Transcript NOPR National Oncologic PET Registry

NOPR
National Oncologic PET Registry
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PET Reimbursement
• Complex, slowly evolving process
• Dependent on FDA approval of PET drugs
– Facilitated by FDAMA (1997)
• Reimbursable clinical indications
– Determined by technology assessment panels of
third-party payers
– Process dominated by Centers for Medicare and
Medicaid Services (CMS)
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Medicare Coverage of PET
• Centers for Medicare and Medicaid Services (CMS)
– Formerly Healthcare Financing Administration (HCFA)
• Standard for reimbursement is “reasonable and
necessary”
• In 1990s, CMS adopted a new evidence-based
approach for making coverage determinations
– Requires peer-reviewed scientific evidence to document
that new technology leads to changes in patient
management and improved health outcomes
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Medicare Coverage of PET
• CMS elected not to consider oncologic
indications for PET broadly
• Rather evaluated the evidence on a cancerspecific and indication-specific basis
• Problematic because the specific evidence
typically has not been very robust
• “Catch 22”
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Medicare Coverage of PET: Recent History
2000
2002
2004
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Further expanded coverage for six prevalent cancers
after new request for broad coverage and public meeting
(PET must either resolve inconclusive results of
standard test or replace standard test)
Individual requests - several other cancers
Suspected Alzheimer’s disease vs. frontotemporal
dementia
Proposed mechanism for expanded coverage
Medicare Reimbursement for Oncologic PET (2005)
• Diagnosis, staging, and restaging of:
Non-small cell lung cancer
Esophageal cancer
Colorectal cancer
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Lymphoma
Malignant melanoma
Head and neck cancer
Staging, restaging, and Rx monitoring of breast cancer
Detection of TG+/RAI– thyroid cancer
Staging of cervical cancer (– CT/MRI outside pelvis)
All other cancers/indications
– National registry
What is the NOPR?
• In 2000, the Centers for Medicare and Medicaid Services
(CMS) expanded its coverage of positron emission
tomography (PET) with F-18 fluorodeoxyglucose (FDG) to
a wide variety of indications for several common cancers but not all cancers.
• In November 2004, CMS proposed expanding PET
coverage to most other cancers, if providers collect
relevant data in a CMS-approved clinical registry.
• CMS Initiative
– Coverage with Evidence Development (CED)
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NOPR
• Is a CMS-approved
– “Coverage with Evidence Development” Program
• Developed for the November 2004 expansion by CMS
– All other cancers and indications except:
• Breast cancer diagnosis and axillary staging
• Melanoma regional nodal staging
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All PET facilities can participate (for a fee)
Requires timely Pre-PET and Post-PET information
All data will be submitted to CMS for payment processing
Cases with patient and physician consent will be used by the
NOPR to assess change in intended management
NOPR
National Oncologic PET Registry
Sponsored by
Managed by
Endorsed by
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Advisor
Objectives & Goals
• Objectives
– Assess the effect of PET on referring physicians’ plans of
intended patient management
• across a wide spectrum of cancer indications for PET that
are currently not covered by the Medicare program, and
• in relation to cancer-type, indication, performance status,
physician’s role in management, and type of PET.
• Goal
– Acquire data that can be used to evaluate PET in a manner
that does not interfere with patient clinical care and minimizes
the burden to the patient, PET center, and referring physician.
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Who owns the NOPR data?
• The Academy of Molecular Imaging, as an agent of 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 ACR.
Who has access to NOPR data?
• The members of the NOPR Working Group, NOPR project
staff at ACR and the Center for Statistical Sciences at
Brown University, and staff of CMS.
• CMS receives data from NOPR for all patients for payment
determination.
• NOPR uses data for research only where consent obtained.
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Data Analysis and Expected Results
• Data analyzed by cancer type and indication (reason for PET).
• For the most frequent cancer indications, interim analysis will
be performed at N=200 to refine sample size estimates.
• If the frequency of change in intended management for a
particular cancer indication is sufficient to suggest benefit,
data (along with summary of published literature) will be
provided to CMS with request for coverage.
• Eventual goal is to achieve broad coverage through analysis of
data across all cancers and indications.
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Institutional Review Board (IRB) Approval &
Subject Informed Consent
• Is this research? Yes, but only for the NOPR. Individual PET
facilities and referring physicians are not engaged in research.
• Is IRB approval needed? Yes. ACR IRB has approved the
NOPR. Individual PET facilities and referring physicians do not
need to obtain IRB approval to participate.
– All data will be sent to CMS. CMS is not engaged in research.
– Patients and referring physicians will be given an IRB-approved
information sheet and asked for oral consent to have their data
included in NOPR research.
– Only cases where both patient and physician give consent will be
included in the NOPR research dataset.
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HIPAA Requirements
• HIPAA requirements met through execution of a
Business Associates Agreement with the American
College of Radiology as an agent for the Academy of
Molecular Imaging and CMS.
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Participation Requirements - PET Facilities
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Any PET facility that is approved to bill CMS for either technical or
global charges can participate in the NOPR.
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Facilities are not required to have or obtain ACR or ICANL accreditation.
Participation Requirements - Patients
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Medicare beneficiaries, including those with Medicare HMO coverage,
who are referred for FDG-PET for essentially all oncologic indications
that are not currently reimbursable under Medicare.
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The Indications table lists the cancers and indications that are and are
not eligible for the Registry.
Verbal consent is necessary for inclusion in the NOPR research dataset;
however, no consent is necessary to submit data to NOPR that will be
sent to CMS payment determination.
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PET Facility Responsibilities
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Collect and enter all required data through the NOPR Web site.
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Patient must be registered within 14 days of the PET scan date
Give patient the Patient Information Sheet
Pre-PET Form must be entered by midnight of the PET scan date
PET Completion Form must be entered within 14 days of case registration
The PET Report & Post-PET forms must be entered within 30 days of scan
PET facility is eligible to bill CMS when all required data are received at
NOPR Operations Office.
Referring Physician Responsibilities
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Complete Pre-PET Form (5 questions) and return it to PET Facility prior
to PET scan.
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Complete Post-PET Form (4 - 7 questions) and return it to PET Facility
within 30 days of PET scan.
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Pre- and Post-PET forms can be returned to the PET facility via FAX,
mail, or hand delivery.
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Cancers & Indications Eligible for Entry in the NOPR
continued on next slide
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Cancers & Indications Eligible for Entry in the NOPR
continued
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Facility and Patient Registration
• Register via the NOPR Web site www.cancerPETregistry.org
– Complete Facility Registration Form
• PET facility information including Medicare Provider Number
• PET facility administrator (the individual responsible for
managing registry activities at the facility)
• Participating interpreting physician(s)
• Equipment details
• Submit Executed Business Associates Agreement (BAA)
• $50 Facility Application Fee
• $50 Processing Fee for Each Patient
– Advance payment held in escrow account
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PET Facility Registration
www.cancerPETregistry.org
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NOPR Web Site
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Information for
– PET Facilities
– Referring Physicians
– Patients
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Blank Forms
Register PET Facilities
Register Patients
PET Facility Tools
– Case Status Reports
– Account Balance
– Fund Account by Credit Card
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Pre-PET Form – 5 Questions
• Reason for the PET Scan
• Cancer Site/Type
• Summary of Disease Stage
– NED, Localized, Regional, Metastatic, Unknown
• Performance Status
– Asymptomatic, Symptomatic, Bedridden
• Intended Patient Management Plan
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Pre-PET Form: Specific Reason For PET
1. Check the single best match for the reason for the PET.
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Diagnosis: To determine if a suspicious lesion is cancer
Diagnosis
– Unknown primary tumor: To detect a primary tumor site in a patient with a
confirmed or strongly suspected metastatic lesion
– Paraneoplastic: To detect a primary tumor site in a patient with a presumed
paraneoplastic syndrome
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Initial staging of histologically confirmed, newly diagnosed cancer
Monitoring treatment response: during chemotherapy, radiotherapy, or
combined modality therapy
Restaging after completion of therapy
Suspected recurrence of a previously treated cancer
Pre-PET Form: Intended Patient Management Plan
5. If PET were not available, your current management
strategy would be (select one)?
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Observation (with close follow-up)
Additional imaging (CT, MRI) or other non-invasive diagnostic tests
Tissue biopsy (surgical, percutaneous, or endoscopic).
Treatment (if treatment is selected, then also complete the following)
Treatment Goal: (check one)  Curative  Palliative
Type(s): (check all that apply)
–  Surgical  Chemotherapy (including biologic modifiers)
–  Radiation  Other  Supportive care
Pre-PET
Web Form
2.
42 Primary and Metastatic Sites Listed
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Pre-PET
Web Form
continued
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Post-PET Form – 4 to 7 Questions
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Questions Customized by Specific Reason for PET (Indication)
4 - 7 Questions per Indication
Most Require a Yes or No Answer
2 Questions are Repeated from the Pre-PET Form
– Intended Patient Management Plan
– Planned Cancer Care Provider
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Post-PET
Web Form
Suspected
Cancer
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NOPR Workflow
Referring MD
Requests PET
Ask Patient
For Consent
Pre-PET
Questionnaire
PET
Done
PET
Reviewed
& Reported
Post-PET
Questionnaire
Sent
Includes Question for
Referring Physician
Consent
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Clinical
Actions
Ongoing
Questionnaire
Completed
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Timeline
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Timeline
No Waiting Period
Providers Bill Medicare
Using Appropriate
Claim Form & Codes
Hospitals Use
UB/1450 Claim Form
Technical Only
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Non-Hospitals Use
1500 Claim Form
Professional/Technical/Global
FDG-PET Procedure and Supply Codes
2006
Description
HCPCS
Code
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78811
Tumor imaging, positron emission tomography (PET);
limited area (eg, chest, head/neck)
78812
Tumor imaging, positron emission tomography (PET);
skull base to mid-thigh
78813
Tumor imaging, positron emission tomography (PET);
whole body
78608
Brain imaging, positron emission tomography (PET);
metabolic evaluation
A9552
Fluorodeoxyglucose F-18 FDG, diagnostic,
per study dose, up to 45 millicuries
FDG-PET/CT Procedure and Supply Codes
2006
Description
HCPCS
Code
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78814
Tumor imaging, positron emission tomography (PET) with
concurrently acquired computed tomography (CT) for attenuation
correction and anatomical localization;
limited area (eg, chest, head/neck)
78815
Tumor imaging, positron emission tomography (PET) with
concurrently acquired computed tomography (CT) for attenuation
correction and anatomical localization; skull base to mid-thigh
78816
Tumor imaging, positron emission tomography (PET) with
concurrently acquired computed tomography (CT) for attenuation
correction and anatomical localization; whole body
A9552
Fluorodeoxyglucose F-18 FDG, diagnostic,
per study dose, up to 45 millicuries
For Carriers on 1500 Claim Form Use Modifier
2006
HCPCS
Modifier
QR
Description
Item or service provided as routine care in a Medicare specified
study or Medicare qualifying clinical trial
Modifier Use by Providers to Identify NOPR Claims
Use only with procedure, not necessary with the radiopharmaceutical billed on the
same DOS as the procedure.
CMS Transmittal 956, 5/19/06.
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Hospitals ONLY on 1450 Claim Form (UB)
2006
Description
Hospital
Revenue/ICD 9 CM
Codes
0343
Diagnostic Radiopharmaceutical
0404
PET Procedures
V70.7
Examination of participants in clinical trial
V70.7 Use in the Second Diagnosis Position FL 68
From Current CMS policy CR 3741
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Case 1
A 72-year-old woman with diffuse large cell nonHodgkin's lymphoma is undergoing chemotherapy
with R-CHOP. PET/CT (skull-base to proximal thigh)
is requested after the second cycle of treatment for
monitoring of therapy.
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Hospital
Revenue
Code
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2006
HCPCS/
ICD 9 CM
Codes
Description
0404
78815
Tumor imaging, positron emission tomography (PET) with concurrently
acquired computed tomography (CT) for attenuation correction and
anatomical localization; skull base to mid-thigh
0343
A9552
Fluorodeoxyglucose F-18 FDG, diagnostic,
per study dose, up to 45 millicuries
N/A
202.80
Other Lymphomas (malignant): Not otherwise specified (NOS)
Case 2
A 67-year-old man has a history of glioblastoma multiforme of
left parietal lobe treated with surgery, radiation therapy, and
temazolamide. Follow-up MRI demonstrates a new 8 mm focus
of contrast enhancement adjacent to the original tumor bed.
Brain PET is requested for restaging, to distinguish recurrent
tumor for radiation necrosis.
2006
Hospital
Revenue
Code
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2006
HCPCS/
ICD 9 CM
Codes
Description
0404
78608
Brain imaging, positron emission tomography (PET);
metabolic evaluation
0343
A9552
Fluorodeoxyglucose F-18 FDG, diagnostic,
per study dose, up to 45 millicuries
N/A
191.3
Malignant neoplasm of brain, parietal lobe
Case 3
A 68-year-old woman has newly diagnosed dermatomyositis
and progressive weight loss. CT of the chest, abdomen, and
pelvis demonstrated no evidence of malignancy. Whole-body
PET/CT is requested to detect an occult malignancy as the
cause of her paraneoplastic syndrome.
2006
Hospital
Revenue
Code
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2006
HCPCS/
ICD 9 CM
Codes
Description
0404
78816
Tumor imaging, positron emission tomography (PET) with concurrently
acquired computed tomography (CT) for attenuation correction and
anatomical localization; whole body
0343
A9552
Fluorodeoxyglucose F-18 FDG, diagnostic,
per study dose, up to 45 millicuries
N/A
710.3
Dermatomyositis
N/A
783.21
Abnormal Loss of Weight
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.
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Medigap Insurance for Co-Payments
• Medigap insurance should cover the co-payment for a
registry PET scan, as for any other Medicare covered
service.
Managed Medicare Plans – Medicare Advantage
• Managed Medicare plans such as Medicare
Advantage should pay any claims that would be
covered by Medicare.
– Follow Pre-Authorization as required by the plan
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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 insurance coverage other than
Medicare, including Medicaid, are not eligible to
participate in the NOPR.
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Does NOPR Apply to Inpatients?
• Yes.
• The technical charge for a PET study on a Medicare
inpatient is not billed directly, but 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.
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I have registered my facility with NOPR and have not sent
any money. What do I need to do NOW to prepare for a
smooth transition?
• Down Load IRB Materials & Operations Manual; implement the
required procedures.
• Put systems in place to identify (up front) NOPR patients and put
triggers into billing systems to hold claims (back end). If external MD
reading, ensure the reader does the same.
• Meet/communicate with referring physicians regarding required
forms/timelines and set up efficient processes prior to accepting
patients.
• Decide how your facility will handle ABNs for NOPR patients.
• Watch for notice of registry activation and e-mails containing facility
ID#, passwords and invoice.
• Print patient and physician consent information for appropriate
distribution
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NOPR Working Group
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Chair, Bruce Hillner, MD, Virginia Commonwealth University
Co-chair, Barry A. Siegel, MD, Washington University
R. Edward Coleman, MD, Duke University
Anthony Shields, MD, Wayne State University
Statistician: Dawei Liu, PhD, Brown University
Epidemiologist: Ilana Gareen, PhD, Brown University
NOPR Operations Office
American College of Radiology
1818 Market Street, Suite 1600
Philadelphia, PA 19103
215-717-0859
800-227-5463 x 4859
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Endorsing Organizations’ Educational Contacts
• Academy of Molecular Imaging
– Sue Halliday, [email protected]
• American College of Radiology
– Joy Brown, [email protected]
• American College of Radiology Imaging Network
– Nancy Fredericks, [email protected]
• American Society of Clinical Oncology
– Nancy Daly, [email protected]
• Society of Nuclear Medicine
– Denise Merlino, [email protected]
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