NOPR National Oncologic PET Registry

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NOPRNational 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
  cancer-specific 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

• 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)
• 2002 Individual requests - several other cancers
• Suspected Alzheimers disease vs. frontotemporal
  dementia
• 2004 Proposed mechanism for expanded coverage

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Medicare Reimbursement for Oncologic PET (2005)

• Diagnosis, staging, and restaging of
• Non-small cell lung cancer Lymphoma
• Esophageal cancer Malignant melanoma
• Colorectal cancer 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

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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
• 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

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NOPRNational Oncologic PET Registry
NOPRNational Oncologic PET Registry
Sponsored by
Advisor
Managed by
Endorsed by
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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, physicians 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 N200 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

• Any PET facility that is approved to bill CMS for
  either technical or global charges can
  participate in the NOPR.
• Facilities are not required to have or obtain ACR
  or ICANL accreditation.

Participation Requirements - Patients

• 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.
• 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

• Collect and enter all required data through the
  NOPR Web site.
• 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

• Complete Pre-PET Form (5 questions) and return it
  to PET Facility prior to PET scan.
• Complete Post-PET Form (4 - 7 questions) and
  return it to PET Facility within 30 days of PET
  scan.
• 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
NOPRcontinued
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Facility and Patient Registration

• Register via the NOPR Web site www.cancerPETregist
  ry.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 Registrationwww.cancerPETregistry.o
rg
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NOPR Web Site

• Information for
• PET Facilities
• Referring Physicians
• Patients
• Blank Forms
• Register PET Facilities
• Register Patients
• PET Facility Tools
• Case Status Reports
• Account Balance
• Fund Account 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.

• 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
• 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

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Pre-PET Form Intended Patient Management Plan
5. If PET were not available, your current
management strategy would be (select one)?

• 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

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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

• 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 FormSuspected Cancer
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NOPR Workflow
PET Reviewed Reported
Clinical Actions Ongoing
Referring MD Requests PET
PET Done
Ask Patient For Consent
Post-PET Questionnaire Sent Includes Question
for Referring Physician Consent
Questionnaire Completed
Pre-PET Questionnaire
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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
Non-Hospitals Use 1500 Claim Form Professional/Te
chnical/Global
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FDG-PET Procedure and Supply Codes
2006 HCPCS Code Description
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
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FDG-PET/CT Procedure and Supply Codes
2006 HCPCS Code Description
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
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For Carriers on 1500 Claim Form Use Modifier
2006 HCPCS Modifier Description
QR 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 Hospital Revenue/ICD 9 CM Codes Description
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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A 72-year-old woman with diffuse large cell
non-Hodgkin'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.
Case 1
2006 Hospital Revenue Code 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)
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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.
Case 2
2006 Hospital Revenue Code 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
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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.
Case 3
2006 Hospital Revenue Code 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
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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

• 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 800-2
27-5463 x 4859
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Endorsing Organizations Educational Contacts

• Academy of Molecular Imaging
• Sue Halliday, shalliday_at_eplushealthcare.com
• American College of Radiology
• Joy Brown, jbrown_at_phila.acr.org
• American College of Radiology Imaging Network
• Nancy Fredericks, nfredericks_at_phila.acr.org
• American Society of Clinical Oncology
• Nancy Daly, dalyn_at_asco.org
• Society of Nuclear Medicine
• Denise Merlino, denise_at_merlinohccc.com