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://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