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Coverage and Other Payment 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.
Recent ACCC Policy Statements
- Prior Authorization Policies for On-label Treatments in Oncology
- States Implementing a Tax on Physician Gross Receipts or State Sales Taxes on Chemotherapy Medicines in the Field of Oncology
Off-Label Coverage Issues
- 2009 ACCC Co-sponsors Congressional Educational Forum on Off-Label Use of Cancer Drugs
- 2008 Off-Label Compendia Survey Report
- 2008 CMS Releases Guidance on Use of Drug Compendia
- Off-Label Use of Anticancer Therapies: Physician Prescribing Trends and the Impact of Payer Coverage Policy. In 2006, the Association of Community Cancer Centers, the Biotechnology Industry Organization, and the Pharmaceutical Research and Manufacturers of America commissioned Covance Market Access Services Inc., a global reimbursement policy and health economics and outcomes research firm, to examine issues related to off-label use of anticancer therapies.
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 Submits Comments to CMS on Proposed NCD on PET to Identify Bone Metastasis December 29, 2009
- ACCC Submits Comments to CMS About AHRQ Draft Technology Assessment and Off-Label Indications for Targeted Therapies) November 16, 2009
- Proposed Coverage Decision Memorandum for FDG Positron Emission Tomography to Guide Initial Management of Cervical Cancer (CAG-00181R2) September 11, 2009
- ACCC Submits Comments About Comparative Effectiveness Research June 9, 2009
- ACCC's Comment Letter to CMS Regarding the National Coverage Analysis (NCA) Tracking Sheet for FDG Positron Emission Tomography (FDG PET) for the Initial Staging of Cervical Cancer June 5, 2009
- ACCC's Comment Letter to CMS Regarding Proposed National Coverage Decision (NCD) on Positron Emission Tomography (FDG PET) for Solid Tumors February 4, 2009
- 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) May 31, 2007
- ACCC's Comment Letter to CMS on Clinical Trial Policy (CPR) May 4, 2007
- ACCC's Comment Letter Regarding Erythropoiesis Stimulating Agents (ESAs) for non-renal Disease Indications to the Centers for Medicare & Medicaid Services (CMS) April 2007
- 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 March 2006
Useful Links:
- Sample ESA Order/Charge Sheet
- CMS Medicare Coverage Database
- National Cancer Institute Cancer Bulletin (Most Recent Issue)
- States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
Other Payment Issues
Medicare beneficiaries have been eligible to enroll in the Part D prescription drug benefit beginning since January 2006. Part D, enacted by the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, will have a significant impact on the practice of medicine and the Medicare beneficiaries that receive needed medical therapies.
