess the concordance by type of intended management (treatment vs. non-treatment);
b. Assess when treatment is intended, if the same type of treatment is actually delivered;
c. Assess whether the level of agreement between intended and actual management differs if the
referring physician is or is not the treating provider;
d. Assess if the level of concordance differs by treatment goal; and
e. Assess if the above levels of agreement differ among indications for PET.
Agreement between the post-PET intended management and the actual management as reported in Medicare
claims data will be assessed using kappa statistics and intra-class correlation coefficients (ICC). Additional
analyses will focus on ranking the differences between intended and actual management on an ordinal scale
(none – actual management and intended management are identical; minor – actual management varies from
the intended management plan, but only by the addition or deletion of one component; major – the actual
management differed in its primary components or its intended purpose; complete – no aspect of the
intended management plan was implemented), and evaluating the effect of various covariates on this ordinal
scale. Patient co-morbidity and performance status will be obvious, important co-variants.
4) For specific cancer, testing indication, and referring physician interpretation of the PET’s impact on future
prognosis, assess whether a) specific types of management are associated with different one-year survivals
Page 22
and b) when a major change in intended management occurs how this compares (in rank order) to
maintaining the same management or alternative changes in intended management in terms of the relative
one-year survival.
Cox regression models will be used to assess the association between a change in intended management and
patients’ survival outcome. The indication for PET, the physician's assessment of patient prognosis postPET, pre-PET summary stage and performance status will be included as covariates.
5) Assess the effect of PET used to monitor ongoing therapy on intended patient management.
The case report forms for treatment monitoring have been revised to enhance clarity and to provide further
details about intended management. Comparisons between the Pre-PET and the Post-PET plan for
treatment monitoring will include potential changes in the physician’s treatment goal, the physician’s
summary impression of the patient’s level of clinical response, and if and how the planned course of
management will be adjusted. Cases of treatment monitoring will be stratified between those cases where
the treatment goal is curative vs. palliative and non-metastatic disease vs. known metastatic disease.
Page 23
10.0 References
1.
Hillner BE, Siegel BA, Liu D, et al. Impact of positron emission tomography/computed tomography and
positron emission tomography (PET) alone on expected management of patients with cancer: initial
results from the National Oncologic PET Registry. J Clin Oncol 2008;26:2155-61.
2.
Hillner BE, Siegel BA, Shields AF, et al. Relationship Between Cancer Type and Impact of PET and
PET/CT on Intended Management: Findings of the National Oncologic PET Registry. J Nucl Med
2008;49:1928-35.
3.
Hillner BE, Siegel BA, Shields AF, et al. The impact of positron emission tomography (PET) on
expected management during cancer treatment: findings of the National Oncologic PET Registry.
Cancer 2009;115:410-8.
4.
Hintze, J. (2008). PASS 2008. NCSS, LLC. Kaysville, Utah. (Sample size and power software)
5.
Scott AM, Gunawardana DH, Kelley B, et al. PET changes management and improves prognostic
stratification in patients with recurrent colorectal cancer: results of a multicenter prospective study. J
Nucl Med 2008; 49:1451-7.
6.
Scott AM, Gunawardana DH, Bartholomeusz D, Ramshaw JE, Lin P. PET changes management and
improves prognostic stratification in patients with recurrent head and neck cancer: results of a
multicenter prospective study. J Nucl Med 2008; 49:1593-1600.
7.
Scott AM, Gunawardana DH, Wong J, et al. Positron emission tomography changes management,
improves prognostic stratification and is superior to gallium scintigraphy in patients with low-grade
lymphoma: results of a multicentre prospective study. Eur J Nucl Med 2009; 36:347-53.
8.
Chatterton BE, Shon IH, Baldey A, et al. Positron emission tomography changes management and
prognostic stratification in patients with esophageal cancer: results of a multicentre prospective study.
Eur J Nucl Med 2009; 36:354-61.
Page 24
Appendix I
National Oncologic PET Registry (NOPR)
Workflow & Web Site Applications
1. PET Facility Registration
a. PET Facilities will register for the NOPR via http://www.cancerPETregistry.org/ by completing the PET
Facility Pre-Registration & Registration Forms, submitting an executed Business Associates Agreement
(BAA) and paying the $50 registration fee.
b. The Pre-Registration Form requires the basic information needed to create a new site account in the
database and assign a unique user password:
• Name of the Imaging Center
• Facility E-mail Address. This user will be the PET Facility Admin User. The Admin User will
receive all e-mail correspondence and notices from the database and be able to modify facility
account info including adding and deleting registered physicians and staff.
• Name of Person Registering the PET facility
c. A confirmation e-mail is generated containing the assigned facility ID and a second e-mail is generated
that contains the password. The facility can then login to their account and complete the PET Facility
Registration Form. The PET Facility Registration Form requires:
• Facility mailing address and telephone number
• Facility Medicare Provider Number or National Provider Identification Number
• The name of the business entity responsible for escrow payments
• Name and e-mail address of the Facility’s NOPR contact person (Admin User)
• The physical address of the PET facility
• Name and UPIN for each participating physician who will interpret PET scans
• Name and e-mail for each staff person (in addition to the Admin User) who will be allowed to
register patients and enter data into the database. This will trigger an e-mail with their username and
password to be sent by the database.
• Description of each PET scanner
• Calculation of the initial escrow deposit
• Setting the amount to trigger a low escrow balance e-mail
d. When the PET Facility Registration Form is submitted, an e-mail is generated that confirms completion
of the form. A second e-mail is generated that contains an invoice for the $50 application fee and the
amount the facility wishes to deposit into their escrow account.
• Facilities can pay the invoice with a check or via a credit card payment on the NOPR Web site.
Checks should be made payable to the ACR-NOPR and mailed to the American College of
Radiology, 1818 Market Street, Suite 1600, Philadelphia PA 19103. The facility ID# must be
written on the check.
• Facilities will be sent an email when their escrow account dips below their pre-specified amount and
subsequent payments to the escrow account can be made by check or credit card.
• Facilities will be notified by e-mail when their deposit is received.
• Registered PET facility staff who are allowed to register patients and enter data will also receive emails containing their facility number, username and password.
Page 25
e. Facilities can begin entering patients on the NOPR when their BAA, facility registration fee, and escrow
deposit are submitted to NOPR headquarters. Please allow 48 hours for processing of these materials
before scheduling the first patient entry for your facility.
2. Clinician Refers a Patient to the PET Facility
When the PET Facility determines that a referral qualifies for the registry (is eligible for Medicare and the
scan is for an eligible indication) it must then verify that the referring physician will complete the Pre- and
Post PET Forms within 30 calendar days of the PET scan. The referring physician can also complete the
Pre-PET Form in advance (blank forms are available for downloading on the Web site) and send it to the
Facility with the referral.
3. Patient is Entered into the NOPR
a. The PET Facility enters the patient into the NOPR by completing the Case Registration Form on the
Web site by entering the following information:
• Patient’s first and last name
• Patient’s date of birth
• Patient’s Social Security Number
• Patient’s gender, ethnicity, race, and zip code
• Referring physician’s name, UPIN, telephone #, and Fax #
• Date patient is scheduled for the PET scan (must be within 2 weeks of registration)
b. When the Case Registration Form is completed, the database will:
• Assign a case number
• Deduct $50 from the PET Facility’s escrow account
a. c.
A confirmation e-mail is sent to the PET Facility containing:
• Case ID number
• Directions & timeline for data submission
• Fax cover sheet for delivery of the Pre-PET Form to the referring physician with (if not already
submitted with the referral)
• Pre-PET Form (if not submitted with the referral)
d. At some time before the PET study, or when the patient arrives for the PET scan, the PET facility will
provide the patient with the ACR IRB approved standard NOPR Patient Information Sheet that is posted
on the NOPR Web site. The patient will be able to contact the NOPR directly for more information, if
necessary. The patient will indicate his or her consent verbally to staff at the PET facility, either on the
day of the PET study or by telephone within two working days after the PET study is completed.
Written consent is not required. The PET facility will note in the database, on the PET Report Form, if
the patient gave or withheld consent for use of his or her data in future NOPR research. The PET
facility will note on the PET Report Form if the patient gave or withheld consent for use of his or her
data in future NOPR research.
4. Pre-PET Form Submission
a. The referring physician completes the Pre-PET Form (if not already submitted with the referral) and
sends it to the PET Facility by:
• Fax
• Hand or Postal Delivery
b. The PET Facility enters the data on the Pre-PET Form into the database via the Web site by midnight
the day of the scan.
Page 26
c. It is the PET Facility’s responsibility to ensure that the Pre-PET Form is entered into the database by
midnight of the date of the scan. Entries after that deadline will be deemed ineligible.
d. The PET Facility will receive a confirmation e-mail that the form has been entered.
5. Patient Undergoes PET Scan
Note that the Pre-PET Form must be entered into the database by midnight of the day of the scan or the case
will be ineligible. If the PET scan is not performed within 14 calendar days of case registration the case is
cancelled, the $50 registration fee is returned to the escrow account, and PET Facility is notified by e-mail.
6. PET Facility Sends PET Report to Referring Physician and the Database
a. The PET Facility transmits the PET report to the referring physician.
b. The PET Facility uploads the PET report to the database by completing the PET Report Submission
Form on the Web site and submitting the report as free text on that form or as an attached, jpeg, or PDF
b. The PET facility notes on the PET Report Form if the patient gave or withheld consent for use of his or
her data in future NOPR research.
c. The PET Completion Form must be entered prior to the PET Report Submission Form. If the PET
Report Submission Form is not entered within 7 calendar days of the PET scan date, an e-mail reminder
is sent every 7 days until 30 calendar days after the PET scan at which time the case is declared
ineligible.
7. Referring Physician Completes Post-PET Form
a. After the PET scan is completed, the appropriate Post-PET Form (as determined by information
supplied on Pre-PET Form) is e-mailed to the PET facility for delivery to the referring physician.
b. This form will also include fax cover sheet and an ACR IRB-approved Referring Physician Information
Sheet for the physician. The physician will indicate on the Post-PET Form whether consent for use of
the response data in future NOPR research has been given or withheld.
c. The referring physician completes the appropriate Post-PET Form and returns it to the PET Facility by:
• Fax
• Hand or Postal Delivery
d. If the Post-PET Form is not entered into the database an e-mail reminder is sent every 7 calendar days to
PET Facility until 30 calendar days after the PET scan at which time the case is declared ineligible.
e. It is the responsibility of the PET Facility to ensure that the Post-PET Form is entered into the database
within 30 calendar days of the PET scan. If the PET Facility receives a second reminder (day 14) that
the Post-PET form has not been entered into the database, the PET Facility should confirm that the
referring physician has received it and fax or hand deliver a second copy to the referring physician.
8. The PET Facility is Notified by the Database that the Case is Complete
A confirmation e-mail is sent by the database to the PET Facility when all data items are received.
9. The PET Facility Bills CMS for Reimbursement. (If applicable, the interpreting physician also bills
CMS.)
10. General Considerations
a. Data entered into the database can only be changed via an email to NOPR Headquarters.
b. If the database is down or otherwise unavailable, and failure to enter a form will cause the case to
become ineligible, the PET Facility will Fax a paper copy of the completed form to NOPR Headquarters
c.
d.
e.
f.
Page 27
and then enter it into the database as soon as the database is operational. This is the only instance in
which a form may be entered after a due date.
If all of the required CRFs are not entered into the database within 30 calendar days of the PET scan the
case is declared incomplete and is ineligible. The registration fee is not refundable.
All data will be sent to CMS. Data for a particular patient will be used for NOPR research and included
in the research dataset only if BOTH the patient and the referring physician consent to use of the data for
this purpose.
The PET Facility can use the NOPR Web site to:
• Check on its escrow account balance
• Change its password
• Add to or update its list of Facility Scanners
• Add to or update its list of Facility Radiologists
• Add to or update its list of staff members who can register patients and enter data into the data base
• Review the status of all cases; review the list of received/outstanding forms
All interested parties may obtain the following information from the NOPR Web site:
• A description of the NOPR
• The manual of operations
• A copy of all case report forms
• Instructional/tutorial documents
• Contact information
Page 28
Appendix II
Case Report Forms
Form
Last Revised Date
Patient Information Sheet
03/30/09
(Spanish translation available at: http://www.cancerpetregistry.org/pdf/patient_info_spanish.pdf)
Referring Physician Information Sheet
03/30/09
PET Facility Pre-Registration Form
03/30/09
PET Facility Registration Form
03/30/09
03/30/09
Pre-PET Form
11/30/09
PET Completion Form
03/30/09
PET Report Submission Form
03/30/09
Post-PET Forms (complete one based on initial indication):
Post-PET Restaging Cancer Form
Post-PET Suspected Cancer Recurrence Form
Post-PET Treatment Monitoring Form
Post-PET Suspected Cancer Form
Post-PET Paraneoplastic Syndrome Form
Post-PET Initial Staging Form
03/30/09
03/30/09
03/30/09
11/30/09
11/30/09
11/30/09
PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to
respond to a collection of information unless it displays a valid OMB control
number. The valid OMB control number for this information collection is 09380968. The time required to complete this information collection is estimated to
average five (5) minutes per response, including the time to review instructions,
search existing data resources, gather the data needed, and complete and review
the information collection. If you have comments concerning the accuracy of the
time estimate(s) or suggestions for improving this form, please write to: CMS,
7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-2605, Baltimore, Maryland 21244-1850.
Page 29
The National Oncologic PET Registry (NOPR)
Patient Information Sheet
You are being invited to take part in a research study conducted by the National Oncologic PET Registry (NOPR). Before
you decide whether or not to participate, it is important for you to understand why the research is being done and what it
will involve. Please take time to read the following information carefully. Talk to your family or friends about the study
to help you decide whether or not you wish to take part. If you have any questions or if you would like more information
after reading the information sheet, please go to the NOPR website, www.cancerpetregistry.org, or contact the NOPR staff
by telephone toll free at 800-227-5463, ext. 4859. Your doctor who ordered the PET scan and the staff at the PET facility
where your scan will be performed will not be able to answer your questions concerning this research study. The NOPR
staff will be able to assist you and answer any questions you may have.
You are being asked to participate in this research study because you are a Medicare patient and your doctor has ordered a
PET or a PET/CT scan for you that is currently not covered (paid for) by Medicare. The PET scan has been ordered to
evaluate your cancer. Having the PET scan is not the research in this study. PET scans are part of routine clinical care.
For the research, the NOPR will study how the information obtained from the PET scan is used by your doctor.
WHY IS THIS STUDY BEING DONE?
The Centers for Medicare and Medicaid Services (CMS), a Federal agency that manages the Medicare program, currently
pays for PET scans that are ordered to evaluate cancer only for certain specific cancer types and reasons. CMS has a new
policy called “coverage with evidence development” (CED) to pay for PET scans ordered for most other types of cancer
and reasons. This means Medicare will pay for these additional PET or PET/CT scans in the same way that it pays for
approved cancers and reasons.
CMS wants to determine if they should pay for PET scans for evaluating more types of cancer. In order to collect the
information needed to make this decision, CMS will provide payment for the PET scans of patients who are properly
registered with the National Oncologic PET Registry (NOPR). In addition, if you and your doctor agree to participate in
the research, your information will be entered into the registry and will then be analyzed to determine how PET scans
effect the way doctors plan treatment for their patients.
In order for Medicare to pay for your PET scan, Medicare is requiring that your doctor provide certain information about
the reason for your scan and how the scan results may influence your treatment. This information will be sent by the PET
facility to Medicare as a requirement for payment for your PET scan. In addition, the NOPR is requesting your consent to
use this information for research. Specifically, the NOPR plans to study how PET scans affect the treatment plans of the
doctors who order PET scans. Eventually, the results of this research may help to obtain coverage by Medicare and other
insurers for a wider range of cancers.
WHAT WILL HAPPEN IF I TAKE PART IN THIS STUDY?
CMS will collect information about you from your doctor as a requirement of paying for your PET scan. Your personal
information such as your name, date of birth, social security number, and your doctor’s information will be entered into
NOPR database through a secure web site. All this information will be stored at the American College of Radiology
Imaging Network (ACRIN). ACRIN is a national leader in clinical research involving cancer patients. This database is
secure and meets the requirements for the protection of patient confidentiality as required by the U.S. Privacy Rule
(HIPAA).
As part of Medicare requirement for payment, your doctor will be asked to complete a brief questionnaire regarding
his/her request for PET or PET/CT scan and what the doctor would do if PET or PET/CT were not available. After the
(Page last revised March 30, 2009)
Page 30
PET scan is performed, your doctor will be asked to complete a second questionnaire about how the results of the scan
affected your care. These forms must be completed and submitted to the NOPR within a specified period in order for the
scan to be eligible for payment. NOPR will send your information to CMS so that your PET scan will be paid for by
Medicare, like any other covered benefit.
If you agree to participate in the research part of the NOPR, you are giving permission to use your health information for
research. However, your information will only be used by the NOPR for research if you and your doctor give permission
to use it for research purposes.
WHAT OTHER OPTIONS ARE THERE?
You may choose not participate in this study. You can choose to have a PET or PET/CT scan without participating in the
registry study. If you choose not to participate in the NOPR research study, the PET scan payment will not be affected.
ARE THERE POTENTIAL BENEFITS TO TAKING PART IN THE STUDY?
There is no immediate direct benefit to you for your participation in this research study. Whether or not you (or your
doctor) agree to have your information used for the NOPR research study, Medicare will pay for the PET scan so long as
your doctor provides the information Medicare requires for payment. If the research study leads to routine coverage by
Medicare of your type of cancer (or the reason for your PET scan), you may benefit in the future if you need another PET
scan. Other patients with cancer in the future may also be helped if the research leads to routine coverage of PET by
Medicare or other health insurance providers.
WHAT ARE THE RISKS OF THE STUDY?
There are no physical risks associated with this study. There is, however, the potential risk of loss of confidentiality.
Every effort will be made to keep your information confidential; however, this cannot be guaranteed.
WHAT ARE THE COSTS?
There are no additional costs to you associated with participating in the NOPR research study. Medicare will pay for the
PET or PET/CT scan if your information is submitted within a specified timeframe by your doctor. You or your Medicare
supplemental (Medigap) insurance will be responsible for any co-payment costs or deductible payments, just as occurs
with any other medical service covered by Medicare.
WHAT ABOUT CONFIDENTIALITY?
Your information will be kept permanently in a secure electronic database at the ACRIN and may be used for future
research. CMS, the NOPR working group and project staff, and the Center for Statistical Sciences at Brown University
will have access to your information. They are responsible for making a recommendation to CMS on what types of PET
scans should be paid for by Medicare. Your records may be reviewed in order to meet federal regulations. Your name
will never be made public.
WHAT ARE MY RIGHTS?
Your participation in the NOPR research study is voluntary. You may choose not to be in the study. If you agree to be in
the study, you may withdraw from the study at any time. If you withdraw from the study, no new data about you will be
collected for research purposes.
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits. You will
continue to receive your usual medical care whether or not you decide to participate in this study. If you decide to
withdraw from the study, you will need to let your doctor know in writing.
After you had a chance to read this information sheet and made a decision whether you want to participate, please let the
staff at the PET facility know what you have decided. You are not required to sign a consent form to participate in this
research, but you must let the PET facility staff know whether or not you wish to participate either before you leave the
PET facility or at a later date but no more than two (2) working days after you have your PET scan. If you have any
(Page last revised August 18, 2010)
Page 31
questions regarding the NOPR research study or the information sheet, please go to the NOPR website,
http://www.cancerpetregistry.org/ and click on “Info for Patients”, or contact NOPR at (800) 227-5463, ext. 4859 or
[email protected]. If you have any questions or concerns about your rights as a research subject or about harms
related to this research, you can contact Maria Oh, the American College of Radiology (ACR) IRB coordinator, at (800)
227-5463, ext. 4160. You will be given a copy of this information sheet to take home with you.
Approved by the American College of Radiology Institutional Review Board on April 3, 2009.
A Spanish language translation of the NOPR Patient Information Sheet is available on the NOPR Web site at:
http://www.cancerpetregistry.org/pdf/patient_info_spanish.pdf
Page 32
Referring Physician Information Sheet
The purpose of the National Oncologic PET Registry (NOPR) is to prospectively examine how the use of PET scans impacts
the management of patients with suspected or known cancer. This information will be used to develop guidelines for the
effective use of PET in a variety of clinical situations and for future requests to the Centers for Medicare and Medicaid Services
(CMS) to seek coverage for PET for cancer types and indications that are not covered outside of this registry.
Currently, CMS is providing coverage for PET performed for non-covered cancer types and indications under a program known
as “coverage with evidence development” (CED). As a condition of payment, CMS requires that you provide specific patient
information before the PET scan and within 30 days after the PET scan. The information is entered into a secure database
maintained by the NOPR and forwarded to CMS for payment purposes.
Your participation in the research component is voluntary. You may choose not to participate. If you agree to participate, you
may discontinue participation at anytime. If you withdraw from the study, no new data will be collected about you for research
purposes. Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to
which you are otherwise entitled. If you agree to participate, the NOPR investigators will also use the information you provide
for research purposes. Your patient will also be asked to allow his or her information to be used for the same research purposes.
Your patient’s data and PET information in the registry will be used for research only if both you and your patient provide
consent. However, you or your patient may choose not to allow this information to be used for the research component of the
NOPR. If you choose not to participate, your ability to request future PET scans will not be affected.
Whether or not you choose to participate, you will need to complete pre- and post-PET forms which are necessary for payment
by CMS. If you choose to participate in the research study, the same information will become part of the research data. The
Pre-PET Completion Form, which must be completed before or on the day of the PET scan, will ask you questions related to the
reason for requesting the scan, the patient’s cancer type and extent, and the intended management plan if PET were not
available. The Post-PET Form, which must be completed and returned to the PET facility within 30 days after the PET scan,
will ask you questions about the impact of the PET findings on your assessment of the patient’s disease status and your current
management plan for the patient.
You and your patient will not directly benefit from participating in the research component at this time. Your participation will
help to identify the most effective applications of PET in oncology patients. The information will be used by CMS and other
health insurance providers to decide whether to pay for PET scans for a wider range of cancer types or cancer-related
indications in the future. We hope that the decision may help patients with cancer in the future.
There are no direct risks or discomfort associated with your participation. However, the completion of the pre- and post-PET
forms is a requirement for CMS reimbursement. Completion of the forms should take approximately 3 minutes for each form.
Participation in the research component will not require additional time for you and your staff. Your patient will not know your
answers and of your participation in the research.
The NOPR has implemented the necessary infrastructure to ensure security of all data submitted on the pre- and post-PET
forms. However, we cannot guarantee total privacy. The information will be stored permanently at the American College of
Radiology Imaging Network (ACRIN). NOPR investigators will only have access to this information for research purposes, if
you consent. All data collected through the NOPR will be made available to CMS for payment purposes regardless of whether
consent is given for the research component. The staff at the PET facility where the scan will be performed will not be able to
answer any questions concerning this research study. If you have any questions or require any assistance, you can contact the
NOPR project manager toll free at 800-227-5463, ext.4859, or [email protected]. If you have any questions or
concerns about your rights as a research subject or about harms related to this research, you can contact Maria Oh, the American
College of Radiology (ACR) IRB coordinator, at (800) 227-5463, ext. 4160.
If you choose to participate and allow the information collected on the pre- and post-PET forms be used for the research
component of the NOPR, please check the appropriate check box to indicate your participation in the NOPR research
study on the Post-PET Form.
Approved by the American College of Radiology Institutional Review Board on April 3, 2009.
Page 33
Facility Pre-Registration Form
Thank you for your interest in participating in the National Oncologic PET Registry project.
•
Each institution participating in the Registry must complete the Web-based Facility Pre-Registration Form and receive
a unique 4-digit Facility Number and Facility Administrator Password. The Facility Administrator will then log in and
complete the Facility Registration Form. After registration, but before entering its first case on the Registry, the
facility must pay a one-time application fee of $50 and send an executed HIPAA Business Associates
Agreement (BAA) to NOPR Headquarters. Payments can be made by credit card or check. Checks should be
made payable to the ACR-NOPR and mailed to the American College of Radiology, 1818 Market Street, Suite 1600,
Philadelphia, PA 19103. The facility ID# must be written on the check. The BAA can be mailed or FAXed to NOPR
Headquarters (1818 Market Street – Suite 1600, Philadelphia, PA 19103, FAX 215-928-0153). The BAA is available
from the NOPR Web site and must be submitted before patient entry can begin. Please allow 48 hours for
processing of these materials before scheduling the first patient entry for your facility.
•
The entity applying as a PET Facility should be the entity that bills Medicare for either the technical charges or the
global charges for PET studies. In the case of a mobile PET provider that bills Medicare directly, a separate
application form must be completed and a separate Facility ID number will be assigned for each location of service.
•
NOTE: You will receive a confirmation E-mail with instructions on how to log into the NOPR database to
complete the registration process.
1. Name of Imaging Center
2. Facility’s E-mail Address (will be used for all communications)
3. Person Completing this Form: First Name ________________ Last Name: _______________
This person will become the PET Facility Administrator, and the official contact person for the NOPR.
NOTE: After this form is completed a 4 digit Facility ID number and a password will be assigned and
sent to the Facility via E-mail. The Facility must return to the Login page, follow the instructions in the
confirmation e-mail, and complete the Facility Registration Form.
Page 34
PET Facility Registration Form
•
Please complete this form to finalize the NOPR registration process.
•
Once this completed form is submitted, a confirmation e-mail will be sent with an invoice for the escrow account startup funds and the $50 application fee.
•
When the start-up funds are received at NOPR Headquarters an escrow account will be established for the PET
Facility. $50 will be debited from this account each time the facility registers a case on the NOPR. E-mail reminders
will be sent to the PET Facility Administrator when the account balance dips below a minimum level as defined by the
Facility on this Registration Form.
•
The PET Facility can pay the $50 registration fee and initial escrow deposit either by:
o Mailing a check made payable to ACR-NOPR together with a copy of the e-mailed invoice to the American
College of Radiology, 1818 Market Street, Suite 1600, Philadelphia, PA 19103. The facility ID# must be
written on the check; or
o Paying by credit card using the information in the e-mailed invoice and confirmation to log into the facility’s
account on the NOPR Web site.
•
Once the ACR receives the facility registration fee and the executed Business Associates Agreement (BAA), the PET
Facility will be sent an e-mail approval notice and the facility will be eligible to participate in the National Oncologic
PET Registry via the secure Web site.
Only cases that meet the criteria listed in the Coverage Decision will be eligible for registration and CMS reimbursement.
Facility ID #:
1. PET FACILITY INFORMATION
Name of Imaging Center (will be supplied by the system from pre-registration information)
Mailing Address
(street 1)
(street 2)
(city)
(state)
Telephone
x
(zip)
FAX:
Business entity responsible for payment
Medicare Provider Number or National Provider Identifier Number:
PHYSICAL ADDRESS OF THE PET FACILITY
Address
(street 1)
(street 2)
(city)
Telephone
(state)
(zip)
x
2. PET FACILITY ADMINISTRATOR
Official facility contact person for the National Oncologic PET Registry (will be supplied by the system from preregistration information)
E-mail address (will be supplied by the system from pre-registration information)
3. PARTICIPATING PHYSICIANS - who will interpret PET scans. (Web form will accept as many as
needed)
First Name
Last Name
UPIN
First Name
Last Name
UPIN
4. STAFF - who are allowed to register patients and enter data into the database. A username and password
will be emailed to the staff person.
Page 35
First Name
Last Name
E-mail
First Name
Last Name
E-mail
5. EQUIPMENT DESCRIPTIONS – Provide complete information for each PET scanner. (Web Form will
allow for entry of multiple scanners)
Facility’s Scanner Identifier (facility’s name for scanner)
Manufacturer
Fixed
Hospital-Based
Model
Mobile
Not hospital-based (independent diagnostic testing facility)
6. CALCULATION OF ESCROW ACCOUNT
Payment to the National Oncologic PET Registry for each case entered into the database for CMS
reimbursement is required in advance. It is recommended that each facility schedule monthly payments
based on the expected number of cases registered for one month. You may stop participating in the Registry
at any time. Upon letter to the Program Manager any unexpended credit balance will be refunded.
Invoice will be E-mailed to registering facility in the amount calculated below.
Initial Facility registration fee:
$50
Number of cases to prepay @ $50 each ___ x $50 =_________
Total:
__________
7. FUND BALANCE REMINDER
PET Facilities can monitor the balance remaining in their NOPR Account via the secure Website. New
cases can be registered as long as there is a positive balance remaining. It is recommended that each facility
maintain a credit balance at all times commensurate with the facility’s caseload. An E-mail reminder will
be sent from the Registry when your fund balance reaches the minimum threshold established by the PET
Facility.
Please notify our PET Facility when our account balance with the ACR reaches the level selected below:
$250 – 5 cases remaining
$500 – 10 cases remaining
$1,000 – 20 cases remaining
$2,000 – 40 cases remaining
8. HAS THE BUSINESS ASSOCIATE AGREEMENT (BAA) BEEN EXECUTED?
Yes
No
(Please mail or fax (215-928-0153) the BAA to NOPR Headquarters. Note: patients cannot be entered on the Registry until the
BAA is received at Headquarters)
9. NAME OF PERSON SUBMITTING THIS FORM
First Name: ________________ Last Name: __________________
Additional information on the National Oncologic PET Registry can be found on the web site,
http://www.cancerPETregistry.org/ or by contacting the project manager at 215-717-0859.
Page 36
•
This form will be completed by the PET facility via Web-based data entry.
•
The PET scan and the Pre-PET form must be completed within 2 weeks of registering the patient. The pre-PET form
must be completed (and data entered on the Registry web site) no earlier than 2 weeks before the PET scan and no
later than midnight on the day of the PET scan
•
Upon form completion a case number will be assigned.
•
The referring clinician may elect to complete and submit the Pre-PET Form at the time of referral. If the clinician did
not submit a Pre-PET Form with the referral, a case specific Pre-PET Form will be sent electronically with the e-mail
confirmation of case registration to the PET facility for delivery to the referring physician.
PET Facility Log-in Info (facility ID# & password):
1. PATIENT INFORMATION
Date: _____/_____/_____
First Name: ________________
Last Name: __________________
Date of Birth _____/_____/_____
SSN#: __________________
Gender: Male
Female
Ethnicity: Hispanic
[Note: “Hispanic” is defined as a person of Cuban, Mexican, Puerto Rican, South
Not Hispanic
or Central American, or other Spanish culture or origin, regardless of race.]
Unknown
Race: (must check one)
Asian
Black or African American
White or Caucasian
Other
Unknown
Patient’s 5-Digit Zip Code (if outside the U.S. enter 00000): ___ ___ ___ ___ ___
2. REFERRING PHYSICIAN INFORMATION
UPIN#: _________________
OR
NPI#:
Last Name: __________________
First Name: ________________
Office Telephone: (____) _________________ Office Fax: (____) _________________
3. HAS THE PRE-PET FORM BEEN COMPLETED?
(if Yes is checked the PET facility will not be E-mailed a Pre-PET form to complete)
Yes
No
4. PATIENT IS SCHEDULED TO HAVE A PET SCAN ON: _____/_____/_____
(must be within 14 days of registration)
Date:
Page 37
Pre-PET Form
•
•
You have requested a PET scan for an indication for which the Centers for Medicare and Medicaid Services (CMS)
requires pre- and post-PET information from the referring physician as a condition for reimbursement. In order for the
imaging center to be reimbursed this form must be completed and returned to the PET facility before the PET scan is
performed.
You will be required to complete a follow-up form in a timely fashion after the PET scan is done. Thank you for
your assistance completing the brief pre- and post-PET forms.
PET Facility ID #:
Registry Case #:
PATIENT INFORMATION
Date: _____/_____/_____
First Name: ________________
Last Name: __________________
Date of Birth _____/_____/_____
SSN#: __________________
REFERRING PHYSICIAN
UPIN#: _______________ or NPI#: _______________
UPIN#: _______________
Office Telephone: (____) _________________ Office Fax: (____) _________________
Comment to Clinician: The required follow-up questionnaire will be sent to you by the PET facility. By
requesting that this patient be entered on the NOPR you agree to also complete the post-PET follow-up form
and return it to the PET scan facility within 30 days of the PET scan.
The following definitions/instructions are provided to assist you in the completion of Question 1
(“SPECIFIC REASON FOR PET STUDY”) on the next page of this form. This information is derived
from the Medicare National Coverage Determination for PET.
< http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=218>
Covered Indications for PET Scans and Limitations/Requirements for Usage
Initial Treatment Strategy
PET performed as part of an evaluation for determination of an initial treatment strategy (formerly
diagnosis and initial staging) is covered by CMS as an approved indication for PET with specific
exceptions (see below):
PET is explicitly not covered by CMS for initial treatment strategy evaluation for four specific cancer
types/indications: 1) diagnosis and axillary nodal staging of breast cancer; 2) assessment of regional lymph
nodes in melanoma; 3) diagnosis of prostate cancer and initial staging of newly diagnosed prostate cancer; and
4) diagnosis of cervical cancer.
However, PET for initial treatment strategy evaluation is covered only with participation in the NOPR
for certain patients with suspected or proven leukemia.
Page 38
Note: PET is covered only in clinical situations in which (1) the PET results may assist in avoiding an invasive
diagnostic procedure, or in which (2) the PET results may assist in determining the optimal anatomical location
to perform an invasive diagnostic procedure. In general, for most solid tumors, a tissue diagnosis is made prior
to doing a PET scan and therefore the scan is performed for staging rather than diagnosis.
PET is not covered as a screening test (i.e., testing patients without specific signs and symptoms of disease).
Subsequent Treatment Strategy
PET is also a CMS-covered service when used in subsequent treatment strategy evaluation (formerly restaging,
detection of suspected recurrence, and treatment monitoring) patients with the following cancers: breast,
cervix, colorectal, esophageal, head and neck, lymphoma, melanoma, myeloma, non-small cell lung, ovary, and
thyroid. For all other cancers, PET coverage for subsequent treatment strategy evaluation requires participation
in this registry.
PET is covered for restaging and detection of suspected recurrences:
(1)
(2)
(3)
(4)
after completion of treatment for the purpose of detecting residual disease; or
for detecting suspected recurrence or metastasis; or
to determine the extent of a known recurrence:
if it could potentially replace one or more conventional imaging studies when it is expected that
conventional study information is insufficient for the clinical management of the patient.
(5) Restaging applies to testing after a course of treatment is completed, and is covered subject to the
conditions above.
Comment: As noted above, PET is not covered as a screening test (i.e., testing patients without specific
signs and symptoms of disease) and thus is not covered for surveillance of patients treated for cancer in
whom there is no clinical reason to suspect recurrent disease.
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).
Comment: As an example, 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.
1. SPECIFIC REASON FOR PET STUDY
Check the single best match for the reason for the PET (you must check only one of the following)
Restaging after completion of therapy
Suspected Recurrence of a previously treated cancer
Monitoring Treatment Response during chemotherapy (including biologic modifiers)
Monitoring Treatment Response during radiation therapy
Monitoring Treatment Response during combined modality therapy (e.g., chemotherapy ± radiation
± surgery)
Diagnosis (Leukemia Only): To determine if a suspicious lesion is leukemia (answer 2a and 2b)
Diagnosis/Paraneoplastic (Leukemia Only): To detect occult leukemia in a patient with a presumed
paraneoplastic syndrome (answer 2a and 2b)
Initial Staging (Leukemia Only) of pathologically confirmed, newly diagnosed leukemia (answer 2a
and 2b)
Page 39
2. CANCER TYPE
•
Please mark the corresponding box of the cancer type in section 2a and answer question 2b. If your
patient’s cancer is not listed, check the Other box and enter as text the cancer type. For a patient with
metastatic cancer of unknown primary origin, please also mark the corresponding box of the site of
metastatic disease in section 2c.
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.
Stomach (151)
Small Intestine (152)
Anus (154)
Liver and intrahepatic bile ducts (155)
Gallbladder & extrahepatic bile ducts (156)
Pancreas (157)
Retroperitoneum and peritoneum (158)
Lung, small cell (162)
Pleura (163)
Thymus, heart, mediastinum (164)
Bone/cartilage (170)
Connective/other soft tissue (171)
Gastrointestinal stromal tumor (171)
Non-melanoma skin (173)
Kaposi’s sarcoma (176)
Uterus, unspecified (179)
Uterus, body (182)
Prostate (185)
Testis (186)
Penis and other male genitalia (187)
Bladder (188)
Kidney and other urinary tract (189)
Eye (190)
Primary Brain (191)
Leukemia (204-208)
Neuroendocrine tumor (209)
Metastatic cancer of unknown primary
origin (answer question 2c below)
Other, or not listed. Please describe cancer type:
.
and give the first 3 digits of the ICD-9 code. FFF XX
[Acceptable responses are 159, 165, 181, 183, 184, 192 - 195, and 235-238. Note: Ovarian cancer is
a covered indication; use 183 only for other adnexal cancers.]
b. Has this cancer diagnosis been pathologically proven?
Yes
No
c. Unknown primary: dominant site of pathologically proven or strongly suspected metastatic disease
(196-199)
Brain
Bone/bone marrow
Lymph node(s)
Lung
Liver
Other, or not listed. Please describe metastatic site:
.
and give the first 3 digits of the ICD-9 code. FFF XX [Acceptable responses are 196-199.]
Page 40
3. YOUR WORKING SUMMARY STAGE FOR THE PATIENT BEFORE THE PET SCAN IS:
(you must check only one)
No evidence of disease / In remission
Localized only
Regional by direct extension or lymph node involvement or both
Metastatic (distant) with a single suspected site
Metastatic (distant) with multiple suspected sites
Unknown or uncertain
4. PATIENT PERFORMANCE STATUS
Check the box best describing your patient’s global functional status (ECOG Performance Score) (you must
check only one)
(0) Asymptomatic: fully active, able to carry on all activities without restriction.
(1) Symptomatic, fully ambulatory: restricted in physically strenuous activity but ambulatory and able
to carry out work of a light or sedentary nature.
(2)Symptomatic in bed <50% of the day: ambulatory and capable of all self-care but unable to carry
out any work activities. Up and about more than 50% of waking hours.
(3) Symptomatic in bed >50% of the day, but not bedridden: capable of only limited self-care,
confined to bed or chair 50% or more of waking hours.
(4) Bedridden: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
5. ADDITIONAL RESPONSES REQUIRED ONLY IF THE SPECIFIC REASON FOR THE PET
STUDY IS MONITORING TREATMENT RESPONSE
a. Is the currently ongoing treatment intended to be:
Curative
Palliative
b. If the patient is receiving or has recently completed (within the last month) radiation therapy, check one
of the following.
Not applicable; no radiation therapy
Now in week 1 – 2 of radiation therapy
Completed radiation therapy within the last month
c. If the patient is receiving chemotherapy (including biologic modifiers), how many months of the
treatment has been delivered? (check one)
< 1 month
1- 3 months
3- 6 months
> 6 months.
Page 41
d. If your patient completes the currently ongoing therapy, how many total months of treatment (radiation
therapy and/or chemotherapy) do you expect to provide? (check one)
1- 3 months
3- 6 months
6-12 months
Expect to continue treatment for > 12 months
e. What is your current impression (before PET) of your patient’s response to currently ongoing therapy?
(check one)
Clearly responding, but uncertain about degree of response
Possible partial response, but uncertain about degree of response
Suspect no response
Suspect progressive disease
f. 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
6. MANAGEMENT PLAN
If PET were not available, your current management strategy would be? (you must check only one)

Note: If concurrent biopsy and total surgical resection are planned, then mark “surgical” treatment
below.
Curative
Palliative
Surgical
Radiation
Other
Supportive care
Yes
No
6. NAME OF PERSON WHO COMPLETED THE PAPER FORM
First Name:
Last Name:
Date
Page 42
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 of Physician: ________________
__________________
Thank you for your assistance.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0968. The time
required to complete this information collection is estimated to average five (5) minutes per response, including the time to
review instructions, search existing data resources, gather the data needed, and complete and review the information
collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form,
please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore,
Maryland 21244-1850.
Page 43
PET Completion Form
•
This form is completed by the PET Facility via Web-based data entry within 14 days of case registration.
•
The PET scan must be completed within 14 days of case registration. If the case was registered more than 14 days
prior to the PET scan the patient must be re-registered. The original case registration will be cancelled and the $50
will be refunded.
PET FACILITY ID #: __________________
REGISTRY CASE #: __________________
1. DATE SCAN COMPLETED: _____/_____/_____
(must be within 14 days of registration)
2. Scan Type (you must check one)
PET
PET-CT
3. Region(s) Scanned (you must check only one)
Body Only
(Study will be billed using one of the following CPT Codes: 78811-78816. Select this entry even if
the brain was intentionally or incidentally included in a body PET imaging study.)
DEDICATED Brain Only
(Study was performed with a brain acquisition protocol and will be billed using CPT Code 78608.)
Both DEDICATED Body AND Brain
(Brain study was performed with a brain acquisition protocol and will be billed using CPT Code
78608 AND body study was performed and will be billed using one of the following CPT Codes:
78811-78816.)
4. SCANNER INFORMATION
Facility’s Scanner Identifier (facility’s name for scanner) - Pull Down Menu of Facility’s Scanner Info
Date
(auto filled)
Page 44
PET Report Submission Form
•
This form is used to transmit the PET Report. It is completed by the PET facility via Web-based data entry within 30
days of completing the PET scan.
PET FACILITY ID #: __________________
REGISTRY CASE #: __________________
1. DATE SCAN COMPLETED: _____/_____/_____
2. DATE PET REPORT COMPLETED: _____/_____/_____
3. INTERPRETING PHYSICIAN INFORMATION - Pull Down Menu of Facility’s Interpreting Physicians
4. PET REPORT (you must either attach a report file OR enter the report as free text)
Free Text Entry is Preferred
Note that, if both a body PET study and a dedicated brain PET study were performed and reported
separately (rather than in a combined single report), both reports should be submitted. If you are submitting
a PDF or JPEG file, both reports must be combined into a single file.
Attached: PDF
JPEG
Or
Free Text Entry – if checked enter text here:
(Cut & paste from Microsoft Word document or other text document. You must enter the complete text of
the PET report.)
5. AFTER BEING GIVEN THE NOPR PATIENT INFORMATION STATEMENT, DID THE
PATIENT CONSENT TO HAVE HIS OR HER DATA USED FOR NOPR RESEARCH?
YES
NO
Date
(auto filled)
Page 45
Post-PET Restaging Cancer Form
Facility ID #:
Registry Case Number: ______
Patient Name: ______________________
Your patient had a PET scan on: mm/dd/yyyy.
The PET scan was done for restaging of (cancer type). (auto fill cancer type from Pre-PET Form).
•
•
After reviewing the PET report, please complete the following questions and return the form to the PET Facility.
This form must be completed and entered into the NOPR database within 30 days of the PET scan.
1. Compared to your Pre-PET assessment, your impression of the overall extent of disease is? (choose one)
More extensive
No change
Less extensive
2. Did the PET scan show evidence of cancer activity that was not previously documented?
Yes No
a. If yes, is some type of tissue biopsy planned of the area?
Yes No
3. Your Post-PET working clinical staging is: (select only one)
Low probability of local recurrence (including regional lymph nodes) or metastases
Local recurrence (including regional lymph nodes)
Metastatic disease with single site
Metastatic disease with multiple sites
4. Did the PET scan enable you to avoid more tests or procedures?
Yes No
5. In light of the PET findings, which of the following management strategies are you now planning or have
you already undertaken? (you must check only one)
below.
Curative
Palliative
Surgical
Radiation
Other
Supportive care
Yes
No
Page 46
6. I have read the Referring Physician Information Statement and:
I do give my consent for the inclusion of data collected for this patient in NOPR research.
I do NOT give my consent for the inclusion of data collected for this patient in NOPR research.
First Name:
Last Name:
Date
Date
Printed Name of Physician:
Page 47
Post-PET Suspected Cancer Recurrence Form
Facility ID #:
Patient Name: ______________________
The PET scan was done for a suspected recurrence of (cancer type). (auto fill
•
•
cancer type from Pre-PET Form).
1. Compared to your Pre-PET assessment, your impression of the overall extent of disease is: (choose one)
More extensive
No change
Less extensive
2. Did the PET scan show evidence of cancer activity that was not previously documented?
Yes No
If yes, is some type of tissue biopsy planned of the area?
Yes No
3. Your Post-PET working clinical summary staging is: (select only one)
Low probability of local recurrence (including regional lymph nodes) or metastases
Local recurrence (including regional lymph nodes)
Metastatic disease with single site
Metastatic disease with multiple sites
Yes No
below.
Curative
Palliative
Surgical
Radiation
Other
Supportive care
Yes
Page 48
No
First Name:
Last Name:
Date
Date
Page 49
Post-PET Treatment Monitoring Form
Facility ID #:
Patient Name: ______________________
The PET scan was done for treatment response monitoring of (cancer type) to
chemo/radiation/or other therapy (auto fill from Pre-PET data form the cancer type and treatment type).
•
•
below.
Curative
Palliative
Surgical
Radiation
Other
Supportive care
Yes
No
2. What is your current impression (in light of the PET findings) of your patient’s response to currently
ongoing therapy? (check one)
Clearly responding
Partial response
No response or stable disease
Progressive disease
3. Please indicate if and how you will modify your therapeutic plan in light of the PET findings.
(You must check only 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
Page 50
Stop therapy and switch to supportive care
4. If PET were not available, would you have done some type of alternative assessment at this time?
Yes
No
Yes
No
6. In light of the PET results, how has the prognosis for your patient changed? (check one)
Better
No change
Worse
First Name:
Last Name:
Date
Date
Page 51
Post-PET Suspected Leukemia Form
Facility ID #:
Patient Name: ______________________
You previously indicated that the PET scan was done for assessing whether a suspicious lesion is
leukemia.
•
•
This form must be entered into the database within 30 days of the PET scan.
2. Has a tissue biopsy been performed of a suspicious site?

Yes

No
3. Did the PET scan enable you to avoid any tests or procedures?

Yes

No
treatment listed below.
Curative
Palliative
Type(s): (all that apply)
Surgical
Radiation
Other
Supportive care
Yes
No
5. NAME OF PERSON WHO COMPLETED THE PAPER FORM:
First Name: ________________ Last Name: ____________________ Date:
Page 52
Date
Page 53
Post-PET Paraneoplastic Syndrome Form
Facility ID #:
Patient Name: ______________________
You previously indicated that the PET scan was done to detect occult leukemia in a patient with a
suspected paraneoplastic syndrome. (auto fill reason from Pre-PET Form)
•
•
1. Was leukemia (or another primary cancer site) identified by PET?

Yes

No
2. Was a tissue biopsy or surgical excision performed of a suspected tumor?

Yes

No

Yes

No
listed below.

Curative
Palliative
Surgical
Radiation
Other
Supportive care
Yes
No
I Do give my consent for the inclusion of data collected for this patient in NOPR research.
I DO NOT give my consent for the inclusion of data collected for this patient in NOPR research.
6.
Page 54
NAME OF PERSON WHO COMPLETED THE PAPER FORM:
First Name: ________________ Last Name: ____________________ Date:
Date
Page 55
Post-PET Initial Staging Form
Facility ID #:
Patient Name: ______________________
The PET scan was done for initial staging of leukemia
•
•
1. Compared to your Pre-PET assessment, your impression of the extent of the patient’s leukemia is? (check
one)
More extensive
No change
Less extensive
2. Did the PET scan, show evidence of leukemic involvement that was not previously documented?
Yes No
a.
If yes, is some type of tissue biopsy planned of the area?
Yes No
3. Are any more tests or imaging or biopsies planned before starting treatment? Yes No
Yes No
5. Your Post-PET working clinical summary staging is? (you must check only one)
Localized disease only
Systemic disease
Unknown or uncertain
you already undertaken? (you must choose only one)
treatment listed below.
Curative
Palliative
Surgical
Radiation
Other
Supportive care
Yes
No
Page 56
8. NAME OF PERSON WHO COMPLETED THE PAPER FORM:
First Name: _______________ Last Name: _______________________ Date:
Date
Page 57
Appendix III
Cancers and Indications Eligible for Entry in the NOPR
Cancers and indications that are reimbursable by Medicare are NOT eligible for entry in the NOPR. Cancers and indications that are
specifically excluded for Medicare reimbursement are also not eligible for entry in the NOPR.
C = covered – Not eligible for entry in the NOPR
NC = non-covered nationally – Not eligible for entry in the NOPR
NOPR = covered only with entry in the NOPR
C
NOPR
C
C
C
C / NOPR1
C
NOPR
C
NOPR
C
C
C
C
C
C
C
C
C
C
NOPR
NOPR
C
C
C
NOPR
NOPR
NOPR
NOPR
NOPR
C / NC2
C
C
NOPR
C / NC2,3
C
C / NC2,3
C
C
C
NOPR
NOPR
C / NC4
C
C
C
NOPR
NOPR
Initial Treatment
Strategy (formerly
Diagnosis and Initial
Staging)
Indications
Lip, oral cavity, and pharynx (140-149)
Esophagus (150)
Stomach (151)
Small intestine (152) (For carcinoid, see
Neuroendocrine tumor below)
Colon (153) and rectum (154)
Anus (154) (Considered distinct from
rectum; see footnote 1)
Liver and intrahepatic bile ducts (155)
Gallbladder and extrahepatic bile ducts
(156)
Pancreas (157)
Retroperitoneum and peritoneum (158)
Nasal cavity, ear, and sinuses (160)
Larynx (161)
Lung, non-small cell (162)
Lung, small cell (162)
Pleura (163)
Thymus, heart, mediastinum (164)
Bone/cartilage (170)
Connective/other soft tissue (171)
Melanoma of skin (172) (Nasopharyngeal,
ocular and vulvar/vaginal melanomas are
coded based on those anatomic locations;
PET not covered for regional nodal
staging—see footnote 2)
Non-melanoma skin (173)
Female breast (174) (PET not covered for
diagnosis of breast masses or for axillary
nodal staging—see footnotes 2 and 3)
Male breast (175) (PET not covered for
diagnosis of breast masses or for axillary
nodal staging—see footnotes 2 and 3)
Kaposi's sarcoma (176)
Uterus, unspecified (179)
Cervix (180) (PET not covered for diagnosis
of cervical cancer—see footnote 4)
Uterus, body (182)
Placenta (181)
C
C
C
Subsequent
Treatment Strategy
(Includes Treatment
Monitoring, Restaging
and Detection of
Suspected
Recurrence)
C
C
NOPR
Version:November 30, 2009
Page 58
C
C
Subsequent
Treatment Strategy
(Includes Treatment
Monitoring, Restaging
and Detection of
Suspected
Recurrence)
C
NOPR
C
NOPR
NC
C
C
C
C
C
C
NOPR
NOPR
NOPR
NOPR
NOPR
NOPR
NOPR
C
NOPR
C
C / NOPR5
C
NOPR
C
NOPR
C
C
NOPR
C
C
NOPR
C
C
NOPR
NOPR
NOPR
NOPR
Initial Treatment
Strategy (formerly
Diagnosis and Initial
Staging)
Indications (continued)
Ovary (183.0)
Uterine adnexa (183.2-183.9)
Other and unspecified female genitalia
(184) (Includes vulvar/vaginal melanoma)
Prostate (185)
Testis (186)
Penis and other male genitalia (187)
Bladder (188)
Kidney and other urinary tract (189)
Eye (190) (Includes ocular melanoma)
Primary Brain (191)
Other and unspecified nervous system
(192)
Thyroid (193) (Covered for subsequent
treatment strategy only if specific
requirements met—see footnote 5;
otherwise NOPR)
Other endocrine glands and related
structures (194)
Metastatic cancer / cancer of unknown
primary origin (196-199)
Lymphoma (200-202)
Myeloma (203)
Leukemia (204-208)
Neuroendocrine tumor (209)
All other solid tumors
All other cancers not listed herein
Footnotes
1
Some Medicare contractors include anal cancer in their local coverage of “colorectal cancer”; for PET facilities served by those
carriers, PET for subsequent treatment evaluation of anal cancer would be a covered indication.
2
PET is non-covered for initial staging of axillary lymph nodes in patients with breast cancer and of regional lymph nodes in
patients with melanoma, but is covered for detection of distant metastatic disease in high-risk patients with breast cancer or
melanoma.
3
PET is non-covered for “diagnosis” of breast cancer to evaluate a suspicious breast mass. However, PET is covered for initial
treatment strategy evaluation of a patient with axillary nodal metastasis of unknown primary origin or in a patient with a
paraneoplastic syndrome potentially caused by an occult breast cancer.
4
PET is non-covered for diagnosis of cervical cancer, but is covered for initial staging of cervical cancer.
5
To qualify as a covered indication for subsequent treatment strategy evaluation, thyroid cancer must be of follicular cell origin
and been previously treated by thyroidectomy and radioiodine ablation and the patient must have a serum thyroglobuilin > 10
ng/mL and a negative whole-body I-131 scan. Patients who do not qualify for this covered indication (e.g., because the tumor is
of other than follicular cell origin, the thyroglobulin is not elevated, or I-131 whole-body imaging was not performed or is
positive) can be entered on NOPR.
IMPORTANT NOTES
•
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 the
requirement for 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
Page 59
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 ICD-9-CM® codes in the table above are provided for reference purposes only and for guidance in completion of the
cancer type on the pre-PET form for cases included in the NOPR. Each provider should refer to the coverage policy of its
®
respective Medicare contractor to determine which ICD-9-CM codes are indicative of medical necessity. Note also that,
although PET is covered to aid in the diagnosis of strongly suspected cancers, claims submitted with the appropriate noncancer ICD-9-CM® code(s) may not be paid without medical necessity appeal.
•
PET imaging of the brain with CPT code 78608 is covered for those cancers and indications designated by “C” in the table
above and is covered only under NOPR for those cancers and indications indicated by “NOPR” in the table above.
Page 60
Appendix IV
HIPAA Compliance and IRB Approval for the NOPR
HIPAA Compliance and Participation in the NOPR
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires that providers (Covered
Entities as that term is defined under HIPAA) have in place an agreement with any Business Associate if the
parties in their business dealings exchange Protected Health Information (PHI), as that term is defined in the
HIPAA regulations. Under the regulations, submission of claims data by a PET facility (Covered Entity) to the
American College of Radiology (ACR) (Business Associate) requires execution of a business associate
agreement.
This business associate agreement (BAA) serves the purpose of obtaining satisfactory assurance that the
Business Associate will appropriately safeguard any PHI received from the Covered Entity. With this
agreement in place, the exchange of information between the Covered Entity and the Business Associate will
meet HIPAA requirements without disruption of the business arrangement.
In order to facilitate the submission of your claims data to the NOPR, the ACR has developed a Business
Associates Agreement (BAA) for your use. (The BAA is available at www.cancerPETregistry.org under
Sample Forms.) This agreement fully complies with the requirements of HIPAA and is available on the NOPR
Web site.
Institutional Review Board (IRB) Approval for Registry
The only entity engaged in research is the registry itself (i.e., NOPR) because the NOPR intends to use the data
it is collecting for research purposes when both the patient and the referring physician have consented to the use
of the information for this purpose. The ACR IRB has granted approval for the NOPR to engage in research
using these data as described in the original NOPR research plan and this revised research plan (see letters
below from ACR IRB).
Individual PET facilities and referring physicians and their staff are not engaged in research and therefore are
not required to have IRB approval for their participation in the activities of the NOPR. Submission of the
information for the registry (pre-PET and post-PET case report forms and the PET scan report) is required by
CMS for payment for PET studies for all Medicare-insured patients with cancer indications included in the
registry. Additionally, CMS is not conducting research.
Any participating PET facility may nevertheless elect to have its local IRB review its participation in the
NOPR. Some IRBs require, as a matter of institutional policy, that they review all research conducted in the
institution, even if only to determine that the facility is not engaged in the research. Materials are provided
below to assist in this process (See below, Submission Materials for Institutional IRB Review). The Office of
Human Research Protections (OHRP) has reviewed the NOPR procedures for protection of human research
subjects and finds them to be in compliance with the applicable DHHS regulations. Any individual IRBs with
questions can contact OHRP.
Informed Consent Requirements
The data collected by the NOPR will be used for two different purposes: (1) payment determination by CMS;
and (2) research use by NOPR. Accordingly, two different protocols will be followed concerning the informed
consent requirements and the release of patient and physician identified data.
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Data Collected for CMS
The data collected by the NOPR as required by CMS under the National Coverage Decision for PET for
payment determination is not considered research data and will be sent, in its entirety, to CMS on a schedule
determined by CMS.
Data Collected for NOPR Research
The data entered in the registry also will be used as the basis of research by the NOPR to make
recommendations and/or observations concerning the impact of PET on patient management. The subjects of
this research are the patients who are entered into the NOPR and the referring physicians who provide data on
their intended patient management plan. The subjects providing this data can give or withhold consent to allow
their data to be used for purposes of the research being conducted at NOPR. This is similar to obtaining
subjects’ consent for involvement in research conducted through a survey or other similar activity conducted at
any institution.
Although NOPR must obtain consent before a patient’s data may be used for research purposes, NOPR has
qualified for a waiver of the requirement that such consent be in writing. Pursuant to Section 46.117(c)(2) of
the Department of Health and Human Services (HHS) regulations on the protection of human subjects, an IRB
may waive the requirement of written consent if “the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside of the research
context.”
The ACR IRB has determined during their review that the registry’s research activities are of minimal risk and a
written documentation of consents have been waived for both the patient and the referring physician under Title
45 CFR 46 § 46.117(c)(2). Both the patient and the referring physician must be provided with the ACR IRB
approved information sheets to inform the subjects that their data may be used in research and they must
verbally either give or withhold consent to allow their data to be used for research.
Patient Information Sheet – The standard NOPR Information Sheet for patients is posted on the NOPR Web
site, and participating PET facilities are required to give a copy of it to each Medicare patient prior to
performing a PET scan that will be covered by the NOPR. The consent form incorporates the eight basic
elements of informed consent, as provided by Section 46.116(a) of the Code of Federal Regulations. The
patient’s consent or refusal to have their data included in NOPR research will be included as a required data
element in the database.
Referring Physician Information Sheet – The Information Sheet for referring physicians will be included in the
post-PET Forms. The referring physician’s consent or refusal to have their response data included in NOPR
research will be a required data element in the database as documentation of the referring physician’s response.
Physicians who do not consent to have the data collected on this form (and the pre-PET Form) used in NOPR
research are still required to submit all of the required data elements in order to have the PET study reimbursed
by CMS; however, their data elements will be excluded from the research dataset used by NOPR investigators.
Data for a particular PET scan will be used in research only if BOTH the patient and the referring physician
consent to use of the data for this purpose.
If patients or referring physicians have questions about the NOPR research, they can contact NOPR for
information before agreeing to participate. If they have questions about the requirements for Medicare coverage
and payment for PET scans they can refer to guidance posted on the CMS MLM Matters Website
(http://www.cms.hhs.gov/MLNMattersArticles) or they can contact CMS. Patients and physicians can change
their decision to consent or not to consent to use of their data in the NOPR research by contacting their PET
facility. The PET facility will inform NOPR headquarters and the database record will be changed to reflect the
wishes of the patient and/or physician.
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Submission Materials for Institutional IRB Review (If Required)
Abstract
The National Oncologic PET Registry (NOPR) [http://www.cancerpetregistry.org/] was developed and began
collecting data in 2006. The NOPR was created in response to the Centers for Medicare and Medicaid Services
(CMS) proposal to expand coverage for positron emission tomography (PET) with F-18 fluorodeoxyglucose
(FDG) to include cancers and indications not eligible for Medicare reimbursement at that time. Medicare
reimbursement for these cancers became available if the patient's referring physician and the provider submit
data to a clinical registry to assess the impact of PET on cancer patient management (“coverage with evidence
development” [CED]).
application at http://www.cancerPETregistry.org/.
facility prior to the PET scan and the Post-PET Form is completed and returned within 30 days of the PET scan.
bill CMS for the study.
confidentiality required by HIPAA. The primary goal of this registry is to provide CMS with data needed to
make payment determinations and is not considered research. All data entered in the registry database will be
delivered to CMS as part of its payment determination process. The, secondary, or research, goal of the NOPR
is to assess the effect of PET on referring physicians’ plans of intended patient management across the spectrum
of the expanded cancer indications. The subjects of the NOPR research, patients and referring physicians, can
consent (or not) to allow their data to be used for purposes of the research being conducted at NOPR, just as
subjects can consent to being involved in research conducted through a survey or other similar activity at any
institution. The dataset used by NOPR investigators will contain only the data of patients and physicians when
both have consented to have the data included.
The NOPR officially began accepting patient registrations on May 8, 2006. During nearly three years of
operation, over 100,000 patients have undergone PET under NOPR’s mechanism that allows for Medicare
coverage of these scans. The NOPR investigators have published several peer-reviewed manuscripts
documenting the impact of PET on referring physicians’ intended management in patients with cancer. Based
in part on these results, the NOPR investigators asked CMS in March 2008 to reconsider its coverage policy for
PET. On January 6, 2009, CMS released its draft coverage decision related to PET that proposes major changes
to current coverage (http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=218). In response to this
proposal, the NOPR investigators have revised the registry based on the proposed changes in coverage and to
conform to additional requirements for a new CED program. On April 3, 2009, CMS announced its new
coverage policy (http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=218). Under this new policy,
CMS expanded coverage for the use of PET for initial evaluation of patients with cancer to nearly all cancer
types and also allows for use of PET in subsequent treatment strategy evaluations for an expanded number of
cancers. However, for certain other cancers, the use of PET in initial treatment strategy evaluations and,
particularly, in subsequent treatment strategy evaluations will still be covered by CMS only if patients are
enrolled in an approved clinical trial or registry. The NOPR has sought and obtained CMS approval to continue
its data collection to allow for coverage of PET scans performed for these cancers and indications under this
successor CED program.
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Project Summary
The National Oncologic PET Registry (NOPR) [http://www.cancerPETregistry.org/] was developed in response
to the Centers for Medicare and Medicaid Services (CMS) proposal to expand coverage for positron emission
tomography with F-18 fluorodeoxyglucose (PET) to include cancers and indications not presently eligible for
Medicare reimbursement. Medicare reimbursement for these cancers can now be obtained if the patient's
referring physician and the provider submit data to a clinical registry to assist in CMS payment determinations.
The NOPR is implementing this registry for CMS. The NOPR is sponsored by the Academy of Molecular
Imaging (AMI) and managed by the American College of Radiology (ACR) through the American College of
Radiology Imaging Network (ACRIN). The NOPR is endorsed by the ACR, the American Society for Clinical
Oncology (ASCO), and the Society for Nuclear Medicine (SNM).
application at http://www.cancerPETregistry.org/. Below is a brief summary of the data collection procedure.
When a patient eligible for entry into the NOPR presents at the PET facility, the facility contacts the
referring physician and obtains confirmation that the referring physician will submit the required preand post-PET Forms.
The facility registers the patient on the NOPR via a Web form, at which time a Registry case number is
assigned.
The NOPR will send confirmation to the PET facility and e-mail a request for the pre-PET data to the
PET facility for delivery to the referring physician.
The referring physician must complete and return the Pre-PET Form to the PET facility for entry into
the NOPR database by midnight of the day of the PET scan.
At some time before the PET study, or when the patient arrives for the PET scan, the PET facility will
provide the patient with the ACR IRB approved standard NOPR Patient Information Sheet that is posted
on the NOPR Web site. The patient will be able to contact the NOPR directly for more information, if
necessary. The patient will indicate his or her consent verbally to staff at the PET facility. Written
consent is not required. The PET facility will note in the database if the patient gave or withheld
consent for use of his or her data in future NOPR research.
After the PET scan is performed, the PET facility sends the PET report to the referring physician, enters
the study completion date into a Web form, and submits the report text electronically to the NOPR
database.
After the PET Report Form is entered, the database will send the PET facility a patient-specific PostPET Form and a fax cover sheet for delivery of the Post-PET Form to the referring physician. This form
will also include an ACR IRB approved Referring Physician Information Sheet for the physician. The
physician will indicate on the Post-PET Form to whether consent for use of the response data in future
NOPR research is given or withheld consent for use of the response data in future NOPR research. This
form must be completed, returned to the PET facility, and entered into the NOPR database within 30
days of the PET scan.
The patient's referring physician must agree to complete pre- and post-PET data collection forms consisting of
approximately 6 questions regarding the patient's planned management.

The Pre-PET Form must be completed and signed by the referring physician and returned to the PET
facility prior to the patient's PET scan.
After the PET is performed a patient-specific Post-PET Form will be e-mailed to the referring physician
for completion within 30 days.
facility prior to the PET scan and the Post-PET Form is completed and signed by the referring physician and
returned within 30 days of the PET scan.
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bill CMS for the study. All collected data will be submitted to CMS. The dataset compiled for use by NOPR
investigators will only contain only the data for those PET scans where both the patient’s and the referring
physician’s consent have been obtained.
The primary goal of this registry is to provide CMS with data needed to make payment determinations and is
not considered research. All data entered in the registry database will be delivered to CMS as part of their
payment determination process. The, secondary, or research, goal of the NOPR is to assess the effect of PET on
referring physicians’ plans of intended patient management across the spectrum of the expanded cancer
indications. The subjects of the NOPR research, patients and referring physicians, can consent (or not) to allow
their data to be used for purposes of the research being conducted at NOPR, just as subjects can consent to
being involved in research conducted through a survey or other similar activity at any institution. The dataset
used by NOPR investigators will contain only the data of patients and physicians who have consented to have
their data included. It is anticipated that sufficient numbers of patients and physicians who have consented to
have their data included in the research dataset should be accrued to accurately estimate the proportion of
change in the intended treatment management after PET. These data will be classified and evaluated by cancer
type and by clinical indication.
confidentiality required by HIPAA.
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Letter from CMS on Registry Participation for Reimbursement Under the National Coverage Determination
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Initial ACR IRB Approval Letter for the NOPR
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Appendix V
Resources for Project Management, Data Security, and Quality Assurance
The American College of Radiology (ACR), founded in 1923, is a professional medical organization composed
of diagnostic radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and
medical physicists. The ACR Philadelphia Office has been actively involved in clinical research for 30 years
providing administrative, data management, information technology, image archival, and statistical support for
over 300 research studies. The office employs over 100 people dedicated to clinical trial management and is the
headquarters for three major National Cancer Institute research efforts (ACRIN, RTOG, PCS), the office also
provides clinical trial support services for many diverse industry funded projects.
Current Clinical Trial Management Projects
American College of Radiology Imaging Network (ACRIN)
ACRIN was funded in 1999 to assess emerging radiologic technologies and answer imaging questions of
clinical importance. Since then ACRIN has established itself as one of most respected leaders in cancer research
with 18 clinical trials involving 120 different institutions and more than 80,000 patients with the ultimate goal
of enhancing and expanding how medical imaging and image-guided therapy are used to diagnose and care for
cancer patients. Two major screening projects have completed patient enrollment – the Digital Mammographic
Imaging Screening Trial enrolled 49,500 women to assess the accuracy of digital mammography technology
and the Lung Cancer Screening Trial enrolled 18,000 patients to determine if screening using molecular
markers and CT can improve mortality in high-risk patients. In February 2005 ACRIN opened the National CT
Colonography Trial which is the largest multicenter study to compare the effectiveness of state-of-the-art CT
colonography (virtual colonoscopy) to conventional colonoscopy. Supplemented with a $7 million grant from
the National Cancer Institute, the trial will enroll 2,800 participants at 15 sites and provide the most definitive
data concerning CT colonography’s role as a colorectal cancer screening tool. ACRIN has also opened
protocols using percutaneous radiofrequency ablation for bone metastases, hepatic chemoembolization, and
MRI & CT as staging or screening tools.
ACRIN has recently developed a PET Core Lab to provide a single centralized center for the collection,
processing, archiving and quality control of PET images associated with clinical trials. The core laboratory
interfaces with participating sites of multi-center trials conducted by ACRIN and other cooperative groups, in
order to: (1) qualify sites’ equipment and images, (2) perform quality assurance review of patient and phantom
data, (3) provide advanced processing and quality assurance of quantitative patient image data, (4) provide
blinded diagnostic interpretations, (5) perform quantitative analysis of images, and (6) integrate PET and
PET/CT data with radiation therapy planning data where applicable to the trial. In order to accomplish these
objectives ACRIN has equipped workstations from each of the major PET manufacturers with direct fiber
network access to the archive for swift retrieval and display. It is planned that any image review, including
quantitative evaluation, will be conducted on these platforms. The images will be indexed in a MS-SQL
database which will include case, project and institution data along with DICOM header information should it
be available. In addition to providing support to trials involving PET imaging, it is envisioned that the core
laboratory would undertake clinical research studies specific to enhancing the use of PET imaging technology
by validating SUV readings, developing a common workstation capable of presenting any vendor’s images, and
advancing work to standardize DICOM formatting of PET images.
Radiation Therapy Oncology Group (RTOG)
The RTOG, established in 1968, is the national leader in conducting research studies to increase the survival
and improve the quality of life of patients diagnosed with cancer by evaluating new forms of radiotherapy
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delivery and evaluating existing treatments and identifying new protocols. The primary areas of RTOG research
include brain tumors, lung cancer, head and neck cancer, gastrointestinal cancers, genitourinary tract cancers,
sarcomas, gynecologic cancer, breast cancer, and symptom management.
This group of physicians, physicists, biologists, and biostatisticians currently has a roster of 40 studies open for
patient enrollment. There are currently 250 participating institutions and since its inception, RTOG has
conducted over 300 protocols and accrued over 36,000 patients. The group is collecting long-term follow-up
data on over 19,000 patients. RTOG research is internationally. During the last year more than 40 papers were
presented at medical conferences, including 18 papers at the 2004 annual meeting of the American Society for
Therapeutic Radiology and Oncology and 24 papers at the 2005 annual meeting of the American Society of
Clinical Oncology. In addition, RTOG were published papers in the leading peer-reviewed medical journals,
including The New England of Medicine, The Lancet, the International Journal of Radiation Oncology Biology
Physics, the Journal of the National Cancer Institute, and the Journal of Clinical Oncology.
Patterns of Care Study in Radiation Oncology (PCS)
Funded in 1973 to compare recommended management guidelines to the actual practice of radiation therapy
throughout all types of facilities in the U.S, the PCS has made possible the identification of new approaches to
radiation oncology leading to improved patient outcome and/or reduced complications. The current PCS
program builds on prior findings of six national process and outcome surveys in radiation oncology to further
enhance cancer patient management.
Industry Sponsored Research
ACR Philadelphia has conducted clinical trial research on behalf of over 20 pharmaceutical and biological agent
manufacturers. These corporations rely upon our national network of contracted facilities, and our ability to
rapidly collect, review and analyze study data.
Resources for Project Management, Data Security, and Quality Assurance
Project Management
As detailed above, ACR has extensive experience in the management of clinical trials. As is its custom, ACR
will assign a Project Manager for the National Oncologic PET Registry (NOPR). Working with the NOPR
Working Group the Project Manager will be responsible for coordinating all aspects of the registry
development, implementation, monitoring and reporting. The Project Manager will be a resource for the PET
Facilities in need of information or help with the Web-based applications.
Informatics
The Management Information Systems (MIS) Department of the American College of Radiology Philadelphia
Office provides computer and informatics services. The department has a long history of outstanding support to
large national cooperative groups and is completely familiar with their unique needs of clinical trial
management. In addition, MIS staff from the ACR headquarters in Reston, VA is available for advice and
counsel to the Philadelphia staff.
The MIS Department operates the Clinical Trials Management System (CTMS), which provides service for all
grant activities directed from the Philadelphia office. This system was written by the ACR and became
operational in October 1999. It is a comprehensive system, providing a modern informatics infrastructure that
enables ACR to conduct trials using sophisticated electronic collection techniques via the World Wide Web. It
also provides a wide array of management tools that are invaluable in supporting the needs of both the HQ and
the Biostatistical & Data Management Center (BDMC). The BDMC, though located in Providence, RI, has
complete, real time access to the system via a dedicated private T1 line. Since 1999, multiple enhancements
have been added to the system to assure that it remains up-to-date and provides the latest in informatics
capabilities. The system has particularly strong capabilities in interfacing with participating facilities via the
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World Wide Web. Details of both the hardware and software components of the ACR system are covered in the
Resources section.
ACR has developed a range of leading edge Web applications based on the Web Application Server, LAN
Application tool, and Database platform. These software tools provide very effective business solutions to the
Data Management office in Philadelphia, the BDMC, and the participating facilities.
Since its very beginning, the American College of Radiology Imaging Network (ACRIN) has been a near paper
free organization, with the primary method of communication with participants being the ACRIN Web site.
With proper credentials, institutions are able to access the ACRIN web site and perform the following:
• Enter patients into studies;
• Receive treatment arm assignment, case number, and any other identifying information;
• Directly enter clinical information into electronic case report forms;
• Print copies of patient specific case report forms, if desired;
• Obtain a patient specific schedule of future reporting requirements;
• Review the latest version of all protocols and print out hard copies, if desired;
• Update administrative information in the headquarters database;
• Transmit and download images to/from an electronic image archive;
• Receive up-to-date information concerning group operations.
The Web based clinical data capture system has evolved over several years, and now provides an array of
electronic case report forms that are very easy to use. The forms are generated dynamically “on the fly”
according to the response to previous questions. This means that the user of the form never has to see a question
that does not need to be answered, thus assuring that the forms can be completed quickly and with minimum
difficulty. Edit checks are performed as the data are entered, and errors are quickly communicated back to the
user so that they can be corrected before the data is entered into the database. This produces final data of the
highest quality and accuracy.
Security
The ACR database provides digital trust services that will enable participating facilities to access information,
communicate, and engage in transactions with confidence. These secure services help the Headquarters and the
BDMC streamline processes and reduce administrative costs needed to protect patient information. ACR’s
methods to conduct online transactions and transfer clinical information ensure the confidentiality of patient
records and protect high-value information with services, which ensure that only authorized parties can access
information via the Web.
Security at the ACR Philadelphia computer facility entails both physical and software restraints limiting access
to patient data. The computer facility is located within the office space of the ACR Philadelphia office and both
the main office and computer room entrances are secured by combination locks, 24 hours a day. The security
capabilities in Windows 2003 Servers are built on standard protocols and supported by the Active Directory.
System Administrator manages user accounts and access rights from a central location using Active Directory
(AD) by granting or denying access rights, and delegating security administration. The Network is protected at
Logon using public key authentication protocols. Data is secured in the Network (local network and subnets)
using an authentication protocol. For an additional level of security within a site, network data is encrypted. All
network communications are encrypted for specific clients using Internet Protocol Security (IPsec). All dial-up
and Internet access is protected by user and password identification using SSL. System access as well as
individual programs have user account/password protection against unauthorized use. Unauthorized users are
refused access utilizing a combination of software and hardware protection schemes. Inactive terminals are
logged off automatically and locked from further use except as authorized by the system administrator.
SilverStream Application Server has the Management Console called Server Management Console (SMC) that
can keep track of number of Clients connected. It can provide the client certificate level in HTTPS. It provides
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the capability of tracking the users through sessions that stores user information securely with the help of
cookies. Data flow through SilverStream Application is very much secured and SMC plays key role in all theses
security related issues. System accounts for both current employees and registered institutions are maintained
by system administration personnel and are continuously updated based upon changing user environments.
Log-in records, both successful and failed, are maintained and periodically reviewed to check for habitual
efforts to gain unauthorized access.
System security is further enhanced by automatic backup procedures. Each server and workstation computer in
the network is backed up to tape nightly. Backups are performed to DAT tapes capable of storing from 12 to
100. The security capabilities in Windows 20003 Server are built on standard protocols and supported by the
Active Directory. Backups are performed for both short and long-term storage with tapes maintained in-house
and off-site storage.
d.
Quality Assurance
The NOPR manual of operations gives a detailed description of the data requirements and the timeline for data
submission. The statistical section provides the framework in which the Working Group will make decisions
concerning coverage recommendations.
The quality assurance program for the NOPR will revolve around the validation checks that are built into the
Web-based data entry applications. PET Facilities will not be able to complete the data form entry process if
there are missing data elements or if the data elements are outside specified range values. In addition, patient
identifiers will be collected so that CMS will have the option of including Registry compliance in its standard
auditing procedures. PET Facilities are instructed to keep all paper copies and e-mails received from referring
physicians as source data.
e.
Resources
The ACR Philadelphia office is housed on two floors (24,000 sq. ft.) of a major downtown office building. The
space was configured to ACR’s needs in 2004. Available computer hardware and software includes:
Software
Microsoft 2003 Advanced/Terminal Server, Microsoft 2000/XP Workstation, Oracle Collaboration Suite Portal,
SilverStream Web Application Server, Microsoft Office 2003 Professional Edition, Adobe PDF Writer 6.0 and
PageMaker 7.0, Citrix Metaframe Server XP, Sun Solaris 9.0, Red Hat Linux, Norton Internet Security and
Anti-Virus, Document Imaging System, Clinical Trials Application, RightFAX Network FAX, Microsoft SQL
Server 2000/2005, Macromedia Dreamweaver 4.0, Sybase PowerBuilder 9.0, Claris FileMaker Pro5, EndNote
4.0 and Veritas BackupExec 8.0, Commvault Galaxy Backup and Borland JBuilder Java Developer Tool Kit,
MicroSoft.Net, Microsoft IIS Server.
Major Equipment
Dell PowerEdge 6400 Clinical Database, Dell PowerEdge 2500 FTP Server, IBM x440 SilverStream Web
Server, Compaq DL380 Document Server, Compaq DL360 Citrix Metaframe, BlueArc Si7500 NAS
Diagnostic Image Storage, IBM Pentium 4 3.0 GHz Domain Controllers, IBM Pentium 4 2.8 GHz Printserver,
IBM Pentium 4 2.8GHz File Server, IBM Pentium III 1.2 GHz Fax Server, DELL 2650 Pentium Xeon 3GHz
Collaboration Suite Server, 1 Kingston 1.2 Terabyte Image storage, 1 Cisco 3620 Router, 1 Cisco 2524 Router,
2 Cisco 2501 Router, 1 Cisco PIX 500 Firewall, Juniper Networks N50 Firewall, Juniper Network Virtual
Private Network, Tumbleweed Anti-Spam Appliance, ADIC Scalar 220 Autoloader Tape Backup, Ricoh Aficio
2090 high-volume photocopier, Ricoh Aficio 2045e, Ricoh Aficio 2238C color copier, Ricoh Aficio 1060
copier, Ricoh Aficio 2090 copier,heat bind machines, Pitney Bowes postage machine, Pitney Bowes 3400 FAX,
Pitney Bowes 9550 FAX, Pitney Bowes 9720 FAX, Pitney Bowes 9640 FAX, Xerox DWC 635 FAX, 100+ PC
Pentium 4 workstations, 35 PC Pentium III 1GHz workstations, 15 Pentium notebook computers, 20 HP Laser
printers, 1 HP 4500 Laser Color Printer, 3 Xerox 8200 Phaser printer, 4 Xerox N2125 Printer, 6 Fujitsu
ScanRight M3096EX document scanner w/sheet feeder, HP4C flatbed color document scanner, 3 media center
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w/LCD large screen projection system, 2 High Definition Plasma Screen Display, 2 Tanberg Video
Conferencing System.
Computer
Clinical Data Computers: (2) Dedicated Dual Pentium III Xeon 700 MHz clustered, each with 3 Gigabytes of
memory, (3) 9.0 Gigabyte system disks on RAID (Level 1), (1) 180 Gigabyte RAID (Level 5), ADIX Tape
Library Backup System, and multiple PC Pentium 4 workstations.
Document Imaging Computer: Dedicated Dual Pentium 4 3.0 GHz system, with 2 Gigabytes of memory, (2) 9.0
Gigabyte system disks on RAID (Level 1), (3) 6 Terabyte RAID (Level 5) ADIC Tape Library Backup System
and multiple PC Pentium 4 workstations.
Diagnostic Imaging System: Dedicated Dual Pentium 4 2.8 GHz system, with 3 Gigabytes of memory, (2) 9.0
Gigabyte system disks on RAID (Level 1), (3) 6 Terabyte RAID (Level 5), (1) Autoloader Library with dual
AIT-3 tape drive and multiple PC Pentium 4 workstations, (1) Sun Spark workstation with Solaris Operating
System, One Red Hat Linux Workstation, Kodak LS-75 Laser Film Scanner and multiple dual-monitor, highresolution display workstations. BlueArc Si7500 6 Terabytes of Storage System for images is utilized with
symmetric multi-processing operating system to maximize throughput speed and data availability.
Website Computers: Dedicated Pentium III Xeon 900 MHz with 3 Gigabytes of memory, (2) 18.0 Gigabyte
system disks n RAID (Level 1), advanced security and reliability. Hosted in Demilitarized Zone of the
Firewall, these web servers are separated from the sensitive internal information disallowing access to internal
network via Web Site. J2EE compliant SilverStream Application and Web Server are utilized to provide the
most complete foundation for building and deploying cross-platform, high performance, standards-based Web
applications with load balancing, server and session-level fail over, outstanding scalability and fault tolerance
ensuring user interactions are not disrupted even if a server crashes. The Website delivers the highest levels of
trust and security for online transactions using 128-bit strong-encryption certificates. This protects confidential
information from interception and hacking.
Automated Backup Tape Libraries: Tape libraries deliver fast file access and high capacity for automated
backup and storage for distributed networks and servers. They provide up to 10 Terabyte of storage and up to
60 Gigabyte per hour per-drive sustained throughput. Multiple tape drives in these auto libraries provide higher
performance, redundancy, and allow scalability-drives to be added to increase performance or to upgrade to
newer technology.
Internet Links:
DS3: Dedicated DS3 connection linked to the Internet Service provider and National Backbone Network
provides fast, reliable, secure and direct access to the Internet minimizing network delays due to extensive
routing. It also means guaranteed bandwidth at 15 Megabytes/sec upgradeable to 45 Mbps. The link is
configured using Cisco 3620 multiservice platform Router with 80 MHz IDT R4700 RISC Processor and 64
MB DRAM.
T1: Integrated T1 link to Brown University for shared data access. This line is configured using a Cisco 2524
modular router and offers a bandwidth of 1.54 Megabytes/sec.
T1: Leased line T-1 with an available bandwidth of 1/54 Megabytes/sec extends the regional LAN to the
corporate headquarters in Reston, Virginia, creating a WAN environment via Cisco 1720 multi-protocol router.
T1: Backup internet access offers redundant solutions for our Internet Access implemented over a Cisco 2524
multi-protocol router.