```

[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 967 Introduced in House (IH)]

107th CONGRESS
  1st Session
                                H. R. 967

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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 8, 2001

Ms. Pryce of Ohio (for herself, Mrs. Maloney of New York, Mrs. Myrick, 
 and Mr. Bentsen) introduced the following bill; which was referred to 
the Committee on Energy and Commerce, and in addition to the Committees 
on Education and the Workforce, and Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL

 
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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Access to Cancer Clinical Trials Act 
of 2001''.

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

    (a) Group Health Plans.--
            (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:

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

    ``(a) Coverage.--
            ``(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--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(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; and
                    ``(C) may not discriminate against the individual 
                on the basis of the individual's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--
                    ``(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--
                            ``(i) in the cases of drugs and devices, 
                        the investigational item or service, itself; or
                            ``(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.
                    ``(B) Exclusion.--Such routine patient costs do 
                include costs for the following:
                            ``(i) Conventional care.--Items or services 
                        that are typically provided absent a clinical 
                        trial.
                            ``(ii) Administrative items.--Items or 
                        services required solely for the provision of 
                        the investigational item or service (such as 
                        the administration of a noncovered 
                        chemotherapeutic agent), the clinically 
                        appropriate monitoring of the effects of the 
                        item or service, or the prevention of 
                        complications.
                            ``(iii) Reasonable and necessary care.--
                        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.
            ``(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.
    ``(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:
            ``(1)(A) The individual has been diagnosed with cancer.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) Either--
                    ``(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); or
                    ``(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).
    ``(c) Payment.--
            ``(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.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate, or
                    ``(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).
    ``(d) Approved Clinical Trial Defined.--
            ``(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:
                    ``(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:
                            ``(i) NIH.--The National Institutes of 
                        Health.
                            ``(ii) CDC.--The Centers for Disease 
                        Control and Prevention.
                            ``(iii) AHRQ.--The Agency for Health Care 
                        Research and Quality.
                            ``(iv) HCFA.--The Health Care Financing 
                        Administration.
                            ``(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.
                            ``(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.
                            ``(vii) DOD; va; doe.--Any of the following 
                        if the conditions described in paragraph (2) 
                        are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(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.
                    ``(C) Exempt drug trial.--The study or 
                investigation is a drug trial that is exempt from 
                having such an investigational new drug application.
            ``(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--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health, and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
                no interest in the outcome of the review.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials.''.
            (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:

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

    ``(a) Coverage.--
            ``(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--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(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; and
                    ``(C) may not discriminate against the individual 
                on the basis of the individual's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--
                    ``(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--
                            ``(i) in the cases of drugs and devices, 
                        the investigational item or service, itself; or
                            ``(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.
                    ``(B) Exclusion.--Such routine patient costs do 
                include costs for the following:
                            ``(i) Conventional care.--Items or services 
                        that are typically provided absent a clinical 
                        trial.
                            ``(ii) Administrative items.--Items or 
                        services required solely for the provision of 
                        the investigational item or service (such as 
                        the administration of a noncovered 
                        chemotherapeutic agent), the clinically 
                        appropriate monitoring of the effects of the 
                        item or service, or the prevention of 
                        complications.
                            ``(iii) Reasonable and necessary care.--
                        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.
            ``(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.
    ``(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:
            ``(1)(A) The individual has been diagnosed with cancer.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) Either--
                    ``(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); or
                    ``(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).
    ``(c) Payment.--
            ``(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.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate, or
                    ``(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).
    ``(d) Approved Clinical Trial Defined.--
            ``(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:
                    ``(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:
                            ``(i) NIH.--The National Institutes of 
                        Health.
                            ``(ii) CDC.--The Centers for Disease 
                        Control and Prevention.
                            ``(iii) AHRQ.--The Agency for Health Care 
                        Research and Quality.
                            ``(iv) HCFA.--The Health Care Financing 
                        Administration.
                            ``(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.
                            ``(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.
                            ``(vii) DOD; va; doe.--Any of the following 
                        if the conditions described in paragraph (2) 
                        are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(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.
                    ``(C) Exempt drug trial.--The study or 
                investigation is a drug trial that is exempt from 
                having such an investigational new drug application.
            ``(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--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health, and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
                no interest in the outcome of the review.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials.''.
            (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''.
            (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:

``Sec. 714. Coverage for individuals participating in approved cancer 
                            clinical trials.''.
            (3) Internal revenue code amendments.--
                    (A) In general.--Subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986 is amended--
                            (i) in the table of sections, by inserting 
                        after the item relating to section 9812 the 
                        following new item:

                              ``Sec. 9813. Coverage for individuals 
                                        participating in approved 
                                        cancer clinical trials.''; and
                            (ii) by inserting after section 9812 the 
                        following:

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

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan provides coverage 
        to a qualified individual (as defined in subsection (b)), the 
        plan--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(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; and
                    ``(C) may not discriminate against the individual 
                on the basis of the individual's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--
                    ``(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--
                            ``(i) in the cases of drugs and devices, 
                        the investigational item or service, itself; or
                            ``(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.
                    ``(B) Exclusion.--Such routine patient costs do 
                include costs for the following:
                            ``(i) Conventional care.--Items or services 
                        that are typically provided absent a clinical 
                        trial.
                            ``(ii) Administrative items.--Items or 
                        services required solely for the provision of 
                        the investigational item or service (such as 
                        the administration of a noncovered 
                        chemotherapeutic agent), the clinically 
                        appropriate monitoring of the effects of the 
                        item or service, or the prevention of 
                        complications.
                            ``(iii) Reasonable and necessary care.--
                        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.
            ``(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.
    ``(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:
            ``(1)(A) The individual has been diagnosed with cancer.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) Either--
                    ``(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); or
                    ``(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).
    ``(c) Payment.--
            ``(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.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate, or
                    ``(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).
    ``(d) Approved Clinical Trial Defined.--
            ``(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:
                    ``(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:
                            ``(i) NIH.--The National Institutes of 
                        Health.
                            ``(ii) CDC.--The Centers for Disease 
                        Control and Prevention.
                            ``(iii) AHRQ.--The Agency for Health Care 
                        Research and Quality.
                            ``(iv) HCFA.--The Health Care Financing 
                        Administration.
                            ``(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.
                            ``(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.
                            ``(vii) DOD; va; doe.--Any of the following 
                        if the conditions described in paragraph (2) 
                        are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(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.
                    ``(C) Exempt drug trial.--The study or 
                investigation is a drug trial that is exempt from 
                having such an investigational new drug application.
            ``(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--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health, and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
                no interest in the outcome of the review.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's coverage with respect to clinical trials.''.
                    (B) Conforming amendment.--Section 4980D(d)(1) of 
                such Code is amended by striking ``section 9811'' and 
                inserting ``sections 9811 and 9813''.
    (b) Individual Health Insurance.--Part B of title XXVII of the 
Public Health Service Act is amended--
            (1) by redesignating the first subpart 3 (relating to other 
        requirements) as subpart 2; and
            (2) by adding at the end of subpart 2 the following new 
        section:

``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.''.
    (c) Effective Dates.--
            (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, 2002.
            (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.
            (3) Collective bargaining exception.--In the case of a 
        group health plan maintained pursuant to 1 or more collective 
        bargaining agreements between employee representatives and 1 or 
        more employers ratified before the date of enactment of this 
        Act, the amendments made subsection (a) shall not apply to plan 
        years beginning before the later of--
                    (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 enactment of this Act), or
                    (B) January 1, 2002.
        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.
    (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--
            (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; and
            (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.
    (e) Study and Report.--
            (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.
            (2) Report to congress.--Not later than January 1, 2005, 
        such Secretary shall submit a report to Congress that contains 
        an assessment of--
                    (A) any incremental cost to group health plans and 
                health insurance issuers resulting from the provisions 
                of this section; and
                    (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.
                                 <all>
```