S 2999 ISCommentsClose CommentsPermalink

To amend 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.CommentsClose CommentsPermalink

May 8, 2008

Mr. BROWN (for himself, Mr. SPECTER, and Mr. WHITEHOUSE) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink

To amend 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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the `Access to Cancer Clinical Trials Act of 2008'.CommentsClose CommentsPermalink

SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS.

(a) Group Health Plans-CommentsClose CommentsPermalink





(1) PUBLIC HEALTH SERVICE ACT AMENDMENTS- Subpart 2 of part A of title XXVII of the Public Health Service Act is amended by adding at the end the following new section:CommentsClose CommentsPermalink

`SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS.

`(a) Coverage-CommentsClose CommentsPermalink





`(1) IN GENERAL- If a group health plan (or a health insurance issuer offering health insurance coverage in connection with the plan) provides coverage to a qualified individual (as defined in subsection (b)), the plan or issuer--CommentsClose CommentsPermalink





`(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);CommentsClose CommentsPermalink





`(B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; andCommentsClose CommentsPermalink





`(C) may not discriminate against the individual on the basis of the individual's participation in such trial.CommentsClose CommentsPermalink





`(2) EXCLUSION OF CERTAIN COSTS-CommentsClose CommentsPermalink





`(A) IN GENERAL- For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services provided in the clinical trial that are otherwise generally available to the qualified individual, except--CommentsClose CommentsPermalink





`(i) in the cases of drugs and devices, the investigational item or service, itself; orCommentsClose CommentsPermalink





`(ii) items and 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.CommentsClose CommentsPermalink





`(B) INCLUSIONS- Such routine patient costs include costs for items or services that are typically provided absent a clinical trial.CommentsClose CommentsPermalink





`(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.CommentsClose CommentsPermalink





`(b) Qualified Individual Defined- For purposes of subsection (a), the term `qualified individual' means an individual who is a participant or beneficiary in a group health plan and who meets the following conditions:CommentsClose CommentsPermalink





`(1)(A) The individual has been diagnosed with cancer.CommentsClose CommentsPermalink





`(B) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of such illness.CommentsClose CommentsPermalink





`(2) Either--CommentsClose CommentsPermalink





`(A) the referring physician is a participating health care professional and has concluded that the individual's participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); orCommentsClose CommentsPermalink





`(B) the participant or beneficiary provides medical and scientific information establishing that the individual's participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1).CommentsClose CommentsPermalink





`(c) Payment-CommentsClose CommentsPermalink





`(1) IN GENERAL- Under this section a group health plan (or health insurance issuer offering health insurance coverage in connection with the plan) shall provide for payment for routine patient costs described in subsection (a)(2) but is not required to pay for costs of items and services that are customarily provided by the research sponsors free of charge for individuals participating in the trial.CommentsClose CommentsPermalink





`(2) PAYMENT RATE- In the case of covered items and services provided by--CommentsClose CommentsPermalink





`(A) a participating provider, the payment rate shall be at the agreed upon rate, orCommentsClose CommentsPermalink





`(B) a nonparticipating provider, the payment rate shall be at the rate the plan would normally pay for comparable items and services under subparagraph (A).CommentsClose CommentsPermalink





`(d) Approved Clinical Trial Defined-CommentsClose CommentsPermalink





`(1) IN GENERAL- In this section, the term `approved clinical trial' means a clinical research study or clinical investigation that relates to the treatment of cancer (including related symptoms) and is described in any of the following subparagraphs:CommentsClose CommentsPermalink





`(A) FEDERALLY FUNDED TRIALS- The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following:CommentsClose CommentsPermalink





`(i) NIH- The National Institutes of Health.CommentsClose CommentsPermalink





`(ii) CDC- The Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





`(iii) AHRQ- The Agency for Health Care Research and Quality.CommentsClose CommentsPermalink





`(iv) CMS- The Centers for Medicare & Medicaid Services.CommentsClose CommentsPermalink





`(v) COOPERATIVE CENTER- A cooperative group or center of any of the entities described in clauses (i) through (iv) or the Departments of Defense or Veterans Affairs.CommentsClose CommentsPermalink





`(vi) CENTER SUPPORT GRANTEES- A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.CommentsClose CommentsPermalink





`(vii) DOD; VA; DOE- Any of the following if the conditions described in paragraph (2) are met:CommentsClose CommentsPermalink





`(I) The Department of Veterans Affairs.CommentsClose CommentsPermalink





`(II) The Department of Defense.CommentsClose CommentsPermalink





`(III) The Department of Energy.CommentsClose CommentsPermalink





`(B) FDA DRUG TRIAL UNDER IND- The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.CommentsClose CommentsPermalink





`(C) EXEMPT DRUG TRIAL- The study or investigation is a drug trial that is exempt from having such an investigational new drug application.CommentsClose CommentsPermalink





`(2) CONDITIONS FOR DEPARTMENTS- The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines--CommentsClose CommentsPermalink





`(A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, andCommentsClose CommentsPermalink





`(B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.CommentsClose CommentsPermalink





`(e) Construction- Nothing in this section shall be construed to limit a plan's or issuer's coverage with respect to clinical trials.'.CommentsClose CommentsPermalink





(2) ERISA AMENDMENTS- (A) Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 is amended by adding at the end the following new section:CommentsClose CommentsPermalink

`SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS.

`(a) Coverage-CommentsClose CommentsPermalink





`(1) IN GENERAL- If a group health plan (or a health insurance issuer offering health insurance coverage in connection with the plan) provides coverage to a qualified individual (as defined in subsection (b)), the plan or issuer--CommentsClose CommentsPermalink





`(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);CommentsClose CommentsPermalink





`(B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; andCommentsClose CommentsPermalink





`(C) may not discriminate against the individual on the basis of the individual's participation in such trial.CommentsClose CommentsPermalink





`(2) EXCLUSION OF CERTAIN COSTS-CommentsClose CommentsPermalink





`(A) IN GENERAL- For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services provided in the clinical trial that are otherwise generally available to the qualified individual, except--CommentsClose CommentsPermalink





`(i) in the cases of drugs and devices, the investigational item or service, itself; orCommentsClose CommentsPermalink





`(ii) items and 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.CommentsClose CommentsPermalink





`(B) EXCLUSION- Such routine patient costs do include costs for items or services that are typically provided absent a clinical trial.CommentsClose CommentsPermalink





`(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.CommentsClose CommentsPermalink





`(b) Qualified Individual Defined- For purposes of subsection (a), the term `qualified individual' means an individual who is a participant or beneficiary in a group health plan and who meets the following conditions:CommentsClose CommentsPermalink





`(1)(A) The individual has been diagnosed with cancer.CommentsClose CommentsPermalink





`(B) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of such illness.CommentsClose CommentsPermalink





`(2) Either--CommentsClose CommentsPermalink





`(A) the referring physician is a participating health care professional and has concluded that the individual's participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); orCommentsClose CommentsPermalink





`(B) the participant or beneficiary provides medical and scientific information establishing that the individual's participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1).CommentsClose CommentsPermalink





`(c) Payment-CommentsClose CommentsPermalink





`(1) IN GENERAL- Under this section a group health plan (or health insurance issuer offering health insurance coverage in connection with the plan) shall provide for payment for routine patient costs described in subsection (a)(2) but is not required to pay for costs of items and services that are customarily provided by the research sponsors free of charge for individuals participating in the trial.CommentsClose CommentsPermalink





`(2) PAYMENT RATE- In the case of covered items and services provided by--CommentsClose CommentsPermalink





`(A) a participating provider, the payment rate shall be at the agreed upon rate, orCommentsClose CommentsPermalink





`(B) a nonparticipating provider, the payment rate shall be at the rate the plan would normally pay for comparable items and services under subparagraph (A).CommentsClose CommentsPermalink





`(d) Approved Clinical Trial Defined-CommentsClose CommentsPermalink





`(1) IN GENERAL- In this section, the term `approved clinical trial' means a clinical research study or clinical investigation that relates to the treatment of cancer (including related symptoms) and is described in any of the following subparagraphs:CommentsClose CommentsPermalink





`(A) FEDERALLY FUNDED TRIALS- The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following:CommentsClose CommentsPermalink





`(i) NIH- The National Institutes of Health.CommentsClose CommentsPermalink





`(ii) CDC- The Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





`(iii) AHRQ- The Agency for Health Care Research and Quality.CommentsClose CommentsPermalink





`(iv) CMS- The Centers for Medicare & Medicaid Services.CommentsClose CommentsPermalink





`(v) COOPERATIVE CENTER- A cooperative group or center of any of the entities described in clauses (i) through (iv) or the Departments of Defense or Veterans Affairs.CommentsClose CommentsPermalink





`(vi) CENTER SUPPORT GRANTEES- A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.CommentsClose CommentsPermalink





`(vii) DOD; VA; DOE- Any of the following if the conditions described in paragraph (2) are met:CommentsClose CommentsPermalink





`(I) The Department of Veterans Affairs.CommentsClose CommentsPermalink





`(II) The Department of Defense.CommentsClose CommentsPermalink





`(III) The Department of Energy.CommentsClose CommentsPermalink





`(B) FDA DRUG TRIAL UNDER IND- The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.CommentsClose CommentsPermalink





`(C) EXEMPT DRUG TRIAL- The study or investigation is a drug trial that is exempt from having such an investigational new drug application.CommentsClose CommentsPermalink





`(2) CONDITIONS FOR DEPARTMENTS- The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines--CommentsClose CommentsPermalink





`(A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, andCommentsClose CommentsPermalink





`(B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.CommentsClose CommentsPermalink





`(e) Construction- Nothing in this section shall be construed to limit a plan's or issuer's coverage with respect to clinical trials.'.CommentsClose CommentsPermalink





(B) Section 732(a) of such Act (29 U.S.C. 1191a(a)) is amended by striking `section 711' and inserting `sections 711 and 714'.CommentsClose CommentsPermalink





(C) The table of contents in section 1 of such Act is amended by inserting after the item relating to section 713 the following new item:CommentsClose CommentsPermalink





`Sec. 714. Coverage for individuals participating in approved cancer clinical trials.'.CommentsClose CommentsPermalink





(3) INTERNAL REVENUE CODE AMENDMENTS-CommentsClose CommentsPermalink





(A) IN GENERAL- Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended--CommentsClose CommentsPermalink





(i) in the table of sections, by inserting after the item relating to section 9812 the following new item:CommentsClose CommentsPermalink





`Sec. 9813. Coverage for individuals participating in approved cancer clinical trials.';CommentsClose CommentsPermalink





andCommentsClose CommentsPermalink





(ii) by inserting after section 9812 the following:CommentsClose CommentsPermalink

`SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS.

`(a) Coverage-CommentsClose CommentsPermalink





`(1) IN GENERAL- If a group health plan provides coverage to a qualified individual (as defined in subsection (b)), the plan--CommentsClose CommentsPermalink





`(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);CommentsClose CommentsPermalink





`(B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; andCommentsClose CommentsPermalink





`(C) may not discriminate against the individual on the basis of the individual's participation in such trial.CommentsClose CommentsPermalink





`(2) EXCLUSION OF CERTAIN COSTS-CommentsClose CommentsPermalink





`(A) IN GENERAL- For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services provided in the clinical trial that are otherwise generally available to the qualified individual, except--CommentsClose CommentsPermalink





`(i) in the cases of drugs and devices, the investigational item or service, itself; orCommentsClose CommentsPermalink





`(ii) items and 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.CommentsClose CommentsPermalink





`(B) EXCLUSION- Such routine patient costs do include costs for items or services that are typically provided absent a clinical trial.CommentsClose CommentsPermalink





`(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.CommentsClose CommentsPermalink





`(b) Qualified Individual Defined- For purposes of subsection (a), the term `qualified individual' means an individual who is a participant or beneficiary in a group health plan and who meets the following conditions:CommentsClose CommentsPermalink





`(1)(A) The individual has been diagnosed with cancer.CommentsClose CommentsPermalink





`(B) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of such illness.CommentsClose CommentsPermalink





`(2) Either--CommentsClose CommentsPermalink





`(A) the referring physician is a participating health care professional and has concluded that the individual's participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); orCommentsClose CommentsPermalink





`(B) the participant or beneficiary provides medical and scientific information establishing that the individual's participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1).CommentsClose CommentsPermalink





`(c) Payment-CommentsClose CommentsPermalink





`(1) IN GENERAL- Under this section a group health plan shall provide for payment for routine patient costs described in subsection (a)(2) but is not required to pay for costs of items and services that are customarily provided by the research sponsors free of charge for individuals participating in the trial.CommentsClose CommentsPermalink





`(2) PAYMENT RATE- In the case of covered items and services provided by--CommentsClose CommentsPermalink





`(A) a participating provider, the payment rate shall be at the agreed upon rate, orCommentsClose CommentsPermalink





`(B) a nonparticipating provider, the payment rate shall be at the rate the plan would normally pay for comparable items and services under subparagraph (A).CommentsClose CommentsPermalink





`(d) Approved Clinical Trial Defined-CommentsClose CommentsPermalink





`(1) IN GENERAL- In this section, the term `approved clinical trial' means a clinical research study or clinical investigation that relates to the treatment of cancer (including related symptoms) and is described in any of the following subparagraphs:CommentsClose CommentsPermalink





`(A) FEDERALLY FUNDED TRIALS- The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following:CommentsClose CommentsPermalink





`(i) NIH- The National Institutes of Health.CommentsClose CommentsPermalink





`(ii) CDC- The Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





`(iii) AHRQ- The Agency for Health Care Research and Quality.CommentsClose CommentsPermalink





`(iv) CMS- The Centers for Medicare & Medicaid Services.CommentsClose CommentsPermalink





`(v) COOPERATIVE CENTER- A cooperative group or center of any of the entities described in clauses (i) through (iv) or the Departments of Defense or Veterans Affairs.CommentsClose CommentsPermalink





`(vi) CENTER SUPPORT GRANTEES- A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.CommentsClose CommentsPermalink





`(vii) DOD; VA; DOE- Any of the following if the conditions described in paragraph (2) are met:CommentsClose CommentsPermalink





`(I) The Department of Veterans Affairs.CommentsClose CommentsPermalink





`(II) The Department of Defense.CommentsClose CommentsPermalink





`(III) The Department of Energy.CommentsClose CommentsPermalink





`(B) FDA DRUG TRIAL UNDER IND- The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.CommentsClose CommentsPermalink





`(C) EXEMPT DRUG TRIAL- The study or investigation is a drug trial that is exempt from having such an investigational new drug application.CommentsClose CommentsPermalink





`(2) CONDITIONS FOR DEPARTMENTS- The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines--CommentsClose CommentsPermalink





`(A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, andCommentsClose CommentsPermalink





`(B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.CommentsClose CommentsPermalink





`(e) Construction- Nothing in this section shall be construed to limit a plan's coverage with respect to clinical trials.'.CommentsClose CommentsPermalink





(B) CONFORMING AMENDMENT- Section 4980D(d)(1) of such Code is amended by striking `section 9811' and inserting `sections 9811 and 9813'.CommentsClose CommentsPermalink





(b) Individual Health Insurance- Part B of title XXVII of the Public Health Service Act is amended--CommentsClose CommentsPermalink





(1) by redesignating the first subpart 3 (relating to other requirements) as subpart 2; andCommentsClose CommentsPermalink





(2) by adding at the end of subpart 2 the following new section:CommentsClose CommentsPermalink

`SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS.

`The provisions of section 2707 shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as they apply to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small or large group market.'.CommentsClose CommentsPermalink





(c) Effective Dates-CommentsClose CommentsPermalink





(1) GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE COVERAGE- Subject to paragraph (3), the amendments made by subsection (a) apply with respect to group health plans for plan years beginning on or after January 1, 2009.CommentsClose CommentsPermalink





(2) INDIVIDUAL HEALTH INSURANCE COVERAGE- The amendment made by subsection (b) applies with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after such date.CommentsClose CommentsPermalink





(3) COLLECTIVE BARGAINING EXCEPTION- In the case of a group health plan maintained pursuant to one or more collective bargaining agreements between employee representatives and one or more employers ratified before the date of the enactment of this Act, the amendments made by subsection (a) shall not apply to plan years beginning before the later of--CommentsClose CommentsPermalink





(A) the date on which the last collective bargaining agreements relating to the plan terminates (determined without regard to any extension thereof agreed to after the date of the enactment of this Act), orCommentsClose CommentsPermalink





(B) January 1, 2009.CommentsClose CommentsPermalink





For purposes of subparagraph (A), any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by subsection (a) shall not be treated as a termination of such collective bargaining agreement.CommentsClose CommentsPermalink





(d) Coordination of Administration- The Secretary of Labor, the Secretary of the Treasury, and the Secretary of Health and Human Services shall ensure, through the execution of an interagency memorandum of understanding among such Secretaries, that--CommentsClose CommentsPermalink





(1) regulations, rulings, and interpretations issued by such Secretaries relating to the same matter over which two or more such Secretaries have responsibility under the provisions of this Act (and the amendments made thereby) are administered so as to have the same effect at all times; andCommentsClose CommentsPermalink





(2) coordination of policies relating to enforcing the same requirements through such Secretaries in order to have a coordinated enforcement strategy that avoids duplication of enforcement efforts and assigns priorities in enforcement.CommentsClose CommentsPermalink





(e) Study and Report-CommentsClose CommentsPermalink





(1) STUDY- The Secretary of Health and Human Services, jointly with the Secretaries of Labor and the Treasury, shall study the impact on group health plans and health insurance issuers of requiring group health plans and health insurance coverage to cover routine patient care costs for individuals with serious and life threatening diseases other than cancer.CommentsClose CommentsPermalink





(2) REPORT TO CONGRESS- Not later than January 1, 2012, such Secretary shall submit a report to Congress that contains an assessment of--CommentsClose CommentsPermalink





(A) any incremental cost to group health plans and health insurance issuers resulting from the provisions of this section; andCommentsClose CommentsPermalink





(B) a projection of expenditures of such plans and issuers if coverage of routine patient care costs in an approved clinical trial program were extended to individuals entitled to benefits under such plans or health insurance coverage who have a diagnosis other than cancer.CommentsClose CommentsPermalink