[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3110 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 3110

To amend the Public Health Service Act, the Employee Retirement Income 
Security Act of 1974, and the Internal Revenue Code of 1986 to provide 
  coverage for individuals participating in approved cancer clinical 
                                trials.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 19, 1999

  Mr. Salmon (for himself, Mr. Kolbe, and Mr. Shadegg) introduced the 
following bill; which was referred to the Committee on Commerce, and in 
  addition to the Committees on Ways and Means, and Education and the 
 Workforce, 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 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 ``Dr. Sydney E. Salmon Access to 
Cancer Clinical Trials Act of 1999''.

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

    (a) Group Health Plans.--
            (1) Public health service act amendments.--(A) 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 subsections (b), (c), and (d) 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 participant's or beneficiaries 
                participation in such trial.
            ``(2) Exclusion of certain costs.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(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.
            ``(C) The individual's participation in the trial offers 
        meaningful potential for significant clinical benefit for the 
        individual.
            ``(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 
        reasonably expected to be paid for by the sponsors of an 
        approved clinical trial.
            ``(2) Routine patient care costs.--
                    ``(A) In general.--For purposes of this Act, 
                `routine patient care costs' shall include the costs 
                associated with the provision of items and services 
                that--
                            ``(i) would otherwise be covered under the 
                        group health plan if such items and services 
                        were not provided in connection with an 
                        approved clinical trial program; and
                            ``(ii) are furnished according to the 
                        protocol of an approved clinical trial program.
                    ``(B) Exclusion.--For purposes of this Act, 
                `routine patient care costs' shall not include the 
                costs associated with the provision of--
                            ``(i) an investigational drug or device, 
                        unless the Secretary has authorized the 
                        manufacturer of such drug or device to charge 
                        for such drug or device; or
                            ``(ii) any item or service supplied without 
                        charge by the sponsor of the approved clinical 
                        trial program.
            ``(3) 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 or services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a cancer clinical research study or 
        cancer clinical investigation approved by an Institutional 
        Review Board.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's coverage with respect to clinical trials.
    ``(f) Plan Satisfaction of Certain Requirements; Responsibilities 
of Fiduciaries.--
            ``(1) In general.--For purposes of this section, insofar as 
        a group health plan provides benefits in the form of health 
        insurance coverage through a health insurance issuer, the plan 
        shall be treated as meeting the requirements of this section 
        with respect to such benefits and not be considered as failing 
        to meet such requirements because of a failure of the issuer to 
        meet such requirements so long as the plan sponsor or its 
        representatives did not cause such failure by the issuer.
            ``(2) Construction.--Nothing in this section shall be 
        construed to affect or modify the responsibilities of the 
        fiduciaries of a group health plan under part 4 of subtitle B.
    ``(g) Study and Report.--
            ``(1) Study.--The Secretary shall analyze cancer clinical 
        research and its cost implications for managed care, including 
        differentiation in--
                    ``(A) the cost of patient care in trials versus 
                standard care;
                    ``(B) the cost effectiveness achieved in different 
                sites of service;
                    ``(C) research outcomes;
                    ``(D) volume of research subjects available in 
                different sites of service;
                    ``(E) access to research sites and clinical trials 
                by cancer patients;
                    ``(F) patient cost sharing or copyament costs 
                realized in different sites of service;
                    ``(G) health outcomes experienced in different 
                sites of service;
                    ``(H) long term health care services and costs 
                experienced in different sites of service;
                    ``(I) morbidity and mortality experienced in 
                different sites of service; and
                    ``(J) patient satisfaction and preference of sites 
                of service.
            ``(2) Report to congress.--Not later than January 1, 2005, 
        the Secretary shall submit a report to Congress that contains--
                    ``(A) an assessment of any incremental cost to 
                group health plans resulting from the provisions of 
                this section;
                    ``(B) a projection of expenditures to such plans 
                resulting from this section;
                    ``(C) an assessment of any impact on premiums 
                resulting from this section; and
                    ``(D) recommendations regarding action on other 
                diseases.''.
            (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 subsections (b), (c), and (d) 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 participant's or beneficiaries 
                participation in such trial.
            ``(2) Exclusion of certain costs.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(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.
            ``(C) The individual's participation in the trial offers 
        meaningful potential for significant clinical benefit for the 
        individual.
            ``(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 
        reasonably expected to be paid for by the sponsors of an 
        approved clinical trial.
            ``(2) Routine patient care costs.--
                    ``(A) In general.--For purposes of this Act, 
                `routine patient care costs' shall include the costs 
                associated with the provision of items and services 
                that--
                            ``(i) would otherwise be covered under the 
                        group health plan if such items and services 
                        were not provided in connection with an 
                        approved clinical trial program; and
                            ``(ii) are furnished according to the 
                        protocol of an approved clinical trial program.
                    ``(B) Exclusion.--For purposes of this Act, 
                `routine patient care costs' shall not include the 
                costs associated with the provision of--
                            ``(i) an investigational drug or device, 
                        unless the Secretary has authorized the 
                        manufacturer of such drug or device to charge 
                        for such drug or device; or
                            ``(ii) any item or service supplied without 
                        charge by the sponsor of the approved clinical 
                        trial program.
            ``(3) 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 or services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a cancer clinical research study or 
        cancer clinical investigation approved by an Institutional 
        Review Board.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's coverage with respect to clinical trials.
    ``(f) Plan Satisfaction of Certain Requirements; Responsibilities 
of Fiduciaries.--
            ``(1) In general.--For purposes of this section, insofar as 
        a group health plan provides benefits in the form of health 
        insurance coverage through a health insurance issuer, the plan 
        shall be treated as meeting the requirements of this section 
        with respect to such benefits and not be considered as failing 
        to meet such requirements because of a failure of the issuer to 
        meet such requirements so long as the plan sponsor or its 
        representatives did not cause such failure by the issuer.
            ``(2) Construction.--Nothing in this section shall be 
        construed to affect or modify the responsibilities of the 
        fiduciaries of a group health plan under part 4 of subtitle B.
    ``(g) Study and Report.--
            ``(1) Study.--The Secretary shall analyze cancer clinical 
        research and its cost implications for managed care, including 
        differentiation in--
                    ``(A) the cost of patient care in trials versus 
                standard care;
                    ``(B) the cost effectiveness achieved in different 
                sites of service;
                    ``(C) research outcomes;
                    ``(D) volume of research subjects available in 
                different sites of service;
                    ``(E) access to research sites and clinical trials 
                by cancer patients;
                    ``(F) patient cost sharing or copyament costs 
                realized in different sites of service;
                    ``(G) health outcomes experienced in different 
                sites of service;
                    ``(H) long term health care services and costs 
                experienced in different sites of service;
                    ``(I) morbidity and mortality experienced in 
                different sites of service; and
                    ``(J) patient satisfaction and preference of sites 
                of service.
            ``(2) Report to congress.--Not later than January 1, 2005, 
        the Secretary shall submit a report to Congress that contains--
                    ``(A) an assessment of any incremental cost to 
                group health plans resulting from the provisions of 
                this section;
                    ``(B) a projection of expenditures to such plans 
                resulting from this section;
                    ``(C) an assessment of any impact on premiums 
                resulting from this section; and
                    ``(D) recommendations regarding action on other 
                diseases.''.
            (B) Clerical amendment.--The table of contents in section 1 
        of the Employee Retirement Income Security Act of 1974 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 or issuer--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsections (b), (c), and (d) 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 participant's or beneficiaries 
                participation in such trial.
            ``(2) Exclusion of certain costs.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(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.
            ``(C) The individual's participation in the trial offers 
        meaningful potential for significant clinical benefit for the 
        individual.
            ``(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 reasonably expected to be paid for 
        by the sponsors of an approved clinical trial.
            ``(2) Routine patient care costs.--
                    ``(A) In general.--For purposes of this Act, 
                `routine patient care costs' shall include the costs 
                associated with the provision of items and services 
                that--
                            ``(i) would otherwise be covered under the 
                        group health plan if such items and services 
                        were not provided in connection with an 
                        approved clinical trial program; and
                            ``(ii) are furnished according to the 
                        protocol of an approved clinical trial program.
                    ``(B) Exclusion.--For purposes of this Act, 
                `routine patient care costs' shall not include the 
                costs associated with the provision of--
                            ``(i) an investigational drug or device, 
                        unless the Secretary has authorized the 
                        manufacturer of such drug or device to charge 
                        for such drug or device; or
                            ``(ii) any item or service supplied without 
                        charge by the sponsor of the approved clinical 
                        trial program.
            ``(3) 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 or services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a cancer clinical research study or 
        cancer clinical investigation approved by an Institutional 
        Review Board.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's coverage with respect to clinical trials.
    ``(f) Plan Satisfaction of Certain Requirements; Responsibilities 
of Fiduciaries.--
            ``(1) In general.--For purposes of this section, insofar as 
        a group health plan provides benefits in the form of health 
        insurance coverage through a health insurance issuer, the plan 
        shall be treated as meeting the requirements of this section 
        with respect to such benefits and not be considered as failing 
        to meet such requirements because of a failure of the issuer to 
        meet such requirements so long as the plan sponsor or its 
        representatives did not cause such failure by the issuer.
            ``(2) Construction.--Nothing in this section shall be 
        construed to affect or modify the responsibilities of the 
        fiduciaries of a group health plan under part 4 of subtitle B.
    ``(g) Study and Report.--
            ``(1) Study.--The Secretary shall analyze cancer clinical 
        research and its cost implications for managed care, including 
        differentiation in--
                    ``(A) the cost of patient care in trials versus 
                standard care;
                    ``(B) the cost effectiveness achieved in different 
                sites of service;
                    ``(C) research outcomes;
                    ``(D) volume of research subjects available in 
                different sites of service;
                    ``(E) access to research sites and clinical trials 
                by cancer patients;
                    ``(F) patient cost sharing or copyament costs 
                realized in different sites of service;
                    ``(G) health outcomes experienced in different 
                sites of service;
                    ``(H) long term health care services and costs 
                experienced in different sites of service;
                    ``(I) morbidity and mortality experienced in 
                different sites of service; and
                    ``(J) patient satisfaction and preference of sites 
                of service.
            ``(2) Report to congress.--Not later than January 1, 2005, 
        the Secretary shall submit a report to Congress that contains--
                    ``(A) an assessment of any incremental cost to 
                group health plans resulting from the provisions of 
                this section;
                    ``(B) a projection of expenditures to such plans 
                resulting from this section;
                    ``(C) an assessment of any impact on premiums 
                resulting from this section; and
                    ``(D) recommendations regarding action on other 
                diseases.''.
                    (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.--(1) Part B of title XXVII of the 
Public Health Service Act is amended by inserting after section 2752 
the following new section:

``SEC. 2753. STANDARD RELATING PATIENT FREEDOM OF CHOICE.

    ``(a) In General.--The provisions of section 2707(a) 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.
    ``(b) Notice.--A health insurance issuer under this part shall 
comply with the notice requirement under section 714(b) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
referred to in subsection (a) as if such section applied to such issuer 
and such issuer were a group health plan.''.
    (2) Section 2762(b)(2) of such Act (42 U.S.C. 300gg-62(b)(2)) is 
amended by striking ``section 2751'' and inserting ``sections 2751 and 
2753''.
    (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, 2000.
            (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, 2000.
        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.
                                 <all>