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What is the NOPR?
Has the NOPR Been Approved by the Medical Community?
When Did the NOPR Open?
What PET Facilities Can Join the Registry?
Does my Site Need IRB Approval to Participate in the NOPR?
How Do I Register My PET Facility?
Do PET Facilities with Multiple Locations and Mobile Facilities Have to Register Each Location Separately?
Can a PET Facility Make Changes to the Posted NOPR Business Associates Agreement (BAA)?
What Patients are Eligible for the NOPR?
Does NOPR Apply to Oncologic PET performed with Radiopharmaceuticals other than FDG?
What are the PET Facility's Responsibilities?
What are the Referring Physician's Responsibilities?
Can a Nurse or Nurse Practitioner Complete the Pre-and Post-PET Forms?
How to Obtain Medicare Reimbursement
Does the NOPR Apply to Hospitalized Medicare Inpatients?
Can PET Facilities Require Patients to Sign an Advance Beneficiary Notice (ABN)?
Will a Medicare Patient's Medigap Insurance Cover the Cost of the Co-payment for a Registry PET Scan?
Will Medicare Advantage Plans Reimburse for Patients Entered in the Registry?
Is Pre-Authorization Still Needed for Patients in Managed Medicare Plans?
Will Non-Medicare Insurers Reimburse for Patients Entered in the Registry?
Who Has Access to NOPR Data?
Who Owns the NOPR Data?
Why Can't We Attach Our PET Scan Report as a Word Document?
What is the NOPR?
The National Oncologic PET Registry (NOPR) 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 assess the impact of FDG-PET on cancer
patient management. 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).
Has the NOPR Been Approved by the Medical Community?
The NOPR received input from, and is endorsed by, the American College
of Radiology (ACR), the American Society of Clinical Oncology
(ASCO), and the Society for Nuclear Medicine (SNM).
The NOPR worked with the Centers
for Medicare and Medicaid Services (CMS) to
develop this registry.
When Did the NOPR Open?
The NOPR began accepting facility registrations in late November 2005
but patient registration did not begin until May 8, 2006.
What PET Facilities Can Join the Registry?
Any PET facility that is approved to bill CMS for either technical or
global charges can apply to participate in the NOPR. Sites are not
required to have ACR or ICANL accreditation to participate.
Does my Site Need IRB Approval to Participate in the NOPR?
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 of the Operations Manual for more details).
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. 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. The dataset
used by NOPR investigators for research will contain only the data of
patients and physicians when both have consented to have the data
included.
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 I 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 IRBs with questions can contact OHRP.
How Do I Register My PET Facility?
Interested facilities will register via the Facility Registration
tool on the NOPR Web site, www.CancerPETregistry.org.
The facility will complete the Facility Pre-Registration and
Registration Forms online through the PET Facility Registration link. After completing the Registration process the facility
must send an executed ACR HIPAA Business Associates Agreement (BAA) to NOPR
Headquarters at 1818 Market Street, Philadelphia, PA 19103. The ACR
HIPAA BAA is available on the NOPR Web site under Sample Forms. NOPR
will assign a facility ID number and send an invoice for the facility
registration fee ($50) and the escrow account (amount determined by the
facility). Please allow 48 hours for processing of these materials
before scheduling the first patient entry for your facility. Checks
should be made payable to the ACR-NOPR and mailed to the American
College of Radiology, P.O. Box 2348, Merrifield, VA 22116-2348.
Do PET Facilities with Multiple Locations and Mobile Facilities Have to Register Each Location Separately?
Yes, entities providing PET services at multiple locations and mobile
PET providers must register each location of service separately even if
they all bill using the same Medicare Provider Number.
Can a PET Facility Make Changes to the Posted NOPR Business Associates Agreement (BAA)?
No. Each participating PET facility must execute a HIPAA Business
Associates Agreement (BAA). To facilitate your registration, the BAA
posted on the NOPR Web site must be executed. We understand that you
may wish to use your own BAA. However, because of the number of
facilities expected to participate in the NOPR, it is not practical for
the NOPR to provide legal review for different agreements to ensure
compliance with HIPAA requirements. We are fully prepared to comply
with the HIPAA requirements and believe the BAA on the NOPR Web site
meets the requirements of both the HIPAA Privacy and Security rules.
What Patients are Eligible for the NOPR?
Medicare beneficiaries, including those with conventional Medicare
coverage and those with Medicare HMO coverage, 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 Indications tables
list the cancers and indications that will and will not be accepted in
the Registry.
Patients with insurance coverage other than Medicare, including
Medicaid, are not eligible to participate in the NOPR. Patients with
managed Medicare health plans, such as Medicare Advantage, are eligible
for the NOPR. Medicare or a managed Medicare plan must be the primary
insurance.
Does NOPR Apply to Oncologic PET performed with Radiopharmaceuticals other than FDG?
No.
What are the PET Facility's Responsibilities?
The PET facility is responsible for collecting and entering patient data
into the Registry database through a web application at
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 physician will submit the pre- and post-PET data requirements.
- The facility registers the patient on the NOPR via a Web form, at which time a Registry case number is assigned.
- The NOPR e-mail's confirmation to the PET facility.
- If the PET facility indicated on the Case Registration Form that the Pre-PET was not yet submitted, the database will e-mail a copy of the pre-PET form and a fax cover sheet for the PET facility to send to the referring physician.
- The referring physician must complete and return the Pre-PET Form to the PET facility and the PET facility must enter the Pre-PET Form 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, either on the day of the PET study or 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.
- After the PET scan is performed, the PET facility sends the PET report to the physician, enters the study completion date into a Web form, and submits the report text electronically to the NOPR database. Note that the PET scan must be completed and the PET Scan Completion Form must be entered into the database within 14 days of case registration or the case will be marked as ineligible.
- After the PET Report Submission Form is received, the database will send the PET facility a patient-specific Post-PET Form for delivery to the referring physician. This form will also include an ACR IRB approved Referring Physician Information Sheet. 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. All data will be sent to CMS, but the dataset used by NOPR investigators for research will contain only the data of patients and physicians when both have consented to have the data included. This form must be completed, returned to the PET facility, and entered into the NOPR database within 30 days of the PET scan.
What are the Referring Physician's Responsibilities?
The patient's referring physician must agree to complete pre- and
post-PET data collection forms consisting of approximately 5 questions
regarding the patient's planned management.
- he Pre-PET Form must be completed by the referring physician and returned to the PET facility prior to the patient's PET scan. A blank Pre-PET Form can be downloaded from the NOPR Web site and sent to the PET facility at the time of patient referral. If the form is not submitted with the referral a patient-specific form will be e-mailed to the PET facility for delivery to the referring physician. The Pre-PET Form can be returned to the PET facility via FAX, mail, or hand delivery.
- After the PET study is performed, a patient-specific Post-PET Form will be e-mailed to the PET facility for delivery to the referring physician for completion within 30 days. This form will also include an ACR IRB approved Referring Physician Information Sheet. 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. All data will be sent to CMS, but the dataset used by NOPR investigators for research will contain only the data of patients and physicians when both have consented to have the data included. This form can also be returned to the PET facility via FAX, mail, or hand delivery.
The patient's PET study is eligible for CMS reimbursement only if the
Pre-PET Form is completed and returned to the PET facility prior to the
PET scan and the Post-PET Form is completed and returned within 30 days
of the PET scan.
Can a Nurse or Nurse Practitioner Complete the Pre- and Post-PET Forms?
We anticipate that ancillary personnel often will complete much of both
the pre-PET and post-PET forms, but will ask the referring physician to
provide the answer to the intended management question and to review the
other responses for accuracy.
How to Obtain Medicare Reimbursement
The NOPR database will notify the PET facility when all case data have been entered. After it receives this notification and not before, the PET facility (and the interpreting physician, if technical and professional component billing are performed separately) can bill CMS for the study. Billing should be performed using the appropriate CPT code for (1) tumor PET imaging (78811, 78812, or 78813), (2) tumor PET/CT imaging (78814, 78815, or 78816), or (3) for brain imaging (78608) when a dedicated brain PET study was done for brain tumor evaluation. For specific details regarding how to bill studies performed as part of the registry, providers should refer to current official Medicare claims and coverage instructions:
The Medicare Claims Processing Manual for PET Under the CMS-Approved National Coverage Determinations (Transmittal 956)
Medicare Medlearn Matters
The Medicare Claims Processing Manual for PET (Transmittal 527):
The National Coverage Determinations Manual Transmittal 31:
Medicare Medlearn Matters
We caution PET facilities, especially those with automated billing
systems, to set up in advance, internal mechanisms to hold these claims
until all of the required case data for the NOPR have been entered and
this has been acknowledged by the NOPR database. Each PET facility can
check on the status of its patients at any time via the reporting tools
available on the NOPR Web site.
Does the NOPR Apply to Hospitalized Medicare Inpatients?
Yes. Note that the technical charge for a PET study on a Medicare
inpatient is not billed directly, but rather is considered to be covered
by the Diagnostic Related Grouping (DRG) payment to the hospital for
that patient. Inclusion of the patient in the NOPR is necessary,
however, for professional component reimbursement for the PET study.
Can PET Facilities Require Patients to Sign an Advance Beneficiary Notice (ABN)?
A PET facility can ask registry patients to sign an ABN. This decision
is left up to each PET facility. However, an ABN should not be
necessary. If patient eligibility is carefully checked before the
patient is entered into the registry and before the PET scan is
performed and if the facility works closely with its referring
physicians to ensure that the required paperwork is submitted in a
timely fashion, there will be no need to obtain ABNs.
Will a Medicare Patient's Medigap Insurance Cover the Cost of the Co-payment for a Registry PET Scan?
Yes, Medigap insurance should cover the co-payment, as for any other
Medicare covered service.
Will Managed Medicare Plans Such as Medicare Advantage Reimburse for Patients Entered in the Registry?
Managed Medicare plans such as Medicare Advantage should pay any claims
that would be covered by Medicare. If the managed Medicare plan does not
have a NOPR-participating facility in its network, patients must be
referred to a NOPR-participating facility without incurring an
out-of-network co-payment. A Medicare Advantage Plan may not "opt out"
of NOPR. Medicare Advantage physicians and PET facilities must follow
NOPR's published operational procedures for obtaining PET scans.
Pre-authorization/certification may be required by the Medicare
Advantage plan depending upon the plan's guidelines.
Is Pre-Authorization Still Needed for Patients in Managed Medicare Plans?
Yes, providers will still need to follow HMO guidelines for pre-authorization.
Will Non-Medicare Insurers Reimburse for Patients Entered in the Registry?
No, there are no non-Medicare insurers who have elected to reimburse for
patients entered in the registry. Patients with Medicaid and other
types of insurance coverage other than Medicare are not eligible to
participate in the NOPR. Medicare or a managed Medicare plan must be the
primary insurance for coverage under NOPR.
Who Has Access to NOPR Data?
The members of the NOPR working group, NOPR project staff at the
American College of Radiology (ACR)
and the Center for Statistical Sciences at Brown University, and staff
of the Centers for Medicare and Medicaid Services (CMS).
Who Owns the NOPR Data?
The Academy of Molecular Imaging, as an Agent of the Centers for
Medicare and Medicaid Services (CMS), will
maintain ownership of the data collected by American College of
Radiology (ACR) for the NOPR. The
data will reside in an electronic database at the ACR.
Why Can't We Attach Our PET Scan Report as a Word Document?
In an effort to minimize the spread of computer viruses, the PET Report
Submission Form will accept only PDF and JPEG files as uploaded
attachments. Text from Microsoft Word documents, or any other type of
text file, can be cut and pasted into the text field on the form.
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