Coverage Issues
Medicare's current coverage rules effectively provide beneficiary access to innovative therapies, used in conformity with evolving standards of care. The Medicare statute requires carriers to cover off-label uses of cancer therapies when such uses are supported by citations in certain compendia or by clinical evidence in peer-reviewed literature.
Cancer patients frequently require treatment with the most innovative and cutting-edge therapies. Many advances in cancer care involve the discovery of new uses for drugs already approved by the Food and Drug Administration (FDA) for other indications. These off-label uses are a significant part of common medical practice. They are integral to patient care as well as to the discovery of new treatments. Medicare policies that restrict access to off-label cancer therapies would have a significant adverse impact on treatment of cancer patients.
Medicare coverage policies and off-label issues continue to be a primary area of focus for ACCC. ACCC has emerged as a leader in this area, and is committed to ensuring that our members' views are considered as policies are developed.
- Off-Label Coverage Issues
- Coverage with Evidence DeUvelopment
- Principle Statements
- CMS-NCI Pilot Project Trials
Erythropoiesis Stimulating Agents (ESAs) Issues:
- FDA Approves Changes to ESA Labeling
- ACCC request to reconsider ESA NCD
- Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications
- ACCC's Comments on CMS's NCA Tracking Sheet for Erythropoiesis Stimulating Agents (ESAs) for Non-Renal Disease Indications
- Frequently Asked Questions On Use of Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions
- ACCC Hospital Survey Impact of Proposed NCD on ESAs for Hospitals
Comment Letters:
- ACCC's Comment Letter to CMS Regarding the Reconsideration of the Clinical Research Policy August 17, 2007
- ACCC's Comment Letter to CMS Regarding the Medicare National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs)
- ACCC's Comment Letter to CMS on Clinical Trial Policy (CPR)
- ACCC's Comment Letter Regarding Erythropoiesis Stimulating Agents (ESAs) for non-renal Disease Indications to the Centers for Medicare & Medicaid Services (CMS)
- ACCC's Comment Letter Regarding Characteristics of Compendia Used for Medicare Part B Coverage of Drugs and Biologicals Employed in an Anti-Cancer Chemotherapeutic Regimen
Useful Links:
- Sample ESA Order/Charge Sheet
- CMS Medicare Coverage Database
- National Cancer Institute Bulletin
- Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (full text)
- States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
Matt Farber, Manager, Provider Economics & Public Policy,Phone 301.984.9496, ext. 221, Email mfarber@accc-cancer.org
