I

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
2

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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Access to Cancer Clin3 ical Trials Act of 2001’’.

4 SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN

5 APPROVED CANCER CLINICAL TRIALS.

6 (a) GROUP HEALTH PLANS.—

7 (1) PUBLIC HEALTH SERVICE ACT AMEND8 MENTS.—Subpart 2 of part A of title XXVII of the

9 Public Health Service Act is amended by adding at

10 the end the following new section:

11 ‘‘SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING

12 IN APPROVED CANCER CLINICAL TRIALS.

13 ‘‘(a) COVERAGE.—

14 ‘‘(1) IN GENERAL.—If a group health plan (or

15 a health insurance issuer offering health insurance

16 coverage in connection with the plan) provides cov17 erage to a qualified individual (as defined in sub18 section (b)), the plan or issuer—

19 ‘‘(A) may not deny the individual partici20 pation in the clinical trial referred to in sub21 section (b)(2);

22 ‘‘(B) subject to subsection (c), may not

23 deny (or limit or impose additional conditions

24 on) the coverage of routine patient costs for

25 items and services furnished in connection with

26 participation in the trial; and
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1 ‘‘(C) may not discriminate against the in2 dividual on the basis of the individual’s partici3 pation in such trial.

4 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—

5 ‘‘(A) IN GENERAL.—For purposes of para6 graph (1)(B), subject to subparagraph (B), rou7 tine patient costs include all items and services

8 provided in the clinical trial that are otherwise

9 generally available to the qualified individual,

10 except—

11 ‘‘(i) in the cases of drugs and devices,

12 the investigational item or service, itself; or

13 ‘‘(ii) items and services that are pro14 vided solely to satisfy data collection and

15 analysis needs and that are not used in the

16 direct clinical management of the patient.

17 ‘‘(B) EXCLUSION.—Such routine patient

18 costs do include costs for the following:

19 ‘‘(i) CONVENTIONAL CARE.—Items or

20 services that are typically provided absent

21 a clinical trial.

22 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items

23 or services required solely for the provision

24 of the investigational item or service (such

25 as the administration of a noncovered
4

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1 chemotherapeutic agent), the clinically ap2 propriate monitoring of the effects of the

3 item or service, or the prevention of com4 plications.

5 ‘‘(iii) REASONABLE AND NECESSARY

6 CARE.—Items or services needed for rea7 sonable and necessary care arising from

8 the provision of an investigational item or

9 service, including the diagnosis or treat10 ment of complications.

11 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one

12 or more participating providers is participating in a

13 clinical trial, nothing in paragraph (1) shall be con14 strued as preventing a plan or issuer from requiring

15 that a qualified individual participate in the trial

16 through such a participating provider if the provider

17 will accept the individual as a participant in the

18 trial.

19 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur20 poses of subsection (a), the term ‘qualified individual’

21 means an individual who is a participant or beneficiary

22 in a group health plan and who meets the following condi23 tions:

24 ‘‘(1)(A) The individual has been diagnosed with

25 cancer.
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1 ‘‘(B) The individual is eligible to participate in

2 an approved clinical trial according to the trial pro3 tocol with respect to treatment of such illness.

4 ‘‘(2) Either—

5 ‘‘(A) the referring physician is a partici6 pating health care professional and has con7 cluded that the individual’s participation in

8 such trial would be appropriate based upon the

9 individual meeting the conditions described in

10 paragraph (1); or

11 ‘‘(B) the participant or beneficiary pro12 vides medical and scientific information estab13 lishing that the individual’s participation in

14 such trial would be appropriate based upon the

15 individual meeting the conditions described in

16 paragraph (1).

17 ‘‘(c) PAYMENT.—

18 ‘‘(1) IN GENERAL.—Under this section a group

19 health plan (or health insurance issuer offering

20 health insurance coverage in connection with the

21 plan) shall provide for payment for routine patient

22 costs described in subsection (a)(2) but is not re23 quired to pay for costs of items and services that are

24 customarily provided by the research sponsors free

25 of charge for individuals participating in the trial.
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1 ‘‘(2) PAYMENT RATE.—In the case of covered

2 items and services provided by—

3 ‘‘(A) a participating provider, the payment

4 rate shall be at the agreed upon rate, or

5 ‘‘(B) a nonparticipating provider, the pay6 ment rate shall be at the rate the plan would

7 normally pay for comparable items and services

8 under subparagraph (A).

9 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—

10 ‘‘(1) IN GENERAL.—In this section, the term

11 ‘approved clinical trial’ means a clinical research

12 study or clinical investigation that relates to the

13 treatment of cancer (including related symptoms)

14 and is described in any of the following subpara15 graphs:

16 ‘‘(A) FEDERALLY FUNDED TRIALS.—The

17 study or investigation is approved or funded

18 (which may include funding through in-kind

19 contributions) by one or more of the following:

20 ‘‘(i) NIH.—The National Institutes of

21 Health.

22 ‘‘(ii) CDC.—The Centers for Disease

23 Control and Prevention.

24 ‘‘(iii) AHRQ.—The Agency for Health

25 Care Research and Quality.
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1 ‘‘(iv) HCFA.—The Health Care Fi2 nancing Administration.

3 ‘‘(v) COOPERATIVE CENTER.—A coop4 erative group or center of any of the enti5 ties described in clauses (i) through (iv) or

6 the Departments of Defense or Veterans

7 Affairs.

8 ‘‘(vi) CENTER SUPPORT GRANTEES.—

9 A qualified non-governmental research en10 tity identified in the guidelines issued by

11 the National Institutes of Health for cen12 ter support grants.

13 ‘‘(vii) DOD; VA; DOE.—Any of the fol14 lowing if the conditions described in para15 graph (2) are met:

16 ‘‘(I) The Department of Veterans

17 Affairs.

18 ‘‘(II) The Department of De19 fense.

20 ‘‘(III) The Department of En21 ergy.

22 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The

23 study or investigation is conducted under an in24 vestigational new drug application reviewed by

25 the Food and Drug Administration.
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1 ‘‘(C) EXEMPT DRUG TRIAL.—The study or

2 investigation is a drug trial that is exempt from

3 having such an investigational new drug appli4 cation.

5 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The

6 conditions described in this paragraph, for a study

7 or investigation conducted by a Department, are

8 that the study or investigation has been reviewed

9 and approved through a system of peer review that

10 the Secretary determines—

11 ‘‘(A) to be comparable to the system of

12 peer review of studies and investigations used

13 by the National Institutes of Health, and

14 ‘‘(B) assures unbiased review of the high15 est scientific standards by qualified individuals

16 who have no interest in the outcome of the re17 view.

18 ‘‘(e) CONSTRUCTION.—Nothing in this section shall

19 be construed to limit a plan’s or issuer’s coverage with

20 respect to clinical trials.’’.

21 (2) ERISA AMENDMENTS.—(A) Subpart B of

22 part 7 of subtitle B of title I of the Employee Re23 tirement Income Security Act of 1974 is amended by

24 adding at the end the following new section:
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1 ‘‘SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN

2 APPROVED CANCER CLINICAL TRIALS.

3 ‘‘(a) COVERAGE.—

4 ‘‘(1) IN GENERAL.—If a group health plan (or

5 a health insurance issuer offering health insurance

6 coverage in connection with the plan) provides cov7 erage to a qualified individual (as defined in sub8 section (b)), the plan or issuer—

9 ‘‘(A) may not deny the individual partici10 pation in the clinical trial referred to in sub11 section (b)(2);

12 ‘‘(B) subject to subsection (c), may not

13 deny (or limit or impose additional conditions

14 on) the coverage of routine patient costs for

15 items and services furnished in connection with

16 participation in the trial; and

17 ‘‘(C) may not discriminate against the in18 dividual on the basis of the individual’s partici19 pation in such trial.

20 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—

21 ‘‘(A) IN GENERAL.—For purposes of para22 graph (1)(B), subject to subparagraph (B), rou23 tine patient costs include all items and services

24 provided in the clinical trial that are otherwise

25 generally available to the qualified individual,

26 except—
10

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1 ‘‘(i) in the cases of drugs and devices,

2 the investigational item or service, itself; or

3 ‘‘(ii) items and services that are pro4 vided solely to satisfy data collection and

5 analysis needs and that are not used in the

6 direct clinical management of the patient.

7 ‘‘(B) EXCLUSION.—Such routine patient

8 costs do include costs for the following:

9 ‘‘(i) CONVENTIONAL CARE.—Items or

10 services that are typically provided absent

11 a clinical trial.

12 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items

13 or services required solely for the provision

14 of the investigational item or service (such

15 as the administration of a noncovered

16 chemotherapeutic agent), the clinically ap17 propriate monitoring of the effects of the

18 item or service, or the prevention of com19 plications.

20 ‘‘(iii) REASONABLE AND NECESSARY

21 CARE.—Items or services needed for rea22 sonable and necessary care arising from

23 the provision of an investigational item or

24 service, including the diagnosis or treat25 ment of complications.
11

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1 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one

2 or more participating providers is participating in a

3 clinical trial, nothing in paragraph (1) shall be con4 strued as preventing a plan or issuer from requiring

5 that a qualified individual participate in the trial

6 through such a participating provider if the provider

7 will accept the individual as a participant in the

8 trial.

9 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur10 poses of subsection (a), the term ‘qualified individual’

11 means an individual who is a participant or beneficiary

12 in a group health plan and who meets the following condi13 tions:

14 ‘‘(1)(A) The individual has been diagnosed with

15 cancer.

16 ‘‘(B) The individual is eligible to participate in

17 an approved clinical trial according to the trial pro18 tocol with respect to treatment of such illness.

19 ‘‘(2) Either—

20 ‘‘(A) the referring physician is a partici21 pating health care professional and has con22 cluded that the individual’s participation in

23 such trial would be appropriate based upon the

24 individual meeting the conditions described in

25 paragraph (1); or
12

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1 ‘‘(B) the participant or beneficiary pro2 vides medical and scientific information estab3 lishing that the individual’s participation in

4 such trial would be appropriate based upon the

5 individual meeting the conditions described in

6 paragraph (1).

7 ‘‘(c) PAYMENT.—

8 ‘‘(1) IN GENERAL.—Under this section a group

9 health plan (or health insurance issuer offering

10 health insurance coverage in connection with the

11 plan) shall provide for payment for routine patient

12 costs described in subsection (a)(2) but is not re13 quired to pay for costs of items and services that are

14 customarily provided by the research sponsors free

15 of charge for individuals participating in the trial.

16 ‘‘(2) PAYMENT RATE.—In the case of covered

17 items and services provided by—

18 ‘‘(A) a participating provider, the payment

19 rate shall be at the agreed upon rate, or

20 ‘‘(B) a nonparticipating provider, the pay21 ment rate shall be at the rate the plan would

22 normally pay for comparable items and services

23 under subparagraph (A).

24 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
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1 ‘‘(1) IN GENERAL.—In this section, the term

2 ‘approved clinical trial’ means a clinical research

3 study or clinical investigation that relates to the

4 treatment of cancer (including related symptoms)

5 and is described in any of the following subpara6 graphs:

7 ‘‘(A) FEDERALLY FUNDED TRIALS.—The

8 study or investigation is approved or funded

9 (which may include funding through in-kind

10 contributions) by one or more of the following:

11 ‘‘(i) NIH.—The National Institutes of

12 Health.

13 ‘‘(ii) CDC.—The Centers for Disease

14 Control and Prevention.

15 ‘‘(iii) AHRQ.—The Agency for Health

16 Care Research and Quality.

17 ‘‘(iv) HCFA.—The Health Care Fi18 nancing Administration.

19 ‘‘(v) COOPERATIVE CENTER.—A coop20 erative group or center of any of the enti21 ties described in clauses (i) through (iv) or

22 the Departments of Defense or Veterans

23 Affairs.

24 ‘‘(vi) CENTER SUPPORT GRANTEES.—

25 A qualified non-governmental research en-
14

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1 tity identified in the guidelines issued by

2 the National Institutes of Health for cen3 ter support grants.

4 ‘‘(vii) DOD; VA; DOE.—Any of the fol5 lowing if the conditions described in para6 graph (2) are met:

7 ‘‘(I) The Department of Veterans

8 Affairs.

9 ‘‘(II) The Department of De10 fense.

11 ‘‘(III) The Department of En12 ergy.

13 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The

14 study or investigation is conducted under an in15 vestigational new drug application reviewed by

16 the Food and Drug Administration.

17 ‘‘(C) EXEMPT DRUG TRIAL.—The study or

18 investigation is a drug trial that is exempt from

19 having such an investigational new drug appli20 cation.

21 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The

22 conditions described in this paragraph, for a study

23 or investigation conducted by a Department, are

24 that the study or investigation has been reviewed
15

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1 and approved through a system of peer review that

2 the Secretary determines—

3 ‘‘(A) to be comparable to the system of

4 peer review of studies and investigations used

5 by the National Institutes of Health, and

6 ‘‘(B) assures unbiased review of the high7 est scientific standards by qualified individuals

8 who have no interest in the outcome of the re9 view.

10 ‘‘(e) CONSTRUCTION.—Nothing in this section shall

11 be construed to limit a plan’s or issuer’s coverage with

12 respect to clinical trials.’’.

13 (B) Section 732(a) of such Act (29 U.S.C.

14 1191a(a)) is amended by striking ‘‘section 711’’ and

15 inserting ‘‘sections 711 and 714’’.

16 (C) The table of contents in section 1 of such

17 Act is amended by inserting after the item relating

18 to section 713 the following new item:

‘‘Sec. 714. Coverage for individuals participating in approved cancer clinical

trials.’’.

19 (3) INTERNAL REVENUE CODE AMEND20 MENTS.—

21 (A) IN GENERAL.—Subchapter B of chap22 ter 100 of the Internal Revenue Code of 1986

23 is amended—
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1 (i) in the table of sections, by insert2 ing after the item relating to section 9812

3 the following new item:

‘‘Sec. 9813. Coverage for individuals participating in approved

cancer clinical trials.’’; and

4 (ii) by inserting after section 9812 the

5 following:

6 ‘‘SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING

7 IN APPROVED CANCER CLINICAL TRIALS.

8 ‘‘(a) COVERAGE.—

9 ‘‘(1) IN GENERAL.—If a group health plan pro10 vides coverage to a qualified individual (as defined in

11 subsection (b)), the plan—

12 ‘‘(A) may not deny the individual partici13 pation in the clinical trial referred to in sub14 section (b)(2);

15 ‘‘(B) subject to subsection (c), may not

16 deny (or limit or impose additional conditions

17 on) the coverage of routine patient costs for

18 items and services furnished in connection with

19 participation in the trial; and

20 ‘‘(C) may not discriminate against the in21 dividual on the basis of the individual’s partici22 pation in such trial.

23 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—
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1 ‘‘(A) IN GENERAL.—For purposes of para2 graph (1)(B), subject to subparagraph (B), rou3 tine patient costs include all items and services

4 provided in the clinical trial that are otherwise

5 generally available to the qualified individual,

6 except—

7 ‘‘(i) in the cases of drugs and devices,

8 the investigational item or service, itself; or

9 ‘‘(ii) items and services that are pro10 vided solely to satisfy data collection and

11 analysis needs and that are not used in the

12 direct clinical management of the patient.

13 ‘‘(B) EXCLUSION.—Such routine patient

14 costs do include costs for the following:

15 ‘‘(i) CONVENTIONAL CARE.—Items or

16 services that are typically provided absent

17 a clinical trial.

18 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items

19 or services required solely for the provision

20 of the investigational item or service (such

21 as the administration of a noncovered

22 chemotherapeutic agent), the clinically ap23 propriate monitoring of the effects of the

24 item or service, or the prevention of com25 plications.
18

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1 ‘‘(iii) REASONABLE AND NECESSARY

2 CARE.—Items or services needed for rea3 sonable and necessary care arising from

4 the provision of an investigational item or

5 service, including the diagnosis or treat6 ment of complications.

7 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one

8 or more participating providers is participating in a

9 clinical trial, nothing in paragraph (1) shall be con10 strued as preventing a plan from requiring that a

11 qualified individual participate in the trial through

12 such a participating provider if the provider will ac13 cept the individual as a participant in the trial.

14 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur15 poses of subsection (a), the term ‘qualified individual’

16 means an individual who is a participant or beneficiary

17 in a group health plan and who meets the following condi18 tions:

19 ‘‘(1)(A) The individual has been diagnosed with

20 cancer.

21 ‘‘(B) The individual is eligible to participate in

22 an approved clinical trial according to the trial pro23 tocol with respect to treatment of such illness.

24 ‘‘(2) Either—
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1 ‘‘(A) the referring physician is a partici2 pating health care professional and has con3 cluded that the individual’s participation in

4 such trial would be appropriate based upon the

5 individual meeting the conditions described in

6 paragraph (1); or

7 ‘‘(B) the participant or beneficiary pro8 vides medical and scientific information estab9 lishing that the individual’s participation in

10 such trial would be appropriate based upon the

11 individual meeting the conditions described in

12 paragraph (1).

13 ‘‘(c) PAYMENT.—

14 ‘‘(1) IN GENERAL.—Under this section a group

15 health plan shall provide for payment for routine pa16 tient costs described in subsection (a)(2) but is not

17 required to pay for costs of items and services that

18 are customarily provided by the research sponsors

19 free of charge for individuals participating in the

20 trial.

21 ‘‘(2) PAYMENT RATE.—In the case of covered

22 items and services provided by—

23 ‘‘(A) a participating provider, the payment

24 rate shall be at the agreed upon rate, or
20

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1 ‘‘(B) a nonparticipating provider, the pay2 ment rate shall be at the rate the plan would

3 normally pay for comparable items and services

4 under subparagraph (A).

5 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—

6 ‘‘(1) IN GENERAL.—In this section, the term

7 ‘approved clinical trial’ means a clinical research

8 study or clinical investigation that relates to the

9 treatment of cancer (including related symptoms)

10 and is described in any of the following subpara11 graphs:

12 ‘‘(A) FEDERALLY FUNDED TRIALS.—The

13 study or investigation is approved or funded

14 (which may include funding through in-kind

15 contributions) by one or more of the following:

16 ‘‘(i) NIH.—The National Institutes of

17 Health.

18 ‘‘(ii) CDC.—The Centers for Disease

19 Control and Prevention.

20 ‘‘(iii) AHRQ.—The Agency for Health

21 Care Research and Quality.

22 ‘‘(iv) HCFA.—The Health Care Fi23 nancing Administration.

24 ‘‘(v) COOPERATIVE CENTER.—A coop25 erative group or center of any of the enti-
21

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1 ties described in clauses (i) through (iv) or

2 the Departments of Defense or Veterans

3 Affairs.

4 ‘‘(vi) CENTER SUPPORT GRANTEES.—

5 A qualified non-governmental research en6 tity identified in the guidelines issued by

7 the National Institutes of Health for cen8 ter support grants.

9 ‘‘(vii) DOD; VA; DOE.—Any of the fol10 lowing if the conditions described in para11 graph (2) are met:

12 ‘‘(I) The Department of Veterans

13 Affairs.

14 ‘‘(II) The Department of De15 fense.

16 ‘‘(III) The Department of En17 ergy.

18 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The

19 study or investigation is conducted under an in20 vestigational new drug application reviewed by

21 the Food and Drug Administration.

22 ‘‘(C) EXEMPT DRUG TRIAL.—The study or

23 investigation is a drug trial that is exempt from

24 having such an investigational new drug appli25 cation.
22

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1 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The

2 conditions described in this paragraph, for a study

3 or investigation conducted by a Department, are

4 that the study or investigation has been reviewed

5 and approved through a system of peer review that

6 the Secretary determines—

7 ‘‘(A) to be comparable to the system of

8 peer review of studies and investigations used

9 by the National Institutes of Health, and

10 ‘‘(B) assures unbiased review of the high11 est scientific standards by qualified individuals

12 who have no interest in the outcome of the re13 view.

14 ‘‘(e) CONSTRUCTION.—Nothing in this section shall

15 be construed to limit a plan’s coverage with respect to clin16 ical trials.’’.

17 (B) CONFORMING AMENDMENT.—Section

18 4980D(d)(1) of such Code is amended by strik19 ing ‘‘section 9811’’ and inserting ‘‘sections

20 9811 and 9813’’.

21 (b) INDIVIDUAL HEALTH INSURANCE.—Part B of

22 title XXVII of the Public Health Service Act is amended—

23 (1) by redesignating the first subpart 3 (relat24 ing to other requirements) as subpart 2; and
23

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1 (2) by adding at the end of subpart 2 the fol2 lowing new section:

3 ‘‘SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING

4 IN APPROVED CANCER CLINICAL TRIALS.

5 ‘‘The provisions of section 2707 shall apply to health

6 insurance coverage offered by a health insurance issuer

7 in the individual market in the same manner as they apply

8 to health insurance coverage offered by a health insurance

9 issuer in connection with a group health plan in the small

10 or large group market.’’.

11 (c) EFFECTIVE DATES.—

12 (1) GROUP HEALTH PLANS AND GROUP

13 HEALTH INSURANCE COVERAGE.—Subject to para14 graph (3), the amendments made by subsection (a)

15 apply with respect to group health plans for plan

16 years beginning on or after January 1, 2002.

17 (2) INDIVIDUAL HEALTH INSURANCE COV18 ERAGE.—The amendment made by subsection (b)

19 applies with respect to health insurance coverage of20 fered, sold, issued, renewed, in effect, or operated in

21 the individual market on or after such date.

22 (3) COLLECTIVE BARGAINING EXCEPTION.—In

23 the case of a group health plan maintained pursuant

24 to 1 or more collective bargaining agreements be25 tween employee representatives and 1 or more em-
24

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1 ployers ratified before the date of enactment of this

2 Act, the amendments made subsection (a) shall not

3 apply to plan years beginning before the later of—

4 (A) the date on which the last collective

5 bargaining agreements relating to the plan ter6 minates (determined without regard to any ex7 tension thereof agreed to after the date of en8 actment of this Act), or

9 (B) January 1, 2002.

10 For purposes of subparagraph (A), any plan amend11 ment made pursuant to a collective bargaining

12 agreement relating to the plan which amends the

13 plan solely to conform to any requirement added by

14 subsection (a) shall not be treated as a termination

15 of such collective bargaining agreement.

16 (d) COORDINATION OF ADMINISTRATION.—The Sec17 retary of Labor, the Secretary of the Treasury, and the

18 Secretary of Health and Human Services shall ensure,

19 through the execution of an interagency memorandum of

20 understanding among such Secretaries, that—

21 (1) regulations, rulings, and interpretations

22 issued by such Secretaries relating to the same mat23 ter over which two or more such Secretaries have re24 sponsibility under the provisions of this Act (and the
25

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1 amendments made thereby) are administered so as

2 to have the same effect at all times; and

3 (2) coordination of policies relating to enforcing

4 the same requirements through such Secretaries in

5 order to have a coordinated enforcement strategy

6 that avoids duplication of enforcement efforts and

7 assigns priorities in enforcement.

8 (e) STUDY AND REPORT.—

9 (1) STUDY.—The Secretary of Health and

10 Human Services, jointly with the Secretaries of

11 Labor and the Treasury, shall study the impact on

12 group health plans and health insurance issuers of

13 requiring group health plans and health insurance

14 coverage to cover routine patient care costs for indi15 viduals with serious and life threatening diseases

16 other than cancer.

17 (2) REPORT TO CONGRESS.—Not later than

18 January 1, 2005, such Secretary shall submit a re19 port to Congress that contains an assessment of—

20 (A) any incremental cost to group health

21 plans and health insurance issuers resulting

22 from the provisions of this section; and

23 (B) a projection of expenditures of such

24 plans and issuers if coverage of routine patient

25 care costs in an approved clinical trial program
26

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1 were extended to individuals entitled to benefits

2 under such plans or health insurance coverage

3 who have a diagnosis other than cancer.

Æ