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Opening of National Oncologic PET Registery Hits Snag.
03.14.06
The opening of the National Oncologic PET Registery (NOPR) has hit yet another government snag. On February 10, 2006 the Centers for Medicare and Medicaid Services (CMS) announced that an agreement had been made with NOPR to collect data regarding PET scans. NOPR was given an exemption to the human protection regulations because the scan itself is considered medically necessary and it is the accumulation of patient data and its possible release which is the "risk" to which patients participating in NOPR are exposed. The Office for Human Research Protections (OHRP) has now taken the position that the NOPR does not qualify for exemption under the human protection regulations.

The problem is that many small free-standing PET facilities do not have IRBs and are unlikely to go through the extensive and lengthly process necessary to set one up nor to pay thousands of dollars to an independent IRB to review the protocol. This would limit patient access to those who could go to a research center with an IRB and delay the process until those centers could obtain approval by their IRB. There is also some concern about who would administer the consent and at what point in the process (i.e. could the patient even be referred to a PET facility before consent is obtained.)

We are asking that advocates who want to help move this process forward send separate letters to Mark McClellan and Michael Leavitt (instructions for doing so below). There is also a sample letter which you may or may not want to use. ( See PDFs of IMF President Susie Novis' letters.)

SEND LETTERS TO:


The Honorable Mark McClellan, M.D., Ph.D.
Administrator
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Room 314-G
Washington, DC 20201

Dear Dr. McClellan:

The Honorable Michael O. Leavitt
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Leavitt:


To expedite receipt of signed letters, following are several options:

  1. Email PDF of a letter - signed by someone on behalf of an advocacy group or by an individual advocate - to Brian Carey at: BCarey@foleyhoag.com, and he will deliver to Dr. McClellan and Secretary Leavitt.

  2. Or fax a signed letter to Brian at 617-832-7000

  3. Or email a Word copy of the letter to Brian and note that a signed copy is in the mail to Dr. McClellan and Secretary Leavitt.

SAMPLE LETTER:

Dear

I am writing to express my concern that Medicare beneficiaries are being denied access to positron emission tomography (PET) due to a delay in the activation of the National Oncologic PET Registry (NOPR). As a patient advocate working to improve the lives of people with cancer, I believe that access to positron emission tomography PET through participation in NOPR is vital to helping cancer patients receive appropriate and timely diagnosis and treatment.

On February 10, 2006 the Centers for Medicare and Medicaid Services (CMS) announced that an agreement had been made with NOPR to collect data regarding PET scans. It is our understanding that the Office for Human Research Protections (OHRP) has now taken the position that the NOPR does not qualify for exemption under the human protection regulations. As a patient advocate, I believe that there is minimal risk to Medicare beneficiaries participating in the NOPR. Meeting the requirements of this directive will place unnecessary constraints on the ability of patients to take advantage of this potentially life-saving program. Additionally, the information collected by the NOPR will facilitate the transition to routine coverage by the CMS for many currently non-covered cancer indications for this important diagnostic test.

Since CMS announced the project in January 2005, the NOPR has worked diligently with the oncology community to develop processes that protect patients' privacy rights and meet the requirements set forward by CMS. Nearly 500 PET facilities nationwide are registered to take part in the NOPR and many hundreds of patients are now waiting to participate. It is most regrettable that agency delay is denying these patients-many of whom have little money or time to spare-access to a technology so important for their care.

All the necessary pieces are in place to launch this crucial program. We believe that taking the determination of exemption away from the local IRBs has delayed the opening of this landmark project and may impair the diagnosis and treatment of cancer for many people. I urge you to work with CMS, OHRP and stakeholders to move forward immediately with the NOPR.

Sincerely,

Update from American College of Radiology Imaging Network (ACRIN) on NOPR


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