March 13, 2006
The Honorable Mark McClellan, M.D., Ph.D.
Administrator
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Room 314-G Washington, DC 20201
RE:
UNFORTUNATE DELAY IN ACTIVATION OF THE NATIONAL
ONCOLOGIC PET REGISTRY
Dear Dr. McClellan:
On behalf of the International Myeloma Foundation (the IMF),
a not-for-profit foundation dedicated to supporting myeloma
patients and their families, I am writing to express our
concern that, as a result of a delay in the activation of the
National Oncologic PET Registry (NOPR), Medicare
beneficiaries with myeloma and other forms of cancer are
being denied access to positron emission tomography (PET).
The IMF believes that access to positron emission tomography
PET through participation in NOPR is vital to helping newly
diagnosed myeloma patients be accurately staged prior to
treatment and is of significant importance in helping many
other 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.
We understand 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. The IMF
considers that there is minimal risk to Medicare
beneficiaries participating in the NOPR. Meeting the
requirements of this directive will place inappropriate
constraints on the ability of patients to take advantage of
this critically important and well-considered 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 first announced this 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 more than simply 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.
The essential components have all been put in place to launch
this important initiative. By taking the determination of
exemption away from the local IRBs, OHRP is delaying the
opening of this landmark project and may impair the diagnosis
and treatment of myeloma and other cancers for many people.
On behalf of the myeloma community, I urge you to work with
OHRP and other stakeholders to move forward immediately with
the NOPR.
Please feel able to contact me directly if I can provide
additional information that will assist you to move NOPR
forward at an early date.
Sincerely,
Susie Novis
President
March 13, 2006
The Honorable Michael O. Leavitt
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
RE:
UNFORTUNATE DELAY IN ACTIVATION OF THE NATIONAL ONCOLOGIC
PET REGISTRY
Dear Secretary Leavitt:
On behalf of the International Myeloma Foundation (the IMF), a
not-for-profit foundation dedicated to supporting myeloma
patients and their families, I am writing to express our
concern that, as a result of a delay in the activation of the
National Oncologic PET Registry (NOPR), Medicare beneficiaries
with myeloma and other forms of cancer are being denied access
to positron emission tomography (PET). The IMF believes that
access to positron emission tomography PET through
participation in NOPR is vital to helping newly diagnosed
myeloma patients be accurately staged prior to treatment and
is of significant importance in helping many other 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. We understand 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. The IMF considers that
there is minimal risk to Medicare beneficiaries participating
in the NOPR. Meeting the requirements of this directive will
place inappropriate constraints on the ability of patients to
take advantage of this critically important and well-
considered 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 first announced this 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 more than simply 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.
The essential components have all been put in place to launch
this important initiative. By taking the determination of
exemption away from the local IRBs, OHRP is delaying the
opening of this landmark project and may impair the diagnosis
and treatment of myeloma and other cancers for many people.
On behalf of the myeloma community, I urge you to work with
CMS, OHRP and stakeholders to move forward immediately with
the NOPR.
Please feel able to contact me directly if I can provide
additional information that will assist you to move NOPR
forward at an early date.
Sincerely,
Susie Novis
President