108th Congress

Access to Clinical Trials

S. 10, H.R. 597, H.R. 2021, S. 1945, S. 2003, S. 2083, H.R. 4628

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 affect the success of clinical trials, which occasionally cannot proceed because there are too few participants.

For 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” bills, 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. In the past, freestanding bills that addressed only access to clinical trials have also been presented.

Provisions of the Legislation/Impact on NIH

S. 10, H.R. 597, S. 1945, S. 2083, H.R. 4628

Section 129 of S. 10, the Health Care Coverage Expansion and Quality Improvement Act; Section 119 of H.R. 597, the Patient Protection Act; Section 602 of S. 1945, the Bipartisan Patient Protection Act of 2003; S. 2083, the Bipartisan Patient Protection Act of 2004; and Section 119 of H.R. 4628, the Patients’ Bill of Rights Act of 2004, contained the same clinical trials language. Section 201 of S. 2003, the Health Information for Quality Improvement Act, was not patients’ bill of rights legislation, but it contained similar provisions regarding access to clinical trials.

• Coverage: Group health plans and health insurance issuers would have been prohibited from denying a qualified individual the opportunity to participate in a clinical trial and would have been required to pay the “routine patient costs” associated with the clinical trial.
• Routine Patient Costs: Although the legislation did not specifically define routine patient costs, it did specify what they are not: tests or measurements conducted primarily for the purpose of the clinical trial. Items and services reasonably expected (as determined by the Secretary of Health and Human Services [HHS]) to be paid for by the sponsors of the approved clinical trial would also have not been considered routine patient costs. S. 2003 specified that routine patient costs include items or services that are 1) typically provided absent a clinical trial, 2) required solely for the provision of the investigational item or service, clinically appropriate monitoring of the effects of the item or service, or prevention of complications, and 3) needed for reasonable and necessary care arising from the provision of an investigational item or service, including the diagnosis or treatment of complications. S. 2003 states that in the cases of drugs and devices, routine patient costs do not include the investigational item or service itself or items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient.
• Qualified Individual: A qualified individual would have been 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 have been 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 have been at the agreed-on rate. Providers outside the network would have been paid at the rate the insurer would normally pay for comparable services.
• Approved Clinical Trial: An approved clinical trial would have been 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 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 had to be reviewed and approved through a system of peer review that the Secretary of HHS deemed to be comparable with the peer review of studies and investigations used by NIH and that ensured an unbiased review of the highest scientific standards by qualified individuals who had no interest in the outcome of the review. S. 2003 would have also included studies approved or funded by the Centers for Disease Control and Prevention (CDC); Agency for Healthcare Research and Quality (AHRQ); the Center for Medicare and Medicaid Services (CMS); a cooperative group or center supported by NIH, CDC, AHRQ, CMS, DoD, or VA; a qualified nongovernmental research entity identified in the guidelines issued by NIH for center-supported grants; and the Department of Energy (DOE), if the Secretary of HHS deemed that its system of peer review is comparable to that of NIH.

In addition, Section 194 of S. 10, Section 702 of H.R. 597, and Section 604 of S. 2083 contained a Sense of the Senate resolution that individuals with serious diseases should have the opportunity to participate in a federally approved or funded clinical trial.

H.R. 2021

The Access to Cancer Clinical Trials Act of 2003 would have amended 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 included:

• Coverage: Group health plans could not have discriminated against a qualified individual or denied participation in a clinical trial nor could they have denied, limited, or imposed additional conditions on the coverage of routine patient costs for items and services associated with the study.
• Qualified Individual: A qualified individual would have been defined as a person diagnosed with cancer and eligible to participate based on the trial protocol. In addition, the referring physician must have been a participating health care professional who has concluded that the individual’s participation would be appropriate. The participant could have also provided medical and scientific information establishing that his or her participation in the trial would be appropriate.
• Payment: The group health plan would have been 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 have had 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 have included 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 have required 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 have been at the agreed-on rate. Providers outside the network would have been paid at the rate the insurer would normally pay for comparable services.
• Approved Clinical Trial: An approved clinical trial would have been 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 have included those funded by NIH, CDC, AHRQ, CMS, or a cooperative group or center of any of these agencies. Center-supported grantees would have also qualified as an approved clinical trial. For clinical trials at VA, DoD, or DOE to have been approved, the study or investigation would have had to be reviewed and approved through a system of peer review that the Secretary of HHS deemed to be comparable to the peer review of studies and investigations used by NIH and that ensured an unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

Status and Outlook

S. 10, the Health Care Coverage Expansion and Quality Improvement Act, was introduced by Senator Thomas A. Daschle (D-SD) on January 7, 2003, and was referred to the Senate Committee on Finance. No further action occurred on this legislation during the 108th Congress.

H.R. 597, the Patient Protection Act, was introduced by Representative Charles Norwood (R-GA) on February 5, 2003, 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 occurred on this legislation during the 108th Congress.

H.R. 2021, the Access to Cancer Clinical Trials Act of 2003, was introduced by Representative Deborah Pryce (R-OH) on May 7, 2003, 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 occurred on this legislation during the 108th Congress.

S. 1945, the Bipartisan Patient Protection Act of 2003, was introduced by Senator John McCain (R-AZ) on November 24, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.

S. 2003 was introduced by Senator Hillary Rodham Clinton (D-NY) on December 9, 2003, and was referred to the Senate Committee on Finance. No further action occurred on this legislation during the 108th Congress.

S. 2083, the Bipartisan Patient Protection Act of 2004, was introduced by Senator Barbara Boxer (D-CA) on February 12, 2004, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 108th Congress.

H.R. 4628, the Patients’ Bill of Rights Act of 2004, was introduced by Representative John D. Dingell (D-MI) on June 21, 2004, 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 occurred on this legislation during the 108th Congress.