Please
review and endorse our letter to Thomas Scully, Administrator,
Centers for Medicare and Medicaid Services (CMS) after considering
the policy excerpt below. Our letter
describes why we view this policy as a serious threat to the
survival and the quality of life of patients fighting lymphoma and
other cancers.
“Now,
as a result of the increasing number of novel therapies on the
market and the impact of new drugs and biologicals on the Medicare
program, it is prudent for Medicare to perform its traditional
coverage analysis for appropriate drugs and biologicals as it does
for all other items and services to ensure that it only pays for
those products that are clinically effective. For drugs and
biologicals, Medicare will continue to use FDA approval as a default
for a reasonable and necessary determination of an FDA-approved
indication unless CMS decides otherwise.” …
… CMS may choose to perform a reasonable and necessary
determination in several circumstances, including, but not limited
to the following: the drug or biological in question represents a novel,
complex or controversial treatment, may be costly to the
Medicare program, may be subject to overutilization or misuse, or
received marketing approval based on the use of surrogate outcomes."
Source: 66718 Federal Register / Vol. 67, No. 212
/ Friday, November 1, 2002 / Rules and Regulations (Full text: http://www.lymphomation.org/hopps%20update.pdf)
We will also send a copy of the letter
to Rep. Michael Bilirakis,
Chairman, Energy & Commerce Committee, Subcommittee on Health.
You may also wish to express your
concern directly to the Congressional oversight committee by
clicking here.
Thank you,
Karl Schwartz
Patients Against Lymphoma
