| West Virginia Oncology Society |
Since the beginning of the year, the policy landscape has changed significantly with regard to
insurance coverage of clinical trials. The federal health reform law (the Patient Protection and
Affordable Care Act, PPACA or P.L. 111-148) enacted by President Obama in March 2010
establishes a federal requirement for health insurers and plans to provide coverage of clinical trials
beginning in January 2014. At the state level, three states (Iowa, Alaska, and Kentucky) passed
legislation and two states (Florida and South Carolina) negotiated agreements with insurers to
provide coverage for clinical trial routine services since the beginning of the year.
PPACA establishes in federal law a minimum coverage requirement that applies to all health plans
and insurance issuers - starting January 2014. As such, it will set the standard for health plans and
insurers regulated by either federal or state laws. States can continue to pass laws that are more
expansive, but all state-regulated insurers will now be subject to the federal coverage
requirement - even insurers located in states without any law or coverage agreement in place. The
law also ensures coverage for those people who obtain their health insurance through the Federal
Employees Health Benefits Program.
The federal law includes an exemption from the coverage requirement for plans and insurers in
existence at the time of enactment so long as no changes are made to the plan or insurance
product. PPACA gives the Department of Health and Human Services wide latitude to define the so-
called Grandfathered Plans. ASCO is engaging in analysis and advocacy work related to this
provision to ensure that it does not result in large numbers of plans or insurers being exempt from
the coverage requirement.
The federal law requires coverage of routine patient care costs for phase I, II, III, and IV clinical
trials for the prevention, detection or treatment of cancer or other life-threatening diseases. The
law applies to trials that are approved or funded by the federal government, including trials from
the following:
• National Institutes of Health (NIH)
• Centers for Disease Control and Prevention
• Agency for Healthcare Research and Quality
• Centers for Medicare & Medicaid Services
• Cooperative groups or centers of the above agencies and the Departments of Defense and
Veterans Affairs
• Qualified non-governmental research entities identified by NIH guidelines
The requirement also applies to clinical trials that are conducted under a Food and Drug
Administration investigational new drug (IND) application, as well as trials exempt from an IND
application.
ASCO is aware of 29 states (Arizona, California, Colorado, Connecticut, Delaware, Georgia, Illinois,
Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Missouri, Nevada, New
Hampshire, New Mexico, North Carolina, Ohio, Oregon, Rhode Island, Tennessee, Texas, Vermont,
Virginia, West Virginia, Wisconsin, and Wyoming) and the District of Columbia that currently have
statutes requiring coverage of clinical trials. The Alaska legislature also passed a bill (SB 10)
requiring coverage, but - as of May 11 - it is awaiting the governor's signature. Six states (Florida,
Georgia, Nebraska, New Jersey, Michigan, and South Carolina) have negotiated comprehensive
coverage agreements. In the case of Georgia, the state law requires coverage of pediatric cancers,
but the agreement provides coverage of adult cancers.
ASCO is preparing a detailed analysis of the federal statute and its impact on state coverage
requirements. Additional information will be included in subsequent issues of Cancer Policy Today.
In the meantime, please contact researchpolicy@asco.org with questions or for additional
information.
insurance coverage of clinical trials. The federal health reform law (the Patient Protection and
Affordable Care Act, PPACA or P.L. 111-148) enacted by President Obama in March 2010
establishes a federal requirement for health insurers and plans to provide coverage of clinical trials
beginning in January 2014. At the state level, three states (Iowa, Alaska, and Kentucky) passed
legislation and two states (Florida and South Carolina) negotiated agreements with insurers to
provide coverage for clinical trial routine services since the beginning of the year.
PPACA establishes in federal law a minimum coverage requirement that applies to all health plans
and insurance issuers - starting January 2014. As such, it will set the standard for health plans and
insurers regulated by either federal or state laws. States can continue to pass laws that are more
expansive, but all state-regulated insurers will now be subject to the federal coverage
requirement - even insurers located in states without any law or coverage agreement in place. The
law also ensures coverage for those people who obtain their health insurance through the Federal
Employees Health Benefits Program.
The federal law includes an exemption from the coverage requirement for plans and insurers in
existence at the time of enactment so long as no changes are made to the plan or insurance
product. PPACA gives the Department of Health and Human Services wide latitude to define the so-
called Grandfathered Plans. ASCO is engaging in analysis and advocacy work related to this
provision to ensure that it does not result in large numbers of plans or insurers being exempt from
the coverage requirement.
The federal law requires coverage of routine patient care costs for phase I, II, III, and IV clinical
trials for the prevention, detection or treatment of cancer or other life-threatening diseases. The
law applies to trials that are approved or funded by the federal government, including trials from
the following:
• National Institutes of Health (NIH)
• Centers for Disease Control and Prevention
• Agency for Healthcare Research and Quality
• Centers for Medicare & Medicaid Services
• Cooperative groups or centers of the above agencies and the Departments of Defense and
Veterans Affairs
• Qualified non-governmental research entities identified by NIH guidelines
The requirement also applies to clinical trials that are conducted under a Food and Drug
Administration investigational new drug (IND) application, as well as trials exempt from an IND
application.
ASCO is aware of 29 states (Arizona, California, Colorado, Connecticut, Delaware, Georgia, Illinois,
Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Missouri, Nevada, New
Hampshire, New Mexico, North Carolina, Ohio, Oregon, Rhode Island, Tennessee, Texas, Vermont,
Virginia, West Virginia, Wisconsin, and Wyoming) and the District of Columbia that currently have
statutes requiring coverage of clinical trials. The Alaska legislature also passed a bill (SB 10)
requiring coverage, but - as of May 11 - it is awaiting the governor's signature. Six states (Florida,
Georgia, Nebraska, New Jersey, Michigan, and South Carolina) have negotiated comprehensive
coverage agreements. In the case of Georgia, the state law requires coverage of pediatric cancers,
but the agreement provides coverage of adult cancers.
ASCO is preparing a detailed analysis of the federal statute and its impact on state coverage
requirements. Additional information will be included in subsequent issues of Cancer Policy Today.
In the meantime, please contact researchpolicy@asco.org with questions or for additional
information.
| Update on Insurance Coverage of Clinical Trials |
American Society of Clinical Oncology (ASCO)