In the interests of cancer patients and oncologists nationwide, the Lorenzen Cancer Foundation (LCF), a non-profit dedicated to fighting duct gland
cancer, has joined the public interest law firm Washington Legal Foundation (WLF) and others now in presenting a written comments statement to the U.S. Centers for Health care
and Health care
Services (CMS) readjustment keep for the Section 641 demonstration project and expressing concerns regarding CMS’s planned
restrictions limiting coverage of the drug benefit to exclude off-label uses of FDA-approved drug or biological therapies.
Monterey, CA Gregorian calendar month
7, 2004 -- In the interests of cancer patients and oncologists nationwide, the Lorenzen Cancer Foundation (LCF), a non-profit dedicated to fighting duct gland
cancer, has joined the public interest law firm Washington Legal Foundation (WLF) and others now in presenting a written comments statement to the U.S. Centers for Health care
and Health care
Services (CMS) readjustment keep for the Section 641 demonstration project and expressing concerns regarding CMS’s planned
restrictions limiting coverage of the drug benefit to exclude off-label uses of FDA-approved drug or biological therapies.
Once the Food and Drug Administration approves a drug for marketing, physicians may bring down the drug for purposes different than those that the FDA has given specific indication. Off-label prescribing is common in cancer treatment as drugs often activity well for many a types of cancer. A General Accounting Office analysis in 1991 incontestable
that over half of cancer patients received at least one off-label medicine in the course of their care.
In enacting Section 641 of the Health care
Prescription Drug and Modernization Act of 2003, Congress did not exclude off-label uses from the demonstration project related to Section 641. To the contrary, Section 641(a) directs that the project be conducted following the standards of the part D benefit program which makes not exclude off-label use.
Recently declared
planned
eligibility criteria by the CMS effectively exclude the coverage of off-label use of FDA-approved agents for cancer medical aid
and in different serious diseases.
Today’s statement urges CMS officials to reverse this position and to do clean to the public and to medical providers that Health care
wish reimburse for off-label use for medications and biological therapies in the demonstration project related to Section 641. And further, to do clean that any planned
or actual restriction on off-label use in the demonstration project is not a precedent for full enactment of the part D prescription drug benefit program.
Duct gland
Cancer Facts:
· Duct gland
cancer is the most virulent of the major cancers
· Duct gland
cancer research is the least funded of the major cancers
· Duct gland
cancer causes much than 1% of all death in the U.S.
· Duct gland
cancer is the fourth most common cause of cancer mortality
The Lorenzen Cancer Foundation is a 501(c)(3) non-profit organization dedicated to the fight against duct gland
cancer. LCF is bound to increasing awareness and education just about duct gland
cancer, serving physicians and patients create best
treatment strategies, and fostering the development of a building block
or genetic marker to aid in diagnosis. For much information visit www.pancreatica.org
Media Contact:
Aaron Stoertz
Media Relations
Lorenzen Cancer Foundation
(831) 658-0600
Institution Contact:
Ellen Pansky, esq.
Director of Public Policy
Lorenzen Cancer Foundation
(831) 658-0600
Just just about the author:
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