107th Congress

Access to Clinical Trials

S. 1052, H.R. 2563, S. 889, H.R. 2315, H.R. 967, S. 257, and S. 1976

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 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 provide protections or rights for enrollees, such as coverage for emergency care services, access to specialists, and prohibition of gag rules. Many of these managed care reform bills, better known as "Patients' Bill of Rights" (PBOR) bills, contained provisions that would require 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.

Although no legislation to give all Americans the option to participate in clinical trials became law, a National Coverage Decision became effective on September 19, 2000, requiring Medicare to pay for the routine costs of a qualified clinical trial.

In the 107th Congress, eight PBOR bills and two freestanding clinical trials bills were introduced. Of the PBOR bills, the following two received the most attention by Congress: S. 1052, the Bipartisan Patient Protection Act, which passed the Senate on June 29, 2001, and H.R. 2563, the Bipartisan Patient Protection Act.

Provisions of the Legislation/Impact on NIH

The clinical trials sections of S.1052, H.R. 2563, S. 889, and H.R. 2315 are described below.

S. 1052—Bipartisan Patient Protection Act
H.R. 2563—Bipartisan Patient Protection Act
S. 889—Bipartisan Patient Protection Act of 2001
H.R. 2315—Patients' Bill of Rights Act of 2001

Although these were competing PBOR bills, the clinical trials sections were very similar. Group health plans and health insurance issuers would have been prohibited from discrimination of any kind against an individual for participating in a clinical trial.

• 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 were 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 also were not considered routine patient costs. H.R. 2315 added transportation and procedures to the exclusions.
• 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, for the person to be qualified, 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 could provide medical and scientific information establishing that the individual's participation in the trial would be appropriate based on the person's meeting the conditions described above.
• Use of In-Network Providers: If an in-network physician conducted a clinical trial for which the patient is qualified, nothing could have prevented the in-network physician from requiring the patient to participate in the 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 clinical 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). However, H.R. 2315 stated that the only FDA clinical trials that would be approved would have been those for cancer. S. 889 did not include FDA because, according to Senator Bill Frist (R-TN), the number of clinical trials and the cost of each trial are unknown. H.R. 2563 also included a National Cancer Institute (NCI) center support grant as an approved clinical trial. All the bills state that 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 determines to be comparable with the peer review of studies and investigations used by NIH and that ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.
• Study and Report: H.R. 2315 and S. 889 would have required the Secretary of HHS to study the impact on group health plans and health insurance issuers for covering routine patient care costs and report to Congress by January 1, 2006. No such language was present in S. 1052 or H.R. 2563.
• Standards for Determining Routine Patient Costs: S. 889 contained additional language that would have required the Secretary of HHS to establish standards for the coverage of routine patient costs.

H.R. 967—Access to Cancer Clinical Trials Act of 2001

H.R. 967 would have amended the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the 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. Details are provided below.

• Coverage: Group health plans could not have discriminated against or denied a qualified individual 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, for the person to be qualified, the referring physician must have been a participating health care professional who concluded that the individual's participation would have been appropriate. The participant could have also provided medical and scientific information establishing that the individual's participation in the trial would have been 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 were provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient. The health plan would not have to pay for costs of items and services that are provided customarily by the research sponsors free of charge for 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 conducted a clinical trial for which the patient was 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 clinical investigation that relates to the treatment of cancer and is federally funded or is under an investigational new drug application reviewed by FDA. Federally funded trials would have been those funded by NIH, the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare & Medicaid Services, or a cooperative group or center of any of these agencies. Center support grantees would also have qualified as an approved clinical trial. For clinical trials at the VA, DoD, or U.S. Department of Energy 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 determined to be comparable with the peer review of studies and investigations used by NIH and that ensured unbiased review of the highest scientific standards by qualified individuals who had no interest in the outcome of the review.

S. 257—Improved Patient Access to Clinical Studies Act of 2001

S. 257 would have amended the Employee Retirement Income Security Act of 1974 and the Public Health Service Act by requiring group health plans to pay for items and services provided in the course of an approved clinical trial. S. 257 was identical to S. 117 from the 106th Congress.

S. 1976—National Cancer Act of 2002

Sections 201 through 203 of S. 1976 would have amended the Public Health Service Act and the Employee Retirement Income Security Act of 1974. Provisions would have required group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. The Director of NCI would also have been required to establish a program to increase patient and provider participation in cancer clinical trials. Details are provided below.

• Coverage: Group health plans could not have discriminated against or denied a qualified individual participation in a clinical trial. In addition, they could not 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 who had been diagnosed with cancer by a qualified provider, who was eligible to participate based on the trial protocol, and whose treatment was being provided with therapeutic or palliative intent. The referring physician must have been a participating health care professional who had concluded that the individual's participation would have been appropriate based on the conditions described above. The participant could have also provided medical and scientific information establishing that the individual's participation in the trial would have been appropriate.
• Payment: The group health plan would have been required to pay for routine patient costs for items and services furnished in connection with participation in the clinical trial, except for tests or measurements conducted primarily for the purpose of the clinical trial. The plan was not required to pay for items and services (as determined by the appropriate Secretary) to be paid for by the sponsors of the approved clinical trial.
• Use of In-Network Providers: If an in-network physician conducted a clinical trial for which the patient was qualified, the group health plan or health insurance issuer could have required the patient to participate in that particular clinical trial. This section also stipulated that nothing in this section should prevent a qualified individual from participating in a trial even if the plan or issuer did not have a participating in-network provider.
• 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 clinical investigation approved and funded by NIH, a cooperative group or center of NIH, the VA, DoD, CDC, or AHRQ. FDA-approved trials would also have been included. For clinical trials at one of these agencies to be approved, they must have been reviewed and approved through a system of peer review that the appropriate Secretary determined 1) to be comparable to the system of peer review used by NIH, and 2) ensured unbiased review of the highest ethical standards by qualified individuals who had no interest in the outcome of the review. An approved clinical trial was also defined as a trial conducted by a qualified non-Government research entity that was in compliance with Part 46 of Title 45, CFR, also known as the Common Rule. The research must have also been reviewed and approved through an institutional review board that had been registered with the U.S. Department of Health and Human Services (DHHS) and had received an appropriate Federal assurance from DHHS of compliance with the Common Rule.
• Coverage for Clinical Trials Under Other Public Health Insurance: This section specified that individuals receiving coverage under Medicaid, Medicare, the State Children's Health Insurance Program, the Federal Employee Health Benefits Program, programs offered by DoD, a medical program of the Indian Health Service or tribal organization, and a health benefit plan in the Peace Corps were also covered.

Status and Outlook

Although there was no further action on the following bills, it is anticipated that similar legislation will be introduced in the 108th Congress.

S. 1052 was introduced on June 14, 2001, by Senator John McCain (R-AZ), and was sent directly to the Senate floor for consideration. The bill was debated from June 21 through June 29. During the debate, the following amendments passed: 1) a nonbinding Sense of the Senate resolution by Senator McCain regarding access to clinical trials, 2) a genetic nondiscrimination in health insurance amendment by Senator John Ensign (R-NV), and 3) an amendment by Senator Don Nickles (R-OK) that would apply the PBOR protections to Federal employees. Another amendment of interest to NIH, which was submitted and subsequently withdrawn, was the Human Germline Gene Modification Prohibition Act of 2001, introduced by Senator Sam Brownback (R-KS). S. 1052 was passed by a vote of 59 to 36 on June 29. The President indicated that he would veto S. 1052 if it came to his desk in its current form. A conference committee to reconcile S. 1052 and H.R. 2563 never met.

H.R. 2563 was introduced on July 19, 2001, by Representative Greg Ganske (R-IA), and was jointly referred to the House Committees on Education and the Workforce, on Energy and Commerce, and on Ways and Means. The House passed the measure on August 2, by a vote of 226 to 203. H.R. 2563 and S. 1052 were never conferenced.

S. 889 was introduced on May 15, 2001, by Senator Frist, and was referred to the Senate Committee on Health, Education, Labor and Pensions. Although the President endorsed this legislation, no further action occurred.

H.R. 2315 was introduced on June 26, 2001, by Representative Ernest Lee Fletcher (R-KY), and was jointly referred to the House Committees on Education and the Workforce, on Energy and Commerce, and on Ways and Means. On July 6, the bill was referred to the House Energy and Commerce Subcommittee on Health. Although the President stated he supported this measure, no further action occurred.

H.R. 967 was introduced on March 8, 2001, by Representative Deborah Pryce (R-OH), and was jointly referred to the House Committees on Education and the Workforce, on Energy and Commerce, and on Ways and Means. On March 20, the bill was referred to the House Energy and Commerce Subcommittee on Health and to the House Ways and Means Subcommittee on Health. On April 30, the bill was referred to the House Education and the Workforce Subcommittee on Employer-Employee Relations.

S. 257 was introduced on February 6, 2001, by Senator Olympia J. Snowe (R-ME), and was referred to the Senate Committee on Health, Education, Labor and Pensions.

S. 1976 was introduced on February 28, 2002, by Senator Dianne Feinstein (D-CA), and was referred to the Senate Committee on Health, Education, Labor and Pensions.