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.
ACCC Advocacy Alerts
ACCC Position Statements
- 340B Drug Discount Program
- Medicare Payment for Cancer Patient Treatment Education
- Chemotherapy Drug Shortages
- Medicare Average Sales Price
ACCC Advocacy Letters
- ACCC Comment Letter to U.S. House Energy & Commerce Committee on Section 603 of the Bipartisan Budget Act of 2015
- ACCC Comment Letter on 21st Century Cures, H.R. 6
- Coalition Letter in Support of Medicare Coverage of LDCT Lung Screening
- Sunshine Act Final Rule Summary and FAQs
- ACCC Submits Comments to CMS on EHB Proposed Rule
- ACCC Submits Comments to CMS on Accountable Care Organizations
Off-Label Coverage Issues
- Impact of Payer Coverage and Reimbursement Policies on Off-label Use of Anticancer Therapies. In 2013, ACCC updated its joint survey on off-label utilization by cancer care providers to understand the utilization of off-label therapy in cancer care and to determine the impact of payer coverage policies on prescribing.
- HR 1055: Part D Off-Label Prescription Parity Act
- 2008 Off-Label Compendia Survey Report
- 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.
- ACCC Comment Letter to Institute for Clinical and Economic Review (ICER) on Value Assessment Framework, September 12, 2016
- ACCC Comment Letter to CMS on Proposed MACRA Rule, June 27, 2016
- ACCC Comments to proposed 340B Omnibus Guidance, October 27, 2015
- ACCC Comments to Medicaid-Managed Care Proposed Rule, July 28, 2015
- ACCC Comments to 2016 Proposed IPPS Rule, June 16, 2015
- ACCC Comments to CMS on Proposed Expanded Coverage for Stem Cell Transplantation, May 29, 2015
- ACCC Comments to CMS on Compendium Revision Request, May 20, 2015
- ACCC Comments to CMS Proposal to Expand Speech Generating Devices Coverage, May 20, 2015
- ACCC Comments on MSSP and ACOs Proposed Rule, February 6, 2015
- ACCC Comments on CMS Proposed Coverage Decision on LDCT for Lung Cancer Screening, December 10, 2014
- ACCC Comments on Coverage and Reimbursement by CMS of LDCT for Lung Screening, March 7, 2014
- ACCC Comments to Proposed Part D Rule, February 24, 2014
- ACCC Comments on 90-Day Rule, February 3, 2014
- Sample ESA Order/Charge Sheet
- CMS Medicare Coverage Database
- 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.