109th Congress

Access to Clinical Trials

H.R. 2259, S. 1012, H.R. 2650, H.R. 6247

Background

Managed care organizations (MCOs) usually will not pay associated costs (e.g., hospital stays, radiology, and laboratory work) incurred in connection with standard or investigational treatment. Thus, many people covered by MCOs are unable to participate in clinical trials and are denied the benefits of new therapies and treatment options. This limiting of participants can also affect the success of clinical trials, which occasionally cannot proceed because there are too few participants.

During the past several sessions of Congress, legislation has been introduced to reform managed care. These bills would have provided protections or rights for enrollees, such as coverage for emergency care services, access to specialists, and the prohibition of gag rules. Many of these managed care reform bills, better known as “patients’ bill of rights” legislation, contained provisions that would have required MCOs to pay for the costs associated with a clinical trial, with the exception of the intervention and related tests and measurements. Freestanding bills that addressed only access to clinical trials have also been introduced.

Provisions of H.R. 2259, S. 1012, and H.R. 2650 include the following:

• Coverage: Group health plans and health insurance issuers would be prohibited from denying a qualified individual the opportunity to participate in a clinical trial and would be required to pay the “routine patient costs” associated with the clinical trial.
• Routine Patient Costs: Although the legislation does not specifically define routine patient costs, it does specify what they are not: tests or measurements conducted primarily for the purpose of the clinical trial. Items and services reasonably expected to be paid for by the sponsors of the approved clinical trial (as determined by the Secretary of Health and Human Services [HHS]) would also not be considered routine patient costs.
• Qualified Individual: A qualified individual would be defined as a person who has a life-threatening or serious illness for which no standard treatment is effective, is eligible to participate in an approved clinical trial, and has the potential to benefit significantly from the clinical trial. In addition, the referring physician must be a participating health care professional who has concluded that the individual’s participation would be appropriate based on the individual’s meeting the conditions above, or the participant must provide medical and scientific information establishing that his or her participation in the trial would be appropriate based on his or her ability to meet the conditions described above.
• Use of In-Network Providers: If an in-network physician is conducting a clinical trial for which the patient is qualified, the patient could be required to participate in that particular clinical trial.
• Payment Rate: The payment rate of covered items and services provided by an in-network provider conducting a clinical trial would be at the agreed-on rate. Providers outside the network would be paid at the rate that the insurer would normally pay for comparable services.
• Approved Clinical Trial: An approved clinical trial would be defined as a clinical research study or investigation approved or funded by the National Institutes of Health (NIH), a cooperative group or Center of NIH, or the U.S. Food and Drug Administration (FDA). In order for clinical trials at the U.S. Departments of Veterans Affairs (VA) and of Defense (DOD) to be approved, the study or investigation would have to be reviewed and approved through a system of peer review that the Secretary of HHS deems to be comparable to the peer review of studies and investigations used by NIH and that ensures an unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

H.R. 6247, the Access to Cancer Clinical Trials Act of 2006, would amend the Public Health Service Act, Employee Retirement Income Security Act of 1974, and Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. Provisions of the bill include the following:

• Coverage: Group health plans would not be permitted to discriminate against a qualified individual or deny participation in a clinical trial, nor could they deny, limit, or impose additional conditions on the coverage of routine patient costs for items and services associated with the study.
• Qualified Individual: A qualified individual would be defined as a person diagnosed with cancer and eligible to participate based on the trial protocol. In addition, the referring physician must be a participating health care professional who has concluded that the individual’s participation would be appropriate. The participant could also provide medical and scientific information establishing that his or her participation in the trial would be appropriate.
• Payment: The group health plan would be required to pay for all items and services provided in the clinical trial, except for the drug, device, or investigational item or service or items and services that are provided solely to satisfy data collection and analysis needs and are not used in the direct clinical management of the patient. The health plan would not be required to pay for costs of items and services that are provided customarily by the research sponsors free of charge to individuals participating in the trial. Routine patient costs would include 1) conventional care, 2) administrative items, and 3) items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, including the diagnosis or treatment of complications.
• Use of In-Network Providers: If an in-network physician is conducting a clinical trial for which the patient is qualified, the group health plan or health insurance issuer could require the patient to participate in that clinical trial.
• Payment Rate: The payment rate for covered items and services provided by an in-network provider conducting a clinical trial would be at the agreed-on rate. Providers outside the network would be paid at the rate the insurer would normally pay for comparable services.
• Approved Clinical Trial: An approved clinical trial would be defined as a clinical research study or investigation that relates to the treatment of cancer and is federally funded or under an investigational new drug application being reviewed by FDA. Federally funded trials would include those funded by NIH, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the Centers for Medicare & Medicaid Services, or a cooperative group or center of any of these agencies. Center-supported grantees would also qualify as an approved clinical trial. For clinical trials at VA, the Department of Defense, or the Department of Energy to be approved, the study or investigation would be reviewed and approved through a system of peer review that the Secretary of HHS deems to be comparable to the peer review of studies and investigations used by NIH and that ensure an unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

Status and Outlook

H.R. 2259 was introduced by Representative John D. Dingell (D-MI) on May 11, 2005, and was jointly referred to the House Committees on Energy and Commerce, on Education and the Workforce, and on Ways and Means. No further action has occurred on this legislation.

S. 1012 was introduced by Senator Edward M. Kennedy (D-MA) on May 12, 2005, and was referred to the Senate Committee on Finance. No further action has occurred on this legislation.

H.R. 2650 was introduced by Representative Charles Norwood (R-GA) on May 26, 2005, and was jointly referred to the House Committees on Energy and Commerce and on Ways and Means. No further action has occurred on this legislation.

H.R. 6247 was introduced by Representative Deborah Pryce (R-OH) on September 28, 2006, and was jointly referred to the House Committees on Energy and Commerce, on Education and the Workforce, and on Ways and Means. No further action has occurred on this legislation.